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Cidara Therapeutics

Cidara is conducting a phase 2b trial for CD388 with 5.000 participants during the 2024 northern hemisphere influenza season. CD388 has received FDA Fast-Track designation. CD388 is a drug-Fc conjugate, consisting of antibody fragments combined with antivirals. The cooperation with Johnson & Johnson has ended, and Cidara is conducting the phase 2b trial independently. For that Cidara managed to secure 240 million USD in private placement financing and has reacquired all global rights to CD388 development and commercialization from Johnson & Johnson. Additionally Cidara has announced a workforce reduction of 30% and divested the antifungal drug Rezafungin to fully focus on CD388 and some cancer therapies also based on drug-Fc conjugates. With the recent changes Cidara is set up to focus on advancing and benefiting from a single technology, named the Cloudbreak platform. The market capitalization was approximately 80 million USD in March 2024.
The recent Cidara Corporate Presentation slides can be found here:
https://www.cidara.com/wp-content/uploads/2024/08/Cidara-Corporate-Presentation-August-2024-2.pdf

Cidara estimates that it will achieve approximately $128 million in cost savings over the patent life of rezafungin comprised of approximately $67 million in clinical development expense, including the cost of the potential upsizing of the ReSPECT trial and CMC costs over the next three years, and an additional approximately $61 million in forecasted obligations through the expected patent life of rezafungin. “We are proud to have advanced rezafungin from preclinical development to approval in the US, EU, and UK for the treatment of patients suffering from life-threatening fungal infections.” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With that accomplished, we believe the substantial cost savings enabled by this transaction will enable us to deploy our capabilities to progress our promising Cloudbreak pipeline and create opportunities to advance potentially transformational new therapies in oncology and other disease areas.”
Source: Cidara Therapeutics Announces Divestiture of Rezafungin to Mundipharma* to Focus on Advancing the Clinical Development of Cloudbreak DFC Pipeline
Cidara Therapeutics (...) today announced that it has entered into a definitive agreement with Johnson & Johnson to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B.
Concurrent with the acquisition, Cidara closed a definitive agreement for the sale of preferred stock in a private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (BVF), and Canaan Partners. The private placement provides $240 million in gross proceeds that will be used by Cidara to develop CD388 as a universal preventative against seasonal and pandemic influenza A and B, beginning with a Phase 2b clinical trial in the upcoming Northern Hemisphere influenza season. The proceeds from the private placement fund the upfront payment under the agreement with Johnson & Johnson and are expected to provide runway beyond topline data from CD388’s Phase 2b trial. (...)
Dr. Stein continued, “This reacquisition of CD388, along with the capital to advance it through Phase 2b development, is transformational for Cidara and especially for those who could benefit from a long-acting, universal preventative against all forms of influenza. In our Phase 2b study later this year, we will evaluate the efficacy and safety of CD388 in providing season-long, universal protection from influenza. We believe that CD388 may have significant advantages beyond and in addition to flu vaccines, with the potential for universal protection even in the absence of a robust immune response and without the requirement for seasonal influenza strain prediction.”
All responsibility for future development, manufacturing, and commercialization activities of CD388 will be assumed by Cidara. In exchange for reacquiring the exclusive global development and commercial rights to CD388, Johnson & Johnson has received from Cidara a one-time upfront payment of $85 million and is eligible to receive potential additional development, regulatory, and commercial milestone payments.
Source: Cidara Therapeutics Reacquires Global Development and Commercial Rights to CD388 and Announces Private Placement Financing of $240 Million

CureVac

CureVac is one of the pioneers of mRNA technology with a strong patent portfolio. CureVac cooperates with GSK as larger commercialization partner. The first GSK/CureVac mRNA vaccine study for seasonal influenza started in May 2023 and CureVac is part of the influenza pandemic preparations of the German government. The seasonal influenza vaccine development has advanced to a phase 2 study. In April 2024 positive phase 2 study interim data was published. Also in April 2024 the start of a phase 1/2 study of an mRNA vaccine for H5N1 has been announced. CureVac investors are SAP founder Dietmar Hopp, followed by the German government and GSK. Despite the lack of commercial success, this company has strong support and potential. The market capitalization was approximately 700 million USD in March 2024, a more than 95% decline from Covid-19 valuations.

CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that the first participant was dosed in the Phase 1 part of a combined Phase 1/2 study of multivalent, modified mRNA seasonal flu vaccine candidates, developed in collaboration with GSK. The tested multivalent vaccine candidates address all four WHO-recommended flu strains.
Source: CureVac Announces Dosing of First Participant in Combined Phase 1/2 Study of Multivalent, Modified Influenza Vaccine Candidates Developed in Collaboration with GSK
CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), and GSK today announced that they have entered into a contract with the German federal government to supply mRNA vaccines within a broader tender for pandemic preparedness in Germany. Following a setup period of a maximum of two years, the contract grants the German federal government access to CureVac’s manufacturing capacity until 2029, enabling rapid availability of 80 million mRNA-based vaccine doses during the remainder of the current pandemic or in future infectious disease outbreaks.
Source: CureVac and GSK Enter into Pandemic Preparedness Contract with German Government
CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that its motion to transfer the ongoing patent litigation filed by Pfizer/BioNTech in the federal district court of Massachusetts has been granted, moving the case to the Eastern District of Virginia. The transfer is expected to significantly accelerate progress of the litigation, allowing for a likely 2024 trial date.
The motion to transfer the case is now part of a broadened counterclaim CureVac is filing that alleges infringement of nine U.S. patents by the manufacture and sale of the SARS-CoV-2 vaccine Comirnaty®. This significantly expands the scope of the case beyond the three patents originally named by Pfizer/BioNTech. These nine patents cover foundational and highly relevant separate innovations in mRNA vaccine design, formulation and manufacturing specific to SARS-CoV-2 vaccines.
Source: CureVac Announces Developments in Patent Litigation with Pfizer/BioNTech
CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced selection of a promising vaccine candidate for continued clinical development based on positive data from an interim analysis of the ongoing Phase 1 part of a combined Phase 1/2 study, conducted in collaboration with GSK.
Source: CureVac Advances Seasonal Flu Study to Phase 2 in Collaboration with GSK Following Selection of Promising mRNA Vaccine Candidate with Broad Coverage
CureVac (...) today announced the start of the Phase 1 part of a combined Phase 1/2 study of an investigational influenza A (H5N1) pre-pandemic vaccine candidate developed in collaboration with GSK. The H5N1 avian influenza virus is considered a potential future pandemic threat, known to sporadically cross species from its original bird host to other animal hosts and humans. The monovalent vaccine candidate is based on CureVac’s proprietary second-generation mRNA backbone and encodes an influenza A H5-antigen.
Source: CureVac Announces Start of Combined Phase 1/2 Study in Avian Influenza (H5N1); Development in Collaboration with GSK
Under the terms of the new agreement, GSK will assume full control of developing and manufacturing these candidate vaccines. GSK will have worldwide rights to commercialise the candidate vaccines. The agreement represents the latest step in GSK’s ongoing investment in vaccine platform technologies, matching the best platform to each pathogen to develop best-in-class vaccines. mRNA is an adaptable vaccine technology with demonstrated application in emerging and constantly changing viral pathogens due to its ability to support rapid strain change. GSK continues to develop and optimize its mRNA capabilities through investments and partnerships, including in AI/ML-based sequence optimisation, nanoparticle design and manufacturing. CureVac will receive an upfront payment of €400 million and up to an additional €1.05 billion in development, regulatory and sales milestones and tiered royalties in the high single to low teens range. The new agreement replaces all previous financial considerations from the prior collaboration agreement between GSK and CureVac. CureVac further retains exclusive rights to the additional undisclosed and preclinically validated infectious disease targets from the prior collaboration together with the freedom to independently develop and partner mRNA vaccines in any other infectious disease or other indication. CureVac’s ongoing patent litigation against Pfizer/BioNTech is unaffected by the new agreement.
Source: GSK and CureVac to Restructure Collaboration into New Licensing Agreement
The cost savings, combined with an upfront payment of €400 million and up to €1.05 billion in milestones plus tiered royalties from the GSK agreement, will extend CureVac’s cash runway into 2028.
Source: CureVac Initiates Strategic Restructuring to Align Resources with Focus on High-Value mRNA Pipeline Opportunities

GSK

GSK is clearly motivated to combat influenza. However, the results are mixed. There were narcolepsy issues with the pandemic H1N1 vaccine. The cooperation with Biota regarding marketing of Relenza ended in litigation. The post phase 2 cooperation with Vir Biotechnology  regarding VIR 2482 recently ended in phase 2, with GSK being not at fault. Nonetheless GSK has commercial success, with existing contracts about the potential delivery of more than 200 million H5N1 vaccine doses and 80 million mRNA vaccine doses from a cooperation with CureVac. GSK has established a long-term partnership, secured access to the mRNA technology and owns 7.4% of CureVac stock. The first GSK/CureVac mRNA vaccine study for seasonal influenza started in May 2023. In April 2024 positive phase 2 study interim data was published. Also in April 2024 the start of a phase 1/2 study of an mRNA vaccine for H5N1 has been announced. The market capitalization was approximately 90 billion USD in March 2024.

This agreement with HERA concludes a series of contracts secured by GSK this year, under which it could provide at least 200 million doses of pandemic influenza vaccine to governments around the world. In February 2022 GSK extended its pandemic influenza vaccine stockpile contract with the United States Government. This was followed by a renewed agreement, in June, for supply of pandemic influenza vaccines to the World Health Organization (WHO), and in July a contract with the Government of Canada for both seasonal and pandemic influenza vaccines.
Source: GSK signs agreement to support pandemic preparedness in Europe
CureVac (...) today announced the start of the Phase 1 part of a combined Phase 1/2 study of an investigational influenza A (H5N1) pre-pandemic vaccine candidate developed in collaboration with GSK. The H5N1 avian influenza virus is considered a potential future pandemic threat, known to sporadically cross species from its original bird host to other animal hosts and humans. The monovalent vaccine candidate is based on CureVac’s proprietary second-generation mRNA backbone and encodes an influenza A H5-antigen.
Source: CureVac Announces Start of Combined Phase 1/2 Study in Avian Influenza (H5N1); Development in Collaboration with GSK
GSK is walking away from a core piece of its $345 million bet on Vir Biotechnology. The partners have ended their collaboration on anti-influenza antibodies, freeing Vir to “actively” pitch the candidates to other companies while continuing to work with GSK on different respiratory pathogens.
Source: GSK, Vir end flu drug alliance, removing key piece of $345M pact

Shionogi

The neuraminidase inhibitor baloxavir marketed as Xofluza has officially been developed by Roche and Shionogi. Shionogi has exclusive rights for Japan and Taiwan, and is entitled to royalties worldwide. The market capitalization was approximately 14 billion USD in March 2024, much less than Roche with approximately 200 billion USD.

The FDA granted approval of Xofluza to Shionogi & Co., Ltd.
Source: FDA approves new drug to treat influenza
Under the terms of this agreement, Shionogi will conduct development of S-033188 in collaboration with Roche worldwide, with the exception of Japan and Taiwan which will be retained exclusively by Shionogi. Shionogi received an undisclosed upfront payment from Roche and is also eligible to receive milestone payments upon successful completion of key development and registration milestones, including marketing approval. Roche will have the right to commercialize S-033188 worldwide (excluding Japan and Taiwan), with Shionogi retaining certain co-promotion rights in the US. Shionogi shall be entitled to receive royalties from Roche on S-033188 sales.
Source: Shionogi Enters into a License and Collaboration Agreement with Roche for its Anti-Flu Drug, S-033188
Laninamivir was the most widely used antiviral for the treatment of influenza in Japan before the launch of baloxavir. According to reports of the Japanese Ministry of Health, Labor and Welfare, laninamivir's market share was about 47% in the 2015–2017 influenza seasons. After the launch of baloxavir, in 2018–2019 lanamivir had the second largest market (21%) after baloxavir (38%).
Source: Cost-effectiveness of baloxavir marboxil compared to laninamivir for the treatment of influenza in Japan

Daiichi Sankyo

Daiichi Sankyo, a large Japanese pharmaceutical company, has developed a new neuraminidase inhibitor called laninamivir, marketed as Inavir. Inavir has first been approved in Japan in 2013. The market capitalization was approximately 60 billion USD in March 2024.

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), announced today that it received approval in Japan to market Inavir® Dry Powder Inhaler 20mg (generic name: Laninamivir Octanoate Hydrate) for the prevention of influenza in both adults and children.
Source: Daiichi Sankyo Receives Approval for the Use of Inavir® to Prevent Influenza
Laninamivir was the most widely used antiviral for the treatment of influenza in Japan before the launch of baloxavir. According to reports of the Japanese Ministry of Health, Labor and Welfare, laninamivir's market share was about 47% in the 2015–2017 influenza seasons. After the launch of baloxavir, in 2018–2019 lanamivir had the second largest market (21%) after baloxavir (38%).
Source: Cost-effectiveness of baloxavir marboxil compared to laninamivir for the treatment of influenza in Japan

Moderna

A phase 3 study of an mRNA seasonal influenza vaccine was successfully completed. The final results show a strong immune response against influenza A and influenza B. Phase 1 and 2 clinical trials for an H5N1 pandemic influenza mRNA vaccine are ongoing and Moderna has secured funding from BARDA for a phase 3 trial. The market capitalization was approximately 40 billion USD in March 2024.

In its lawsuit, Moderna sought for damages – i.e., a share of Pfizer’s revenues over the vaccine-rather than seeking for an injunction to prevent Pfizer and BioNtech from selling the vaccine, as is often the case in patent infringement claims. Moderna alleged that its researchers developed the mRNA structure years before and that Pfizer and BioNtech then applied it to their own vaccines.
Earlier this month, Pfizer and BioNtech sought to dismiss the lawsuit in Boston Court and filed a counterclaim against Moderna. Both companies claimed that the mRNA structure and the lipids used in their vaccines were different from those developed by Moderna, so they argued that Moderna's patents were invalid and asked the Court to revoke them.
Source: Pfizer and BioNtech countersue Moderna – Advocate General’s Opinion in case C-686/21
Biotech firm Promosome LLC sued Moderna (MRNA.O), Pfizer (PFE.N) and BioNTech (22UAy.DE), in federal court in San Diego, California, on Tuesday, accusing their COVID-19 vaccines of infringing a patent related to messenger RNA technology.
Source: Moderna, Pfizer hit with new patent lawsuits over COVID vaccines
Moderna (MRNA.O) on Wednesday said its flu vaccine had generated a stronger immune response against all four A and B strains of the influenza virus compared to traditional flu shots in a late-stage trial.
Source: Moderna flu shot succeeds in late-stage study
Moderna, Inc. (NASDAQ:MRNA) today announced a project award of $176 million through the Rapid Response Partnership Vehicle (RRPV) to accelerate the development of mRNA-based pandemic influenza vaccines. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). (...) In 2023, Moderna initiated a Phase 1/2 study to generate safety and immunogenicity data of investigational pandemic influenza vaccine (mRNA-1018) in healthy adults 18 years of age and older. The study includes vaccine candidates against H5 and H7 avian influenza viruses. Results from the study are expected in 2024 and will inform Phase 3 development plans.
Source: Moderna Receives Project Award through BARDA's Rapid Response Partnership Vehicle Consortium to Accelerate Development of mRNA-based Pandemic Influenza Vaccine

CSL

Audenz is the most modern and approved H5N1 vaccine on the market, with an egg-free production process. Audenz is the second generation of CSL H5N1 vaccines. CSL has extensive pandemic inluenza vaccine contracts, including 150 million doses within six months for the US government. CSL also published pre-clinical data of an mRNA vaccine targeting H5N1. A cooperation with Arcturus is supposed to provide access to more mRNA technology. The market capitalization was approximately 90 billion USD in March 2024.

Under the terms of the public-private partnership, established in 2009, Seqirus would position itself to deliver 150 million influenza vaccine doses to the U.S. government to support an influenza pandemic response within six months.
Source: Seqirus Announces U.S. FDA Approval for Multi-Dose Vial Presentation of First-Ever Adjuvanted, Cell-Based Pandemic Influenza Vaccine
Due to the additional NA antigen, bicistronic A(H5N1) vaccines not only raised a potent neutralizing response to pandemic A(H5N1), but also to A(H1N1) and produced cross-reactive humoral and cellular responses in mice and ferrets. NA demonstrated a notable immune response without compromise of the immune response to HA raised by our sa-mRNA bicistronic influenza vaccines. The meaningful and cross-reactive immune responses raised by the sa-mRNA influenza vaccine candidates resulted in protection from influenza infection.
Source: CSL Announces Positive Preclinical Data for Self-Amplifying Messenger RNA (sa-mRNA) Influenza Vaccine Candidates
Under the agreement, CSL will have the exclusive license to Arcturus' next generation mRNA technology in the fields of influenza, COVID-19 and other respiratory viral diseases, and a non-exclusive license in the multi-pathogen pandemic preparedness field with the right to turn exclusive.
Source: CSL Announces Closing of Global Collaboration and Licensing Agreement with Arcturus Therapeutics
But the idea of bundling H5N1 vaccine into the seasonal flu shot would cause regulatory challenges. The virus is not very immunogenic, meaning it doesn’t trigger a strong immune response in people. Research done nearly 20 years ago showed that in order to achieve what would probably be a protective response, the vaccine would need to be given in two massive doses; later research showed two regular sized doses with an adjuvant, a compound that boosts the immune response a vaccine generates, would likely provide protection. Most seasonal flu shots do not contain an adjuvant — the sole exception is a vaccine for seniors sold by Seqirus, which contains the company’s MF-59 adjuvant. Adding an adjuvant to the seasonal shots would change the vaccines enough that new licenses might be needed — a big lift for manufacturers. In addition, studies would be needed to make sure that the H5N1 component did not erode the immune response to the other components of the vaccines.
Source: When should we start making H5N1 vaccine, and who will make that decision? In short, it’s complicated
The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza.
Source: Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial

Arcturus Therapeutics

Arcturus as a pioneer of mRNA technology has a licensing agreement with CSL. Arcturus Therapeutics has received FDA clearance for phase 1 bird flu vaccine trial. The market capitalization was approximately 1 billion USD in March 2024, much less than CSL with 90 billion USD.

Under the agreement, CSL will have the exclusive license to Arcturus' next generation mRNA technology in the fields of influenza, COVID-19 and other respiratory viral diseases, and a non-exclusive license in the multi-pathogen pandemic preparedness field with the right to turn exclusive.
Source: CSL Announces Closing of Global Collaboration and Licensing Agreement with Arcturus Therapeutics
Arcturus will receive $200 million upfront and is eligible to receive over $1.3 billion in development milestones and over $3 billion in commercial milestones. In addition, the Company is eligible to receive a 40% net profit share for COVID-19 vaccine products and up to double-digit royalties for vaccines against flu, pandemic preparedness and three other respiratory pathogens.
Source: Arcturus Announces Collaboration with CSL to Develop and Commercialize Self-amplifying mRNA Vaccines
Arcturus will expand its current influenza vaccine program to include development of a pandemic influenza vaccine based on its proprietary self-amplifying mRNA platform with the support of the Biomedical Advanced Research and Development Authority (...) The award provides $63.2 million over three years to support preclinical, manufacturing, nonclinical safety studies, along with development and regulatory support for Arcturus’ self-amplifying mRNA vaccine platform technology for rapid pandemic influenza response through Phase 1 clinical studies.
Source: Arcturus Announces $63.2 Million Award from the U.S. Government to Support Development of Self-amplifying mRNA Vaccine for Rapid Pandemic Influenza Response
The clinical study is funded by Biomedical Advanced Research and Development Authority (BARDA) and designed to enroll approximately 200 healthy adults in the United States. (...) The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza.
Source: Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial

Pfizer

Pfizer and BioNtech are in litigation with CureVac, Moderna, and Arbutus. The market capitalization was approximately 160 billion USD in March 2024.

In 2018, Pfizer entered into a worldwide collaboration and license agreement with BioNTech under which Pfizer has the exclusive right to carry out the clinical development and commercialization of mRNA‐based influenza vaccines. Upon potential approval and commercialization, BioNTech would receive a royalty on Pfizer’s sales.
Source: Pfizer Initiates Phase 3 Study of mRNA-Based Influenza Vaccine
In its lawsuit, Moderna sought for damages – i.e., a share of Pfizer’s revenues over the vaccine-rather than seeking for an injunction to prevent Pfizer and BioNtech from selling the vaccine, as is often the case in patent infringement claims. Moderna alleged that its researchers developed the mRNA structure years before and that Pfizer and BioNtech then applied it to their own vaccines.
Earlier this month, Pfizer and BioNtech sought to dismiss the lawsuit in Boston Court and filed a counterclaim against Moderna. Both companies claimed that the mRNA structure and the lipids used in their vaccines were different from those developed by Moderna, so they argued that Moderna's patents were invalid and asked the Court to revoke them.
Source: Pfizer and BioNtech countersue Moderna – Advocate General’s Opinion in case C-686/21
CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that its motion to transfer the ongoing patent litigation filed by Pfizer/BioNTech in the federal district court of Massachusetts has been granted, moving the case to the Eastern District of Virginia. The transfer is expected to significantly accelerate progress of the litigation, allowing for a likely 2024 trial date.
The motion to transfer the case is now part of a broadened counterclaim CureVac is filing that alleges infringement of nine U.S. patents by the manufacture and sale of the SARS-CoV-2 vaccine Comirnaty®. This significantly expands the scope of the case beyond the three patents originally named by Pfizer/BioNTech. These nine patents cover foundational and highly relevant separate innovations in mRNA vaccine design, formulation and manufacturing specific to SARS-CoV-2 vaccines.
Source: CureVac Announces Developments in Patent Litigation with Pfizer/BioNTech
Arbutus Biopharma (ABUS.O) on Tuesday sued U.S. drugmaker Pfizer Inc (PFE.N) and its German partner BioNTech SE in a New Jersey district court, claiming their mRNA COVID-19 vaccines infringe five of Arbutus' patents.
Source: Arbutus files patent lawsuit against Pfizer/BioNTech over COVID vaccines
Pfizer said in a statement on Wednesday that it “would be prepared to deploy the company’s capabilities to develop a vaccine for strategic stockpiles”, confirming that it had launched a phase-one trial for a pandemic flu vaccine last December.
Source: US close to deal to bankroll Moderna bird flu vaccine trial

BioNTech

Pfizer and BioNTech are in litigation with CureVac, Moderna, and Arbutus. BioNTech would receive royalties from sales of Pfizer mRNA influenza vaccines. The market capitalization was approximately 20 billion USD in March 2024.

In 2018, Pfizer entered into a worldwide collaboration and license agreement with BioNTech under which Pfizer has the exclusive right to carry out the clinical development and commercialization of mRNA‐based influenza vaccines. Upon potential approval and commercialization, BioNTech would receive a royalty on Pfizer’s sales.
Source: Pfizer Initiates Phase 3 Study of mRNA-Based Influenza Vaccine
CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced that its motion to transfer the ongoing patent litigation filed by Pfizer/BioNTech in the federal district court of Massachusetts has been granted, moving the case to the Eastern District of Virginia. The transfer is expected to significantly accelerate progress of the litigation, allowing for a likely 2024 trial date.
The motion to transfer the case is now part of a broadened counterclaim CureVac is filing that alleges infringement of nine U.S. patents by the manufacture and sale of the SARS-CoV-2 vaccine Comirnaty®. This significantly expands the scope of the case beyond the three patents originally named by Pfizer/BioNTech. These nine patents cover foundational and highly relevant separate innovations in mRNA vaccine design, formulation and manufacturing specific to SARS-CoV-2 vaccines.
Source: CureVac Announces Developments in Patent Litigation with Pfizer/BioNTech
In its lawsuit, Moderna sought for damages – i.e., a share of Pfizer’s revenues over the vaccine-rather than seeking for an injunction to prevent Pfizer and BioNtech from selling the vaccine, as is often the case in patent infringement claims. Moderna alleged that its researchers developed the mRNA structure years before and that Pfizer and BioNtech then applied it to their own vaccines.
Earlier this month, Pfizer and BioNtech sought to dismiss the lawsuit in Boston Court and filed a counterclaim against Moderna. Both companies claimed that the mRNA structure and the lipids used in their vaccines were different from those developed by Moderna, so they argued that Moderna's patents were invalid and asked the Court to revoke them.
Source: Pfizer and BioNtech countersue Moderna – Advocate General’s Opinion in case C-686/21
Arbutus Biopharma (ABUS.O) on Tuesday sued U.S. drugmaker Pfizer Inc (PFE.N) and its German partner BioNTech SE in a New Jersey district court, claiming their mRNA COVID-19 vaccines infringe five of Arbutus' patents.
Source: Arbutus files patent lawsuit against Pfizer/BioNTech over COVID vaccines

SAB Biotherapeutics

SAB has successfully completed a phase 2a study for SAB-176 antibodies. So far all results pertain to seasonal influenza, not avian influenza. SAB-176 has received FDA Breakthrough Therapy and Fast-Track designations. A new study is now examining the possibility of intramuscular application in cooperation with and funded by the US military. SAB is also working on antibodies to delay the onset or progression of type 1 diabetes. SAB also gained pandemic response experience with the development of a Covid-19 antibody. The market capitalization was approximately 40 million USD in March 2024.

SAB-176 has now received both Breakthrough and Fast Track designations from FDA – signifying its potential to fundamentally improve influenza treatment and prophylaxis
Source: SAB Biotherapeutics Announces U.S. FDA Grants Breakthrough Therapy Designation to SAB-176 Influenza Immunotherapy
SAB-176, an investigational drug, is a fully-human polyclonal antibody being studied for treatment and post-exposure prophylaxis of pandemic and seasonal influenza in patients who are at high-risk for severe influenza outcomes.
Source: SAB Biotherapeutics Program Targeting Influenza: SAB-176
SAB Biotherapeutics (...) today announced that the Navy Medical Research Command (NMRC) is moving forward with a safety and tolerability study to evaluate SAB-176, a therapy being investigated for use as a pre- and post-exposure prophylactic treatment for influenza type A and type B, pursuant to the Cooperative Research and Development Agreement that governs the relationship between SAB and the NMRC.
With funding for research provided by the Henry Jackson Foundation, this partnership will move forward a pharmacokinetic (PK), safety and tolerability study designed as a double-blinded, randomized study with intramuscular SAB-176 administered to healthy volunteers. The NMRC Clinical Trials Center, located in Bethesda, Maryland, will be conducting this PK study under the leadership of Cmdr. Nehkonti Adams, Director, NMRC Clinical Trials Center.
SAB has utilized its proprietary DiversitAb™ platform to manufacture SAB-176, fully human polyclonal antibodies targeting influenza from Transchromosomic (Tc) Bovine™. SAB-176 is a novel multi-target biologic that has shown sustained neutralization activity across multiple virus strains of Influenza A and B. In 2023, the U.S. Food and Drug Administration granted Breakthrough Therapy and Fast Track Designations to SAB-176 based on the results of the completed clinical proof-of-concept Phase 2 study in an influenza challenge model with intravenous (IV) formulation. SAB-176, along with several other fully human anti-infective immunoglobulins developed by SAB have been administered through IV to over 700 healthy volunteers and patients. This will be the first study to examine intramuscular administration of any DiversitAb™ platform product. The DiversitAb™ platform produces fully human target-specific biologics that can be delivered across a range of therapeutic areas, including infectious diseases and autoimmune conditions like type 1 diabetes (T1D).
SAB Chairman and CEO Samuel J. Reich stated that “we are pleased to continue our collaboration with the NMRC to explore new routes of administration for our products. (...)
Source: SAB Biotherapeutics Announces Clinical Partnership with Naval Medical Research Center to Advance Potential Influenza Treatment
The NIH cut the sponsored phase 3 trial as hospitalizations waned and the pandemic changed course. (...) According to Sullivan, SAB-185 worked. It reduced symptoms seven days faster in an active comparator trial and offered a different mechanism of action to the drugs currently being used to treat patients with COVID-19. (...) Sullivan said his team now knows how to quickly grow manufacturing capacity, speed from phase 1 to phase 3 and more. (...) “We developed capacities well beyond what we were prior to the pandemic, just based upon the experience that we had in developing SAB-185, ”
Source: After 'live fire exercise' with COVID-19, SAB turns tactical experience back to diabetes program

Roche

Despite the fact that the oseltamivir patents have expired, there is still money to be made. Roche has established long-term business relationships and with Tamiflu a valueable brand. Google Trends shows that Tamiflu dwarfs all other influenza drugs. Roche will also use existing business relationships to sell baloxavir (Xofluxa), which is still protected by patents. In case of a pandemic Roche would probably benefit more from brand recognition than from improvements offered by baloxavir. The market capitalization was approximately 200 billion USD in March 2024.

Under the terms of this agreement, Shionogi will conduct development of S-033188 in collaboration with Roche worldwide, with the exception of Japan and Taiwan which will be retained exclusively by Shionogi. Shionogi received an undisclosed upfront payment from Roche and is also eligible to receive milestone payments upon successful completion of key development and registration milestones, including marketing approval. Roche will have the right to commercialize S-033188 worldwide (excluding Japan and Taiwan), with Shionogi retaining certain co-promotion rights in the US. Shionogi shall be entitled to receive royalties from Roche on S-033188 sales.
Source: Shionogi Enters into a License and Collaboration Agreement with Roche for its Anti-Flu Drug, S-033188

BioCryst Phamaceuticals

Peramivir (Rapivap), produced by BioCryst Pharmaceuticals and patent protected, may become a more relevant alternative in a severe pandemic or in case of widespread resistance mutations. A single infusion may provide the safest treatment option in times of minimal standards of care. Resistance mutations against neuraminidase inhibitors are currently rare, but would make peramivir a much more attractive option. This study shows that the NA-S247N mutation causes resistance to oseltamivir and zanamivir, but causes no resistance to peramivir. This study reports a highly reduced susceptibility to peramivir in case of the NA-H275Y mutation, although 3 to 4 times less reduced than to oseltamivir. Zanamivir (Relenza) and laninamivir (Inavir) are much less affected by the NA-H275Y mutation.
Oral inhalation of zanamivir and laninamivir or a five day treatment regime with oseltamivir pills may become difficult for patients in critical conditions. A single infusion of peramivir (Rapivap) or a single pill of baloxavir (Xofluxa) may be more practical. In case of a high case fatality rate efficiency and health care worker safety may become a priority. A combination of both drugs does not improve the outcome.
The market capitalization was approximately 1 billion USD in March 2024.

Dec 22, 2014 Approval FDA Approves Rapivab (peramivir) to Treat Influenza Infection
Source: Rapivab FDA Approval History
Peramivir is administered as a single-dose via the intravenous route providing a valuable therapeutic alternative for critically ill patients or those unable to tolerate other administration routes.
Source: Peramivir: A Novel Intravenous Neuraminidase Inhibitor for Treatment of Acute Influenza Infections
Of the 22 S247N variants detected, nine were cultured and in an NA inhibition assay showed a mean six-fold reduction in oseltamivir sensitivity, a three-fold reduction in zanamivir sensitivity, and no significant reduction in peramivir sensitivity compared to the mean IC50 (concentration required to inhibit 50% of NA activity) of sensitive influenza A(H1N1)2009 viruses (Table).
Source: Increased detection in Australia and Singapore of a novel influenza A(H1N1)2009 variant with reduced oseltamivir and zanamivir sensitivity due to a S247N neuraminidase mutation
The studies have shown that peramivir resistance among influenza A/H1N1pdm09 viruses ranges from 1.3%–3.2% and is less than 1% for influenza A/H3N2 and B viruses. The most commonly occurring mutation leading to reduced effectiveness of peramivir is H274Y (H275Y N1 numbering), resulting in a 100–400-fold increase in IC50. It appears rapidly in immunocompromised individuals or hematopoietic cell transplant recipients treated with peramivir administered via the intravenous route. In vivo studies on mice showed that peramivir could be effective in the treatment of infections caused by oseltamivir-resistant A/H1N1/H274Y influenza virus.
Source: Evolution of Influenza Viruses—Drug Resistance, Treatment Options, and Prospects
Combining baloxavir with NAIs did not result in superior clinical outcomes compared with NAIs alone.
The combination of baloxavir plus NAI was well tolerated. The findings suggest that combination antivirals would not be routinely indicated in clinical practice for hospitalised patients with severe influenza.
Source: Combining baloxavir marboxil with standard-of-care neuraminidase inhibitor in patients hospitalised with severe influenza (FLAGSTONE): a randomised, parallel-group, double-blind, placebo-controlled, superiority trial

Takeda

The market capitalization was approximately 45 billion USD in March 2024.

In 2010, Takeda and Baxter International Inc. (Headquarters: Deerfield, Illinois, U.S.A., “Baxter”) entered into a development, license and technology transfer agreement in which Baxter licensed exclusive rights to its proprietary cell culture-based pandemic influenza vaccine technology for the Japanese market.
Source: Takeda Announces the New Drug Application Approval of Cell Cultured Influenza vaccine H5N1 "TAKEDA" 1mL and Cell Cultured Influenza vaccine(Prototype) "TAKEDA" 1mL in Japan for Prevention of Pandemic Influenza

Baxter

Baxter has developed a vaccine that doesn't rely on eggs, just like CSL with Audenz. While there no recent news, Baxter managed to sell a large amount of H1N1 vaccines during the 2009 pandemic. The market capitalization was approximately 20 billion USD in March 2024.

In 2010, Takeda and Baxter International Inc. (Headquarters: Deerfield, Illinois, U.S.A., “Baxter”) entered into a development, license and technology transfer agreement in which Baxter licensed exclusive rights to its proprietary cell culture-based pandemic influenza vaccine technology for the Japanese market.
Source: Takeda Announces the New Drug Application Approval of Cell Cultured Influenza vaccine H5N1 "TAKEDA" 1mL and Cell Cultured Influenza vaccine(Prototype) "TAKEDA" 1mL in Japan for Prevention of Pandemic Influenza
VEPACEL has the potential to generate a broader immune response than conventional egg-derived vaccines due to its use of Vero cell technology, which allows for use of the natural influenza virus (identical in protein composition to the virus circulating in nature) in vaccine production. Unlike traditional egg-grown influenza vaccines, eggs are not used in the VEPACEL manufacturing process.
Source: Baxter Receives Marketing Authorization in European Union for VEPACEL Pre-Pandemic Influenza Vaccine
Baxter was one of five companies that paid California state authorities $22.5m following accusations of Medicaid fraud, and the company also paid out $400,000 to Hawaii. In Alaska, Baxter agreed to pay compensation to settle a court claim. The company is also facing court action in Mississippi. Illinois has recovered $6.8m from Baxter, according to reports.
Despite the scandal, Baxter was one of two companies awarded the contract to produce 132 million doses of vaccine for Britain. The other company, GlaxoSmithKline, received a "positive opinion" for its drug, Pandemrix, last month. Britain is reported to have ordered enough swine flu vaccine to give each person two doses. The growing cost of the vaccines has prompted concerns from politicians, but the Department of Health and the drug companies have declined to say exactly how much each vaccine costs.
Source: Swine flu vaccine supplier has to pay back millions

Sanofi

Sanofi created the first FDA-approved H5N1 vaccine. While Sanofi was the first company to test mRNA influenza vaccines, there are no positive results reported so far. The market capitalization was approximately 120 billion USD in March 2024 with a 4% dividend.

Sanofi pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has licensed its H5N1 vaccine, the first avian influenza vaccine for humans in the U.S. Sanofi pasteur, in collaboration with the National Institutes of Health, submitted a Biologics License Application to the FDA for this H5N1 vaccine. The licensure serves as a first key step in achieving the government’s goal of stockpiling vaccine intended to protect those who are at increased risk of exposure to the H5N1 influenza virus contained in the vaccine during the early stages of a pandemic.
Source: FDA Licenses First U.S. Vaccine for Humans Against Avian Influenza
Sanofi (SASY.PA) said that trials show the currently available mRNA technology behind the most successful COVID-19 shots will not be effective against influenza and it is already working on a next generation of shots.
Source: Sanofi says it's back to the drawing board on mRNA flu vaccines
Manufacturing an emergency pandemic flu vaccine would likely involve GSK, Sanofi, and CSL Seqirus, foreign companies with U.S. manufacturing plants that are all suppliers of the annual flu vaccine.
Source: U.S. Could Vaccinate a Fifth of Americans in a Bird Flu Emergency

Viatris

Mylan produced a seasonal influenza vaccine and is now part of Viatris. Viatris produces Influvac Tetra. The market capitalization was approximately 14 billion USD in March 2024.

Mylan is now part of Viatris, a new global healthcare company committed to empowering people to live healthier at every stage of life.
Source: Mylan - Now a Part of Viatris

Supernus Pharmaceuticals

Adamas Pharmaceuticals produced Amantadine and Rimantadine and is now part of Supernus Pharmaceuticals. Currently all or most influenza strains have developed a resistance against those drugs. The market capitalization was approximately 1.8 billion USD in March 2024.

Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) today announced that it has successfully completed its previously announced acquisition of Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS).
Source: Supernus Pharmaceuticals Completes Acquisition of Adamas Pharmaceuticals
Resistant mutants to the Matrix-2 (M2) inhibitors such as adamantanes (amantadine and rimantadine) have been detected globally. All currently circulating influenza viruses are resistant to M2 inhibitors
Source: European Centre for Disease Prevention and Control

AstraZeneca

AstraZeneca has developed an intranasally administered vaccine for seasonal influenza, but can also use the technology to produce a H5N1 vaccine if needed. The market capitalization was approximately 200 billion USD in March 2024.

This medicine is authorised for use in the European Union.
Source: European Medicines Agency (EMA)
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the conditional approval of Pandemic Live Attenuated Influenza Vaccine (P/LAIV). P/LAIV is indicated for the prevention of influenza in an officially declared pandemic in children and adolescents from 12 months to less than 18 years of age.
This positive recommendation allows a vaccine containing a strain of pandemic potential to be developed and authorised in advance of a pandemic being declared. Once the World Health Organisation has declared an actual pandemic, a variation dossier specific for the pandemic strain can be submitted to the EMA for an accelerated assessment and approval. This provides an additional public health tool to protect European children when the next pandemic emerges.
P/LAIV is an intranasally administered vaccine that contains a live attenuated H5N1 strain of influenza virus. The vaccine is based on the same biologically-active components currently used to make AstraZeneca/MedImmune’s approved seasonal influenza vaccine, Fluenz™ Tetra. P/LAIV differs from Fluenz Tetra, because it protects against a single influenza A pandemic strain as opposed to four seasonal strains in Fluenz Tetra.
The positive CHMP opinion was based on a review of safety and immunogenicity studies of the H5N1 vaccine conducted in collaboration with the US National Institutes of Health as well as by the comprehensive clinical data that demonstrate the safety and efficacy for Fluenz Tetra in children.
Source: Pandemic influenza vaccine receives positive CHMP opinion

Novartis

Novartis has tried, but failed to produce an effective H5N1 vaccine. The market capitalization was approximately 200 billion USD in March 2024.

Clinically relevant levels of heterologous immunity were observed when the 2 doses of vaccine were administered either 2 or 3 weeks apart; however, the licensure criterion for seroprotection was not met in this case.
Source: A phase III, randomized, open-label study to assess the tolerability and immunogenicity of an H5N1 influenza vaccine administered to healthy adults with a 1-, 2-, 3-, or 6-week interval between first and second doses

Johnson & Johnson

After failed attemps to develop the monoclonal antibodies CR6261 and CR8020, the monoclonal antibody CR9114 and the more innovative multidomain antibody MD3606 remain in the pre-clinical stage. Johnson & Johnson was conducting the CD388 phase 2a study with Cidara Therapeutics. The cooperation has ended and potential milestone payments would be dwarfed by the market capitalization. The market capitalization was approximately 400 billion USD in March 2024.

Cidara Therapeutics (...) today announced that it has entered into a definitive agreement with Johnson & Johnson to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B.
Concurrent with the acquisition, Cidara closed a definitive agreement for the sale of preferred stock in a private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (BVF), and Canaan Partners. The private placement provides $240 million in gross proceeds that will be used by Cidara to develop CD388 as a universal preventative against seasonal and pandemic influenza A and B, beginning with a Phase 2b clinical trial in the upcoming Northern Hemisphere influenza season. The proceeds from the private placement fund the upfront payment under the agreement with Johnson & Johnson and are expected to provide runway beyond topline data from CD388’s Phase 2b trial. (...)
Dr. Stein continued, “This reacquisition of CD388, along with the capital to advance it through Phase 2b development, is transformational for Cidara and especially for those who could benefit from a long-acting, universal preventative against all forms of influenza. In our Phase 2b study later this year, we will evaluate the efficacy and safety of CD388 in providing season-long, universal protection from influenza. We believe that CD388 may have significant advantages beyond and in addition to flu vaccines, with the potential for universal protection even in the absence of a robust immune response and without the requirement for seasonal influenza strain prediction.”
All responsibility for future development, manufacturing, and commercialization activities of CD388 will be assumed by Cidara. In exchange for reacquiring the exclusive global development and commercial rights to CD388, Johnson & Johnson has received from Cidara a one-time upfront payment of $85 million and is eligible to receive potential additional development, regulatory, and commercial milestone payments.
Source: Cidara Therapeutics Reacquires Global Development and Commercial Rights to CD388 and Announces Private Placement Financing of $240 Million

Vir Biotechnology

Vir Biotechnology has discontinued the development of monoclonal antibodies against influenza.
In 2023 a phase 2 study of antibody VIR-2482 has failed, resulting in a significant loss of market capitalization. Based on this experience, Vir Biotechnology was developing VIR-2981 antibodies against influenza A and B. Vir Biotechnology has sufficient cash reserves due to a successful Covid-19 antibody. The market capitalization was approximately 1.4 billion USD in March 2024.

Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus.
Source: Vir Biotechnology Awarded U.S. Government Contract to Support Pandemic Preparedness for Influenza and Other Infectious Disease Threats
GSK is walking away from a core piece of its $345 million bet on Vir Biotechnology. The partners have ended their collaboration on anti-influenza antibodies, freeing Vir to “actively” pitch the candidates to other companies while continuing to work with GSK on different respiratory pathogens.
Source: GSK, Vir end flu drug alliance, removing key piece of $345M pact
The organizational realignment and optimization include phasing out programs in influenza, COVID-19, and the Company’s T cell-based viral vector platform, as well as a workforce reduction of approximately 25% or approximately 140 employees.
Source: Vir Biotechnology Reports Second Quarter 2024 Financial Results and Announces Strategic Restructuring to Prioritize Clinical-Stage Pipeline Opportunities

Xencor

Xencor technology has been used for the failed VIR-2482 antibody. The market capitalization was approximately 1.3 billion USD in March 2024.

VIR-2482, which incorporates Xencor’s Xtend™ technology, also has been half-life engineered so that a single dose has the potential to last the entire flu season.
Source: Vir Biotechnology Achieves Target Enrollment for Groundbreaking Phase 2 PENINSULA Trial Evaluating VIR-2482 for Prevention of Seasonal Influenza A