Would it be the best thing that we spend money to have a vaccine for pandemic flu that never happened? That would be a great outcome as far as I’m concerned.
BARDA, stockpiles, research agreements, conflicts
Preparation for an (avian) influenza pandemic is a complicated undertaking. This page features important agreements regarding funding, capacity, and research. By far the most active institution in orchestrating and funding this effort is BARDA, the Biomedical Advanced Research and Development Authority. Typically smaller innovative companies team up with a bigger partner for studies and commercialization.
Far more adversarial is the increasing amount of patent litigation regarding the mRNA technology. An overview can be found here, but the situation is still increasing in complexity. It remains to be seen how much the commercial benefactors of the Covid-19 pandemic will have to pay to much less prominent companies who may have invented the mRNA technology.
the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program was established by the Biomedical Advanced Research and Development Authority (BARDA) in 2005 with the goal of building and maintaining a stockpile of vaccines for influenza viruses with pandemic potential to vaccinate 20 million people in the critical workforce in the event of a pandemic
In October 2021, Seqirus announced a new $34.95 million agreement with BARDA to develop two influenza A(H2Nx) virus vaccine candidates: the first using the adjuvanted, cell-based combination platform technology used by AUDENZ™, and the second using Seqirus’ next-generation self-amplifying mRNA (sa-mRNA) platform.
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.
VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a prophylactic for influenza A. It has the potential to address the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response.
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Under the collaboration agreement signed with GSK in 2021, GSK has an exclusive option to lead post-Phase 2 development and commercialization of VIR-2482.
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.
Seqirus, a world leader in influenza vaccines and pandemic response, announced today that following Health Canada’s approval of FOCLIVIA® (adjuvanted, egg-based A strain H5N1 pandemic influenza vaccine), the Company is ready to fulfil its role in Canada’s influenza pandemic preparedness plans.
Seqirus Canada is an influenza pandemic vaccine partner to the Canadian Government through the Public Health Agency of Canada (PHAC). The contract requires Seqirus to be on standby to rapidly manufacture and deliver a large number of vaccine doses to help protect Canadians against the influenza strain identified by the World Health Organization (WHO) when an influenza pandemic is declared.
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.
CSL Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced that 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), selected CSL Seqirus to deliver an H5N8 A/Astrakhan virus vaccine candidate for assessment in a Phase 2 clinical study that is anticipated to begin in Q2 2023.
This agreement is the third award that CSL Seqirus has received from BARDA in the last twelve months, following an April 2022 award to produce an H5N8 A/Astrakhan cell-based synthetic influenza Working Seed lot, as well as a separate October 2021 award to develop one influenza A(H2Nx) vaccine virus candidate utilizing its cell-based and adjuvant technologies, and clinically assessing both the cell-based as well as its next-generation self-amplifying mRNA platform, further underscoring the importance of public-private partnerships in bolstering pandemic preparedness.
This agreement is the third award that CSL Seqirus has received from BARDA in the last twelve months, following an April 2022 award to produce an H5N8 A/Astrakhan cell-based synthetic influenza Working Seed lot, as well as a separate October 2021 award to develop one influenza A(H2Nx) vaccine virus candidate utilizing its cell-based and adjuvant technologies, and clinically assessing both the cell-based as well as its next-generation self-amplifying mRNA platform, further underscoring the importance of public-private partnerships in bolstering pandemic preparedness.
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.
As part of its proactive measures, Japan’s Health Ministry has set a target of stockpiling vaccines to protect a significant portion of its population. The ambitious goal is to secure enough vaccines to safeguard 10 million individuals from the potential ravages of an H5N1 bird flu outbreak.
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today its commitment to donate 60 million doses of H5N1 vaccine to the World Health Organization (WHO) over 3 years for the establishment of an H5N1 vaccine global stockpile.
“The H5N1 virus is currently circulating in some of the poorest regions of the world and an outbreak of pandemic influenza would most likely hit populations living in areas with limited access to vaccines. This donation of H5N1 vaccine aims to address the needs of those most vulnerable populations,” said Wayne Pisano, President and Chief Executive Officer of sanofi pasteur. “In addition to supporting the efforts of governments, it is essential that industry collaborates with international organizations such as WHO, the Bill and Melinda Gates Foundation and other global health players. This is the best way to build a stockpile of vaccines for developing nations, ready to be deployed on the ground in the event of a pandemic flu outbreak,” added Pisano.
“The H5N1 virus is currently circulating in some of the poorest regions of the world and an outbreak of pandemic influenza would most likely hit populations living in areas with limited access to vaccines. This donation of H5N1 vaccine aims to address the needs of those most vulnerable populations,” said Wayne Pisano, President and Chief Executive Officer of sanofi pasteur. “In addition to supporting the efforts of governments, it is essential that industry collaborates with international organizations such as WHO, the Bill and Melinda Gates Foundation and other global health players. This is the best way to build a stockpile of vaccines for developing nations, ready to be deployed on the ground in the event of a pandemic flu outbreak,” added Pisano.
GSK plc (LSE/NYSE: GSK) today announced it had signed a framework contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA) for the reservation of future production and supply of 85 million doses of its pandemic influenza vaccine Adjupanrix [pandemic influenza vaccine (split virion, inactivated, adjuvanted).
This is one of the first contracts signed by HERA since it was established in September 2021. Its core mission is to prevent, detect, and rapidly respond to health emergencies through working closely with other EC and national health agencies, industry and international partners to improve Europe’s readiness for health emergencies.
This is one of the first contracts signed by HERA since it was established in September 2021. Its core mission is to prevent, detect, and rapidly respond to health emergencies through working closely with other EC and national health agencies, industry and international partners to improve Europe’s readiness for health emergencies.
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.
Biota, which licensed Relenza to GSK in 1990, had claimed GSK had breached its contract to adequately promote and market the drug, causing it to lose millions in royalties.
Biota is entitled to a royalty on sales of Relenza by GSK through to the end of the product's patent life. For their part in the drug's discovery, CSIRO received a share of Biota's royalties from Relenza.
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.
GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac today announced the signing of a strategic collaboration agreement for the research, development, manufacturing and commercialisation of up to five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The collaboration complements GSK’s existing mRNA capabilities with CureVac’s integrated mRNA platform.
CureVac’s leadership in mRNA technology, along with its mRNA manufacturing capability, complements GSK's existing scientific leadership in vaccines, including GSK's own self-amplifying mRNA (SAM) vaccine technology platform, and further builds on GSK's growing capability in mAbs innovation, aligned to its R&D focus on the science of immunology. Advancing mRNA-based vaccine and treatment technologies is also expected to play a role in further improving response against future pandemics.(...)
Under the terms of the deal, GSK will make an equity investment in CureVac of £130m (€150m), representing close to a 10% stake, an upfront cash payment of £104m (€120m) and a one-time reimbursable payment of £26m (€30m) for manufacturing capacity reservation, upon certification of CureVac’s commercial scale manufacturing facility currently under construction in Germany.
CureVac will be eligible to receive development and regulatory milestone payments of up to £277m (€320m), commercial milestone payments of up to £329m (€380m) and tiered royalties on product sales.
CureVac’s leadership in mRNA technology, along with its mRNA manufacturing capability, complements GSK's existing scientific leadership in vaccines, including GSK's own self-amplifying mRNA (SAM) vaccine technology platform, and further builds on GSK's growing capability in mAbs innovation, aligned to its R&D focus on the science of immunology. Advancing mRNA-based vaccine and treatment technologies is also expected to play a role in further improving response against future pandemics.(...)
Under the terms of the deal, GSK will make an equity investment in CureVac of £130m (€150m), representing close to a 10% stake, an upfront cash payment of £104m (€120m) and a one-time reimbursable payment of £26m (€30m) for manufacturing capacity reservation, upon certification of CureVac’s commercial scale manufacturing facility currently under construction in Germany.
CureVac will be eligible to receive development and regulatory milestone payments of up to £277m (€320m), commercial milestone payments of up to £329m (€380m) and tiered royalties on product sales.
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.
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.
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.
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.
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.
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.
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.
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.
The Access to Advanced Health Institute (AAHI) announced today that it has been awarded a project agreement worth up to $9.9 million through the Medical CBRN Defense Consortium (MCDC) Other Transaction Authority (OTA) to develop a prototype intranasal bivalent influenza RNA vaccine candidate based on AAHI’s self-amplifying RNA (saRNA) platform that targets both pandemic A(H5N1) and A(H7N9) influenza virus pathogens.
This prototype project was awarded on behalf of the U.S. Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.
AAHI’s innovative RNA platform, which delivers saRNA bound to the exterior of a nanostructured lipid carrier (NLC), entered first-in-human clinical trials in May 2022 with Phase 1/2 clinical trials of the “AAHI-SC2” COVID-19 vaccine candidate (NCT05370040).
This prototype project was awarded on behalf of the U.S. Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.
AAHI’s innovative RNA platform, which delivers saRNA bound to the exterior of a nanostructured lipid carrier (NLC), entered first-in-human clinical trials in May 2022 with Phase 1/2 clinical trials of the “AAHI-SC2” COVID-19 vaccine candidate (NCT05370040).
As part of a recent prioritization of its R&D business, Janssen has announced its intention to discontinue internal development of the majority of its infectious disease pipeline, including JNJ-0953 (CD388). However, at this time, Janssen has not informed Cidara of any intention to terminate the agreement between the two parties. Cidara continues to work in collaboration with Janssen to complete the Phase 1 (NCT05285137 and NCT05619536) and Phase 2a (NCT05523089) clinical trials and will be reimbursed for all ongoing development activities by Janssen as per the Janssen Collaboration Agreement.
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.
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.
Under this agreement, Fujifilm grants Hisun Pharmaceutical a license to use its Favipiravir-related patents** in China to develop, manufacture and market an anti-influenza drug in China. Fujifilm will receive a lump-sum payment and royalties once such a influenza drug is successfully introduced to the market.
Avigan Tablet, created by the Fujifilm Group company Toyama Chemical Co., Ltd., is an anti-influenza drug approved for manufacturing and marketing in Japan in March 2014.
Cidara to receive a $7 million milestone payment and is eligible to receive an additional $685 million in milestones, plus royalties (...) Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, has announced that Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has delivered to Cidara its Election to Proceed Notice for CD388 (JNJ-0953) which is being developed for the universal prevention of influenza A and B. Responsibility for future development, manufacturing and commercialization activities of CD388 will be assumed by Janssen, which intends to transfer its rights and obligations under the agreement to another entity.
CSL Seqirus, a business of CSL (ASX: CSL), today announced that it has signed an agreement with the UK government to develop and supply pandemic influenza vaccines in the event of an influenza pandemic. Under the terms of the agreement, should an influenza pandemic be declared, the UK government would have the option to purchase more than 100 million doses of pandemic vaccines from the CSL Seqirus manufacturing plant in Liverpool in a rapid timeframe.
In the pan-European dispute between Moderna and BioNTech over mRNA patents, the patent holder Moderna has now suffered a defeat at the European Patent Office. The Opposition Division has revoked one of the patents-in-suit.
On 19 December 2023, the Federal Patent Court declared the German part of the European patent EP 1 857 122 B1 (...) of CureVac of Tübingen invalid following an action for revocation brought by BioNTech from Mainz. This means that the patent is ab initio invalid for the German territory, with retroactive effect from the outset.
However, the judgement is not yet legally binding. CureVac (the company works together with Glaxo Smithkline (GSK)) has already announced that it will appeal to the Federal Court of Justice (second instance).
The UK Health Security Agency (UKHSA) has agreed a deal for millions of life-saving vaccines to be produced in the UK if a future influenza pandemic is ever declared.
The advance purchase agreement (APA) means healthcare company CSL Seqirus will be on standby to produce over 100 million influenza pandemic vaccines if or when they are needed.
UKHSA and its predecessor organisations have had similar agreements in the past, but this is the first time the manufacturing process will be based entirely in the UK, giving better security of access if global demand ever outweighs supply.
Leyden Laboratories B.V. (the “Company” or “Leyden Labs”), today announces the development of an intranasal spray protecting against influenza A and influenza B based on the human monoclonal antibody CR9114. Leyden Labs has entered into an exclusive licensing agreement with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize CR9114 for mucosal administration. CR9114 is a human monoclonal antibody that protects against both influenza A and B in preclinical models. With the exclusive license to mucosal administration of CR9114, Leyden Labs is developing easy-to-use products that provide immediate protection against contracting and spreading multiple strains of influenza. This supports Leyden Labs’ mission to optimize mucosal protection against entire viral families to prevent future pandemics.
Under the terms of the licensing agreement, Janssen will provide Leyden Labs with a worldwide, exclusive license to develop and commercialize CR9114 for mucosal administration. Janssen will receive an upfront payment and is eligible to receive development and sales-based milestone payments and tiered royalties on potential sales. The agreement was facilitated by Johnson & Johnson Innovation.
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. (...)
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. (...)
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.”
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.
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.
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.
In legal cases being run simultaneously across Europe and the US, Moderna is not seeking to stop the use of the BioNTech/Pfizer vaccine but it wants judges to declare its patents have been infringed and ultimately to receive compensation.
In its London lawsuit filed with the High Court, Moderna said BioNTech and Pfizer had obtained “significant benefits” from the sale of “infringing products”.
One set of chunks in the vaccine stockpile are premade antigens, the part of the vaccine that trains the body’s immune system to defend against the virus. No one knows exactly what the influenza virus that starts the next pandemic might look like, and so no one knows exactly which antigen might be needed.
The other set of stockpiled chunks are adjuvants, the additives used to boost human immune responses to vaccines. The adjuvants in the stockpile appear to be CSL Seqirus’ MF59, which is used in one of the company’s seasonal flu vaccines, and GSK’s AS03. Since AS03 isn’t used in any of GSK’s seasonal flu vaccines, the U.S. government pays GSK to maintain a capacity to ramp up production if necessary.
“Federal funding for pandemic influenza has not kept up with the threat, even by the government’s own assessments,” Tom Daschle, former Senate majority leader and head of the Coalition To Stop Flu, which includes public health organizations and vaccine manufacturers, said in a statement Tuesday.
The government group responsible for defining requirements for medical countermeasures called for $1.15 billion in funding for pandemic influenza for 2025, Daschle said. But the $335 million in Biden’s 2025 budget request fell far short. (Congress appropriated $335 million for pandemic influenza preparedness in the most recent appropriations bill.)
Boucher said ASPR is looking to add mRNA H5N1 vaccine to the stockpile, having recently issued a request for proposals from manufacturers. It is still assessing the submissions it generated, he said.
But she stressed that beyond additional testing of one of the vaccine candidates, drug companies are also developing mRNA vaccines. The federal government is in talks to help with that too, she said.
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.
The EU’s health crisis authority will sign a contract with Seqirus next Tuesday to secure hundreds of thousands of doses of its H5N1 flu shot adapted to protect people against the latest deadly strain of bird flu — and first doses will head to Finland.
The Health Emergency Preparedness and Response Authority (HERA) will sign the joint procurement contract with Seqirus on behalf of 15 member countries, a senior Commission official with knowledge of the matter told POLITICO.
The first batch of vaccines will be immediately shipped to Finland, the official said, where workers in mink farms are considered at risk of contracting the virus from contaminated animals.
The contract is currently for 640,000 doses, with the possibility to buy up to 40 million doses over four years.
The U.S. government has awarded $176 million to Moderna (MRNA.O)
, opens new tab to advance development of its bird flu vaccine, the company said on Tuesday, as concerns rise over a multi-state outbreak of H5N1 virus in dairy cows and infections of three dairy workers since March.
Funds from the U.S. Biomedical Advanced Research and Development Authority will be used to complete late-stage development and testing of a pre-pandemic mRNA-based vaccine against H5N1 avian influenza.
U.S. officials said on a press call that late-stage testing would begin in 2025, pending results expected in the coming weeks of Moderna's phase 1 trial. The late-stage trial would likely focus on safety and immune response.
The contract includes options to accelerate the development timeline if needed, based on an increase in human cases, the severity of cases or human-to-human transmission of the virus.
The Health Emergency Preparedness and Response Authority (HERA) will sign the joint procurement contract with Seqirus on behalf of 15 member countries, a senior Commission official with knowledge of the matter told POLITICO.
The first batch of vaccines will be immediately shipped to Finland, the official said, where workers in mink farms are considered at risk of contracting the virus from contaminated animals.
The contract is currently for 640,000 doses, with the possibility to buy up to 40 million doses over four years.
The Administration for Strategic Preparedness and Response’s (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) is providing approximately $72 million to CSL Seqirus, Sanofi, and GSK to complete the next steps in influenza A(H5) vaccine manufacturing as part of national preparedness. (...) Separately, BARDA is providing $121.4 million to CSL Seqirus for general pandemic influenza preparedness and vendor managed inventory (VMI) of additional adjuvant of the company’s H5 influenza vaccine. Adjuvant is used in some vaccines to help create a stronger immune response for people receiving the vaccine and can allow vaccines to be made with less antigen to aid in protecting more people in an influenza pandemic.
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.