Category Archives: Biotech Companies Vaccines

GSK and CureVac to Restructure Collaboration into New Licensing Agreement

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  • GSK acquires full rights to develop, manufacture and commercialize globally mRNA candidate vaccines for influenza and COVID-19, including combinations
  • CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced
     

London UK; TÜBINGEN, Germany/BOSTON, MA, USA – July 3, 2024 – GSK plc (LSE/NYSE: GSK) and CureVac N.V. (Nasdaq: CVAC) today announced they have restructured their existing collaboration into a new licensing agreement, allowing each company to prioritize investment and focus their respective mRNA development activities.

Since 2020, GSK and CureVac have worked together to develop mRNA vaccines for infectious diseases. Through this collaboration, GSK and CureVac currently have vaccine candidates for seasonal influenza and COVID-19 in Phase 2 and avian influenza in Phase 1 clinical development. All candidates are based on CureVac’s proprietary second-generation mRNA backbone. Data generated to date for these candidate vaccines are promising and demonstrate their potential to be best-in-class new vaccines.

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.

Tony Wood, Chief Scientific Officer, GSK said: “We are excited about our flu/COVID-19 programs and the opportunity to develop best-in-class mRNA vaccines to change the standard of care. With this new agreement, we will apply GSK’s capabilities, partnerships and intellectual property to CureVac’s technology, to deliver these promising vaccines at pace.”

Alexander Zehnder, Chief Executive Officer, CureVac said: “The collaboration with GSK has been instrumental in developing promising, late clinical-stage vaccine candidates, leveraging our proprietary mRNA platform. This new licensing agreement puts us in a strong financial position and enables us to focus on efforts in building a strong R&D pipeline.”

Completion of the new agreement remains subject to certain antitrust and regulatory approvals and customary closing conditions.

About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

About CureVac
CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media Contact
Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
patrick.perez@curevac.com

CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

 

Sanofi and Novavax announce co-exclusive licensing agreement to co-commercialize COVID-19 vaccine and develop novel flu-COVID-19 combination vaccines

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Sanofi and Novavax announce co-exclusive licensing agreement to co-commercialize COVID-19 vaccine and develop novel flu-COVID-19 combination vaccines

  • Agreement provides patients with broader access to a protein-based non-mRNA adjuvanted COVID-19 vaccine through combined commercial strength, from 2025 onwards
  • Accelerates potential for development of a novel flu-COVID-19 combination product based on authorized vaccines with demonstrated efficacy and tolerability, potentially offering patients enhanced convenience and protection

Paris and Gaithersburg, Md., United States. May 10, 2024. As part of Sanofi’s commitment to developing a diverse portfolio of best-in-class vaccines, the company has entered into a co-exclusive licensing agreement with Novavax, a biotechnology company headquartered in Maryland, US.

The terms of the agreement include: a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing Advance Purchase Agreements and in India, Japan, and South Korea where Novavax has existing partnership agreements); a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s flu vaccines; and a non-exclusive license to use the Matrix-M adjuvant in vaccine products. In addition, Sanofi will take a minority (<5%) equity investment in Novavax.

Jean-Francois Toussaint
Global Head of Vaccines R&D
“With flu and COVID-19 hospital admission rates now closely mirroring each other, we have an opportunity to develop non-mRNA flu-COVID-19 combination vaccines offering patients both enhanced convenience and protection against two serious respiratory viruses. We’re excited by the prospect of combining Novavax’s adjuvanted COVID-19 vaccine that has shown high efficacy and favorable tolerability, with our rich portfolio of differentiated flu vaccines that have demonstrated superior protection against flu and its serious complications. Improved tolerability and thermostability, without compromise on efficacy, are what regulators, recommending bodies, and patients will demand.”

John Jacobs
CEO, Novavax

“This collaboration is important for Novavax and for global public health. Our new partnership combines Novavax’s proprietary recombinant protein and nanoparticle technologies, Matrix™ adjuvant, and R&D expertise with Sanofi’s world-class leadership in launching and commercializing innovative vaccines. Together, we can broaden access to both our COVID-19 vaccine and our adjuvant to ensure more individuals can benefit from the protection vaccines can provide. Novavax is now in a stronger position to refocus our efforts on leveraging our technology platform and novel adjuvant in research and development and pipeline expansion to help advance our mission of developing life-saving vaccines to fight infectious diseases.” 

Under the terms of the licensing agreement:

  • Novavax will receive an upfront payment of $500 million and up to $700 million in development, regulatory and launch milestones, up to $1.2 billion in total.
  • Starting in 2025, Sanofi will book sales of Novavax’s adjuvanted COVID-19 vaccine and will support certain R&D, regulatory, and commercial expenses.
  • Novavax will receive tiered double-digit percentage royalty payments on sales by Sanofi of COVID-19 vaccines and flu-COVID-19 combination vaccines.
  • Sanofi will be solely responsible for development and commercialization of any novel flu-COVID-19 combination vaccine containing a Sanofi flu vaccine.
  • Outside of the collaboration, each party may develop and commercialize their own flu-COVID-19 vaccines and adjuvanted products at their own cost.
  • Novavax is entitled to additional launch and sales milestones opportunities of up to $200 million plus mid-single digit royalties for each additional Sanofi vaccine product developed under a non-exclusive license with Novavax’s Matrix-M adjuvant technology.
  • In addition, Sanofi will take a minority (<5%) equity investment in Novavax.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance the immune response. The Company’s portfolio includes its COVID-19 vaccine, and its pipeline includes CIC and stand-alone influenza vaccine candidates. In addition, Novavax’s adjuvant is included in the University of Oxford and Serum Institute of India’s R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more.

About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com

Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com

Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com
Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Tarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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PANCREACTIC CANCER: SUCCESFUL TRIAL AGAINST PANCREATIC CANCER WITH DEFENCE’S ARM-002 ANTI-CANCER VACCINE

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Vancouver, BC, Canada, May 1st, 2024 – Defence Therapeutics Inc. (“Defence” or the “Company”), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology therapeutics and drug delivery technologies, is pleased to announce the successful completion of a pre-clinical vaccination trial using its ARM-002TM vaccine against pancreatic cancer. The vaccine was shown to be therapeutically effective against pre-established pancreatic cancer especially when combined with the anti-PD-1 immune-checkpoint inhibitor.

In the context of an in vivo pre-clinical study, Defence tested its ARM-002TM vaccine pulsed with a pancreatic cancer lysate in combination with the anti-PD-1 immune-checkpoint in animals with pre-established Pan02 tumors. Animals’ follow-up revealed that the vaccine is indeed potent as all treated animals remained alive for over 40 days (equivalent to almost 5 years in the human scale) with tumor growth heavily impaired/blocked compared to other treatments/controls. Since Defence is interested in targeting “hard-to-treat” cancers, these results represent an important infliction point and an incentive to redirect its Phase I trial using the ARM-002TM anti-cancer vaccine to target pancreatic cancer.

Pancreatic cancer begins when uncontrolled cellular growth occurs in the pancreas. It is rarely diagnosed at early stages when the chance of curing the disease is the greatest as it often doesn’t cause symptoms until it metastasises to other organs. This classifies this type of cancer as a “hard-to-treat” cancer as patients at that point face limited treatment options.

Treatment for pancreatic cancer depends on the cancer stage as well as its location. Although the first goal of pancreatic cancer treatment is to get rid of the cancer, this unrealistic option often shifts to improving quality of life and keeping the cancer from growing or causing more harm. As such, treatments available for pancreatic cancer often involve surgery, radiation, chemotherapy or a combination, and are associated with limited clinical benefits or life-related complications. For instance, even if surgery to remove the whole pancreas is performed, patients would then rely on taking medicine their entire life to replace the hormones and enzymes made by the pancreas. Alternatively, chemotherapy (often combined with radiation therapy) can shrink the cancer, but it is often associated with resistance and/or relapse. As these standards of care fail in large set of patients, the next available option relies on immunotherapy, which uses the body’s immune system to kill cancer cells.

“Defence’s goal is to bring our proprietary and innovative immune therapies to the clinical stage for the benefit of the cancer patients. We often say that our Accum® platform is highly versatile as it can lead to the development of verticals promoting different products for multiple indications. This also applies to a single product as it can be adapted to various diseases as demonstrated with our ARM-002TM vaccine in vivo pre-clinical studies, which was shown to impair the growth of solid T-cell lymphoma, melanoma and now pancreatic cancer” says Mr. Plouffe, Chief Executive Officer of Defence Therapeutics.

Pancreatic Cancer Market size is estimated to surpass USD 36 Billion by the end of 2036, growing at a CAGR of 18% during the forecast period of 2024-2036. In 2023, the industry size of the pancreatic cancer was over USD 6 Billion. The growth of the market can be attributed to the rising prevalence of cancer cases among people across the world.

https://www.researchnester.com/reports/pancreatic-cancer-market/5299

About Defence:

Defence Therapeutics is a publicly-traded clinical-stage biotechnology company working on engineering the next generation vaccines and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUM® technology, which enables precision delivery of vaccine antigens or ADCs in their intact form to target cells. As a result, increased efficacy and potency can be reached against catastrophic illness such as cancer and infectious diseases.

For further information:

Sebastien Plouffe, President, CEO and Director

P: (514) 947-2272

Splouffe@defencetherapeutics.com

www.defencetherapeutics.com

Cautionary Statement Regarding “Forward-Looking” Information

This release includes certain statements that may be deemed “forward-looking statements”. All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects”, “plans”, “anticipates”, “believes”, “intends”, “estimates”, “projects”, “potential” and similar expressions, or that events or conditions “will”, “would”, “may”, “could” or “should” occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company’s management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management’s beliefs, estimates or opinions, or other factors, should change.

Neither the CSE nor its market regulator, as that term is defined in the policies of the CSE, accepts responsibility for the adequacy or accuracy of this release.

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Bavarian Nordic – poxviral-based vaccine

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Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases.

Bavarian Nordic – poxviral-based vaccine

Bavarian Nordic has built its foundation around two poxviral-based vaccine platform technologies, Modified Vaccinia Ankara – Bavarian Nordic (MVA-BN) and Vaccinia-Fowlpox-TRICOM (VF-TRICOM) that have the potential to support a broad product pipeline in both infectious diseases and cancer immunotherapies. Both technologies can be manufactured at commercial scale at Bavarian Nordic’s own facility, which was recently expanded to accommodate the production of multiple products. Bavarian Nordic focuses on developing product candidates to address cancer and infectious diseases by leveraging several core strengths:

  • Extensive R&D expertise in vaccines and immunotherapy
  • Broadly applicable platform technology
  • Multiple clinical stage development programs, including two Phase 3 trials
  • Flexible, commercial scale manufacturing facility
  • Significant financial resources resulting from IMVAMUNE supply contracts and government-funded R&D programs

Through a long-standing collaboration with the U.S. Government, Bavarian Nordic has developed a portfolio of biological countermeasures, including the non-replicating smallpox vaccine, IMVAMUNE, which is stockpiled for emergency use by the U.S. and other governments. The vaccine is approved in the EU (under the trade name IMVANEX) and in Canada. Bavarian Nordic and its partner Janssen are pioneering the development of an Ebola vaccine, which has been fast-tracked by authorities in response to the current situation in West Africa. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies based on its versatile pox-virus based technologies, including PROSTVAC, which is currently in Phase 3 clinical development for the treatment of advanced prostate cancer. The company has partnered with Bristol-Myers Squibb for the potential commercialization of PROSTVAC.

Bavarian Nordic is a biotech company headquartered in Denmark, Germany and USA. Bavarian Nordic’s shares are listed on Nasdaq Copenhagen under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The company has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol BVNRY.

More about Bavarian Nordic : www.bavarian-nordic.com

Bavarian Nordic – poxviral-based vaccine – poxviral – vaccine – PROSTVAC – IMVANEX – IMVAMUNE

Bavarian Nordic – poxviral-based vaccine – poxviral – vaccine – PROSTVAC – IMVANEX – IMVAMUNE

Scancell – innovative ImmunoBody

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Scancell – innovative ImmunoBody

scancell

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