Cedilla Therapeutics | October 25, 2021
Cedilla Therapeutics a biotechnology company bringing a new dimension to precision oncology, today announced that it has raised an additional $25 million in an expansion of its Series B financing, bringing the total amount raised to $82.6 million. The oversubscribed Series B expansion includes new investors RA Capital Management, Janus Henderson Investors, Woodline Partners LP and Logos Capital, along with participation from existing investor Third Rock Ventures.“We are grateful for the support from our new and existing investors, which reflects the promise of our novel approach to conditionally modulating proteins as well as the unique potential of our lead programs, inhibitors against TEAD and CDK2, two critical but historically undruggable targets,” said Alexandra Glucksmann, Ph.D., President and Chief Executive Officer of Cedilla Therapeutics. “With this financing, we plan to accelerate and expand our development efforts by progressing our most advanced programs toward the clinic while continuing to invest in ongoing discovery efforts against additional high value cancer targets.”
Proceeds from the financing will support Cedilla’s continued growth and development of its two lead programs, an inhibitor of TEAD for the treatment of solid tumors, such as mesothelioma and certain squamous cell carcinomas, and a highly selective inhibitor of CDK2/Cyclin E for the treatment of multiple tumor types, including CDK4/6-resistant breast cancer, ovarian, uterine, stomach and esophageal cancers. The company plans to initiate investigational new drug application-enabling studies for the TEAD program in the first half of 2022 and for the CDK2 program in the second half of 2022.
In conjunction with the financing, Jake Simson, Ph.D., Partner at RA Capital Management, joins Cedilla’s Board of Directors.
Dr. Glucksmann continued, “We are pleased to welcome Jake to our Board of Directors. He brings a wealth of experience advising companies from the earliest stages of company formation through their maturation into fully integrated biopharmaceutical organizations. We look forward to his many contributions as we continue to grow Cedilla into a clinical-stage organization with a robust and growing portfolio of product candidates.”
“Cedilla brings a new dimension to precision oncology by conditionally modulating proteins in their functional state Preclinical data generated to-date suggest that Cedilla’s lead programs may challenge historical perceptions of TEAD and CDK2 as undruggable targets and could offer patients new options that would be well-tolerated and extremely effective. In addition, Cedilla’s approach, based on a deep understanding of how the cellular context modulates protein activity, could deliver superior inhibitors against a range of other key cancer drivers. I look forward to partnering with the team with the aim to deliver a broad portfolio of small molecule medicines, each with potential profound benefit to patients.”
Jake Simson, Ph.D., Partner at RA Capital Management
About Cedilla Therapeutics
Cedilla Therapeutics is bringing a new dimension to precision oncology. We have discovered new ways to selectively inhibit oncogenic drivers with small molecules that conditionally modulate proteins in their functional state. Our conditional inhibitors are unlocking critical and elusive cancer targets including TEAD and CDK2. We are a driven and patient-focused team. x
Pfizer, BioNTech | May 10, 2021
Pfizer Inc. and BioNTech SE confirmed today the filing of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in people aged 16 and above. Companies will send data to help the BLA to the FDA on a rolling basis in the coming weeks, along with a proposal for Priority Review. If the BLA has been completed and duly approved for review by the FDA, the FDA will set a target date for a determination under the Prescription Drug User Fee Act (PDUFA).
The Pfizer-BioNTech COVID-19 Vaccine is now available in the United States under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) on December 11, 2020. Since then, the firms have distributed more than 170 million doses of the vaccine in the United States. The next step in the comprehensive FDA evaluation process is the submission of a BLA, which includes longer-term follow-up data for acceptance and approval.
Pfizer and BioNTech started the BLA process by providing the nonclinical and clinical data needed to justify the licensure of the COVID-19 vaccine for use in people aged 16 and up. This covers the most recent analyses from the pivotal Phase 3 clinical trial, in which the vaccine's effectiveness and safety profile were detected up to six months after the second dose. In the coming weeks, the companies will submit the required manufacturing and facility details for licensure, completing the BLA.
Pfizer and BioNTech have since submitted to expand the new EUA for their COVID-19 vaccine to cover individuals aged 12 to 15. The firms plan to send a supplemental BLA to facilitate vaccine licensure in this age group until the requisite data is available six months after the second vaccine dose.
BioNTech and Pfizer collaborated to create the Pfizer-BioNTech COVID-19 Vaccine, which is built on BioNTech's patented mRNA technology. BioNTech is the European Union's Marketing License Holder, as well as the holder of emergency use authorizations or similar in the United States (along with Pfizer), the United Kingdom, Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.
The Pfizer-BioNTech COVID-19 Vaccine has not been authorized or licensed by the United States Food and Drug Administration (FDA), but it has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in people aged 16 and up. The emergency use of this product is only permitted for the duration of the declaration the circumstances justify the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act until the declaration is terminated or the authorization is revoked sooner.
At Pfizer, they utilize science and its global resources to deliver treatments to patients that significantly extend and change their lives. In the discovery, development, and manufacture of health care products, including innovative medicines and vaccines, they aim to set the benchmark for consistency, safety, and value. Every day, Pfizer colleagues collaborate in developing and emerging markets to advance wellness, prevention, treatments, and remedies for today's most feared diseases. As one of the world's leading innovative biopharmaceutical firms, they partner with health care providers, governments, and local communities to promote and improve access to reliable and affordable health care around the world.
Biopharmaceutical New Technologies is a next-generation immunotherapy firm that is developing novel cancer and other severe disease therapies. For the accelerated production of new biopharmaceuticals, the company makes use of a diverse set of computational discovery and therapeutic drug platforms. Its oncology product candidates include individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies, and small molecules from Fosun Pharma and Pfizer.
AlivaMab | May 13, 2021
AlivaMab Discovery Services, LLC ("ADS"), a pioneer in the discovery of superior antibody therapeutics, announced today the formation of its new Antibody Engineering Department, headed by Jonah Rainey, Ph.D. Jonah joins ADS as Vice President of Antibody Engineering, bringing 15 years of experience from Macrogenics Inc. in antibody engineering, discovery, and development, MedImmune, LLC/AstraZeneca PLC, Gritstone Bio, Inc., and, most recently, Immetas Therapeutics, Inc. Jonah's expertise in antibody engineering includes bispecific antibodies, some of which have reached clinical trials, antibody-drug conjugates, Fc modification, in vitro display for antibody discovery and optimization, and structural modeling.
“An increasing number of leading pharma and biotechs realize that ADS's pre-existing platform process adds exceptional value to their antibody drug discovery efforts. I am excited to be leading the initiative at ADS to develop new capabilities that will expand the scope and importance that we offer to our clients' drug discovery and development projects. The new Antibody Engineering Department's commitment will help to ensure that ADS delivers the best antibody drug candidates,” said Jonah Rainey, Vice President of Antibody Engineering at AlivaMab Discovery Services.
“Today, we significantly expand the ADS discovery platform by adding a new pillar of antibody engineering to our existing pillars of Ablexis' AlivaMab® Mouse, the leading transgenic animal technology for antibody drug discovery, a suite of AMMPD immunization technologies to address even the most challenging targets, a broad sampling of the immune repertoire through function-first high-throughput deep sequencing, and a broad sampling of the immune repertoire through function-first high-throughput sequence analysis. “Jonah's skills and abilities complement and reinforce the ADS team's accumulated decades of experience in discovery and development. We assist our clients in delivering quality medicines to patients quicker by combining team, technology, and partnership.”
About AlivaMab Discovery Services
AlivaMab Discovery Services is a privately-owned biotechnology company that develops an integrated antibody therapeutic discovery platform that combines innovative technologies and deep expertise to produce superior antibody therapeutics on time. Throughout their careers, the team has completed over 200 discovery projects, yielding several antibody drug candidates in clinical trials. ADS offers a wide range of antibody therapeutic candidates with complex molecular and epitope profiles, functional and kinetic characterization, and superior developability profiles.ADS is trusted by organizations ranging from global pharmaceutical firms to virtual biotechnology companies because of its business model that relies solely on partners instead of developing an internal product pipeline.