MEDICAL

Pfizer and BioNTech Begin Rolling Submission of Biologics License Application for FDA Approval of COVID-19 Vaccine in the U.S

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.

About Pfizer
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.

About BioNTech
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.

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INDUSTRIAL IMPACT

SkylineDx raises new capital from Novalis LifeSciences and Van Herk Investments

SkylineDx | December 22, 2021

SkylineDx announced it received a capital investment from USA based investment and advisory firm Novalis LifeSciences, and one of Benelux' largest biotech investors Van Herk Investments, to further solidify its position in the USA dermatology diagnostics market. SkylineDx is at a critical growth stage in their development now that the first products are introduced to the USA market, and Novalis LifeSciences has demonstrated impressive successes with their strategic and operational advice to their portfolio companies. Marijn E. Dekkers, founder and chairman of Novalis LifeSciences, will be named board member of SkylineDx' Board of Directors. He brings a long track record of industry-related strategic leadership experience as the former CEO of Bayer AG, CEO of Thermo Fisher Scientific and his role in the recent 600M USD acquisition of Decipher Biosciences by Veracyte. SkylineDx' dermatology program, often referred to as the Falcon R&D Program, currently overarches four dedicated dermatology initiatives, focused on prognostic and predictive biomarker development covering two skin cancers: melanoma and squamous cell carcinoma. These indications affect approximately 1.9 million patients annually in the United States only. One of these initiatives generated its first commercially available product, branded as Merlin Test, for which SkylineDx aims to accelerate the clinical adoption with this joint investment. "It is a great honor to have Marijn and Novalis LifeSciences as our first specialized USA investor on board, with all their incredible experience and know-how. Together we aim to further extend SkylineDx' USA investor base and continue expanding our strong footprint there. Our mission is to improve a patient's quality of life by enabling them to benefit from personal insights at the genomic level of their disease. We are excited to be working with Marijn and his team to continue fulfilling this mission." Dharminder Chahal, CEO SkylineDx Marijn Dekkers comments: "I have monitored the progress of SkylineDx for several years now, and I am excited about the leading edge position the company has built in predictive biomarkers for melanoma and various other cancers. I very much look forward to working with the SkylineDx team to bring these sophisticated diagnostic tests to patients around the globe." About SkylineDx SkylineDx is a biotechnology company, focused on research & development of molecular diagnostics in oncology and inflammatory diseases. The company is headquartered in Rotterdam and complemented with a field medical and scientific affairs team in the USA and a CAP/CLIA certified laboratory in San Diego. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predict a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. About Novalis LifeSciences Novalis LifeSciences LLC is a boutique investment and advisory firm that was founded in 2017 by Marijn E. Dekkers, and is based in Hampton, NH, USA. With a team of experienced operating executives from the Life Science industry, Novalis funds and advises visionary Life Science entrepreneurs. The firm has approximately USD 500M under management in two investment funds.

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INDUSTRIAL IMPACT

Cyclica launches Perturba Therapeutics, a spin out from the University of Toronto, creating the next-generation oncology biotech

Cyclica Inc. | February 10, 2022

Cyclica Inc. a neo-biotech with the vision to advance the most robust and sustainable drug discovery pipeline, launches Perturba Therapeutics Inc. a spin out from the Stagljar Lab at the University of Toronto, Donnelly Centre for Cellular and Biomolecular Research. Perturba is advancing a rich pipeline of assets from undrugged protein-protein interactions (PPIs). Only a small subset of biologically important drug targets are currently being explored within the pharma industry. Perturba is taking this challenge on by integrating Cyclica’s comprehensive AI-augmented proteome-wide drug design technology with two first-in-class live cell-based assays from the Stagljar Lab. With this integrated AI-augmented drug design and empirical phenotypic approach, Perturba is developing precision therapies that modulate PPIs and PPI-mediated biological processes with a focus on difficult-to-treat cancers. Perturba will initially focus on advancing two EGFR triple mutant inhibitors for non-small cell lung cancer, and four programs targeting small GTPases for various intractable cancers. Naheed Kurji, Co-Founder, CEO and President of Cyclica indicates that “More than half of all human disease-related proteins are considered undruggable using conventional approaches. As a result, patients suffering from life threatening diseases are left waiting for treatment. What others view as “undruggable”, we see as potential. Perturba represents an important franchise in the pursuit of our cancer strategy. We’re so excited to partner with Professor Stagljar and the world class Stagljar Lab in driving forward our shared vision.” "over the past two years, my lab has developed two high impact, live cell-based technologies for studying protein-protein interactions and identifying novel drug molecules – MaMTH-DS and SIMPL. Combining these two technologies with Cyclica’s world-class AI-drug design approach will usher in a new way to conduct drug discovery for highly intractable targets in an unprecedented way at scale. I’ve known Naheed and the team at Cyclica for years and jointly have shown multiple proof points using our platforms with a program targeting an osimertinib resistant EGFR triple mutant that we will be progressing in Perturba, and a program targeting an oncogenic KRAS in a separate collaboration that gave us confidence to target other small GTPases in Perturba.” Dr. Igor Stagljar, Professor at University of Toronto’s Temerty Faculty of Medicine and Principal Investigator at the Donnelly Centre Seasoned drug developer Rick Panicucci, PhD, SVP at BridgeBio Pharma and a long time advisor at Cyclica has been appointed as non-executive Chairman of Perturba to help oversee the company's strategy. Su Dharmawardhane Flanagan, PhD, Tony Hunter, PhD and Ming Tsao, MD, have been appointed to Perturba’s Scientific Advisory Board. Cyclica will provide initial funding for Perturba and will seek external funding from strategic partners as required. “I’ve been involved in drug discovery & development for over 25 years. What I can say with certainty is that the way things will be done going forward is going to be very different from how it was done before. I’ve been an advisor at Cyclica for 6 years and have witnessed first hand the power of AI and data-first approaches to drive drug discovery fast and with quality. Now, with Perturba and integrating AI drug design and phenotypic assays opens a whole new way of design-make-test-analyze at scale for target classes that have been ignored for too long,” shares Panicucci. About Perturba An integrated oncology focused biotech company for unaddressable and undrugged targets. Founded in 2021 as a venture between Cyclica and the Stagljar Lab at the University of Toronto, Perturba integrates Cyclica’s AI-augmented drug discovery platform with sensitive, live-cell drug screening assays, MaMTH-DS and SIMPL from the Stagljar lab. Perturba is developing precision therapies at scale that modulate PPIs and PPI-mediated biological processes. About Cyclica Cyclica advances molecules that embrace the complexity of disease. A neo-biotech whose work spans dozens of collaborations with large pharma, biotech and several joint ventures. We are a passionate team of biotech and pharma professionals, biologists, chemists, and computer scientists who live and labour at the intersection of our collective expertise. About the Stagljar Lab and the Donnelly Centre The Stagljar lab at the University of Toronto is one of the world leading labs in the field of proteomics/chemical genomics, developing high-throughput technologies to facilitate the study of the protein-protein interactions (PPIs) of various human membrane proteins involved in cancer and rare genetic diseases such as cystic fibrosis. The Stagljar lab is currently directing major proteomics/chemical genomics projects to map how integral membrane proteins interact to produce either healthy or diseased cells, to identify novel therapeutic targets, and to screen for novel drugs using artificial intelligence platforms, in particular to target lung, colon, breast and pancreatic cancer. In close collaboration with medicinal chemists and clinical investigators, the Stagljar lab investigates the molecular mechanisms behind challenging, unexplained observations on drugs and on pathological events.

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CELL AND GENE THERAPY

Takeda to Acquire Adaptate Biotherapeutics to Develop Novel Gamma Delta (γδ) T Cell Engager Therapies Targeting Solid Tumors

Takeda | January 11, 2022

Takeda Pharmaceutical Company Limited announced the exercise of its option to acquire Adaptate Biotherapeutics a UK company focused on developing antibody-based therapeutics for the modulation of variable delta 1 (Vδ1) gamma delta (γδ) T cells. Through the acquisition, Takeda will obtain Adaptate’s antibody-based γδ T cell engager platform, including pre-clinical candidate and discovery pipeline programs. Adaptate’s γδ T cell engagers are designed to specifically modulate γδ T cell-mediated immune responses at tumor sites while sparing damage to healthy cells. The planned acquisition of Adaptate follows Takeda’s recently exercised option to acquire GammaDelta Therapeutics and is intended to further accelerate the development of innovative γδ T cell-based therapies. Combining GammaDelta’s cell therapy-based platform and Adaptate’s antibody-based γδ T cell engager platform with Takeda’s strong research and development organization positions Takeda to be at the leading edge in deploying the full potential of γδ T cells in the fight against cancer. The planned acquisition complements Takeda’s ongoing efforts to research and develop cell engagers for solid tumor applications, bolstered by the novel T cell engager COBRA platform, which was acquired from Maverick Therapeutics in another successful build-to-buy collaboration. “Partnering with early-stage innovators to access cutting-edge platforms in the fight against cancer is at the center of our R&D strategy. Adaptate’s γδ T cell engager platform and the team’s deep understanding of γδ T cell biology gives us an opportunity to develop a new class of therapeutics that tap into powerful innate immune mechanisms. The planned acquisition will strengthen our immuno-oncology R&D efforts as part of our ongoing pursuit of life-transforming medicines for patients with cancer.” Christopher Arendt, Ph.D., Head of Oncology Cell Therapy and Therapeutic Area Unit of Takeda Adaptate was formed in 2019 as a spin-out company from GammaDelta with investment from Abingworth LLP and Takeda, in which Takeda received an exclusive right to purchase Adaptate for a pre-negotiated upfront payment. The acquisitions of Adaptate and GammaDelta are expected to be finalized in Q1 of Takeda’s fiscal year 2022, pending completion of review under applicable antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S. “Our acquisition by Takeda recognizes the tremendous work put in over the last two years by Adaptate’s incredibly talented team,” said Dr. Natalie Mount, CEO of Adaptate. “We have rapidly demonstrated, in preclinical models, the therapeutic potential of our novel Vδ1-targeting antibodies, and this move brings us an exciting step closer to realizing the full potential for Vδ1 T cell targeted therapies to improve treatment outcomes for cancer patients.” In addition, Tim Haines, Chair & Managing Partner at Abingworth noted, “Having played an instrumental role in creating Adaptate, we are delighted to see the impressive developments of its γδ T cell therapeutic antibody portfolio to date, under the leadership of Natalie Mount. We look forward to seeing Takeda progress Adaptate’s very promising therapeutic antibodies into the clinic.” Takeda’s oncology pipeline focuses on novel strategies that leverage the power of the immune system, with a focus on innate immunity. Innate immune responses serve as the body’s first defense mechanism against disease and involve the orchestration of a broad arsenal of mechanisms and cell types, including γδ T cells and natural killer (NK) cells, that may help to overcome cancer’s ability to evade immune recognition. Adaptate has discovered a unique set of antibodies that selectively modulate γδ T cell activity in the tumor microenvironment. The antibodies provide a precisely targeted signal to the immune system, thereby offering the opportunity for superior efficacy and safety compared to conventional immuno-oncology approaches in solid tumors. Takeda’s Commitment to Oncology Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. About Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in healthcare in approximately 80 countries and regions. About Adaptate Biotherapeutics Adaptate Biotherapeutics is an immunotherapy company developing an innovative portfolio of therapeutic antibodies designed to modulate the activity of a patient’s own cytotoxic gamma delta T cells in situ. Our exquisitely targeted approach offers the potential to safely and effectively address the challenges often encountered by current cancer immunotherapies.

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CELL AND GENE THERAPY

Exact Sciences Acquires PreventionGenetics to Accelerate Availability of Hereditary Cancer Testing for More Patients

Exact Sciences Corporation | January 10, 2022

Exact Sciences Corp. announced it has acquired PreventionGenetics, a genetic testing laboratory, to complement its advanced cancer diagnostics portfolio and support its entrance into hereditary cancer testing (HCT). PreventionGenetics provides the clinical lab, expertise, and foundational technology necessary to accelerate the availability of HCT and help more patients know their germline risk of cancer and other diseases. "PreventionGenetics is a natural fit with Exact Sciences, and we're thrilled to have their talented team join in our mission to make earlier cancer detection a routine part of medical care. We share in PreventionGenetics' belief that genetics can transform medicine, improve lives, and help eradicate cancer. With our deep relationships in primary care and PreventionGenetics' strong reputation among genetics specialists, Exact Sciences can help more people understand their inherited risk of cancer to catch it earlier and treat it more effectively." Kevin Conroy, Exact Sciences chairman and CEO Nearly 300,000 health care providers and more than 200 large U.S. health systems rely on Exact Sciences' Cologuard® and Oncotype DX® tests in primary care, women's health, oncology, and other specialties. In partnership with the PreventionGenetics team, Exact Sciences plans to leverage its unmatched commercial reach in diagnostics to expand hereditary cancer and genetic testing throughout the U.S. and globally. PreventionGenetics is a CLIA-certified and CAP-accredited clinical DNA testing laboratory, providing more than 5,000 predefined genetic tests for nearly all clinically relevant genes, additional custom panels, and comprehensive germline whole exome and whole genome sequencing tests. With a goal to improve lives through genetic testing, PreventionGenetics offers tests spanning decades of life including proactive health and wellness, cancer risk and screening, pediatric and adult-onset rare diseases, and others. These high-quality genetic tests are supported by deep sequencing capabilities and more than 100 peer-reviewed publications. Like Exact Sciences, the PreventionGenetics team is relentless in their pursuit of quality. This focus, combined with a best-in-class customer experience and turnaround times, has earned PreventionGenetics a strong reputation and brand recognition among genetics specialists and counselors. Transaction Terms Under the terms of the agreement, PreventionGenetics received total consideration of $190 million, comprised of 50% in Exact Sciences common stock and 50% in cash. PreventionGenetics expects preliminary, unaudited 2021 revenue of approximately $36 million and $3 million in adjusted EBITDA. XMS Capital served as financial advisor to Exact Sciences and K&L Gates served as its legal advisor. CrossTree Capital served as financial advisor to PreventionGenetics, and Winston & Strawn served as legal advisor. About PreventionGenetics Founded in 2004 and located in Marshfield, Wisconsin, PreventionGenetics is a CLIA and ISO 15189:2012 accredited laboratory. PreventionGenetics delivers clinical genetic testing of the highest quality at fair prices with exemplary service to people around the world. PreventionGenetics has 25 PhD geneticists on staff and provides tests for nearly all clinically relevant genes including the powerful and comprehensive germline whole genome sequencing test, PGnome® and whole exome sequencing test, PGxome®. About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer.

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