PHARMACY MARKET, PHARMA TECH
Sanofi and Innate Pharma | December 19, 2022
Innate Pharma SA and Sanofi announced an expansion of their collaboration, with Sanofi licensing a natural killer cell engager program targeting B7H3 from Innate’s ANKETTM. Sanofi will also have the option to add up to two additional ANKETTM targets. Upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.
Innate and Sanofi signed a first NK cell engagers collaboration in 2016 for the generation and evaluation of up to two bispecific NK cell engagers, which are currently being evaluated by Sanofi’s R&D team, with one of these molecules already in clinical studies.
“At Sanofi, we are exploring the potential of NK cells for cancer immunotherapy, a key pillar for our oncology strategy. Our relationship with Innate aligns with our commitment to work with promising French companies and supports our ambition to develop a diverse portfolio of next-generation NK cell engagers, highly synergistic with Sanofi’s allogeneic NK cell platform, engineered lymphokines that stimulate NK cells, and growing Immuno-oncology pipeline. As a leading global company with roots in France, we are proud to collaborate to support the French healthcare ecosystem.”
Valeria Fantin, Ph.D., Global Head of Oncology Research at Sanofi
Yannis Morel, Ph.D., Executive Vice President, Product portfolio strategy & Business development at Innate Pharma
“Building on the success of our existing collaboration on hematologic targets, we are pleased to expand and strengthen our partnership with Sanofi on NK Cell Engagers with the addition of up to three new programs, including in solid tumors. Sanofi’s investment in Innate further validates the value of our ANKETTM platform and its potential to address multiple tumor types. By incorporating various tumor antigen binders, NK Cell Engagers are a versatile technology that may provide new options for patients and offer clinical benefit across multiple cancers, whilst also maintaining a good safety profile. This agreement also highlights Innate’s strategy to build a broad portfolio of ANKET programs addressing different types of cancer.”
Under the terms of the new license agreement, Innate will receive €25m upfront payment and up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales. Closing of the transaction is subject to HSR approval.
ANKETTM is Innate's proprietary platform for developing next-generation, multi-specific natural killer cell engagers to treat certain types of cancer.
This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer. It leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.
Our latest innovation, the tetra-specific ANKET molecule, is the first NK cell engager technology to engage activating receptors a tumor antigen and an interleukin-2 receptor via a single molecule.
About 2016 Sanofi/Innate research collaboration and licensing agreement
In 2016, Sanofi and Innate entered into a research collaboration and licensing agreement for the generation and evaluation of up to two bispecific NK cell engagers, using technology from Innate Pharma and Sanofi’s proprietary bispecific antibody format as well as tumor targets.
A Phase 1/2 clinical trial by Sanofi is ongoing, evaluating IPH6101/SAR’579 the first NKp46/CD16-based CD123-targeted ANKETTM NK cell engager, in patients with relapsed or refractory acute myeloid leukemia B-cell acute lymphoblastic leukemia or high-risk myelodysplastic syndrome.
In the summer 2022, Sanofi had made the decision to progress IPH6401/SAR’514 into investigational new drug (IND)-enabling studies. IPH6401/SAR’514 is a BCMA-targeting NK cell engager using Sanofi’s proprietary CROSSODILE® multi-functional platform, which comprises the Cross-Over-Dual-Variable-Domain (CODV) format. It induces a dual targeting of the NK activating receptors, NKp46 and CD16, for an optimized NK cell activation, based on Innate’s ANKETTM proprietary platform.
Under the terms of the original license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales. To date, €13m milestone payments to Innate have been announced.
About Sanofi’s approach to NK therapies in oncology
At Sanofi, we are exploring the intrinsic abilities of Natural Killer cells to create new immunotherapies for patients with cancer. Natural Killer cell-based therapies are a key pillar within Sanofi’s Oncology strategy. By activating the innate power of NK cells, Sanofi is advancing a diverse and complementary range of NK-based therapeutics to transform immune biology. The breadth of our modalities and unique strength to innovate end-to-end maximizes the therapeutic possibilities for more people with cancer.
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 some 100 countries, 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.
About Innate Pharma
Innate Pharma S.A. is a global, clinical-stage oncology-focused biotech company dedicated to improving treatment and clinical outcomes for patients through therapeutic antibodies that harness the immune system to fight cancer.
Innate Pharma’s broad pipeline of antibodies includes several potentially first-in-class clinical and preclinical candidates in cancers with high unmet medical need.
PHARMACY MARKET, PHARMA TECH
Jazz Pharmaceuticals plc and Zymeworks Inc. | December 28, 2022
Jazz Pharmaceuticals plc and Zymeworks Inc. recently informed that the former has chosen to keep its exclusive rights to develop and sell Zymeworks' Zanidatamab in key markets, such as the U.S., Europe, and Japan, as part of the license and collaboration agreement made in October 2022.
A pivotal trial in previously treated HER2-amplified biliary tract tumors (BTC) found that 41.3% (95% CI: 30.4, 52.8) of recruited patients with HER2-amplified and expressing (IHC2+ and 3+) illness achieved an objective response as judged by independent central review. The median response length was 12.9 months (95% CI: 5.95 to not attained). In this trial, Zanidatamab's safety profile was similar to what had been found in previous studies of monotherapy, while no new safety signals were found.
Jazz Pharmaceuticals stated that the compelling top-line clinical data from the pivotal study in patients with BTC demonstrated the transformative potential of Zanidatamab. This big win gives the company more confidence that it can make this medicine better for cancer patients who have big unmet needs. Even though its main focus will be on the ongoing clinical trials for BTC and GEA, these data will add to the growing amount of evidence that Zanidatamab is effective against a wide range of HER2-expressing cancers.
Zymeworks expressed that the collaboration with Jazz is going well, which will speed up the global development of Zanidatamab in many types of cancer and may give patients with hard-to-treat cancers and few treatment options access to a basic HER2-targeted drug.
Jazz will pay Zymeworks $325 million to exercise its option to develop and sell Zanidatamab in all countries except Asia-Pacific in the fourth quarter of 2022.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals, founded in 2003 and located in Dublin (Ireland), innovates to improve the lives of patients and their families. The company transforms biopharmaceutical discoveries into innovative medications to reimagine what's possible.
Zymeworks develops next-generation multifunctional biotherapeutics. Zanidatamab is a new Azymetric™ HER2-targeted bispecific antibody being examined in numerous Phase 1, Phase 2, and pivotal clinical trials globally as a targeted therapeutic option for patients with HER2-positive solid tumors. Zanidatamab Zovodotin (ZW49) is a bispecific antibody-drug combination in Phase 1 clinical development. It combines Zanidatamab's unique design and antibody framework with Zymeworks' ZymeLink™ linker-cytotoxin.
BUSINESS INSIGHTS, PHARMACY MARKET
XtalPi Inc. | December 20, 2022
XtalPi, a pioneering pharmaceutical technology company powered by artificial intelligence and automation, announced a strategic collaboration with the Experimental Drug Development Centre Singapore's national platform for drug discovery and development hosted by the Agency for Science, Technology and Research of Singapore to discover novel treatment candidates for non-small cell lung cancer.
Lung cancer is the second most common cancer and the leading cause of cancer death worldwide. NSCLC accounts for over 80% of all lung cancer cases and its incidence continues to increase globally. The estimated global market size for NSCLC therapeutics will exceed USD20 billion by 2027, according to Research and Markets. Despite increasing interest and investment in drug research, there remains significant unmet needs for effective targeted therapy options for NSCLC patients to achieve better outcomes.
In this collaboration, XtalPi joins forces with EDDC to apply its AI technology, automation platform, and expert domain knowledge to discover promising candidates against a NSCLC target chosen by EDDC. XtalPi will leverage its quantum physics and AI-driven platform to generate and screen through millions of molecules in de novo drug design. The predicted top-performing molecules with desirable drug properties will be validated and optimized in its robotics-powered synthesis and testing lab through iterations. EDDC will offer valuable insight and data on the novel NSCLC target, further accelerating the drug discovery process and propelling the program towards development.
"We are delighted to establish this strategic collaboration with EDDC. XtalPi is committed to serving patients globally by advancing the speed, scale, novelty, and success rate of drug R&D with AI and automation. Through this partnership, we hope to continue expanding our collaborations with top-tier research institutes in the booming Pan-Asia biotech community, drive the quick translation of new discoveries into much-needed therapeutics, and contribute to the improved health and longevity of patients in Asia and around the world."
Dr. Shuhao Wen, co-founder and chairman of XtalPi
Professor Damian O'Connell, Chief Executive Officer of EDDC, comments: "We are excited to partner XtalPi in the translation of science and research into effective and targeted therapies that enable the treatment of cancer. With XtalPi's expertise in AI and automation technologies, we are confident that this collaboration will accelerate the development of potential targeted therapy options for NSCLC patients, which are very much needed."
Founded in 2014, XtalPi founders recognized a common hurdle in drug development having to do with solid polymorphism, which could be successfully tackled with quantum physics predictions. Since then, XtalPi has maintained its focus on identifying and then attacking traditional bottlenecks in biopharmaceutical R&D through innovative technologies. Through considerable capital investments in automation and personnel, XtalPi now has four locations worldwide and employs approximately 1000 employees.