BUSINESS INSIGHTS, PHARMA TECH
ADC Therapeutics | January 03, 2023
Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September.
Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer.
The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL.
Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs.
ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein.
According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics.
About ADC Therapeutics
ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.
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.
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.