Douglas Pharmaceuticals | January 27, 2023
A clinical advisory board has been established to support Douglas Pharmaceuticals' lead program R-107, an oral extended-release dose of racemic ketamine being developed as an adjunctive or stand-alone therapy for treatment-resistant depression.
Douglas Pharmaceuticals is a New Zealand-based pharmaceutical company specializing in the development of specialty generic and repurposed medications (TRD).
Peter Surman, Chief Scientific Officer expressed, "We are very excited to bring together a group of world-class experts in the field of psychiatry, to help guide our late-stage development of R-107." "We believe their deep knowledge in the field, insights and contributions will be instrumental in charting an efficient course through pivotal clinical studies in TRD," he added.
(Source – Cision PR Newswire)
Some of the members of the clinical advisory board are as follows:
• Prof. Paul Glue [MB, ChB (Otago), MD (Bristol), FRCPsych]
• Prof. Alan F. Schatzberg, [MD] • Prof. Sanjay J. Mathew [MD]
• Prof. Allan Young [MB, ChB, MPhil, Ph.D., FRCP (Edin.), FRCPC, FRCPsych]
• Prof. Wiesław J. Cubała, [MD, PhD]
• Prof. Colleen Loo [MBBS (Hons), FRANZCP, MD]
About Douglas Pharmaceuticals
New Zealand's largest private pharmaceutical and healthcare firm, Douglas Pharmaceuticals, employs over 700 people and exports to over 40 countries. The company provides creative, competitive, and high-quality healthcare solutions to 'improve lives'. It designs, manufactures, and distributes unique and generic products, preferring those with significant intellectual property and technological complexity in high-unmet need sectors. The company's presence in international markets continues to grow, exposing New Zealand to the world. It is dedicated to improving people's health all around the globe. Some of the products that the company works with cutting-edge partners to develop, make, market, and distribute are pharmaceuticals, nutraceuticals, automated compliance systems, and consumer healthcare items.
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.
BUSINESS INSIGHTS, PHARMA TECH
Epredia | January 19, 2023
On January 18, 2023, PHC Group, a healthcare company renowned in diagnostics and life sciences, announced that it would join the RegeneratOR Innovation Accelerator to grow its presence in regenerative medicine. The Wake Forest Institute for Regenerative Medicine (WFIRM) and the RegenMed Development Organization (ReMDO) are the two institutions expediting the discovery and translation of regenerative medicine therapeutics located in the Innovation Quarter.
PHC Group, being an early partner of ReMDO's RegeneratOR Test Bed, offered advanced tissue processing technologies as well as support to researchers for prototype and product development. In addition, another ReMDO program, the Innovation Accelerator, was formed to give space and support to companies with innovative or emerging regenerative medicine technologies.
PHC Group is now opening a local office within the Innovation Accelerator. Its holding companies and partners include Epredia, a precision cancer diagnostics company whose products are used by researchers and pathologists worldwide, and Aiforia, a medical software company that develops artificial intelligence software for image analysis in pathology. Aiforia's collection of preclinical and clinical pathology instruments is distributed globally by Epredia.
The firms work together to deliver slide imaging and AI-based solutions that enable researchers to investigate and extract information beyond the scope of human visual perception. Thus, clinical research, drug discovery, and translational studies with the goal of better understanding disease states are all linked together through diagnostic microscopic imaging and artificial intelligence.
PHC Group's presence, along with Epredia and Aiforia's superior technology assistance at the Innovation Accelerator, will also pave the path for RegeneratOR's newest initiative, the RegenMed Clinical Trials Catalyst.
As a part of Wake Forest University School of Medicine and the academic core of the newly merged Advocate Aurora Health and Atrium Health, the Catalyst will have access to 5.5 million patients, serving 67 hospitals in North Carolina, Wisconsin, South Carolina, Georgia, Alabama, and Illinois.
Epredia is a leading comprehensive laboratory solutions provider for instruments and consumables in anatomic pathology, histology, and cytology. It was established through an acquisition by PHC Group from Thermo Fisher Scientific. The company provides solutions for cancer diagnostics through its renowned brands: Richard Allen Scientific, Erie Scientific, Microm, Shandon, and Menzel-Glaser. Epredia is committed to realizing its aim of advancing cancer diagnostics for patients worldwide in order to save lives.