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Exelixis and BioInvent Establish Exclusive Option and License Agreement to Develop Novel Antibody-Based Immuno-Oncology Therapies

On June 16, 2022 Exelixis, Inc. (Nasdaq: EXEL) and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV) reported that the companies have entered into an option and license agreement focused on the identification and development of novel antibodies for use in IO therapeutics (Press release, Exelixis, JUN 16, 2022, View Source [SID1234616017]). The collaboration is intended to expand Exelixis’ portfolio of antibody-based therapies and will combine BioInvent’s cancer immunology and antibody biology expertise with Exelixis’ expertise and resources in antibody engineering and antibody-drug conjugate (ADC) technologies, and proven history of developing and commercializing oncology therapeutics. Target and antibody discovery will be performed using BioInvent’s proprietary n-CoDeR antibody library and patient-centric F.I.R.S.T screening platform, which together allow for parallel target and antibody discovery.

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Under the terms of the agreement, Exelixis will pay BioInvent an upfront fee of $25 million in exchange for rights to select three targets identified using BioInvent’s proprietary F.I.R.S.T platform and n-CoDeR library. BioInvent will be responsible for initial target and antibody discovery activities, and characterization of antibody mechanism of action. Exelixis will have the right to exercise an option to in-license any of the target programs upon identification of a development candidate directed to that target. Upon option exercise, Exelixis will pay BioInvent an option exercise fee and will assume responsibility for all future development and commercialization activities for the development candidate, including potential ADC and bispecific antibody engineering activities. In addition, BioInvent will be eligible for success-based development and commercialization milestones, as well as tiered royalties on the annual net sales of any products that are successfully commercialized under the collaboration.

"Expanding our biotherapeutics pipeline is a key strategic priority, and this agreement provides Exelixis with access to BioInvent’s antibody and cancer immunology expertise centered around the innovative F.I.R.S.T discovery platform, which rapidly screens samples from patients with cancer to identify antibodies and targets with promising therapeutic potential," said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer, Exelixis. "We believe this patient-centric and biology-driven approach has great potential to identify novel targets and enable the development of differentiated antibody-based IO therapies."

"BioInvent is committed to translating our expertise in cancer immunology and antibody mechanism of action into innovative IO therapies that can improve outcomes for patients," said Martin Welschof, CEO, BioInvent. "Exelixis has a demonstrated track record of success in both commercializing important new oncology medicines and establishing highly productive collaborations that integrate diverse and complementary skill sets and technologies – such as toxin and cytokine conjugation of monoclonal antibodies for ADC and bispecific monoclonal antibody technologies – to enable the identification and development of innovative therapies with significant clinical and commercial potential. We believe that our cancer immunology expertise and discovery platform will support Exelixis’ mission to expand its biologic pipeline, and we very much look forward to working together."

VAR2 PHARMA RAISES AN ADDITIONAL 10M EURO TO FUND CLINICAL TRANSLATION OF THE ONCOFETAL CHONDROITIN SULFATE ANTIBODY PROGRAM

On June 15, 2022 VAR2 Pharmaceuticals reported through a Distinguished Innovator grant from Novo Foundation to the company’s collaborator, University of Copenhagen, the ofCS antibody program has been awarded 1M euro to finalize the preclinical development of the novel cancer targeting antibodies. The grant was partly awarded to promote public private partnerships and entrepreneurship at University of Copenhagen.

(Press release, VAR2 Pharmaceuticals, JUN 15, 2022, View Source [SID1234662312])

ImmuneOnco’s IMM27M，an ADCC-enhanced CTLA-4 antibody completed the first patient enrollment and dosing

On June 15, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") reported that its newly developed ADCC-enhanced CTLA-4 antibody (IMM27M) completed the first patient enrollment and first dosing (Press release, ImmuneOnco Biopharma, JUN 15, 2022, View Source [SID1234655655]). The administration and the infusion process was smooth.

The target CTLA-4 is the first clinically validated immune checkpoint and the first antibody drug (ipilimumab) approved for marketing in 2011. The price of one dose in the first prescription issued in China is￥28,000.

IMM27M is an IgG1 antibody against CTLA-4. It has been genetically engineered to enhance ADCC activity. Comparing to the similar drug Ipilimumab, its efficacy in animals is much better at the same dosage (see the fig.). And IMM27M can remove the tumor completely at as low as 0.3 mg/kg.

Dr. Tian, Wenzhi, the founder, chairman and CEO of ImmuneOnco, said: "We are very pleased that our next-generation CTLA-4 antibody project, IMM27M, completed the first patient enrollment and dosing. Multiple repeatable in vivo studies have demonstrated that IMM27M has strong anti-tumor activity and can be combined with various drugs in the company’s pipeline. The combination therapy of CTLA-4 with PD1/PD-L1 has been proven to have clear clinical synergy, and indeed BMS’ ipilimumab combined with Opdivo has been approved by the FDA for multiple indications including melanoma, colorectal cancer, renal cell carcinoma, hepatocellular carcinoma, and non-small cell lung cancer.We believe that IMM27M have great value for clinical development."

"We will continue to advance the research of the IMM27M project to bring good news to cancer patients."

Coya Therapeutics Secures Option Agreement for Exclusive Worldwide Rights to Exosome Engineering Technology from Carnegie Mellon University

On June 15, 2022 Coya Therapeutics, Inc. (Coya), a clinical-stage biotechnology company developing multiple first-in-class and best-in-class approaches that enhance regulatory T cells (Tregs) function in vivo, including autologous and allogeneic Treg-derived exosome therapeutics, and novel biologics, reported the execution of an option agreement for exclusive worldwide rights to a novel and proprietary technology platform enabling exosome engineering from Carnegie Mellon University (Press release, Coya Therapeutics, JUN 15, 2022, View Source [SID1234635089]).

The exclusive option agreement involves the intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids (EPHs), a tether-based exosome functionalization strategy that enables Treg exosomes to be homed to proteins of interest, while delivering select payloads into those targeted cells.

"This collaboration with Carnegie Mellon University further solidifies Coya’s thought leadership in the global exosome therapeutics field, beyond Treg-derived exosomes alone," stated Howard Berman, Ph.D., CEO of Coya Therapeutics. "Nanoengineering exosomes with such manufacturing efficiency to produce EPHs that can be customized to any surface protein, delivering growth factors or drugs, while enhancing cellular uptake and bioactivity is the future of targeted therapies."

Previously, most techniques to modify exosomes relied on complex molecular biology tools or degradation of exosomes innate functionality. EPHs overcome many of these limitations by creating a method that rapidly and efficiently modifies exosomes with a DNA-cholesterol tether. The technology leverages single stranded synthetic DNA with attached cholesterol, binding a complementary strand of DNA linked to a bioactive agent. As a result, a number of different types of cargos can be readily attached to the exosome surface while also tethering immune modulating cargoes inside the exosome.

"The next step of our development program will be to leverage EPHs to validate functional activity of our Treg-derived exosomes that home in and bind to high profile protein targets that drive specific disease processes. Additionally, these EPHs will be loaded with identified payloads to enhance efficacy," stated Adrian Hepner, M.D., Ph.D., Chief Medical Officer of Coya Therapeutics.

Drs. Subha Das and Phil Campbell of Carnegie Mellon University added: "Targeted Treg exosome therapeutics that are directed to epitopes and proteins of interest, while delivering potent growth factors, drugs or other cargo, represent an innovative platform that is advantageous on many fronts relative to other CAR Treg directed platforms. We are excited and committed in joining this collaboration with Coya Therapeutics."

BioStock Life Science Spring Summit

On June 15, 2022 Sprint Bioscience CEO Erik Kinnman presented the company at BioStock Life Science Spring Summit, June 8-9, 2022 (Presentation, Sprint Bioscience, JUN 15, 2022, View Source [SID1234616438]).