On November 30, 2021 Synaffix B.V., a biotechnology company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with best-in-class therapeutic index, reported the expansion of its license agreement with Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need (Press release, Synaffix, NOV 30, 2021, View Source [SID1234596604]).

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Under the expanded license agreement, Mersana will expand its access to Synaffix’s GlycoConnect site-specific ADC bioconjugation technology for six additional ADC targets. The license rights granted to Mersana are tied to specific ADC targets to be selected and provide non-exclusive access to deploy GlycoConnect site-specific ADC bioconjugation technology against the specified targets. Under the expanded deal, Synaffix is eligible to receive upfront and milestone payments on a per-target basis with a total potential deal value exceeding $1 billion plus royalties. This builds on the long-term relationship between the two companies announced in 2019.

Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics, said:

"Our collaboration with Synaffix and use of the GlycoConnect site-specific ADC bioconjugation technology has yielded highly innovative ADC products with superior characteristics. Based on the data that we generated to date across multiple programs, we have gained the confidence to significantly expand our collaboration with Synaffix and elect GlycoConnect as our preferred site-specific ADC bioconjugation technology."

Peter van de Sande, Chief Executive Officer of Synaffix, said:

"We are delighted to expand our collaboration with Mersana, a leader in ADC innovation, who will be utilizing our GlycoConnect platform to build out their pipeline with innovative ADC cancer therapeutics. We are honored to see the confidence that Mersana has placed in our platform, demonstrating once again the added value GlycoConnect can bring to innovative ADCs."

Mersana will continue to be responsible for the research, development, manufacturing and commercialization of any resulting ADC products.

This licensing agreement expansion follows three recent ADC technology out-licensing agreements with Kyowa Kirin, a global specialty pharmaceutical company; ProfoundBio, an emerging oncology biotherapeutics company; and Innovent Biologics, a leading biopharmaceutical company developing innovative medicines for the treatment of major diseases. Other collaborators include ADC Therapeutics and Shanghai Miracogen. Twelve ADCs using Synaffix’s technology are currently in development of which three are in clinical development.

On November 30, 2021 PCI Biotech Holding ASA (OSE: PCIB), a cancer focused biopharmaceutical company with a unique intracellular delivery technology via Photochemical Internalisation and Immunicum AB (publ; IMMU.ST), a biopharmaceutical company focused on hard-to-treat established tumors and the prevention of cancer recurrence, reported an extension of their current collaboration (Press release, PCI Biotech, NOV 30, 2021, View Source [SID1234596457]).

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The companies jointly research the possibility to overcome current hurdles in cancer immunotherapy by introducing tumor independent immune targets into the tumor microenvironment, in combination with vaccination or adoptive immunotherapies. The so-called Tumor Independent Antigen concept, which has been invented by Immunicum, could benefit from PCI Biotech’s antigen delivery technologies based on Photochemical Internalisation. Following the encouraging results of the first set of in vitro experiments, during which the delivery protocol of the combination treatment has been optimized, the companies have decided to move ahead to evaluate the novel therapeutic concept in animal models. While the first experiments were conducted by Immunicum, this further in vivo evaluation will be carried out by PCI Biotech.

Commenting on the announcement PCI Biotech’s CEO, Per Walday said: "The results of the initial collaborative experiments are encouraging, supporting the immune response enhancing capability of the fimaVacc platform technology. We are committed to this collaboration and are looking forward to the next series of experiments in animal models, which are aimed to generate data that could pave the way to a potential joint development program."

Erik Manting, CEO of Immunicum added: "At Immunicum, we are continuously studying novel immunotherapy concepts aimed to address hard-to-treat established tumors and to overcome the limitations of currently available cancer therapies. In this collaboration, we are combining our know-how and technology basis with that of PCI Biotech to design potential novel therapeutic concepts and we look forward to advancing the collaboration through in vivo studies as an important next step."

On November 30, 2021 Orion Biotechnology, a clinical stage company unlocking the therapeutic potential of G Protein-Coupled Receptors (GPCRs) with a novel drug modality, proven discovery platform and best-in-class molecules, reported the successful completion of its OB-004 lead optimization (Press release, Orion Biotechnology, NOV 30, 2021, View Source [SID1234596387]). OB-004 is a GPCR targeted protein analog of CCL2 that targets the CCR2 receptor. The CCL2/CCR2 pathway plays an important role in oncology, inflammatory, metabolic, and neurological disorders.

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Using its proprietary drug discovery technology, Orion successfully completed the development of OB-004 from target identification to lead optimization in only 6 months, a significant reduction in discovery time compared to industry averages. Furthermore, based on inhibition of in vitro signaling, OB-004 is a best-in-class CCR2 antagonist compared to other small molecule CCR2 antagonists in development. This is yet another example demonstrating the superiority of Orion’s discovery platform and novel drug modality to target complex GPCRs.

"Development of a best-in-class CCR2 antagonist in 6 months is an extraordinary accomplishment and validates the power and versatility of our drug discovery platform" said Dr. Oliver Hartley, Vice President of Drug Discovery at Orion Biotechnology. "This powerful tool will allow Orion to rapidly expand its pipeline and also provides us with the opportunity to collaborate with other groups in facilitating the identification and development of GPCR targeted drugs, including the ability to target orphan GPCRs".

Dr. Ian McGowan, Chief Medical Officer at Orion Biotechnology, added "The rapid development of a potent CCR2 antagonist will provide us with the opportunity to evaluate OB-004 in several important diseases with significant unmet medical need including oncological, metabolic, and inflammatory disorders. I look forward to advancing OB-004 into preclinical efficacy studies early next year".

On November 30, 2021 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it is scheduled to participate in the following upcoming events (Press release, Arrowhead Pharmaceuticals, NOV 30, 2021, View Source [SID1234596346]):

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4th Annual Evercore ISI HealthCONx Conference

December 2, 2021, 1:00 p.m. ET – Chris Anzalone, Ph.D., Arrowhead’s president and CEO, will participate in a fireside chat presentation

18th Global Cardiovascular Clinical Trialists Forum

December 3, 2021 – James Hamilton, MD, MBA, Arrowhead’s senior vice president of discovery & translational medicine, will participate in a panel discussion titled, "Developments in Hypertriglyceridemia Trials"

A copy of the presentation materials and/or live webcast links may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.

On November 30, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical-stage cell therapy company and the ASX leader in cell therapy, reported that it has entered into an exclusive option to license agreement with Case Western Reserve University (CWRU) for a Clinically validated, Off the shelf, Robust, Enhanced Natural Killer (CORE-NK) cell platform – a platform technology that provides the optimal foundation for the development of multiple next generation NK and CAR-NK products (Press release, Chimeric Therapeutics, NOV 30, 2021, View Source [SID1234596312]).

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Natural killer (NK) cells have innate safety features and the natural ability to target and destroy cancer cells through both indirect and direct mechanisms. The challenge with natural killer (NK) cells is that they are not naturally abundant or active enough to overcome cancer.

Dr. David Wald, a leading expert in immuno-oncology at Case Western Reserve University in Ohio, USA designed and developed the CORE-NK platform, enhancing the natural anti-cancer properties of NK cells to be robust and active enough to overcome cancer.

The CORE-NK platform utilizes a foundation of healthy donor NK cells, activating and expanding them to establish an enhanced, off the shelf NK cell platform that can provide an abundant supply of highly active NK cells. Preclinical data on the CORE-NK platform was published in the prestigious family of Nature publications in 2019.

In May 2018 a phase 1 clinical trial was initiated at the Case Comprehensive Cancer Center to study the CORE-NK platform in patients with both solid tumours and blood cancers. The phase 1 clinical trial of the CORE-NK platform was completed in June 2021 with clinical data expected in 2022. The trial examined the safety, bioactivity and efficacy of the CORE-NK platform cells at 3 dose levels in patients with both blood cancers and solid tumours.

With the clinical validation from the phase 1 trial complete, the CORE-NK platform provides the ideal off the shelf platform for the development of next generation NK and CAR-NK products.

Chimeric intends to begin a research collaboration with CWRU to further enhance and engineer the CORE-NK platform cells to develop a next generation CORE-NK platform and three initial CAR-NK products.

"The clinical experience we’ve had with the CORE-NK platform gives us tremendous confidence in the development path for optimized NK and CAR NK products. We look forward to working in close collaboration with Chimeric to bring forward the next generation of NK and CAR NK products to the clinic," said Dr. Wald, MD, PhD, Associate Professor of Pathology Case Western Reserve University School of Medicine and Member, Immune Oncology Program, Case Comprehensive Cancer Center, Associate Director for Basic Research, University Hospitals, Wesley Center for Immunotherapy.

The next generation CORE-NK platform will be developed with enhanced activation and expansion features with plans to study it as a combination therapy in blood cancers.

Three initial CAR-NK products will be developed using the next generation CORE-NK platform as a backbone leveraging Chimeric’s existing pipeline of chimeric antigen receptors (CARs); a CLTX CAR-NK (CHM 1301), a CDH17 CAR-NK (CHM 2301) and a currently undisclosed target CAR-NK (CHM 3301).

Chimeric will also explore additional opportunities to further leverage the CORE-NK platform to develop additional NK and CAR NK products through internal development and/or partnerships with other biotech and pharmaceutical companies.

This strategic agreement is transformative for Chimeric propelling the company forward as the Australian leader in cell therapy and as an emerging global cell therapy company with a robust and advanced portfolio of innovative autologous (personalized) and allogeneic (off the shelf) NK and T cell assets.

"The CORE-NK platform is truly transformative for Chimeric. It provides us with a platform technology that triples our current portfolio by enabling us to accelerate the development of multiple new, off the shelf, NK cell assets that work in perfect synergy with our existing pipeline. We could not be more excited to be bringing the CORE-NK platform into our portfolio and to be working in collaboration with Dr. Wald and the expert team at CWRU. Their clinical trial experience with the CORE-NK platform and their expertise in the development of NK cells will catapult our development forward," said Jennifer Chow, CEO Chimeric Therapeutics.

Under the terms of the option agreement, Chimeric has the exclusive right to license the CORE-NK platform for development and commercialization in cancer. Chimeric intends to rapidly move to complete full licensing of the platform and expects to pay CWRU development milestones and industry standard royalty payments based on commercial net sales. Upfront fees associated with the option agreement will be funded entirely from existing cash reserves.

The area of natural killer cells has seen widespread investment and partnership interest with numerous large transactions involving companies such as Merck, Takeda, Janssen and Kite.

Investor webinar

Chimeric Therapeutics CEO and Managing Director Jennifer Chow will hold an investor webinar today, Wednesday 1 December 2021, at 11am AEDT to elaborate on this announcement and take questions.

Click the link below to register:
View Source

After registering, you will receive a confirmation email about how to join the webinar. A recording of the webinar will be available at the same link shortly after the conclusion of the session.