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USPTO Issues Patent Covering Immunophotonics’ Lead Drug Candidate, IP-001

On September 14, 2021 Immunophotonics, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary immune-activating carbohydrate polymers for the treatment of metastatic cancers, reported that the U.S. Patent and Trademark Office has issued U.S. Patent No. 11111316 (Press release, Immunophotonics, SEP 14, 2021, View Source [SID1234590685]). The patent covers the composition of matter of Immunophotonics’ lead drug candidate, IP-001, a proprietary synthetic biopolymer anticipated to have applications in the treatment of cancer and infectious diseases.

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The U.S. patent contains 19 claims encompassing the platform potential of IP-001 and structurally similar carbohydrate polymers and will provide Immunophotonics with patent protection in the U.S. until at least 2033, subject to potential regulatory extension if IP-001 is approved for clinical use by the U.S. Food and Drug Administration. With this issuance, the U.S. has joined over 40 countries in granting Immunophotonics patent protection to the composition of matter underlying IP-001.

Tomas Hode, Chief Innovation Officer at Immunophotonics, stated his excitement about the issuance, remarking, "We are thrilled to expand our patent coverage into the United States alongside other key markets where our composition-of-matter claims have been allowed. This patent not only covers our lead drug candidate, IP-001, but will also serve as the core of a biotechnology platform with the potential for myriad applications for activating the immune system against cancer and other diseases. With this issuance, Immunophotonics has completed a crucial step in its development of a robust patent portfolio in the field of oncology and beyond."

Immunophotonics was represented by Foley Hoag LLP of New York in its prosecution of this patent. "We were pleased with the final claims granted in Patent No. 11111316, which protect a family of molecules with a range of pharmacologically relevant structural features. This patent is an ideal foundation for a wide-ranging pharmaceutical platform," observed Lucas Watkins, Ph.D., Deputy Chair of the Patent Prosecution Practice at Foley Hoag.

Pyxis Oncology Appoints Jay M. Feingold, M.D., Ph.D., as Chief Medical Officer

On September 14, 2021 Pyxis Oncology ("Pyxis" or the "Company") reported the appointment of Jay M. Feingold, M.D., Ph.D., as Chief Medical Officer (Press release, Pyxis Oncology, SEP 14, 2021, View Source [SID1234590283]).

"Jay’s track record of success taking oncology ADC programs from discovery to commercial launch coupled with his deep understanding of clinical development perfectly align with our mission to improve the lives of patients with difficult-to-treat cancer," said Lara Sullivan, M.D., Chief Executive Officer of Pyxis. "We look forward to working closely with Jay to build and execute our development strategies to advance our portfolio of next generation ADC and immunotherapy programs to the clinic."

Dr. Feingold added, "I am excited to lead the clinical development activities for Pyxis’ robust portfolio which presents a significant opportunity to meaningfully impact the lives of patients with cancer. I am eager to work alongside the team to build on the Company’s impressive preclinical data, further strengthen the clinical strategy and shepherd its candidates towards the next stage of development to significantly improve the treatment landscape for patients with cancer."

Dr. Feingold holds 20 years of experience in clinical development and medical affairs with a history of successfully bringing new hematology and oncology drugs to market. Most recently, Dr. Feingold served as Chief Medical Officer and Senior Vice President of ADC Therapeutics, where he led the clinical development of six ADCs for hematologic malignancies and solid tumors. Previously, Dr. Feingold worked as Vice President of U.S. Medical Affairs and Chairman of the Global Medical Affairs Oversight Committee at Daiichi Sankyo. Earlier in his career, Dr. Feingold held various executive roles of increasing responsibility at Wyeth Pharmaceuticals and was a member of the Departments of Medicine and Pediatrics and an Associate Director of the Bone Marrow Transplant Program at the University of Connecticut. Dr. Feingold earned his M.D. and Ph.D. from the Albert Einstein College of Medicine and trained in Pediatrics and Pediatric Hematology and Oncology at the UCLA Center for the Health Sciences.

AbbVie dodges hedge fund lawsuit over failed $55B Shire pursuit

On September 14, 2021 AbbVie reported that faced no shortage of criticism and questioning over its decision to abandon its proposed $55 billion Shire buyout back in 2014 (Press release, FiercePharma, SEP 14, 2021, View Source [SID1234587941]). But after years of legal back-and-forth, the company has escaped one high-profile case from hedge funds that alleged the company misled them about its true intentions .

When AbbVie unveiled its proposed Shire deal in July 2014, the company cited a "strong strategic rationale" for the move—not just the tax benefits of acquiring an Irish drugmaker. But shortly after the U.S. Treasury Department rolled out new rules in September 2014 to crack down on controversial so-called tax inversions, the company gave up on the merger.

That sequence of events led to some big losses at hedge funds, which later sued AbbVie alleging fraud. In their lawsuits, the hedge funds said they bought Shire shares hoping the deal would close but that they suffered losses when AbbVie walked away from the deal in October 2014. They said AbbVie’s public statements didn’t match with its private intentions for pursuing Shire.

In a decision Monday, Cook County Circuit Judge Margaret A. Brennan ruled in AbbVie’s favor, granting summary judgement and tossing the hedge funds’ claims. The plaintiffs were "kind of rolling the dice, hoping to make some money" by buying Shire shares after the buyout announcement, the judge said. They "had to do their own analysis" and "had to be aware that there were possibilities that this may not come through," she added.

Representing AbbVie, Gabor Balassa of law firm Kirkland Ellis said the company’s statements about the merger talks—both before and after the July 14, 2014, announcement—contained cautionary language and opinions about the proposed deal, not statements of fact.

RELATED: Hedge fund sues AbbVie for scuttling $55B Shire buyout

The hedge funds saw things differently. Representing the plaintiffs, Robert B. Tannenbaum of Bartlit Beck said AbbVie "repeatedly" told its clients the deal was "not driven by the tax benefits" but that it was "strategically and financially compelling well beyond the tax benefits." That didn’t match with the company’s behind-the-scenes beliefs, Tannenbaum told the court, as evidenced by the company’s decision to walk away from the deal after the U.S. Treasury Department rolled out its anti-inversion rules.

Even after the U.S. Treasury Department issued those rules, AbbVie’s CEO Richard Gonzalez said in a memo to Shire employees that he was "more confident than ever about the potential of our combined organizations," Tannenbaum pointed out.

Behind the scenes, AbbVie’s execs sought the deal primarily for tax purposes, Tannenbaum said. At the time, tax inversions were "extremely controversial and nearly universally unpopular." In that environment, AbbVie developed a "messaging strategy," he said, to talk up more favorable aspects of the deal.

"AbbVie pursued this false messaging strategy to minimize government scrutiny of the deal, avoid long-term reputational harm as a tax avoider and to avoid losing essential Shire shareholder support for the deal," Tannenbaum said.

SPECIAL REPORT: Biopharma’s top broken, unfulfilled or abandoned promises | AbbVie, Rick Gonzalez

In 2016, hedge fund Elliott Management sued AbbVie over the failed merger, and other funds followed with their own lawsuits over subsequent years. Discovery in the litigation has spanned years, with lawyers taking nearly 100 depositions.

In a separate case, AbbVie settled with Shire shareholders in 2019 for an undisclosed amount.

After AbbVie and Shire parted ways on their talks, Takeda ended up buying the Irish drugmaker in 2018 for $62 billion. AbbVie, for its part, scored another megamerger with its massive Allergan buyout. AbbVie and Allergan merged last May in a deal worth $63 billion.

i2020 Accelerator Announces the Launch of Gwynant Therapeutics and Celyn Therapeutics to Develop Novel Small Molecules for Oncology Targets

On September 14, 2021 i2020, an accelerator program backed by the San Diego-based venture company Torrey Pines Investment, reported two new start-up investments together with OrbiMed Advisors (Press release, i2020 Accelerator, SEP 14, 2021, View Source [SID1234587795]). The start-up proceeds will finance new oncology-focused companies: Gwynant Therapeutics and Celyn Therapeutics. The companies will use the proceeds to bring proprietary small molecule products to the clinic targeting cancer. With this new financing, the partners continue to build a robust innovative asset pipeline focused on breakthrough drug targets. The new investment from i2020 and OrbiMed brings the total funding for 9 companies in the Loch platform to over $68.5 million. The Loch platform aims to rationally design and develop novel targeted treatments for cancer, immunological and neurodegenerative diseases.

In connection with the financing, Carl Gordon and Iain Dukes from OrbiMed, Nikolay Savchuk from Torrey Pines Investment and Augustine Lawlor from Health Care Ventures have joined the Boards of Gwynant and Celyn Therapeutics.

The Loch platform and its programs are supported by the AI and computer aided drug design of Molsoft LLC and ChemDiv Inc., San Diego, CA, as well as other research partners from i2020 Accelerator’s global network.

Nucleai and Jefferson Health Launch a Strategic Collaboration to Discover Novel Spatial Immunotherapy Biomarkers Utilizing Nucleai’s Spatial Biology Platform

On September 14, 2021 Nucleai, a leader in AI-powered spatial biology, and Jefferson Health, a leading cancer center, reported that they have entered into a strategic collaboration to discover spatial immunotherapy biomarkers, leveraging Nucleai’s ATOM platform and Jefferson’s repository of pathology and clinical data (Press release, Nucleai, SEP 14, 2021, View Source [SID1234587793]). The mutual collaboration will help advance AI-based solutions in discovering histological biomarkers and patient selection in clinical trials and clinical settings. The Israeli Innovation Authority supports the collaboration as part of the International Health-Tech Pilot Program.

Nucleai’s ATOM platform analyzes pathology images using computer vision and machine learning methods to model the tumor and the immune system’s spatial characteristics, creating unique and specific histological biomarkers that may predict patient response to therapy. These biomarkers hold the potential to provide a better understanding of cancer biology, enable further stratification of responder/non-responder patient populations, and improve the success rate of clinical trials and patient care. Nucleai leverages proprietary multimodal datasets of pathology images and clinical data from leading hospitals and Health Maintenance Organizations (HMOs) in the U.S and Israel to develop its platform.

As part of the collaboration between Nucleai and Jefferson, the two parties will test the utility of AI-based predictive biomarkers in a real-world clinical setting and assess the clinical benefit that the novel platform could provide for cancer patients treated with immunotherapy.

"It is now clear that analysis of digital pathology through computational approaches opens access to "hidden" information that is beyond the resolution of a pathologist’s examination through a microscope. We look forward to working with Nucleai to "unlock" such information to learn new disease mechanisms and using it to help our patients," said Stephen Peiper, Peter A. Herbut Professor and Chair Department of Pathology, Anatomy and Cell Biology at Thomas Jefferson University and Senior Vice President for the Enterprise Pathology and Laboratory Medicine Service Line of Jefferson Health System.

"Jefferson is dedicated to providing the highest-quality, compassionate clinical care for patients, preparing tomorrow’s professional leaders for 21st century careers, and discovering new treatments to define the future of care. The collaboration with Nucleai epitomizes this vision," said Zvi Grunwald, the Director of the Jefferson Israel Center.

"We are thrilled to launch this collaboration with Jefferson Health and are honored to be included in the Israeli Innovation Authority pilot program. Nucleai brings a unique spatial biology perspective into precision medicine, and we are eager to apply our platform to support novel biomarker discovery, diagnostics development, and clinical decision support," Nucleai CEO Avi Veidman said in a statement.