HUYABIO Announces the Exclusive License of the KRAS Inhibitor from Shanghai Jemincare Pharmaceutical

On December 2, 2021 HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations, reported it had licensed exclusive worldwide ex-China rights to the KRAS inhibitor, JMKX1899, from Shanghai Jemincare Pharmaceutical Co., Ltd. Jemincare will retain the relevant rights in the greater China area (Press release, HUYA Bioscience, DEC 2, 2021, View Source [SID1234596454]).

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Mr. Hong Liang, President of Jemincare Pharmaceutical Group, said, "We are delighted to work with HUYABIO to explore global development of this unique KRAS inhibitor. This is our first new chemical entity program outlicensed to a global partner. HUYABIO has generated a lot of experience to bring innovative drugs from China to global market. We look forward to generating the clinical efficacy and safety data from global clinical trial since the candidate has huge potential to fill strong unmet needs."

KRAS is one of the most mutated oncogenes in human cancers. The prevalent G12C mutation drives tumor growth and metastasis and has become an important validated target for therapy especially in lung and colorectal cancer. Targeting the GTP pocket of KRAS in the switch-II region, which has made KRAS druggable, enables the development of more potent and potentially effective inhibitors.

JMKX1899 is a KRAS inhibitor independently developed by Jemincare. Data from preclinical studies shows it has strong blood-brain-barrier crossing capability and has no risk of hERG inhibition and drug-drug-interaction. Jemincare filed the IND with the NMPA in October 2021. The parties will work closely to file the IND with the US FDA in 2021 to move towards clinical development.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, "We are excited to have added the clinical stage KRAS inhibitor to our oncology pipeline especially to test in combination with our SHP2 inhibitor against a variety of solid tumors. We’re delighted to have an excellent partner Jemincare to co-develop combinations that can benefit patients worldwide."

Plus Therapeutics to Present at MedInvest Oncology Investor Conference

On December 2, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics, will present a company overview during the MedInvest Oncology Investor Conference on Tuesday, December 7th at 12:00 p.m. ET (Press release, Cytori Therapeutics, DEC 2, 2021, View Source [SID1234596403]).

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A webcast of the Company’s pre-recorded presentation, along with a live Q&A session, will be available under the ‘Events’ tab of the Investor Relations section of the Plus Therapeutics website at www.plustherapeutics.com or at https://bit.ly/3l2jsfW.

OpenBench and Tavros Therapeutics Announce Collaboration to Pursue First-in-class Cancer Target

On December 2, 2021 Tavros Therapeutics, a privately held biotechnology company discovering first-in-class cancer therapies, and OpenBench, an emerging leader in AI-enabled small molecule discovery, reported a collaboration in which OpenBench will identify novel, potent antagonists against an undisclosed cancer target that was identified by Tavros’s proprietary functional genomics platform (Press release, Tavros Therapeutics, DEC 2, 2021, View Source [SID1234596421]).

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Under the terms of the agreement, OpenBench will receive payment for the identification and experimental confirmation of novel chemotypes that meet Tavros’s potency and developability criteria. In exchange, Tavros gains exclusive access to OpenBench’s proprietary screening technology with respect to the promising cancer target. Financial terms were not disclosed.

"Tavros is eager to identify quality hit molecules against this high-impact, first-in-class target, and we think OpenBench’s virtual screening platform is perfectly suited to accelerate our drug development timelines. We hope to continue this partnership and take on other promising drug targets identified by Tavros’s proprietary functional genomics discovery platform," said Tavros CEO Eoin McDonnell.

"We are excited to enrich Tavros’s efforts to make a breakthrough therapeutic discovery addressing a serious clinical need," said OpenBench CTO James Yoder. "We feel confident that the partnership will bear fruit and the OpenBench virtual screening platform will identify promising novel chemical material that maximizes the likelihood of Tavros’s success in lead optimization, translation, and clinical development campaigns."

OpenBench adds Tavros to a growing list of partners that includes HemoShear Therapeutics and two other undisclosed U.S.-based biotechnology companies.

EOM PHARMACEUTICALS, INC. AND IMMUNOCELLULAR THERAPEUTICS, LTD. ANNOUNCE ENTRY INTO AND CLOSE OF DEFINITIVE MERGER AGREEMENT

On December 2, 2021 EOM Pharmaceuticals, Inc. ("EOM"), a privately held, clinical-stage pharmaceutical company, and ImmunoCellular Therapeutics, Ltd. (OTC: IMUC) ("ImmunoCellular") reported that the companies have entered into and closed on a merger agreement pursuant to which the shareholders of EOM are now the majority shareholders of the combined company (Press release, EOM Pharmaceuticals, DEC 2, 2021, View Source [SID1234618848]). The merger will create a public company that will continue EOM’s focus on advancing novel immunomodulatory and retinal disease drug agents to address a range of inflammatory, viral, retinal, and other diseases. ImmunoCellular will be renamed EOM Pharmaceuticals Holdings, Inc. Pending the assignment of a new ticker symbol, EOM Pharmaceuticals’ Common Stock will continue to be quoted on the OTC Markets under the ticker symbol "IMUC." EOM may consider in the future changing the principal listing of the Company Common Stock to a national exchange, assuming it will then meet the relevant listing requirements.

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The combined company’s two pipeline assets are EOM613 and EOM147.

• EOM613 is an investigational peptide-nucleic acid solution believed to have both antiinflammatory and pro-inflammatory broad-spectrum cytokine effects. Patients are currently enrolled in R 1 : RESCUE, a Phase 1/2a open-label clinical study in Brazil evaluating EOM613 treatment in severe hospitalized COVID-19 patients with "cytokine storm" immune responses. EOM expects to announce data from this trial in first quarter 2022. Further clinical development of EOM613 includes planning a Phase 2a multi-center trial for cancer cachexia in the U.S. and initiating exploratory trials for rheumatoid arthritis.

• EOM147 is an investigational, reformulated broad-spectrum aminosterol with a unique intracellular mechanism for the treatment of retinal diseases. EOM147 affects multiple angiogenic growth factors such as VEGF, PdGF, and bFGF. This mechanism of action is uniquely differentiated from other retinal therapies that are only anti-VEGF and administered as an intraocular injection. The novel formulation, administered as an eye drop, represents a potential breakthrough that does not require intraocular injection. Planning is underway for Phase 2 ophthalmic trials for macular edema in patients with diabetic retinopathy and wet age-related macular degeneration (wet-AMD).

EOM Founder, Board Chairman, and Chief Operating Officer Eli Goldberger said, "EOM’s merger with ImmunoCellular provides the resources necessary to advance our lead program, EOM613, as a potential treatment for COVID-19, as well as support the development of both EOM613 and EOM147. We look 2 forward to advancing our pipeline assets and delivering value to all our stakeholders, including patients, the scientific and medical community, and our stockholders."

"COVID-19 continues to pose a grave threat to millions of people worldwide and to challenge the medical and scientific community as it seeks to understand and treat the underlying causes and symptoms of this devastating disease," said EOM Chief Executive Officer and Director Irach Taraporewala, Ph.D. "We are grateful to the investigators and patients in Brazil who are currently participating in our EOM613 clinical trial and look forward to reporting initial results in early 2022."

"After an extensive review of strategic options for ImmunoCellular, we are pleased to announce the merger with EOM," said Gary S. Titus, ImmunoCellular’s Chairman of the Board. "We believe EOM’s focus on advancing novel immunomodulatory and retinal disease agents addressing unmet medical needs, as well as its experienced management team and board of directors, represent a potentially meaningful opportunity for stockholders in the newly combined company to realize long-term value."

About the Merger Pursuant to the merger agreement, EOM shareholders have exchanged all of their EOM common stock for newly issued shares of ImmunoCellular common and Series C convertible preferred stock. Postmerger, ImmunoCellular’s then-current equity holders will own approximately 3.5% and the former EOM equity holders will own approximately 96.5% percent of ImmunoCellular’s common stock, calculated on a fully diluted basis. Effective with the merger, all existing officers and directors of EOM have assumed their same positions in the new company and all existing officers and directors of ImmunoCellular have resigned. The transaction has been unanimously approved by the board of directors of both companies. EOM Pharmaceuticals Holdings, Inc. will be headquartered in Montvale, NJ. Bridgeway Capital Partners and its affiliates served as exclusive financial advisor to EOM on the transaction.

Management and Organization

The new senior leadership team at EOM Pharmaceuticals Holdings, Inc. includes Chief Executive Officer Irach Taraporewala, Ph.D.; EOM Founder, Board Chairman, and Chief Operating Officer Eli Goldberger; EOM Co-founder, Chief Scientific Officer and Medical Director Shalom Z. Hirschman, M.D; Wayne I. Danson, Chief Financial Officer and Treasurer; and Scientific Advisor and Chair of the Scientific Advisory Board, Frank L. Douglas, Ph.D., M.D.

Astellas and Dyno Therapeutics Announce Research Collaboration to Develop Next-Generation AAV Gene Therapy Vectors for Skeletal and Cardiac Muscle

On December 1, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Dyno Therapeutics, Inc. (President and CEO: Eric Kelsic, Ph.D., "Dyno") reported an option and license agreement was signed on November 23 to develop next-generation adeno-associated virus (AAV) vectors for gene therapy directed to skeletal and cardiac muscle using Dyno’s CapsidMap platform (Press release, Astellas, DEC 2, 2021, View Source [SID1234596344]).

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Dyno’s CapsidMap platform represents a transformative approach applying in vivo experimental data and machine learning to create novel AAV capsids – the cell-targeting protein shells of viral vectors – designed to optimize tissue targeting and immune-evading properties, in addition to improving packaging capacity and manufacturability. Unlike traditional approaches, CapsidMap is uniquely well-suited to simultaneously optimize capsids for delivery across multiple organs, with the goal of enabling more effective whole-body treatment for many diseases.

With the establishment of the Astellas Gene Therapies Center of Excellence following the 2020 acquisition of Audentes Therapeutics Inc., Astellas is a leader in genetic medicines, working alongside its world-renowned partners to build a portfolio of potentially life-changing gene therapies. This research collaboration combines Dyno’s AI-powered AAV vector engineering capabilities with Astellas Gene Therapies global leadership in AAV-based pipeline assets.

"Through our efforts in gene therapy and the Astellas Gene Therapies Center of Excellence, Astellas strives to identify, develop and deliver transformative gene-based therapies for patients with genetic diseases who currently have few or no effective treatment options. Our principal focus is on developing adeno-associated virus delivered therapies for the treatment of well-defined serious diseases," said Naoki Okamura, Chief Strategy Officer and Chief Financial Officer, Chief Business Officer at Astellas. "We are dedicated to delivering novel approaches and utilizing new technologies that can deliver transformational value for patients."

"We are so happy to be partnering with Astellas, a world leader in developing gene therapies. Dyno and Astellas each bring unique strengths to this collaboration, together enabling more rapid creation of new therapies for patients with great unmet need," said Dyno’s CEO and co-founder Eric D. Kelsic, Ph.D. "This partnership demonstrates the flexibility of Dyno’s platform to precisely design the delivery properties of gene therapy vectors towards multi-organ and disease-specific profiles, applying the scientific insights we are rapidly learning across all our partnered and internal vector engineering programs using CapsidMap."

Under the terms of the agreement, Dyno will design novel AAV capsids with improved functional properties for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities, including manufacturing, of gene therapy product candidates using the novel capsids. Dyno will receive an $18 million upfront payment and be eligible to receive additional payments during the research phase of the collaboration as well as clinical and sales milestone payments and royalties for any resulting products. The aggregate potential value of future milestone and royalty payments to Dyno exceeds $235 million per product and over $1.6 billion in total value.