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Wall Street Journal: GeoVax Labs Shares Rise 12% After Licensing Deal for Cancer Treatment

On September 30, 2021 GeoVax Labs Inc. shares were up 12% to $4.68 after the company said reported that it entered into an assignment and license agreement with PNP Therapeutics Inc., granting GeoVax exclusive rights to develop and commercialize Gedeptin, a novel patented product for the treatment of solid tumors (Press release, Southern Research Institute, SEP 30, 2021, View Source [SID1234590563]).

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The biotechnology company said the license provides exclusive worldwide rights to key intellectual property, including Gedeptin patents, know-how, regulatory filings, clinical materials and trademarks.

The patent portfolio covering Gedeptin was originally licensed from the University of Alabama at Birmingham and Southern Research Institute by PNP. Under the License, GeoVax will become the successor to PNP under its license agreement with UAB/SRI.

Detailed financial terms of the transaction weren’t disclosed, but include a combination of upfront payments, milestone fees, and royalties on net sales.

A Phase 1/2 trial, evaluating the safety and efficacy of repeat cycles of Gedeptin therapy in patients with recurrent head and neck squamous cell carcinoma, with tumors accessible for injection and no curable treatment options, is currently enrolling. The initial stage of the study is being funded by the U.S. Food and Drug Administration pursuant to its Orphan Products Clinical Trials Grants Program. The FDA also has granted Gedeptin orphan drug status for the intra-tumoral treatment of anatomically accessible oral and pharyngeal cancers, including cancers of the lip, tongue, gum, floor of mouth, salivary gland and other oral cavities.

Vernalis (a fully owned subsidiary of HitGen Inc) and Servier achieve a milestone in their oncology drug discovery collaboration

On September 30, 2021 Vernalis, a fully owned subsidiary of HitGen Inc., and Servier reported the achievement of a research milestone in one of their oncology drug discovery collaborations, triggering an undisclosed milestone payment to Vernalis (Press release, Vernalis, SEP 30, 2021, View Source;utm_medium=rss&utm_campaign=vernalis-a-fully-owned-subsidiary-of-hitgen-inc-and-servier-achieve-a-milestone-in-their-oncology-drug-discovery-collaboration [SID1234590562]).

Vernalis and Servier’s partnership has been running successfully since 2007 with a number of collaborations on different therapeutic targets. This particular collaboration was established in January 2017 in which Vernalis’ proprietary fragment and structure-based drug discovery platform is combined with the oncology expertise at Servier on a challenging protein target which is implicated in many different cancers. This milestone recognizes success in achieving a particular research milestone. The financial terms of the agreement are not disclosed.

"The milestone further validates our fragment and structure-based drug discovery platform and the strength and success of our relationship with Servier. We look forward to working together to develop exciting new cancer treatment opportunities to add to the already disclosed successes with Bcl-2 and Mcl-1", commented James Murray, Research Director at Vernalis.

"This research milestone is the result of highly interactive joint efforts between chemists, biochemists and biologists from both companies and hopefully will lead to new treatments for cancer patients," commented Frederic Colland, Head of Hard-to-treat Cancer research program at Servier. "This research program is in line with Servier’s strategy, which has made oncology one of its foremost priorities to respond the growing needs for therapeutic solutions."

Under the current agreement, Vernalis receives fees for work undertaken as well as research and development milestones and potentially royalties on sales.

Nimbus Therapeutics Publishes Structural Analysis Highlighting Mechanisms for Selective Inhibition of CTPS1

On September 30, 2021 Nimbus Therapeutics, a biotechnology company designing breakthrough medicines through structure-based drug discovery and development, reported that research in the Proceedings of the National Academy of Sciences describing the structural basis for isoform-specific inhibition of human CTPS1 (CTP synthase 1) (Press release, Nimbus Therapeutics, SEP 30, 2021, View Source [SID1234590561]). Selective inhibition of CTPS1 is a promising approach for the treatment of autoimmune and other T cell-driven diseases, but little is known about the mechanisms underlying selective versus non-selective inhibition.

Nimbus scientists, in partnership with researchers from the University of Washington and Schrödinger, used cryo-electron microscopy (cryo-EM) to characterize the activity of CTPS inhibitors in binding to, inhibiting and distinguishing between CTPS1 and its isoform CTPS2. The cryo-EM research was funded by Nimbus and led by professor Justin Kollman at the University of Washington.

"We’re proud to have conducted this impactful research in partnership with our valued colleagues at University of Washington and Schrödinger, further building on Nimbus’ long history of fruitful academic collaborations," said Peter Tummino, Ph.D., Chief Scientific Officer at Nimbus. "The insights we have published will be instrumental in our efforts to develop selective inhibitors of CTPS1 that can potentially offer a powerful new means of treating autoimmune diseases and T cell-driven cancers."

"A defining feature of Nimbus’ structure-based drug discovery approach is our use of leading-edge computational technology, including cryo-EM, to characterize drug targets in unprecedented detail," said Scott Edmondson, Ph.D., Senior Vice President and Head of Chemistry at Nimbus. "The discoveries made in this research, together with Nimbus’ expertise in computational chemistry, molecular sciences and disease biology, will inform our ongoing development of highly selective small-molecule CTPS1 inhibitors."

The paper, entitled "Structural basis for isoform-specific inhibition of human CTPS1," published online in the Proceedings of the National Academy of Sciences this week: View Source

ImmixBio Announces FDA Orphan Drug Designation for IMX-110 for the Treatment of Soft Tissue Sarcoma

On September 30, 2021 Immix Biopharma, Inc. ("ImmixBio"), a biotechnology company pioneering Tissue Specific Therapeutics (TSTx)TM for oncology and inflammation, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to IMX-110 for the treatment of soft tissue sarcoma (Press release, Immix Biopharma, SEP 30, 2021, View Source [SID1234590560]).

The FDA’s Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases, or conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to 7 years of market exclusivity in the U.S. upon regulatory approval.

"We are pleased to receive FDA’s orphan drug designation in soft tissue sarcoma for IMX-110, the first clinical-stage product of our SMARxT Tissue-Specific Platform," said Ilya Rachman MD PhD, ImmixBio Founder & CEO. "We are thrilled to potentially contribute to expanding therapeutic options for oncology patients, beginning with soft tissue sarcoma."

Gabriel Morris, ImmixBio Chief Financial Officer, added: "Orphan drug designation for IMX-110 represents a substantial value creating step along our path of building a strong, independent biopharmaceutical organization."

About IMX-110

IMX-110 is a Tissue-Specific TherapeuticTM built on ImmixBio’s TME NormalizationTM Technology encapsulating a poly-kinase inhibitor and apoptosis inducer delivered deep into the tumor micro-environment, or TME. ImmixBio’s TME Normalization Technology enables IMX-110 to circulate in the bloodstream, then exit through porous tumor blood vessels, and accumulate in the TME. IMX-110 then simultaneously attacks all 3 components of the TME (cancer associated fibroblasts, or CAFs; tumor-associated macrophages/immune cells, or TAMs, and cancer itself), severing the critical lifelines between the tumor and its metabolic and structural support. IMX-110’s TME Normalization Technology causes tumor apoptosis, a non-inflammatory tumor-cell death (vs. necroptosis, which results in repeat reignition of the inflammatory cascade leading to tumor progression).

IMX-110 is currently being evaluated in a phase 1b/2a open-label, dose-escalation/dose-expansion safety, tolerability and pharmacokinetic study in patients with advanced solid tumors in the United States and Australia.

CBMG Holdings Completes $120 Million in Series A Funding, Accelerating Development of CAR-T Therapy Pipelines and R&D for Innovative Solid Tumor Therapies

On September 30, 2021 CBMG Holdings (or the "Company"), a Cayman Island biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer and degenerative diseases, reported the closing of a $120 million Series A investment, led by AstraZeneca-CICC Fund, Sequoia Capital China and Yunfeng Capital (Press release, Cellular Biomedicine Group, SEP 30, 2021, View Source [SID1234590559]). Both new and certain existing investors, including GIC and TF Capital, subscribed to the Series A financing.

This round of financing will largely be used to accelerate the clinical development of the Company’s immune-oncology platform. Specifically, C-CAR039, an anti-CD19/CD20 bispecific CAR-T therapy for the treatment of patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL) and C-CAR088, a B cell maturation antigen (BCMA) therapy for patients with late-stage relapsed/refractory (r/r) multiple myeloma (MM), as well as armored CAR-T therapies and tumor-infiltrating lymphocytes (TIL) therapies targeting solid tumors. In addition, the capital injection will support the continuing development of the Company’s stem cell platform, including the study of acute respiratory distress syndrome (ARDS) using allogeneic human adipose mesenchymal stem cell exosomes (haMSC-Exos) and extracellular vesicle, and the data compilation from its off-the-shelf product AlloJoin applying adipose-derived stem cells in the treatment of Phase II knee osteoarthritis (KOA) clinical trial in China.

This round of financing will be used to accelerate the clinical development of the Company’s immune-oncology platform.

One of the earliest pure-play biotechnology companies from China to be approved for listing on the NASDAQ Market, Cellular Biomedicine Group successfully completed its privatization in February 2021.

As a result of its strong research and development and cell and gene therapy manufacturing know-how, Cellular Biomedicine Group was invited to present two abstracts at the esteemed American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June. Among them, C-CAR039 for r/r NHL displayed a very encouraging safety and efficacy profile, with the potential to be a Best-in-Class drug. The U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted CBMG an Orphan Drug Designation (ODD) to C-CAR039, for the treatment of Follicular Lymphoma, an indolent form of non-Hodgkin Lymphoma.

"We are pleased to complete this Series A funding shortly after our successful privatization", commented Tony (Bizuo) Liu, Chairman and CEO of CBMG Holdings. "We are blessed to have our long-term investors continue to support us before, during, and after, privatization. Thank you, Novartis, Sailing Capital, and other long-term investors for believing in us. Accolades from shareholders has helped continue to attract new strategic investors. I am grateful to Yunfeng Capital, GIC and TF Capital for continuing to increase their investment after the initial privatization investment. We are honored that AstraZeneca-CICC Fund, Sequoia Capital China and other high-quality, valuable new partners have joined the shareholder base. With the support of these long-term and new, marquee investors, we affirm our mission of ‘Saving Lives and Revitalizing Lives’ and bringing to market innovative therapies to address significant unmet medical needs."