On January 10, 2023 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic liver diseases, reported that its research collaborator, Carlos Perez-Stable, PhD, from the University of Miami Miller School of Medicine and Miami Veterans Affairs/Research, today presented new findings from a preclinical study on the Company’s lead drug candidate, rencofilstat, a potent inhibitor of cyclophilins, in a presentation at the 2023 State of Florida Cancer Symposium in Tampa, Florida (Press release, Hepion Pharmaceuticals, JAN 10, 2023, View Source [SID1234626146]).

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The presentation, entitled "A New Strategy to Increase Proteotoxic Stress in Prostate Cancer," highlighted a preclinical study which investigated the killing of cultured prostate cancer cells by rencofilstat in combination with a proteasome inhibitor, ixazomib. Proteosome inhibitors are a class of anti-cancer agents that are used for the treatment of multiple myeloma and other blood cancers. They kill cancer cells by inducing a process called proteotoxic stress. There has been long-standing interest in expanding the use of proteosome inhibitors for solid tumors, but clinical trials to date have not shown durable anti-tumor efficacy. The present study showed that rencofilstat could synergistically increase the proteotoxic stress and in vitro cancer killing properties of ixazomib. These results suggest that the addition of rencofilstat could expand the use of proteosome inhibitors for existing applications, or possibly for other cancers, such as prostate cancer.

In this preclinical study, rencofilstat and ixazomib were applied at low concentrations to several types of prostate cancer cell lines, and also to non-cancerous prostate cells. Neither drug alone at low concentrations caused proteotoxic stress or killed the cells. However, in combination they induced sustained proteotoxic stress and killed 70% – 90% of the cancer cells (4 different cell lines) over two days. In contrast, the drug combination caused only mild, transient stress and no killing of the non-cancer cells.

"The selective killing of several cancer cell lines by this drug combination without killing the non-cancer cells occurred because cancer cells are especially susceptible to proteotoxic stress due to their aggressive growth and high demand for proteins," said Dr. Perez-Stable. "Certain isoforms of cyclophilins participate in the efficient synthesis and function of proteins and contribute significantly to cancer cell growth. Inhibiting those cyclophilins with rencofilstat and impairing protein turnover with ixazomib together stressed the cells beyond a threshold and triggered their death."

"Dr. Perez-Stable’s findings open up new opportunities, in addition to our Phase 2 trials in NASH, for investigation of potential cancer treatments and therapeutic use of rencofilstat," said Daren Ure, PhD, Hepion’s Chief Scientific Officer. "The findings are similar to those of a previous, independent study in which cyclophilin inhibition in combination with the proteosome inhibitor, carfilzomib, synergistically killed multiple myeloma cells.1 A synergistic anti-cancer effect also has been observed in a liver cancer study in mice with a combination of rencofilstat and a checkpoint inhibitor, anti-PD1 antibody. Thus, evidence is accumulating that rencofilstat could potentiate the anti-cancer activities of multiple agents, through multiple mechanisms, and across a variety of cancer types. This makes us very optimistic that rencofilstat will have tremendous versatility as an anti-cancer agent."

Reference

1Nature Medicine, 2021 27(3):491-503. doi: 10.1038/s41591-021-01232-w

On January 10, 2023 Helsinn Group ("Helsinn"), a fully integrated, global biopharma company with a track record of over forty years of commercial execution and a strong focus in oncology and rare diseases, following the announcement of the newly appointed CEO, Dr Melanie Rolli, reported a financing agreement with Oberland Capital Management LLC ("Oberland Capital") (Press release, Helsinn, JAN 10, 2023, View Source [SID1234626145]).

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Guided by its core values of respect, integrity and quality, Helsinn’s strategy focuses on being the partner of choice as a commercial-stage enterprise with a strong focus in oncology and rare diseases, able to reach patients worldwide through its integrated CMC/manufacturing/supply and commercial platform complemented by scientific and technological expertise.

Riccardo Braglia, Executive Chairman of Helsinn, commented: "Helsinn has partnership agreements with over 40 long-standing partners worldwide in 190 countries, and is a partner of choice for the biotech and pharma sector due to its expertise and late-stage development and commercialization of oncology and rare disease products. With its strong position which supports the integrated CMC, manufacturing, supply and commercial platform complemented by scientific and technical expertise, Helsinn is positioned to get more products to patients worldwide."

Dr Melanie Rolli, recently appointed Chief Executive Officer at Helsinn, said: "I am pleased that we have secured this funding from Oberland Capital which will allow us to expand the portfolio of late- and commercial-stage oncology and rare disease products. With an underlying stable business and this additional financial strength, we are well positioned to identify and partner with companies that share our focus on extending and improving the lives of people with cancer all over the world."

William Clifford, Partner at Oberland Capital added: "We are excited to partner with Helsinn and support its strategy of in-licensing or acquiring oncology and rare disease products that address unmet medical needs. Our flexible investment structure is designed to enable Helsinn to expand its robust commercial platform and to generate significant operating leverage."

On January 10, 2023 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, reported that it has closed a secured convertible credit agreement (the "credit agreement") with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva, Inc. (Nasdaq: INVA) (collectively, "Innoviva"), Armata’s largest shareholder (Press release, AmpliPhi Biosciences, JAN 10, 2023, View Source [SID1234626144]). The gross proceeds to the Company from the transaction are $30 million, before deducting estimated transaction-related expenses payable by the Company.

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Armata intends to use the net proceeds from this transaction to continue clinical development of AP-PA02 and AP-SA02. Additionally, these funds will finance the completion of an advanced biologics cGMP manufacturing facility with the technology and capacity to support production of complex multi-component phage therapeutics. When completed, Armata’s new manufacturing facility is expected to enable the Company to execute late-stage and registrational trials and create strategic partnership opportunities leveraging the Company’s core strength in advanced biologics manufacturing.

The credit agreement provides for a one-year term loan facility in an aggregate amount of $30 million at an interest rate of 8.0% per annum. Pursuant to the credit agreement, the balance on the loan, including all accrued and unpaid interest thereon, will convert into shares of Armata’s common stock upon the occurrence of a qualified financing. Any portion of the balance on the loan, including all accrued and unpaid interest thereon, may also be converted into shares of Armata’s common stock at Innoviva’s option once a registration statement covering the resale of such securities has been declared effective by the U.S. Securities and Exchange Commission ("SEC"). The loan is secured by substantially all of the assets of Armata and its domestic and foreign material subsidiaries. Armata has not issued any warrants in connection with the agreement.

On January 10, 2023 Abbvie presented its corporate presentation (Presentation, AbbVie, JAN 10, 2023, View Source [SID1234626143]).

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On January 10, 2023 AbbVie (NYSE: ABBV), and Anima Biotech (Anima), reported a collaboration to discover and develop mRNA biology modulators for three targets across Oncology and Immunology (Press release, AbbVie, JAN 10, 2023, View Source [SID1234626142]). Anima will use its mRNA Lightning platform to discover novel mRNA biology modulators against the collaboration targets providing AbbVie exclusive rights to license and further develop and commercialize the programs.

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"This collaboration will give AbbVie access to Anima’s leading technology platform and deep expertise in mRNA biology and will help further strengthen AbbVie’s world class capabilities in discovering and developing drugs to make a difference in patient’s lives," said Jonathon Sedgwick, Ph.D., vice president and global head of discovery research, AbbVie. "Modulating mRNA biology with small molecules is a new approach and has the potential to address ‘undruggable’ targets with implications across multiple therapy areas."

"Anima’s differentiated approach in the field of small molecule mRNA drugs combines phenotypic screening with AI-driven elucidation of the mechanisms of action. The power of our mRNA Lightning platform is validated by our multiple partnerships and a growing internal pipeline," said Yochi Slonim, co-founder and chief executive officer, Anima. "We are excited to partner with AbbVie, a recognized global leader in Oncology and Immunology, and are looking forward to start working with their excellent scientific team in a close collaboration."

Under the terms of the agreement, Anima will receive an upfront payment of $42 million and may be eligible to receive up to $540 million in option fees and research and development milestones in the aggregate across the three targets, with potential for further commercial milestones as well as tiered royalties on net sales. AbbVie has an option to expand the collaboration with up to three additional targets under the same terms as the initial collaboration, which may increase the potential value of the collaboration.