On January 18, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported the positive recommendation from its safety review committee to advance to the fifth dose level (650 mg/m2) in its camsirubicin Phase 1b trial in patients with advanced soft tissue sarcoma (ASTS) (Press release, Monopar Therapeutics, JAN 18, 2023, View Source [SID1234626330]). This decision was made following a review of safety data from the patients in the first four dose cohorts.

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"Clearance to go to this higher dose level is an important milestone for the trial as this class of drugs is known to have dose-dependent anti-tumor activity," said Chandler Robinson, MD, Monopar’s Chief Executive Officer. "We continue to see a favorable safety profile compared to doxorubicin, and the Phase 1b data to-date shows an improvement in median progression free survival from what was observed in the prior camsirubicin Phase 2 trial (265mg/m2). We are looking forward to evaluating the 650 mg/m2 dose level, which is nearly 2.5x higher than the highest dose evaluated in any prior camsirubicin clinical trial."

Further information about this actively enrolling, open-label, dose-escalation Phase 1b clinical trial is available at www.ClinicalTrials.gov under study identifier NCT 05043649.

About Camsirubicin

Camsirubicin is a novel, proprietary analog of the widely used cancer drug doxorubicin. It has been previously investigated in ASTS patients in a Phase 1 and a single-arm Phase 2 clinical trial. In these studies, no camsirubicin-treated patients developed the irreversible cardiotoxicity common to doxorubicin at higher cumulative doses. The most frequent adverse event observed in the Phase 1 study was neutropenia, which was mitigated in the Phase 2 study using prophylactic G-CSF. Based on encouraging clinical results from prior clinical trials, the current Phase 1b trial is designed to test camsirubicin at progressively higher doses than previously administered while using concomitant prophylactic G-CSF to prevent neutropenia.

About Soft Tissue Sarcoma

Soft tissue sarcomas (STS) are a diverse type of cancer that typically develop in the connective tissue of the body. According to the American Cancer Society, in 2021, an estimated 13,460 new STS cases were diagnosed in the U.S. alone, and about 5,350 people will not survive their disease. These tend to be the advanced cases; those with sarcomas that are unresectable and/or have metastasized. The average life expectancy from time of diagnosis for those patients with advanced disease (ASTS) is about 12 to 15 months. Doxorubicin is the current standard of care in the 1st-line setting for ASTS, and has been for decades, since there have been no 1st-line therapeutic advancements that have improved overall survival for this patient population.

On january 18, 2023 Labcorp (NYSE: LH), a leading global life sciences company, reported it will release its financial results for the fourth quarter and full year 2022 before the market opens on Thursday, Feb. 16, 2023 (Press release, LabCorp, JAN 18, 2023, View Source [SID1234626329]). The company will host a conference call and webcast beginning at 9 a.m. ET that day to discuss the results. The earnings press release and accompanying financial information will be posted on the Labcorp Investor Relations website.

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The call will be webcast live on the Labcorp Investor Relations website. Participants may also register for the call by clicking on this link, to receive the dial-in numbers and unique PIN to access the call. The webcast and dial-in are listen-only. It is recommended that participants join 10 minutes prior to the start, although participants may register and join at any time during the call.

A replay of the webcast will be available approximately two hours after the conclusion of the live event, and will be available until Feb. 2, 2024. To access the webcast recording, visit the Labcorp Investor Relations website.

On January 18, 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"), fibrotic diseases, hepatocellular carcinoma ("HCC"), and other chronic diseases, reported positive results of preclinical studies examining rencofilstat as a potential therapeutic for multiple myeloma ("MM") (Press release, Hepion Pharmaceuticals, JAN 18, 2023, View Source [SID1234626328]).

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Rencofilstat exerted anti-cancer activity across a large panel of MM cell lines, and most potently, in combination with bortezomib, a proteosome inhibitor and first-line treatment for MM. These results strengthen Hepion’s oncology initiatives and further support rencofilstat’s poly-indication potential.

The combination of rencofilstat and bortezomib produced 100% cytotoxicity in cell culture experiments across all 16 MM cell lines, including three lines that are characterized as bortezomib-resistant. The cytotoxic activity of rencofilstat plus bortezomib was synergistic in every cell line, showing greater cytotoxicity in combination than the sum of the two drugs individually. Rencofilstat administered individually resulted in reduced cell numbers in most cell lines, and the suppressive effect of rencofilstat correlated to reduced gene expression levels of cyclophilins A and D, two of the known targets of rencofilstat. Most of the experiments were performed by Diag2Tec (Montpellier, France), a contract research organization with expertise in MM.

These results were consistent with an independent study that reported that cyclophilin A inhibition should be considered as a therapeutic strategy for resistant MM.1 They were also similar to recent studies showing that a combination of rencofilstat and another proteosome inhibitor, ixazomib, synergistically killed prostate cancer cells. Together, they provide strong rationale for considering a rencofilstat-proteosome inhibitor combination for clinical investigation in MM or other cancers.

"These results provide further support for the development of rencofilstat as a therapeutic agent in oncology and other indications," said Daren Ure, PhD, Hepion’s Chief Scientific Officer. "They validate years of research from the academic community documenting many therapeutic effects of cyclophilin inhibition. Rencofilstat’s antifibrotic activity is strongly linked to cyclophilin B inhibition, whereas its anti-cancer activity in the MM studies appears to depend on cyclophilins A and D. Interestingly, another entirely different mode of anti-cancer activity was previously highlighted in preclinical liver cancer studies, where rencofilstat exerted a synergistic, anti-tumor effect in combination with the checkpoint inhibitor, anti-PD1 antibody. Rencofilstat’s ability to target multiple processes as a single drug is one of its main advantages. Another key benefit is rencofilstat’s favorable safety profile in clinical trials to date, which creates opportunities for combining it with other drug therapies."

Hepion has now documented beneficial effects of rencofilstat in experimental models of fibrosis in multiple organs, liver cancer, prostate cancer, thrombosis-related platelet activation, viral infections, lung injury, and MM.

Robert Foster, PharmD, PhD, Hepion’s Chief Executive Officer, stated, "While our two active Phase 2 clinical trials in NASH are Hepion’s major current focus, these latest results afford us the opportunity to continue to create a ‘pipeline within a product.’ Thorough scientific and strategic analyses are being conducted to characterize the growing list of disease indications that are possible candidates for rencofilstat treatment. At the same time, we are exploring additional business development initiatives and non-dilutive funding to support clinical trials in oncology, as recently announced."

On January 18, 2023 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, reported that management will participate in the following investor conferences (Press release, Gritstone Oncology, JAN 18, 2023, View Source [SID1234626327]).

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B. Riley Securities’ 3rd Annual Oncology Conference (Fireside Chat)
Date and Time: Thursday, January 19, 2023 at 12:30pm ET
Presenter: Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer

2023 BIO CEO & Investor Conference (Panel)
Panel Title: Prioritizing CRO Spending Through a High-Inflation, Sparse-Funding Period
Date and Time: Monday, February 6, 2023 at 2:00pm ET
Presenter: Celia Economides, Chief Financial Officer

SVB Securities Global Biopharma Conference (Fireside Chat)
Date and Time: Thursday, February 16, 2023 at 1:40pm ET
Presenter: Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer

Live webcast and/or archived replays will be available via View Source Archived replays will be accessible for at least 30 days following the corresponding event.

On January 18, 2023 Pluristyx and panCELLa today are excited to reported the granting of a patent used in their universal, off-the-shelf, induced pluripotent stem cells (iPSCs) (Press release, panCELLa, JAN 18, 2023, View Source [SID1234626300]). The Great Britain Patent Office on January 4, 2023 issued patent number GB2588249B extending panCELLa’s protection of its induced Allogeneic Cell Tolerance (iACT Stealth) technology (WO/2018/227286) to the United Kingdom.

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The iACT Stealth technology, exclusively licensed by panCELLa from Mount Sinai Hospital, allows clinical-grade cell therapy products and tissues to avoid rejection by the patient after transplant and reduces or eliminates the need for the immunosuppression currently required for tissue transplants. The iACT Stealth technology is available for evaluation under the ‘Try- before-you-buy’ research evaluation model as a stand-alone product or in combination with FailSafe and SafeHarbor platform technologies.

Mahendra Rao, Co-Chairman of the Board at panCELLa and Chief Scientific Officer at Pluristyx commented, "As we integrate Pluristyx and panCELLa into a single entity, we have continued to fund and protect the development of our industry-leading platform technologies for use in iPSCs. We are extremely pleased with the grant of claims by the Great Britain patent office to protect our iACT Stealth technology. iACT Stealth is immediately available in custom or catalog format for quick evaluation and adoption by our academic and industry partners."

Benjamin Fryer, Chief Executive Officer at Pluristyx, said: "At the new Pluristyx, we believe that the unique combination of iACT Stealth, FailSafe, and SafeHarbor technologies are the cornerstone of future cell therapies. With a single cell line and license, a sponsor can now develop, manufacture, and commercialize their universal cell or tissue therapy using our off-the-shelf technologies and gene-edited cells. This unique combination of proprietary gene edits simplifies manufacturing, reduces business and process costs, and offers a chance to revolutionize iPSC-based therapeutic development."