On September 21, 2023 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported that its wholly owned subsidiary, iBio CDMO LLC, and Woodforest National Bank ("Woodforest") have entered into a sixth amendment (the "Amendment") to their November 1, 2021 credit agreement (the "Credit Agreement"), extending the Agreement’s maturity date from November 1, 2023 to the earlier of December 31, 2023 or the acceleration of maturity of the term loan in accordance with the Credit Agreement (Press release, iBioPharma, SEP 21, 2023, View Source [SID1234635310]). The extension of the maturity date is intended to afford the Company sufficient time to close the pending sale of its cGMP biologics manufacturing facility (the "CDMO Facility"), which is anticipated to occur before the end of calendar 2023.

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The sale of the CDMO Facility will complete the divestiture of iBio’s contract development and manufacturing business in Texas, paving the way for the Company’s continued advancement of its AI drug discovery platform and immunotherapy pipeline out of its research and development center in California.

"The sale of our facility will mark an important turning point for iBio and our full transformation into an antibody discovery and development company," said Martin Brenner, DVM, Ph.D., iBio’s Chief Executive Officer and Chief Scientific Officer. "Over the past year, we have made critical investments into our tech stack, our people, and our preclinical pipeline to create a next-generation antibody discovery company that integrates the best of science and machine learning to tackle drug discovery’s most difficult challenges. I look forward to our team’s continued innovations and what they may bring to the rapidly evolving field of immuno-oncology at iBio and with our partners."

"We appreciate Woodforest’s flexibility providing iBio the time necessary to close on the sale of the facility," said iBio’s Chief 47Financial Officer, Felipe Duran. "Once the sale closes and the Woodforest loan is paid in full, the net proceeds will extend our cash runway to help support continued advancement of our immuno-oncology assets and AI-based drug discovery platform."

On September 21, 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 results from a study with in which the anti-cancer activity of Hepion’s lead drug candidate, rencofilstat, was tested in a high through-put screen on 850 cancer cell lines spanning 28 types of cancer at the PRISM lab at the Broad Institute of MIT and Harvard (Press release, Hepion Pharmaceuticals, SEP 21, 2023, View Source [SID1234635309]).

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The Broad Institute is one of the few institutions in the world with such an expansive cancer cell line screening program. By utilizing advanced technologies and global collaborations, the Broad Institute has become a global leader in understanding cancer and other human diseases and helping to develop effective therapeutics.

Rencofilstat was administered at eight concentrations to each cancer cell line in culture for 5 days, followed by measurement of surviving cells to determine how effectively the drug candidate killed or suppressed proliferation of the cancer cells. Defining "anti-cancer responsiveness" as 50% or greater reduction in viability following treatment, 26% of all tested cancer cell lines (220/850) spanning 86% of cancer cell types (24/28) were responsive to rencofilstat. Some of the rencofilstat-sensitive cell lines were HCC cells, which further supports Hepion’s plans for a clinical trial in this indication. Furthermore, the reductions in viability in responsive cells occurred at drug concentrations similar to those observed in individuals participating in Hepion’s NASH clinical trials. Thus, administration of rencofilstat to cancer patients with the standard regimen of once-daily oral dosing may be efficacious for those with responsive types of cancer.

The screening study also integrated additional information collected by the Broad Institute about the cancer cell lines, such as gene mutations, gene expression, and protein and metabolic profiles, to provide insights into rencofilstat’s mechanisms of action and identify biomarkers associated with its anti-cancer activity. Some of the markers uncovered by these analyses were related to familiar rencofilstat mechanisms, whereas others pointed to new processes. Genes known to be mutated in HCC or other types of cancer, including ATM, PTPRB, HNF1A, NOTCH1, ALK, TP63, IDH2 and MAP3K, were among the many genes identified to possibly influence the sensitivity of cells to rencofilstat.

"The results from this high-throughput screen provide valuable insights into how rencofilstat directly arrests cancer cells and adds to the discoveries being made from our in-house research. These direct effects on cancer cell lines may be an important part of rencofilstat’s anti-cancer activity," remarked Daren Ure, Hepion’s Chief Scientific Officer. "We have already observed that rencofilstat fights cancer through other indirect mechanisms, and in particular by changing the tissue environment in which the tumor grows. For example, we previously found that rencofilstat altered the immune cell composition of liver tumors in mice, suggesting an enhanced immune attack on the tumors. Directly targeting cancer cells while simultaneously modulating their microenvironment provides additional weapons for attacking cancer. Our ongoing research aims to further define the characteristics of liver cancer and other types of cancer that make them most susceptible to rencofilstat, and to thereby help identify who may benefit most from treatment."

On September 21, 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 that its Chief Executive Officer, Robert Foster, PharmD, PhD, will participate in a panel discussion during the 2023 Cantor Global Healthcare Conference on Wednesday, September 27, 2023 at 9:45 a.m. ET in NYC (Press release, Hepion Pharmaceuticals, SEP 21, 2023, View Source [SID1234635308]).

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A link to the live and archived webcast may be accessed on the Company’s website at www.hepionpharma.com under "Events" in the Investors section.

On September 21, 2023 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported it will hold a formal presentation on Sept. 28 at the Cantor Fitzgerald Global Healthcare Conference in New York (Press release, Elevar Therapeutics, SEP 21, 2023, View Source [SID1234635307]).

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The presentation details are as follows:
Date/Time: Sept. 28 from 3-3:30 p.m. ET
Presenters: Saeho Chong, chief executive officer; Paul Friel, chief commercial officer; Wade Smith, chief financial officer

"The recent months have been very busy at Elevar as we bring our lead development drug, rivoceranib, through the final stages of clinical development as a potential treatment option for those confronted with unresectable hepatocellular carcinoma (uHCC)," said Chong. "We look forward to updating our peers at the Cantor Fitzgerald Global Healthcare Conference about this effort and our broader clinical and commercial development plans."

Supported by its Phase 3 CARES-310 results, Elevar in May submitted a new drug application to the U.S. Food and Drug Administration (FDA) for rivoceranib plus camrelizumab as a first-line treatment option for uHCC. Jiangsu Hengrui Pharmaceuticals Co., Ltd., the developer of camrelizumab, submitted a biologics license application. The FDA granted a May 2024 Prescription Drug User Fee Act date for the combination.

Elevar’s presentation will examine continued development opportunities for rivoceranib; the drug’s positioning in the market and commercialization plans; the CARES-310 trial outcomes and subgroup analysis; and Elevar’s worldwide rights for rivoceranib, which exclude China, where rivoceranib has been approved as a single agent for the treatment of gastric cancer since 2014 and as a first-line treatment in combination with camrelizumab for uHCC since January 2023.

On September 21, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that James Oliviero, President and Chief Executive Officer, will participate in a panel presentation at the Cantor Global Healthcare Conference on Thursday, September 28, 2023, at 10:20 a.m. ET in New York City (Press release, Checkpoint Therapeutics, SEP 21, 2023, View Source [SID1234635306]). The Company will also attend in-person one-on-one meetings during the conference.

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A webcast of the presentation will be available on the News & Events page, located within the Investors section of Checkpoint’s website, View Source, for approximately 30 days after the meeting.