On April 15, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the company’s Phase 1 first-line study of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA) (Press release, Panbela Therapeutics, APR 15, 2021, View Source [SID1234583757]). SBP-101 is the company’s first polyamine metabolic inhibitor therapeutic candidate.

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The company has agreed to include in the design of all future studies the exclusion of patients with a history of retinopathy or at risk of retinal detachment and scheduled ophthalmologic monitoring for all patients. Additionally, in future dose-finding studies screening for retinal toxicity will be included.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression or peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse events are being evaluated and patients with a history of retinopathy or at risk of retinal detachment are excluded from SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

On April 15, 2021 Iktos’s AI technology, reported that based on deep generative models, helps bring speed and efficiency to the drug discovery process (Press release, Iktos, APR 15, 2021, View Source [SID1234580475]). Iktos’ technology automatically designs virtual novel molecules that have all of the characteristics of a successful drug molecule.

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Iktos AI is the first company to release user-friendly and high-performance de novo design software for multi-parameter optimization that can be used by any medicinal or computational chemist, whatever their level of expertise, in deep learning and computer programming.

BioExcel is partnering with Iktos on the application of advanced molecular modelling and simulation techniques to expedite drug design.

On April 15, 2021 NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of Natural Killer (NK) cell therapies, reported that it has appointed Steven Cha, M.D. as its Chief Medical Officer (Press release, NKGEN Biotech, APR 15, 2021, View Source [SID1234578709]). Dr. Cha will oversee the clinical development of NKGen Biotech’s lead product SNK01 as well as its pipeline of other novel NK cell therapies.

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"We are extremely pleased to have Steven join the NKGen Biotech team during this rapid growth phase for the Company," said Stephen Chen, Chief Operating Officer. "His broad expertise and leadership in oncology, early and late-stage drug development, and proficiency with business development transactions make him an ideal fit for NKGen Biotech," he concluded.

Dr. Cha has 15 years of R&D industry experience encompassing both large and small pharmaceutical companies. Since 2018 he has served as Vice President of Oncology at Samumed LLC, a privately held clinical-stage biotechnology company. Prior to that Dr. Cha was Senior Director, Global Clinical Lead at Pfizer focused on early oncology development. In his earlier roles Dr. Cha was Head of the metastatic breast cancer franchise at Puma Biotechnology, Senior Medical Director, Clinical Development at MEI Pharma, Medical Director at Allergan where he worked on Botox in urologic disorders, and Medical Director at Amgen where he was primarily focused on Nplate and blinatumomab.

Dr. Cha joins NKGen Biotech during an exciting period as the Company advances its allogeneic program towards IND filing while continuing work on SNK01 in refractory solid tumors in both monotherapy and combination therapy partnered programs.

"NK cell therapy represents a highly promising novel treatment paradigm in oncology," said Dr. Cha. "I am extremely enthusiastic about joining the NKGen Biotech team to work on SNK01 and the follow-on allogeneic and CAR-NK programs, which I believe have the potential to become best-in-class NK cell therapies for oncology patients."

Dr. Cha completed a BS in Biochemistry and Cell Biology from the University of California, San Diego and obtained his M.D. from the Tufts University School of Medicine. He has also completed fellowships in Hematology and Blood and Marrow Transplant at Stanford University.

On April 15, 2021 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a preclinical-stage biopharmaceutical company focused on the discovery, development and commercialization of irreversible small molecules to treat patients with genetically defined cancers, reported the pricing of its initial public offering of 9,000,000 shares of its common stock at a public offering price of $17.00 per share (Press release, Biomea Fusion, APR 15, 2021, View Source [SID1234578177]). All of the shares of common stock are being offered by Biomea. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Biomea, are expected to be $153.0 million. Biomea’s common stock is expected to begin trading on The Nasdaq Global Select Market on April 16, 2021, under the ticker symbol "BMEA." The offering is expected to close on April 20, 2021, subject to satisfaction of customary closing conditions. In addition, Biomea has granted the underwriters a 30-day option to purchase up to an additional 1,350,000 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.

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J.P. Morgan Securities LLC, Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering.

Registration statements relating to the securities has been filed with the Securities and Exchange Commission and was declared effective on April 15, 2021. The offering is being made only by means of a prospectus, copies of which may be obtained from, when available from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attn: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On April 15, 2021 Race Oncology Limited ("Race") reported to share details of a recent scientific publication in the prestigious journal Nature Communication, confirming Bisantrene is a highly effective inhibitor of the Fat Mass and Obesity associated protein (FTO)1 (Press release, Race Oncology, APR 15, 2021, View Source [SID1234578162]).

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This independent work was performed by a research team at the University of Chicago led by prominent Professors Chuan He and Yu-Ying He, and builds on the original identification of Bisantrene as a potent FTO inhibitor by Professor Chen and his team at the City of Hope Hospital in 20202. Prof. Chuan He’s team was the first to identify FTO as a m6A RNA demethylase3 and its involvement in many cancers.

In this new work, the University of Chicago team has identified that FTO plays a critical role in the development of skin cancers caused by low-level arsenic exposure (which promotes tumour growth) and that Bisantrene-targeted inhibition of FTO limits the growth of these skin cancers in both cell culture and mice.

The importance of this work is highlighted by the ongoing replication crisis in cancer research where many of the most exciting discoveries have not been able to be repeated in independent laboratories4. Independent confirmation of Bisantrene’s ability to target FTO further supports the clinical potential of Race’s Pillar 1 program (ASX announcements: 30 November 2020).