On October 11, 2023 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported recent updates in its lung cancer detection program for early-stage disease (Press release, Nucleix, OCT 11, 2023, View Source [SID1234635869]). At the American College of Chest Physicians (CHEST) 2023 Annual Meeting yesterday, Dr. Peter Mazzone, M.D., MPH, Director of the Lung Cancer Program and Lung Cancer Screening Program for the Respiratory Institute at the Cleveland Clinic and co-principal investigator of the Sightline study, presented initial performance data from the Sightline study, a prospective multi-center, case-control study evaluating the performance of Lung EpiCheck. Additionally, the company strengthened its leadership team with the appointment of Mathias Ehrich, M.D., as its chief scientific officer.

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Data Presented at CHEST

Earlier this year, the company announced that the Nucleix EpiCheck Lung Atlas, which utilizes next-generation sequencing (NGS) and is focused on stage I disease, had identified many promising, novel biomarkers for the early detection of lung cancer. Dr. Mazzone’s presentation, "Enhanced detection of early-stage lung cancer with an ultrasensitive plasma-based methylation assay," outlined initial performance data of the company’s Lung EpiCheck polymerase chain reaction (PCR) assay, which includes novel biomarkers discovered as part of the development of the Nucleix EpiCheck Lung Atlas.

In an initial evaluation of clinical performance, the Lung EpiCheck PCR assay demonstrated an AUC between 0.841 – 0.871; stage I non-small cell lung cancer (NSCLC) sensitivity ranged between 87.1% – 87.2%; and overall sensitivity ranged between 89.9% – 91.6%. These data were based on an analysis of 813 subjects (188 cases and 625 controls) at high-risk of lung cancer. Tumor characteristics in these subjects were similar to the screening arm of the National Lung Screening Trial, with 60% early-stage (stage I & II) NSCLC and 65% of stage I tumors smaller than 20mm.

"Over the past few months, we’ve made incredible progress on our lung cancer program, having recently premiered data on the Nucleix EpiCheck Lung Atlas and enrolled more than 4,000 patients in the Sightline study," said Chris Hibberd, chief executive officer of Nucleix. "We are encouraged by this data readout presented at CHEST, as it further demonstrates the discovery capabilities of the Nucleix EpiCheck Lung Atlas and the potential of Lung EpiCheck as a non-invasive test to aid in the detection of early-stage lung cancer in people at high risk for lung cancer."

"The five-year survival rates for lung cancer are up to 10 times greater when detected early,i but unfortunately, most patients are still diagnosed in later stages of the disease," said Dr. Mazzone. "The Sightline investigators are very excited with the results demonstrating that a tool like Lung EpiCheck could have a major impact on lung cancer screening, as it offers a simple and non-invasive solution to catch the disease at stage I or II when patients have much higher chances to be cured."

Key Executive Appointed

Mathias Ehrich, M.D., joins Nucleix with more than two decades of medical and scientific experience. Previously the co-founder, chief scientific officer and chief medical officer of Juno Diagnostics, Dr. Ehrich brings significant expertise in diagnostics and product development using NGS-based screening tools. Prior to Juno Diagnostics, Dr. Ehrich lead the innovation and advancement of the world’s first NGS-based, cell-free DNA test for non-invasive prenatal screening. At Nucleix, Dr. Ehrich will lead and oversee R&D, product development, clinical development, and strategic research for the company’s lung cancer detection program for early-stage disease.

"I was impressed by the data the company presented on the Nucleix EpiCheck Lung Atlas earlier this year, the potential of its Lung EpiCheck assay and the company’s differentiated approach for the discovery and identification of novel biomarkers for non-invasive lung cancer screening," said Dr. Ehrich. "I am honored to join the team and look forward to further advancing this program to detect lung cancer earlier when treatment can be more effective for patients."

On October 11, 2023 Scholar Rock Holding Corporation (Nasdaq: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported the pricing of an upsized underwritten public offering of 12,408,760 shares of its common stock at a public offering price of $6.85 per share (Press release, Scholar Rock, OCT 11, 2023, View Source [SID1234635868]). The aggregate gross proceeds to Scholar Rock from this offering are expected to be approximately $85.0 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares are being offered by Scholar Rock. The offering is expected to close on October 16, 2023, subject to the satisfaction of customary closing conditions. In addition, Scholar Rock has granted the underwriters a 30-day option to purchase up to an additional 1,861,314 shares of common stock at the public offering price, less the underwriting discounts and commissions.

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Scholar Rock intends to use the net proceeds from the offering to advance apitegromab, develop its clinical and preclinical pipeline, as well as for working capital and other general corporate purposes.

J.P. Morgan Securities LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. BMO Capital Markets Corp. and Wedbush Securities Inc. are acting as co-managers for the offering.

The securities described above are being offered by Scholar Rock pursuant to a shelf registration statement on Form S-3 (No. 333-268329) that was declared effective by the Securities and Exchange Commission (SEC) on November 25, 2022. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering were filed with the SEC on October 11, 2023, and are available on the SEC’s website located at www.sec.gov. A copy of the final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting: 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]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at 800-747-3924 or by email at [email protected].

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

On October 11, 2023 ImmPACT Bio USA, Inc. ("ImmPACT BIO"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, reported that it will participate at the BIO Investor Forum, to be held from October 17-18, 2023 in San Francisco, CA (Press release, ImmPACT-Bio, OCT 11, 2023, View Source [SID1234635867]).

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Sumant Ramachandra, M.D., Ph.D., ImmPACT Bio’s president and chief executive officer, will participate in a panel discussion entitled "Opportunities in Bispecific Therapy Development," on Tuesday, October 17, 2023 at 11:00 AM PT.

On October 11, 2023 Allorion Therapeutics (Allorion), a clinical-stage biotechnology company dedicated to the discovery and development of next-generation targeted drugs for cancer and autoimmune diseases, reported the dosing of its first patient in the Phase 1/2 trial of ARTS-021 (NCT05867251) (Press release, Allorion Therapeutics, OCT 11, 2023, View Source [SID1234635865]). This open-label, first-in-human study is currently ongoing in the US and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ARTS-021 in adult patients with advanced or metastatic solid tumors.

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ARTS-021 is a potent and highly selective CDK2 inhibitor formulated specifically for targeting HR+/HER2- breast cancers and CCNE1-amplified cancers. The objective is to enhance therapeutic efficacy and overcome resistance in these hard-to-treat cancer types. "Dosing the first patient with ARTS-021 marks a pivotal milestone given there remains an unmet need for highly selective CDK2 inhibitors," commented Greg Berk, MD, Chief Medical Officer of Allorion Therapeutics. "In 2023, nearly 300,000 new cases of HR-positive breast cancer were diagnosed and there remains very few treatment options. In addition, CCNE1 amplification, a frequently observed genetic alteration in human cancer, is present in 10 to 20% of ovarian cancer with no approved targeted therapies. With the advancement of the ARTS-021 program, there is potential for a transformative treatment that could notably enhance the lives of HR-positive breast cancer patients and those with CCNE1-amplified tumors."

On October 11, 2023 Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) ("Coeptis" or "the Company"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, reported that it has expanded its exclusive license agreement with the University of Pittsburgh to include the SNAP-CAR technology platform in natural killer (NK) cells (Press release, University of Pittsburgh, OCT 11, 2023, View Source [SID1234635864]). This amended agreement builds upon the original exclusive license agreement with the University of Pittsburgh for SNAP-CAR T-Cell, a "universal" CAR T technology platform designed to target multiple antigens simultaneously and potentially address a range of hematologic and solid tumors, including HER2-expressing cancer.

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The addition of SNAP-CAR NK adds a third NK-focused technology to Coeptis’ development portfolio. Recently Coeptis completed an exclusive license agreement with Deverra Therapeutics, which included rights to a proprietary allogeneic stem cell expansion and differentiation platform for the generation of NK cells from pooled donor cord blood CD34+ cells that are being used without HLA matching in first-in-human clinical trials. This highly scalable and cost-effective cell generation platform combined with the universal SNAP-CAR technology has the potential to generate a first-in-class fully universal (no HLA matching and antigen agnostic) targeted cell therapy. Coeptis has also obtained exclusive rights from VyGen Bio to negotiate towards the acquisition of the GEAR cell therapy and companion diagnostic platforms, including CD38-GEAR-NK, a natural killer (NK) cell therapy for the treatment of CD38+ cancers with an initial focus on multiple myeloma.

"The original exclusive license agreement with the University of Pittsburgh was a watershed moment for Coeptis, and with the growing recognition of the potential of NK cells, we believe this amendment is another extremely important step for this partnership and for Coeptis," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "Expanding this agreement to include engineering of NK cells to generate SNAP-CAR NK therapies highlights our commitment to being on the leading edge of this important technology with a team that is fully capable of expanding upon the existing technology to incorporate and synergize with complementary technologies that we have brought inhouse to Coeptis, including assets recently in-licensed from Deverra Therapeutics."

"We are pleased to expand our partnership with Coeptis as we work to advance our efforts in developing a universal CAR-T system and believe NK cells have the potential to be an important cell type for developing better treatments for a range of cancers," said Jason Lohmueller, Ph.D., Assistant Professor of Surgery and Immunology in the Division of Surgical Oncology Research, University of Pittsburgh. "Expanding this agreement to include allogeneic NK cells enables our teams to develop cell therapies that can be developed with off-the-shelf convenience and greater access to patients. We continue to strive for therapies that can target multiple antigens simultaneously while also offering greater control over toxicity."