On October 12, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that the European Patent Office (EPO) has granted the company a new patent based on EP Patent No. 3323834 covering its lead drug candidate mitazalimab, a CD40 monoclonal antibody currently being evaluated in a Phase 2 study in 1st line metastatic pancreatic cancer (Press release, Alligator Bioscience, OCT 12, 2023, View Source [SID1234635880]).

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The patent, titled "Anti-CD40 Antibodies, Uses and Methods", protects composition of matter for mitazalimab and other CD40 monoclonal antibodies until 2038 (including potential supplementary term). The new patent expands protection for mitazalimab in Europe and brings the total number of patents in the mitazalimab intellectual property portfolio to 48 granted patents and 25 pending patents covering multiple territories, including Europe, North America, Asia, and more.

"The protection of our intellectual property is one of the key pillars of our business strategy, providing a strong foundation for our drug development program and our plans to commercialize our assets," said Søren Bregenholt, CEO of Alligator Bioscience. "The granting of this new patent is a significant addition to our overall patent portfolio, providing vital further protection for our lead clinical asset in Europe. It also comes at an excellent timing with mitazalimab making outstanding progress in the clinic and advancing on its route to market."

Mitazalimab is being evaluated in combination with chemotherapy, mFOLFIRINOX, in the OPTIMIZE-1 Phase 2 study in 1st line metastatic pancreatic cancer. The study is progressing and is on track for top-line readout in early Q1 2024.

On October 11, 2023 SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, reported that it has dosed the first patients in the combination therapy arms of its Phase 1/2 CLAUDIO-01 trial. CLAUDIO-01 is evaluating SOTIO’s potent antibody-drug conjugate SOT102 in patients with gastric and pancreatic cancer (Press release, SOTIO, OCT 11, 2023, View Source [SID1234635870]). The combination arms will be the first clinical evaluation of SOT102’s potential as a first-line cancer treatment in combination with current standard of care. In the gastric cancer arm, SOT102 will be combined with mFOLFOX plus nivolumab. In the pancreatic cancer arm, SOT102 will be combined with Nab-paclitaxel plus gemcitabine.

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"The initiation of the combination arms in our Phase 1/2 CLAUDIO-01 trial represents an exciting clinical milestone in the development of SOT102 and our pursuit to provide novel and improved treatment options for patients suffering from solid tumors. The opportunity to evaluate SOT102 as part of a first-line treatment regimen will provide us valuable insights that could greatly expand the patient population who could benefit from this therapy," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. "We look forward to collaborating with our clinical sites to carry out these studies, as we work to deliver immunotherapies that can make a meaningful difference in the lives of patients with solid tumors."

CLAUDIO-01 (EudraCT number: 2021-005873-25) is a Phase 1/2 first-in-human, open-label, multicenter trial to assess the safety and preliminary efficacy of SOT102. SOTIO is progressing dose-finding studies in the trial’s monotherapy arm, in which SOT102 is used as a later-stage treatment. In the trial’s combination arm, by contrast, SOT102 will be dosed in combination with standard-of-care as a first-line treatment for patients with advanced/metastatic gastric/gastroesophageal junction (GEJ) or pancreatic cancers. To date the trial has reported no dose-limiting toxicities.

About SOT102

SOT102 is a potent antibody-drug conjugate that combines the clinically-validated target Claudin 18.2 (CLDN18.2) with a powerful toxin to address gastric, pancreatic and other cancers that have very few targeted treatments available. Preclinical data from studies of SOT102 have demonstrated potent anti-tumor efficacy in vitro and in vivo. SOT102 is currently being studied for the treatment of gastric and pancreatic cancers in the CLAUDIO-01 Phase 1/2 clinical trial at leading centers in Europe and the United States.

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.