Gastrointestinal Neoplasms

BOSTON, Oct. 31, 2024 /PRNewswire/ -- In a remarkable development for cancer research, patients with advanced-stage cancer have benefited from SUPLEXA, a personalized treatment that trains the patient's own immune cells to fight cancer. "Cancer often gains the upper hand by suppressing the immune system. Our approach flips the script: we isolate immune cells from this suppressive environment, we reactivate their inherent cancer-fighting abilities in a laboratory, and return them back to the patient", said Dr Frank Borriello, Founder and CEO of Boston-based Alloplex Biotherapeutics[1]. While the science behind SUPLEXA is sophisticated, the process for patients and clinicians is surprisingly straight-forward. A single 50 mL blood draw from the patient is all it takes to develop a complete course of SUPLEXA therapy. With nothing more than standard lab equipment, the patient's white blood cells are isolated and 'trained' outside the body (ex vivo) using Alloplex's proprietary ENLIST immune cell training technology. About a month later, the enhanced blood cells are infused into the patient, where they not only seek out and destroy rogue cancer cells — that had, until then, evaded the immune system — but improve the overall immune health of the patient. Full results of the first-in-human trial[2] will be released at the 2024 SITC conference in November. The Australian study showed no treatment-related serious adverse events — unsurprising, given that SUPLEXA is made from the patients' own immune cells that have simply undergone a training process to improve their functionality before being reintroduced to the patient. Remarkably, and in addition to its strong safety profile, SUPLEXA transformed the lives of patients with various cancer types. Its most striking results were observed in patients with a specific type of advanced colorectal cancer (CRC) and renal cell carcinoma (RCC). Three CRC patients derived significant clinical benefit: one achieved a complete response (CR), another a partial response (PR) and another stable disease (SD). "Many of these patients sustained a strong clinical response for up to two years," said Dr. Borriello. Of the ten RCC patients, one achieved a partial response (PR) and six achieved stable disease (SD) while only 3 had progressive disease (PD). Patients with other solid tumors, including melanoma, breast and lung cancer, also demonstrated long-term SD with SUPLEXA. While quality of life assessments were not formally captured in this study, patients reported improvements in their well-being, a reduction in pain and improved symptom control. For the participating patients who had exhausted all standard treatment options, "SUPLEXA has been a remarkable experience," said Principal Investigator, Assoc. Professor Rohit Joshi[3], who led the first-in-human study across three sites in Australia[4]. "It's also allowed them to continue with their normal lives, have a vacation, take up new hobbies and spend more time with family and friends," said Assoc. Prof. Rohit Joshi. FDA Opens Door to Proceed With encouragement from the FDA to proceed with an Investigational New Drug (IND) submission, Alloplex Biotherapeutics plans to initiate Phase 2 clinical trials of SUPLEXA in early 2025. The trial will combine SUPLEXA with immune checkpoint inhibitors (ICIs) in patients with a specific type of colorectal cancer. The goal is to test, in a controlled clinical setting, whether SUPLEXA's complementary mechanisms can enhance patient outcomes by amplifying the effectiveness of ICIs, which are the standard of care for this type of cancer. Notes: Alloplex Biotherapeutics is a private Boston-based company founded in 2016 with a singular focus on developing its ENLIST immune cell training platform for cancer. SUPLEXA cells represent the first candidate to emerge from this platform that harnesses and amplifies the innate capabilities of the immune system, Full clinical and scientific results of the trial will be presented at the Society for Immunotherapy of Cancer 'SITC' meeting in Houston, Texas in early November 2024. Abstracts #378 and #678 will be presented in the Immune Engineering Workshop and at the Annual Meeting. Assoc. Professor Rohit Joshi, MBBS, MD, FRACP, FACP, FRCP, is a highly published and renowned medical oncology consultant. He is an Associate Professor at the University of South Australia and University of Adelaide; and Director of Cancer Research SA ('CRSA'). The company's first-in-human clinical trial enrolled 35 patients with a variety of advanced cancer types. It was an open label, single-agent, basket study across three clinical sites in Australia and concluded in June 2024. The three sites in Australia where the SUPLEXA trial was carried out are: (1) Cancer Research SA ('CRSA') in Adelaide, South Australia; (2) Southern Oncology Research United ('SOCRU') in Adelaide, South Australia, and (3) Greenslopes Private Hospital / Gallipoli Medical Research Foundation, in Brisbane, Queensland. Full Media Kit: An extensive library of backgrounders, Q&As, images (including headshots) and videos is available at Media Contact Email: [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SOUTH SAN FRANCISCO, CA, USA I October 30, 2024 I TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (“BBOT” or the “Company”), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, has announced that the first patient has been dosed with BBO-10203 in the BREAKER-101 trial. BBO-10203 is a first-in-class orally bioavailable RAS:PI3Ka breaker that blocks the interaction between RAS and PI3Kα to inhibit PI3Kα-AKT signaling in tumors, without directly inhibiting the catalytic activity of PI3Kα. “I am thrilled to partner with BBOT to bring a potentially transformable new therapeutic to the clinic,” said Dr. Minal Barve, Chief Medical Officer and Principal Investigator at Mary Crowley Cancer Research, Dallas, TX. “BBO-10203 represents a first-in-class drug with potential to address high unmet medical needs and change the landscape of cancer care. We look forward to evaluating BBO-10203 in the BREAKER-101 trial.” BBO-10203 was designed to bind covalently and selectively to the RAS-binding domain (RBD) of PI3Kα. This selective inhibition is agnostic to the mutational status of PI3Kα and RAS, and in preclinical models, results in complete inhibition of RAS-driven pAKT signal at single digit nanomolar concentration. Additionally, no hyperglycemia was observed in preclinical species treated with BBO-10203. The discovery of BBO-10203 was the result of a collaboration between the RAS Initiative at Frederick National Laboratory, Lawrence Livermore National Laboratory, and BBOT. “BBO-10203 is a first-in-class program that inhibits the interaction of the two most mutated oncogenes in human cancer, and it will allow us to test, for the first time, the importance of RAS-coordinated activation of the MAPK and AKT signaling pathways,” said Pedro Beltran, PhD, Chief Scientific Officer of BBOT. “The discovery of BBO-10203 was made possible by the dedicated collaboration between academic, national laboratory, and industry experts that synergized to advance medicines for patients suffering from cancer.” The BREAKER-101 trial will enroll patients globally with locally advanced or metastatic HER2-positive breast cancer, HR-positive/HER2-negative breast cancer, KRAS mutant advanced colorectal cancer, and KRAS mutant advanced non-small cell lung cancer. “There is a tremendous opportunity to improve the standard of care in oncology by inhibiting oncogenic pAKT signaling without the metabolic side effects observed with kinase inhibitors, and the initiation of the Phase 1 study of BBO-10203 marks an important milestone in this regard,” said Yong (Ben) Ben, MD, Chief Medical and Development Officer of BBOT. “The second IND within six months of establishing BBOT clearly demonstrates our team’s capability in advancing our novel programs into the clinic. This novel mechanism and scientific rationale behind it will allow tremendous combination opportunities that optimally inhibit both pAKT and pERK – an approach we hope will bring unprecedented benefit to patients with RAS-driven cancers.” About TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics (BBOT) BridgeBio Oncology Therapeutics (BBOT) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. Initially formed as a subsidiary of BridgeBio, BBOT completed a $200M private financing with external investors in 2024 with the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit bridgebiooncology.com . SOURCE: BridgeBio Oncology Therapeutics

This approval marks the second international marketing authorization for sugemalimab outside of China, following its recent approval by the European Commission. The approval is based on results from the Phase 3 GEMSTONE-302 clinical trial, which demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) in treatment-naive patients with metastatic NSCLC. Long-term survival data from the GEMSTONE-302 study were presented at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. CStone is actively communicating with regulatory authorities, including the European Medicines Agency (EMA) for marketing authorization applications for additional indications of sugemalimab. CStone has entered into a strategic commercialization partnership with Ewopharma for sugemalimab in Central & Eastern Europe and Switzerland, with further collaborations expected soon in regions including Western Europe, Latin America, the Middle East, and Southeast Asia. SUZHOU, China, Oct. 31, 2024 /PRNewswire/ -- CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. This marks the second overseas approval for sugemalimab following its recent authorization by the European Commission. Dr. Jason Yang, CEO, President of R&D and Executive Director of the Board at CStone, said, "This approval is a significant milestone in our global expansion strategy. Sugemalimab is the first domestic anti-PD-L1 antibody to receive approval outside of China and has already entered the world's second-largest pharmaceutical market, the EU. Now, with the UK approval, sugemalimab continued to expand its presence in the European market. The long-term survival data, recently presented at this year's ESMO Congress, further confirmed sugemalimab's value in the frontline treatment landscape for metastatic NSCLC." Dr. Yang added, "We are actively pursuing additional partnerships across Western Europe, Latin America, the Middle East, Southeast Asia, and Canada, and expect to finalize some of these agreements shortly. Meanwhile, we are communicating with the European Medicines Agency (EMA) and other agencies for additional regulatory applications for other sugemalimab indications, including Stage III NSCLC, first-line gastric cancer, and first-line esophageal squamous cell carcinoma, aiming to bring innovative treatment options to more patients globally." The MHRA's approval is primarily based on the data from GEMSTONE-302, a multicenter, randomized, double-blind phase 3 trial. The study demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) compared to placebo combined with chemotherapy in treatment-naïve patients with metastatic NSCLC. Study results have been published in The Lancet Oncology and Nature Cancer, and have been presented at multiple international academic conferences in both oral and poster sessions. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED