Intestinal 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

HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the enrollment of the first patient in its randomized, controlled, multicenter Phase III clinical study (AK117-302) for head and neck squamous cell carcinoma. This trial evaluates the innovative PD-1/VEGF bispecific antibody ivonescimab in combination with Akeso's next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS≥1) recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The AK117-302 study represents a significant milestone as the first Phase III clinical trial globally to investigate a CD47 monoclonal antibody therapy for solid tumors. This trial is the fifth Phase III study for ivonescimab, utilizing PD-1/L1 monoclonal antibody therapy as a positive control, and the third Phase III study comparing ivonescimab with pembrolizumab. The AK117-302 trial underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore, it highlights our capability to maximize the number of cancer patients globally that can benefit from our product portfolio through a strategic approach to clinical development. In 2022, there were 770,000 new cases of head and neck cancer globally, with 84,000 cases reported in China. Squamous cell carcinoma of the head and neck (HNSCC) accounts for over 90% of these cancers. Unfortunately, the five-year survival rate for patients with recurrent/metastatic HNSCC (R/M HNSCC) is just 3.6%. While targeted therapies and immunotherapies have improved treatment options, the median overall survival (OS) remains below one year. Pembrolizumab has emerged as the first-line standard treatment for R/M HNSCC and is recommended in both CSCO and NCCN guidelines. However, many patients do not respond adequately, and the overall survival benefit remains limited. There is a critical unmet need for more effective therapies to help HNSCC patients achieve long-term survival. At the 2024 European Society for Medical Oncology (ESMO) Congress, Akeso reported initial positive data on its combination therapy of ivonescimab and ligufalimab. This combination demonstrated significant tumor reduction and survival benefits, particularly for HNSCC patients, who require rapid tumor shrinkage. The preliminary efficacy data from this therapy surpassed that of previously disclosed PD-1 studies, positioning it as a potentially new immunotherapy option for HNSCC patients. About Ligufalimab (AK117) AK117, independently developed by Akeso, is a next-generation humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα, in order to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors. Currently, several phase II clinical trials are underway to investigate the potential of AK117 in combination with azacitidine for hematological tumors, as well as AK117 alone or in combination with ivonescimab and cadonilimab for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles, with no observed dose-limiting toxicity events. Additionally, the Chinese Phase II clinical study of the first-line treatment for unfit AML using AK117 in combination with venetoclax and zzacitidine, as well as the international multicenter Phase II clinical study of AK117 for treating MDS, are both ongoing with patient enrollment. About Ivonescimab (AK112/SMT112) Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics's license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab's first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them , 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED