Botensilimab

Five months after the FDA blocked its plans for accelerated approval, Agenus is moving ahead with discussions with potential pharma partners to chart a more conventional registrational path for its anti-CTLA-4 drug combo that has new Phase 2 data in advanced colorectal cancer. There are a variety of different partnership proposals on the table, with some focused on co-developing and others on financing, Agenus chief medical officer Steven O’Day told Endpoints News in an interview. “These negotiations are active — they’re moving forward,” he said. During its second-quarter earnings call last year, the company already indicated that it was looking for partnerships for botensilimab, which is combined with its PD-1 candidate balstilimab (BOT/BAL). According to data presented Saturday at the ASCO Gastrointestinal Cancers Symposium in San Francisco, the biotech’s 75 mg dose of botensilimab combined with balstilimab achieved a 19% objective response rate in patients with refractory microsatellite stable metastatic colorectal cancer that had spread to certain body parts but not the liver. This compares well with an ORR of zero for the control arm, which featured standard-of-care: Bayer’s Stivarga or Taiho Pharmaceutical’s Lonsurf. The 75 mg treatment cohort also achieved a 55% disease control rate. This means that more than half the patients treated with the combo were no longer progressing, O’Day said. Hello, Traci Lang You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? Hello, Traci Lang You’re an essential part of the biopharma world. Share your voice on this important question to help shape our understanding of the industry. Can you help us out? The company has regulatory “alignment” to move forward with the 75 mg regimen in a Phase 3 trial with survival as a primary endpoint, he added. In July 2024, the FDA advised Agenus against pursuing accelerated approval for BOT/BAL based on data from previous Phase 1 and 2 studies in relapsed or refractory non-microsatellite instability-high colorectal cancer. The agency said that response rates in this population have not always translated to survival outcomes, adding it wanted to see a definitive survival study. Now that a Phase 3 is in the cards, Agenus has several options as to the specific subset of colorectal cancer patients it advances in, O’Day said. Other than the late-line setting, “we can also move into earlier-line metastatic colon and neoadjuvant” disease, he said. The company shared results from various BOT/BAL-based regimens in these other settings at ASCO GI. “But clearly the Phase 3 refractory [setting] is the most set up in terms of the work that’s been done with dose and contribution and a large database,” O’Day said. Agenus is no stranger to regulatory struggles. In 2021, the drugmaker withdrew its accelerated BLA for balstilimab in second-line cervical cancer shortly after the FDA cleared Merck’s Keytruda for full approval in the same setting. In August 2024, Bristol Myers Squibb turned its back on a pact with Agenus for a bispecific anti-TIGIT drug that featured more than $1 billion in potential milestones. Last month, the biotech launched a biologics manufacturing business to help it make money. In November, it had just $44.8 million in consolidated cash.

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Jan. 22, 2025 /PRNewswire/ -- USA News Group News Commentary – Big developments are expected this week at the 2025 ASCO Gastrointestinal Cancers Symposium, running January 23-25 in San Francisco. This year's event is particularly critical as researchers highlight the alarming rise in cancer rates among people under 50, with gastrointestinal cancers leading the increase. Colorectal and pancreatic cancers, two of the top three deadliest cancer types, remain significant concerns as pancreatic cancer mortality continues to climb. Among the innovators presenting at the symposium are Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Agenus Inc. (NASDAQ: AGEN), Guardant Health, Inc. (NASDAQ: GH), Xilio Therapeutics, Inc. (NASDAQ: XLO), and RenovoRx, Inc. (NASDAQ: RNXT). Continue Reading Pelareorep Factsheet (PRNewsfoto/USA News Group) The article continued: According to USD Analytics' recently introduced study, the Global Pancreatic Cancer Treatment Market is expected to soar in the upcoming years, growing at a 7.6% CAGR. Analysts at Precedence Research project that the global stomach cancer treatment market will grow at a 12.54% CAGR to US17.6 billion by 2034. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today shared details about the data it will present at the ASCO GI symposium. The presentations will highlight pelareorep, an innovative immunotherapy that trains the immune system to target cancer by turning "cold" tumors—typically resistant to treatment—into "hot" tumors that respond better to therapy. In relapsed anal cancer, 4 out of 12 evaluable patients achieved a partial response for a response rate of 33%, and one patient achieved a remarkable complete response, meaning their cancer became undetectable and remained so for over 15 months. To put this into perspective, similar treatments typically achieve response rates of only 10-24%. This underscores pelareorep's potential to deliver life-changing results in some of the toughest-to-treat cancers. "In relapsed anal cancer, the efficacy signal that was initially reported continues to outperform historical control trials with the inclusion of additional patients," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "Importantly, the complete response we observed previously continued beyond the 12 months initially reported. Together, these results point to a clinically meaningful synergy between pelareorep and checkpoint inhibitors like atezolizumab." In pancreatic cancer, pelareorep has also demonstrated strong potential to improve outcomes for patients with this aggressive disease. The upcoming ASCO GI presentation will feature new safety data showing that pelareorep can be combined with modified FOLFIRINOX, another widely used chemotherapy regimen for patients with pancreatic cancer. "Our new safety data indicate its ability to also be combined with modified FOLFIRINOX, thus expanding its potential to benefit patients with metastatic pancreatic cancer," added Dr. Heineman. "We will continue to provide updates on the safety and efficacy of pelareorep-based combination therapy from these cohorts as they become available." This builds on prior results from the GOBLET study, where pelareorep, combined with atezolizumab, gemcitabine, and nab-paclitaxel, achieved a 62% objective response rate—more than double historical averages of 25%. These findings were pivotal in earning pelareorep FDA Fast Track designation in 2022, highlighting its promise to fill the critical unmet need for more effective pancreatic cancer therapies. The ability to pair pelareorep with modified FOLFIRINOX represents an important step forward in expanding treatment options for metastatic pancreatic cancer. These results not only highlight pelareorep's versatility but also its potential to enhance outcomes across multiple standard-of-care therapies. "I am quite pleased by these recent updates from the GOBLET study as they continue to provide potential new treatment options for patients in need of alternatives while maintaining a manageable safety profile," said Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial. "I've been especially impressed with the ability of pelareorep-based therapies to work across multiple challenging cancer indications and with multiple standards of care, including chemotherapy and checkpoint inhibitors, so I look forward to additional data readouts that can help improve the treatment paradigm." As Oncolytics Biotech advances its clinical programs and prepares for pivotal studies, the growing body of evidence continues to solidify pelareorep as a transformative therapeutic option for patients in desperate need of effective treatments. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: Agenus Inc. (NASADAQ: AGEN), a leader in immuno-oncology, recently announced it too will share five presentations at ASCO GI's symposium featuring botensilimab (BOT, an Fc-enhanced anti-CTLA-4 antibody) plus balstilimab (BAL, an anti-PD-1 antibody), and showcasing BOT/BAL's consistent activity in microsatellite stable (MSS) colorectal cancer (CRC), which accounts for over 80% of CRC cases and has limited treatment options, as well as its efficacy in microsatellite instability-high (MSI-H) CRC. Additionally, one presentation will feature BOT/BAL and invariant natural killer T cells (iNKTs) in patients with refractory gastric cancer. "These presentations will highlight BOT/BAL's potential to benefit patients across colorectal cancer treatment settings, including the neoadjuvant, late-line, and first-line settings," said Dr. Garo Armen, Chairman and CEO of Agenus. "We aim to transform outcomes at every stage of disease and deliver renewed hope for patients worldwide." ALX Oncology Holdings Inc. (NASDAQ: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients' lives, also recently announced that updated results from its Phase 2 ASPEN-06 clinical trial were accepted for oral presentation at ASCO GI 2025. ASPEN-06 is a global clinical trial testing evorpacept, ALX Oncology's innovative therapy designed to block the "don't eat me" signal used by cancer cells to evade the immune system. The study is evaluating evorpacept in combination with trastuzumab, CYRAMZA® (ramucirumab), and paclitaxel (a combination known as TRP) compared to TRP alone in patients with HER2-positive gastric or gastroesophageal junction cancer who have previously received anti-HER2 treatments. This approach aims to enhance the effectiveness of existing therapies and improve outcomes for patients with this aggressive cancer type. Xilio Therapeutics, Inc. (NASDAQ: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, recently announced its plans to present initial data from its ongoing Phase 2 trial for vilastobart (XTX101), a tumor-activated, Fc-enhanced, high affinity binding anti-CTLA-4, in combination with atezolizumab (Tecentriq®) in patients with metastatic microsatellite stable colorectal cancer (MSS CRC) at the ASCO GI Symposium. In addition, the company also announced preliminary data from Phase 1 dose escalation for XTX301, an investigational tumor-activated IL-12. "We are encouraged by the early evidence of responses in patients with cold tumors, including MSS colorectal cancer, reported for the combination of vilastobart and atezolizumab in Phase 1C dose escalation earlier this year, and we look forward to sharing initial Phase 2 data for the combination in MSS CRC at ASCO GI in January," said Katarina Luptakova, M.D., Chief Medical Officer of Xilio. "In addition, the preliminary Phase 1 data we reported today for XTX301, our tumor-activated IL-12, highlight its promising clinical profile, including no dose-limiting toxicities reported to date and consistent interferon gamma signaling observed throughout treatment cycles." RenovoRx, Inc. (NASDAQ: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared delivery platform, also announced that three of its abstracts were accepted to be presented at several upcoming industry conferences, including ASCO GI 2025. RenovoRx is pioneering a novel therapy platform called TAMP, which delivers chemotherapy directly to the tumor through the arterial wall, potentially reducing side effects and improving treatment effectiveness compared to standard intravenous therapy. Their ongoing Phase III TIGeR-PaC trial, evaluating this approach with their FDA-cleared RenovoCath device, is expected to complete patient enrollment and a key interim analysis by mid-2025. "These abstracts support the potential for our TAMP therapy platform to provide a meaningful advancement in the standard of care for cancer treatment," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "TAMP focuses on drug concentration optimization in tumors by delivering therapies with our RenovoCath delivery system. This targeted approach to cancer treatment is designed to enable physicians to isolate segments of the vascular anatomy closest to tumors and ensure precise therapeutic delivery, while potentially minimizing a therapy's toxicities versus the standard of care. Specifically, our approach enables physicians to utilize RenovoCath to use pressure to force chemotherapy across the arterial wall near the tumor site to bathe the target tumor." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. 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