CX-904

USA News Group Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, May 15, 2024 /PRNewswire/ -- USA News Group – Hope is rising in the fight against one of the deadliest cancers in the world, as a new study recently claimed that a blood test can accurately detect early-stage pancreatic cancer with 97% accuracy. According to Johns Hopkins Medicine, up to 10% of patients who receive an early diagnosis become disease-free after treatment, meaning the earlier it's detected, the better the patient's chances to survive. The American Cancer Society estimates that about 66,440 people (34,530 men and 31,910 women) will be diagnosed with pancreatic cancer in the USA this year, projecting about 51,750 people will succumb to the disease. Working diligently behind the scenes, several biotech drug developers are making progress in new treatments, including recent updates from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Candel Therapeutics, Inc. (NASDAQ: CADL), ABVC BioPharma, Inc. (NASDAQ: ABVC), CytomX Therapeutics, Inc. (NASDAQ: CTMX), and Amgen Inc. (NASDAQ: AMGN). Pelareorep, an intravenously delivered immunotherapeutic agent being developed by Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), is gaining momentum as a potential treatment for multiple cancers, especially breast cancer and pancreatic cancer. In late 2022, the FDA granted pelareorep Fast Track Designation for treating pancreatic cancer, following promising clinical results. Now Oncolytics has recently announced a preliminary collaboration with the Global Coalition for Adaptive Research (GCAR), with the purpose of commencing planning activities for the evaluation of pelareorep in the treatment of first-line metastatic pancreatic ductal adenocarcinoma (PDAC), as part of GCAR's anticipated master protocol for metastatic pancreatic cancer. GCAR's activities are already underway to finalize the seamless Phase 2/3 master protocol design that will evaluate multiple investigational therapies for pancreatic cancer treatment. Thus, the intent of the pelareorep study will be to produce registration-enabling data. "We are thrilled to collaborate with GCAR and are honored that pelareorep has been selected as the first therapeutic for evaluation in GCAR's planned adaptive trial in pancreatic cancer patients," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "We believe this opportunity presents a strategic and efficient pathway forward for the development of pelareorep to address an urgent need for pancreatic cancer patients. GCAR's anticipated trial design seeks to cut registrational study time and reduce trial costs, speeding up the journey to potentially deliver effective cancer treatment sooner." Oncolytics is also now advancing its lead asset further, having recently received regulatory clearance to evaluate pelareorep in combination with modified FOLFIRINOX +/- Tecentriq (from Roche) in pancreatic cancer in a new cohort from its ongoing GOBLET study, following German regulatory and ethics approvals. The new cohort is bolstered by a US$5 million Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an inventive initiative aimed at rapidly advancing the development of new treatments for pancreatic cancer. Achieving these positive results from the pelareorep/mFOLFIRINOX combination could greatly elevate Oncolytics' prospects in tackling pancreatic cancer. Oncolytics has previously reported encouraging data from pelareorep paired with gemcitabine and nab-paclitaxel. The Oncolytics team believes that if the mFOLFIRINOX combination demonstrates improvements in response rate over historical control trials, this treatment approach could move forward to a registration-enabling study, offering two potential pelareorep-based therapies for pancreatic cancer patients. Additionally, planned translational research studies for this cohort will further explore the understanding of pelareorep's mechanism of action, including its impact on the tumor microenvironment (TME). As a part of this evaluation, Oncolytics will examine the relationship between tumor responses and the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, an effect noted in previous pancreatic cancer studies. The company plans to start enrolling patients into the mFOLFIRINOX/pelareorep study cohort in Q2 2024. For Candel Therapeutics, Inc. (NASDAQ: CADL), the FDA granted Orphan Drug Designation to their leading multimodal biological candidate, CAN-2409, for pancreatic cancer treatment. This recognition came shortly after Candel shared updated overall survival data from its ongoing randomized phase 2 clinical trial of CAN-2409 combined with valacyclovir (prodrug) and standard-of-care chemoradiation, followed by surgery for borderline resectable pancreatic ductal adenocarcinoma (PDAC). "We recently reported data from the phase 2 randomized clinical trial of CAN-2409 in borderline resectable pancreatic cancer, showing that CAN-2409, when added to standard of care, more than doubled the median overall survival obtained with standard of care alone," said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. "We are pleased that the FDA has now granted Candel with both Orphan Drug and Fast Track Designation to this program, as we seek to reshape the treatment paradigm in pancreatic cancer." Clinical-stage biopharmaceutical company ABVC BioPharma, Inc. (NASDAQ: ABVC) recently announced it has entered into a definitive agreement with private company OncoX BioPharma, Inc. in its fight against pancreatic cancer. Through its affiliate Rgene Corporation, ABVC and OncoX are set to collaborate on combination therapy the duo believes will help treat pancreatic cancer and improve patient outcomes significantly, with ABVC and Rgene set to receive an aggregate license fee of $12.5 million in cash or shares from OncoX within the next 30 days. "We are excited to announce this collaboration with OncoX, which represents a significant step forward in our commitment to developing transformative treatments for pancreatic cancer," said Dr. Uttam Patil, CEO of ABVC. "By combining our strengths, we can make meaningful progress in addressing this devastating disease. The collaboration will draw on ABVC's portfolio of combination therapies pipeline, which has shown promise in preclinical and early clinical studies." Among ABVC's portfolio is its ABV-1703 (IND 136309) for pancreatic cancer therapy. As part of an Investigational New Drug (IND) application for ABV-1703 is the proposal for the clinical investigation of BLEX 404 as a combination therapy drug with chemotherapy. BLEX 404 is made with the active ingredient glucan, which is extracted from Grifola frondose (maitake mushrooms), an edible fungus with high medical and commercial value in Asia. "This partnership exemplifies our dedication to advancing the field of oncology and bringing hope to patients facing pancreatic cancer," said Wen-Pin Yen, CEO of OncoX. "Together with ABVC, we are committed to pushing the boundaries of innovation to improve outcomes for patients in need. The two companies aim to deliver a novel treatment option for pancreatic cancer patients by combining their resources, expertise, and innovative approaches." Leading drug developer in the field of masked, conditionally activated biologic therapeutics, CytomX Therapeutics, Inc. (NASDAQ: CTMX), recently announced positive initial data from its ongoing CX-904 Phase 1a dose escalation clinical study with its global development partner, Amgen Inc. (NASDAQ: AMGN). CytomX and Amgen are collaborating on CX-904, a bispecific PROBODY candidate designed to engage T-cells by targeting the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells. Within the clinical study results, CX-904 not only demonstrated a favorable safety profile with no cytokine release syndrome, but also presented encouraging initial signs of efficacy observed for CX-904 in advanced pancreatic cancer, including 2 of 6 patients (33%) with a confirmed partial response, and all 6 patients (100%) with disease control. "We are delighted to share these initial results today for CX-904, a highly innovative masked T-cell engager that embodies our vision at CytomX of transforming lives with safer, more effective therapies," said Sean McCarthy, D.Phil., CEO and Chairman of CytomX. "These data build on more than a decade of innovation at CytomX, and, we believe, open broad new possibilities for T-cell engagers across many targets and cancer types. We look forward to continuing to explore the potential of this exciting agent in multiple EGFR positive cancers and to determining longer term strategy with our global development partner, Amgen." 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- CX-904 demonstrated a favorable safety profile with no cytokine release syndrome (CRS) of any grade observed in step-dosing cohorts and no grade >1 CRS observed overall - - Encouraging initial signs of efficacy observed for CX-904 in advanced pancreatic cancer, including 2 of 6 patients (33%) with a confirmed partial response and all 6 patients (100%) with disease control - - Preliminary pharmacokinetic and pharmacodynamic analyses are supportive of PROBODY® T-Cell Engager platform mechanism of action - - Dose escalation and optimization continue - - Management to hold conference call today at 5 p.m. EDT / 2 p.m. PDT - May 08, 2024 -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologic therapeutics, today announced positive initial data from the ongoing CX-904 Phase 1a dose escalation clinical study, demonstrating a favorable safety profile and confirmed anti-cancer activity. CX-904 is an investigational, masked, conditionally activated PROBODY T-cell engager designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment. “We are delighted to share these initial results today for CX-904, a highly innovative masked T-cell engager that embodies our vision at CytomX of transforming lives with safer, more effective therapies,” said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX. “These data build on more than a decade of innovation at CytomX, and, we believe, open broad new possibilities for T-cell engagers across many targets and cancer types. For EGFR specifically, a target that is present on normal epithelial tissues, we are very encouraged to see CX-904 working as designed by eliciting meaningful tumor reductions in a very difficult to treat tumor type and with a favorable overall safety profile. We look forward to continuing to explore the potential of this exciting agent in multiple EGFR positive cancers and to determining longer term strategy with our global development partner, Amgen.” As of the April 16, 2024 data cutoff, the Phase 1 study had enrolled 35 patients with advanced metastatic solid tumor types that are generally known to express EGFR, including pancreatic, colorectal (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), gastric, and esophageal cancers. Patients enrolled in the study were heavily pre-treated and had a median of 4 prior lines of therapy. As of the data cutoff, 19 patients were enrolled into initial non-step dosing cohorts with target doses ranging from 0.007 mg to 6 mg, and 16 patients were subsequently enrolled into step-dosing cohorts with target doses ranging from 5 mg to 10 mg and with tocilizumab prophylaxis. Enrollment into a cohort with a target dose of 15 mg is ongoing. As of the cutoff date, CX-904 demonstrated a favorable safety profile that supports administration and monitoring of enrolled patients in an outpatient setting.1 There were no observed cases of CRS of any grade in step-dosing cohorts to-date. In non-step dosing cohorts, only Grade 1 CRS was observed in patients treated at the highest dose of 6 mg. Among all treated patients, the most common treatment-related adverse events (TRAEs) were rash, arthralgia, arthritis, pruritis, and vomiting, the majority of which were low grade, being observed in 14 (40%), 13 (37%), 5 (14%), 5 (14%) and 5 (14%) patients, respectively. Grade 3 TRAEs were tenosynovitis (n=1), arthralgia (n=2), arthritis (n=1), and rash (n=1). Eight patients had measurable tumor reduction at data cutoff, including 2 of 6 efficacy-evaluable patients (33%) with pancreatic cancer with confirmed partial responses per RECIST 1.1. All 6 efficacy-evaluable patients with pancreatic cancer achieved disease control (objective response or stable disease). For the two patients with a confirmed partial response, one patient (6 mg target dose) achieved an 83% tumor reduction. The second patient (5 mg target dose) with a confirmed response achieved a 51% tumor reduction and remained on study treatment as of the data cutoff. In addition, a third pancreatic cancer patient maintained stable disease with no evidence of tumor growth through 3.5 months of study treatment and remained on treatment as of the data cutoff. Preliminary pharmacokinetic and pharmacodynamic data were consistent with the PROBODY TCE mechanism of action, including maintained masking in circulation, and CD8+ T-cell margination and tumor infiltration. CX-904 Phase 1a dose escalation and optimization continue, with future enrollment focused on determining a recommended Phase 2 dose, or doses. The Company expects to provide an additional Phase 1a dose escalation update by the end of 2024. These additional data will inform discussions with CytomX partner, Amgen, towards initiation of Phase 1b expansion cohorts in specific EGFR positive tumor types. CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss the first quarter 2024 results and provide an initial CX-904 Phase 1a clinical data update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at https://ir.cytomx.com/events-and-presentations. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company’s website for at least 30 days. CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked biologics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY® therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), T-cell engagers, and immune modulators such as cytokines. CytomX’s clinical-stage pipeline includes CX-904, CX-2051 and CX-801. CX-904 is a masked, conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells. CX-904 is partnered with Amgen in a global co-development alliance. CX-2051 is a masked, conditionally activated ADC directed toward epithelial cell adhesion molecule, EpCAM, with potential applicability across multiple EpCAM-expressing epithelial cancers. CX-2051 was discovered in collaboration with Immunogen, now part of AbbVie. CX-801 is a masked interferon alpha-2b PROBODY® cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and X (formerly Twitter). The content above comes from the network. if any infringement, please contact us to modify.