December 2025 Type C Meeting confirmed immune biomarkers suitability to establish surrogate clinical efficacy that could support BLA under Accelerated Approval PathwayPre-specified clinical outcomes data correlates with Immune biomarker signatureCompany positioned to review completed Phase 2b clinical & biomarker data and confirmatory Phase 3 trial protocol with U.S. FDA, EMA and U.K. MHRA in 2Q/26Company expects to initiate confirmatory Phase 3 trial in Australia in 3Q/26Company anticipates receiving a BL ...

BioInvent International AB Publishes Annual Report 2025 Back to the Newsroom BioInvent International AB Publishes Annual Report 2025 LUND, SE / ACCESS Newswire/ March 31, 2026 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV), a biotech company focused on the discovery and development of novel and first-in-class immunomodulatory antibodies for cancer immunotherapy, today announced that the Annual Report for 2025 has been published. The Annual Report is atta ...

Poolbeg Pharma PLC (AIM:POLB, OTC:POLBF, FRA:POLBF) CEO Jeremy Skillington talked with Proactive's Stephen Gunnion about the company securing its first national patent for POLB-001 targeting cancer immunotherapy-induced cytokine release syndrome (CRS). Skillington explained that the patent, granted by IP Australia, covers the use of p38 MAPK inhibitors, including POLB-001, to prevent and treat CRS. He highlighted that the protection is broad and supported by proprietary data generated by the company, foll ...

SELLAS Life Sciences Group Inc. (NASDAQ:SLS) is one of the popular penny stocks on Robinhood to buy. On March 17, SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) announced that it will present preclinical data on SLS009 at the American Association for Cancer Research annual meeting on April 21, 2026. SELLAS Life Sciences (SLS) to Present SLS009 Data at AACR 2026 SLS009, alternatively known as tambiciclib, is a selective CDK9 inhibitor. Put simply, this is a treatment designed to stop a specific “worker” pr ...

Core Viewpoint - Candel Therapeutics Inc is making significant strides in advancing its lead cancer immunotherapy, with plans for new phase 3 trials and a regulatory filing, while reporting its financial results for Q4 and full year 2025 [1] Clinical Development - The company plans to initiate a pivotal phase 3 clinical trial for its lead candidate, aglatimagene besadenovec (CAN-2409), targeting patients with progressive metastatic non-squamous non-small cell lung cancer (NSCLC) who have failed prior treatments, set for Q2 2026 [2] - A Biologics License Application (BLA) for aglatimagene in localized intermediate- to high-risk prostate cancer is expected to be submitted in Q4 2026 [2] - Preparations for the regulatory filing for aglatimagene in prostate cancer are ongoing, including work on chemistry, manufacturing, and controls, as well as clinical study reports [3] - Follow-up clinical data from the phase 3 prostate cancer trial is anticipated in Q2 2026, with biomarker data expected in Q3 2026 [3] - The FDA has granted Fast Track and Regenerative Medicine Advanced Therapy designations for aglatimagene in localized prostate cancer and Fast Track designation for NSCLC [4] Financial Position - Candel raised approximately $100 million through a follow-on equity offering in February 2026 and entered a $130 million term loan facility, drawing $50 million at closing [8] - A $100 million royalty funding deal was secured, contingent on FDA approval of aglatimagene in localized prostate cancer, with RTW Investments receiving a capped, tiered single-digit percentage of annual US net sales [9] - Research and development expenses for Q4 2025 totaled $11 million, up from $4.8 million in Q4 2024, with full-year R&D expenses increasing to $30.5 million from $19.3 million [11] - General and administrative expenses rose to $4.7 million in Q4 2025 from $3.3 million a year earlier, with full-year G&A expenses increasing to $17.8 million from $14.1 million [12] - The company reported a net loss of $29.5 million for Q4 2025, compared to a net loss of $14.1 million in Q4 2024, while the full-year net loss narrowed to $38.2 million from $55.2 million in 2024 [13] - Candel ended 2025 with $119.7 million in cash and cash equivalents, compared to $102.7 million at the end of 2024, with existing cash expected to fund operations into Q1 2028 [14]

Core Insights - Akeso, Inc. announced long-term survival analysis data for cadonilimab, a treatment for recurrent or metastatic cervical cancer, showing a 100% 24-month overall survival (OS) rate in complete responders [1] - The study highlights cadonilimab's ability to convert deep tumor remission into long-term disease control and survival benefits, providing a new therapeutic option for advanced cervical cancer patients [1] Survival Outcomes - In a study with a median follow-up of 26.5 months, complete responders had a median OS that was not reached, with a 24-month OS rate of 100.0% [1] - For partial responders, the median OS was also not reached, with a 24-month OS rate of 63% and a median progression-free survival (PFS) of 11.17 months [1] - The 12-month PFS rate for complete responders was 84.6%, while for partial responders it was 47.3% [1] PD-L1 Expression Status - The study included over 18% of patients with PD-L1 CPS < 1, demonstrating that cadonilimab achieved a median OS of 17.5 months across the overall population [1] - Updated data showed durable survival benefits with 18-month and 24-month OS rates of 47.8% and 40.9%, respectively, for both PD-L1 positive and negative patients [1] Cadonilimab's Mechanism and Approval - Cadonilimab is the first approved bispecific antibody cancer immunotherapy, launched in 2022, showing superior efficacy in challenging settings like immunotherapy-resistant tumors [1] - The drug targets both PD-1 and CTLA-4, overcoming limitations of existing therapies and is currently approved for three indications in China [1] Clinical Development and Pipeline - Akeso is advancing cadonilimab's global clinical development and is involved in 11 registrational/Phase III studies across various tumor indications [1] - The company has a robust pipeline of over 50 innovative assets, with 26 candidates in clinical trials and 7 new drugs commercially available [1]

Core Insights - Compugen Ltd. is a clinical-stage cancer immunotherapy company that utilizes AI/ML for drug target discovery [1] - The company will participate in two upcoming investor conferences, including the Oppenheimer 36th Annual Healthcare Life Sciences Conference and the Leerink Partners 2026 Global Healthcare Conference [1] Company Overview - Compugen is focused on developing cancer immunotherapies through its AI/ML powered computational discovery platform, Unigen™ [1] - The company has two main programs targeting TIGIT: COM902, a fully owned anti-TIGIT antibody in Phase 1, and rilvegostomig, an Fc-reduced PD-1/TIGIT bispecific antibody in Phase 3 development by AstraZeneca [1] - Additional programs include COM701, a potential first-in-class anti-PVRIG antibody, and GS-0321, a high affinity anti-IL-18 binding protein antibody licensed to Gilead [1] Upcoming Events - The Oppenheimer conference will take place on February 26, 2026, featuring a fireside chat at 2 PM ET [1] - The Leerink Partners conference is scheduled for March 9, 2026, with a fireside chat at 8:40 AM ET [1] - Live webcasts of the fireside chats will be available on Compugen's Investor Relations website [1]

Core Insights - TuHURA Biosciences has filed an Investigational New Drug Application (IND) for TBS-2025, a novel VISTA inhibiting antibody, aimed at treating mutNPM1 relapsed/refractory Acute Myeloid Leukemia (AML) in combination with a menin inhibitor [1] - The company plans to initiate a Phase 2 study in early Q2 2026, targeting menin inhibitor naïve patients, with preliminary results expected in Q3 2026 [1] - TBS-2025 is expected to address the unmet medical need in AML treatment, as current therapies have low complete response rates of less than 25% [1] Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company focused on developing novel therapeutics to overcome resistance to cancer immunotherapy [1] - The company’s lead product, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors and is currently in a Phase 3 trial for advanced Merkel Cell Carcinoma [1] - TBS-2025 was acquired through the merger with Kineta Inc. and is moving into Phase 2 development for mutNPM1 r/r AML [1] Scientific Rationale - Scientific evidence indicates that mutations like mutNPM1 drive VISTA expression on leukemic cells, contributing to poor therapy responses and high relapse rates in AML [1] - The removal of the VSIR gene, which encodes for VISTA, in murine models has shown enhanced immune response and improved survival rates [1] - TBS-2025 demonstrated a favorable safety profile in a Phase 1 trial, with an optimal Phase 2 dose anticipated to be 750mg every three weeks [1]

Group 1 - Iovance Biotherapeutics Inc. expects to achieve full-year 2025 revenue guidance of $250 to $300 million in the first full calendar year of Amtagvi sales [1][2] - Amtagvi, the treatment regimen for advanced melanoma, is projected to have peak sales potential of up to $1 billion [1] - The company has $307 million in cash and cash equivalents, which will fund operations through the second quarter of 2027 [2] Group 2 - Lifileucel, an in-development treatment for lung cancer, has a commercial opportunity that could be up to 7 times larger than the current melanoma treatment market [2] - Enrollment and data updates for Lifileucel are expected to be completed this year, with a launch anticipated in the second half of 2027 [2] - Iovance Biotherapeutics specializes in developing and commercializing cell therapies as novel cancer immunotherapy products [2]

Core Viewpoint - OS Therapies Inc. has initiated a Biologics License Application (BLA) submission to the FDA for OST-HER2, targeting the prevention or delay of recurrent pulmonary metastatic osteosarcoma, with expectations for approval by September 30, 2026 [1][5]. Company Developments - The company has submitted the Non-Clinical and Chemistry, Manufacturing, and Controls (CMC) modules of the BLA to the FDA and requested a Rolling Review [1][5]. - A Type D Meeting is anticipated in March 2026 to discuss new Comparative Oncology biomarker data from the Phase 2b clinical trial in humans and a similar trial in canines [1][5]. - The final clinical BLA module is expected to be submitted by the end of March 2026 [5]. Designations and Approvals - OST-HER2 has received Orphan Disease Designation (ODD), Fast Track Designation from the FDA and EMA, and Rare Pediatric Disease Designation (RPDD) from the FDA [3][4]. - If Accelerated Approval is granted before September 30, 2026, the company will be eligible for a Priority Review Voucher (PRV), which it intends to sell [3][4]. Clinical Trial Results - Positive data from the Phase 2b clinical trial of OST-HER2 demonstrated statistically significant benefits in the 12-month event-free survival (EFS) primary endpoint [4]. Future Developments - OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), utilizing proprietary technology for enhanced delivery of therapeutic payloads [6].