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Orca Bio to Present Clinical Data on Its Pipeline of High-Precision Cell Therapies at the 52nd Annual Meeting of the EBMT

On March 2, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that clinical data will be presented in seven oral and poster sessions at the 52nd Annual Meeting of the EBMT from March 22-25 in Madrid.

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The encore presentations will include data on the company’s pipeline of investigational allogeneic T-cell immunotherapies for the treatment of multiple hematologic malignancies, including Orca-T and Orca-Q.

"Our participation at this year’s meeting of the EBMT provides an important opportunity to engage directly with the global transplant community as we continue our shared efforts to advance the field of allogeneic stem cell transplant," said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. "As we progress toward the potential FDA approval of Orca-T, the strength and consistency of our data reinforce our commitment to delivering a new therapy for patients with blood cancer. We look forward to being in Madrid to connect with clinicians and partners from around the world and to participate in scientific exchange focused on improving patient outcomes."

The EBMT abstracts are now available at www.ebmt.org/annual-meeting-2026. Details of the Orca Bio presentations follow:

Oral Session: OS14 | Graft Manipulation and Conditioning

Title: Orca-T Demonstrates Favorable Quality of Life and Healthcare Resource Use Compared to Standard AlloHSCT plus Tac/MTX for GVHD Prevention in a Randomized Phase 3 Clinical Trial (Precision-T)

Date and Time: Wednesday, March 25 at 08:30 AM – 08:39 AM CET

Location: N107

Oral Session: OS14 | Graft Manipulation and Conditioning

Title: Clinical Outcomes in Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients: An Observational Comparison

Date and Time: Wednesday, March 25 at 08:39 AM – 08:48 AM CET

Location: N107

Oral Session: OS12 | Acute GVHD – Clinical

Title: Cost-Effectiveness of Orca-T vs Allo-HCT with Conventional GVHD Prophylaxis for the Treatment of Advanced Hematologic Malignancies in the United States

Date and Time: Tuesday, March 24 at 2:39 PM – 2:48 PM CET

Location: N101-102

Poster Session: A

Title: Interim Clinical Outcomes in Orca-T with Reduced Intensity Conditioning: An Observational Comparison to Registry-Based Post-Transplant Cyclophosphamide Patients

Presentation ID: A038

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

Poster Session: A

Title: Scalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy

Presentation ID: A145

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

Poster Session: A

Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors

Presentation ID: A043

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

Poster Session: A

Title: Clinical Outcomes in Myelodysplastic Syndrome Patients Treated with Orca-T or Post-Transplant Cyclophosphamide Patients: A Registry-Based Comparison

Presentation ID: A085

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.

About Orca-Q
Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.

(Press release, Orca Bio, MAR 2, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-to-present-clinical-data-on-its-pipeline-of-high-precision-cell-therapies-at-the-52nd-annual-meeting-of-the-ebmt [SID1234663181])

Oncolytics Biotech® Launches Randomized Colorectal Cancer Study

On March 2, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported the initiation of a metastatic colorectal cancer ("mCRC") Phase 2 study that will be referred to as REO 033.

In this trial, second-line ("2L") RAS-mutated (which includes KRAS), microsatellite-stable ("MSS") mCRC patients will be randomized to a control arm of bevacizumab (Avastin) and fluorouracil, leucovorin, irinotecan ("FOLFIRI") or an experimental arm of pelareorep, bevacizumab, and FOLFIRI. The study is powered for statistical significance, with each study arm expected to enroll 30 patients. All participants will have failed their initial treatment with platinum-based chemotherapy. The primary endpoint of the study is objective response rate ("ORR"), with progression-free survival ("PFS"), overall survival ("OS"), safety, and biomarker analysis as other endpoints. The trial will be sponsored by Oncolytics with Sanjay Goel, M.D., M.S., FASCO, Professor of Medicine at Rutgers Cancer Institute of New Jersey, as the Lead Investigator. The Company is expecting to initiate the first study site later this month and provide preliminary data by year-end.

"I am honored to lead this study as I have a long track record working with pelareorep and have witnessed its ability to improve patient outcomes in a meaningful way," said Dr. Goel. "The colorectal cancer data we recorded in the REO 022 study continues to be compelling to this day, as evidenced by the Fast Track Designation, and I hope we can generate additional exciting data in this new trial to support registration."

The previous REO 022 clinical study of pelareorep, bevacizumab, and FOLFIRI in this population demonstrated a median OS of 27 months and a median PFS of 16.6 months, both of which substantially exceed the median 11.2- and 5.7-month OS and PFS, respectively, observed for standard-of-care therapy. Similarly, ORR in the same study was 33% for pelareorep-containing therapy compared to approximately 10% for standard-of-care treatment.1-2 Last month, the Company announced that pelareorep in combination with bevacizumab and FOLFIRI was granted Fast Track Designation by the U.S. Food & Drug Administration in 2L KRAS-mutant, MSS mCRC.

"The potential to improve clinical outcomes compared to the standard-of-care in the second-line setting would have the potential to benefit patients around the world who are affected by colorectal cancer," said Dr. Van Morris, Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX, and member of the Oncolytics Biotech Gastrointestinal Scientific Advisory Board. "An immunotherapy with the potential to improve outcomes would improve treatment options in colorectal cancer and would be highly welcomed, especially as we are seeing more and more younger patients being diagnosed with colorectal cancer."

(Press release, Oncolytics Biotech, MAR 2, 2026, View Source [SID1234663180])

Lantheus Receives FDA Tentative Approval for Lutetium Lu 177 Dotatate (PNT2003), Radioequivalent to LUTATHERA®

On March 2, 2026 Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that it has received U.S. Food and Drug Administration (FDA) tentative approval for the Abbreviated New Drug Application (ANDA) for Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent1 version of LUTATHERA (lutetium Lu 177 dotatate). LUTATHERA is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

"As the first radioequivalent to LUTATHERA to receive FDA tentative approval, PNT2003 marks an important step forward in Lantheus’ work to advance treatment options for patients with GEP-NETs. This milestone comes at a time when advances in imaging and evolving clinical guidelines are enabling the identification of more patients who stand to benefit from targeted radiopharmaceutical therapies. As the leading radiopharmaceutical-focused company, we remain committed to meeting this growing demand and look forward to making PNT2003 available to patients pending final FDA approval," said Mary Anne Heino, Chief Executive Officer of Lantheus.

The FDA tentative approval indicates that the FDA has completed its review of the ANDA and that it meets the requirements for approval under the Federal Food, Drug and Cosmetics Act. Full approval of the ANDA is subject to the expiration of the 30-month stay in June 2026, triggered in connection with a Hatch-Waxman patent litigation.

Lantheus licensed exclusive worldwide rights (excluding certain territories) to PNT2003 from POINT Biopharma Global, Inc. in December 2022. To read the press release announcing that licensing transaction, please click here. POINT was acquired by Eli Lilly and Company in December 2023.

About GEP-NETs
Neuroendocrine tumors (NETs) are rare, often slow-growing cancers that can develop throughout the body. A subset known as gastroenteropancreatic NETs (GEP-NETs) affects the digestive system and pancreas and may be functional or non-functional depending on hormone activity.2 Over the last few decades, the incidence of GEP-NETs has increased significantly, with the prevalence in the U.S. estimated to be approximately 200,000 patients.3 Because GEP-NETs often grow slowly and cause non-specific symptoms, up to 50% are initially misdiagnosed, with patients waiting an average of 4.3 years from symptom onset to diagnosis.

(Press release, Lantheus, MAR 2, 2026, View Source [SID1234663179])

Kairos Pharma Announces Signing of Binding Strategic Asset Acquisition of Exclusive Worldwide Rights to CL-273 From OrbiMed and Torrey Pines Investment-Backed Celyn Therapeutics

On March 2, 2026 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported that it has entered into binding terms to acquire CL-273 from Celyn Therapeutics, Inc., a company backed by OrbiMed and Torrey Pines Investment.

John Yu, M.D., Kairos Pharma Chief Executive Officer, commented: "The signing of binding terms to acquire CL-273 represents a pivotal step in building Kairos Pharma’s next generation of targeted therapies for EGFR-mutant lung cancer. This transaction is expected to be value-accretive. CL-273’s AI-designed, wild-type-sparing pan-EGFR profile positions it as a potentially best-in-class asset in a large, fast-growing $16.2 billion lung cancer market with significant unmet needs due to the development of resistance. Given its prestigious backing, we believe partnering with Celyn Therapeutics offers additional high-quality science to our existing pipeline. We believe in the rigor of the data package supporting CL-273. We further believe that together with an OrbiMed-backed innovator, Kairos Pharma is strongly positioned to deliver a highly differentiated, potentially best-in-class, EGFR inhibitor to patients worldwide."

CL-273 is an investigational, reversible, wild-type-sparing pan-EGFR small-molecule inhibitor discovered using a proprietary AI-driven drug discovery platform backed by OrbiMed and other leading healthcare investors. This unique drug targets the resistant mutations that develop when using EGFR tyrosine kinase inhibitors, thereby reversing resistance. Specifically engineered for EGFR-mutant type of lung cancer (NSCLC), the EGFR-mutated lung cancer treatment market is estimated at $16.2 billion in 2026 (Future Market Insights). EGFR mutations are present in approximately 10–15% of NSCLC cases in Western populations and up to 50% in Asian populations (CoherentMI), creating a substantial addressable patient population worldwide.

Celyn Therapeutics brings deep domain expertise in small-molecule oncology drug development. Kairos Phama believes that OrbiMed’s support of Celyn underscores the quality of CL-273’s discovery and this transaction is expected to align the Company with OrbiMed’s longstanding track record in building category-defining oncology companies. By acquiring CL-273, Kairos aims to accelerate the development of a next-generation, AI-designed EGFR inhibitor for patients with EGFR-mutant NSCLC worldwide.

D. Boral Capital, LLC acted as the sole financial advisor.

(Press release, Kairos Pharma, MAR 2, 2026, View Source [SID1234663178])

WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) Reduced the Risk of Disease Progression or Death by 30% Compared to Cabozantinib in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)

On March 2, 2026 Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada) and Eisai (Headquarters: Tokyo, CEO: Haruo Naito) reported the first presentation of results from the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG (belzutifan), Merck & Co., Inc., Rahway, NJ, USA’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-programmed death receptor-1 (PD-1)/ programmed death-ligand 1 (PD-L1) therapy. These data are being presented as a late-breaking oral abstract at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (abstract #LBA417) and are included in the official ASCO (Free ASCO Whitepaper) GU Press Program.

At a pre-specified interim analysis with a median follow-up of 29.0 months (range, 19.3-49.2), WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS), reducing the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.59-0.84]; p=0.00007) compared to cabozantinib. For WELIREG plus LENVIMA, the median PFS was 14.8 months (95% CI, 11.2-16.6) versus 10.7 months (95% CI, 9.2-11.1) for cabozantinib. A trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was also observed for WELIREG plus LENVIMA (HR=0.85 [95% CI, 0.68-1.05]; p=0.06075). The median OS was 34.9 months (95% CI, 27.5-NR) for WELIREG plus LENVIMA versus 27.6 months (95% CI, 24.0-31.4) for cabozantinib. The trial is continuing, and OS will be evaluated at a subsequent analysis per the clinical trial protocol.

Based on data from the LITESPARK-011 trial, the U.S. Food and Drug Administration (FDA) has accepted two supplemental New Drug Applications (sNDA) for review seeking approval for WELIREG plus LENVIMA for the treatment of adult patients with advanced RCC with a clear cell component following a PD-1 or PD-L1 inhibitor. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of October 4, 2026, for both the WELIREG and LENVIMA sNDAs. Merck & Co., Inc., Rahway, NJ, USA and Eisai will also discuss these data with regulatory authorities worldwide to support potential submissions outside the United States.

"Choosing the right treatment for patients with advanced renal cell carcinoma after immunotherapy has been an ongoing challenge, and treatment options in this setting had not previously been evaluated against a current standard of care tyrosine kinase inhibitor in a Phase 3 trial," said Dr. Robert Motzer, Principal Investigator and Genitourinary Medical Oncologist, Memorial Sloan Kettering Cancer Center. "The LITESPARK-011 study demonstrated a 30% reduction in the risk of disease progression or death with belzutifan plus lenvatinib compared to cabozantinib, and 52.6% of patients experienced a response to treatment. These findings mark a critical step forward for these patients."

"The LITESPARK-011 trial highlights the potential of this first-of-its-kind combination regimen to deliver a meaningful benefit for patients with advanced renal cell carcinoma whose disease progresses after PD-1/L1 therapy," said Dr. M. Catherine Pietanza, Vice President, Global Clinical Development, MSD Research Laboratories. "These WELIREG plus LENVIMA data demonstrate important progress for patients with advanced renal cell carcinoma and reinforce our commitment to improving the lives of patients through innovative treatment strategies."

"The LITESPARK-011 results reinforce LENVIMA’s established role in renal cell carcinoma and highlight the potential of this novel combination to address an area of significant unmet need," said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai. "The acceptance of this regulatory filing is an important milestone, and we remain committed to working toward approval to bring this option to patients as soon as possible. We are grateful to the patients, their families, and the investigators, whose dedication made this research possible."

Additional findings

Data for objective response rate (ORR) and duration of response (DOR), two key secondary endpoints, were also reported. At the first interim analysis with a median follow-up of 19.6 months (range, 9.9-39.8), WELIREG plus LENVIMA met ORR, demonstrating a statistically significant improvement compared to cabozantinib. A confirmed ORR of 52.6% (95% CI, 47.3-57.7) was observed for WELIREG plus LENVIMA versus 39.6% (95% CI, 34.6-44.8) for cabozantinib. At the second interim analysis with a median follow-up of 29.0 months, the median DOR was 23.0 months (95% CI, 2.0-44.3+) for WELIREG plus LENVIMA versus 12.3 months (95% CI, 1.8+-35.9+) for cabozantinib.

WELIREG plus LENVIMA was administered to 370 patients and cabozantinib was administered to 371 patients. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 71.6% of patients receiving WELIREG plus LENVIMA versus 65.8% of patients receiving cabozantinib. Adverse events led to treatment discontinuation in 11.1% of patients receiving WELIREG plus LENVIMA and in 11.3% of patients receiving cabozantinib, respectively. Serious adverse events were observed in 51.6% of patients receiving WELIREG plus LENVIMA versus 43.9% of patients receiving cabozantinib, and AEs led to death in 5.4% of patients (two were treatment-related: thrombotic microangiopathy [n=1] and pneumonitis [n=1]) versus 3.2% (one was treatment-related: hemoptysis [n=1]) of patients, respectively.

LITESPARK-011 is part of a comprehensive late-stage clinical development program for WELIREG comprised of several Phase 2 and Phase 3 trials in pheochromocytoma and paraganglioma, von Hippel-Lindau disease-associated neoplasms and RCC. The Phase 3 LITESPARK-012 trial is evaluating the addition of WELIREG to KEYTRUDA (pembrolizumab), Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy, plus LENVIMA in the first-line advanced RCC disease setting.

WELIREG is approved(New Window) in the U.S., European Union (EU), Japan and other countries for the treatment of adult patients with advanced clear cell RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.

KEYTRUDA plus LENVIMA is approved in the U.S., the EU, Japan and other countries for the treatment of advanced RCC. Lenvatinib is approved as KISPLYX for advanced RCC in the EU.

LENVIMA in combination with everolimus is approved in the U.S., EU and other regions for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy.

Dr. Motzer has provided consulting and advisory services for Merck & Co., Inc., Rahway, NJ, USA and Eisai.

About LITESPARK-011

LITESPARK-011 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT04586231(New Window)) evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced clear cell RCC that has progressed on or after anti-PD-1/L1 therapy. The dual primary endpoints are PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by blinded independent central review (BICR) and OS. Key secondary endpoints include ORR per RECIST v1.1 as assessed by BICR, DOR per RECIST v1.1 as assessed by BICR, and safety. The trial enrolled 747 patients who were randomized to receive WELIREG (120 mg orally once daily) plus LENVIMA (20 mg orally once daily) or cabozantinib (60 mg orally once daily).

About renal cell carcinoma

Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC.1 In 2022, there were about 435,000 new cases of kidney cancer and approximately 156,000 deaths from the disease worldwide.2 RCC is about twice as common in men as in women.1 Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage.

(Press release, Eisai, MAR 2, 2026, View Source [SID1234663177])