Alpha Tau Announces First-Ever Oral Presentation of Alpha DaRT® Pancreatic Cancer Data at Digestive Disease Week (DDW) 2026

On March 31, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT reported that an abstract presenting results of two clinical trials in Jerusalem in patients with pancreatic cancer has been accepted for an oral presentation at Digestive Disease Week (DDW) 2026, the world’s premier international gastroenterology conference. This marks the first time that clinical results of Alpha DaRT in pancreatic cancer patients have been selected for presentation at a major gastroenterology conference.

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The abstract, entitled "Updated Results of Feasibility, Safety, and Tumor Control in Two First-In-Human Trials of a Novel Alpha-Emitting Radionuclide for Pancreatic Adenocarcinoma," has been selected for podium presentation in the Pancreatic Cancer I: Diagnosis and Treatment session on Saturday, May 2, 2026 at 10:30am (Central). The presentation will be led by study Principal Investigator Dr. Harold Jacob, Director of Advanced Gastrointestinal Endoscopy at Hadassah University Medical Center, and is based on combined data from two clinical protocols conducted at Hadassah Medical Center in Jerusalem, Israel.

"The acceptance of this abstract for an oral presentation at DDW is an important milestone for Alpha Tau" stated Uzi Sofer, CEO of Alpha Tau, "It reflects the growing recognition of the potential of our technology to address this devastating disease. With the vast majority of pancreatic cancer patients deemed inoperable at diagnosis, Alpha DaRT seeks to offer a truly novel approach for both locally advanced and metastatic patients, and we look forward to sharing these data at DDW."

Dr. Harold Jacob, commented, "I am gratified that our work has been selected for an oral presentation at DDW. As the first clinical data of Alpha DaRT in pancreatic cancer to be presented at a major gastroenterology forum, this acceptance highlights the importance and potential of this technology. Alpha DaRT is designed to be uniquely suited for delivery by gastroenterologists via EUS, hopefully positioning our specialty at the forefront of a new era in pancreatic cancer therapy.

Dr. Robert Den, Chief Medical Officer of Alpha Tau, commented, "The selection of this abstract for an oral presentation at DDW is a testament to the scientific rigor and clinical significance of the work conducted at Hadassah, and of course to Alpha Tau’s excellent investigational technology. These foundational studies have been instrumental in informing our clinical development program, including the IMPACT pilot study now actively enrolling in the U.S., as well as our ongoing work toward a future pivotal study. The full data will be presented at DDW in May."

About DDW 2026

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. DDW 2026 will be held May 2–5, 2026.

(Press release, Alpha Tau Medical, MAR 31, 2026, View Source [SID1234664077])

CellCentric Initiates DOMMINO-1, a Pivotal Phase 2 Clinical Trial of Inobrodib in Combination with Pomalidomide and Dexamethasone (InoPd) in Relapsed or Refractory Multiple Myeloma

On March 31, 2026 CellCentric, a clinical-stage biotechnology company developing inobrodib as a first-in-a-class, oral p300/CBP inhibitor for the treatment of multiple myeloma, reported the initiation of DOMMINO-1, a pivotal Phase 2 clinical trial evaluating inobrodib 20 mg in combination with standard doses of pomalidomide (pom) and dexamethasone (dex; InoPd) in heavily pretreated patients with relapsed or refractory multiple myeloma (RRMM). The first patient was dosed at The Royal Marsden NHS Foundation Trust in London. Additional sites are now open in the UK and U.S.

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"Dosing the first patient in DOMMINO-1 marks an important milestone as we advance InoPd in registration-enabling studies," said Naseer Qayum M.D., Ph.D., Chief Strategy Officer and Head of R&D at CellCentric. "Inobrodib 20 mg with pom + dex has demonstrated encouraging clinical activity, including a 60% objective response rate, and a tolerability profile consistent with pom-dex alone. Patients who are refractory to pomalidomide and have progressed following bispecifics or other BCMA-directed therapies have very limited options. We believe InoPd may deliver a transformative all-oral treatment for RRMM patients and look forward to further evaluating its potential in this Phase 2 trial."

Care for patients with multiple myeloma has transformed over the last two decades. It is a condition treated with serial therapeutic options. Inobrodib represents a new modality complementary to existing treatments and potentially addresses a major unmet need.

"Advances in multiple myeloma treatment, including bispecific antibodies, have improved patient outcomes. However, many people ultimately relapse or become refractory to these therapies, and new treatment options are urgently needed," said Charlotte Pawlyn, M.D., Honorary Consultant Hematologist at The Royal Marsden NHS Foundation Trust, Group Leader in Myeloma Biology and Therapeutics at The Institute of Cancer Research, London, and Principal Investigator for the DOMMINO‑1 study. "Inobrodib represents a novel mechanism through inhibition of p300/CBP and has demonstrated the ability to be used in combination with established therapies. We look forward to further evaluating InoPd in this trial."

DOMMINO-1 is a Phase 2 open-label, single-arm study enrolling 100 adult patients across clinical sites in the UK and U.S. (NCT07096778). The trial is designed to assess the safety and efficacy of InoPd, with participants receiving inobrodib at a 20 mg dose, as supported by recent dose-optimization work (Project Optimus), shared with the U.S. Food and Drug Administration (FDA) and other regulatory agencies. The primary endpoint is overall response rate, with secondary endpoints including progression-free survival, overall survival and duration of response. Eligible participants in this study, specifically, must have previously received a bispecific antibody and be refractory to at least one proteasome inhibitor, one anti-CD38 monoclonal antibody and pomalidomide.

"InoPd appears to be a promising option in multiple myeloma treatment, not only for its tolerability and efficacy observed to date, but also for the practical benefits it may offer patients," said Nisha Joseph, M.D., Associate Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine in Atlanta and DOMMINO-1 principal investigator at the first U.S. trial site. "More than 70% of patients are treated in the community setting, and an all-oral regimen may facilitate and expand access for those living with this disease, as well as their caregivers and healthcare providers."

About Inobrodib

Inobrodib is a potential new treatment for people with multiple myeloma and other cancers. It has been evaluated in over 450 patients to date. Clinical activity has been seen in both hematologic malignancies and solid tumors. Delivered as an oral capsule, inobrodib is easy for patients to take and designed to be used at home without the need for intensive monitoring.

Alongside InoPd, inobrodib is also being explored in combination with bispecific therapies elranatamab and teclistamab. Proof of concept in a maintenance setting is also being explored. CellCentric maintains all development and commercial rights to inobrodib and is free to expand the program in combination with other agents. The U.S. FDA previously granted Fast Track and Orphan Drug Designations to inobrodib for RRMM.

(Press release, CellCentric, MAR 31, 2026, View Source [SID1234664095])

Caribou Biosciences Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) Designation to CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy

On March 31, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CB-011 for relapsed or refractory multiple myeloma (r/r MM). CB-011, an allogeneic anti-BCMA CAR-T cell therapy, is being evaluated in the company’s ongoing open-label, multicenter CaMMouflage phase 1 clinical trial evaluating patients with r/r MM.

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"Only one in 10 people with multiple myeloma in the U.S. are able to receive CAR-T cell therapies due to long wait times and manufacturing limitations," said Adriana Rossi, MD, director of CAR-T and stem cell transplant clinical program at the center of excellence for multiple myeloma at Mount Sinai and an investigator on the CaMMouflage trial. "This highlights a critical gap in access for patients with relapsed or refractory disease. An off-the-shelf CAR-T cell therapy like CB-011 could help bridge that gap by offering a readily available treatment option to a broader group of patients."

As previously reported in November 2025, 48 patients have been treated in the dose escalation portion of the company’s CaMMouflage phase 1 clinical trial. The 450×106 CAR-T cell dose was selected as the recommended dose for expansion (RDE). In dose escalation, 12 BCMA-naïve patients were treated with the RDE; efficacy outcomes from this cohort included a 92% (11/12) overall response rate (ORR), 75% (9/12) ≥ complete response (CR) rate, and 91% (10/11 evaluable) minimal residual disease (MRD) negativity as of a September 24, 2025, data cutoff. CB-011 has demonstrated a manageable safety profile, with no cases of graft-versus-host disease, immune effector cell-associated enterocolitis, parkinsonism, or cranial nerve palsies observed at any dose level. Treatment emergent adverse events (TEAEs) in ≥25% of all patients treated with CB-011 following the selected lymphodepletion (LD) regimen (N=35) were as follows: neutropenia (80%), anemia (60%), thrombocytopenia (49%), infections (49%), dizziness (31%), cytokine release syndrome (31%), fatigue (31%), leukopenia (29%), decreased appetite (29%), constipation (26%), and pyrexia (26%) as of the data cutoff date.

"The FDA’s RMAT designation for CB-011 recognizes both the significant unmet need in multiple myeloma and the encouraging clinical data we have seen so far in the CaMMouflage trial," said Tina Albertson, MD, PhD, chief medical officer at Caribou Biosciences. "The dose escalation data highlight the potential of CB-011 as the best-in-class allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma. We look forward to initiating discussion with the FDA regarding future clinical development of CB-011 and to reporting additional data this year as we continue to enroll both BCMA-naïve and BCMA-exposed patients in dose expansion."

RMAT designation is a dedicated program designed to expedite the development and review processes for promising therapeutic candidates intended to address an unmet medical need in patients with serious conditions. This designation provides important benefits in the drug development process and is designed to facilitate and expedite development and regulatory review, including providing eligibility for priority and rolling reviews and accelerated approval, if relevant criteria are satisfied.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. The FDA granted CB-011 Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for r/r MM.

About the CaMMouflage phase 1 clinical trial
The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirteen patients were treated with a single dose of CB-011 (50×106 [N=3], 150×106 [N=7], and 450×106 [N=3] CAR-T cells) with an LD regimen of 300 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days, and 35 patients were treated with a single dose of CB-011 (150×106 [N=6], 300×106 [N=13], 450×106 [N=13], and 800×106 [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. The ongoing dose expansion portion of the trial will evaluate safety and efficacy of CB-011 at 450×106 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, MAR 31, 2026, View Source [SID1234664078])

Humanetics Corporation Announces Investigator-Initiated Phase 2 Trial in Patients with Non-Small Cell Lung Cancer and Underlying Interstitial Lung Disease

On March 31, 2026 Humanetics Corporation (Humanetics) reported the launch of a new investigator-initiated clinical trial (IIT) of BIO 300 Oral Suspension (BIO 300), led by Dr. Narek Shaverdian, Director of Thoracic Radiation Oncology at Memorial Sloan Kettering Cancer Center (MSK). This study is designed to evaluate the efficacy of BIO 300 in reducing the toxicity of thoracic radiation therapy in patients with non-small cell lung cancer (NSCLC) and concomitant interstitial lung disease (ILD), compared to historical results. The trial will enroll approximately 24 participants at MSK in New York.

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BIO 300 is a promising candidate in the development pipeline for Humanetics, aimed at improving quality-of-life outcomes for patients receiving radiation therapy for NSCLC, head and neck cancer, and prostate cancer. The product has shown strong potential across complementary therapeutic areas, including inflammatory lung diseases.

Initial clinical research of BIO 300 in NSCLC found lower rates of hematological, pulmonary, and gastrointestinal toxicities compared to historical controls. In multiple clinical studies, the product has been found to be safe and well-tolerated, with no dose-limiting toxicities reported to date.

"Patients with NSCLC and interstitial lung disease represent a historically high-risk population for standard therapies," said Dr. Shaverdian. "This trial aims to develop a new strategy that would allow us to deliver thoracic radiation more safely and effectively through the use of BIO 300, potentially expanding treatment options and improving outcomes for these patients."

This study is a single-arm, prospective, phase II trial that will evaluate the time to Grade ≥ 3 pneumonitis, defined as the time from completion of radiation therapy to the occurrence of Grade ≥ 3 pneumonitis as the primary endpoint. Secondary endpoints include safety assessments, pulmonary function testing, and patient-reported quality of life. The first participant was enrolled in January 2026.

"As BIO 300 has been shown to be safe, while demonstrating efficacy in patients with NSCLC, we believe the same effect can be shown in patients with NSCLC in the setting of ILD," said Dr. Michael D. Kaytor, Chief Scientific Officer at Humanetics. "We are extremely enthusiastic about this clinical study, and the commitment of Dr. Shaverdian and the team at MSK."

(Press release, Humanetics, MAR 31, 2026, View Source [SID1234664096])

Medicilon Signs Five-Year Strategic Cooperation Agreement with BioPartners X to Jointly Promote Innovative Drug R&D

On March 31, 2026 Medicilon reported to have signed a long-term strategic cooperation framework agreement with BioPartners X. Mr. Gong Huimin, Chairman and CEO of BioPartners X, Dr. Liu Tong, Chief Scientist, Mr. Luo Wusong and Mr. Xu Changlu, Vice Presidents of Strategic Investment, and Mr. Li Ao, Non-Clinical Director, together with Dr. Chen Chunlin, Founder and CEO of Medicilon, and Ms. Wang Mingying, Senior Director of Business Development, attended the signing ceremony.

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At the signing ceremony, both parties held in-depth discussions on the directions of future cooperation. BioPartners X has strong capabilities in the transformation of scientific research achievements from universities. With a development vision of building a pipeline of 100 innovative drug IND candidates, BioPartners X boasts enormous innovation potential and broad development prospects. Medicilon and BioPartners X have agreed to fully share resources in business development, industry channels and industrial information, further expand cooperation scenarios, enhance collaboration efficiency, and jointly build a highly interconnected ecosystem for innovative drug research and development. Within the agreed cooperation period, the two parties will focus on innovative drug R&D for major diseases, with the goal of achieving 5 IND submissions, and jointly set a benchmark for cooperation between CROs and innovative pharmaceutical companies.

Complementary Advantages for Long-Term Cooperation
Committed to the ultimate mission of "Making Human Life Better" and adhering to long-termism and the Long March spirit, BioPartners X focuses on therapeutic areas including nephropathy, autoimmune diseases, metabolic diseases, central nervous system disorders, infectious diseases and oncology. It implements its strategic goals through the "Three Concentrations" methodology: concentrating global scientific research strength, global talent resources, and global capital. By integrating core forces in global scientific research, investment and financing, and pharmaceutical operation, the company aims to develop 100 innovative drugs for humanity, benefit global human health and become a world-class innovative pharmaceutical company rooted in China.

As a leading one-stop preclinical R&D platform, Medicilon offers a comprehensive service system covering drug discovery, CMC, preclinical research and IND registration and filing. With international GLP certifications and extensive project experience, Medicilon has helped over 2,000 global clients accelerate new drug development.

Hand in Hand to Accelerate Innovative Drug R&D
During the cooperation period, Medicilon will provide BioPartners X with full-chain R&D services covering four dimensions:
· Drug Discovery: Chemistry, custom synthesis (FFS/FTE), bioactivity screening, protein expression, purification and crystallization, etc.
· Pharmaceutical Research: Full-process services including API process, quality and stability research and filing, as well as formulation process, quality research and production, etc.
· Preclinical Research: Drugability assessment, pharmacodynamics, pharmacokinetics and toxicology studies (single/multiple-dose toxicity, safety pharmacology, reproductive toxicity, etc.).
· Turnkey Services: Integrated services from drug discovery to preclinical research for IND registration and filing, accelerating project progress throughout the cycle.
Building on mutual recognition from prior cooperation, the two parties will integrate resources and collaborate efficiently to shorten new drug R&D cycles, systematically address unmet medical needs.
Chunlin Chen,Chairman and CEO of Medicilon

Medicilon will fully serve as a solid backing for BioPartners X in its innovative drug R&D journey and provide all-round support as it advances toward developing 100 innovative drugs. Leveraging its advantages in one-stop full-process R&D services, Medicilon will coordinate high-quality resources, deeply align with BioPartners X’s R&D needs, and efficiently promote the implementation and effectiveness of cooperative projects.

Huimin Gong,Chairman and CEO of BioPartners X

Medicilon’s technological strength, project experience and service quality in new drug R&D will provide strong support for BioPartners X’s innovative drug pipeline layout and help steadily achieve its long-term strategic goals.

This strategic cooperation marks a crucial step for both parties to base themselves on industrial development and deepen long-term collaboration. Going forward, Medicilon and BioPartners X will uphold long-termism to deeply engage in innovative drug R&D, continuously expand cooperation dimensions.

(Press release, Shanghai Medicilon, MAR 31, 2026, View Source [SID1234664439])