On March 31, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, reported financial results for the year ended December 31, 2025, and highlighted recent business updates including progress in advancing Phase 3 clinical development of its lead candidate IMNN-001 in newly diagnosed advanced ovarian cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"IMUNON continues to make significant progress in advancing IMNN-001, a potential breakthrough for women with newly diagnosed advanced ovarian cancer," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "A final data assessment of the Phase 2 OVATION 2 Study indicates that treatment with IMNN-001 was associated with an overall survival benefit of more than a year in patients treated with IMNN-001 plus chemotherapy and more than two years in women also receiving PARP inhibitors as part of maintenance therapy."

"Unprecedented survival data results from the Phase 2 OVATION 2 Study, coupled with compelling interim results from our MRD study and a clear regulatory path in Phase 3, position IMNN-001 with the potential to deliver transformative impact on ovarian cancer treatment. These new results showing continued improvements in overall survival are especially exciting given that there have been virtually no advances in frontline standard of care for women newly diagnosed with ovarian cancer in the last 35 years," Dr. Lindborg continued.

RECENT DEVELOPMENTS

IMNN-001 Immunotherapy

Final Phase 2 OVATION 2 Study Data Show Continued Overall Survival Improvement with IMNN-001 in Women with Newly Diagnosed Advanced Ovarian Cancer – On March 25, 2026, the Company announced final data from the completed Phase 2 OVATION 2 clinical trial evaluating IMNN-001 in combination with standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT) in 112 women with newly diagnosed advanced ovarian cancer. IMUNON previously reported a median 11.1 month increase in overall survival (40.5 vs. 29.4 months) in the IMNN-001 treatment arm compared to SoC chemotherapy alone. Following the most recent data assessment, the Company reported a median 14.7 month increase in overall survival (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in overall survival (3.6 delta). In addition, the new IMNN-001 data showed that women treated with IMNN-001 and SoC chemotherapy plus poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy achieved a median increase in overall survival of 24.2 months (65.6 vs. 41.4 months) compared to SoC chemotherapy alone.

Importantly, with these new efficacy results, IMNN-001 continued to show a highly favorable safety and tolerability profile, further reinforcing the potential of this IL-12 immunotherapy to represent a landmark advance in treatment of this disease.

R&D Day Highlighting Progress on OVATION 3 Study in Pursuit of First Frontline Immunotherapy for Advanced Ovarian Cancer – On November 10, 2025, the Company hosted an R&D Day, providing updates on new IMNN-001 data and discussing progress with the Phase 3 OVATION 3 Study and IMNN-001’s potential role in transforming the treatment landscape for women with advanced ovarian cancer. Highlights from the R&D Day are summarized below.

Data from the Phase 2 OVATION 2 clinical trial:

Broad impact observed with IMNN-001 treatment on important cancer-fighting cytokines, effectively turning the tumor microenvironment from "cold" to "hot" by activating both innate and adaptive immune systems, renewing the elusive promise of an immunotherapy for ovarian cancer.
Data reinforcing the highly favorable benefit-risk and safety profile of IMMN 001.
The remarkable median 13-month overall survival (OS) benefit observed with IMNN-001 plus standard of care (SoC) chemotherapy, an increase that is considered clinically meaningful compared to SoC alone.

Safety, tolerability and translational insights from the Phase 2 minimal residual disease (MRD) study of IMNN-001:

Rationale for the trial and the importance of frontline therapy as the best opportunity to achieve a cure for ovarian cancer.
New translational data that show IMNN-001 preferentially being taken up by macrophages within the peritoneal fluid and tumor tissue, which then induces a robust response and tumor microenvironment remodeling.
New data supporting the highly favorable benefit-risk and tolerability profile of IMNN-001.
The positive tolerability profile of IMNN-001, including in combination with SoC chemotherapy plus bevacizumab, and in the maintenance setting.

Phase 2 and ongoing Phase 3 trial designs, and the strength of evidence for IMNN-001 from a statistical perspective:

The well-precedented nature of the Phase 3 trial design, which leverages an innovative, adaptive, event-driven approach aligned with prior successful oncology trials that resulted in full approval by the U.S. Food and Drug Administration (FDA) based on an interim analysis of overall survival.
This foundation, supported by conservative power assumptions drawn from Phase 2 clinical data, strong simulation modeling and robust statistical properties, underpins the Phase 3 trial’s high probability for success.

New data further demonstrating IMNN-001 shifted the balance in favor of immune stimulation, remodeling the tumor microenvironment in favor of anti-tumor responses, which is established to be associated with better prognosis.

The presentations from the R&D Day are available on the "Scientific Presentations" page of the IMUNON website at View Source

Translational Data from Phase 2 OVATION 2 Study of IMNN-001 at SITC (Free SITC Whitepaper) 40th Annual Meeting – On November 7, 2025, the Company presented translational data from the Phase 2 OVATION 2 clinical trial of IMNN-001 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, held on November 5-9, 2025, in National Harbor, Maryland.

New data from recently analyzed OVATION 2 Study patient samples demonstrated that IMNN-001 creates a "hot" anti-tumor microenvironment in epithelial ovarian cancer by (i) increasing the recruitment of anti-tumor CD8+, myeloid dendritic cells and M1 macrophages in patient tumors; and (ii) decreasing immunosuppressive markers (IDO, T regulatory [Treg] cells, exhausted CD8, M2 macrophages). These results, including induction of favorable ratios of CD8+/Tregs and CD8+/CD4+ cells, which are both associated with improved patient outcomes, are consistent with the results of the previous OVATION 1 study and with the efficacy seen in the clinic in the OVATION 2 study. This biomarker research confirms local immune activation at the tumor site by IMNN-001.

The SITC (Free SITC Whitepaper) poster presentation is available on the "Scientific Presentations" page of the IMUNON website at View Source

Phase 3 OVATION 3 Study of IMNN-001 in Advanced Ovarian Cancer at the ESMO (Free ESMO Whitepaper) Congress and the IGCS 2025 Annual Global Meeting – On October 14, 2025, the Company announced that a trials-in-progress abstract on the ongoing Phase 3 OVATION 3 clinical trial of IMNN-001 were being presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, held on October 17-21, 2025, in Berlin, Germany with an encore presentation following at the 2025 Annual Global Meeting of the International Gynecologic Cancer Society (IGCS), held on November 5-7, 2025, in Cape Town, South Africa. The poster presentations are available on the "Scientific Presentations" page of the IMUNON website at View Source

PlaCCine DNA Vaccine Technology

PlaCCine DNA Technology Proof-of-Concept Data Presented in Platform Presentations at Leading Vaccine Conferences – On October 17, 2025, the Company announced oral presentations highlighting IMNN-101, its proof-of-concept DNA plasmid vaccine based on the Company’s proprietary PlaCCine technology platform, including proof-of-concept clinical trial results at the following vaccine conferences:

5th Edition of International Vaccines Congress (IVC) Keynote Oral Presentation: A promising novel approach to DNA vaccines, presented on October 23, 2025
10th International Conference on Vaccine Research and Development Oral Presentation: Development of a PlaCCine DNA Technology for Safe, Effective and Durable Vaccines, presented on November 6, 2025

These presentations described the unique design and composition of the PlaCCine technology and its differentiating features including a longer duration of antigen expression, safety, and user compliance, and storage stability at workable temperatures (up to one year at 4°C and one month at 37°C) in comparison to mRNA vaccines and other DNA vaccines requiring viruses or devices for delivery. The immunogenicity of the PlaCCine technology was demonstrated against various pathogens in multiple species and animal models. These presentations also demonstrated safety and immunogenicity of a PlaCCine based vaccine (IMNN-101) targeting a SARS-CoV-2 spike variant in healthy human participants following intramuscular administration. Durable neutralizing antibody (Nab) responses from baseline at six months demonstrating vaccine immunogenicity following a single dose in previously vaccinated or infected individuals with the SARS-CoV-2 underscore the significance of the PlaCCine approach and support continued development in both naive populations using a prime and boost vaccination to determine optimal benefits and in other infectious diseases.

IMNN-101 has been shown to be safe and well tolerated, with no serious adverse effects reported. To advance the development and commercialization of the PlaCCine platform in the prophylactic vaccine competitive landscape, IMUNON will require a strategic partnership(s) with a pharmaceutical or biotechnology company.

CORPORATE DEVELOPMENTS

IMUNON Sharpens Focus on its Promising Pivotal Phase 3 Ovarian Cancer Study – On February 5, 2026, the Company announced a strategic reorganization, the goal of which was to reduce operating expenses while supporting the Company’s focused strategy to rapidly advance the pivotal Phase 3 OVATION 3 clinical trial.

$7.0 Million Registered Direct Offering Priced At-The-Market Under NASDAQ Rules – On December 30, 2025, the Company announced that it entered into a securities purchase agreement for the purchase and sale of 1,939,114 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate of 1,939,114 shares of common stock. Each share of common stock (or pre-funded warrant in-lieu thereof) was sold together with one warrant to purchase one share of common stock at a combined purchase price of $3.61 (or $3.6099 per pre-funded warrant and warrant). The warrants have an exercise price of $3.482 per share, and became exercisable immediately upon issuance, and will expire five years from the date of issuance. The offering closed on December 31, 2025.

FINANCIAL RESULTS FOR THE YEAR ENDED DECEMBER 31, 2025

Cash Management Continues to Focus on the Phase 3 OVATION 3 Study –
IMUNON reported a net loss for 2025 of $14.5 million, or $6.83 per share, compared with a net loss of $18.6 million, or $16.94 per share, for 2024. Operating expenses were $14.7 million for 2025; a 23% decrease compared to 2024.

Research and development (R&D) expenses were $7.8 million for 2025; a 33% decrease compared to 2024. The decrease was due primarily to lower costs associated with the OVATION 2 Study, the Phase 1 proof-of-concept PlaCCine DNA vaccine trial, and development of the PlaCCine DNA vaccine technology platform, partially offset by start-up costs associated with the pivotal Phase 3 OVATION 3 Study.

General and administrative (G&A) expenses were $6.9 million for 2025, a decrease of 8% compared to 2024. This decrease was primarily attributable to headcount reductions and lower employee-related expenses.

Net cash used for operating activities was $13.9 million for full year 2025 compared with $18.9 million for full year 2024. Cash provided by financing activities of $17.1 million for 2025 resulted from two offerings in May 2025 and December 2025 ($13.6 million) and sales under the Company’s at-the-market equity facility ($3.5 million).

As of December 31, 2025, cash and cash equivalents were $8.8 million.

Conference Call and Webcast

The Company will be hosting a conference call to review 2025 financial results and provide a business update today, March 31, 2026, at 11:00 a.m. EDT. To participate in the call, please dial 800-715-9871 (North America/Toll Free) or 646-307-1963 (U.S./Toll) and ask for the IMUNON Year End 2025 Financial Results Call (Conference ID 4157104). A live webcast of the call will also be available here.

An audio replay of the call will be available for 90 days and can be accessed at 800-770-2030 (U.S. and Canada/Toll Free), 609-800-9909 (U.S./Toll) or 647-362-9199 (Canada/Toll) using replay access code 4157104#.

(Press release, IMUNON, MAR 31, 2026, View Source [SID1234664081])

On March 31, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated, commercial-stage immunotherapy company, reported it has secured $75 million in non-dilutive financing under its existing Royalty Interest Purchase Agreement (RIPA) with Oberland Capital, increasing the total committed capital under the Agreement to $375 million. The amended agreement maintains existing terms, with a modest increase in the royalty payback rate while maintaining the royalty cap.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This additional non-dilutive financing gives us the capacity to continue scaling our commercial efforts and expanding globally following recent ANKTIVA approvals, while positioning us to take full advantage of the growth opportunities ahead," said Richard Adcock, President and CEO of ImmunityBio. "The strengthening of the company’s balance sheet through non-dilutive financing from Oberland, combined with the Founder’s reduction of debt, supports our global expansion following recent approvals and the advancement of our immunotherapy pipeline."

Simultaneous with the closing of the amendment to the RIPA, Nant Capital, LLC, an entity affiliated with our Executive Chairman, converted $25 million principal amount with the issuance of 4.6 million shares of the company’s common stock to Nant Capital, LLC and the reduction of debt under the $505 million December 2024 Promissory Note.

"The non-dilutive financing from Oberland and the conversion of debt to equity by Nant Capital, reflect strong confidence in ImmunityBio’s strategy and growth potential as a leading immunotherapy company paving the way for next-generation immunotherapy treatments," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio.

Global Regulatory Approvals

ANKTIVA in combination with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors, is now approved or authorized across five regulatory jurisdictions, representing approximately 34 countries:

United States: U.S. Food and Drug Administration (FDA) approval (April 2024)
United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA) authorization (July 2025)
Kingdom of Saudi Arabia: Saudi Food and Drug Authority (SFDA) accelerated approval for BCG-unresponsive NMIBC CIS (January 2026) and conditional accelerated approval for metastatic non-small cell lung cancer (NSCLC) in combination with checkpoint inhibitors (January 2026), the first jurisdiction globally to authorize ANKTIVA for lung cancer
European Union: European Commission conditional marketing authorization covering all 27 EU member states plus Iceland, Norway, and Liechtenstein (February 2026)
Macau Special Administrative Region (SAR): Pharmaceutical Administration Bureau authorization (March 2026)
This global regulatory footprint of 34 countries was established in under two years from initial U.S. FDA approval in 2024, reflecting rapid international expansion.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor superagonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the dendritic cell membrane-bound IL-15 receptor alpha driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

(Press release, ImmunityBio, MAR 31, 2026, View Source [SID1234664080])

On March 31, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to support or treat diseases promoted by chronic inflammation, reported financial results and recent business highlights for its three months ended December 31, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On November 17, 2025, the Company initiated its first-in-human clinical trial to evaluate HCW9302, the lead product candidate for the Company’s program to develop treatments for autoimmune disorders and proinflammatory diseases, in patients with areata alopecia. HCW9302 is a subcutaneously injectable, first-in-kind interleukin-2 ("IL-2") fusion immunotherapeutic. IL-2, the active component of HCW9302, is the cytokine in humans and other vertebrates responsible for maintaining the proper numbers and functions of Treg cells in the body. Treg cells control excessive inflammation caused by other immune cells, which is the etiology of autoimmune diseases.

The Company believes that HCW9302 can suppress the hair-follicle killing activities of the auto-reactive immune cells by activating and expanding regulatory T cells ("Treg") cells. There are no curative FDA approved treatments of this indication. Alopecia areata causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. The National Alopecia Areata Foundation estimates approximately 160 million people worldwide and 7 million people in the United States have alopecia areata. The condition affects about 2% of the global population at some point in their lifetime.

The Phase 1 multi-center dose-escalation study of HCW9302 is designed to treat up to 30 patients. The primary objectives of the study are to evaluate the safety of HCW9302, injected under the skin (subcutaneously), and to determine the recommended dose level to advance to later phase clinical studies. A preliminary human data read out is expected in the first half of 2026.

Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer said, "We are excited to be the sponsor of this clinical study to evaluate this promising new treatment for alopecia areata. We will be conducting additional ancillary studies to provide further insights into disease responses and the effects of HCW9302 on proliferation and function of immune cells, particularly Treg cells."

Dr. Wong continued, "Based the results of our preclinical studies including non-human primates, we believe the human data read out will show that HCW9302 has superior IL-2Rα affinity and will sustain serum exposure, which could potentially make it favorable for the expansion and in increasing the functionality of Treg for autoimmune disease treatments. HCW9302 was well tolerated in non-human primate studies. If this remains the case in human studies, this would be a significant improvement over conventional IL-2 therapies that have low tolerability profiles. We believe the data will confirm that HCW9302 can achieve strong biological activity at lower therapeutic dose levels, and as a result, will have a favorable tolerability and at the same time can potentially enhance receptor selectivity and reduce off-target effects."

Business Highlights

Upfront License Fee Received for Exclusive Worldwide License for HCW11-006

As of March 16, 2026, we received the full payment of the upfront licensing fee for the exclusive worldwide license for HCW11-006, a preclinical molecule licensed to Beijing Trimmune Biotech Co., Ltd. ("Trimmune"). The Company received $3.5 million in gross proceeds, and $2.9 million net after taxes. In addition to the cash portion of the upfront license fee, the Company received a transferable minority equity interest in Trimmune.

HCW Biologics is eligible to receive additional payments under the license, including development milestone payments and double-digit royalties on future product sales, as well as a portion of the proceeds from certain future transaction(s) involving the licensed molecule, if and when such transaction(s) occur. Upon completion of Phase 1 by the licensee, the Company may exercise its Opt-In Rights to reclaim the rights to the Americas market. For an additional fee, Trimmune may exercise an option to license the China rights to HCW9302, the Company’s clinical-stage molecule, currently being evaluated in a Phase 1 trial in an autoimmune disorder.

Commercial-Ready Molecules Used as Reagents

During the year ended December 31, 2025, the Company launched two of its proprietary fusion protein molecules as commercial-ready molecules used as reagents to be used to support the production of cell-based immunotherapeutics to treat infectious diseases and cancer. While the Company’s focus remains on the development of fusion immunotherapeutics for the treatment of diseases promoted by chronic inflammation, the Company intends to market these reagents directly or through a corporate partnership to generate revenue which could offset development costs for its other immunotherapeutic treatments.

On March 13, 2026, Science Advances, a peer-reviewed, high-impact journal, released a publication with the Company’s data that showed the Company’s proprietary, commercial-ready compound, HCW9206, could fundamentally change how CAR-T cell therapies are manufactured and potential improve their clinical efficacy against diseases such as cancer and HIV. These findings support the Company’s belief that HCW9206 is a leap forward in both clinical potential and manufacturing efficiency.

Fourth Quarter 2025 Financial Results

Revenues: Revenues for the three months ended December 31, 2024 and 2025 were $394,804 and $27,010, respectively. Revenues for the years ended December 31, 2024 and 2025 were $2.6 million and $54,232, respectively. Historically, revenues have been derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. In the year ended December 31, 2025, the Company agreed to a one-year suspension of the Wugen License Agreement in exchange for the exclusive right to market HCW9206 and HCW9201 as reagents and potentially identify a new corporate partner during this period.

Research and development (R&D) expenses: R&D expenses for the three months ended December 31, 2024 and 2025 were $1.0 million and $1.3 million, respectively, an increase of $283,491, or 27%. R&D expenses for the years ended December 31, 2024 and 2025 were $6.4 million and $5.4 million, respectively, a decrease of $1.0 million, or 15%. R&D expenses in the year ended December 31, 2024 were higher than in the comparable period in 2025, due to higher expenses incurred for manufacturing and materials.

General and administrative (G&A) expenses: G&A expenses for the three months ended December 31, 2024 and 2025 were $2.0 million and $1.5 million, respectively, a decrease of $526,175, or 26%. G&A expenses for the years ended December 31, 2024 and 2025 were $6.8 million and $7.7 million, respectively, an increase of $884,832 or 13%. The increase in G&A expenses in 2025 was primarily due to salaries and benefits and professional fees related to audit services, tax and other advisory services, as well as required activities to remain in compliance with SEC regulations and Nasdaq listing rules.

Legal expenses (recoveries), net: Legal expenses and recoveries, net represent the legal fees that the Company incurred for an Arbitration which held its hearing in May 2024, was settled on July 13, 2024, and was dismissed on December 24, 2024. Legal expenses (recoveries), net for the three months ended December 31, 2024 and 2025 were $148,949 and $120,136, respectively. Legal expenses (recoveries), net for the years ended December 31, 2024 and 2025 were $15.9 million and a contra expense of ($1.5) million, respectively. In January 2025, the Company received a $2.0 million insurance reimbursement that was paid directly to the law firm involved in representing Dr. Hing C. Wong, the Company’s Founder and Chief Executive Officer, in the Arbitration. The Company and Dr. Wong reached a settlement agreement in 2025 for the full balance of $7.5 million which was owed for legal fees incurred in connection with the defense for Dr. Wong, resulting in a gain of $5.5 million for the year ended December 31, 2025.

Net (loss) gain: Net (loss) gain for the three months ended December 31, 2024 and 2025 was ($3.4) million and $2.2 million, respectively. Net loss for the years ended December 31, 2024 and 2025 was ($30.0) million and ($6.5) million, respectively.

(Press release, HCW Biologics, MAR 31, 2026, View Source [SID1234664079])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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])

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])