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U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma

On July 13, 2026 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM). Mezigdomide is an oral cereblon E3 ligase modulator, or CELMoD, for the treatment of multiple myeloma. The FDA has granted a Prescription Drug User Fee Act (PDUFA) date of May 13, 2027 for this indication.

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"The FDA’s acceptance of our application for mezigdomide highlights the continued momentum of our targeted protein degradation programs, as we now have two distinct agents under review in relapsed or refractory multiple myeloma, which remains a persistent disease," said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. "We’re rapidly progressing the development of our CELMoD pipeline and are committed to leveraging this platform to bring the next wave of advances for patients in both hematologic malignancies and solid tumors."

The filing was based on positive results from the Phase 3 SUCCESSOR-2 trial (NCT05552976) showing MeziKd demonstrated a clinically meaningful and statistically significant improvement in progression-free survival (PFS) (95% CI: 18.0 months vs. 8.3 months [HR:0.48; p<0.0001]), representing a 52% reduction in the risk of disease progression or death compared with Kd in patients with relapsed or refractory multiple myeloma, including those at first relapse after prior treatment with an anti-CD38 monoclonal antibody and lenalidomide. The safety profile of MeziKd was consistent with that observed in prior studies of mezigdomide, as well as with the known safety profiles of the individual agents in the regimen. Results were recently presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting as a late-breaking oral presentation and published in The Lancet.

Bristol Myers Squibb thanks the patients and investigators involved with the Phase 3 SUCCESSOR-2 study.

About mezigdomide
Mezigdomide is an oral CELMoD specifically optimized to modulate cereblon for maximal and rapid degradation of Ikaros and Aiolos target proteins, leading to higher multiple myeloma cell killing and immune stimulation than traditional immunomodulatory agents. Pre-clinical data suggest mezigdomide enhances T cell function and prevents and reinvigorates an exhausted immune system. Mezigdomide is also being evaluated in the ongoing Phase 3 SUCCESSOR-1 trial vs. standard of care regimen in relapsed or refractory multiple myeloma.

About SUCCESSOR-2
There is a growing number of patients exposed and/or refractory to lenalidomide and anti-CD38 antibodies from first relapse. The SUCCESSOR-2 trial addressed this growing need. SUCCESSOR-2 (NCT05552976) is an inferential, seamless Phase 3, multicenter, randomized, open-label study evaluating the efficacy and safety of mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM).

The primary endpoint of the Phase 3 study is progression-free survival. Key secondary endpoints include overall survival, overall response rate, duration of response, time to progression, time to next treatment, minimal residual disease negativity, and health-related quality of life.

Dose optimization for mezigdomide occurred in stage 1. The mezigdomide dose selected for stage 2 of the study was 1.0 mg. In total, 479 patients (288 MeziKd at 1.0 mg of mezigdomide; 191 Kd) were included in the analysis. Across both arms, median age was 68 with 25.1% of patients ≥75 years old; median number of prior therapies was 2; 92.1% of patients were triple-class-exposed, with 85.8% refractory to an anti-CD38 monoclonal antibody and 75.8% to lenalidomide; 37.2% were exposed to pomalidomide and 7.3% to anti-BCMA treatment. At data cutoff, median follow-up was 10.6 months with 52.4% (MeziKd) and 31.4% (Kd) of patients still on treatment.

About Targeted Protein Degradation and CELMoD
Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered difficult to address. BMS is the only company that has successfully developed and commercialized protein degrader agents for the treatment of multiple myeloma. These agents, known as immunomodulatory drugs (IMiDs), helped establish the current standard of care in the treatment of this disease, which remains without a cure. BMS is building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including CELMoD, ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach enables matching the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provides more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology.

(Press release, Bristol-Myers Squibb, JUL 13, 2026, View Source;Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-New-Drug-Application-for-Mezigdomide-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx [SID1234669168])

Agenus Announces Oversubscribed Private Placement of Up to $340 Million to Advance Registrational ROBBIN Trial of Neoadjuvant BOT+BAL in MSS Colon Cancer

On July 13, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported that it has entered into a securities purchase agreement for a private placement of approximately $85 million in upfront gross proceeds, before the deduction of private placement expenses, and up to an additional $255 million upon the full exercise of purchase warrants. The financing was led by Commodore Capital, with participation from RA Capital Management, TCGX, Invus, and Ligand Pharmaceuticals.

The net proceeds of this financing are expected to support Agenus’ strategic prioritization of botensilimab and balstilimab (BOT+BAL) for the neoadjuvant treatment of microsatellite-stable (MSS) colon cancer, including advancement of ROBBIN1, the Company’s planned registrational Phase 3 neoadjuvant trial in microsatellite-stable (MSS) colon cancer. High-risk Stage II and Stage III MSS colon cancer affect an estimated 38,000 patients annually in the US and more than 200,000 patients worldwide,2 representing an estimated US addressable annual sales opportunity of more than $7 billion, with no new curative-intent therapies approved in more than 20 years.3

As described below, under the terms of the private placement, the Company will issue shares of its common stock (or, in lieu thereof, pre-funded warrants to purchase common stock) for approximately $85 million in upfront gross proceeds, before the deduction of private placement expenses, and an accompanying "Series A" purchase warrant and "Series B" purchase warrant that, if fully exercised, would provide an additional $255 million in gross proceeds, for a combined total of up to $340 million in gross proceeds. Assuming the exercise in full of the warrants, Agenus expects the financing to fund completion of ROBBIN, with runway through year-end 2031. The private placement is expected to close on or about July 15, 2026, subject to customary closing conditions. The upfront purchase price per share, along with the exercise prices for the Series A and Series B warrants, were all priced at a premium to the market closing price per share as of Friday, July 10th, 2026.

Agenus’ Strategic Prioritization of Neoadjuvant BOT+BAL

Across NEST and UNICORN, two independent Phase 2 studies evaluating neoadjuvant BOT+BAL in MSS colorectal cancer (CRC), BOT+BAL has produced deep, durable responses, including pathologic response (PR) in approximately 60-70% of patients, major pathologic response (MPR) in approximately 35-40% of patients and pathologic complete response (pCR) in approximately 30% of patients. Deep pathologic responses (MPR and pCR) in the neoadjuvant setting are positively correlated with event-free survival in many tumor types, including MSS colon cancer.4 With median follow-up of approximately 9 to 18 months, all treated patients remained disease free. This treatment effect has persisted in updates from NEST and UNICORN, and further details are anticipated to be published later this year. Together with observed circulating tumor DNA (ctDNA) clearance during treatment, these data support Agenus’ rationale for prioritizing neoadjuvant BOT+BAL development in the registrational ROBBIN study.5,6

ROBBIN is Agenus’ planned randomized global Phase 3 trial evaluating neoadjuvant BOT+BAL followed by standard of care versus standard of care alone in previously untreated high-risk Stage II and Stage III MSS colon cancer. The ROBBIN trial will enroll 850 patients, randomized 1:1, with event free survival (EFS) as its primary endpoint. Following interactions with the US Food and Drug Administration (FDA), Agenus has aligned with the FDA on key elements of the Phase 3 design, including the patient population, experimental regimen, control arm, primary endpoint, and interim analysis plan.

"We have seen neoadjuvant and perioperative immunotherapy improve outcomes in immunologically ‘hot’ or ‘warm’ tumors such as melanoma and lung cancer, but MSS colon cancer — a ‘cold’ tumor — has resisted standard checkpoint inhibitors. BOT was engineered to overcome that resistance and has produced deep pathologic responses with no recurrences reported in the NEST and UNICORN studies. With the ROBBIN trial, we are bringing this regimen to patients with high-risk Stage II and Stage III MSS colon cancer, where treating an intact tumor gives BOT+BAL its greatest opportunity to generate a durable immune response and improve long-term outcomes," said Dr. Steven O’Day, Chief Medical Officer of Agenus.

In connection with its strategic prioritization of neoadjuvant BOT+BAL in MSS colon cancer, Agenus plans to discontinue financial support for the ongoing BATTMAN Phase 3 study in late-line metastatic MSS CRC. Agenus will honor its obligations to patients currently receiving treatment and will work closely with the Canadian Cancer Trials Group (CCTG) and participating investigators to manage this transition responsibly. The Company remains deeply grateful to the clinicians, site teams, CCTG, and patients who have contributed to advancing BOT+BAL in late-stage disease.

"Since Agenus was founded 32 years ago, our mission has been to harness the immune system to improve outcomes and, where possible, cure cancer," said Garo H. Armen, Ph.D., Founder, Chairman and Chief Executive Officer of Agenus. "Our plan to prioritize neoadjuvant BOT+BAL in MSS colon cancer reflects both the strength of the emerging clinical evidence and the opportunity to bring this important combination regimen to patients where it may have the greatest impact. With ROBBIN, we are advancing a randomized global trial designed to confirm the rapid and deep activity observed across the NEST and UNICORN trials."

Upcoming ROBBIN catalysts include the following:

•
First patient dosed: anticipated in Q1 of 2027

•
Interim pathologic response data: anticipated in second half of 2027

•
Interim analysis of EFS: anticipated in second half of 2029

•
Final analysis of EFS: anticipated in second half of 2030

Conference Call and Webcast

Agenus will host a conference call and live webcast today at 8:30am ET to discuss the financing and ROBBIN trial strategy. The call will feature Myriam Chalabi, M.D., Ph.D., of the Netherlands Cancer Institute, a leading investigator in neoadjuvant immunotherapy for colorectal cancer, and Pashtoon Kasi, M.D., M.S. of City of Hope Hospital, who will provide independent clinical perspectives on the program.

To access the live webcast, please https://bit.ly/3TfulyN | Passcode: 460308

Participants may also join by dialing (309) 205-3325 and using Webinar ID: 973 3388 7478. A replay of the webcast will be available on the Agenus website at View Source following the event.

Up To $340 Million Private Placement

Under the terms of the securities purchase agreement announced today, the Company has agreed to issue and sell (i) 23,035,227 shares of the Company’s common stock (or, in lieu thereof, pre-funded warrants to purchase shares of common stock, with an exercise price of $0.01 per share), (ii) accompanying Series A purchase warrants to purchase 21,144,277 shares of common stock, with an exercise price of $4.02 per share and (iii) accompanying Series B purchase warrants to purchase 33,797,214 shares of common stock, with an exercise price of $5.03 per share. The combined effective purchase price per share (or pre-funded warrant to purchase one share) and accompanying Series A purchase warrant to purchase approximately 0.91791 shares of common stock and Series B purchase warrant to purchase approximately 1.46720 shares of common stock, is $3.69 (less the exercise price of the pre-funded warrant, if applicable).

Each pre-funded warrant will be exercisable immediately and will not expire until exercised in full. Each pre-funded warrant will contain customary beneficial ownership limitation provisions.

Each Series A purchase warrant will be exercisable immediately and will expire upon the earlier of the fifth anniversary of the private placement closing date and the date that is 30 days following the day that the Company publicly discloses (either by press release or Current Report of Form 8-K) that at least 60 patients have been dosed in the Phase 3 clinical trial of the Company’s BOT+BAL combination product candidate for the neoadjuvant treatment of colon cancer (the "ROBBIN" trial). Each Series B purchase warrant will be exercisable immediately and will expire upon the earliest of (i) the fifth anniversary of the private placement closing date, (ii) the date that is 30 days following the day that the Company publicly discloses (either by press release or Current Report of Form 8-K) pathologic response data for at least 50 patients that were dosed with BOT+BAL in the Phase 3 clinical trial of the Company’s BOT+BAL combination product candidate for the neoadjuvant treatment of colon cancer (the "ROBBIN" trial) and (iii) unless the holder thereof shall at such time have exercised in full the Series A purchase warrant held by such holder, 12:01 a.m. (New York City time) on the date immediately following the expiration date of the Series A purchase warrant

Pursuant to the terms of the securities purchase agreement, the Company has also agreed to increase the size of its board of directors to nine directors, including two newly created Class III directorships under the Company’s certificate of incorporation, and, promptly following a designation notice made by Commodore Capital Master LP, cause two individuals designated by Commodore Capital Master LP to be appointed to serve as directors in the newly created Class III directorships.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and will be sold in a private placement pursuant to Regulation D of the Securities Act. The securities being issued in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Concurrently with the execution of the securities purchase agreement, the Company and the investors also entered into a registration rights agreement pursuant to which the Company has agreed to register the resale of the shares of common stock sold in the private placement and the shares of common stock issuable upon exercise of the pre-funded warrants, the Series A purchase warrants and the Series B purchase warrants sold in the private placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the foregoing securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Agenus, JUL 13, 2026, View Source [SID1234669167])

Antengene Announces Receipt of USD 60 Million Upfront Payment from UCB

On July 13, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies, reported that the company has received a USD 60 million upfront payment from UCB. This payment is made pursuant to the worldwide exclusive license agreement for ATG-201, a CD19/CD3 bispecific T-cell engager (TCE) antibody, entered into between the parties in March 2026.

ATG-201 is a CD19 targeting bispecific TCE incorporating steric hindrance masking technology, designed to eliminate CD19-expressing B cells. This bispecific interaction with T and B cells through CD3 and CD19 has demonstrated potential in treating B cell-driven diseases by leveraging the body’s own immune system for precise and potent action.

Under the agreement, Antengene grants UCB a worldwide exclusive license to further develop, manufacture, and commercialize ATG-201, along with access to its associated manufacturing technology.

China’s National Medical Products Administration (NMPA) approved in June this year the Investigational New Drug (IND) application for the Phase I ATTRACT study of ATG-201 for the treatment of B cell related autoimmune diseases. Antengene is progressing the Phase I study of ATG-201 in China and concurrently preparing for its clinical development in Australia.

The receipt of the upfront payment from this license agreement with UCB has further strengthened Antengene’s cash position, providing robust financial support for the advancement of our innovative drug pipeline and accelerating benefits to more patients.

Under the terms of the global exclusive license agreement Antengene is eligible for additional near-term milestone payments of USD 20 million subject to certain conditions. The agreement also includes the potential for future success-based development and commercial milestone payments, as well as tiered royalties on future net sales.

(Press release, Antengene, JUL 13, 2026, View Source [SID1234669160])

Immutep Provides Clinical Update in 1st line NSCLC: Positive Mature Overall Survival Data from INSIGHT-003 and Update from TACTI-004

On July 13, 2026 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapies, reported a significant positive update of the investigator-initiated INSIGHT-003 Phase I trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co. Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) and chemotherapy as 1 st line therapy for advanced/metastatic non-small cell lung cancer (1L NSCLC) in 51 evaluable non-squamous patients.

Key Results from INSIGHT-003 – Data Cutoff – 27 March 2026

Approximately 92% of patients enrolled in INSIGHT-003 had no or low PD-L1 expression (Tumour Proportion Score: TPS <50%), representing a population with significant unmet medical need. With a minimum of 30 months of follow-up, median Overall Survival (mOS) was 30.9 months in the overall population regardless of PD-L1 expression (N=51), with the same mOS observed in patients with TPS <50% (N=47) and 37.8 months in TPS>=50% (N=4).

These mature results continue to compare favourably to the 22.0 month mOS from a registrational trial of anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC regardless of PD-L1 expression. 1 Notably, patients with TPS <50%, for whom PD-L1 inhibitor-based therapies typically perform suboptimally, were overrepresented in INSIGHT-003 compared with historical benchmarks (~92% versus ~68%1 ). No new safety signal was identified since the previous data cut-off.

Update on TACTI-004 Root Cause Analysis

In March 2026, following a planned interim futility analysis, Immutep announced that it would discontinue the TACTI-004 Phase III trial in 1st line NSCLC based on a recommendation from the Independent Data Monitoring Committee (IDMC). In the TACTI-004 futility analysis (N=173), the objective response rate (ORR) in the overall patient population receiving standard of care plus efti ("efti arm") was 42.9% compared with 55.1% in patients receiving standard of care plus placebo ("control arm"). The difference was observed across both squamous and non-squamous histologies, and the efti arm did not demonstrate superiority in any TPS subgroup. By comparison, the ORR in INSIGHT-003 has been 62.7%, despite the high proportion of patients with TPS <50%. Pending a final analysis of all patients, to date no new safety signals have been observed in TACTI-004

Preliminary immune monitoring data generated from TACTI-004 indicate that patients treated with efti exhibited a markedly different immune activation profile compared with that observed in previous studies. This assessment is based on analyses of absolute lymphocyte counts (ALC) and circulating monocyte counts in blood. In particular, these findings contrast with observations from almost 600 patients treated with efti in five earlier studies (AIPAC, AIPAC-003, TACTI-mel, TACTI002 and TACTI-003), which were presented at ASCO (Free ASCO Whitepaper) 20262 , and also contrast with observations from INSIGHT-003.

The TACTI-004 analysis, which includes all recruited and evaluable patients who received a minimum of 12 weeks of treatment, remains ongoing, with additional results expected in Q3 CY2026. The Company will continue to analyse this data as part of its ongoing root cause analysis of a range of potential factors, including manufacturing, and will share the outcome of that analysis as soon as it becomes available. Immutep is being assisted in this process by its partners, including Dr. Reddy’s and WuXi Biologics.

Marc Voigt, CEO of Immutep, said: "We are encouraged by the mature overall survival data from INSIGHT-003 in 1 st line non-squamous NSCLC, which continue to compare favourably with historical benchmarks, particularly given the high proportion of patients in this study with no or low PD-L1 expression. The observed median overall survival of 30.9 months especially in patients with no or low PD-L1 expression reinforces our confidence in efti’s potential to enhance anti-tumour immune responses, including in patient populations that have historically experienced less favourable outcomes.

At the same time, we are completing a comprehensive root cause analysis of TACTI-004 to better understand the factors underlying the outcome of that trial and their implications for the potential future development of efti. Importantly, the differences observed in the immune activation profile between TACTI-004 and prior studies are providing valuable insights to inform our strategy as we evaluate efti’s potential path forward."

Additional results from the root cause analysis related to TACTI-004 are expected in Q3 CY2026.

About Eftilagimod Alfa (Efti)

Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals and cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile has enabled various combinations including with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, JUL 13, 2026, View Source;v=undefined [SID1234669159])

A New Approach to Treating Brain Cancer: HDT Bio Launches Canadian Clinical Program at McGill University

On July 12, 2026 HDT Bio Corp. reported the establishment of HDT Bio Canada Inc., its Canadian subsidiary, formed to advance its cancer immunotherapy programs through Canadian clinical development, Canadian manufacturing, and Canadian regulatory pathways. The company has partnered with McGill University and The Neuro (Montreal Neurological Institute-Hospital) for the clinical development of HDT-401, its investigational locally administered immune activator for glioblastoma.

HDT-401 has already been administered to glioblastoma patients under compassionate use protocols. The results were encouraging enough to inform and shape the design of a formal Phase 1 clinical trial. HDT Bio Canada has completed a pre-Clinical Trial Application meeting with Health Canada, a required regulatory step on the path to trial initiation and has received constructive feedback that advances the program toward CTA submission.

The planned Phase 1 study will be conducted in collaboration with Roberto Diaz, MD, PhD of The Neuro of McGill University at, along with clinical and scientific experts across McGill-affiliated institutions in Montreal. "When you operate on these patients, you understand the problem in a way that is difficult to convey. You resect what you can. You know what remains. And you know the current tools are not enough," said Dr. Diaz. "This program is about changing that."

HDT-401 combines Riboxxim, a precisely engineered molecule licensed from Riboxx GmbH of Dresden, Germany, with HDT Bio’s proprietary LION nucleic acid delivery platform. The LION platform has been evaluated in more than 6,000 patients across multiple clinical programs, providing an extensive foundation of clinical experience.

"Glioblastoma patients have waited decades for something new," said Steven Reed, PhD, Chief Executive Officer of HDT Bio Corp. "We have treated patients with HDT-401 under compassionate use. What we observed was encouraging. That is why we are moving as fast as we can to get this into a formal trial in Canada, with one of the world’s great brain cancer research teams. Our commitment to Canada is significant. We are developing products here, working through Canadian regulatory pathways, and supporting Canadian manufacturing capability. Canadian patients and Canadian science are at the center of this program."

HDT-401 is designed to activate innate immune sensing directly within the tumor bed, converting the glioblastoma microenvironment from immune-suppressed to immune-engaged. The approach is intended to induce inflammatory cytokines, recruit immune effector cells, and support local immune recognition of tumor tissue. Local administration into the tumor or surgical cavity concentrates immune activation at the site of disease while limiting systemic exposure.

"Riboxxim was engineered to solve a problem that earlier TLR3 agonist technologies have never fully addressed: precise, reproducible immune activation without the unpredictability that limited clinical developments and market access. HDT Bio’s approach of delivering Riboxxim is scientifically compelling because it concentrates immune activation exactly where it is needed most," said Prof. Dr. Jacques Rohayem, CEO of Riboxx and the inventor of Riboxxim. "The formulation expertise at HDT Bio has contributed an important step in enabling Riboxxim to become a product that can have a major impact on the treatment of glioblastoma and other cancers. I am pleased to see it advancing to the clinic."

"Glioblastoma remains one of the most difficult cancers to treat because recurrence is common and the tumor environment actively suppresses immune activity," said Roberto Diaz, MD, PhD of McGill University. "These are real patients with no good options. The tumor’s ability to suppress immune activity locally is one of the central reasons it has resisted every treatment we have thrown at it. An approach that targets that immunosuppressive environment directly, at the tumor bed, is where the science points. That is why I am committed to this program."

HDT Bio is also advancing a breast cancer vaccine program in Canada, reflecting the company’s broader commitment to Canadian patients and Canadian clinical infrastructure. For that program, the company has engaged Northern RNA Inc. of Calgary as its Canadian GMP manufacturing partner. Northern RNA is a world-class nucleic acid contract manufacturer.

"This is exactly the kind of program Northern RNA was built to support," said Jared Davis, President and CEO of Northern RNA Inc. "Canadian patients with glioblastoma deserve access to the most innovative treatments being developed anywhere in the world. Manufacturing in Canada, for Canadian patients, with a Canadian clinical partner, is how we help make that happen. We are proud to be part of HDT Bio’s Canadian commitment."

About Glioblastoma Glioblastoma is the most common and aggressive primary malignant brain tumor in adults. The five-year survival rate is below 5 percent. Standard treatment includes maximal safe surgical resection, radiation therapy, and temozolomide chemotherapy, but recurrence is common and survival remains limited. No approved immunotherapy has demonstrated a survival benefit in glioblastoma to date. Despite its devastating prognosis, glioblastoma receives significantly less research funding than other cancers of comparable lethality, leaving patients with few meaningful treatment advances and an urgent need for innovative clinical approaches. The glioblastoma treatment market exceeds $3 billion annually and is projected to reach $4.46 billion by 2030, underscoring both the scale of the disease burden and the commercial opportunity for effective new therapies.

About HDT-401 HDT-401 is an investigational immune activator designed for local administration into the tumor or surgical cavity. It combines Riboxxim, a precisely engineered TLR3/RIG-I agonist licensed from Riboxx GmbH, with HDT Bio’s proprietary LION lipid delivery platform. HDT-401 is intended to stimulate innate immune pathways, promote inflammatory signaling in the tumor microenvironment, and recruit immune cells to support anti-tumor activity. HDT-401 has not been approved by Health Canada, the U.S. Food and Drug Administration, or any other regulatory authority.

(Press release, HDT Bio, JUL 12, 2026, View Source [SID1234669161])