On March 9, 2026 Bristol Myers Squibb (NYSE: BMY) reported positive interim Phase 3 results from the SUCCESSOR-2 study (NCT05552976). In the trial, oral mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus carfilzomib and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM). Safety findings were consistent with the known profile of mezigdomide and the combination regimen. Patients will continue to be followed for survival and safety.

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"We are excited by these results, which underscore Bristol Myers Squibb’s leadership in treating multiple myeloma and our unwavering commitment to patients living with this persistent and challenging disease," said Cristian Massacesi, executive vice president, chief medical officer and head of development at Bristol Myers Squibb. "Importantly, these findings reinforce the value of our CELMoD program and our targeted protein degradation platform, and strengthen our confidence in bringing forward effective, accessible oral treatment options for patients with difficult-to-treat blood cancers and potentially beyond."

"While treatment advances have been meaningful, far too many patients with multiple myeloma still relapse or stop responding—making the need for new options urgent," said Paul Richardson, MD, Director of Clinical Research and Clinical Program Leader at the Jerome Lipper Multiple Myeloma Center, the Dana-Farber Cancer Institute and RJ Corman Professor of Medicine, Harvard Medical School. "These data underscore the potential of MeziKd as an oral regimen that could address a key unmet need for patients previously exposed to anti-CD38 and lenalidomide."

"It is important for patients to have treatment options that offer enduring disease control," said Meletios-A. (Thanos) Dimopoulos, MD, Professor and Chairman, Department of Clinical Therapeutics at Alexandra Hospital, School of Medicine, National and Kapodistrian University of Athens. "These positive interim data show that adding mezigdomide, a CELMoD specifically optimized for enhanced myeloma cell killing and immune activation compared with IMiD agents, to carfilzomib and dexamethasone may provide clinical benefit in earlier relapse."

Data from SUCCESSOR-2 will be presented at a future medical meeting and results will be shared with health authorities.

About SUCCESSOR-2

SUCCESSOR-2 (NCT05552976) is an inferential, seamless Phase 2/3, 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 portion is progression-free survival (PFS). Key secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DoR), time to progression (TTP), time to next treatment (TTNT), minimal residual disease (MRD) negativity, and health-related quality of life (HR-QoL).

About Targeted Protein Degradation and Novel CELMoD Agents

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 "undruggable." 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 agents, 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 provide 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. Learn more about the science behind TPD at Bristol Myers Squibb.

(Press release, Bristol-Myers Squibb, MAR 9, 2026, View Source [SID1234663359])

On March 9, 2026 Xilio therapeutics presented its corporate presentation.

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(Presentation, Xilio Therapeutics, MAR 9, 2026, View Source [SID1234663375])

On March 9, 2026 kyron.bio, a biotechnology company pioneering precision glycoengineering for antibody therapeutic development, reported a strategic partnership with Servier, an international pharmaceutical group governed by a Foundation.

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Under the terms of the agreement, kyron.bio will use its technology to glycoengineer an antibody selected by Servier, who will fund the associated research activities. Servier will have the option to further explore antibody engineering and development opportunities based on the outcomes. Financial details are not disclosed.

kyron.bio’s proprietary glycoengineering platform can enhance therapeutic performance of antibodies by enabling precise control of the glycan structures to improve efficacy, safety, and scalability. In this partnership kyron.bio will seek to demonstrate clear glycan control on the Servier antibody of interest for a specific pre-determined N-glycoform.

To date, engineering of glycans have been under-exploited, due to technical challenges, limiting the use of glycan engineering in drug design. kyron.bio is changing that. The company has developed a scalable, proprietary method to achieve comprehensive control over glycosylation, unlocking the possibility to use precision glycosylation in next generation drug design.

Dr. Emilia McLaughlin, founder and Chief Executive Officer of kyron.bio, said,

"We are delighted that Servier has chosen to explore the potential of our glycoengineering platform. Servier has deep expertise in therapeutic development and combined with our precision glycosylation technology, this partnership provides a powerful opportunity to unlock new levels of antibody performance and deliver better outcomes for patients.

"Precision glycosylation represents a transformative approach in biologics development. By engineering defined glycan profiles, therapeutic antibodies can be optimized for improved immune engagement, pharmacokinetics, and reduced variability."

In 2024, kyron.bio was the winner of the Servier Golden Ticket award which has provided invaluable support and mentorship through the company’s early translational phase and has developed a foundation for understanding the potential of kyron.bio’s technology.

Dr. Emmanuel Nony, Director of External Innovation Europe at Servier, said,

"Meeting kyron.bio as a winner of Servier’s Golden Ticket award has enabled our scientists to develop an understanding of the kyron.bio glycan engineering technology and its exciting possibilities in antibody drug design. This collaboration is opening new frontiers for antibody derivatives as well. Together, we are exploring innovative pathways to optimize drug design and production, with a shared commitment to bringing safer and more effective therapies to patients."

kyron.bio’s strategy is to form strategic drug design partnerships with pharmaceutical and biotech companies working on next-generation antibody therapeutics, alongside in house therapeutic development programs.

A successful company creation from the French Entrepreneur First Scheme, in 2025 kyron.bio raised €5.5m in a seed round from an experienced syndicate of venture investors including HCVC, Verve Ventures, Entrepreneurs First and Saras Capital, as well as private angel investors and the European Innovation Council. It has established an R&D base at the biotech hub Paris Biotech Santé in the Cochin Hospital.

(Press release, Servier, MAR 9, 2026, View Source [SID1234663394])

On March 9, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that an abstract was accepted for oral presentation in the Practice-changing, Paradigm-shifting Clinical Trials in Urology session, as part of the American Urological Association (AUA) 2026 Annual Meeting Plenary Program being held in Washington D.C. from May 15-18, 2026. The presentation will feature new data from the Company’s phase 3 clinical trial of aglatimagene besadenovec (aglatimagene or CAN-2409) in patients with intermediate- to high-risk localized prostate cancer.

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Presentation Details:

Aglatimagene – Localized Prostate Cancer

Abstract Title: Extended follow-up shows accumulating benefit for patients treated with CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) in men with localized prostate cancer: update from PrTK03 randomized phase 3 clinical trial
Presentation Type: Plenary
Presenter: Mark G. Garzotto, M.D., Professor of Urology and Radiation Medicine, Oregon Health & Science University, Chief, Urology Section, Portland VA Medical Center
Session Title: P2s: Practice-changing, Paradigm-shifting Clinical Trials in Urology
Session Date/Time: Friday, May 15, 2026; 11:30 AM – 11:40 AM ET
Location: Hall D, Walter E. Washington Convention Center, Washington, D.C.
Full abstracts will be released by AUA on date and time of presentation. Details from the presentation will be available following the event on the Candel website at View Source

(Press release, Candel Therapeutics, MAR 9, 2026, View Source [SID1234663378])

On March 9, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) – has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed.

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Key findings include:

Tolerability profile supported by dosimetry and low-grade non-hematologic events.
Lesion dosimetry indicates no difference in absorbed dose profile across cohorts.
No adverse drug-drug interactions observed in TLX591-Tx combinations.
Hematologic events are in line with expectations and transient and manageable, with similar rates of recovery across all patient cohorts.
The results from Part 1 are consistent with prior clinical studies of this first-in-class lutetium radio antibody-drug conjugate (rADC) therapy.
Part 1 of the study confirmed the safety profile, biodistribution and dosimetry of TLX591-Tx administered in two doses, 14 days apart, in combination with one of three standard of care (SOC) therapies: abiraterone, enzalutamide or docetaxel. The patient population comprised prostate-specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) patients previously treated with one androgen receptor pathway inhibitor (ARPI).

ProstACT Global is a differentiated Phase 3 trial comparing PSMA-targeted 177Lu-rADC therapy administered with SOC versus SOC alone, a trial design intended to reflect current global clinical practice1. Telix has already advanced the study into Part 2 – a 2:1 randomized treatment expansion – in jurisdictions where the clinical trial has obtained approval from health authorities2. Part 1 data will be presented to the United States (U.S.) Food and Drug Administration (FDA) to seek an Investigational New Drug (IND) amendment to progress Part 2 in the U.S.

Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, Salt Lake City, and ProstACT Global Principal Investigator and Steering Committee member, commented, "These results reinforce the feasibility of integrating TLX591-Tx with current standard of care therapies for mCRPC, including ARPIs such as enzalutamide or abiraterone, or docetaxel. Hematologic events align with those typically seen in this patient population and therapeutic class, and these cases resolved quickly. The dosimetry profile, along with the low-grade nature of non-hematologic adverse events, further supports the tolerability profile of this investigational therapy."

David N. Cade, MD, Group Chief Medical Officer, Telix added, "Despite advances in clinical practice, men with advanced prostate cancer still need improved first and second line treatment options. These results build on prior findings and highlight the potential for TLX591-Tx in combination with contemporary standard of care, to become a new first-line option for patients facing this aggressive disease. We are encouraged by the data and look forward to engaging with the FDA at the earliest opportunity, while continuing to advance enrollment in Part 2 in regions where clinical trial initiation has already been approved."

Summary results

ProstACT Global Part 1 dosed 36 patients, allocated across 3 cohorts:

Cohort 1 (11 patients): TLX591-Tx + enzalutamide.
Cohort 2 (11 patients): TLX591-Tx + abiraterone.
Cohort 3 (14 patients): TLX591-Tx followed by docetaxel.
Safety and tolerability

An acceptable safety profile was observed across combination cohorts and tolerability of TLX591-Tx was consistent with prior studies.
All 36 patients received both doses of TLX591-Tx per protocol, no new safety signals were observed.
Almost all treatment-emergent non-hematologic events were Grade 1 or Grade 2. The most prevalent were fatigue (53%), nausea (28%) and dry mouth (25%).
Hematologic events were transient and manageable.
Grade 3 thrombocytopenia (14%) and neutropenia (22%), and Grade 4 thrombocytopenia (31%) and neutropenia (25%) events were in line with the profile expected for this class of therapy and extent of disease.
Dosimetry and biodistribution

Radiation exposure to key organs was well below established safety limits3.
Limited dose to salivary glands and kidneys.
Lesion dosimetry demonstrated uptake across tumor sites and across all cohorts.
Pharmacokinetics demonstrated sustained activity at 15 days, corroborated by imaging which demonstrated prolonged tumor retention.
No evidence of drug-drug interactions impacting TLX591-Tx targeting, distribution or clearance.
About ProstACT Global

ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multicenter trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET4 imaging agent (such as Illuccix, kit for the preparation of gallium-68 (68Ga) gozetotide injection, or Gozellix, kit for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with one ARPI.

The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies5, collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is primarily cleared through the liver, a comparatively radioresistant organ, instead of the kidneys6. Due to its large molecular weight, TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs7.

Additional information on the Phase 3 ProstACT Global study can be found at: View Source

(Press release, Telix Pharmaceuticals, MAR 9, 2026, View Source [SID1234663395])