Unlocking the potential of Immuno-oncology therapies

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

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

kyron.bio Announces Strategic Partnership with Servier to Advance Precision Glycosylation in Antibody Therapeutics

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])

Candel Therapeutics To Present New Data after Extended Follow Up from Randomized Phase 3 Trial of Aglatimagene Besadenovec in Localized Prostate Cancer at the American Urological Association 2026 Annual Meeting

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])

ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives

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])

Coherus Oncology Reports Full Year and Fourth Quarter 2025 Financial Results and Provides Business Update

On March 9, 2026 Coherus Oncology, Inc. (Nasdaq: CHRS), reported financial results for the full year and fourth quarter 2025, and provided an overview of recent business highlights.

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"We are pleased with our progress in 2025, having doubled LOQTORZI sales while completing the transformation from a biosimilars company to an innovative oncology company focused on overcoming immune resistance in cancer. At the same time, we continued to reduce our overall debt since its peak in 2024 by over 90% to $38.8 million," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "We are now strategically positioned with growing revenues from our foundational PD-1 inhibitor, potential deal opportunities across the portfolio and geographies, and two promising pipeline candidates with multiple 2026 clinical readouts."

"We are aggressively advancing casdozokitug, our first-in-class IL-27 targeting antibody in 1L hepatocellular carcinoma, which demonstrated a 17% complete response rate in a previous Phase 2 study," said Rosh Dias, MD, Chief Medical Officer. "At the same time, we also have a broad clinical program with tagmokitug, our highly selective CCR8 targeting cytolytic antibody, in multiple tumor cohorts including gastrointestinal cancers and head and neck cancer with strong scientific and clinical rationale in each. We now look forward to initiating the combination study with J&J’s T-cell engager pasritamig, in metastatic castration resistant prostate cancer (mCRPC), in the second half of this year."

"Tumor targeted T regulatory cell depleting agents have broad potential applicability in combination with immune agents like TCE and toripalimab, ADCs, T-cell engagers and radiotherapy," said Theresa LaVallee, PhD, Coherus Chief Scientific and Development Officer. "With a potentially best-in-class molecule we look forward to advancing tagmokitug combinations both with partners and with LOQTORZI."

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) Commercial Updates

LOQTORZI net revenue for Q4 2025 was $12.4 million, an 11% increase over $11.2 million in Q3 2025 and a 64% increase over $7.5 million in Q4 2024. Growth in Q4 2025 was driven largely by higher patient demand from both new account starts as well as repeat use in existing accounts. Average duration of treatment among existing patients also continued to grow.
LOQTORZI remains the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC,) representing an overall $250 million addressable market.
In December 2025, compelling six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) were presented at ESMO (Free ESMO Whitepaper) Asia. In this exploratory post-hoc analysis, patients receiving LOQTORZI plus gemcitabine and cisplatin achieved a median OS of 64.8 months, nearly double that of chemotherapy alone (33.7 months), and an observed 38% reduction in risk of death (HR 0.62; 95% CI, 0.45–0.85).
ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

Tagmokitug is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding.

Preclinical and clinical biomarker research for tagmokitug was published in the December 2025 issue of Molecular Cancer Therapeutics, describing the high selectivity, picomolar binding affinity and significant effector mediated killing of CCR8+ cells. The findings showed that tagmokitug demonstrated no off-target binding and selectively eliminated CCR8+ T regulatory cells and not other T cells, supporting its potential as an anti-cancer treatment.
The Phase 1b tagmokitug/toripalimab combination dose optimization studies in 2L HNSCC and 2L upper GI adenocarcinoma cancers are underway, with initial data readouts expected in mid-2026.
A Phase 1b study evaluating the tagmokitug/toripalimab combination, with and without chemotherapy, in 1L and 2L esophageal squamous cell carcinoma (ESCC), respectively, is underway with a first data readout expected in 2H 2026.
A Phase 1b/2a study evaluating tagmokitug/toripalimab combination in 4L+ colorectal cancer is enrolling patients and initial data is expected in 2H 2026.
A Phase 1b clinical study in patients with metastatic castration-resistant prostate cancer (mCRPC) in combination with pasritamig, a T-cell engaging bispecific antibody, is anticipated to begin in 2H 2026.
Casdozokitug is a first-in-class IL-27 antagonistic antibody currently being evaluated in a Phase 2 study in patients with first line uHCC (unresectable hepatocellular carcinoma) to assess treatment benefit, safety and response biomarkers.

Enrollment is ongoing in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC, with the first data readout expected in mid-2026.
Data presented during ASCO (Free ASCO Whitepaper) GI 2025 demonstrated a 38% overall response rate and a 17% complete response rate with the addition of casdozokitug to the current standard of care.
EQUITY FINANCINGS

In October 2025, the Company sold 4,634,995 shares of common stock and warrants with an exercise price of $0.01 per share to purchase 463,498 shares of common stock for net proceeds of approximately $7.9 million. In February 2026, Coherus sold 28,600,000 shares of its common stock in public offering for proceeds of approximately $47.0 million, net of Underwriters’ discounts and commissions.
FOURTH QUARTER 2025 FINANCIAL RESULTS

Net revenue from continuing operations was $12.7 million and $7.7 million during the three months ended December 31, 2025 and 2024, respectively, and $42.2 million and $26.4 million during the years ended December 31, 2025 and 2024, respectively. LOQTORZI net product revenue increased $4.8 million and $21.7 million compared to the three months and full year ended December 31, 2024, respectively, driven primarily by volume growth of LOQTORZI, which launched in January 2024. The increase in the full year period was partially offset by a decrease in other revenue primarily driven by a $6.3 million upfront fee recognized in 2024 for the out-license of rights to commercialize toripalimab within Canada.

Cost of goods sold (COGS) from continuing operations was $4.0 million and $2.8 million during the three months ended December 31, 2025 and 2024, respectively, and $13.8 million and $8.7 million during the years ended December 31, 2025 and 2024, respectively. The increases were primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $31.0 million and $20.8 million for the three months ended December 31, 2025, and 2024, respectively, and $108.9 million and $91.8 million for the years ended December 31, 2025, and 2024, respectively. The increases were primarily due to development costs for casdozokitug and tagmokitug, partially offset by savings from discontinued programs, reduced headcount, and lower infrastructure costs.

Selling, general and administrative (SG&A) expenses from continuing operations were $23.6 million and $29.6 million during the three months ended December 31, 2025, and 2024, respectively, and $100.6 million and $125.5 million during the years ended December 31, 2025, and 2024, respectively. The decreases were driven primarily by lower headcount and decreased operating costs following Coherus’ recent divestitures. The year-over-year decrease was further attributable to net charges for write-offs of intangible assets and associated contingent consideration liabilities totaling $4.2 million in 2025 down from $6.8 million in 2024.

Interest expense from continuing operations was $2.3 million and $1.9 million for the three months ended December 2025 and 2024, respectively, and $9.0 million and $10.7 million for the year ended December 31, 2025, and 2024, respectively. Cash paid for interest, which relates to borrowings reflected in both continuing operations and discontinued operations, was $9.9 million and $25.4 million for the years ended December 31, 2025 and 2024, respectively. The year-over-year decrease was primarily due to lower average outstanding debt.

Net (loss) from continuing operations for the fourth quarter of 2025 was $46.9 million, or $(0.39) per share on a diluted basis, compared to a net loss of $46.1 million, or $(0.40) per share on a diluted basis, for the same period in 2024. Net loss for the year ended December 31, 2025, was $183.1 million, or $(1.56) per share on a diluted basis, compared to a net loss of $215.4 million, or $(1.88) per share on a diluted basis, for the same period in 2024.

Non-GAAP net loss from continuing operations for the fourth quarter of 2025 was $40.4 million, or $(0.34) per share on a diluted basis, compared to $39.4 million, or $(0.34) per share for the same period in 2024. Non-GAAP net loss for the year ended December 31, 2025 was $159.2 million, or $(1.36) per share on a diluted basis, compared to a net loss of $166.5 million, or $(1.45) per share for the same period in 2024. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and marketable securities totaled $172.1 million as of December 31, 2025, compared to $126.0 million as of December 31, 2024. The balance at December 31, 2025 was inclusive of Transition Service Agreement (TSA)-related collections that will be applied to associated TSA payables and accrued liabilities which totaled $65.1 million as of December 31, 2025.

Conference Call Information
When: Monday, March 9, 2026, starting at 4:30 p.m. Eastern Standard Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: View Source

Webcast: View Source

A live and archived webcast will be available on the "Investors" section of the Coherus website at View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

(Press release, Coherus Oncology, MAR 9, 2026, View Source [SID1234663361])