On April 13, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported a collaboration to jointly develop and commercialize next generation radiopharmaceutical therapies.

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The collaboration combines Regeneron’s extensive biologics expertise, including bispecific antibody discovery, with Telix’s radiopharmaceutical development platform, global manufacturing capabilities and supply chain infrastructure. The collaboration will include multiple solid tumor targets from Regeneron’s portfolio of antibodies, generated from VelocImmune mice. With a shared commitment to precision oncology, the parties also plan to develop radio-diagnostics to support patient selection and treatment response assessment.

"At Regeneron, we follow the science to determine the best therapeutic approach for each disease, continuously expanding our toolbox of treatment modalities – from monoclonal and bispecific antibodies to cell therapies and beyond. Targeted radiopharmaceuticals represent a rapidly emerging frontier in oncology and an exciting opportunity to bring new treatment options to patients in need," said John Lin, M.D., Ph.D., Senior Vice President of Oncology & Antibody Technology Research at Regeneron.

"Telix brings deep expertise in radiopharmaceutical development and infrastructure that complements Regeneron’s antibody technologies and oncology portfolio," said Israel Lowy, M.D., Ph.D., Senior Vice President, Clinical Development Unit Head, Oncology at Regeneron. "Regeneron is excited to enter the targeted radiopharmaceuticals space and explore the utility of these agents either as monotherapy or rationally combined with our immunotherapy platform, particularly in areas of high unmet patient need such as lung cancer, where our PD-1 inhibitor is a global standard of care."

"The collaboration with Regeneron reflects a highly complementary set of capabilities and a unique opportunity to explore what true ‘next gen’ biologics-based radiopharmaceuticals can potentially do for patients," said Christian Behrenbruch, D.Phil., Managing Director and Group CEO at Telix. "We are well positioned to work toward the shared goal of advancing next generation precision radiopharmaceuticals for patients with hard-to-treat cancers."

Under the terms of the agreement, Telix will receive an upfront cash payment of $40 million USD from Regeneron for access to its radiopharmaceutical manufacturing platform for four initial therapeutic programs, with Regeneron having the option to expand to include four additional programs with additional upfront payments. Telix and Regeneron will share equally in the global commercialization costs and potential profits, with Telix retaining the option to co-promote certain potential products. Should Telix opt-out of the co-funding model for a particular program, it is instead eligible to receive up to $535 million USD in development and commercial milestones, plus low double-digit royalites on future net sales, for that program.

Telix and Regeneron will also jointly develop diagnostic assets, with Telix leading commercialization and Regeneron receiving a set percentage of profits.

(Press release, Regeneron, APR 13, 2026, View Source [SID1234664323])

On April 13, 2026 Kazia Therapeutics Limited (Nasdaq: KZIA), a clinical-stage oncology company advancing therapies to reprogram cancer biology and overcome treatment resistance, reported the in-licensing of a first-in-class SETDB1-targeted epigenetic drug development platform from QIMR Berghofer.

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The platform includes use of an AI-integrated epigenetic drug discovery engine, enabling rapid, precise, and scalable candidate generation. The lead drug candidate, MSETC, was discovered and optimized using this AI-integrated epigenetic drug discovery engine. MSETC is a highly selective bicyclic peptide designed to target a novel, disease-associated nuclear SETDB1 complex. By targeting SETDB1, the program is intended to restore immune signaling in tumors that have become resistant to immunotherapy, including checkpoint inhibitors.

"SETDB1 represents a compelling emerging target in oncology," said Dr. John Friend, CEO of Kazia Therapeutics. "With this acquisition, we are extending our strategy to target how cancer controls its own behavior by addressing immune resistance at the chromatin level, one of the earliest layers of tumor immune regulation, alongside transcriptional reprogramming with paxalisib and targeted protein degradation with our PD-L1 platform. Together, these programs position Kazia’s pipeline to address cancer therapy across multiple layers of tumor biology."

SETDB1 A High-Value Target in Immune Resistance

SETDB1 is increasingly recognized as a key epigenetic regulator of tumor immune evasion and has been associated with aggressive disease and poorer clinical outcomes in several tumor types. Preclinical studies suggest that inhibition of SETDB1 can restore interferon signaling, enhance antigen presentation, and increase tumor immune recognition.

Internal translational research has also identified a novel SETDB1-associated nuclear complex observed in resistant and metastatic disease settings, supporting continued development of Kazia’s first-in-class therapeutic approach targeting this biology.

The SETDB1 program is supported by extensive peptide screening and optimization, generating a pipeline of candidates with strong selectivity and intracellular targeting capability.

Building a Differentiated, Multi-Layered Oncology Platform

Cancer cells can evade treatment through genetic mutations, but also by dynamically reprogramming how genes and immune signals are regulated. This adaptive behavior underpins resistance to many current therapies, including immunotherapy.

Kazia’s pipeline now spans three complementary layers of cancer control:

● Chromatin-level regulation (SETDB1) restoring immune visibility by reactivating suppressed signaling pathways

● Transcriptional reprogramming (paxalisib) altering gene expression programs that drive tumor growth and immune suppression

● Protein-level control (PD-L1 degrader platform, NDL2) eliminating intracellular PD-L1 and overcoming resistance mechanisms beyond antibody-based therapies

This integrated approach is designed to address tumor resistance at its source and create new opportunities for combination therapies across multiple cancer types.

Positioned Within a Large and Growing Oncology Opportunity

Epigenetic therapies represent a validated and expanding segment of oncology, with multiple approved agents demonstrating clinical impact. Earlier approaches helped establish the importance of epigenetic regulation in cancer but were often limited by broad, non-specific activity and modest clinical impact, particularly in solid tumors.

Advances in the understanding of tumor biology and immune resistance now enable more precise, mechanism-driven approaches. These next-generation strategies are designed to target specific drivers of tumor adaptation and immune evasion, with the potential for broader applicability and improved outcomes, particularly in combination with immunotherapy.

The global epigenetic therapeutics market is estimated to be in the range of $15–20 billion annually and is expected to grow meaningfully over the next decade, driven by next-generation approaches targeting immune resistance and tumor plasticity.

By targeting SETDB1, Kazia is addressing a major unmet need in aggressive, treatment-refractory cancers that account for a significant proportion of cancer-related mortality. The approach is designed to restore immune responsiveness across multiple tumor types, particularly in advanced and metastatic disease settings where treatment options remain limited.

Clear Development Path and Partnering Potential

The SETDB1 program is currently in preclinical development with a defined path toward IND-enabling studies. Kazia plans to generate translational data to support biomarker-driven development and combination strategies with immunotherapies and targeted agents.

Given its broad applicability across tumor types, and its role in immune resistance, the Company believes the program represents a compelling opportunity for early strategic partnerships.

Efficient Pipeline Expansion

Kazia intends to advance the SETDB1 program in parallel with its PD-L1 degrader platform through IND-enabling studies. By leveraging shared CRO resources, coordinated study design, and established scientific collaborations, the Company expects to achieve meaningful execution efficiencies.

The combined cost to advance both programs to IND readiness is expected to be approximately $6 million over 18 months, with a substantial portion of eligible expenditure expected to qualify for the Australian R&D tax incentive. This approach enables Kazia to expand its pipeline while maintaining capital discipline and preserving focus on ongoing clinical programs.

Transaction Terms

Under the terms of the agreement, Kazia has acquired global rights to the SETDB1 platform, including the lead candidate MSETC. Financial terms include an upfront payment of approximately $1.39 million and a tiered revenue-sharing structure aligned with development progress, with no clinical or regulatory milestone obligations.

(Press release, Kazia Therapeutics, APR 13, 2026, View Source [SID1234664321])

On April 13, 2026 Iterion Therapeutics reported that two abstracts featuring its first-in-class TBL1 inhibitor, tegavivint, will be presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Each will highlight the company’s approach to targeting the Wnt/β-catenin pathway, one of the most frequently dysregulated signaling programs in cancer.

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Despite its role in an estimated 25–30% of solid tumors, the Wnt/β-catenin pathway has historically proven difficult to target therapeutically. Earlier efforts focused on inhibiting upstream components of the pathway and were often limited by bone and gastrointestinal toxicities.

Tegavivint takes a differentiated approach by targeting TBL1, a transcriptional regulator required for β-catenin–mediated gene expression. By disrupting the TBL1–β-catenin transcriptional complex, tegavivint promotes degradation of nuclear β-catenin, inhibits oncogenic transcriptional programs driven by Wnt signaling, and has demonstrated potent anti-tumor activity in preclinical models and clinical studies.

"These data further support our strategy of targeting TBL1 as a novel approach to treating Wnt-driven cancers," said Rahul Aras, Ph.D., President and Chief Executive Officer of Iterion Therapeutics. "As clinical momentum builds in hepatocellular carcinoma and our program expands into colorectal cancer and pediatric osteosarcoma, we see the potential for tegavivint to play an important role across multiple cancers where Wnt signaling drives disease."

Iterion recently completed a Phase 1 study of tegavivint in patients with advanced hepatocellular carcinoma (HCC), where the therapy demonstrated encouraging clinical responses and durable disease control in heavily pre-treated patients, along with a favorable tolerability profile. Detailed results from the study are expected to be presented at a scientific conference later this year as the company prepares to advance tegavivint into Phase 2 development in HCC.

The two presentations highlight both the mechanistic basis of tegavivint’s activity and its emerging potential across multiple Wnt-driven cancers.

Building on a recently initiated Phase 1 clinical study in colorectal cancer, one presentation describes the activity of tegavivint in Wnt-driven colorectal cancer models, demonstrating potent anti-tumor activity in preclinical models characterized by activation of the Wnt/β-catenin pathway. These findings support the continued clinical development of tegavivint and exploration of combination strategies in colorectal and other cancers.

A second presentation further characterizes the mechanism of action of tegavivint and the characterization of TBL1 as a druggable therapeutic target within the Wnt/β-catenin pathway. The work highlights how targeting TBL1 can selectively disrupt β-catenin–dependent transcriptional activity and supports the broader potential of this approach across Wnt-driven cancers.

AACR Presentation Details

Poster 1: Tegavivint, a first-in-class TBL1 inhibitor demonstrates potent activity in WNT-driven colorectal cancers
Presenter: Stephen Horrigan, Ph.D., Chief Scientific Officer
Session Title: CL07.02 – Molecular Targeted Therapy
Abstract Number: 3900/6
Date / Time: Monday April 20th, 2026, 2:00-5:00pm
Location: Section 47
Poster 2: Tegavivint directly targets TBL1 to inhibit β-catenin nuclear oncogenic activity
Presenter: Aundrietta Duncan, Ph.D., Sr. Director of Translational Research and Non-Clinical Development
Session Title: ET05.01 – Mechanisms of Anticancer Drug Action
Abstract Number: 5669/15
Date / Time: Tuesday April 21st, 2:00-5:00pm
Location: Section 12

(Press release, Iterion Therapeutics, APR 13, 2026, View Source [SID1234664320])

On April 13, 2026, IDEAYA Biosciences, Inc. (the "Company") and Servier, an independent international pharmaceutical group governed by a foundation, reported clinical data from the Company’s Phase 2/3 registrational trial, OptimUM-02, evaluating darovasertib in combination with crizotinib (darovasertib combination) in patients with first-line ("1L") HLA-A*A2:01-negative metastatic uveal melanoma ("mUM").

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The darovasertib combination met the trial’s primary endpoint of a statistically significant improvement in median progression-free survival ("PFS") relative to the investigator choice of therapy (ICT) arm as assessed by blinded independent central review ("BICR"). The secondary endpoints in the study include overall response rate ("ORR") and duration of response ("DOR"). The topline results were from a total of 313 patients enrolled in the Phase 2b/3 portion of the trial as of the cut-off date of January 23, 2026. The PFS analysis was based on a total of 159 events.

OptimUM-02 is a global, randomized Phase 2/3 trial in 1L HLA-A*A2:01-negative MUM evaluating the darovasertib combination arm of 210 patients versus the ICT arm reflective of real-world clinical practice that consists of 103 patients. The ICT arm was composed of 76% (n=78) ipilimumab plus nivolumab (anti-CTLA-4/PD-1) and 24% (n=25) pembrolizumab (anti-PD-1). The primary endpoint is median PFS as assessed by BICR, which will be used to support an initial New Drug Application ("NDA") submission in the United States.

The Company reported that patients treated with the darovasertib combination reduced their risk of disease progression as assessed by BICR by 58% (Hazard Ratio of 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001) and achieved a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm. The Company also reported that ORR by BICR in the darovasertib combination and ICT arm was 37.1% and 5.8% (p-value: <0.0001), respectively. There were 5 complete responses by BICR observed in the darovasertib combination arm, and no complete responses observed in the ICT arm. The median DOR in the darovasertib combination arm was 6.8 months. The overall survival ("OS") data is not mature. However, the Company observed that, in the OptimUM-02 study, there is an early trend in improvement in OS with the darovasertib combination arm versus the ICT arm. The darovasertib combination was generally well-tolerated with a manageable safety profile consistent with prior reported results and known side-effects of each drug. The most common Grade 3+ treatment emergent adverse events included diarrhea, syncope, and hypotension. The treatment related serious adverse events rate in the darovasertib combination was in the single digit percent range.

Based on these data, the Company will target to submit an NDA to the U.S. Food and Drug Administration ("FDA") in the second half of 2026. The Company plans to provide additional details from OptimUM-02 at a major medical conference in 2026.

(Press release, Ideaya Biosciences, APR 13, 2026, View Source [SID1234664318])

On April 13, 2026 Genmab A/S (Nasdaq: GMAB) reported new data demonstrating that rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC), evaluated in combination with bevacizumab in patients with advanced ovarian cancer, showed a safety profile consistent with the known safety profiles of Rina-S and bevacizumab. These data are from the combination therapy cohort D2 of the multi-part Phase 1/2 RAINFOL-01 study and were presented during an oral session at the 2026 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO) in San Juan, Puerto Rico.

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"Advanced ovarian cancer is a complex and difficult-to-treat disease, and the ability for investigational therapies such as Rina-S to be safely combined with bevacizumab can provide clinicians with more options to help improve disease control and manage resistance," said Cara Mathews, M.D., study investigator and Associate Professor, Obstetrics and Gynecology at the Women and Infants Hospital, Brown University. "Rina-S has shown a manageable safety profile as a monotherapy, and these safety data suggest that it may be combined with a standard-of-care therapy such as bevacizumab without significantly increasing the risk of additional side effects."

As of data cutoff, 40 patients with recurrent ovarian cancer had received Rina-S (120 mg/m2) plus bevacizumab every three weeks until disease progression or unacceptable toxicity. The primary endpoint was safety and tolerability. The combination of Rina-S and bevacizumab was tolerable, with manageable adverse events (AEs). The safety profile of the combination was consistent with the known safety profiles of the individual agents, with no new or unexpected safety signals. The most common (≥25%) treatment-emergent AEs (TEAEs) included nausea (80%), fatigue (67.5%), anemia (55%), and neutropenia (45%). No safety signals of ocular toxicities, peripheral neuropathy or interstitial lung disease were reported, and no clinically significant bleeding was observed. Serious TEAEs occurred in six patients (15.0%), and TEAEs leading to Rina-S dose reductions occurred in 11 patients (27.5%). Rina-S and bevacizumab discontinuation occurred in two patients (5%). No fatal TEAEs were reported.

"Today’s safety results from RAINFOL-01 add to the growing body of clinical evidence supporting further development of Rina-S in advanced ovarian cancer, including its potential to be used in a combination regimen," said Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab. "Rina-S has the potential to meaningfully expand treatment possibilities for patients with certain gynecologic cancers, and we look forward to further investigating additional opportunities, alone and with other therapies, as Rina-S advances through late-stage clinical development."

Rina-S is advancing through late-stage development supported by a growing portfolio of clinical trials, including the ongoing Phase 1/2 RAINFOL-01 trial (NCT05579366), the Phase 3 RAINFOL-02 trial (NCT06619236) in patients with platinum-resistant ovarian cancer (PROC), the Phase 3 RAINFOL-03 trial (NCT07166094) in patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy, and the Phase 3 RAINFOL-04 trial (NCT07225270) in patients with recurrent platinum-sensitive ovarian cancer (PSOC) as maintenance therapy. Rina-S is also being evaluated in the Phase 2 RAINFOL-05 study (NCT07288177) in patients with non-small cell lung cancer (NSCLC).

About the RAINFOL-01 Trial
RAINFOL-01 (NCT05579366) is an open-label, multicenter Phase 1/2 study designed to evaluate the safety and efficacy of Rina-S Q3W at various doses in solid tumors that are known to express FRα. The study consists of multiple parts including Part D combination therapy cohorts.

About Ovarian Cancer
Ovarian cancer is a major global health issue, with over 320,000 new cases diagnosed annually worldwide.i It ranks as the eighth most common cancer and the eighth leading cause of cancer-related deaths among women globally.ii The disease is often diagnosed at an advanced stage due to its subtle and non-specific symptoms, such as abdominal bloating, pelvic pain and difficulty eating.iii Standard of care for PROC typically involves single-agent chemotherapy (pegylated liposomal doxorubicin (PLD), topotecan, gemcitabine or paclitaxel) and mirvetuximab for FRα-positive (≥75% positive tumor cells) patients.iv,v Approximately 70-90% of women with advanced-stage ovarian cancer worldwide experience a recurrence after initial treatment.vi Ovarian cancer has a low five-year survival rate, which varies significantly by region, but generally hovers around 30-50%.vii,viii

About Rinatabart Sesutecan (Rina-S; GEN1184)
Rina-S (GEN1184) is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRα, a hydrophilic protease-cleavable linker, and exatecan, a TOPO1 inhibitor payload. The clinical trial program for Rina-S continues to expand, including ovarian, endometrial and other cancers with unmet need.

The safety and efficacy of Rina-S has not been established. Please visit View Source for more information.

(Press release, Genmab, APR 13, 2026, View Source [SID1234664317])