HiberCell to Present Preclinical Data Demonstrating the Enhanced Antitumor Activity of HC-7366 in Combination with VEGFR-TKIs in Clear Cell Renal Cell Carcinoma (ccRCC)

On April 14, 2026 HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics to address cancer relapse, metastasis, and resistance, reported the preclinical poster presentation titled, Combination of the GCN2 activator HC-7366 with VEGFR-TKI results in greater efficacy than VEGFR-TKI alone or VEGFR-TKI/HIF-2i combinations in ccRCC which will be highlighted at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17-22 in San Diego, California. The abstract is now available on the AACR (Free AACR Whitepaper) website.

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

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

                  Schedule Your 30 min Free Demo!

The poster will present data showing that HC-7366 enhanced the activity of multiple VEGFR-TKIs, including lenvatinib, cabozantinib, and axitinib in preclinical metastatic ccRCC models, with HC-7366 and VEGFR-TKI doublets outperforming the combination of HIF-2α inhibitor and VEGFR-TKI in several preclinical patient-derived xenograft models. The data further support HC-7366 as a potential strategy to overcome VEGFR-TKI resistance in metastatic ccRCC and provide rationale for clinical evaluation of HC-7366 and VEGFR-TKI combinations in ccRCC. These findings also support HiberCell’s recent initiation of a Phase 1b arm evaluating HC-7366 in combination with cabozantinib in metastatic ccRCC as part of its ongoing clinical study (NCT06234605).

"We’re excited to share these data, which demonstrate the preclinical combination potential of HC-7366 with VEGFR-TKIs, a key standard-of-care therapeutic class in ccRCC," said Nandita Bose, Ph.D., Chief Development Officer of HiberCell. "These findings build on the data presented at the 2024 AACR (Free AACR Whitepaper) Annual Meeting demonstrating the combination potential of HC-7366 with HIF-2α inhibitors and further support our ongoing clinical evaluation of HC-7366 in combination with all three major standard-of-care therapeutic classes in ccRCC: HIF-2α inhibitors, VEGFR-TKIs, and immune checkpoint inhibitors. Collectively, these data suggest HC-7366 may have the potential to emerge as a next-generation, novel therapeutic approach in ccRCC."

Poster Presentation Detail:

Title: Combination of the GCN2 activator HC-7366 with VEGFR-TKI results in greater efficacy than VEGFR-TKI alone or VEGFR-TKI/HIF-2i combinations in ccRCC

Session: Combination Targeted Therapy (Section 42)

Abstract Number: 6485

Date & Time: April 21, 2026, 2:00 pm – 5:00 pm

About HC-7366

HC-7366 is a first-in-class, first-in-human, selective, potent, small molecule activator of the general control nonderepressible 2 (GCN2) kinase. GCN2 is one of the kinases of the integrated stress response (ISR) family, which responds to amino acid deprivation and is a key metabolic stress sensor in cells. While cancer cells utilize the ISR for survival, prolonged or hyperactivation of GCN2 with HC-7366 has been shown to have antitumor and immunomodulatory activity as a monotherapy and in combination with varied SOC agents in preclinical models of both solid and liquid tumors. HC-7366 is currently under clinical development in Phase 1b studies in ccRCC and acute myeloid leukemia (AML).

(Press release, HiberCell, APR 14, 2026, View Source [SID1234664385])

Telix Doses First Patient in Phase 3 IPAX-BrIGHT Trial of TLX101-Tx for Recurrent Glioblastoma

On April 14, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported that the first patient has been dosed with TLX101-Tx (¹³¹I-iodofalan) in Telix’s pivotal IPAX BrIGHT trial1, marking the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma, an aggressive form of brain cancer.

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

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

                  Schedule Your 30 min Free Demo!

The patient was dosed at Austin Health in Melbourne, Australia, under the supervision of Professor Hui Gan. IPAX BrIGHT is assessing the safety and efficacy of TLX101-Tx in combination with chemotherapy (lomustine), compared to chemotherapy alone. The global, multicenter, open-label study will enroll patients with radiographically confirmed recurrent glioblastoma at first recurrence.

Telix’s commitment to advancing care for patients with glioblastoma is driven by the significant unmet need in this space. In the past 25 years, only two drugs have been approved by the United States Food and Drug Administration (FDA) for glioblastoma2, and no standard treatment currently exists for recurrent disease. Patients therefore face limited treatment options after initial therapy. TLX101-Tx offers a novel approach by targeting the L-type amino acid transporter 1 (LAT1), a transporter that enables the radiopharmaceutical to cross the blood-brain barrier and delivers therapy directly to the tumor.

IPAX BrIGHT expands upon promising data from earlier trials in the recurrent glioblastoma setting, including IPAX-13, which reported a median overall survival (OS) of 13 months from the initiation of treatment with TLX101-Tx, or 23 months from initial diagnosis4. Preliminary results from the IPAX-Linz investigator-initiated trial of TLX101-Tx were consistent and confirmatory to IPAX-1, with a median OS of 12.4 months from initiation of treatment and 32.2 months from initial diagnosis5. Beyond the clinical trial setting, an early access program for TLX101-Tx in Europe has dosed 18 patients at first recurrence or later, further establishing the clinical utility of TLX101-Tx.

Professor Gan, Director of Cancer Clinical Trials at Austin Health, said, "Based on the prior safety profile and early efficacy data for TLX101-Tx in the IPAX-1 and IPAX-Linz studies, I am pleased to continue to explore this therapeutic modality in the first radiopharmaceutical pivotal trial in recurrent glioblastoma, where there are currently few effective treatment options."

Dr. David N. Cade, Group Chief Medical Officer, Telix, added, "Through the IPAX BrIGHT trial, we aim to offer a new option for patients affected by glioblastoma. This registration-enabling study represents a major step forward in our mission to improve therapeutic options in neuro-oncology. With very limited innovation in treatment in recent decades, TLX101-Tx has the potential to become a first-in-class therapy that meaningfully improves patient outcomes."

The IPAX BrIGHT study has received regulatory approval in Australia, Austria, Belgium and the Netherlands with approval being sought in additional jurisdictions. Telix’s investigational PET6 imaging agent for glioma, TLX101-Px (floretyrosine F 18) will be used for patient selection in IPAX BrIGHT, as well as assessing metabolic tumor response according to PET RANO 1.07.

About TLX101-Tx

TLX101-Tx (131I-iodofalan) is a systemically administered radiopharmaceutical therapy that targets L-type amino acid transporter 1 (LAT1), which is typically over-expressed in glioblastoma. TLX101-Tx utilizes a small molecule approach due to the need to cross the blood brain barrier, the normal protective barrier that prevents many potential drug candidates entering the brain. In addition to the IPAX-1 and IPAX-Linz studies, TLX101-Tx is also under investigation in the IPAX-2 Phase 1 study in combination with post-surgical standard of care treatment in patients with newly diagnosed glioblastoma8. TLX101-Tx has received orphan drug designation in the U.S. and Europe for the treatment of glioma. TLX101-Tx and TLX101-Px have not received a marketing authorization in any jurisdiction.

About glioblastoma

Glioblastoma (GBM), is a high-grade glioma and the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S.9. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients10, with an expected survival duration of 12-15 months from diagnosis.

(Press release, Telix Pharmaceuticals, APR 14, 2026, View Source [SID1234664384])

4D Path Announces Collaboration with Daiichi Sankyo to Advance AI-Driven Predictive Biomarkers for an Antibody Drug Conjugate Program

On April 14, 2026 4D Path, a company dedicated to personalizing cancer care through a novel, physics-informed approach to predicting tumor response to therapy, reported a collaboration with Daiichi Sankyo (TSE: 4568) to develop next-generation predictive biomarkers in an antibody drug conjugate (ADC) clinical development program.

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

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

                  Schedule Your 30 min Free Demo!

ADCs are among the most promising therapeutic classes in oncology, yet there remains a significant unmet need for scalable biomarkers that predict which patients are most likely to benefit from increasingly complex regimens and combination therapies. This collaboration brings together 4D Path’s ability to compute biologically grounded, physics-informed treatment predictive biomarkers from routine pathology specimens with the ADC innovation leadership of Daiichi Sankyo.

Under the collaboration, 4D Path will apply its proprietary Q-Plasia OncoReader (QPOR) platform to standard Hematoxylin and Eosin (H&E)-stained tumor biopsy slides to compute interpretable, quantitative biomarkers associated with cell-cycle deregulation and tumor microenvironment dynamics. These biomarkers will be evaluated for their ability to identify patients most likely to benefit from the select ADC, helping enable more precise, non-invasive, and cost-effective patient selection, potentially improving response rates and accelerating clinical trials.

This approach is designed to be compatible with both retrospective analyses of archived clinical specimens and prospective evaluation in ongoing and future studies.

"While the introduction of ADCs has improved outcomes for patients, more advanced biomarkers that are predictive of response to these agents is needed. 4D Path’s novel approach to utilizing biological and physical characteristics from routine H&E-stained biopsy slides to predict benefit from ADCs has the potential to improve outcomes, helping patients get the right therapy at the optimal time in their disease course," said Lee Schwartzberg, medical oncologist and Scientific Advisory Board member, 4D Path.

The collaboration is expected to also generate functional mechanistic insights into tumor-specific patterns of response and resistance—helping illuminate how biological context may interact with ADC designs. By transforming routine pathology images into actionable, physics-informed collective tumor state variables, the agreement aims to enrich translational understanding while supporting more personalized and effective treatment strategies.

"The deep precision medicine focus of this collaboration in digital pathology brings in 4D Path’s QPOR platform-derived pan-cancer insights identifying patients likely to respond to treatment, by one-shot computation of cell cycle and tumor microenvironment dynamics from routine tissue images. Additionally, this will potentially shed light on tumor specific biological understanding of response and resistance, enriching knowledge of the relative impact of targets, linkers, and payloads on outcomes and accelerating precision ADC treatments," said Satabhisa Mukhopadhyay, Ph.D., co-founder and chief scientific officer at 4D Path.

This collaboration underscores the industry-wide shift toward AI-driven, image-based biomarkers that can be deployed at scale using standard-of-care specimens—supporting faster, more confident treatment decisions and improving the probability of success in clinical development.

(Press release, Daiichi Sankyo, APR 14, 2026, https://www.businesswire.com/news/home/20260408304934/en/4D-Path-Announces-Collaboration-with-Daiichi-Sankyo-to-Advance-AI-Driven-Predictive-Biomarkers-for-an-Antibody-Drug-Conjugate-Program [SID1234664383])

Novigenix AI to Present Clinical Data at AACR 2026 Linking Immuno-Pharmacodynamics to Radioligand Therapy Response

On April 14, 2026 Novigenix AI, a leader in AI-driven healthcare solutions, reported the presentation of new data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting demonstrating, for the first time in a human clinical setting, the dynamic role of the immune system in response to radioligand therapy in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NET).1

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

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

                  Schedule Your 30 min Free Demo!

The study, conducted in collaboration with RadioMedix, Inc., a clinical-stage biotechnology company, examined the immune response of GEP-NET patients treated with the targeted alpha-emitter 212Pb-DOTAMTATE (AlphaMedix) or beta-emitter 177Lu-DOTATATE (Lutathera) peptide receptor radionuclide therapies (PRRTs). Researchers used the Novigenix AI LITOSeek platform, an AI-enabled liquid biopsy platform designed for longitudinal whole-blood immuno-transcriptomic profiling, to uncover systemic immune responses connected to the treatment.

The study showed that the alpha- and beta- PRRTs induce strong and distinct immune activation patterns in patients achieving clinical response. Two distinct waves of immuno-transcriptomic modulation were identified, likely reflecting kinetics heterogeneity of immune activation between early and late responders, highlighting heterogeneous yet coordinated immune dynamics across patients.

"Preclinical research has consistently pointed to the immune system as a critical mediator of radiotherapy efficacy, but until now, this has been difficult to demonstrate dynamically in patients," said Dr. Pedro Romero, Chief Medical and Scientific Officer, Novigenix AI. "With LITOSeek, we are able to capture these systemic immune responses along the patient journey, providing the first clinical evidence of Immuno-Pharmacodynamics in radioligand therapy and opening new avenues for biomarker-driven patient management."

"This collaboration highlights the power of combining innovative radiopharmaceuticals with advanced liquid biopsy immune monitoring technologies to interrogate treatment response," said Dr. Ebrahim Delpassand, Chief Executive Officer, RadioMedix, Inc. "The ability to observe how targeted radioligand therapies activate the immune system in patients’ response to treatment represents a major step forward for the field and supports the development of more effective, biology-driven treatment approaches."

These findings represent a significant advance in translation research, bridging preclinical insight into clinical reality and establishing Immuno-Pharmacodynamics (ImmunoPD) profiling as a critical dimension of radioligand therapy evaluation. "This work represents a pivotal milestone in translational oncology," said Dr. Brian Hashemi, CEO and Chairman, Novigenix AI. "By unveiling the Immuno-Pharmacodynamic response of patients to radioligand therapies, Novigenix AI is not only validating decades of preclinical research but also redefining how we assess and optimize these treatments in the clinic."

AACR Abstract and Poster Presentation Details

To learn more, view Abstract 3859 and attend the Poster Presentation given by Dr. Pedro Romero, Chief Medical and Scientific Officer at Novigenix AI, at AACR (Free AACR Whitepaper) 2026 on Monday, April 20, 2PM-5PM PST.

Poster #5953; Poster Section 45; Presentation Number 3859. "Dynamic systemic immune modulation in metastatic neuroendocrine tumor (NET) patients treated with targeted alpha-emitter 212 Pb-DOTAMTATE AlphaMedix."

(Press release, Novigenix, APR 14, 2026, View Source [SID1234664382])

CrossBridge Bio Enters an Agreement to be Acquired by Eli Lilly to Advance Next-Generation Dual-Payload Antibody-Drug Conjugates

On April 14, 2026 CrossBridge Bio, Inc., a pre-clinical biotechnology company pioneering the development of next-generation dual-payload antibody-drug conjugates (ADCs) reported a definitive agreement to be acquired by Eli Lilly and Company ("Lilly").

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

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

                  Schedule Your 30 min Free Demo!

CrossBridge Bio, a Houston-based biotechnology firm founded in 2023, is developing a new dual-payload ADC technology originally created by Kyoji Tsuchikama at the University of Texas Health Science Center at Houston (UTHealth Houston). The company is focused on advancing next-generation ADCs with the potential to transform clinical practice. Its lead candidate, CBB-120, is a TROP2-targeting TOP1i/ATRi dual-payload ADC for cancer treatment. It is designed to enhance the therapeutic index and generate more durable responses compared to current TROP2-targeting ADCs, while also addressing key resistance mechanisms. U.S. Food and Drug Administration Investigational New Drug application for CBB-120 is anticipated in 2026.

"We look forward to seeing how Lilly advances our new generation of dual-payload antibody-drug conjugates, including CBB-120, with the potential to meaningfully improve outcomes for patients with limited treatment options. At CrossBridge Bio, we believe our dual-payload ADC platform is uniquely positioned to be transformative in oncology. I’m proud of how well our team has executed and advanced our platform in such a short time since the company’s founding. By becoming a part of Lilly, a leader in patient-focused therapeutic development, we are well-positioned to further accelerate the clinical potential of this approach," said Dr. Michael Torres, Co-Founder and CEO.

Under the terms of the agreement, Lilly will acquire CrossBridge Bio, and CrossBridge Bio shareholders could receive up to $300 million in cash, inclusive of an upfront payment and a subsequent payment upon achieving a specified development milestone.

Cooley LLP is serving as legal counsel to CrossBridge Bio, and Zwick Advisory, LLC acts as a strategic advisor to the Company’s Board of Directors.

(Press release, CrossBridge Bio, APR 14, 2026, View Source [SID1234664381])