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.

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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])

Renaissance Pharma Limited, an Essential Pharma company, secures FDA Fast Track Designation and IND clearance for Daretabart (hu1418K322A) in high-risk neuroblastoma

On April 14, 2026 Renaissance Pharma Limited, an Essential Pharma company focused on development stage assets, reported that the US Food and Drug Administration (FDA) has granted Fast Track Designation for Daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody in development for the treatment of high-risk neuroblastoma (HRNB), a rare paediatric cancer. The designation recognises the significant unmet medical need in HRNB and will support more frequent interactions with the FDA throughout development, as well as eligibility for accelerated and rolling review.

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The company also confirms it has received IND clearance from the FDA, enabling initiation of the SHINE Phase II/III clinical trial in relapse or refractory children with HRNB in the United States. The first commercial-scale Good Manufacturing Practice (GMP) batch of Daretabart (hu1418K322A) has also been successfully manufactured for use in the SHINE trial.

Daretabart (hu1418K322A) is being developed by Renaissance Pharma under an exclusive license agreement with St. Jude Children’s Research Hospital, a global leader in pediatric cancer research and treatment. The antibody targets GD2, a cell surface antigen highly expressed on neuroblastoma cells. By binding to GD2, Daretabart (hu1418K322A) is designed to enhance immune-mediated tumour cell killing, while incorporating novel structural modifications intended to improve tolerability profile.

The programme builds on encouraging Phase II data evaluating Daretabart (hu1418K322A) as part of first-line therapy and in the post-consolidation setting for patients with HRNB. The study demonstrated a three-year event-free survival (EFS) rate of 73.7% and an overall survival (OS) rate of 86.0%. These results were published in the Journal of Clinical Oncology in December 2021.

The successful manufacture of the first commercial-scale GMP batch marks a key operational milestone and underscores Renaissance Pharma’s commitment to ensuring reliable, high-quality supply as the programme advances. This achievement supports ongoing clinical development and represents an important step towards future commercial readiness.

Simon Ball, Interim CEO of Essential Pharma and Director of Renaissance Pharma Limited said: "Daretabart has the potential to make a real difference for children with high-risk neuroblastoma, a disease where outcomes remain deeply inadequate despite intensive treatment. FDA Fast Track Designation is an important external validation of that potential, and together with IND clearance and our ability to manufacture at commercial scale, reflects the strength and maturity of this programme. Having worked exceptionally hard behind the scenes for a number of months, it is with great excitement that we announce this update today. We are executing at pace, and look forward to sharing data from the SHINE trial as it progresses. Today’s news brings us another step closer to delivering Daretabart as a meaningful new treatment option for children facing this aggressive cancer."

(Press release, Essential Pharma, APR 14, 2026, View Source [SID1234664353])

(Press release, Essential Pharma, APR 14, 2026, View Source [SID1234664353])

PanGIA Biotech Non-Invasive Cancer Detection Abstracts Accepted for Presentation at AACR Annual Meeting 2026

On April 14, 2026 PanGIA Biotech, Inc. ("PanGIA Biotech" or "Company") reported that two research abstracts have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2026, taking place April 17–22 in San Diego, California. Both abstracts highlight ongoing development of the Company’s PanGIA Analysis System ("PAS"), a machine learning platform designed to support non-invasive cancer detection through advanced biomarker analysis.

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Reflecting the Company’s continuing research into expanding the capabilities of the PAS across early detection applications, the accepted abstracts include:

"Our mission is to enable earlier detection to help facilitate better patient outcomes, reducing patient mortality. The acceptance of these abstracts is a step in that direction," said Holly Magliochetti, CEO and Co-Founder of PanGIA Biotech. "Opportunities like presenting at AACR (Free AACR Whitepaper) allow us to contribute to the broader conversation shaping the future of cancer diagnostics."

As one of the world’s leading scientific forums for cancer research, the AACR (Free AACR Whitepaper) Annual Meeting brings together clinicians, researchers, and industry leaders to share advances in oncology and translational medicine.

The Company’s research builds on ongoing work to expand the analytical capabilities of the PAS platform and support multi-cancer early detection approaches.

"Presenting this work at AACR (Free AACR Whitepaper) provides an opportunity to share how PanGIA Biotech’s research and development applies machine learning to complex biomolecular signals in non-invasive samples," said Obdulio Piloto, PhD, co-founder and Chief Scientific Officer of PanGIA Biotech and co-author of the studies. "Our research continues to explore how these analytical approaches may support earlier and more scalable cancer detection."

(Press release, PanGIA Biotech, APR 14, 2026, View Source [SID1234664370])

Clinical Data Supporting Targeted Chemotherapeutic Delivery via RenovoRx’s TAMP™ Therapy Platform Presented at 2026 SIR Annual Scientific Meeting

On April 14, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that a clinical data abstract submitted by experts from Moffitt Cancer Center was presented at the 2026 Society of Interventional Radiology (SIR) Annual Scientific Meeting in Toronto, Canada.

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The abstract, entitled "What PET/CT Reveals After Transarterial Microperfusion for Pancreatic Cancer," was presented on April 13, 2026 by a multidisciplinary team of experts, including Dr. Mustafa Al-Roubaie, an Interventional Radiologist at Moffitt Cancer Center and member of RenovoRx’s Medical Advisory Board.

The abstract examined the effectiveness of local, targeted intra-arterial chemotherapy administration using RenovoRx’s patented TAMP (Trans-Arterial Micro-Perfusion) therapy platform. By delivering chemotherapy directly near the tumor site, TAMP helps to overcome the poor vascularity typical of solid tumors like locally advanced pancreatic cancer (LAPC), where intravenous chemotherapy is often less effective. Additionally, the abstract assessed the potential application of metabolic imaging, FDG (fluorodeoxyglucose) PET/CT, in evaluating therapeutic outcomes following targeted intra-arterial drug-delivery via TAMP in patients with refractory disease.

The study concluded that TAMP is a promising approach for localized delivery of chemotherapeutic agents for the treatment of solid tumors such as LAPC, offering the potential for enhanced therapeutic drug-delivery with reduced systemic toxicity. Metabolic imaging further demonstrated dramatic reductions in FDG avidity, suggesting treatment response even when tumor size changed minimally. Eight cycles of intra-arterial chemotherapy were administered over 2 months, using the TAMP therapy platform, which is enabled by the Company’s RenovoCath device. Post-treatment imaging results indicated that PET/CT may detect early treatment response before anatomical changes occur.

"Patients diagnosed with LAPC face a challenging prognosis, due in part to a dense, hypovascular stroma that can restrict the effectiveness of traditional systemic (namely intravenous) chemotherapy," said Dr. Al-Roubaie. "Systemic chemotherapeutic administration is often associated with considerable toxicity and suboptimal tumor penetration. The TAMP therapy platform aims to increase local drug concentration directly near the tumor site while reducing systemic exposure."

Dr. Al-Roubaie continued, "These findings support RenovoRx’s TAMP therapy platform and its ability for local intra-arterial chemotherapeutic delivery directly near the tumor site and the potential for reduced toxicity for patients. These findings may complement RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial evaluating the company’s lead drug-device product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) for the treatment of LAPC."

About RenovoCath
Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

(Press release, Renovorx, APR 14, 2026, View Source [SID1234664386])

Obsidian Therapeutics and Galera Therapeutics Announce Merger Agreement and $350 Million Concurrent Private Placement

On April 14, 2026 Galera Therapeutics, Inc. ("Galera") (OTC: GRTX), a clinical-stage biopharmaceutical company focused on advancing a pan-NOS inhibitor through clinical development for patients with the hardest-to-treat forms of advanced breast cancer, and Obsidian Therapeutics, Inc. ("Obsidian"), a privately-held clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor infiltrating lymphocyte, ("TIL"), cell therapies, reported that they have entered into a definitive merger agreement to combine in an all-stock transaction. The combination will be accomplished by both companies becoming wholly owned subsidiaries of a newly formed company. Upon completion of the transaction, the combined company plans to operate under the name Obsidian Therapeutics, Inc. and will apply to trade on Nasdaq under the ticker symbol "OBX."

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In support of the transaction, Galera and Obsidian have secured commitments for an oversubscribed private placement financing that is expected to result in total gross proceeds of $350 million from a syndicate of new investors, including Balyasny Asset Management, Caligan Partners LP, Eventide Asset Management, Nantahala Capital, Octagon Capital, Redmile, Spruce Street Capital and Trails Edge Capital Partners, and with participation from current Obsidian investors, including Atlas Venture, Deep Track Capital, Foresite Capital, Janus Henderson Investors, Logos Capital, Novo Holdings A/S, Paradigm BioCapital Advisors, Pivotal bioVenture Partners, RA Capital Management, RTW Investments, TCGX and Wellington Management, among other leading investment management firms.

The private placement financing is expected to close immediately prior to completion of the proposed merger transaction. The combined company’s cash and cash equivalents balance at closing, including the funds from the private placement financing, is anticipated to fund the combined company’s operations

into the second half of 2028 and provides runway through key clinical milestones for Obsidian’s lead product candidate, OBX-115. These include Phase 1 data from the ongoing NSCLC trial expected in the first half of 2027, and by year-end 2027, topline data from their melanoma registration-enabling trial. The combined company will also continue to support Galera’s pipeline.

"At Obsidian, we are striving to deliver a best-in-class TIL cell therapy developed using our proprietary protein-regulation technology," said Madan Jagasia, M.D., Chief Executive Officer of Obsidian. "We believe OBX-115 offers an opportunity to provide patients with an improved TIL product and patient experience. This transaction and the support from leading life sciences investors will allow us to advance our development plans for OBX-115 in melanoma and NSCLC."

Obsidian leverages their cytoDRIVE platform to develop engineered TIL cell therapies. OBX-115 is currently in a Phase 2 clinical trial for the treatment of advanced melanoma and a Phase 1 clinical trial for the treatment of NSCLC. OBX-115 is designed with regulatable membrane-bound IL15 (mbIL15), which drives TIL persistence, eliminates the need to dose toxic interleukin-2 (IL2), and enables outpatient administration of low-dose lymphodepletion. Furthermore, OBX-115 can be manufactured using tumor tissue procurement from an outpatient, minimally invasive core needle biopsy. OBX-115 has been granted Fast Track and Regenerative Medicine Advanced Therapy designations from the U.S. Food and Drug Administration for the treatment of patients with unresectable or metastatic melanoma that is resistant to immune checkpoint inhibitor therapy.

"We believe this transaction with Obsidian is the best path forward for Galera and look forward to the combined company’s success," said J. Mel Sorensen, M.D., Chief Executive Officer of Galera. "Obsidian’s pipeline of novel engineered TIL cell therapies and its promising lead product candidate, OBX-115, offer near-term, value creating milestones for Galera stockholders. In addition, Galera stockholders will retain a contingent value right for 95% of all future milestones for up to 10 years arising out of its October 2025 Asset Purchase Agreement with Biossil.ai for its dismutase mimetics."

About the Proposed Transaction

Under the terms of the merger agreement, as of the closing of the proposed transaction, the pre-closing Galera stockholders (other than those investors participating in the private placement financing) are expected to own approximately 1.8% of the combined company, the pre-closing Obsidian stockholders are expected to own approximately 53.2% of the combined company, and investors in the private placement financing are expected to own approximately 45.0% of the combined company. The percentage of the combined company that Galera’s stockholders will own as of the closing of the proposed transaction is subject to adjustment based on the estimated amount of Galera’s net cash immediately prior to the closing date.

The pre-closing Galera stockholders (other than those investors participating in the private placement financing) are expected to receive one contingent value right for each outstanding share of Galera common stock held by such stockholder, representing the right to receive contingent payments upon the occurrence of certain events (including receipt of milestone proceeds under the Biossil.ai agreement).

The transaction has received approval by the Board of Directors of both companies and is expected to close by the third quarter of 2026, subject to certain closing conditions, including, among others, approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the U.S. Securities and Exchange Commission (the "SEC") to register the securities to be issued in connection with the proposed acquisitions of Obsidian and Galera and the satisfaction of other customary closing conditions.

The combined company plans to operate under the name Obsidian Therapeutics, Inc. and will be led by Madan Jagasia, M.D., Obsidian’s current Chief Executive Officer. Obsidian’s Board of Directors will become directors of the combined company, chaired by Maria Fardis, Ph.D., M.B.A., Chief Executive Officer of Lassen Therapeutics and AirNexis Therapeutics.

Leerink Partners is serving as exclusive financial advisor and Goodwin Procter LLP is serving as legal counsel to Obsidian. Leerink Partners, TD Cowen, Piper Sandler, William Blair and LifeSci Capital are acting as placement agents in connection with the concurrent private placement financing. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to the placement agents. Sidley Austin LLP is serving as legal counsel to Galera. Lucid Capital Markets is providing a fairness opinion to Galera’s Board of Directors.

(Press release, Galera Therapeutics, APR 14, 2026, View Source [SID1234664354])