Calidi Biotherapeutics Presents New Data on CLD-501, Its In Situ T-Cell Engager Candidate Targeting TROP-2 at the T-Cell Engager Therapeutic Summit

On June 24, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported data at the T-cell Engager Therapeutic Summit in San Diego, California. The Company presented data on its approach of simultaneously activating T-cells while inducing the expression of T-cell engagers specifically in situ in the tumor microenvironment ("TME"). The poster is available here.

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"The data presented at today’s summit shows the advances we have made with the RedTail platform and our progress in addressing a central challenge in immuno-oncology: how to deliver tumor-specific T-cell engagers effectively in solid tumors" said Calidi Chief Executive Officer Eric Poma, PhD. "The data highlights the ability of the RedTail platform to functionally overexpress complex biologics including cytokines and T-cell engagers, and profoundly alter the tumor microenvironment to allow for T-cell-mediated tumor cell destruction."

RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the TME, and enable high-level expression of therapeutic genetic payloads directly at the tumor site while limiting peripheral exposure. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 superagonist ("IL-15 SA"), a known CD8⁺ T-cell, NK cell, and gamma delta (γδ) T-cell activator, in the TME. The Company expects to file an IND for CLD-401 by the end of 2026.

Data presented at the T-Cell Therapeutic Engager meeting showcased RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. T-cell engagers have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits immune cell infiltration and T-cell activity. By remodeling the TME and driving T-cell activation in concert with expression of a T-cell engager, RedTail is designed to overcome these historical limitations.

The Company is developing CLD-501, a lead candidate targeting TROP2, a cell-surface glycoprotein. TROP2 expression in normal tissue and the high potential for off-tumor / on-target toxicity has made it a difficult target for T-cell engagers. The RedTail approach confines expression of the T-cell engager to the TME, limiting off-tumor interactions. The Company is pursuing additional T-cell engager targets like EGFR, EpCAM, and Nectin-4.

Calidi Biotherapeutics continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, JUN 24, 2026, View Source [SID1234668947])

Passage Bio and Remix Therapeutics Announce Merger Agreement

On June 24, 2026 Passage Bio, Inc. (Nasdaq: PASG) ("Passage Bio") and Remix Therapeutics, Inc. ("Remix"), a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address the underlying drivers of disease, reported that they have entered into a definitive merger agreement to combine in an all-stock transaction. Upon completion of the transaction, the combined company plans to operate under the name Remix Therapeutics, Inc. and expects to trade on Nasdaq under the ticker symbol "RMTX."

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In connection with the proposed merger, Remix has secured commitments for a concurrent oversubscribed private placement financing that is expected to result in total gross proceeds of approximately $100 million from a syndicate of new investors led by Decheng Capital, with participation from Lynx1 Capital Management, Forge Life Science Partners, existing investors and other leading investment management firms.

The private placement financing is expected to close immediately prior to completion of the proposed merger. The combined company’s cash and cash equivalents balance at closing, including the proceeds from the private placement, is anticipated to fund the combined company’s operations into 2028 and provide runway through key clinical milestones, including data from the registrational Phase 2 trial of REM-422 in Adenoid Cystic Carcinoma (ACC); data from the Phase 1 trial in Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) and progression of Remix’s discovery pipeline.

"This transaction marks a transformative step for Remix as we advance our mission to reprogram RNA processing and unlock a new class of medicines with the strength of our seasoned team and support from leading biotechnology investors," said Peter Smith, Ph.D., Co-Founder and CEO of Remix. "We are exceptionally well-positioned to accelerate a pipeline of RNA-targeted small-molecule therapies led by REM-422, an orally available mRNA degrader targeting MYB, a historically undruggable transcription factor implicated across multiple cancers. With this strengthened foundation and compelling REM-422 data in hand, we are focused on rapidly translating our breakthrough science into differentiated therapies for patients who urgently need better options."

"Following a thorough evaluation of strategic alternatives, we are thrilled to have identified Remix as the ideal partner for this transaction. Remix has built a truly differentiated platform in RNA processing modulation, and REM-422’s impactful Phase 1 data in ACC and strong execution of their ongoing registrational study in this underserved disease reflect the quality of their science and team. We believe this combination delivers compelling value for Passage Bio stockholders, providing meaningful participation in a clinical-stage company with a well-defined path to pivotal data. We look forward to supporting the combined company as it advances these important medicines for patients," said Will Chou, M.D., President and CEO of Passage Bio.

About the Proposed Transaction
Under the terms of the merger agreement, as of the closing of the proposed merger, the pre-merger Passage Bio shareholders are expected to own approximately 7% of the combined company and the pre-merger Remix stockholders (inclusive of those investors participating in the financing) are expected to own approximately 93% of the combined company. The percentage of the combined company that Passage Bio shareholders will own as of the closing of the proposed merger is subject to adjustment based on the estimated amount of Passage Bio’s net cash immediately prior to the closing date. In connection with the proposed merger, a contingent value right ("CVR") will be distributed to Passage shareholders of record at the closing date. Each CVR will entitle its holder to receive a pro rata portion of certain net proceeds actually received by the combined company from milestones associated with Passage Bio’s out-licensed pediatric gene therapy pipeline assets, subject to the terms and conditions of a CVR agreement to be entered into at closing. The CVRs will not be transferable (except in limited circumstances), will not be listed on any securities exchange, and will not bear interest. There can be no assurance that any proceeds will be realized or that CVR holders will receive any payment.

The transaction has been unanimously approved by the Board of Directors of both companies and is expected to close in the fourth quarter of 2026, subject to the satisfaction of customary 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 merger and the satisfaction of other customary closing conditions.

The combined company plans to operate under the name Remix Therapeutics, Inc. and will be led by Dr. Smith. Remix’s Board of Directors will become directors of the combined company, chaired by Matthew Patterson. In conjunction with the transaction, Peter Colabuono of Decheng Capital will join the Board of Directors.

Latham & Watkins LLP is serving as legal counsel to Remix. Goldman Sachs & Co. LLC, Jefferies and Evercore ISI are acting as the placement agents in connection with the concurrent private placement financing. RBC Capital Markets and Canaccord Genuity are acting as Capital Markets Advisors. Cooley LLP is serving as legal counsel to the placement agents. Fenwick & West LLP is serving as legal counsel to Passage Bio. Wedbush Securities Inc. is serving as exclusive financial advisor for the transaction.

Conference Call and Webcast Information
The companies will host a conference call and webcast on June 24, 2026 at 4:30 P.M. ET. Participants are invited to listen here or by visiting the Investors & Media section of Passage Bio’s website at investors.passagebio.com.

About REM-422
REM-422 is a potent, selective, and oral small molecule mRNA degrader that induces the reduction of MYB mRNA and subsequent protein expression. REM-422 functions by facilitating the incorporation of a poison exon in the MYB mRNA transcript, leading to nonsense-mediated decay of the transcript. REM-422 is currently in Phase 1/2 clinical studies in both Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The U.S. Food and Drug Administration granted REM-422 Orphan Drug Designation for ACC and AML and Fast Track designation for ACC.

(Press release, Remix Therapeutics, JUN 24, 2026, View Source [SID1234668946])

HUTCHMED Highlights Pivotal Phase II Data for Fanregratinib in Intrahepatic Cholangiocarcinoma Presented at ESMO Gastrointestinal Cancers Congress 2026

On June 24, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported results from the pivotal Phase II registration study of fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma ("ICC") will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress taking place from July 1 to 4, 2026 in Munich, Germany.

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Supported by data from the study, a New Drug Application (NDA) for fanregratinib for the treatment of adult patients with advanced, metastatic or unresectable ICC with fibroblast growth factor receptor ("FGFR") 2 fusion/rearrangement who have previously received systemic therapy has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA) in December 2025.

"The clinical reality for this patient population with advanced FGFR2–fusion/rearrangement ICC is highly challenging, as the entire cohort had progressed on prior chemotherapy, and a significant majority had prior immunotherapy exposure," said Professor Jianming Xu of the Chinese PLA General Hospital and leading Principal Investigator of the study. "The results from this registration-enabling trial represent an important milestone in the targeted treatment landscape for FGFR2-altered ICC. The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option. We are encouraged by these findings and hope to see this innovation translate into clinical practice to address a critical need in gastrointestinal oncology."

This pivotal study is a single-arm, multi-center, open-label, Phase II registration clinical trial conducted across 53 sites in China to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced ICC patients with FGFR2 fusion/rearrangement (NCT04353375). All patients had received at least one line of systemic therapy, of which all had received chemotherapy and 72% had received immunotherapy. The study has met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%). Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).

Fanregratinib exhibited a manageable safety profile consistent with the known mechanism of selective FGFR inhibitors. Drug-related adverse events of Grade 3 or greater were reported in 48.3% of patients, with the most common being elevations in liver enzymes and palmar-plantar erythrodysesthesia syndrome (PPES). Treatment discontinuation due to drug-related adverse events was limited to 2.2% of patients, and no treatment-related deaths were recorded.

Details of the presentation are as follows:

Title: Fanregratinib in fibroblast growth factor receptor 2 (FGFR2)- fusions/​rearrangements intrahepatic cholangiocarcinoma (ICC): Pivotal part of a phase II trial
Lead Author: Jianming Xu, Chinese PLA General Hospital, Beijing, China
Session: Rapid oral session on innovation
Presentation Number: 343RO
Date & Time: Saturday, July 4, 2026, 9:00 am CEST
Location: Room 13a

About Fanregratinib

Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, JUN 24, 2026, View Source [SID1234668945])

HUTCHMED Highlights Pivotal Phase II Data for Fanregratinib in Intrahepatic Cholangiocarcinoma Presented at ESMO Gastrointestinal Cancers Congress 2026

On June 24, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported results from the pivotal Phase II registration study of fanregratinib (HMPL-453) in patients with intrahepatic cholangiocarcinoma ("ICC") will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress taking place from July 1 to 4, 2026 in Munich, Germany.

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Supported by data from the study, a New Drug Application (NDA) for fanregratinib for the treatment of adult patients with advanced, metastatic or unresectable ICC with fibroblast growth factor receptor ("FGFR") 2 fusion/rearrangement who have previously received systemic therapy has been accepted for review and granted priority review by the China National Medical Products Administration (NMPA) in December 2025.

"The clinical reality for this patient population with advanced FGFR2–fusion/rearrangement ICC is highly challenging, as the entire cohort had progressed on prior chemotherapy, and a significant majority had prior immunotherapy exposure," said Professor Jianming Xu of the Chinese PLA General Hospital and leading Principal Investigator of the study. "The results from this registration-enabling trial represent an important milestone in the targeted treatment landscape for FGFR2-altered ICC. The objective response rate and survival metrics achieved by fanregratinib clearly support its therapeutic value as a potent, selective oral treatment option. We are encouraged by these findings and hope to see this innovation translate into clinical practice to address a critical need in gastrointestinal oncology."

This pivotal study is a single-arm, multi-center, open-label, Phase II registration clinical trial conducted across 53 sites in China to evaluate the efficacy, safety and pharmacokinetic of fanregratinib in treating advanced ICC patients with FGFR2 fusion/rearrangement (NCT04353375). All patients had received at least one line of systemic therapy, of which all had received chemotherapy and 72% had received immunotherapy. The study has met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%). Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).

Fanregratinib exhibited a manageable safety profile consistent with the known mechanism of selective FGFR inhibitors. Drug-related adverse events of Grade 3 or greater were reported in 48.3% of patients, with the most common being elevations in liver enzymes and palmar-plantar erythrodysesthesia syndrome (PPES). Treatment discontinuation due to drug-related adverse events was limited to 2.2% of patients, and no treatment-related deaths were recorded.

Details of the presentation are as follows:

Title: Fanregratinib in fibroblast growth factor receptor 2 (FGFR2)- fusions/​rearrangements intrahepatic cholangiocarcinoma (ICC): Pivotal part of a phase II trial
Lead Author: Jianming Xu, Chinese PLA General Hospital, Beijing, China
Session: Rapid oral session on innovation
Presentation Number: 343RO
Date & Time: Saturday, July 4, 2026, 9:00 am CEST
Location: Room 13a

About Fanregratinib

Fanregratinib (HMPL-453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, JUN 24, 2026, View Source [SID1234668945])

Revolution Medicines to Present Clinical Data from RAS(ON) Inhibitor Combination Trials in Pancreatic Cancer at ESMO Gastrointestinal Cancers Congress 2026

On June 24, 2026 Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that four oral and poster presentations highlighting data from its RAS(ON) pipeline will be featured at the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress, taking place July 1–4, 2026 in Munich, Germany.

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The program will include two oral presentations from Phase 1/2 trials evaluating zoldonrasib, an oral RAS(ON) G12D-selective covalent inhibitor, in combination regimens for patients with metastatic RAS G12D pancreatic ductal adenocarcinoma (PDAC). These presentations will report results from zoldonrasib plus chemotherapy in the first line setting, and zoldonrasib plus daraxonrasib, the company’s oral RAS(ON) multi-selective inhibitor, in patients who had received one or more prior lines of therapy.

Additional presentations will include two Phase 3 trials-in-progress posters for RASolute 303, evaluating daraxonrasib as a monotherapy or in combination with gemcitabine and nab-paclitaxel versus standard of care gemcitabine and nab-paclitaxel as a first line treatment for patients with metastatic PDAC, and RASolute 304, evaluating adjuvant daraxonrasib in patients with PDAC who have undergone resection and completed perioperative chemotherapy.

Details of Revolution Medicines’ presentations are listed below.

Revolution Medicines Oral Presentations:

Title: Safety and Efficacy of Zoldonrasib (RMC-9805) Plus Chemotherapy in Patients (pts) with 1L RAS G12D Metastatic Pancreatic Adenocarcinoma (mPDAC)
Abstract: #340O
Presenter: Brian Wolpin, M.D., Dana-Farber Cancer Institute
Session: Proffered Paper Session
Date/Time: July 2; 2:40 p.m. – 2:50 p.m. CEST

Title: Safety and Efficacy of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) in Patients with 2L+ KRAS G12D Metastatic Pancreatic Adenocarcinoma (mPDAC)
Abstract: #341O
Presenter: Nilofer Azad, M.D., Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Session: Proffered Paper Session
Date/Time: July 2; 2:50 p.m. – 3:00 p.m. CEST

Revolution Medicines Posters:

Title: RASolute 303: A Phase 3 Global, Multicenter, Open-Label, Randomized 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma
Abstract: #471TiP
Presenter: Thomas Seufferlein, M.D., Ph.D., University Hospital Ulm
Session: Upper Digestive – Biliary, ampullary and pancreatic cancer
Date/Time: July 3; 3:30 p.m. – 4:30 p.m. CEST

Title: RASolute 304 – A Phase 3 Multicenter, Open-label, Randomized Study of Adjuvant Daraxonrasib Versus Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Adenocarcinoma (PDAC)
Abstract: #472TiP
Presenter: Michel Ducreux, M.D., Ph.D., Institut Gustave Roussy
Session: Upper Digestive – Biliary, ampullary and pancreatic cancer
Date/Time: July 3; 3:30 p.m. – 4:30 p.m. CEST

(Press release, Revolution Medicines, JUN 24, 2026, View Source [SID1234668944])