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Elevar Therapeutics Submits New Drug Application to FDA for Lirafugratinib as Second-Line Treatment Option for Cholangiocarcinoma

On January 28, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug lirafugratinib as a second-line treatment option for cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement.

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CCA, also known as bile duct cancer, is rare, with about 8,000 people in the U.S. diagnosed each year, according to the American Cancer Society.

"This NDA reaffirms Elevar’s mission of bringing life-changing medicines to cancer patients worldwide, including for rare indications and for advanced stages where treatment options are limited," said Dong-Gun Kim, the company’s chief executive officer. "We are excited to work with the FDA as it reviews the submission while simultaneously preparing for a potential commercial launch. We could not be more appreciative of the patients who participated in lirafugratinib-focused clinical trials and everyone who brought us to this crucial point in its development."

The NDA is supported by positive clinical data from the phase 1/2 ReFocus trial (NCT04526106), in which lirafugratinib demonstrated clinically meaningful anti-tumor activity, measured by objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS), as well as manageable and tolerable safety in patients with advanced/metastatic CCA and other solid tumors with fibroblast growth factor receptor 2 (FGFR2) alterations.

The abstract "Efficacy and safety of lirafugratinib in FGFRi-naïve cholangiocarcinoma (CCA) patients harboring FGFR2 fusions/rearrangements (FGFR2 f/r)" was presented earlier this month at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Gastrointestinal Cancers Symposium.

Independent review committee-assessed ORR was 46.5%, and median DOR was 11.8 months (mos) (95% CI, 7.5-13.0), where 76.2% of responses lasted >6 mos. Median PFS was 11.3 mos (95% CI, 9.2, 14.8), with 12-month rate of 49.2%. Median OS was 22.8 mos (95% CI, 18.1-27.2), with 12-month rate of 74.6%. The disease control rate was 96.5%. Most common Grade ≥3 treatment-related adverse events (TRAEs) were palmar-plantar erythrodysesthesia (32.8%) and stomatitis (12.1%). TRAEs led to dose reduction, dose interruption, and treatment discontinuation were observed in 75.9%, 82.8%, and 4.3%, respectively.

Elevar is also developing lirafugratinib for patients with other FGFR2-altered other solid tumors. The company acquired worldwide rights to develop and commercialize lirafugratinib in December 2024. Earlier that year, Relay Therapeutics met with the FDA to discuss data from the ReFocus trial and potential regulatory pathways. The FDA recommended the company first file an NDA for FGFR2-driven CCA, followed by a supplemental NDA for FGFR2-altered other solid tumors.

For more information about lirafugratinib, visit ElevarTX.com.

About Lirafugratinib Lirafugratinib (RLY-4008) is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Preclinically, lirafugratinib demonstrated FGFR2-dependent killing in cancer cell lines and induced regression in in vivo models with minimal inhibition of other targets, including other members of the FGFR family. In addition, lirafugratinib demonstrated strong activity against known clinical on-target resistance mutations in vitro and in vivo preclinical models. Lirafugratinib is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 f/r, who have not treated with prior FGFR inhibitors.

(Press release, Elevar Therapeutics, JAN 28, 2026, View Source [SID1234662322])

Defence Therapeutics Expands Collaboration With Canadian Nuclear Laboratories To Accelerate Its Proprietary Radiopharmaceutical Pipeline

On January 28, 2026 Defence Therapeutics Inc. ("Defence" or the "Company"), a publicly traded biotechnology and precision intracellular drug-delivery company, reported the strengthening of its long-standing collaboration with Canadian Nuclear Laboratories ("CNL") as part of its strategic effort to accelerate and expand its proprietary radiopharmaceutical program.

Defence has been collaborating with CNL on the development of an Accum-enhanced radio-immunoconjugate program. This program is now approaching a key inflection point, with critical results being generated by both lab teams on this program that are intended to support candidate selection and enable preparation for first-in-human clinical studies.

Based on the exciting traction on the lead program, Defence and CNL are expanding their collaboration to initiate multiple other radioisotopes programs with Defence’s proprietary Accum, positioning the Company to rapidly expand its radiopharmaceutical portfolio as new data and strategic priorities emerge.

Radiopharmaceutical therapies require precise intracellular and nuclear localization to maximize efficacy, as radioactive payloads must reach the vicinity of the cell nucleus to induce lethal DNA damage. Defence’s proprietary Accum platform enables active intracellular and nuclear transport, unlocking the full therapeutic potential of targeted radiotherapies while increasing potency and reducing toxicity.

"This collaboration with CNL has become a cornerstone of our radiopharmaceutical strategy," said Sébastien Plouffe, CEO of Defence Therapeutics. "Radiopharmaceuticals now represent one of our top development priorities alongside our ADC program. By deepening our work with CNL and leveraging their world-class nuclear science expertise, we are building a strong, proprietary pipeline in this space and accelerating our path toward the clinic."

"We have worked in close collaboration with Defence on their flagship program, delivering the technical results they require, and we are proud to contribute meaningfully to the advancement of their radiopharmaceutical pipeline," said Dr. Monica Regalbuto, Vice-President, Science & Technology at CNL. "We look forward to contributing our nuclear science expertise to help advance these programs toward the clinic."

This collaboration further strengthens Defence’s position in precision intracellular drug delivery and radiopharmaceutical development, supporting its strategy to transform advanced biologics into safer, more effective first-line cancer therapies.

(Press release, Defence Therapeutics, JAN 28, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-expands-collaboration-with-canadian-nuclear-laboratories-to-accelerate-its-proprietary-radiopharmaceutical-pipeline [SID1234662321])

Calidi Biotherapeutics Provides Corporate Update and Key Value Drivers for 2026

On January 28, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported 2025 successes and provided an update on the Company’s upcoming 2026 milestones.

"I am incredibly proud of the Calidi team for their successful execution of our 2025 priorities," said Eric Poma, PhD, Chief Executive Officer of Calidi. "We demonstrated that in clinically relevant immunocompetent murine models and ex vivo human immune assays, our RedTail platform has been engineered to prevent immune clearance after systemic administration and to only replicate in tumor cells with high specificity. Our data also demonstrate that the platform can effectively express genetic medicines at the tumor site at levels comparable to those achieved with localized dosing while avoiding systemic exposure. This reflects a scalable therapeutic approach that overcomes the limitations of tumor accessibility. I anticipate that we will complete our IND-enabling studies for CLD-401, the lead candidate from the RedTail platform, and submit an IND application by the end of this year."

2025 Accomplishments

First data presented on Calidi’s RedTail platform and selection of first lead candidate, CLD-401. CLD-401 is a tumor-tropic oncolytic virus designed to avoid immune clearance, home to metastatic sites after systemic administration, replicate only in tumors cells, induce an immune priming event at the tumor site, and express high levels of IL-15 superagonist, a potent cytokine that induces NK and T-cell responses to the tumor, in the tumor microenvironment (TME).
Presented new preclinical data surrounding CLD-401 at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) on May 30, 2025, in Chicago, IL., demonstrating enhanced biological efficacy in clinically relevant immunocompetent tumor models through the delivery of IL-15 superagonist to metastatic tumors sites after systemic administration. Calidi also demonstrated the engineered expression of CD55 on the enveloped virus, allowing the virus to avoid immune clearance and enabling systemic administration. The systemic administration of the CD55-expressing enveloped virus allows Calidi to target metastatic disease patients with high unmet need.
CLD-401 data presented at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) on November 7, 2025, in National Harbor, MD., demonstrating that in syngeneic murine models, the RedTail platform is protected from immune clearance after systemic administration and can find and specifically replicate in tumor cells at metastatic sites. The data also demonstrate that the platform can effectively express genetic medicines at the tumor site in concentrations that are similar to what is achievable with localized dosing while avoiding systemic exposure.
Bolstered management team with hiring of new Chief Executive Officer and Chief Medical Officer with deep biopharmaceutical experience
CEO transition to Eric Poma, PhD, bringing more than 25 years of experience in the biopharmaceutical industry, with a strong record of capital fundraising, big pharma collaboration agreements, and clinical program development.
Appointed Guy Travis Clifton, MD, as CMO. Dr. Clifton is a practicing surgical oncologist with over 17 years experience in drug development, early phase and transitional translational trials, and cancer immunotherapy.
Reconstituted Scientific Advisory Board with internationally esteemed advisors to support development of CLD-401 and advance the RedTail platform for the systemic delivery of targeted genetic medicine.
New members added in October 2025:

Mace L. Rothenberg, MD, FACP, former Chief Medical Officer of Pfizer, a physician executive with more than 30 years of experience in drug development, translational research, and risk benefit assessment; and
John Wrangle, MD, MPH, a thoracic oncologist and scientist and expert in translational immunotherapy with extensive experience around IL-15-based treatment in metastatic cancer.
Reduced debt and G&A expenses
Calidi reduced term debt and notes payable (including accrued interest) by $3.1 million in 2025, from $3.8 million at December 31, 2024 to $0.7 million at December 31, 2025 (unaudited).
Calidi reduced G&A expenses by $2.3 million in the first nine months of 2025 compared to the first nine months of 2024, as disclosed in the Company’s Form 10-Q filed with the SEC on November 13, 2025.
2026 Anticipated Milestones

Company intends to file an IND in Q4 2026 for its first RedTail lead candidate, CLD-401, a systemic delivered, targeted genetic medicine engineered to convert tumors into IL-15 superagonist producers.
Phase I study expected to be conducted in a basket of solid tumors, including non-small cell lung cancer, triple-negative breast cancer, and head and neck cancer.
Anticipate streamlined dose escalation study with limited number of doses to be tested.
Initial dose cohort is expected to be in the therapeutic range with the potential for proof-of-concept data early in phase I
Calidi expects to present proof of concept data demonstrating the versatility of RedTail platform to deliver tumor-localized Bi-specific T cell engager (BiTE) alongside T-cell amplifiers.
BiTEs have struggled to drive efficacy in solid tumors because of a lack of activated T-cells in the TME
The RedTail platform allows for the simultaneous delivery of high expression of multiple payloads into TME
BiTE delivery with T-cell amplifiers may overcome the previous limitations of BiTEs in solid tumors
Calidi expects to present proof of concept data for use of RedTail platform into non-oncology indications.
Calidi is exploring new payloads for inflammatory and immune disease
The Company anticipates targeting other cell types via envelope engineering (e.g. CD38, BCMA, etc.)
Calidi expects to leverage selective viral replication in proliferative cells (e.g. activated B cells)

(Press release, Calidi Biotherapeutics, JAN 28, 2026, View Source [SID1234662320])

Tempus Reveals Its AI-Driven IPS Test More Accurately Predicts Immunotherapy Benefit Compared to Conventional Biomarkers

On January 27, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported results from a new study demonstrating that its algorithmic test, Immune Profile Score (IPS), more accurately predicts outcomes for patients receiving immune checkpoint inhibitors (ICIs) than conventional biomarkers, including tumor mutational burden (TMB) and microsatellite instability (MSI), and PD-L1.

IPS is a multimodal biomarker that combines known and novel clinical and immune-related biomarkers from DNA and RNA analysis to predict a patient’s response to ICI-based therapy. The new clinical validation results demonstrate that IPS consistently outperforms conventional biomarkers, highlighting its potential to change the way physicians can identify patients most likely to benefit from immunotherapy. In four independent validation cohorts of pan-cancer metastatic solid organ cancer patients, IPS was shown to be a more accurate predictor of ICI outcomes (HR=0.45) than TMB, MSS, and PD-L1, demonstrating prognostic utility that is independent of those conventional biomarkers.

IPS identified 13% of patients with microsatellite stable colorectal cancer who demonstrated strong real-world overall survival with ICI treatment (HR=0.2), indicating that ICI immunotherapy may be a viable option for a key patient population that might have been overlooked with conventional biomarkers alone. Beyond colorectal cancer, the study’s findings highlight how IPS could expand treatment options for patients with rare cancers. IPS classified 17% of patients with rare metastatic solid tumors as "IPS-High," despite these patients not falling within a cancer-specific FDA-approved ICI label. The significant difference in median real-world overall survival in "IPS High" versus "IPS-Low" patients (HR=0.26) shows that ICI could be a relevant and potentially life-saving option for patients that might otherwise be missed.

"This study builds on previous findings showing that IPS scoring can identify patients who may have better overall survival with ICI therapy. These results are a significant step forward in the personalization of cancer care, particularly for patients that might be missed by conventional biomarkers," said Halla Nimeiri, MD, Chief Development Officer at Tempus. "By leveraging a multimodal algorithm, our IPS test provides a more accurate and comprehensive view than traditional, independent biomarkers, empowering physicians to make more confident treatment decisions for their patients while simultaneously moving the field forward in meaningful ways."

The test is available as an add-on for clinicians ordering Tempus’ xT (DNA) and xR (RNA) assays, helping to manage patients on immunotherapy by utilizing data already collected as part of a patient’s standard sequencing.

(Press release, Tempus, JAN 27, 2026, View Source [SID1234662308])

Anixa Biosciences Receives Notice of Allowance from Mexican Institute of Industrial Property (IMPI) for Patent Covering Breast Cancer Vaccine Technology

On January 27, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Mexican Institute of Industrial Property (IMPI) has issued a Notice of Allowance for a new patent related to its breast cancer vaccine technology. This patent, exclusively licensed from Cleveland Clinic, will provide composition of matter protection for the Company’s novel approach to breast cancer treatment and prevention in Mexico.

With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunotherapy. The Mexican patent complements patents issued in the United States and other key global jurisdictions, and represents an important step toward future regulatory and commercial efforts outside the U.S.

"This newly allowed patent continues the broad international recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue clinical development in the U.S., our growing international patent estate further strengthens our ability to pursue global opportunities and potentially partner with larger pharmaceutical companies for worldwide commercialization."

Breast cancer is typically diagnosed at later stages in Mexico than in the U.S., causing challenges for patients and their physicians. Further, Mexican women have a higher incidence rate of triple-negative breast cancer—the most lethal form of breast cancer.

Anixa’s vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company’s broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention.

(Press release, Anixa Biosciences, JAN 27, 2026, https://www.prnewswire.com/news-releases/anixa-biosciences-receives-notice-of-allowance-from-mexican-institute-of-industrial-property-impi-for-patent-covering-breast-cancer-vaccine-technology-302670617.html [SID1234662307])