aTyr Pharma Announces Research Collaboration with Montefiore Einstein

On October 19, 2026 aTyr Pharma, Inc. (Nasdaq: ATYR) ("aTyr" or the "Company"), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, reported a research collaboration with Albert Einstein College of Medicine to further the development and testing of ATYR2810, the Company’s monoclonal antibody that targets the neuropilin-2 (NRP2) receptor. The collaboration will be led by Bang H. Hoang, M.D., Arnold and Madaleine Penner Professor and Co-Director of Orthopaedic Oncology in the Department of Orthopaedic Surgery at Montefiore Einstein. Dr. Hoang’s research focuses on the pathophysiology and molecular mechanisms of bone and soft tissue cancer, including evaluating the role of NRP2 in pediatric bone cancers such as osteosarcoma.

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"Aggressive solid tumors like osteosarcoma present a profound therapeutic challenge due to an immunosuppressive microenvironment. By selectively blocking the NRP2 signaling pathway, ATYR2810 is designed to disrupt myeloid-driven immune suppression and turn the tumor’s own defense mechanism against itself," said Dr. Hoang. "This innovative strategy potentially offers a highly differentiated approach capable of altering the local tumor niche to mitigate both primary tumor progression and critical metastasis."

ATYR2810 has demonstrated anti-tumor effects in multiple preclinical models, including non-small cell lung cancer, triple-negative breast cancer, renal cell carcinoma and glioblastoma. These findings have been presented at scientific conferences, including the American Academy of Cancer Research, and published in a landmark publication in Science Translational Medicine.

"We are pleased to collaborate with Montefiore Einstein and Dr. Hoang, a leader in pediatric bone cancer, on this important research regarding the role of NRP2 in pediatric osteosarcoma," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr Pharma. "While our focus has been on our tRNA synthetase-derived therapies, we have continued to contribute to the understanding of NRP2 in cancer through our research collaborations, and this collaboration presents an opportunity to investigate its role in another aggressive cancer where NRP2 is implicated."

Pediatric osteosarcoma is the most common type of primary malignant bone cancer in children and adolescents, with approximately 1000 new cases diagnosed every year in the U.S. While osteosarcoma is a bone cancer, it can spread to other organs and tissues in the body, most commonly starting with the lungs. Current standard of care typically includes a combination of chemotherapy and surgery, including limb-sparing surgery. Limb amputation is required in approximately 10% of cases. About 40% of those treated with osteosarcoma will experience a relapse or recurrence. Research that explores the underlying causes and mechanism of metastatic disease may lead to new treatments that can address and manage recurrence, which are greatly needed.

About ATYR2810

ATYR2810 is a fully humanized monoclonal antibody that is designed to specifically and functionally block the neuropilin-2 (NRP2) receptor. NRP2 is a cell surface receptor that is highly expressed in many tumors and is strongly implicated in more aggressive cancer progression, drug resistance development and metastatic spread. Recent data has demonstrated that the expression of NRP2 is also associated with the development of an immunosuppressive tumor microenvironment in a variety of tumors that do not respond to classical checkpoint inhibitors. Increased NRP2 expression is associated with worse outcomes in many cancers, including osteosarcoma, triple negative breast cancer, prostate cancer and pancreatic cancer. ATYR2810 is in preclinical development for the treatment of aggressive cancers where NRP2 is implicate, having successfully completed GLP toxicology testing in non-human primates and cGMP manufacturing.

(Press release, aTyr Pharma, OCT 19, 2026, View Source [SID1234673575])

Iovance Highlights TIL Cell Therapy Platform Across Solid Tumors at the European Society for Medical Oncology (ESMO) Congress 2026

On October 19, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, reported it will present five abstracts from its TIL platform at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, including two oral presentations of new clinical data in previously untreated advanced melanoma and, for the first time, in two soft tissue sarcomas. The congress takes place October 23–27, 2026, in Madrid, Spain.

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The oral presentation of results with lifileucel in two previously treated soft tissue sarcomas, undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS), are from a pilot clinical trial led by Memorial Sloan Kettering Cancer Center (MSKCC) and supported by Iovance. Soft tissue sarcomas are rare and highly heterogeneous cancers comprising approximately 80 tumor subtypes, with an estimated incidence of 4–5 cases per 100,000 people annually in Europe and ~3.5 new diagnoses per 100,000 people in the United States each year.1, 2 For patients with advanced UPS and DDLPS who progress following standard therapies, treatment options remain limited and prognosis is often poor, highlighting the need for new approaches that can deliver meaningful and durable responses.

"This is our first congress presentation of TIL cell therapy in two soft tissue sarcomas with significant unmet need," said Noah Berkowitz, M.D., Ph.D., Chief Medical Officer of Iovance. "The efficacy and durability observed in this early cohort are what moved us quickly toward our ongoing SARATOGA registrational trial of lifileucel in UPS and DDLPS. This is the broadest look yet at how Iovance’s growing TIL platform performs across solid tumors."

A second oral presentation, as a proffered paper, highlights the final Phase 2 results for lifileucel in combination with pembrolizumab in patients with immune checkpoint inhibitor (ICI)-naive advanced melanoma. Additional posters will highlight emerging translational and real-world evidence, including an indirect comparison suggesting that lifileucel may approximately double four-year overall survival rates compared with standard-of-care therapies in anti-PD-1-resistant advanced melanoma. Together, these data continue to expand the evidence base for Iovance’s TIL platform.

"Our Phase 2 results in frontline, advanced melanoma show deep, durable responses with a single treatment of lifileucel added to pembrolizumab," Berkowitz continued. "These data reinforce the scientific rationale behind TILVANCE-301, our Phase 3 trial evaluating lifileucel earlier in the treatment of advanced melanoma, highlighting the opportunity this approach may offer patients who don’t achieve lasting benefit from today’s frontline treatments."

Oral Presentations

Proffered Paper (Abstract #2072O): Efficacy and Safety of Lifileucel and Pembrolizumab in Patients with Immune Checkpoint Inhibitor-Naïve Advanced Melanoma: Final Results from IOV-COM-202 Study
Authors: Andrew J.S. Furness, et al.
Session: Friday, October 23, 2026, 16:15–17:45 CEST
Rapid Oral (Abstract #3725RO): Lifileucel in Patients with Undifferentiated Pleomorphic Sarcoma (UPS) or Dedifferentiated Liposarcoma (DDLS)
Authors: Lauren Banks, et al.
Session: Monday, October 26, 2026, 08:30–10:00 CEST
Poster Presentations

Poster (Abstract #4359P): Enrichment of Putative Tumor-Reactive Clones in NSCLC Patients Responding to Lifileucel: Temporal Single Cell Analysis from a Clinical Trial
Authors: Martin Wermke, et al.
Session: Friday, October 23, 2026, 15:15–16:00 CEST
Poster (Abstract #2117P): Indirect Comparison of Overall Survival (OS) between Lifileucel versus Standard-of-Care (SoC) in US Real-World Settings in Anti-PD-1 Resistant Advanced Melanoma
Authors: Barbara Ma, et al.
Session: Saturday, October 24, 2026, 12:00–12:45 CEST
Poster (Abstract #2125P): Lifileucel versus Nivolumab plus Relatlimab (NIVO+RELA) in Anti–PD-(L)1-Resistant Advanced Melanoma: A Match-Adjusted Indirect Comparison (MAIC) of Efficacy Outcomes
Authors: Gino K. In, et al.
Session: Saturday, October 24, 2026, 12:00–12:45 CEST
The ESMO (Free ESMO Whitepaper) Congress 2026 scientific program and abstracts are available at View Source Presentations will be available following the conclusion of each session on www.iovance.com and the ESMO (Free ESMO Whitepaper) Congress virtual platform.

About SARATOGA

SARATOGA (NCT07741877) is a registrational Phase 2 clinical trial evaluating the safety and efficacy of lifileucel in patients with advanced (metastatic or unresectable) undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy. UPS and DDLPS are high-grade, aggressive soft tissue sarcomas associated with poor prognosis and limited treatment options for patients who progress on chemotherapy.

About TILVANCE

TILVANCE-301 (NCT05727904) is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma.

(Press release, Iovance Biotherapeutics, OCT 19, 2026, View Source [SID1234673574])

Faeth to Present Preclinical Data on PIKTOR in HR+/HER2- Breast Cancer Models at ESMO 2026

On October 19, 2026 Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, reported that it will present preclinical data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 in Madrid, Spain.

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The poster will be presented on Friday, October 23, and will showcase preclinical data intended to inform the ongoing development of PIKTOR in the FTH-PIK-101 Phase 1b/2 trial in HR+/HER2- breast cancer. In the poster, PIKTOR is tested as monotherapy and in combination with fulvestrant, oral SERDs and CDK inhibitors, which are standard and emerging treatments for patients with HR+ breast cancer. Data from mouse xenograft models will be accompanied by cellular assays showing that in these preclinical models, PIKTOR suppressed key signaling nodes in the PAM pathway, including AKT, at rates comparable to or exceeding those observed with tested single-node inhibitors. The poster also compares PIKTOR head-to-head with gedatolisib in two preclinical breast cancer xenograft models.

A copy of the poster will be made available in the Investors section of Faeth’s website at the start of the poster session.

Presentation Details:

Title: Characterising the efficacy of multi-node PI3K/AKT/mTOR pathway inhibition with serabelisib and sapanisertib (PIKTOR) in combination with SERDs and CDK inhibitors in models of HR+/HER2- breast cancer
Abstract Number: 431P
Session: Basic Science Poster Session
Date: Friday, October 23, 2026
Location: Poster Area – Hall 5
Time: 15:15 – 16:00 CEST (9:15 – 10:00 a.m. ET)
Presenter: Oliver Maddocks, Ph.D., Co-Founder & Chief Scientific Officer of Faeth Therapeutics

About PIKTOR

PIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. This multi-node approach is designed to address the signaling feedback reactivation and treatment-emergent resistance mutations that may limit the efficacy of single-node PI3K/AKT/mTOR pathway inhibitors. According to published literature, the PAM pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology.

PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated by year-end 2026. PIKTOR is also being evaluated in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April 2026 and interim data is anticipated in 2027.

(Press release, Faeth Therapeutics, OCT 19, 2026, View Source [SID1234673573])

UroGen Announces FDA Acceptance of the New Drug Application for UGN-103, an Investigational Treatment for Adults with Recurrent LG-IR-NMIBC

On October 19, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for investigational drug UGN-103 (mitomycin) for intravesical solution for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 14, 2027.

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"FDA acceptance of the UGN-103 NDA advances our vision for the next evolution of our portfolio and our continued commitment to transforming the treatment of recurrent LG-IR-NMIBC," said Liz Barrett, President and CEO, UroGen. "Building on our experience with ZUSDURI (mitomycin) for intravesical solution, UGN-103 combines our proprietary RTGel technology with a novel mitomycin formulation, which leverages a streamlined manufacturing process and simplified reconstitution. We look forward to working closely with the FDA during its review and remain focused on delivering innovative treatment options for people living with this highly recurrent disease."

The NDA for UGN-103 is supported by the clinical data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in adult patients with recurrent LG-IR-NMIBC. Treatment with UGN-103 resulted in a 77.8% complete response (CR) rate at three months, and among patients who achieved a CR at three months, the Kaplan-Meier estimated probability of remaining event-free at six months was 94.5%. The three-month CR rate, the six-month duration of response (DOR), and the safety results observed in UTOPIA were consistent with those observed in the pivotal ENVISION trial of ZUSDURI. We are pleased to advance UGN-103 into FDA review as we continue to evaluate its potential role in the treatment of adults with recurrent LG-IR-NMIBC.

About UGN-103
In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for recurrent LG-IR-NMIBC. UGN-103 is designed to reinforce and build on the clinical and commercial foundation of ZUSDURI, the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC. The program maintains UroGen’s innovative and proven RTGel technology, enabling sustained mitomycin exposure in the bladder, while incorporating next-generation enhancements, including a more streamlined manufacturing process and simplified reconstitution to support improved ease of use in clinical practice. UroGen holds U.S. patents covering the combination of its proprietary RTGel technology with medac’s licensed lyophilized mitomycin formulation, as well as the use of UGN-103 in LG-IR-NMIBC, with intellectual property coverage expected to extend into July 2044.

About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the United States every year and of those, an estimated 59,000 are people experiencing recurrence. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about NMIBC at www.BladderCancerAnswers.com.

About UTOPIA
The UTOPIA trial is a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in 99 patients across global sites. Enrolled patients received 75 mg of UGN-103 via intravesical instillation in an outpatient setting once weekly for six weeks. The primary endpoint is CR rate at three months, with responders entering a follow-up phase of up to 12 months to assess DOR. For more information on the UTOPIA study, please visit View Source

(Press release, UroGen Pharma, OCT 19, 2026, View Source [SID1234673572])

ORIC® Pharmaceuticals to Host Conference Call & Webcast to Review Enozertinib Data Being Presented at ESMO Congress 2026

On October 19, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing and commercializing treatments that address mechanisms of therapeutic resistance, reported a conference call and webcast to review clinical data from the ongoing Phase 1b trial of enozertinib in first-line NSCLC patients with EGFR atypical mutations in conjunction with the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23-27, 2026, in Madrid, Spain.

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The conference call and webcast will take place on Friday, October 23, 2026, at 8:00 am ET. ORIC leadership plans to have Dr. Joshua Sabari, Assistant Professor of Medicine at NYU Grossman School of Medicine, join the call to share his perspective on the enozertinib clinical data and the potential of enozertinib to treat first-line NSCLC patients with EGFR atypical mutations. To join the conference call via phone and participate in the live Q&A session, please pre-register online here to receive a telephone number and unique passcode required to enter the call. The live webcast and an audio archive of the conference call will be available through the investor section of ORIC’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.

Full abstracts of the three poster presentations are available for public viewing via the ESMO (Free ESMO Whitepaper) Congress website, here. Posters will be available for public viewing via the ESMO (Free ESMO Whitepaper) Congress website on October 23, 2026.

Poster presentation details:

Title: Enozertinib (ORIC-114), a Brain Penetrant, Highly Selective
EGFR Inhibitor, in Treatment-Naive Metastatic NSCLC with EGFR Atypical Mutations
Presentation Number: 2627P
Session Date & Time: Monday, October 26, 2026; 12:00 – 12:45 p.m. CET
Session Title: Metastatic NSCLC

Title: Rinzimetostat, an Allosteric PRC2 Inhibitor Combined With
Darolutamide: A Global Phase 3 Study in mCRPC Patients
Previously Treated With Abiraterone Acetate (Himalayas-1)
Presentation Number: 2303TiP
Session Date & Time: Friday, October 23, 2026; 3:15 – 4:00 p.m. CEST
Session Title: Metastatic Prostate Cancer

Title: Rinzimetostat, a Next-Generation PRC2 Inhibitor, Enhances
Luminal Fate and AR Signaling While Restricting Lineage
Plasticity in Preclinical Models and Demonstrates Mechanistic Proof-of-Concept in Samples From Patients with mCRPC
Presentation Number: 1128eP
Session Title: Developmental Therapeutics

(Press release, ORIC Pharmaceuticals, OCT 19, 2026, https://investors.oricpharma.com/news-releases/news-release-details/oricr-pharmaceuticals-host-conference-call-webcast-review [SID1234673571])