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Envisagenics and Boehringer Ingelheim Enter Multi-Target Collaboration to Develop First-in-Class Precision Therapies Based on RNA Splicing-Derived Targets for Hard-to-Treat Cancers

On September 22, 2026 Envisagenics reported a multi-year research collaboration and option agreement with Boehringer Ingelheim to validate selected tumor-specific targets for the development of first-in-class precision therapies for people living with solid tumors. Envisagenics has pioneered an artificial intelligence (AI)-powered approach that is transforming alternative RNA splicing into a new frontier for drug discovery.

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Despite significant advances in cancer treatment, progress has not reached all patients equally. Many people with aggressive solid tumors still have few effective treatment options, in part because there are not enough targets that clearly distinguish cancer cells from healthy tissue. Identifying highly tumor-specific targets could create new opportunities to develop precision therapies that recognize and attack cancer cells through different mechanisms while limiting effects on healthy tissue. This could open new treatment options for cancer.

"We’re proud to partner with Boehringer Ingelheim, a recognized leader in oncology with deep expertise in advancing first-in-class precision therapies," said Maria Luisa Pineda, Ph.D., Chief Executive Officer and Co-Founder of Envisagenics. "This collaboration validates our vision that alternative RNA splicing represents one of the richest untapped sources of novel disease-specific therapeutic targets across human disease. By combining our AI-powered SpliceCore platform with Boehringer’s oncology expertise, we can accelerate the development of highly differentiated new medicines for patients."

The agreement supports Boehringer Ingelheim’s oncology strategy of pairing bold modalities with novel, highly tumor-selective targets sourced through long-term partnerships. The collaboration builds on targets previously identified through Envisagenics’ proprietary SpliceCore platform and will further validate their therapeutic potential across multiple therapeutic modalities, including antibody-drug conjugates (ADCs), T-cell engagers (TcEs) and multispecific antibodies. Upon successful completion of the research program, Boehringer Ingelheim will have the option to exclusively license selected targets for further development and commercialization.

"Growing innovation together with partners is central to how we build our oncology pipeline," said Mark Petronczki, Global Head of Oncology Research at Boehringer Ingelheim. "Alternative RNA splicing offers access to a largely unexplored target space, and Envisagenics has built a distinctive capability to investigate it. Through this collaboration, we hope to identify highly tumor-selective targets for the development of new cancer therapies to address the needs of patients who are still waiting for better treatment options."

Alternative RNA splicing is a fundamental biological process that expands proteomic diversity and is frequently dysregulated across human cancers. This generates tumor-specific protein isoforms – a rich source of disease-specific therapeutic targets that remain inaccessible to conventional, gene-centric discovery approaches.

Envisagenics’ proprietary SpliceCore platform combines artificial intelligence, large-scale transcriptomics and experimental validation to identify and prioritize these targets systematically – screening more than 14 million distinct splicing events to predict disease specificity, patient prevalence and therapeutic suitability.

(Press release, Envisagenics, SEP 22, 2026, https://www.globenewswire.com/news-release/2026/09/22/3366249/0/en/envisagenics-and-boehringer-ingelheim-enter-multi-target-collaboration-to-develop-first-in-class-precision-therapies-based-on-rna-splicing-derived-targets-for-hard-to-treat-cancers.html [SID1234671016])

Elevar Therapeutics Receives FDA Conditional Acceptance of LYRFIGTU as Brand Name for Lirafugratinib

On September 22, 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 cancer patients, reported the U.S. Food and Drug Administration (FDA) has granted conditional acceptance of LYRFIGTU as the brand name for lirafugratinib, which is currently under FDA Priority Review as a treatment option for patients with advanced/metastatic cholangiocarcinoma (CCA) harboring FGFR2 fusion or other rearrangement.

The proposed name Lyrfigtu (pronounced leer fig tu) was developed in accordance with the FDA’s guidance on proprietary names. Final acceptance of the Lyrfigtu brand name will be established upon FDA approval of lirafugratinib. In January, the FDA accepted Elevar’s new drug application for lirafugratinib and subsequently granted Priority Review to the application and assigned a Prescription Drug User Fee Act target action date of September 25, 2026.

"The FDA’s conditional acceptance of the Lyrfigtu brand name represents another important milestone in Elevar’s effort to potentially commercialize lirafugratinib and, if approved, introduce a new therapeutic option for patients confronted with cholangiocarcinoma," said Dong-Gun Kim, chief executive officer of Elevar. "With the PDUFA date set for later this month, we are hopeful of a positive result and highly focused on preparing for a potential launch to make the drug available to doctors and patients as quickly as possible, subject to FDA approval."

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

In the Phase 1/2 ReFocus trial (NCT04526106), lirafugratinib demonstrated a confirmed objective response rate (ORR) of 46% and a median duration of response of 11.8 months in patients with the proposed indication. Its safety profile in the clinical data is being evaluated by the FDA as part of the ongoing review process. Adverse events observed in the trial were managed through dose adjustments.

About Lirafugratinib

Lirafugratinib (aka 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. 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 fusion or rearrangement, who have not been treated with prior FGFR inhibitors. Lirafugratinib is an investigational product candidate and has not been approved by the U.S. Food and Drug Administration for any indication. Elevar has an exclusive license to lirafugratinib from Relay Therapeutics, Inc. for commercialization worldwide.

(Press release, Elevar Therapeutics, SEP 22, 2026, View Source [SID1234671015])

MAIA Biotechnology Reports Pivotal Phase 3 Clinical Trial Progress in Advanced Non-Small Cell Lung Cancer

On September 22, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported that enrollment has reached 65 patients in its ongoing pivotal Phase 3 trial, THIO-104, evaluating its novel telomere-targeting therapy as a third-line (3L) treatment for advanced non-small cell lung cancer (NSCLC). The THIO-104 trial currently has 38 trial sites activated in 6 foreign countries (Taiwan, Romania, Turkey, Georgia, Poland and Hungary).

"Reaching 65 randomized patients marks an important milestone in our Phase 3 trial. With additional clinical sites expected to begin enrolling patients, we remain on track to achieve our goal of more than 100 randomized patients by year-end," said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. "As we’ve stated previously, statistical assessments of the Phase 3 trial point to a very high probability of technical success for regulatory approval of ateganosine.1 We believe third-line NSCLC is an excellent market entry segment due to the substantial unmet medical need in this large immunotherapy-resistant and chemotherapy-resistant population. No current standard of care exists in this NSCLC treatment setting and competition for clinical trial patients is limited."

In its most recent assessment, ateganosine sequenced with a checkpoint inhibitor showed 90.5% interim disease control rate (DCR) in heavily pretreated 3L NSCLC in MAIA’s ongoing phase 2 THIO-101 clinical trial. This measure contrasts with reported 25%–35% DCRs for standard third-line chemotherapy regimens.

In July 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. If approved, ateganosine will hold FDA New Chemical Entity (NCE) five-year marketing exclusivity. An NCE is a small molecule drug with a novel active ingredient that hasn’t been previously approved or marketed.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

(Press release, MAIA Biotechnology, SEP 22, 2026, View Source [SID1234671014])

X-Chem Announces Phase 3 Milestone in Collaboration with Relay Therapeutics

On September 22, 2026 X-Chem, a global leader in innovative drug discovery services, reported the achievement of a milestone following Relay Therapeutics’ initiation of a Phase 3 clinical trial of a drug candidate developed from a compound identified through an X-Chem DNA-encoded chemical library (DEL) screen.

Relay Therapeutics, a leader in cutting-edge approaches to drug discovery, licensed an inhibitor of the oncology target phosphoinositide 3- kinase alpha (Pl3Ka) that was discovered through an X-Chem DEL screen. The inhibitor demonstrated differentiated pharmacology, mutant selectivity, a novel allosteric binding site and served as a starting point for Relay’s innovative development of zovegalisib (RLY-2608), currently in a clinical trial. The initiation of this Phase 3 trial represents a milestone under the companies’ Research Collaboration and License Agreement.

"The unique selectivity and binding site of RLY-2608 are a testament to the power of the X-Chem DEL platform to discover unique chemical matter with differentiated pharmacology," said X-Chem CEO Karen Lackey. "We are thrilled that our discovery platforms helped provide a starting point for a potential new treatment for patients with breast cancer. Hats off to the Relay team for having the drive and vision to push this project forward."

"X-Chem’s excellence in DEL technology was apparent from the very beginning of this exciting project, and we are pleased to continue to advance the clinical development of zovegalisib in patients with PI3Ka-driven diseases," said Relay CEO Sanjiv Patel.

(Press release, X-Chem, SEP 22, 2026, View Source [SID1234671013])

Cartography Biosciences to Participate in Upcoming Investor Conferences

On September 22, 2026 Cartography Biosciences, Inc., a clinical-stage biotechnology company advancing a differentiated pipeline of antibody-based cancer therapies, reported that CEO and co-founder Kevin Parker, Ph.D., will participate in the following upcoming investor conferences:

BofA Healthcare Trailblazers Private Company Conference: September 23-24 in Boston
Needham Private Biotech and MedTech Company Virtual 1×1 Forum: October 13-14
Goldman Sachs Healthcare Private Company Conference: October 19 in New York City
Leerink Partners Biopharma Private Company Connect: October 20-21
UBS Global Biopharma Conference: November 16-17 in London

(Press release, Cartography Biosciences, SEP 22, 2026, View Source [SID1234671011])