On September 3, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven clinical -stage oncology company developing targeted therapies for cancer that are being advanced using its proprietary computational biology and machine learning platform, reported the successful completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) (Press release, Lantern Pharma, SEP 3, 2025, View Source [SID1234655744]). The meeting provided critical guidance on the regulatory pathway and trial design for a planned pediatric trial focused on CNS cancers, including Atypical Teratoid Rhabdoid Tumor (ATRT).

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During the Type C meeting, the FDA provided constructive feedback on the proposed clinical trial structure, which includes a parallel cohort specifically for ATRT patients to accelerate data collection in this ultra-rare population. Additionally, the agency confirmed the potential incorporation of spironolactone as a combination agent, to allow for the assessment of spironolactone’s synergistic effects with Lantern’s lead investigational therapy, LP-184/STAR-001 in enhancing the potential efficacy in CNS cancers. This feedback aligns with Lantern’s strategy to advance precision oncology solutions for pediatric patients facing limited treatment options. Lantern is now preparing to submit an IND (investigational new drug) application amendment for LP-184/STAR-001 under its wholly owned subsidiary, Starlight Therapeutics, based on the guidance and dialogue from the Type C meeting.

Lantern’s program for ATRT has received Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA, underscoring the urgent unmet need for innovative therapies in these aggressive childhood brain cancers. The planned trial is expected to enroll pediatric patients across multiple sites, with primary endpoints focused on progression-free survival, overall response rate, and quality-of-life measures.

"We are thrilled with the constructive dialogue and positive feedback from our Type C meeting with the FDA," said Panna Sharma, President and CEO of Lantern Pharma. "This guidance not only reinforces our trial design but also highlights the potential of our AI platform, RADR, in identifying and optimizing combination regimens like spironolactone for these devastating pediatric CNS cancers. We remain committed to rapidly advancing this program with the aim of bringing hope to children and families affected by brain cancer."

Lantern Pharma continues to leverage its proprietary RADR AI platform to accelerate drug development, reduce costs, and identify patient responders across oncology indications. The company plans to submit an Investigational New Drug (IND) application amendment incorporating the FDA’s guidance in the coming months, with planned trial initiation targeted for Q1 2026.

On September 3, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported new data from an AstraZeneca phase 3 clinical trial in lung cancer (NeoADAURA) (Press release, Personalis, SEP 3, 2025, View Source [SID1234655743]). The findings demonstrate that Personalis’ highly sensitive molecular residual disease (MRD) test, NeXT Personal, is a strong predictor of outcomes in patients with stage II-IIIb, EGFR-mutated non-small cell lung cancer (NSCLC) receiving neoadjuvant therapy.

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The findings, which will be presented at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain on September 7 (abstract OA02.02), demonstrate that NeXT Personal can be a more sensitive and accurate measure of MRD in the neoadjuvant setting. This supports findings in other cancer types that NeXT Personal can help doctors understand how patients are responding to neoadjuvant therapy, with the potential to guide future treatment decisions.

Key findings about NeXT Personal from the new NeoADAURA analysis:

More sensitive: NeXT Personal demonstrated significantly higher baseline sensitivity for ctDNA detection compared to another gene-mutation based test, providing a more accurate assessment of disease burden.
Prognostic: Baseline MRD status, as determined by NeXT Personal, was a strong prognosticator of clinical outcomes across all treatment arms.
Associates with pathological response: Pre-surgical MRD negativity and clearance on the NeXT Personal test were shown to be associated with major pathological response (MPR).
Useful for monitoring treatment: Osimertinib-containing regimens improved pre-surgical MRD clearance vs pbo+CT, showing the utility of ctDNA for monitoring neoadjuvant therapy response.
"The NeoADAURA results are a significant step forward for patients with early-stage lung cancer," said Richard Chen, Chief Medical Officer and EVP of R&D at Personalis. "This study from AstraZeneca shows that ultra-sensitive ctDNA detection enabled by NeXT Personal is critical for accurately assessing neoadjuvant treatment response. It also highlights how more-sensitive detection of ctDNA can unlock crucial insights in the neoadjuvant setting. We are proud to continue our productive relationship with AstraZeneca as we work to advance the frontier of cancer care."

The NeoADAURA trial (NCT04351555) is a global, randomized, placebo-controlled, double-blind, multi-center study of neoadjuvant osimertinib with or without chemotherapy versus placebo plus chemotherapy for patients with resectable EGFRm NSCLC.

This collaboration also builds on previous work with AstraZeneca showing the importance of highly sensitive ctDNA analysis for tracking treatment response and predicting cancer recurrence. This includes a recent publication of Phase 3 CALLA cervical cancer study results showing that NeXT Personal detected traces of cancer DNA in patients with locally advanced cervical cancer up to ~16 months ahead of standard of care imaging.

The NeoADAURA data presentation follows Personalis’ recent submission for Medicare coverage for its NeXT Personal liquid biopsy test for use in patients with lung cancer. This marks the third indication for which the company is seeking coverage for its ultra-sensitive, whole-genome-based, tumor-informed molecular residual disease (MRD) and recurrence test.

On September 3, 2025 Nektar Therapeutics (Nasdaq: NKTR) reported that the company will be webcasting its participation in the H.C. Wainwright 27th Annual Global Investment Conference being held September 8-10, 2025 in New York City and the Stifel Virtual Immunology and Inflammation Forum being held September 15-16, 2025 (Press release, Nektar Therapeutics, SEP 3, 2025, View Source [SID1234655742]).

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H.C. Wainwright 27th Annual Global Investment Conference on Wednesday, September 10, 2025 – webcast to be available at 10:30 a.m. Eastern Time / 7:30 a.m. Pacific Time – link here

Stifel 2025 Virtual Immunology and Inflammation Forum on Monday, September 15, 2025 – webcast to be available at 2:30 p.m. Eastern Time / 11:30 a.m. Pacific Time – link here
The presentations will be accessible via the webcast links above as well as on the Investor Events section of the Nektar website: View Source Replays of the presentations will be available for 30 days.

If you would like to request a one-on-one meeting with company management during the conferences, please reach out to your respective representative.

On September 3, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, reported the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for IDE892, a potential best-in-class MTA-cooperative inhibitor of PRMT5 (Press release, Ideaya Biosciences, SEP 3, 2025, View Source [SID1234655741]). The company is targeting to begin a Phase 1 dose escalation trial of IDE892 in MTAP-deleted lung cancer in the fourth quarter of 2025, with the goal of advancing into combination trials with IDE397, IDEAYA’s proprietary MAT2A inhibitor, in the first half of 2026.

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Approximately 15-20% of non-small cell lung cancer (NSCLC) is MTAP-deleted. Extensive studies indicate that elevated MTA/SAM ratios in MTAP-deleted cancers create a tumor-specific vulnerability to MTA-cooperative PRMT5 inhibition. This effect is substantially enhanced in combination with MAT2A inhibition, leading to an important combination therapy opportunity in an area of substantial unmet need. In addition to MTAP-deleted lung cancer, IDEAYA will target to clinically evaluate other high priority MTAP solid tumor indications as both IDE892 monotherapy and in combination with IDE397.

"We are excited to advance IDE892 into clinical studies for patients with MTAP-deleted lung cancer, where we believe the inhibition of PRMT5 in combination with MAT2A could have synergistic anti-tumor activity," said Michael White, Chief Scientific Officer, IDEAYA Biosciences. "IDE892 is the culmination of a comprehensive optimization of the biophysical and pharmacokinetic properties required to maximize therapeutic benefit as a combination partner with IDE397, and to generate a potential best-in-class MTA-cooperative PRMT5 inhibitor profile."

Registration for IDEAYA’s 10-Year Anniversary R&D Day can be accessed here or at the investors section of the IDEAYA website at View Source

On September 3, 2025 Galvanize ("Galvanize") Therapeutics, Inc, a commercial-stage medical technology company pioneering pulsed electric field (PEF) therapies for oncology and chronic lung disease reported it has successfully raised an oversubscribed $100 million Series C financing (Press release, Galvanize Therapeutics, SEP 3, 2025, View Source [SID1234655740]). The round was led by Sofinnova Partners, a leading European life sciences venture capital firm, with participation from a global syndicate of top-tier investors including Norwest Venture Partners, Elevage Medical Technologies, Ally Bridge Group, Perceptive Xontogeny Venture Fund, Janus Henderson Investors and Longaeva. Existing investors Fidelity Management & Research Company, T. Rowe Price, Gilmartin Capital, Intuitive Surgical and the company’s founding investor, Apple Tree Partners ("ATP"), also participated in the round.

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Proceeds from the financing will be used to expand the company’s commercial footprint and advance its clinical and development activities related to Aliya PEF in solid tumors and RheOx therapy for chronic bronchitis. The company will also use the funds to continue to innovate its novel PEF platform, a non-pharmacologic intervention which uses non-thermal, short-duration, highly focused electrical pulses that destabilize cellular pathologic processes in hopes of changing the disease trajectory for these patients.

Concurrent with the financing, Doug Godshall, former CEO of Shockwave Medical and HeartWare International, was appointed Chairman and CEO of Galvanize Therapeutics, while Jonathan Waldstreicher assumed the role of President and Chief Strategy Officer.

Mr. Godshall commented: "I began following Galvanize in 2016 and became actively involved when I joined the board as Chairman in 2021. I have grown increasingly enthusiastic about the company’s prospects over the last year as the team continued advancing our portfolio and commencing our initial commercial efforts. Galvanize’s Aliya and RheOx technologies hold great promise in the fields of solid tumor oncology and chronic bronchitis. There are millions of patients who are underserved by today’s largely pharmaceutical approaches, and I feel fortunate to be able to join the team as we seek to meaningfully improve the outcomes of those who are suffering with these chronic diseases."

As part of the financing, Antoine Papiernik, Chairman and Managing Partner of Sofinnova Partners, Zack Scott, M.D., General Partner at Norwest, and David Lewis, Managing Partner at Gilmartin Capital, have joined the Board of Directors.

Mr. Papiernik added: "We have closely followed Galvanize for years and are impressed by its technology, strong team, and execution. Partnering again with Doug after our Shockwave success, and working with such a powerful syndicate, was an opportunity we couldn’t refuse. We believe Galvanize’s PEF program could significantly improve treatment and benefit patients with serious unmet needs."