On September 9, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported the publication of a study in JCO Precision Oncology validating the clinical utility of the company’s PurIST algorithmic diagnostic (Press release, Tempus, SEP 9, 2025, View Source [SID1234655894]). The study provides the largest real-world evidence to date supporting the integration of PurIST into routine clinical care for patients with advanced PDAC, with the aim of informing first-line chemotherapy selection and improving patient outcomes.

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Pancreatic cancer remains one of the most lethal malignancies, with limited therapeutic options and a five-year survival rate of just 12%. For patients with advanced, unresectable PDAC, the two most common first-line chemotherapy regimens, FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GnP), have shown variable efficacy, and clinicians have lacked robust biomarkers to guide optimal therapy selection. To address this challenge, Tempus collaborated with GeneCentric to develop and deploy PurIST, a clinically validated, RNA-based algorithm test that classifies PDAC tumors as either "classical" or "basal" subtypes.

The Tempus-led study analyzed a real-world cohort of 931 patients with advanced PDAC, using the Tempus xR RNA sequencing platform to assign PurIST subtypes. Patients were treated with either first-line FFX or GnP, and clinical outcomes were assessed according to PurIST classification. The study’s findings establish PurIST as both a prognostic and predictive biomarker, enabling clinicians to personalize first-line therapy for advanced PDAC patients and maximize the likelihood of improved survival.

Prognostic Value: Among patients treated with FFX (N=536), those with the classical subtype had a significantly longer median overall survival (OS) of 11.8 months, compared to 7.0 months for basal subtype patients (Hazard Ratio [HR]=1.86; p<0.001).
Predictive Value: In patients with the classical subtype and good performance status (ECOG 0 or 1, N=311), treatment with FFX was associated with a 33% relative risk reduction in death compared to GnP (HR=0.67; p<0.009). No comparable benefit was observed in basal subtype patients.
"Pancreatic cancer is a challenging disease, and the ability to match patients to the most effective first-line therapy is critical. Prior research has suggested that certain molecular subtypes are associated with distinct prognoses and responses to therapy, but until now, large-scale real-world validation in a clinical setting has been lacking," said Ezra Cohen, MD, Chief Medical Officer, Oncology. "Our study demonstrates that PurIST subtyping enables a biomarker-driven approach to therapy selection, addressing a major unmet need in the management of pancreatic cancer."

"PurIST is a step forward for pancreatic cancer molecular testing, giving healthcare providers a new tool to better inform personalized treatment options for this devastating disease," said Michael Milburn, PhD, President and CEO of GeneCentric and co-author on the publication. "GeneCentric’s collaboration with Tempus allowed us to validate the algorithm leveraging the power of Tempus’ multimodal data to rapidly deliver a much-needed test for patients with PDAC."

On September 9, 2025 NKGen Biotech, Inc. (OTC: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ("NK") cell therapeutics, reported the successful completion of its acquisition of a majority equity stake in NKMax Co., Ltd. ("NKMax"), a Korean biotechnology company, out of bankruptcy (Press release, NKGEN Biotech, SEP 9, 2025, View Source [SID1234655878]). This acquisition marks a transformative step for NKGen, granting full control over key global manufacturing infrastructure, intellectual property ("IP"), and exclusive commercialization rights, while solidifying the Company’s position as an independent and vertically integrated leader in NK cell therapeutics.

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This transaction is a culmination of a multi-year journey that has seen NKGen overcome significant challenges, emerge stronger, and continue its unwavering commitment to advancing groundbreaking cell therapies. Originally founded as a subsidiary of NKMax in 2017, NKGen has long benefited from its parent’s financial backing to drive the development of its innovative NK cell therapy platform. In October 2023, NKGen made the pivotal decision to go public in the U.S., securing a $25 million backstop commitment from NKMax to fund clinical development of NKGen’s flagship Alzheimer’s treatment. However, NKMax ultimately provided only $10 million of the $25 million backstop initially committed, marking the start of financial challenges for NKGen.

There were several unforeseen and unfortunate circumstances which led to the suspension of trading of NKMax shares on the KOSDAQ Korean Stock Exchange, and NKMax’s subsequent collapse into bankruptcy in 2024. This created significant financial challenges and uncertainty for NKGen which negatively impacted its own stock, ability to raise funds and eventual delisting from Nasdaq. In response to these challenges, NKGen’s leadership acted swiftly, with the support of AlpineBrook Capital GP 1 Limited ("AlpineBrook"), which recognized the potential of the combined companies. AlpineBrook provided the majority of the $17 million funding to NKGen for the purchase of NKMax shares. The entirety of the funding for the NKMax shares was provided by AlpineBrook and NKGen CEO Dr. Paul Y. Song, with terms to be finalized and disclosed in due course. This strategic partnership and infusion of capital are a testament to AlpineBrook’s confidence in the long-term growth and success of NKGen, now poised to leverage its newly acquired assets to drive future commercialization.

"This is more than an acquisition, it’s a turning point in our company’s history," said Paul Y. Song, M.D., Chairman and CEO of NKGen. "The past couple of years have been incredibly challenging, but we had an unwavering belief in the science behind our therapy and its true potential to change lives. This belief drove each of us, at every level of the company, to make sacrifices, stay committed, and keep building even though our future was very uncertain. With the support of AlpineBrook, who recognized our dedication and scientific promise, we have been blessed with the chance to now fully integrate NKMax’s capabilities and expertise into NKGen while taking full control of all IP and global distribution rights. We believe removing the uncertainty of the parent company overhang has also begun to generate renewed interest from U.S. and international investors alike and will allow us to enter a new era of opportunity and long-term growth. We believe the acquisition of NKMax will also allow us to rapidly expand and forge partnerships throughout Asia and the Middle East."

Dr. Song continued, "I am incredibly optimistic about the future of our lead therapeutic candidate, troculeucel, which has already been granted fast track designation by the U.S. Federal Drug Administration. We are consistently demonstrating cessation of disease progression and/or demonstrable cognitive improvements in over 90% of all Alzheimer’s patients treated to date and we are eagerly awaiting the completion of enrollment and generation of clinical and biomarker data from our double blinded randomized Phase 2 trial for moderate stage Alzheimer’s disease. With past challenges behind us, we are more focused and energized than ever, now turning our attention to advancing our clinical trials both in the U.S. and globally, with the goal of delivering this groundbreaking therapy to the patients who need it the most."

Looking ahead, we believe NKGen is well-positioned to accelerate the clinical development of its lead Alzheimer’s therapy, troculeucel, and expand its pipeline of NK cell therapies. With full ownership of NKMax’s manufacturing infrastructure and IP, the company expects to be primed for global commercial success and further strategic partnerships. The Company anticipates significant investor interest, as it enters a new chapter focused on long-term value creation for shareholders and patients worldwide.

About Troculeucel

Troculeucel is a novel cell-based, patient specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. Troculeucel is the International Nonproprietary Name ("INN") for SNK01 assigned by the World Health Organization ("WHO"). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen’s journey toward bringing this therapy to market.

On September 9, 2025 Tubulis reported the appointment of Halley Gilbert, JD, as Chief Legal Officer and Chief Operating Officer (CLO/COO) (Press release, Tubulis, SEP 9, 2025, View Source [SID1234655896]). Bringing over 20 years of transaction and operations experience in the biopharmaceutical industry, Ms. Gilbert will further expand Tubulis’ leadership capabilities at a pivotal stage of clinical and corporate development. In this newly created role, she will leverage her combined expertise as an attorney and seasoned biotech executive to shape Tubulis’ strategy and support the continued growth of the company’s U.S. presence. Ms. Gilbert will be responsible for legal and administrative functions and play a key role in executing strategic transactions for the company.

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"Halley’s extensive legal and operational experience and deep commitment to supporting rapidly growing biotech companies make her an ideal addition to our team as we further expand our clinical and business operations," said Dr. Dominik Schumacher, CEO and Co-founder of Tubulis. "Her industry know-how and strategic leadership will be instrumental as we advance our lead ADC candidates through clinical development and continue to expand our pipeline with new modalities."

"ADCs are transforming the oncology landscape, and Tubulis is leading the way with its differentiated approach to ADC design," said Halley Gilbert, JD, CLO and COO of Tubulis. "Their innovative platforms and exciting research ethos allow them to unlock the full therapeutic potential of this powerful drug class. I am thrilled to be joining such a motivated team and look forward to helping shape the path toward commercialization and delivering a meaningful clinical impact to patients."

Ms. Gilbert brings extensive legal and operational experience within the life sciences industry, having served as CLO and COO at both public and private biotech companies. Most recently, she served as Chief Legal Officer of Cargo Therapeutics and played a key leadership role in the company’s initial public offering and subsequent sale. Prior to Cargo, Ms. Gilbert was the first employee of Invyvid, Inc. (formerly Adagio), where she enabled the company’s rapid growth from launch to IPO, and accelerated its transition from early R&D to late-stage clinical development. In addition, for the past five years, Ms. Gilbert has been a member of the Board of Directors at Vaxcyte, Inc., Arcutis Biotherapeutics, and CytomyX Therapeutics, Inc.

On September 9, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported five-year follow-up results on overall survival (OS) from the Phase 3 EMPOWER-Lung 3 trial, which evaluated Libtayo (cemiplimab) plus platinum-based chemotherapy versus chemotherapy alone as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations (Press release, Regeneron, SEP 9, 2025, View Source [SID1234655879]). The late-breaking data will be presented in a mini oral session at the IASLC 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer.

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"After more than five years of follow-up, the EMPOWER-Lung 3 trial continues to demonstrate sustained survival – with an impressive overall survival probability of 19.4% at five years – when Libtayo is added to chemotherapy in patients with advanced non-small cell lung cancer," said Ana Baramidze, M.D., Ph.D., Head of Clinical Research Department at Todua Clinic, Tbilisi, Georgia. "Long-term results across tumor histologies were also reported, including a notable 22.3-month median overall survival for squamous NSCLC patients. Collectively, these data underscore Libtayo’s utility across a variety of patient types, both as a single agent and in combination with chemotherapy."

The five-year results for Libtayo plus chemotherapy presented at WCLC add to the breadth of long-term data for Libtayo in advanced NSCLC, including five-year outcomes from the EMPOWER-Lung 1 trial that were presented at WCLC 2024 confirming durable survival benefit as monotherapy.

At this year’s WCLC, five-year efficacy results, with a median follow-up of 60.9 months, found Libtayo plus chemotherapy remained superior to chemotherapy alone:

21.1-month median OS versus 12.9 months, representing a 34% reduction in the risk of death (hazard ratio [HR]: 0.66; 95% confidence interval [CI]: 0.53–0.83). The five-year probability of survival was 19.4% for the Libtayo combination versus 8.8% for chemotherapy.
8.2-month median progression-free survival (PFS) versus 5.5 months, representing a 42% reduction in the risk of disease progression (HR: 0.58; 95% CI: 0.47–0.72).
43.6% objective response rate (ORR) versus 22.1%. The ORR included a complete response rate of 6.4% versus 0%.      
16.4-month median duration of response (DoR) versus 7.3 months.
Also presented at WCLC were exploratory subgroup analyses that demonstrated survival benefits for patients treated with Libtayo plus chemotherapy compared to chemotherapy alone regardless of tumor histology or PD-L1 expression level. Specific efficacy results included a:

22.3-month median OS among patients with squamous histology (n=133) versus 13.8 months (n=67), representing a 32% reduction in risk of death (HR: 0.68; 95% CI: 0.49–0.94).
19.4-month median OS among patients with non-squamous histology (n=179) versus 12.4 months (n=87), representing a 38% reduction in risk of death (HR: 0.62, 95% CI: 0.46–0.82).
24.0-month median OS among patients with PD-L1 ≥1% (n=217) versus 12.1 months (n=110), representing a 46% reduction in risk of death (HR: 0.54; 95% CI: 0.41–0.70).
The safety profile at five years remained consistent with previously reported data. The median duration of exposure was 39 weeks to Libtayo plus chemotherapy and 21 weeks to chemotherapy alone. Adverse events (AEs) of any grade occurred in 96.5% of Libtayo plus chemotherapy patients (49% ≥Grade 3) and 95% of chemotherapy patients (33% ≥Grade 3). The most common AEs of any grade occurring in at least 10% of Libtayo plus chemotherapy patients included anemia (46%), alopecia (38%), nausea (25%), increase of alanine aminotransferase (18%), arthralgia (18%), decreased appetite (18%), hyperglycemia (18%), increase of aspartate transaminase (16%), neutropenia (16%), fatigue (15%), constipation (14%), thrombocytopenia (14%), dyspnea (14%), asthenia (13.5%), vomiting (13%), decreased weight (13%), increased blood creatinine (13%), insomnia (12%), hypoalbuminemia (11%), diarrhea (11%). Among Libtayo patients, treatment-related adverse events were ≥Grade 3 in 30% and led to permanent discontinuation in 4.5% and death in 1%, compared to 18%, 1% and 0.7% in the chemotherapy arm, respectively.

About the Phase 3 Trial
The randomized, multicenter Phase 3 trial, called EMPOWER-Lung 3, investigated a first-line combination treatment of Libtayo and platinum-doublet chemotherapy, compared to platinum-doublet chemotherapy alone. The trial enrolled 466 patients with locally advanced or metastatic NSCLC, as well as squamous or non-squamous histologies across all PD-L1 expression levels and with no ALK, EGFR and ROS1 aberrations.

Patients were randomized 2:1 to receive either Libtayo 350 mg (n=312) or placebo (n=154) administered intravenously every 3 weeks for 108 weeks, plus platinum-doublet chemotherapy administered every 3 weeks for 4 cycles. The primary endpoint was OS, and key secondary endpoints were PFS and ORR. The probability of survival and PFS were calculated according to Kaplan-Meier estimates.

Notably, patients in the trial had a variety of baseline characteristics commonly considered difficult-to-treat. Among those enrolled, 43% had tumors with squamous histology, 67% had tumors with <50% PD-L1 expression, 15% had inoperable locally advanced disease not eligible for definitive chemoradiation, and 7% had pretreated and clinically stable brain metastases. Additionally, 84% of patients had an ECOG 1 performance status. ECOG performance status assesses patient ability to conduct daily living activities and prognosis on a scale of increasing severity ranging from 0 (no symptoms) to 5 (death).

On September 9, 2025 Abdera Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging its advanced antibody engineering ROVEr platform to design and develop tunable precision radiopharmaceuticals for cancer, reported initial clinical data from its ongoing Phase 1a trial of ABD-147 in patients with small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC) that support continued dose escalation (Press release, Abdera Therapeutics, SEP 9, 2025, View Source [SID1234655897]). The data were presented in a poster session at the IASLC 2025 World Conference on Lung Cancer in Barcelona, Spain.

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ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a potent alpha-emitting isotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is expressed in approximately 85% of patients with SCLC, an intrinsically radiosensitive cancer.

"These data with ABD-147 validate the mechanistic promise of DLL3-targeted alpha radiotherapy and mark an important step toward a modality that could reshape SCLC treatment," said Lisa Bodei, M.D., Ph.D., Nuclear Medicine Physician and Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center. "While early, at the first dose level, we observed selective tumor uptake, predicted biodistribution without evidence of alteration, and disease stabilization in advanced disease following platinum-based therapy. These findings support continued dose escalation and further evaluation in SCLC, where treatment options remain limited."

Phase 1a Trial Overview and Key Findings

The Phase 1 trial is designed to evaluate the safety and tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of 225Ac-ABD147 in patients with locally advanced or metastatic SCLC and LCNEC following platinum-based chemotherapy. Dosimetry analysis using Indium-111 (111In) was conducted to track ABD-147 distribution in the body and to measure radiation doses to organs.

Data as of data cutoff date of August 15, 2025 from a total of six patients enrolled in the first dose cohort demonstrate:

PK: Human PK was consistent with preclinical models in multiple species, with minimal inter-patient variability
Biodistribution: Favorable tumor uptake with rapid clearance from the blood and key organs, including the kidneys
Dosimetry: Projected administered activity of 225Ac-ABD147 across all planned doses is within established safety limits for all organs, including kidneys, liver and bone marrow
Imaging: CT confirmed ABD-147 uptake in target lesions, supporting DLL3 specificity
Safety: ABD-147 has been tolerated, with no infusion-related events, no dose modifications and no dose-limiting toxicities observed to date. Treatment-related adverse events included one case of paresthesia (tingling sensation) that resolved rapidly, and one case of thrombocytopenia. Five serious adverse events were observed in two patients – three instances of dyspnea and two deaths due to co-morbidities – all of which were deemed unrelated to study drug.
Preliminary anti-tumor activity: Disease stabilization has been observed, including one patient who received multiple cycles of ABD-147 with over four months of follow-up.
Based on these initial data, the independent safety review committee recommended continuation of dose escalation with ABD-147.

"The presentation of our first-in-human data for ABD-147 marks an important milestone for Abdera and reinforces the promise of our precision radiopharmaceuticals for difficult-to-treat cancers," said Philippe Bishop, M.D., chief medical officer of Abdera Therapeutics. "These data highlight the power of our ROVEr platform to engineer finely tunable radiopharmaceuticals with optimal tumor accumulation and healthy tissue clearance. I am incredibly proud of the team’s work to bring ABD-147 to this important stage. As we advance dose escalation, our focus remains on unlocking the full potential of ABD-147 for patients with DLL3-expressing tumors."

About ABD-147

ABD-147 is a targeted radiopharmaceutical biologic therapy designed to deliver Actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to solid tumors expressing delta-like ligand 3 (DLL3) with high affinity. DLL3 is a protein in the Notch pathway that is critical for the development and regulation of neuroendocrine versus epithelial cell differentiation in the lungs. In certain high grade neuroendocrine carcinomas including small cell lung cancer (SCLC), DLL3 is upregulated and specifically expressed on the cell surface in more than 80% of cases. In contrast, DLL3 is absent or very rarely expressed on the surface of nonmalignant cells. Given the high specificity of DLL3 expression on cancer cells and the distinct mechanism of action, DLL3 represents a compelling target for treating SCLC and other DLL3+ solid tumors with targeted radiotherapy.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy and Orphan Drug Designation to ABD-147 for the treatment of neuroendocrine carcinoma. ABD-147 is currently being evaluated in a first-in-human Phase 1 clinical trial in patients with SCLC or large cell neuroendocrine carcinoma of the lung who have previously received platinum-based therapy.

About Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

The global incidence for SCLC and LCNEC has been reported to represent approximately 325,000 patients and is expected to increase 4% annually through 2029. In the U.S., the incidence has been reported to be approximately 35,000 new cases annually. Fifteen percent of all lung cancer cases are high-grade neuroendocrine cancers. These cancers have the most aggressive clinical course of any type of pulmonary tumor and often metastasize to other parts of the body, including the brain, liver and bone. Without treatment, the median survival from diagnosis has been reported to be only two to four months. With treatment, the overall survival at five years is 5% to 10% for SCLC, and 15% to 25% for LCNEC. SCLC and LCNEC generally carry a poor prognosis and new treatment options are urgently needed.