On September 9, 2025 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that management will participate in a fireside chat today, September 9th, 2025, at the Morgan Stanley 23rd Annual Global Healthcare Conference at 3:20 pm ET (Press release, Celldex Therapeutics, SEP 9, 2025, View Source [SID1234655882]). A live webcast of the presentation will be available on the "Events & Presentations" page of the "Investors" section of the Celldex website. A replay will be available for 90 days following the event.

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On September 9, 2025 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, reported the initiation of patient dosing in Phase 2 of an ongoing Phase 1/2 clinical trial evaluating efarindodekin alfa (XTX301), a tumor-activated IL-12, as a monotherapy in patients with certain advanced solid tumors (Press release, Xilio Therapeutics, SEP 9, 2025, View Source [SID1234655881]). In addition, today Xilio announced the achievement of a $17.5 million development milestone under Xilio’s license agreement with Gilead Sciences, Inc. (Gilead) and updated data from the ongoing Phase 1 trial for efarindodekin alfa.

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"We are pleased to announce the initiation of the Phase 2 clinical trial for efarindodekin alfa (XTX301), a tumor-activated IL-12, in patients with advanced solid tumors," said René Russo, Pharm.D., president and chief executive officer of Xilio. "The achievement of this important milestone highlights the promising Phase 1 data demonstrated for efarindodekin alfa to date, including two partial responses in late-line patients with advanced solid tumors and a generally well-tolerated safety profile. These data also provide further clinical validation for our proprietary masking technology and approach, which we believe is best-in-class and has potential across a wide range of therapies and modalities."

"We are encouraged by the totality of data observed to date for efarindodekin alfa (XTX301) as a monotherapy in patients with advanced solid tumors, and we are excited for the potential that IL-12 has to treat a broad range of tumor types," said Bernard Fine, vice president, oncology early development at Gilead. "We look forward to advancing the efarindodekin alfa (XTX301) program in the Phase 2 trial in partnership with Xilio."

Efarindodekin alfa (XTX301): tumor-activated IL-12

Efarindodekin alfa (XTX301) is an investigational tumor-activated IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. In March 2024, Xilio entered into an exclusive license agreement with Gilead related to Xilio’s tumor-activated IL-12 program, including efarindodekin alfa. Xilio is evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 1/2 clinical trial in patients with advanced solid tumors.

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As of a data cutoff date of September 2, 2025, at dose levels up to the recommended Phase 2 dose (RP2D), efarindodekin alfa has been generally well-tolerated in Phase 1, and the majority of treatment-related adverse events were Grade 1 or 2.

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In Phase 1 as of the data cutoff date, efarindodekin alfa has also demonstrated encouraging anti-tumor activity, including two partial responses in patients with advanced solid tumors (one confirmed, one unconfirmed), as well as sustained interferon gamma (IFNɣ) signaling without evidence of tachyphylaxis throughout treatment cycles.

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Based on these promising Phase 1 data, Xilio recently selected an initial RP2D and schedule for efarindodekin alfa and initiated patient dosing in the Phase 2 portion of the trial evaluating efarindodekin alfa as a monotherapy in patients with certain advanced solid tumors.

In connection with the initiation of Phase 2, Xilio achieved a development milestone of $17.5 million.

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Xilio recently completed enrollment in Phase 1A monotherapy dose escalation and evaluation of those patients is ongoing. In addition, Xilio continues to enroll patients in the Phase 1B monotherapy dose expansion portion of the ongoing Phase 1/2 clinical trial of efarindodekin alfa.

Efarindodekin alfa has not been approved by any regulatory agency and its efficacy and safety have not been established.

Financial Guidance

As of June 30, 2025, Xilio had cash and cash equivalents of $121.6 million. Based on its current operating plans, Xilio anticipates that its cash and cash equivalents as of June 30, 2025, together with the $17.5 million development milestone achieved under the license agreement with Gilead, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2027. Xilio expects to receive payment of the $17.5 million development milestone by the fourth quarter of 2025.

About the Gilead License Agreement

In March 2024, Xilio entered into an exclusive global license agreement with Gilead to develop and commercialize efarindodekin alfa (XTX301), a tumor-activated IL-12, and specified other molecules directed to IL-12.

Xilio is responsible for conducting clinical development for efarindodekin alfa through the initial Phase 2 portion of the ongoing Phase 1/2 clinical trial. Following the delivery by Xilio of a specified clinical data package for efarindodekin alfa related to the Phase 1/2 clinical trial, Gilead can elect to transition responsibilities for the development and commercialization of efarindodekin alfa to Gilead, subject to the terms of the license agreement and payment by Gilead of a $75.0 million transition fee.

If Gilead exercises its option for efarindodekin alfa, Xilio will be eligible to receive up to $500.0 million in specified development, regulatory and sales-based milestones and will be eligible to receive tiered royalties ranging from high single digits to mid-teens on annual global net product sales.

About Efarindodekin Alfa (XTX301) and the Phase 1/2 Clinical Trial

Efarindodekin alfa (XTX301) is an investigational masked IL-12 designed to potently stimulate anti-tumor immunity and reprogram the tumor microenvironment (TME) of poorly immunogenic "cold" tumors towards an inflamed or "hot" state. In March 2024, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. for Xilio’s tumor-activated IL-12 program, including efarindodekin alfa. Xilio is currently evaluating the safety and tolerability of efarindodekin alfa as a monotherapy in patients with advanced solid tumors in the Phase 1 portion of a first-in-human, multi-center, open-label Phase 1/2 clinical trial and the safety and efficacy of efarindodekin alfa as a monotherapy in the Phase 2 portion in patients with advanced solid tumors. The Phase 2 portion of the trial is anticipated to enroll approximately 40 patients in specific tumor types at multiple sites in the United States. Please refer to NCT05684965 on www.clinicaltrials.gov for additional details.

On September 9, 2025 Tscan therapeutics presented its corporate presentation (Presentation, TScan Therapeutics, SEP 9, 2025, View Source [SID1234655880]).

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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 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.