On October 1, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported an update on the ongoing Phase 1 dose escalation study of BDC-4182, a next-generation Boltbody ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology (Press release, Bolt Biotherapeutics, OCT 1, 2025, View Source [SID1234656398]). A strong immune response was observed at the initial dose levels and the Company is in the process of modifying the clinical trial protocol to allow for step-up dosing, which has been successfully used commercially for T-cell engagers. BDC-4182 preclinical data supports this approach.

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As a result of the update to the clinical trial protocol for BDC-4182, Bolt now expects to report initial clinical data in the third quarter of 2026. To conserve capital and maintain long-term shareholder value, the Company is implementing a workforce reduction of approximately 50%, extending its cash runway into 2027.

"I want to sincerely thank all of our colleagues impacted by this decision. Their commitment and valuable contributions have been essential in developing our novel BoltbodyTM ISAC technology and these potential new treatment options for patients with cancer," said Willie Quinn, President and Chief Executive Officer. "Amid challenging market conditions, our strategic imperative is the clinical advancement of BDC-4182 and the support of our ISAC collaborations to increase shareholder value. We look forward continuing our mission and to providing updates on BDC-4182 later next year."

On October 1, 2025 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, reported that it will present and host institutional investor meetings at the 37th Annual Piper Sandler Healthcare Conference being held on December 2-4, 2025 at the Lotte New York Palace Hotel in New York, NY (Press release, Immix Biopharma, OCT 1, 2025, View Source [SID1234656379]).

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The Company will be available for one-on-one meetings during the conference. Interested investors should contact their Piper Sandler representative to request meetings. A link to access the replay, when available, will be posted to the Immix website on the Presentation & Events page under the Investors section.

On October 1, 2025 Jecho Biopharmaceuticals Co., Ltd. (hereinafter referred to as "Jechobio") reported it has made another breakthrough in independently developed innovative drugs, offering a tribute to the National Day through scientific achievement (Press release, Jecho Laboratories, OCT 1, 2025, View Source [SID1234656380]).

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Jechobio has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration (NMPA), officially approving the clinical trial of JL19001 injection for the treatment of non-muscle-invasive bladder cancer (NMIBC).

Looking ahead, Jechobio will continue to uphold its innovation-driven mission, accelerate its drug development efforts, and contribute to advancing human health and well-being worldwide.

About JL19001 Injection

JL19001 injection is a Class I innovative drug jointly developed by Jecho laboratories, Inc. (USA) and Jecho Biopharmaceuticals Co., Ltd. It is a fusion protein composed of recombinant human serum albumin (HSA) and an IL-15Rα/IL-15 complex, designed to activate NK cells and CD8⁺ T cells, enhancing both innate and adaptive immune responses.

When used in combination with Bacillus Calmette–Guérin (BCG), JL19001 is intended to treat non-muscle-invasive bladder cancer (NMIBC) by helping avoid bladder removal surgery, thus improving patient survival rates and quality of life.

On October 1, 2025 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of clinical research across its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, which is taking place in Berlin, Germany from October 17 to 21 (Press release, Eisai, OCT 1, 2025, View Source [SID1234656400]).

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Among the notable presentations is data from the Phase 3 Study 309/KEYNOTE-775 trial, which evaluated lenvatinib (LENVIMA), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA*1), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy versus treatment of physician’s choice for patients with advanced endometrial carcinoma. The presentation will feature 5-year overall survival data providing deeper insights into long-term treatment for patients affected by this disease (NCT03517449; Abstract #1119P).

"The 5-year overall survival follow-up from Study 309/KEYNOTE-775 being presented at ESMO (Free ESMO Whitepaper) highlights the consistency of the study data over time, supporting the established role of lenvatinib plus pembrolizumab in the treatment landscape of endometrial cancer and underscoring Eisai’s commitment to generating the long-term evidence that patients, families, and healthcare providers rely on to make informed treatment decisions," said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc. "Our research in endometrial cancer, alongside our data in renal cell carcinoma and innovative pipeline approaches, reflects our dedication to our human health care concept to address unmet medical needs and advance treatment options for people living with cancer."

Further endometrial cancer research includes additional 1-year follow-up results from the Phase 3 LEAP001 study in first-line advanced or recurrent endometrial carcinoma (NCT03884101; Abstract #1114P), as well as a combined analysis examining post-(neo)adjuvant therapy outcomes from both the Study 309/KEYNOTE-775 and LEAP-001 studies (Abstract #1124P). In renal cell carcinoma (RCC), final analysis data from the CLEAR study comparing lenvatinib plus pembrolizumab versus sunitinib in patients with advanced RCC with or without bone metastases will be presented (NCT02811861; Abstract #2603P).

Research from Eisai’s pipeline includes clinical and biomarker results from Study 102 evaluating E7386, a CREB-binding protein (CBP)/β-catenin interaction inhibitor, in combination with lenvatinib in patients with advanced or recurrent endometrial carcinoma (NCT04008797; Abstract #1153P).

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. Regular abstracts will be made available via the ESMO (Free ESMO Whitepaper) website on 12:05 AM Central European Summer Time (CEST) on Monday, October 13, 2025. Latebreaking abstracts accepted for presentation at ESMO (Free ESMO Whitepaper) as a Proffered Paper or Mini Oral will be published on the ESMO (Free ESMO Whitepaper) website at 12:05 AM CEST on the day of presentation. Posters will be on display from 9:00 AM – 5:00 PM CEST on the day of their poster session.

Cancer Type Study/Compound Presentation Title Presentation Type & Details
Lenvatinib Plus Pembrolizumab
Gynecologic Cancer
Study 309/
KEYNOTE-775
Lenvatinib plus pembrolizumab (L+P) vs
treatment of physician’s choice (TPC) for
advanced endometrial cancer (EC): 5-Year
outcomes from Study 309/KEYNOTE-775
Poster Session
Presentation #1119P
October 18, 2025
LEAP-001
First-line lenvatinib + pembrolizumab (L+P) vs
chemotherapy (CT) for advanced or recurrent
endometrial cancer (EC): additional 1-year
follow-up results from ENGOT-en9/LEAP-001
Poster Session
Presentation #1114P
October 18, 2025
Study 309/
KEYNOTE-775 and
LEAP-001
Lenvatinib + pembrolizumab (L+P) in participants
(Pts) with advanced or recurrent endometrial
cancer (aEC): Study 309/KEYNOTE-775 and
ENGOT-en9/LEAP-001 post-(neo)adjuvant
therapy outcomes
Poster Session
Presentation #1124P
October 18, 2025
Gastrointestinal Cancer LEAP-014
Lenvatinib plus pembrolizumab and
chemotherapy versus pembrolizumab and
chemotherapy in untreated metastatic
esophageal squamous cell carcinoma: the
randomized Phase 3 LEAP-014 Study
Proffered Paper Session
Presentation #LBA79
October 17, 2025
2:40-2:50 PM
Genitourinary Cancer CLEAR
Final analysis of lenvatinib + pembrolizumab
(L+P) vs sunitinib (S) in patients with advanced
renal cell carcinoma (aRCC) with or without bone
metastases in CLEAR
Poster Session
Presentation #2603P
October 18, 2025
Pipeline
Gynecologic Cancer E7386*2
Clinical and biomarker results from E7386 study
102: global dose-expansion cohort of E7386 +
lenvatinib (LEN) in patients (pts) with
advanced/recurrent endometrial cancer (aEC)
that progressed on platinum-based
chemotherapy (PBC) and an anti-PD-(L)1
immunotherapy (IO)
Poster Session
Presentation #1153P
October 18, 2025
The following presentations represent studies including lenvatinib treatment sponsored by MSD.
Cancer Type Study/Compound Presentation Title Presentation Type & Details
Genitourinary Cancer
LITESPARK-010
Belzutifan plus lenvatinib for Chinese participants
(pts) with previously treated advanced clear cell
renal cell carcinoma (ccRCC): updated results of
cohort 1 of the LITESPARK-010 study
Poster Session
Presentation #2615P
October 18, 2025
KEYMAKER-U03A
First-line pembrolizumab-based regimens for
advanced clear cell renal cell carcinoma:
KEYMAKER-U03 substudy 03A
Proffered Paper Session
Presentation #LBA96
October 18, 2025
8:30-8:40 AM
Melanoma KEYMAKER-U02B
First-line pembrolizumab alone or with
investigational agents for advanced melanoma:
updated results from the phase 1/2 KEYMAKERU02 substudy 02B
Poster Session
Presentation #1621P
October 20, 2025

In March 2018, Eisai and MSD, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy from MSD, pembrolizumab. Eisai and MSD are studying the lenvatinib plus pembrolizumab combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program. Lenvatinib plus pembrolizumab is approved in the U.S., the EU, Japan and other countries for the treatment of advanced RCC and certain types of advanced endometrial carcinoma. Lenvatinib is approved as KISPLYX for advanced RCC in the EU.

On October 1, 2025 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported dosing of the first patient in a cohort of the KOMET-007 clinical trial (NCT05735184) (Press release, Kura Oncology, OCT 1, 2025, View Source [SID1234656381]). This cohort evaluates ziftomenib, a once-daily, investigational oral menin inhibitor, combined with cytarabine and daunorubicin (7+3) as well as quizartinib, for patients with newly diagnosed acute myeloid leukemia (AML). Despite recent advances, including regulatory approvals of FLT3 inhibitors such as quizartinib, patients with FLT3/NPM1 co-mutations face a high risk of relapse and limited durable treatment options. Ziftomenib is the only menin inhibitor to have received Breakthrough Therapy Designation by the Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory NPM1-mutated AML.

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"Patients with FLT3/NPM1 co-mutated AML, a significant subset of newly diagnosed cases, face high relapse rates and limited durable treatment options," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "Preclinical data demonstrate that ziftomenib synergizes with FLT3 inhibitors such as quizartinib, potentially enhancing activity without increasing toxicity. The KOMET-007 trial, alongside our recently launched KOMET-017 registrational trial combining ziftomenib with intensive and non-intensive chemotherapy, reflects our commitment to integrating menin inhibition across AML treatment regimens to improve patient outcomes."

"Initiation of the FLT3 inhibitor cohort in the KOMET-007 trial marks a pivotal advancement in addressing the urgent needs of patients with FLT3/NPM1 co-mutated AML," said Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. "FLT3 mutations play a critical role in AML, driving aggressive leukemia cell proliferation, leading to poor prognosis, higher relapse rates, and shorter overall survival. Kyowa Kirin is proud to collaborate with Kura Oncology to advance this innovative menin inhibitor combination, aiming to improve outcomes for AML patients throughout the continuum of care."

The trial arm will evaluate safety, tolerability and activity of intensive chemotherapy and quizartinib in combination with ziftomenib in adult patients with newly diagnosed FLT3-ITD / NPM1 co-mutated AML. Primary and secondary endpoints include complete remission (CR) and composite complete remission (CRc). More information regarding this trial arm and the KOMET-007 trial is available at www.clinicaltrials.gov (identifier: NCT05735184).

Ziftomenib is currently under clinical development, and its safety and efficacy have not been established by any regulatory authority.