On November 4, 2025 Leidos Holdings, Inc. reported financial results for the third quarter of fiscal year 2025, highlighted by robust earnings and revenue growth.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Leidos continues to deliver exceptional results through the strength of our portfolio of mission-critical work as well as the innovation, agility, and discipline of our talented workforce," said Leidos Chief Executive Officer Tom Bell. "Despite the government shutdown, we are raising our 2025 earnings and margin guidance and holding firm on our 2025 revenue and cash guidance. Moreover, we are optimistic about our future given our alignment with the priorities of the administration and confidence that our customers will move out aggressively in search of smarter and more efficient outcomes for the nation."

(Press release, Leidos, NOV 4, 2025, View Source [SID1234661778])

On November 4, 2025 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported that it will hold an investor event at the Society of Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) Annual Meeting centered around the Company’s groundbreaking RedTail platform and its lead candidate, CLD-401.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The presentation will take place at the SITC (Free SITC Whitepaper) Annual Meeting on Friday, November 7th from 8:30AM to 9:30AM in the National Harbor Room 15 at the Gaylord National Hotel and Convention Center in National Harbor, Maryland.

The presentation will also be live streamed: (View Source).

Speakers at the event will include:

· Dr. Dmitriy Zamarin of the Icahn Genomics Institute and the Precision Immunology Institute at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. Dr. Zamarin is a world renowned expert in virotherapy. Dr. Zamarin is a member of Calidi’s Scientific Advisory Board (SAB).

· Dr. Antonio F. Santidrian, Chief Scientific Officer of Calidi, responsible for leading all of the Company’s research and development initiatives.

· Dr. John M. Wrangle, a thoracis medical oncologist at the Medical University of South Carolina (MUSC). Dr Wrangle is an expert on the clinical development of IL-15 superagonist. Dr. Wrangle is also a member of Calidi’s SAB.

· Dr. Travis Clifton, Chief Medical Officer of Calidi and a surgical oncologist with over 17 years of experience in drug development, early phase and translational clinical trials, and cancer immunotherapy.

"We are excited to hold our first investor event," said Eric Poma, PhD, Chief Executive Officer. "We believe CLD-401 and the RedTail platform represent important breakthroughs in the area of genetic medicine, and we look forward to updating the investment community on our progress."

Calidi is currently conducting IND-enabling studies for CLD-401 and anticipates submitting an Investigational New Drug (IND) application by the end of 2026. The company is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, NOV 4, 2025, View Source [SID1234659347])

On November 4, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the company has entered into an agreement to receive funds managed by Blackstone Life Sciences ("Blackstone") for the development of sacituzumab tirumotecan (sac-TMT), an investigational antibody-drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), a protein found on the surface of various cancer cells. Merck is currently evaluating sac-TMT in 15 global Phase 3 clinical trials spanning six tumor types, including breast, endometrial and lung cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This agreement positions Merck to harness the potential of sac-TMT, a promising ADC candidate targeting TROP2, while we continue to advance our broad and expansive pipeline," said Caroline Litchfield, chief financial officer, Merck. "We are making important investments to drive patient impact and revenue growth, and to sustain our business for the future while remaining disciplined towards maintaining an appropriate financial profile."

Under the terms of the agreement, Blackstone will pay Merck $700 million (which is non-refundable, subject to termination provisions provided for in the agreement) to fund a portion of the development costs for sac-TMT expected to be incurred throughout 2026. In return, Blackstone is eligible to receive low-to-mid single-digit royalties on net sales of sac-TMT across all approved indications in Merck’s marketing territories contingent upon receipt of regulatory approval in the U.S. for first-line treatment of triple-negative-breast cancer based on findings of the TroFuse-011 clinical trial.

"Sac-TMT is an innovative asset that has the potential to improve patient care across many forms of cancer," said Dr. Nicholas Galakatos, global head, Blackstone Life Sciences. "We are excited to be collaborating with Merck to realize the full value of this high priority product and contribute to our partner’s revenue growth by leveraging our scale capital and expertise."

Sac-TMT is being developed as part of an exclusive license and collaboration agreement with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., a holding subsidiary of Sichuan Kelun Pharmaceutical Co, Ltd. ("Kelun-Biotech"), which is unchanged by this agreement with Blackstone. Merck will retain decision-making authority and control over the development, manufacturing, and commercialization of sac-TMT; Blackstone will not receive any rights to sac-TMT.

About sacituzumab tirumotecan (sac-TMT)

Sac-TMT is an investigational ADC that consists of three components: 1) a TROP2-targeting monoclonal antibody, sacituzumab, 2) a cytotoxic payload from the topoisomerase 1 inhibitor class, and 3) a novel, irreversible but hydrolyzable linker, which joins the monoclonal antibody and the cytotoxic payload leveraging proprietary linker conjugation technology. The average drug-to-antibody ratio of sac-TMT is 7.4. TROP2 is highly expressed in a variety of epithelial-derived tumors and can promote tumor cell proliferation, invasion and metastasis. TROP2 ADCs specifically target TROP2-expressing tumor cells to deliver cytotoxic effects and have shown encouraging anti-tumor activity in clinical studies.

Sac-TMT was developed by Kelun-Biotech. Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Under a collaboration agreement, Kelun-Biotech has granted Merck the exclusive rights to develop, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macau and Taiwan).

(Press release, Merck & Co, NOV 4, 2025, View Source [SID1234659363])

On November 4, 2025 Vivesto AB, an oncology-focused development company, reported that positive results were obtained from preclinical studies in an animal model of Acute Myeloid Leukemia (AML), in which Cantrixil was combined with drugs used in standard of care treatments. Vivesto also announced that a new international patent application covering the treatment of hematological cancer with Cantrixil in combination with other treatments has been filed, with the potential to significantly strengthen the IP position.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The drug candidate Cantrixil has been evaluated in vivo in combination with other anti-cancer drugs in an animal model involving difficult to treat human AML cancer. The results demonstrate clear positive effects of Cantrixil alone and even stronger effects when Cantrixil was combined with other anti-cancer drugs. These positive results confirm previous preclinical in vitro and in vivo efficacy data that have shown strong effects of Cantrixil alone and synergistic effects when combined with standard of care treatments, and support continued development of Cantrixil in hematological cancer, especially in AML.

"Hematological cancer is one of Vivesto’s priority focus areas, and we are pleased to report successful results from yet another preclinical study supporting further development of the Cantrixil program. The next steps involve further pre-clinical studies ahead of moving the program into clinical development," said Erik Kinnman, CEO of Vivesto. "Vivesto also filed a new international patent application for the treatment of hematological cancer with Cantrixil that may further increase the value of the program."

Vivesto is continuing the planning of activities needed to bring Cantrixil into clinical trials, and in parallel will investigate opportunities to partner the project to optimize the development program.

(Press release, Vivesto, NOV 4, 2025, View Source [SID1234659379])

On November 4, 2025 iLeukon Therapeutics, Inc., a San Diego-based clinical-stage biotechnology company developing next-generation mRNA-based immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application and a phase II protocol evaluating ILKN421H in combination with pembrolizumab for first line and post-IO treatment of patients with advanced NSCLC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ILKN421H is a novel LNP-formulated mRNA therapy encoding a non-alpha HSA–IL-2v fusion protein for the treatment of cancer. Administered intravenously every three weeks, ILKN421H achieves efficient and preferential mRNA expression in lymphoid organs with an extended half-life of IL-2v approximately 20 hours. Its non-alpha IL-2v design selectively expands stem-like CD8 T and NK cells, while the mRNA platform overcomes cytokine-sink limitations seen with protein-based IL-2 therapies—offering the potential for greater efficacy with reduced systemic toxicity.

In a first-in-human, open-label Phase I study (NCT05978102), ILKN421H demonstrated antitumor activity and a favorable safety profile, with no cases of vascular-leak syndrome or hypotension. In this trial evaluating ILKN421H as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, ILKN421H was well tolerated, with no dose-limiting toxicities and no maximum tolerated dose reached among the 45 enrolled patients. Combination therapy with pembrolizumab, in first-line NSCLC, achieved a confirmed objective response rate (ORR) of 80% (n=16/20) regardless of PD-L1 expression, with median progression-free survival (PFS) not yet reached and projected to exceed 12 months. The summary of this Phase I study was selected as an oral presentation at the upcoming SITC (Free SITC Whitepaper) Annual Meeting, and the results will be presented on November 8, 2025.

"Next-generation IL-2 agents have been a major focus of the immuno-oncology field for the past decade," said Haining Huang, Chief Executive Officer of iLeukon Therapeutics. "ILKN421H expands cytotoxic lymphocytes—CD8 T cells and NK cells—by up to five- and twenty-five-folds respectively, the first IL-2 based treatment that achieved this level of immune promotion safely. We believe ILKN421H can enhance the efficacy of checkpoint inhibitors, such as pembrolizumab, and may also support future modalities including TIL and in vivo CAR-T therapies. With FDA clearance to proceed to phase II, we look forward to advancing ILKN421H globally to meet the significant unmet needs and to improve the outcomes for patients with NSCLC and potentially other types of cancers in the future."

(Press release, iLeukon Therapeutics, NOV 4, 2025, View Source [SID1234659397])