On November 11, 2025 BioNtech presented its corporate presentation.

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(Presentation, BioNTech, NOV 11, 2025, View Source [SID1234659810])

On November 11, 2025 The U.S. Food and Drug Administration (FDA) reported it has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic designed to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. This is the first Promega companion diagnostic to receive FDA approval.

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OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue. MSI status can be used to guide treatment decisions and support precision oncology strategies in endometrial carcinoma.

"This approval underscores the critical role diagnostics play in accurately matching the right patients, at the right time with the right therapy," says Alok Sharma, Global Clinical Market Director at Promega. "We are committed to delivering reliable tools that guide clinical decisions and help improve patient outcomes."

The approval was supported through a collaboration with Merck, which markets KEYTRUDA plus LENVIMA in collaboration with Eisai Co., Ltd. Together, the companies are working to advance personalized medicine and expand access to diagnostics that enable informed therapeutic choices.

OncoMate MSI Dx Analysis System was previously cleared by the FDA as the first PCR-based molecular diagnostic for identifying colorectal cancer patients who may benefit from additional testing to diagnose Lynch syndrome. This approval applies to the United States and its territories. Promega MSI technology has received additional regulatory approvals in China and the European Union.

Learn more about Promega MSI technology here.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

(Press release, Promega, NOV 11, 2025, View Source [SID1234659767])

On November 11, 2025 TriSalus Life Sciences Inc. (Nasdaq: TLSI) ("TriSalus" or the "Company"), an oncology company integrating novel delivery technology with standard of care therapies to transform treatment for patients with solid tumors, reported that Mary Szela, Chief Executive Officer and President, and David Patience, Chief Financial Officer, will participate in the following investor conferences in November:

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Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum
Management will participate in one-on-one meetings and participate in a corporate overview on Thursday, November 20, at 2:30 p.m. ET. Click here for a link to the live webcast.

37th Annual Piper Healthcare Conference in New York, NY
Management will participate in one-on-one meetings and participate in a corporate overview on Tuesday, December 2, at 3:10 p.m. ET. Click here for a link to the live webcast.

A webcast replay of the corporate overview will be available for 90 days following the presentation in the Events section of the TriSalus Investor website at www.investors.trisaluslifesci.com.

(Press release, TriSalus Life Sciences, NOV 11, 2025, View Source [SID1234659766])

On November 11, 2025 iLeukon Therapeutics, Inc., a San Diego-based clinical-stage biotechnology company developing next-generation mRNA-based immunotherapies, reported new clinical results from the ongoing first-in-human Phase I trial (NCT05978102) of ILKN421H, presented during a Late-Breaking Clinical Oral Session at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, MD.

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The study evaluates ILKN421H, a lipid-nanoparticle (LNP)-formulated mRNA encoding a non-α HSA–IL-2 variant (IL-2v), as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors, including first-line non-small cell lung cancer (NSCLC). The presentation highlighted ILKN421H’s unique scientific design and distinct pharmacologic advantages that enable potent immune activation with a favorable safety profile.

Key Advantages of ILKN421H in Preclinical Research:

Stem-like CD8+ T Cell Amplification: ILKN421H selectively expands PD1- stem-like CD8⁺ T cells, a subset capable of self-renewal and durable antitumor immunity.
Lymphoid Specific Expression and Reduced Systemic Exposure: ILKN421H mRNA is predominantly expressed in lymphoid organs, such as the spleen and lymph nodes, with <5% expressed in liver and other organs. This targeted biodistribution reduces the systemic exposure of IL–2v while enhancing its immune activity.
Overcoming the Cytokine-Sink Effect and a Remarkable Amplification of CD8+ T and NK cells: Unlike protein-based IL-2 therapies that are rapidly internalized by the targeting cells which terminates the IL-2 signaling towards T cell proliferation, ILKN421H’s sustained mRNA–mediated production bypasses the cytokine-sink effect. This enables robust CD8+ T/NK cell proliferation with 1/100 of systemic IL-2v exposure compared with other protein based counterparts like PEG-IL-2v.
Favorable Safety and Tolerability
Across 45 patients with advanced solid tumors, ILKN421H was well tolerated with no dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) was not reached. There were no Grade 4 adverse events (AEs), no treatment-related deaths, and no serious adverse events (SAEs) occurring in more than one patient. The Grade 3 AEs observed in more than one patient included anemia, decreased neutrophil count, decreased platelet count, fever, and hypokalemia. The safety profile of ILKN421H in combination with pembrolizumab is generally similar to that of pembrolizumab alone. No vascular leak syndrome (VLS) or hypotension were observed. These findings highlight ILKN421H’s favorable safety and tolerability relative to earlier-generation IL-2 therapeutics.

Reliable and Robust PK/PD
Pharmacokinetic data from the Phase I study demonstrated prolonged IL-2v expression with a half-life of approximately 20 hours. Pharmacodynamic study showed marked increase of peripheral CD8⁺ T cells and NK cells, up to 10-fold and 25-fold respectively. No ADA was detected, and no sign of reduced IL-2v expression or pharmacological effect was observed after repeated administration up to 30 cycles (Q3W per cycle).

Clinical Efficacy
In patients with first-line (1L) non-small cell lung cancer (NSCLC) regardless of PD-L1 expression levels (n=20), ILKN421H in combination with pembrolizumab demonstrated promising efficacy, with a confirmed objective response rate (ORR) of 80% (16/20 patients). When analyzed by PD-L1 status, ORR was 87% in PD-L1–positive patients and 60% in PD-L1–negative patients. Median progression-free survival (PFS) has not yet been reached and is projected to exceed 12 months. In the post–immunotherapy (post-IO) NSCLC cohort (n=3), ILKN421H combined with pembrolizumab achieved an ORR of 33.3% (1/3 patients), including one partial response (PR) and one patient with durable stable disease (SD) lasting more than 14 months. Together, these results highlight the clinical promise of ILKN421H in both first-line and post-IO NSCLC, supporting its continued development across treatment settings.

Advancement to Phase II Development
Based on these favorable Phase I results, the FDA has cleared iLeukon’s IND application and Phase II protocol to evaluate ILKN421H in combination with pembrolizumab for both 1L and post-IO treatment of NSCLC. "These Phase I results validate the novel design of ILKN421H and demonstrate its potential to deliver meaningful clinical benefit for patients with cancer," said Haining Huang, Ph.D., Chief Executive Officer of iLeukon Therapeutics. "ILKN421H defines the next evolution of IL-2 therapy by combining mRNA technology with selective immune activation to deliver durable efficacy and a favorable safety profile. We look forward to advancing this program into Phase II evaluation."

(Press release, iLeukon Therapeutics, NOV 11, 2025, View Source [SID1234659765])

On November 11, 2025 Salarius Pharmaceuticals, Inc. ("Salarius" or the "Company") (NASDAQ: SLRX) reported the pricing of an underwritten public offering for gross proceeds of approximately $7 million before deducting underwriting discounts and commissions and other offering expenses.

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The offering is comprised of 2,514,335 shares of its common stock ("Common Stock") and pre-funded warrants to purchase 2,152,331 shares of Common Stock, in each case with accompanying Series A Warrants to purchase up to an aggregate of 4,666,666 shares of Common Stock and Series B Warrants to purchase up to an aggregate of 4,666,666 shares of Common Stock. The combined public offering price per share of Common Stock and accompanying warrants is $1.50 per share and accompanying warrants, and the combined public offering price per pre-funded warrant and accompanying warrants is $1.4999 per pre-funded warrant and accompanying warrants. The warrants issued in this offering are fixed priced and do not contain any variable pricing features or alternative exercise provisions. All of the securities are being sold by Salarius.

Ladenburg Thalmann & Co. Inc. is acting as sole book-running manager in connection with the offering.

The closing of the offering is expected to occur on or about November 12, 2025, subject to the satisfaction of closing conditions, including consummation of the Company’s proposed business combination transaction with Decoy Therapeutics Inc. ("Decoy"). In addition, Salarius has granted the underwriter an option for a period of 45 days to purchase up to an additional 699,999 shares of Common Stock, and/or 699,999 Series A Warrants, and/or 699,999 Series B Warrants at their respective public offering prices, less underwriting discounts and commissions.

Salarius expects to use the net proceeds from the offering (i) to advance the clinical development of Salarius’ and Decoy’s research and development programs; (ii) to pay off certain of Decoy’s outstanding promissory notes as required thereby; and (iii) for other general corporate purposes, including working capital, research and development, and capital expenditures.

Each pre-funded warrant has an exercise price of $0.0001 per pre-funded warrant, and is immediately exercisable until such pre-funded warrant is exercised in full. Each of the Series A Warrants and Series B Warrants has an exercise price of $1.50. The Series A Warrants will be exercisable for a period of five years from the date of issuance. The Series B Warrants will be exercisable for a period of one year from the date of issuance.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333- 284368) that became effective in accordance with Section 8(a) of the Securities and Exchange Act of 1933, as amended, on November 10, 2025.

The securities are being offered by means of a prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus relating to the offering was filed with the Securities and Exchange Commission (the "SEC") on October 21, 2025, and is available on the SEC’s website at www.sec.gov. The final prospectus relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website at www.sec.gov. Before investing in the offering, you should read prospectus relating to the offering in their entirety as well as the other documents that Salarius has filed with the SEC that are incorporated by reference in the prospectus relating to the offering, which provide more information about Salarius and the offering. Electronic copies of the final prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

(Press release, Salarius Pharmaceuticals, NOV 11, 2025, View Source [SID1234659764])