On April 30, 2025 Ingenium Therapeutics, a clinical-stage biotechnology company advancing allogeneic natural killer (NK) cell therapies, reported that it has received positive regulatory feedback from the U.S. Food and Drug Administration (FDA) following a Pre-Investigational New Drug (Pre-IND) meeting (Press release, Ingenium Therapeutics, APR 30, 2025, View Source [SID1234652401]).

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Ingenium has conducted multiple investigator-initiated trials in South Korea, enrolling over 140 patients with acute myeloid leukemia (AML), including a Phase 2 randomized clinical trial with long-term overall survival follow-up. These studies have generated robust non-clinical and clinical data supporting the safety and efficacy profile of Gengleucel.

Based on its review of these data, the FDA has provided positive feedback on Ingenium’s proposal to initiate a Phase 2 trial of Gengleucel in the United States without a preceding Phase 1 study. This regulatory milestone may streamline Gengleucel’s clinical development pathway and may accelerate access for patients with measurable residual disease-positive (MRD+) AML.

The planned multicenter study will be conducted at leading cancer centers across the United States, including a world-renowned institution in Texas. Gengleucel is positioned to become the first NK cell therapy in AML to use MRD negativity as a primary endpoint, underscoring its potential to improve outcomes by eradicating minimal residual disease and reducing relapse risk.

"We are thrilled with the FDA’s guidance, which reflects the rigor of our clinical research and the significant therapeutic potential of Gengleucel, especially in targeting minimal residual disease," said Kevin Koh, CEO of Ingenium Therapeutics. "Launching our U.S. Phase 2 trial at premier cancer centers marks a major milestone in our mission to deliver novel immunotherapies to AML patients with MRD."

The trial is expected to begin in early 2026 and will evaluate Gengleucel’s ability to achieve MRD negativity and reduce relapse and mortality. To ensure reliable clinical operations and product supply, Ingenium is transferring its manufacturing technology to a Texas-based manufacturing facility.

About Gengleucel

Gengleucel is a non-engineered, allogeneic NK cell therapy composed of memory NK cells with enhanced activating receptor expression and increased secretion of IFN-gamma, granzyme, and perforin. These features drive potent anti-cancer activity and sustained in vivo persistence. Clinical trials have demonstrated Gengleucel’s favorable safety, tolerability, and efficacy in high-risk AML and MDS populations. Gengleucel has been granted Orphan Drug Designation by the U.S. FDA for the treatment of AML.

On April 30, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators presented positive preclinical data for Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of KRASG12C mutant non-small cell lung cancer (NSCLC) (Press release, Genprex, APR 30, 2025, View Source [SID1234652385]).

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This data were presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 25-30, 2025 in Chicago, Illinois.

"We are pleased to have this positive preclinical data presented before an audience of the world’s leading cancer researchers, which provides further support for the therapeutic potential of REQORSA both alone and in combination with targeted therapies in NSCLC," said Ryan Confer, President and Chief Executive Officer at Genprex. "We believe REQORSA could be a potential therapeutic treatment for Ras inhibitor resistant lung cancer either alone or in combination with Ras inhibitors, and these studies support the potential expansion of future clinical studies in our pipeline."

The featured Genprex-supported poster presented at AACR (Free AACR Whitepaper) 2025:

Title: Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy

Session Category: Experimental and Molecular Therapeutics

Session Title: Drug Resistance in Molecular Targeted Therapies 3

Session Date and Time: Tuesday, April 29 from 2-5 p.m. CT

Location: Poster Section 17

Poster Board Number: 12

Abstract Presentation Number: 5517

In the poster, entitled, "Overcoming sotorasib acquired resistance in KRASG12C mutant NSCLC by TUSC2 gene therapy," researchers demonstrated that TUSC2 gene therapy (REQORSA) effectively overcomes sotorasib (LUMAKRAS) acquired resistance (AR) in KRASG12C mutant NSCLC mouse xenografts. The data indicate that TUSC2 transfection significantly reduced colony formation and markedly increased apoptosis in two AR cell lines. Re-expression of TUSC2 in AR PDXOs significantly decreased the viability of organoids compared with the empty vector. The H23AR tumors exhibited significantly lower sensitivity to sotorasib than their parental counterparts. However, treatment with REQORSA was highly effective in controlling tumor growth compared to treatment with sotorasib alone or the control groups. REQORSA alone also exhibited a strong antitumor effect on TC314AR PDXs. Sotorasib alone showed no significant antitumor activity in these models. However, a synergistic antitumor effect was observed when TC314AR PDX tumors were treated with the combination of REQORSA and sotorasib. In conclusion, researchers demonstrated that REQORSA, alone or in combination with sotorasib, induced apoptosis, inhibited colony formation, and showed significant antitumor efficacy in KRASG12C mutant sotorasib-acquired resistant xenograft and PDX tumors.

This AACR (Free AACR Whitepaper) poster has been made available on Genprex’s website at www.genprex.com.

About Reqorsa Gene Therapy

REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

On April 30, 2025 PanGIA Biotech, a company advancing urine-based, AI-driven diagnostics for early cancer detection, reported that an abstract co-authored by researchers from PanGIA Biotech, Entopsis Inc., and Genetics Institute of America has been accepted for presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place May 30–June 3, 2025, in Chicago, Illinois (Press release, PanGIA Biotech, APR 30, 2025, View Source [SID1234652402]).

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The abstract, titled Development and validation of an AI-enabled prediction of prostate cancer (PCa) using urine-based liquid biopsy (Abstract #3080), has been accepted for presentation in the poster session titled Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology.

The presentation highlights collaborative research contributing to PanGIA’s AI-driven, urine-based diagnostic platform. The work integrates biomolecular pattern analysis and machine learning to support the development of scalable, non-invasive solutions in cancer care.

ASCO 2025 Presentation Details

Date: June 2, 2025
Time: 1:30 – 4:30 p.m. CDT
Location: McCormick Place, Chicago, IL
"This presentation reflects our focus on developing non-invasive, scalable diagnostics rooted in the promise of liquid biopsy innovation," said Holly Magliochetti, CEO of PanGIA Biotech. "We remain committed to advancing technologies that may support earlier cancer detection and improve access to care globally."

Co-authors on the abstract include researchers from PanGIA Biotech, Entopsis Inc., and the Genetics Institute of America.

On April 30, 2025 GSK reported strong start to 2025 with growth in sales, profits and earnings (Press release, GlaxoSmithKline, APR 30, 2025, View Source [SID1234652386]).

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Specialty Medicines growth drives Q1 performance:

Total Q1 sales £7.5 billion +2% AER; +4% CER

Specialty Medicines sales £2.9 billion (+17%); Respiratory, Immunology and Inflammation £0.8 billion (+28%); Oncology £0.4 billion (+53%); HIV sales £1.7 billion (+7%)
Vaccines sales £2.1 billion (-6%); Shingrix £0.9 billion (-7%); Meningitis vaccines £0.4 billion (+20%); and Arexvy £0.1 billion (-57%)

General Medicines sales £2.5 billion (stable); Trelegy £0.7 billion (+15%)

Total operating profit +50% and Total EPS +56% driven by lower CCL charges

Core operating profit +5% and Core EPS +5% reflecting strong Specialty Medicines performance and disciplined
increased investment in R&D portfolio progression, new asset launches and growth assets
Cash generated from operations exceeded £1 billion with free cash flow of £0.7 billion
Q1 2025
£m % AER % CER
Turnover 7,516 2 4
Total operating profit 2,216 49 50
Total operating margin % 29.5% 9.2ppts 9.0ppts
Total EPS 39.7p 55 56
Core operating profit 2,533 4 5
Core operating margin % 33.7% 0.5ppts 0.3ppts
Core EPS 44.9p 4 5
Cash generated from operations 1,301 16
Pipeline progress and investment delivering future growth opportunities:
5 major new FDA product approvals expected in 2025:
Q1 2025 approvals: Penmenvy, meningitis vaccine; Blujepa, first-in-class antibiotic treatment for uUTIs
Positive ACIP recommendations for Penmenvy (and Arexvy (adults 50-59))
Further approvals expected for: Nucala (COPD); Blenrep (multiple myeloma); and depemokimab (severe asthma and nasal polyps)
14 key opportunities expected to launch 2025-2031 each with PYS potential above £2 billion
Data presented at CROI for VH184, VH499 and N6LS support development plans for ULA HIV regimens
Breakthrough designation granted for GSK’227 B7H3 ADC for 2L osteosarcoma
Pivotal/Phase III trials expected to start in 2025 for: Respiratory (depemokimab COPD programme – ENDURA); Oncology (GSK’227 B7H3 ADC ES-SCLC; IDRx-42 2L GIST; Ojjaara (MDS)); and HIV (Q4M treatment)
Investment in targeted business development continues
Acquisition of IDRx completed
New partnership with ABL Bio in neurodegenerative diseases; and novel research collaboration with UK Dementia Research Institute & HDRUK to investigate shingles vaccination with prevention of dementia
Continued commitment to shareholder returns
Dividend declared of 16p for Q1 2025; 64p expected for full year 2025
£273 million of shares bought back as part of the £2 billion share buyback programme commenced in Q1 2025
Confident for delivery of 2025 guidance
Continue to expect 2025 turnover growth 3% to 5%; Core operating profit growth 6% to 8%; Core EPS growth 6% to 8%

Emma Walmsley, Chief Executive Officer, GSK:
"GSK continues to make strong progress, demonstrating the quality, strength and resilience of our portfolio. Specialty Medicines, our largest business, delivered strong sales contributions in the quarter and R&D progress continued, with two of the five FDA product approvals expected this year now secured, and the acquisition of a promising new oncology asset.
We are very focused on preparing for launches of Blenrep, Nucala and depemokimab, and pivotal trials for potential new medicines in respiratory, oncology, HIV and hepatitis. This momentum, together with the strength of our portfolio and proven ability to drive operating leverage, underpin our confidence in guidance for the year and our longer-term outlooks."

On April 30, 2025 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology focused medical technology business seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications, reported preliminary financial results for Q1 2025 and that it has entered into a securities purchase agreement with certain investors for shares of its common stock to raise approximately $22.0 million in gross proceeds (Press release, TriSalus Life Sciences, APR 30, 2025, View Source [SID1234652403]). Additionally, as further described below, the Company committed to commence an exchange offer with respect to its outstanding Series A Convertible Preferred Stock (the "Preferred Stock"), which is intended to simplify the Company’s capital structure.

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Preliminary Unaudited First Quarter 2025 Financial Results

Full financial results for the quarter ended March 31, 2025 are in the process of being finalized, however, initial and preliminary results show revenue, driven solely by the TriNav Infusion System, of approximately $9.2 million for the first quarter of 2025. This represents growth of approximately 42% versus the first quarter of 2024.

Private Placement

The private placement is being led by Nantahala Capital and includes investments by Broadfin Holdings and additional healthcare-focused institutional investors. Canaccord Genuity is acting as the sole placement agent for the private placement.

The Company will issue an aggregate of 5,500,000 shares of its common stock at a purchase price of $4.00 per share. The private placement is expected to close on or about May 2, 2025, subject to satisfaction of customary closing conditions. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock issued in the private placement and intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

Simplifying the Capital Structure

In connection with the private placement, TriSalus has entered into a Tender and Support Agreement with certain holders representing approximately 55% of outstanding shares of Preferred Stock. The Company has agreed to:

Launch a registered exchange offer pursuant to a registration statement on Form S-4 to be filed with the SEC to offer all preferred holders the opportunity to exchange their shares of Preferred Stock into a number of shares of common stock calculated based on a fixed value of $10.00 per share of Preferred Stock plus accrued dividends that would have accrued through August 10, 2027, divided by $4.00 per share; and
Convene a special meeting of stockholders to, among other things, vote on an amendment to the Certificate of Designations for the Preferred Stock that would (i) allow TriSalus to call and convert outstanding shares of Preferred Stock under specific terms and (ii) eliminate the conversion price reset provision currently scheduled for July 2027.
The Company expects to launch the exchange offer by the end of the second quarter of 2025 and to hold the special meeting in the third quarter of 2025. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

About Preliminary Financial Results

The preliminary results set forth above are unaudited, are based on management’s initial review of the Company’s results for the quarter ended March 31, 2025, and are subject to revision based upon the Company’s quarter-end closing procedures. Actual results may differ materially from these preliminary unaudited results following the completion of quarter-end closing procedures, final adjustments or other developments arising between now and the time that the Company’s financial results are finalized. In addition, these preliminary unaudited results are not a comprehensive statement of the Company’s financial results for the quarter ended March 31, 2025, should not be viewed as a substitute for full, unaudited financial statements for the quarter ended March 31, 2025, and are not necessarily indicative of the Company’s results for any future period.