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 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 FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, reported that a plixorafenib abstract has been selected for poster presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), taking place May 30-June 3, 2025 in Chicago (Press release, Fore Biotherapeutics, APR 30, 2025, View Source [SID1234652384]).

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At ASCO (Free ASCO Whitepaper) 2025, Karisa Schreck, M.D., Ph.D., from the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, will present a trials-in-progress poster highlighting the study design of the global registration-intended FORTE Master Protocol, which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are BRAF V600 Recurrent Primary Central Nervous System Tumors, Rare BRAF V600 Mutated Solid Tumors and Solid Tumors with BRAF Fusions.

Poster Presentation Details:

Title: FORTE: A phase 2 master protocol assessing plixorafenib for BRAF-altered cancers
Poster Session: Central Nervous System Tumors
Date and Time: Saturday, May 31, 2025, 9:00 a.m. – 12:00 p.m. CT
Abstract Number: TPS2091
Presenter: Karisa Schreck, M.D., Ph.D., Johns Hopkins University

On April 30, 2025 Endevica Bio, a privately held company developing first-in-class peptide drug candidates, reported the dose administration for the first patient in a Phase 2 trial for its experimental drug TCMCB07 (B07) to prevent weight loss in cancer patients undergoing chemotherapy (Press release, Endevica Bio, APR 30, 2025, View Source [SID1234652383]).

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The trial, being conducted in partnership with WuXi Clinical, will include 20 sites and 100 patients who are diagnosed with stage 4 metastatic colorectal cancer.

In the trial, patients are dosed with B07 as they begin chemotherapy and during the first several rounds of chemotherapy. The primary endpoint is preventing weight loss, which can lead to a debilitating condition called cachexia, a life-threatening wasting syndrome associated with chronic diseases, including cancer.

"This marks an important milestone in our commitment in developing a potentially life changing treatment for cachexia," said Russell Potterfield, Chief Executive Officer and Executive Chair of Endevica. "Each trial brings us closer to offering a viable solution for this debilitating disease, and we remain dedicated to making a lasting impact on the lives of those affected."

"We are incredibly excited to have our first patient dosed with B07 in individuals diagnosed with metastatic colorectal cancer who are undergoing chemotherapy," said Dr. Daniel Marks, Chief Medical and Scientific Officer of Endevica Bio. "Since there is no FDA approved therapeutic for cancer cachexia, this trial is a crucial step to provide a therapy for an area of huge unmet clinical need, and we look forward to the results."

In 2024, Endevica Bio completed its Phase 1 clinical trial with preliminary findings supporting its strong safety and efficacy. Last November, the Journal of Clinical Investigation, showed that B07 improved the appetite and preserved lean mass and fat mass in rodent models of cancer and its associated combination chemotherapy. This same study showed the strong potential of B07 to alleviate chemotherapy-induced anorexia and weight loss for millions of patients worldwide.

About TCMCB07
TCMCB07 is a melanocortin‐3/4 antagonist peptide candidate in clinical development for the treatment of cachexia. It is designed to be a first-in-class peptide drug with the ability to cross the blood-brain barrier and act on previously inaccessible target receptors to modulate the body’s behavioral and metabolic response to chronic illness. Pre-clinical animal trial results show significant lean muscle mass retention (e.g., a reversal of the cachectic condition) during administration of the drug. The results are consistent in cachexia arising from many different types of chronic disease.

On April 30, 2025 Domain Therapeutics ("Domain" or "the Company"), the GPCR experts harnessing deep receptor biology to develop breakthrough treatments for patients, reported new clinical and preclinical data for its key oncology programs DT-9081 and DT-7012, and preclinical insights on its PAR2 biased NAM program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Chicago, USA (Press release, Domain Therapeutics, APR 30, 2025, View Source [SID1234652379]).

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The presentations underscore Domain’s commitment to redefining cancer therapy and the potential of GPCRs to modulate the tumor microenvironment (TME) and enhance anti-tumor immunity. Details on the poster presentations are highlighted below:

Poster presentation #7450 titled "Clinical PK, PD and safety analysis of a phase I clinical trial of DT-9081, an EP4R-antagonist, for RP2D determination in patients with advanced solid tumors", details Phase I clinical trial results for DT-9081, a novel EP4 receptor antagonist. The findings outline DT-9081’s promising potential to inhibit tumor growth and enhance immune response in patients with advanced solid tumors. Administered orally once daily, DT-9081 has demonstrated:

Sustained EP4R target engagement as shown by cytokine release measurements and dose-proportional pharmacokinetics (PK) exposure with the best target coverage profile reported at the dose of 600 mg
An acceptable safety profile with no dose-limiting toxicities (DLT) observed at the highest doses (400 mg and 600 mg). In addition, one-third of patients achieved stable disease after two cycles of treatment
The comprehensive evaluation of safety, tolerability, and PK/pharmacodynamics (PD) profile of DT-9081 allowed to select 600 mg as the RP2D for further clinical development in advanced solid tumors.

Poster presentation #7080 titled "Comprehensive Characterization of DT-7012, a Differentiated CCR8-Depleting Antibody for the Treatment of Solid Tumors", details preclinical and benchmark data highlighting the sophisticated profile of DT-7012, a Treg depleting anti-CCR8 monoclonal antibody. The study highlighted that DT-7012:

Demonstrates a broad pattern of CCR8 binding, high affinity to CCR8, and potent effector functions, enabling effective targeting and selective depletion of CCR8+ Tregs in patient samples
Exhibits high specificity for CCR8, avoiding depletion of circulating immune cells and presenting a favorable safety profile
Maintains functional efficacy, preserving antagonistic activities (ADCC/ADCP) even under high concentrations of the CCR8 ligand CCL1 and effectively blocking CCL1-induced receptor internalization
The highly differentiated and competitive properties of DT-7012 differentiate it from other clinical anti-CCR8 candidates, positioning it as a promising therapeutic solution to overcome immune evasion mechanisms and enhance anti-tumor immune responses in solid tumors. These preclinical findings support the advancement of DT-7012 into Phase I/II trials, anticipated to start in 2025.

Poster presentation #6157, titled "PAR2 inhibitors reduce resistance to immunotherapy against cancer", details the groundbreaking research in collaboration with Prof. John Stagg, demonstrating the promising potential of its PAR2 biased NAM in overcoming resistance to immune checkpoint blockade (ICB) and addressing T cell dysfunction in cancer. The preclinical findings revealed that PAR2 biased NAM:

Synergizes with anti-PD1 therapy, turning macrophage phenotype and cytokine profile toward a pro-inflammatory TME
Promotes antigen-presenting cells and T cells, facilitating robust antitumoral responses
This research provides critical insights into the mechanisms of PAR2 inhibition, positioning Domain’s PAR2 biased NAM program as a transformative therapeutic approach to overcome tumor resistance to ICB and restore effective immune control.

Stephan Schann, Chief Scientific Officer of Domain Therapeutics, said: "The exciting data presented at AACR (Free AACR Whitepaper) 2025 further validates our unique and differentiated drug discovery and development approach, built on our proprietary platform and deep expertise in GPCR biology. These findings underscore the transformative potential of our compounds to address significant unmet medical needs and illustrate our commitment to provide better treatments for patients, a goal that is profoundly important to us."

Prof. John Stagg, Principal Investigator at the Centre Hospitalier de l’Université de Montréal (CHUM), Canada and Member of Domain Therapeutics’ Scientific Advisory Board, commented: "This collaboration with Domain Therapeutics, a unique GPCR company, highlights the importance of tackling challenging targets like PAR2. The comprehensive research presented at AACR (Free AACR Whitepaper) 2025, which explores PAR2’s role in the tumor microenvironment, demonstrates its potential to combat resistance mechanisms and improve treatment efficacy, paving the way for new advancements in immuno-oncology."