Alligator Bioscience announces upcoming presentation of REACtiVe-2 Phase 1 data at ESMO Congress 2025

On July 25, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that data from the Phase 1 REACtiVe-2 trial (NCT05650918) of the CD40 agonist mitazalimab in combination with dendritic cell vaccination (Amphera’s MesoPher) will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place on 17–21 October in Berlin, Germany (Press release, Alligator Bioscience, JUL 25, 2025, View Source [SID1234654521]).

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The study, led by Erasmus MC Cancer Institute, evaluated the safety, tolerability, and immunologic activity of mitazalimab in combination with MesoPher following chemotherapy with mFOLFIRINOX in patients with metastatic pancreatic cancer. The data will be presented in a poster entitled "REACtiVe-2: Phase I Evaluation of Dendritic Cell Vaccination and Agonistic CD40 Therapy Following (m)FOLFIRINOX in Metastatic Pancreatic Cancer".

LaNova Medicines Receives FDA IND Clearance for LM-350, a Novel CDH17-Targeting ADC

On July 24, 2025 LaNova Medicines Ltd. reported that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for LM-350, its innovative antibody-drug conjugate (ADC) targeting CDH17 (Press release, LaNova Medicines, JUL 24, 2025, View Source [SID1234656026]).

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LM-350 was developed using LaNova’s next-generation ADC platform, LM-ADC. It is a highly selective ADC that targets cadherin-17 (CDH17) with strong internalization capacity. The molecule features a wild-type IgG1 backbone and retains antibody-dependent cell-mediated cytotoxicity (ADCC) activity. In preclinical studies, LM-350 demonstrated potent anti-tumor efficacy across multiple xenograft models, with particularly strong activity in colorectal cancer cells resistant to MMAE or irinotecan.

CDH17 plays a key role in tumor invasion and metastasis and is highly expressed in approximately 99% of colorectal cancers, 86% of gastric adenocarcinomas, 79% of esophageal adenocarcinomas, and 50% of pancreatic ductal adenocarcinomas [1,2] .Gastrointestinal (GI) cancers—including colorectal, gastric, pancreatic, and Esophageal cancers—are among the most prevalent and deadly cancer types worldwide. In 2022, global incidence exceeded 4 million cases, underscoring the significant unmet medical need in this area.

First half of 2025: Solid growth, investments and pipeline progress pave the way for two key launches in H2

On July 24, 2025 Boehringer Ingelheim reported a significant progress in its pipeline across key therapeutic areas as it reached major milestones in the first half of the year (Press release, Boehringer Ingelheim, JUL 24, 2025, View Source [SID1234655575]).

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"We are stepping up our investments in R&D beyond our plans announced in April," said Hubertus von Baumbach, Chairman of the Board of Managing Directors. "The data read-outs that we received in MASH and will receive for oncology, mental health, and pulmonary fibrosis give us reason to accelerate our launch preparedness for these late-stage assets. We are pleased to see our pipeline developing at such pace."

Boehringer advanced its pipeline across clinical phases with five new phase I, II, or III initiations in cardiometabolic diseases, mental health, and oncology, and achieved two additional fast track designations for programs in inflammation. At the same time, the company announced nine R&D partnership agreements, significantly bolstering its human pharma portfolio across all therapeutic areas and tech platforms.

"As our pipelines continue to expand, both in depth and breadth, we need to apply a rigorous focus where we allocate our resources," said Frank Hübler, Member of the Board of Managing Directors with responsibility for Finance. "We want to accelerate our pipeline where we can, to deliver innovative medicines to patients ever faster."

Net sales rose by 7.4%* year-on-year to EUR 12.9 billion in the first six months of 2024, driven by ongoing high patient demand for Boehringer’s medications, especially for the JARDIANCE product family and OFEV in Human Pharma, and NEXGARD in Animal Health.

Human Pharma
As Boehringer prepares for its future portfolio and ongoing and upcoming launches, the past months were marked by developments across all focus therapy areas. For the remainder of the year, more news is expected across the portfolio with data read-outs in oncology (Zongertinib), mental health (Iclepertin) and pulmonary fibrosis (Nerandomilast).

The company’s efforts to advance holistic cardiovascular, renal and metabolic (CRM) health met some major milestones. Positive Phase II data for survodutide in metabolic dysfunction-associated steatohepatitis (MASH) showed groundbreaking results in liver disease due to MASH, with 83.0% of adults treated with survodutide achieving significant improvements versus 18.2% for placebo (response difference: 64.8%; CI 51.1%-78.6%, p<0.0001). Also, a sub analysis demonstrated that up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) achieved an improvement in fibrosis without worsening of MASH vs placebo, 25.9% [response difference: 38.6% (95% CI 18.1% – 59.1%), p=0.0005].1

The company initiated a Phase III trial in chronic heart failure for its novel selective aldosterone synthase inhibitor (ASi) in combination with empagliflozin. In an upcoming Phase III trial in chronic kidney disease for ASi, Boehringer will collaborate with Oxford Population Health.

Boehringer has joined a multi-year sponsorship of the American Heart Association’s Cardiovascular-Kidney-Metabolic Health Initiative. The initiative, which was announced recently, will allow the company to better understand the burden of people affected by diseases in these interconnected areas and enable better care.

Boehringer is committed to re-entering oncology with targeted investments. Phase Ia/Ib trial of Zongertinib, a HER2-specific tyrosine kinase inhibitor in patients with HER2 aberration-positive solid tumors, showed that Zongertinib was well tolerated and demonstrated promising efficacy. 2 The Brightline-1 trial investigating Brigimadlin in dedifferentiated liposarcoma did not meet its primary endpoint, though the benefit-risk assessment remains positive. Data for both oncology trials will be presented at conferences in the coming months.

In the first six months of 2024, the Human Pharma business grew by 9.3%* year on year. Net sales stood at EUR 10.3 billion. Growth was driven primarily by the JARDIANCE family and OFEV. To meet growing demand, the company continues high investments in its production and supply network. In January, Boehringer announced a further expansion and upgrade of its plant in Koropi, Greece. With an investment of EUR 120 million, the company will increase the manufacturing capacity of new and existing medications, some of them in the late-stage development.

Animal Health
In livestock, the VAXXITEK portfolio of poultry vaccines continues to expand and grew by 15.9%*. The company launched BULTAVO 3, a new vaccine that protects cattle and sheep against bluetongue virus serotype 3 (BTV-3). It is the first BTV-3 vaccine that prevents clinical signs and mortality. BULTAVO 3 has been licensed for emergency use in the Netherlands, Belgium, and Germany. Recent outbreaks of BTV-3 in the three countries caused severe losses for farmers and are threatening neighboring countries.

In the Animal Health business, growth was slower than expected in the first six months, with sales up 0.9%* compared to the same period last year to EUR 2.5 billion. This was primarily due to lower-than-expected sales in the U.S. pet business and challenging market conditions in China, especially impacting the swine vaccine business. Most other markets delivered solid growth.

With the recent launches of NEXGARD PLUS for dogs and NEXGARD COMBO for cats, sales of the NEXGARD parasiticides brands grew by 15.9%*. FRONTPRO, the first approved over-the-counter chewable tablet against ticks and fleas for dogs, is now available in most countries in Europe and continues to drive growth in the region. In pet therapeutics, sales of VETMEDIN, indicated for use in dogs with congestive heart failure, grew by 16.1%*.

Pipeline Outlook
Looking ahead, the company aims for up to 25 new treatment launches in Human Pharma until 2030. In Animal Health, 20 additional launches are expected across markets until 2026, including product updates, indication expansion and new products.

Roche continues strong momentum with 7% growth (CER) in the first half of 2025

On July 24, 2025 Hoffmann-La Roche reported second quarter 2025 results (Presentation, Hoffmann-La Roche, JUL 24, 2025, View Source [SID1234655540]).

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Pfizer Completes Licensing Agreement with 3SBio

On July 24, 2025 Pfizer Inc. (NYSE: PFE) reported the completion of a global, ex-China, licensing agreement with 3SBio, Inc. (01530.HK) granting Pfizer exclusive rights for the development, manufacturing and commercialization of 3SBio’s SSGJ-707, a bispecific antibody targeting PD-1 and VEGF developed using 3SBio’s proprietary CLF2 platform (Press release, Pfizer, JUL 24, 2025, View Source [SID1234654518]). This agreement solidifies Pfizer at the forefront of innovative cancer research and further enhances the company’s robust oncology pipeline.

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"We are excited to contribute our significant expertise and resources to advance rapidly the development of the SSGJ-707 program including novel combination strategies across a number of our major tumor areas of focus," said Chris Boshoff, M.D., Ph.D., Chief Scientific Officer and President, Research & Development, Pfizer. "This is an important candidate that combines two key targets in a promising class of medicines, complementing our antibody-drug conjugate portfolio and further demonstrates our commitment to advancing pioneering science to deliver transformative cancer medicines and new hope to people living with cancer."

SSGJ-707 is currently undergoing several clinical trials in China for non-small cell lung cancer (NSCLC), metastatic colorectal cancer, and gynecological tumors. Positive interim Phase 2 results evaluating the safety and efficacy of SSGJ-707 as monotherapy in patients with advanced NSCLC were recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Pfizer plans to manufacture drug substance for SSGJ-707 in Sanford, North Carolina, and drug product in McPherson, Kansas. The clinical development plan for SSGJ-707 moving forward will include trial sites across the U.S. and rest of world with priority to the Phase 3 global development plan for NSCLC and other solid tumors. The first Phase 3 global studies will initiate enrollment in the U.S.

Under the terms of the agreement, 3SBio will receive a payment of $1.25 billion. Pfizer will also make a $100 million equity investment in 3SBio. Additionally, the agreement provides Pfizer the option to extend the license to include exclusive development and commercialization rights to SSGJ-707 in China. In exchange for the exclusive rights in China, Pfizer will pay 3SBio up to $150 million in option payments.