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.

Novocure Reports Second Quarter 2025 Financial Results

On July 24, 2025 Novocure (NASDAQ: NVCR) reported financial results for the second quarter that ended June 30, 2025 (Press release, NovoCure, JUL 24, 2025, View Source [SID1234654517]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"With the first half of 2025 complete, I am pleased to report continued progress towards our clinical, regulatory and commercial milestones. In Q2, we grew our glioblastoma and non-small cell lung cancer businesses and advanced our efforts to bring Tumor Treating Fields therapy to new patient populations," said Ashley Cordova, CEO, Novocure. "With one launch ongoing and two more on the horizon, we are well-positioned in both the near and long term. This is a pivotal period for Novocure."

Financial updates for the second quarter ended June 30, 2025:

Total net revenues for the quarter were $158.8 million, an increase of 6% compared to the same period in 2024. This increase is primarily driven by active patient growth across our major markets.
The U.S., Germany, France and Japan contributed $94.3 million, $19.1 million, $18.4 million and $9.5 million, respectively, with other active markets contributing $13.0 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.6 million.
Recognized revenue from Optune Lua in the quarter was $2.4 million, including $1.1 million from non-small cell lung cancer (NSCLC) and $1.3 million from malignant pleural mesothelioma (MPM).
Gross margin for the quarter was 74% compared to 77% in the prior year. The reduction of gross margin was primarily driven by the roll out of our Head Flexible Electrode (HFE) transducer array for use with Optune Gio, the NSCLC launch where we are treating on-label patients at risk prior to establishing broad reimbursement, and increased tariffs.
Research, development and clinical studies expenses for the quarter were $55.8 million, an increase of 2% from the same period in 2024. This was primarily driven by increased direct clinical trial expenses related to the ramp of the LUNAR-2 and KEYNOTE D58 trials.
Sales and marketing expenses for the quarter were $57.1 million, an increase of 1% compared to the same period in 2024. This primarily reflects higher costs associated with the expansion of our NSCLC sales force.
General and administrative expenses for the quarter were $44.0 million, an increase of 17% compared to the same period in 2024. This increase was primarily driven by higher share-based compensation expenses and higher personnel and professional service expenses to support the NSCLC launch and general company build-out, particularly on the enterprise technology side.
Net loss for the quarter was $40.1 million with loss per share of $0.36.
Adjusted EBITDA* for the quarter was $(9.9) million.
Cash, cash equivalents and short-term investments were $911.5 million as of June 30, 2025.
Operational updates for the second quarter ended June 30, 2025:

As of June 30, 2025, there were 4,331 total active patients on TTFields therapy globally.
Optune Gio
1,598 prescriptions for Optune Gio for the treatment of glioblastoma were received in the quarter, a decrease of 1% from the same period in 2024. The U.S., Germany, France and Japan contributed 963; 199; 179 and 101 prescriptions, respectively, with the remaining 156 prescriptions contributed by other active markets.
As of June 30, 2025, there were 4,194 Optune Gio active patients on therapy, an increase of 7% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,177; 581; 453 and 451 Optune Gio active patients, respectively, with the remaining 532 active patients contributed by other active markets.
Optune Lua
143 total prescriptions for Optune Lua were received in the quarter. 121 Optune Lua prescriptions were received for the treatment of NSCLC and 22 prescriptions were received for the treatment of MPM.
As of June 30, 2025, there were 137 active Optune Lua patients on therapy, including 94 patients treated for metastatic NSCLC and 43 patients treated for MPM.
Quarterly updates and achievements:

In May 2025, Novocure presented the results of the Phase 3 PANOVA-3 clinical trial at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. PANOVA-3 met its primary endpoint, demonstrating a statistically significant extension in overall survival in patients treated with TTFields therapy together with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. Patients treated with TTFields therapy also exhibited a statistically significant extension in pain-free survival (secondary endpoint) and distant progression-free survival (post hoc analysis). The presentation was selected for inclusion in ‘Best of ASCO (Free ASCO Whitepaper)’ program and the data were simultaneously published in the Journal of Clinical Oncology.
In July 2025, Novocure presented final quality of life data from the PANOVA-3 trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025. Patients treated with TTFields therapy demonstrated a statistically significant and clinically meaningful benefit across multiple quality of life measures of pain (secondary endpoint) and significantly delayed the need for opioid pain medication (post hoc analysis) for patients with unresectable, locally advanced pancreatic adenocarcinoma. A significant delay in deterioration across measures of health status was observed, preserving quality of life longer in patients treated with TTFields therapy.
Anticipated clinical and regulatory milestones:

Novocure plans the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the treatment of unresectable, locally advanced pancreatic cancer based on results of the Phase 3 PANOVA-3 clinical trial in Q3 2025.
Novocure plans the submission of a PMA application to the FDA for the treatment of brain metastases from NSCLC based on results of the Phase 3 METIS clinical trial in H2 2025.
The topline data readout from the Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer is expected in H1 2026.
The topline data readout from the Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma is expected in H1 2026.
Conference call details

Novocure will host a conference call and webcast to discuss second quarter 2025 financial results at 8:00 a.m. EDT today, Thursday, July 24, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.