On April 24, 2025 Mosaic Therapeutics, Ltd (‘Mosaic’, or ‘the Company’) a targeted oncology therapeutics company dedicated to resolving cancer’s complexity with new combination therapies for patients, reported the in-licensing of two clinical-stage oncology programs from Astex Pharmaceuticals (‘Astex’), a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd (Press release, Mosaic Therapeutics, APR 24, 2025, View Source [SID1234652123]). Mosaic has identified proprietary combinations incorporating the licensed products and their targets and this agreement gives Mosaic the exclusive rights to develop those combination products for patients for whom there are no, or limited, treatment options.

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As part of the agreement, Astex has taken an equity stake in Mosaic equating to a fully-diluted ownership stake of 19% equity upfront and a further 3% dependent on clinical milestones, which will consolidate the partnership between these two innovation-driven businesses. Astex will also receive potential future revenue shares. Dr. Harren Jhoti, co-founder, president and chief executive officer of Astex, will also take an observer role on the Mosaic Board. Other financial details have not been disclosed.

Mosaic’s platform identifies combinations of pairs of oncology drugs predicted to have synergistic activity in biomarker-defined patient populations and expected to lead to greater efficacy and durability of response than achieved as monotherapy. The development strategy for each combination product is to seek a broad, biomarker-defined label across multiple tumour types. The two small molecule assets from Astex are ASTX029, an ERK1/2 inhibitor discovered by Astex that has completed a Phase 2 clinical study and ASTX295 an MDM2 antagonist discovered by Astex in collaboration with the Cancer Research UK Drug Discovery Unit at Newcastle University, that has completed a Phase 1 clinical study. Each of the two licensed compounds has been studied in more than 100 patients and demonstrated differentiated safety profiles within their target class and single-agent activity as monotherapies, enabling use in combination therapies.

"Mosaic’s mission is to bring novel targeted combination medicines to patients who need them," said Dr. Edward Hodgkin, Managing Partner of Syncona Investment Management Limited and Chair of Mosaic. "The in licensing of these two clinical-stage assets provides a step change in our development pipeline, allowing Mosaic to progress targeted drug combinations in novel biomarker-defined settings and enabling the delivery of precision medicines for patients who currently have few therapeutic options. Excitingly the deal significantly accelerates Mosaic’s development path, with the first clinical combination study expected to commence in 2026."

"We recognise the significance of Mosaic’s platform, which has identified these two assets as anchor components of a pipeline of potential combination products," said Dr. Harren Jhoti, co-founder, president and chief executive officer of Astex. "Both drug targets are well-characterised drivers of many cancers, and we are excited to be working with the experienced team at Mosaic to expand the Company’s pipeline in combination therapies with high unmet medical need."

On April 24, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that its ultra-sensitive Signatera Genome assay is now broadly available to physicians in the United States (Press release, Natera, APR 24, 2025, View Source [SID1234652122]).

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This launch is supported by a large genome-based molecular residual disease (MRD) study, which was accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In this clinical validation study of more than 3,000 samples from multiple cancer types – including breast cancer, colorectal cancer, non-small cell lung cancer, melanoma, and renal cell carcinoma – Signatera Genome was able to detect circulating tumor DNA (ctDNA) significantly ahead of clinical recurrence with excellent performance. In addition, postsurgical Signatera-positive patients had inferior recurrence-free survival compared to Signatera-negative patients, consistently across the different cancers that were evaluated. Additional clinical utility data on the Signatera Genome assay, including predictive data, will be presented at the conference.

Signatera Genome is available in CLIA, IUO and RUO and was designed to improve patient management as an ultra-sensitive assay for the detection of ctDNA. The test’s bespoke assay is designed from a whole genome sequence of a patient’s tumor and matched normal DNA. It benefits from Natera’s patented multiplex polymerase chain reaction and next generation sequencing technology (mPCR-NGS), using a targeted and deep sequencing approach to detect tiny traces of tumor DNA at frequencies as low as 1 part per million (PPM). An RUO version of the assay is available that detects below 1 PPM.

"We are extremely pleased with the emerging evidence for our Signatera Genome assay, providing an ultrasensitive MRD detection tool for physicians," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer. "We look forward to sharing the results of this study, which further demonstrates the clinical utility of Signatera across disease indications."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage from Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

On April 24, 2025 Novocure (NASDAQ: NVCR) reported financial results for the first quarter ended March 31, 2025. 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) (Press release, NovoCure, APR 24, 2025, View Source [SID1234652121]).

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"This is a period of meaningful momentum for Novocure," said Ashley Cordova, CEO Novocure. "After years in a single commercial indication, our footprint is expanding across new indications, new centers, and new physician specialties. Our lung launch is progressing. Our pipeline is advancing. And our commitment to patient-forward innovation is stronger than ever. We look forward to updating you on our progress as the year unfolds."

Financial updates for the first quarter ended March 31, 2025:

Total net revenues for the quarter were $155.0 million, an increase of 12% compared to the same period in 2024. This increase is primarily driven by active patient growth across our major markets and to a lesser extent from reimbursement improvements.
The U.S., Germany, France and Japan contributed $93.2 million, $18.7 million, $17.9 million and $8.7 million, respectively, with other active markets contributing $11.9 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 $1.5 million, including $0.8 million from malignant pleural mesothelioma (MPM), and $0.7 million from metastatic non-small cell lung cancer (NSCLC).
Gross margin for the quarter was 75% compared to 76% in the prior year period.
The reduction of gross margin was primarily driven by the roll out of our HFE arrays and the NSCLC launch, where we are treating on-label patients at risk prior to establishing broad reimbursement.
The global tariff environment is changing rapidly. On April 9, 2025 the U.S. temporarily delayed implementation of new tariffs by 90 days, resulting in a 10% tariff for most countries. If the current pause is extended through year-end, Novocure could see an increase in import duties of up to $8 million in 2025. If the tariffs return to pre-April 9 rates after the current 90-day pause, Novocure could see an increase in import duties of up to $11 million in 2025. Novocure is closely monitoring the evolving tariff landscape with the intent to mitigate impacts on our supply chain costs where possible.
Research, development and clinical studies expenses for the quarter were $53.8 million, an increase of 4% from the same period in 2024.
Sales and marketing expenses for the quarter were $55.8 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 $44.8 million, an increase of 13% compared to the same period in 2024. This was primarily driven by a $2.3 million one-time expense to retire a production line related to supply chain optimization efforts and higher personnel costs associated with our launch of NSCLC and preparations for additional future indication launches
Net loss for the quarter was $34.3 million with loss per share of $0.31.
Adjusted EBITDA* for the quarter was $(5.0) million.
Cash, cash equivalents and short-term investments were $929.1 million as of March 31, 2025.
Operational updates for the first quarter ended March 31, 2025:

As of March 31, 2025, there were 4,268 total active patients on TTFields therapy globally.
Optune Gio
1,608 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 908; 198; 207 and 118 prescriptions, respectively, with the remaining 177 prescriptions contributed by other active markets.
As of March 31, 2025, there were 4,162 active Optune Gio patients on therapy, an increase of 9% from the same period in 2024. The U.S., Germany, France and Japan contributed 2,157; 573; 463 and 445 Optune Gio active patients, respectively, with the remaining 524 active patients contributed by other active markets.
Optune Lua
127 total prescriptions for Optune Lua were received in the quarter. 92 Optune Lua prescriptions were received for the treatment of metastatic NSCLC and 35 prescriptions were received for the treatment of malignant pleural mesothelioma (MPM).
As of March 31, 2025, there were 106 active Optune Lua patients on therapy, including 62 patients treated for metastatic NSCLC patients and 44 patients treated for MPM.
Beginning in Q1 2026, Novocure intends to stop reporting new prescriptions received in period and will provide active patients on TTFields therapy by indication and by material market as the key operating statistics.
Quarterly updates and achievements:

In 2024, Novocure announced the Phase 3 PANOVA-3 clinical trial met its primary endpoint, demonstrating a statistically significant extension in overall survival. The results of the Phase 3 PANOVA-3 clinical trial will be presented as a late-breaking abstract at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) scientific congress. Novocure plans to host an investor event with live webcast featuring the trial principal investigator and Novocure leadership following the presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.
In April, Novocure received CE Mark for the use of Optune Lua concurrently with immune checkpoint inhibitors or docetaxel in adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen.
Anticipated clinical milestones:

Data from Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer (H1 2026)
Data from Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma (H1 2026)
Conference call details

Novocure will host a conference call and webcast to discuss first quarter 2025 financial results at 8:00 a.m. EDT today, Wednesday, April 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.

On April 24, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported a strategic collaboration with Pfizer, Inc. (NYSE: PFE), to support the development and commercialization of Pfizer’s oncology portfolio using the Guardant Infinity smart liquid biopsy platform (Press release, Guardant Health, APR 24, 2025, View Source [SID1234652120]).

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Under the multi-year collaboration agreement, Guardant and Pfizer aim to:

Utilize Guardant’s portfolio of liquid biopsy tests in Pfizer’s global clinical studies
Evaluate the clinical utility of (a) circulating tumor DNA (ctDNA) level as a surrogate endpoint to monitor therapy response and (b) related blood-based epigenomic analyses
The collaboration will also provide Pfizer with access to Guardant’s liquid biopsy tests in China for their global clinical trials that include China cohorts. In July 2022, Guardant announced a strategic partnership with Adicon Holdings Limited, a leading independent clinical laboratory company based in China, to offer Guardant tests to biopharmaceutical companies conducting clinical trials in China. Cancer is the leading cause of death in China, with over three million cancer-related deaths in 2020.

On April 24, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) (Press release, Akeso Biopharma, APR 24, 2025, View Source [SID1234652118]). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with least one other prior line of therapy. Penpulimab-kcqx was developed independently by Akeso, with further development and commercialization managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group.

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This milestone marks penpulimab-kcqx as Akeso’s first internally developed innovative biologic to receive FDA approval. The approval underscores the robust clinical research behind penpulimab-kcqx and marks Akeso’s successful entry into the United States regulatory system for the first time. This achievement highlights the company’s innovative drug development capabilities and its commitment to adhering to the highest international standards in pharmaceutical quality management.

The FDA’s approval of penpulimab-kcqx validates Akeso’s international drug development strategy and expansion capabilities. This approval lays a strong foundation for Akeso’s continued clinical development efforts in the global therapeutics markets.

Penpulimab-kcqx has been approved in China for two indications: 1. first-line treatment of advanced NPC, and 2. second or later line treatment of advanced NPC. The recent FDA approval of penpulimab-kcqx offers a new, immunotherapy option for advanced NPC patients in the US.

The FDA approval is based on the international Phase III clinical trial AK105-304 and the pivotal AK105-202 study, which supported the two Biologics License Application (BLA) for penpulimab-kcqx. These studies demonstrated the drug’s clinical benefits and favorable safety profile across two stages of treatment for metastatic NPC. AK105-304 is a randomized, double-blind, international Phase III trial that enrolled NPC patients of diverse ethnicities. The data will be presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Previously, the FDA granted penpulimab-kcqx Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for NPC treatment, highlighting the critical unmet need for this therapy.

According to the WHO 2020 Global Cancer Statistics, over 133,000 new NPC cases are diagnosed annually worldwide, with more than 70% of the patients presented with locally advanced disease. Recurrent or metastatic NPC has a poor prognosis and limited survival. Penpulimab-kcqx’s FDA approval will expand the number of NPC patients that can benefit from its treatment.

Prof. Chaosu Hu, Principal Investigator of penpulimab-kcqx from Fudan University Shanghai Cancer Center, commented: "This milestone enhances international treatment guidelines for advanced NPC and extends the benefits of China’s innovations to global patients, ultimately reshaping the treatment landscape for metastatic NPC worldwide."

Prof. Xiaozhong Chen, Investigator of penpulimab-kcqx from Zhejiang Cancer Hospital, added: "The FDA approval of penpulimab-kcqx confirms its high efficacy and low toxicity, positioning China’s innovative drug development in alignment with international standards."

Dr. Yu Xia, Founder, Chairwoman, President & CEO of Akeso, expressed: "We are very excited by the approval of penpulimab-kcqx’s approval in the US FDA for first line and later line NPC. Beyond reaching our first international regulatory milestone, this approval also provides an important immunotherapy treatment option for patients with NPC in the United States. The FDA approval of penpulimab-kcqx not only highlights the quality of our innovation but also underscores Akeso’s focus on delivering treatments for difficult to treat cancers for patients around the world. We are deeply grateful to all the researchers, participants, and patients who have contributed to this success. Akeso will continue to advance first and best in class therapies, including bispecific antibodies and CD47 inhibitors, challenge global standards of care and unlocking the full potential of our pipeline for cancer patients everywhere."