On January 21, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported clinical validation data for its OncodetectTM MRD test at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI.) Results from Alpha-CORRECT, a study with one of the longest MRD surveillance monitoring periods to date, showed the Oncodetect test achieved 78% sensitivity at the post-surgical timepoint and 91% sensitivity during the surveillance monitoring period, with specificities of 80% and 94%, respectively (Press release, Exact Sciences, JAN 21, 2025, View Source [SID1234649790]). The complete findings of the study, which primarily included patients with stage III colon cancer, will be published in a peer-reviewed scientific journal on January 25.

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"We’re thrilled to bring our MRD solution to the rapidly growing molecular residual disease market, helping more patients get access to critical, high-quality testing," said Brian Baranick, general manager of Precision Oncology at Exact Sciences. "These data demonstrate the strong performance of Oncodetect. Building on the foundation of Oncotype DX and two decades of trust from physicians and patients, Exact Sciences is well positioned to lead the way with its robust commercial and operational infrastructure, to ensure patients across the U.S. have access to MRD testing."

In addition to the data shared at ASCO (Free ASCO Whitepaper) GI, Oncodetect achieved its primary endpoint in the Beta-CORRECT study. Results confirm a significant association between MRD positivity and recurrence in patients with stage III colon cancer. The data extend Oncodetect’s prognostic value to patients with stage II and IV colon cancer and rectal cancer. Findings from the independent Beta-CORRECT clinical validation study, which was a subset analysis from the GALAXY study, also demonstrated promising performance of Oncodetect as an MRD test. Results will be presented at an upcoming scientific conference.

"There is a critical need to better understand and monitor for residual cancer following surgery," said Takayuki Yoshino, MD, deputy director at the National Cancer Center Hospital East in Japan. "The Oncodetect test represents an exciting development in the field. I am pleased to partner with Exact Sciences, encouraged by the emerging data from the Beta-CORRECT study, and look forward to sharing further insights in the coming months."

The company plans to provide the Oncodetect test to patients across the United States through its Precision Oncology platform, combining 20 years of deep relationships with healthcare professionals through Oncotype DX, a broad portfolio of oncology solutions, and the advanced ExactNexusTM technology platform.

Strategic Partnerships Support Multi-Cancer Evidence Generation

Exact Sciences has partnered with the National Surgical Adjuvant Breast and Bowel Project (NSABP) and Flatiron Health to generate additional clinical evidence across multiple solid tumor types.

Exact Sciences is conducting multiple studies to strengthen evidence in colorectal cancer. The international-basedCORRECT-Istudy and the pivotal, US-basedCORRECT-IIstudy with the NSABP will assess the association between ctDNA and recurrence at specific post-surgical timepoints in patients with stage II and III colorectal cancer. These studies will further validate ctDNA’s role in colorectal cancer recurrence monitoring.
An additional study with the NSABP,EXActDNA-003, is one of the largest prospective MRD studies across all subtypes of early-stage breast cancer. Additional research in breast cancer waspreviously announced with the West German Study Group.
The company has also partnered withFlatiron Healthon a multi-year, prospective real-world study that will be integrated into routine clinical care, with the goal of accelerated enrollment across a broad range of solid tumors.
"The NSABP is committed to advancing colorectal and breast cancer care through innovative clinical studies that redefine diagnostics and treatments," said Dr. Norman Wolmark, MD, chairman of the NSABP Foundation and contact principal investigator and co-chair at NRG Oncology. "Both the CORRECT-II and EXActDNA-003 studies are designed to utilize ctDNA in addressing critical gaps left by previous MRD trials. Through our collaboration with Exact Sciences, we aim to integrate ctDNA analysis to deliver a more precise and comprehensive approach to recurrence detection."

About the Oncodetect test

Molecular residual disease (MRD) refers to the presence of tumor-specific DNA in the body. These fragments of genetic information, known as circulating tumor DNA (ctDNA), are shed into the bloodstream by tumors, and their presence may indicate that cancer is present . Exact Sciences’ MRD offering leverages our in-house capabilities in whole exome sequencing to offer a tumor-informed MRD test for a personalized approach to detecting and monitoring residual cancer in patients with solid tumors. By identifying somatic genomic alterations in tumor DNA and detecting a subset in ctDNA from blood, the Oncodetect test may enable the detection of ctDNA before, during, and after treatment. This critical information can guide therapy decisions and monitor for cancer recurrence.

On January 21, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing powerful circular RNA technology for next generation nucleic acid medicine, reported that it has entered a partnership with 4basebio PLC of Cambridge, UK, for joint development and in vivo delivery testing of synthetic circVec DNA vectors (Press release, Circio, JAN 21, 2025, View Source [SID1234649789]).

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"The circVec technology achieves up to 70 times prolonged RNA half-life and 15-fold increase in protein levels vs. standard mRNA-based expression in vivo using plasmid DNA," said Dr. Thomas Hansen, CTO of Circio. "We have therefore now partnered with 4basebio, a world-leader in next-generation DNA vectors for therapeutic applications. Combining 4basebio´s vector and delivery expertise with Circio´s circVec powerful expression technology has the potential to create a durable, repeat-dosable, non-viral platform for future synthetic DNA gene therapies."

Dr. Emily Young, Head of Non-Viral Delivery for 4Basebio added: "We are delighted to partner with Circio to develop the next generation of DNA gene therapies and vaccines. 4Basebio’s synthetic DNA offers fast, scalable and cost-effective manufacturing advantages compared to plasmid DNA. Combining these capabilities with the superior expression of Circio’s circVec technology, in addition to 4Basebio’s Hermes DNA-delivery platform, promises to establish extremely robust and durable DNA therapeutics."

Under the collaboration, 4basebio has successfully developed and validated circVec vectors in their proprietary synthetic hpDNA and opDNA formats, including formulation into Hermes LNP formulations optimized for in vivo delivery of DNA payloads. Both parties will now in parallel proceed to test the performance of these circVec-op/hpDNA vectors in mouse models. If successful, the results will create the foundation for a continued collaboration to develop and test future therapeutic candidates for genetic medicine, vaccines and other potential applications.

On January 21, 2025 Catalent, Inc., a leader in enabling the development and supply of better treatments for patients worldwide, reported a strategic collaboration with Galapagos NV (Euronext & NASDAQ: GLPG), a biotechnology company with operations in the U.S. and Europe, to support decentralized manufacturing for clinical studies of GLPG5101, Galapagos’ investigational CAR-T therapy for relapsed/refractory non-Hodgkin lymphoma (NHL) indications (Press release, Catalent, JAN 21, 2025, https://www.catalent.com/catalent-news/catalent-announces-collaboration-with-galapagos-to-further-expand-galapagos-decentralized-car-t-manufacturing-network-in-the-u-s/ [SID1234649788]). Catalent’s commercial cell therapy manufacturing facility in Princeton, New Jersey, will support manufacturing for Galapagos’ upcoming trials in New Jersey, New York, and surrounding areas.

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Galapagos’ innovative decentralized manufacturing platform for cell therapies is designed to be deployed close to cancer treatment centers. This class of therapies has shown promising results in patients with NHL, even those who have failed with other therapies. By bringing the manufacturing process closer to patients, Galapagos’ platform has the potential to deliver fresh, fit, stem-like early memory cell therapy with a median vein-to-vein time of seven days, thereby avoiding cryopreservation and eliminating the need for bridging therapy.

"Catalent is passionate about increasing patient access to life-changing cell therapies like those being developed by Galapagos," said Delara Motlagh, at Vice President, Global Cell Therapy and Plasmid DNA at Catalent. "We are delighted by this collaboration to support Galapagos’ decentralized cell therapy approach to bring these pioneering treatments to more patients with certain aggressive forms of NHL in a median vein-to-vein time of seven days. With our highly experienced cell therapy team, state-of-the-art facility network, and central location, we enable timely delivery of these important therapies."

Financial terms of the agreement are not disclosed.

On January 21, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, reported that the company will host a virtual event on Thursday, January 23, at 1:00 p.m. PT/4:00 p.m. ET to discuss updated data from the ASPEN-06 Phase 2 clinical trial evaluating the company’s investigational CD47-blocker evorpacept in patients with previously treated HER2-positive advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer (Press release, ALX Oncology, JAN 21, 2025, View Source [SID1234649787]).

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The ASPEN-06 data will be featured in an oral presentation (Abstract #332) at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) earlier the same day.

2025 ASCO (Free ASCO Whitepaper) GI Presentation Details
Title: Final analysis of the randomized phase 2 part of the ASPEN-06 study: A phase 2/3 study of evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with HER2-overexpressing gastric/gastroesophageal cancer (GC).
Abstract Number: 332
Presenter: Kohei Shitara, M.D., Director of the Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa in Japan
Presentation Date and Time: Thursday, January 23, 9:15 a.m. – 10:00 a.m. PT
Session Information: Rapid Oral Abstract Session A: Cancers of the Esophagus and Stomach
Location: Level 2 Ballroom

Company Conference Call and Webcast Information
During the virtual company conference call and webcast event for investors, ALX company leadership will review the updated ASPEN-06 data. The event will be webcast live and a replay will be available after the call by visiting the "Investors" section of ALX Oncology’s website and selecting "Events and Presentations."

Date & Time: Thursday, January 23, 1:00 p.m. PT/4:00 p.m. ET
Webcast Access: View Source

On January 20, 2025 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), reported a distribution and marketing partnership with LEO Pharma for toripalimab in Europe (Press release, Shanghai Junshi Bioscience, JAN 20, 2025, View Source [SID1234656131]). This collaboration aims to promote the accessibility of toripalimab in Europe, offering high-quality, innovative treatments to patients across up to 32 European countries.

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Toripalimab, independently developed by Junshi Biosciences, is a monoclonal antibody targeting PD-1 for the treatment of multiple malignant tumors. To date, toripalimab has been approved for marketing in over 35 countries and regions around the world. In 2024, toripalimab received approvals from both the European Commission (EC) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the following indications: 1) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC); 2) in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). Toripalimab is the first and only drug in Europe for the treatment of NPC, and the only first-line treatment for advanced or metastatic ESCC, regardless of tumor PD-L1 expression status.

Under the agreement, LEO Pharma will be responsible for toripalimab’s distribution, promotion, sales, etc., in up to 32 countries, including all member states of the European Union (EU) and the European Economic Area (EEA), as well as Switzerland and the United Kingdom. TopAlliance Biosciences Europe will remain the Marketing Authorization Holder (MAH) for toripalimab in Europe, retaining responsibility for product development, manufacturing, registration, pharmacovigilance, quality management, etc. LEO Pharma will make payments, including an upfront payment, milestone payments if LEO Pharma wishes to pursue any subsequently approved indications, and a revenue share of a double-digit percentage on the net sales of toripalimab throughout the collaboration territory.

Dr. Sheng YAO, Senior Vice President of Junshi Biosciences and CEO of TopAlliance Biosciences, said, "The partnership with LEO Pharma has established a significant milestone for Junshi Biosciences in the European market and is closely aligned with the company’s global expansion strategy. Europe has been identified as a pivotal strategic region for the corporate business growth. As the Marketing Authorization Holder (MAH) of the product in Europe, the company has already established a local operational center and is actively collaborating with local health authorities to prepare for the successful commercial launch of toripalimab in Europe. As a century-old multinational pharmaceutical company headquartered in Europe, LEO Pharma has established a mature distribution network and rich marketing expertise in the local markets. By leveraging both parties’ strengths in R&D, manufacturing, and commercialization, we believe toripalimab will be efficiently integrated into the Europe markets benefitting local patients-in-need. Moving forward, we will continue to implement our ‘In China, For Global’ strategy and work with partners to provide high-quality, innovative therapies from China to patients worldwide."

Jean Monin, Executive Vice President of Thrombosis Business Unit, LEO Pharma, commented, "We are excited to partner with Junshi Biosciences, supplementing LEO Pharma’s Thrombosis business, which already serves patients with cancer-associated thrombosis. The distribution and marketing partnership for LOQTORZI brings an important new treatment option to areas of high unmet medical need and focuses on a specialty hospital product that complement our existing heparin-based anti-coagulation treatments for cancer-associated thrombosis and other specialty patients. Leveraging our commercial platform, LOQTORZI will create valuable synergies and drive continued growth."

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe, and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are ten approved indications for toripalimab in the Chinese mainland:

unresectable or metastatic melanoma after failure of standard systemic therapy;
recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;
locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);
in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);
in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);
in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC).
The ten indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China.

Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries around the global, including the Singapore Health Sciences Authority (HSA).