On May 28, 2025 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported new data to be presented from the Beta-CORRECT clinical validation study at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Exact Sciences, MAY 28, 2025, View Source [SID1234653438]). Results from Beta-CORRECT, a subset of the GALAXY cohort, validate the performance of its tumor-informed molecular residual disease (MRD) test, Oncodetect, in predicting recurrence in stage II–IV colorectal cancer. These data confirm the test’s role in supporting treatment and surveillance decisions.

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Building on this momentum and its commitment to innovation, Exact Sciences will introduce a next-generation version of the test leveraging the Broad Institute’s MAESTRO technology. Early data show the test will track up 5,0002 patient specific variants and detect ctDNA* levels below 1 part per million.1 The test will be available to both new and existing customers in 2026.

"We launched the Oncodetect test to give clinicians and patients a powerful tool for detecting cancer recurrence earlier and with greater precision—progress that’s already being realized," said Brian Baranick, Executive Vice President and General Manager, Precision Oncology at Exact Sciences. "We continue to innovate and look forward to introducing the next iteration of the Oncodetect test, which leverages whole-genome sequencing and proprietary technology developed in collaboration with the Broad Institute to enhance sensitivity and expand clinical utility."

The Beta-CORRECT study demonstrates that the Oncodetect test significantly improves prognosis prediction compared to traditional standard of care methods †,3,4,5

Data presented at ASCO (Free ASCO Whitepaper) from the Beta-CORRECT clinical validation study confirm that the Oncodetect test accurately predicts recurrence in stage III colorectal cancer3—consistent with findings from the Alpha-CORRECT study—and extends this association to stages II and IV.4

Exact Sciences’ largest MRD clinical study to date, with more than 400 patients, demonstrates those with ctDNA-positive results after therapy and during surveillance showed a 24- and 37-fold increased risk of recurrence, respectively.4 By quantifying ctDNA levels across multiple timepoints, the Oncodetect test enables physicians to more effectively guide treatment decisions and surveillance strategies in clinical practice.3,4

Advancing the Oncodetect test with next generation innovation

The next-generation MRD test, currently in validation across multiple solid tumor types, will track up to 5,000 patient-specific variants2 with a limit of detection below 1 part per million,1 enabling scalable monitoring and broad clinical utility. Exact Sciences holds exclusive rights to the Broad Institute’s MAESTRO technology, a whole-genome sequencing method able to detect low-frequency ctDNA mutations with high accuracy. This technology advances the ability to look broadly across thousands of mutations while reducing the sequencing depth required to achieve an ultra-low limit of detection at a highly attractive cost point. Through continued innovation in MRD, Exact Sciences is advancing solutions with the potential to change clinical practice.

"The precision and sensitivity seen in the next generation test reflect deep scientific collaboration and a shared commitment to advancing MRD technology," said Viktor Adalsteinsson, Ph.D., Director, Gerstner Center for Cancer Diagnostics at the Broad Institute. "This approach to innovation will continue to raise the bar for recurrence monitoring, treatment response assessment, and, ultimately, patient outcomes."

On May 28, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Bristol Myers Squibb received European Commission (EC) approval of a new Opdivo (nivolumab) subcutaneous formulation developed with ENHANZE, Halozyme’s proprietary recombinant human hyaluronidase enzyme (rHuPH20), for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib (Press release, Halozyme, MAY 28, 2025, View Source [SID1234653455]).

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"The European approval of Opdivo SC represents an advancement for certain cancer patients, who now have the option to receive their Opdivo as a 3-to-5-minute SC injection," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This approval is just one of the 11 growth catalysts for our commercialized SC products expected this year."

The positive EC decision is supported by positive results from the Phase 3 CheckMate -67T trial. For more information on the study and its findings, please view Bristol Myers Squibb’s press release issued on May 28, 2025.

The approval by the EC is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway.

On December 27, 2024, subcutaneous nivolumab and hyaluronidase-nvhy, marketed under the brand name Opdivo Qvantig, was approved by the U.S. Food and Drug Administration.

On May 28, 2025 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported the approval of the Investigational New Drug (IND) by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) in combination with azacitidine for the treatment of myeloid malignancies, including but not limited to myelodysplastic syndromes (MDS) (Press release, InnoCare Pharma, MAY 28, 2025, View Source [SID1234653471]).

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Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells.

Myelodysplastic syndrome (MDS) is a group of heterogeneous clonal myeloid diseases characterized by the abnormal proliferation of hematopoietic stem cells, recurrent genetic abnormalities, myelodysplasia, ineffective hematopoiesis, peripheral-blood cytopenia, and a high risk of progression to acute myeloid leukemia (AML). The annual incidence of myelodysplastic syndromes is about 4 cases/100,000 people/year (reaching 40–50/100,000 in patients aged ≥ 70 years).

Mesutoclax has been granted Breakthrough Therapy Designation (BTD) by the CDE for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL). This marks the first BCL2 inhibitor to receive BTD recognition in China. The Company is accelerating patient enrollment of a Phase III registrational trial of mesutoclax in combination with orelabrutinib as a first line therapy for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), as well as a clinical trial of mesutoclax for the treatment of AML.

Dr. Jasmine Cui, the Co-founder, Chairwoman, and CEO of InnoCare, said, "Mesutoclax is an important global asset of our company in the field of hematology. We are delighted to receive approval to initiate the clinical trial for the fourth indication of our BCL2 inhibitor. We will accelerate the clinical development of mesutoclax across multiple indications in China and globally to bring benefits to patients as early as possible."

On May 27, 2025 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update (Press release, BioLineRx, MAY 27, 2025, View Source [SID1234653388]).

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"Following our announcement last November that we out-licensed APHEXDA, our FDA-approved stem cell mobilization agent, to Ayrmid Ltd., we have been actively evaluating new assets in the areas of oncology and rare disease where we can leverage our drug development and regulatory expertise to bring new medicines to market," said Philip Serlin, Chief Executive Officer of BioLineRx. "I remain optimistic that we will announce a meaningful transaction this year."

"At the same time, APHEXDA is performing well under the stewardship of Ayrmid, and I believe this license agreement will contribute significant long-term value to our company," Mr. Serlin concluded.

Financial Updates

Completed financing in January 2025 raising gross proceeds of $10 million.
Successfully reduced operating expense run rate by over 70% beginning January 1, 2025, through the APHEXDA program transfer to Ayrmid and the resulting shutdown of the Company’s U.S. commercial operations in Q4 2024, as well as additional headcount and other operating expense reductions.
Reaffirms cash runway through the second half of 2026.
APHEXDA Performance Update

APHEXDA generated sales of $1.4 million in the first quarter of 2025, providing royalty revenues to the Company of $0.3 million.
Clinical Updates

Motixafortide

Pancreatic Ductal Adenocarcinoma (mPDAC)

Additional trial sites were activated for the CheMo4METPANC Phase 2b clinical trial, which is expected to have a positive impact on patient recruitment. Full enrollment in the randomized trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx, is planned for completion in 2027, with a prespecified interim analysis planned when 40% of progression free survival (PFS) events are observed.
An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial has been accepted for a poster presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting on Saturday, May 31st. Key highlights include:
Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent definitive radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response.
An analysis of pre- and on-treatment biopsies revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination.
Sickle Cell Disease (SCD) & Gene Therapy

Enrollment is continuing into the multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD). The trial is sponsored by St. Jude Children’s Research Hospital.
Reported continued progress of a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. The trial is sponsored by Washington University School of Medicine in St. Louis.
Financial Results for the Quarter Ended March 31, 2025

Revenues for the three-month period ended March 31, 2025 were $0.3 million, a decrease of $6.6 million, compared to revenues of $6.9 million for the three-month period ended March 31, 2024. The significant decrease in revenues from 2024 to 2025 reflects the one-time revenues recorded in 2024 relating to the out-licensing transaction with Gloria during the fourth quarter of 2023, as well as the change in the Company’s operations following the out-licensing of APHEXDA to Ayrmid during the fourth quarter of 2024. The revenues in 2025 reflect the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The revenues in 2024 primarily reflect a portion of the up-front payment received by the Company and a milestone payment achieved under the license agreement with Gloria, which collectively amounted to $5.9 million, as well as $0.9 million of net revenues from product sales of APHEXDA in the U.S.
Cost of revenues for the three-month period ended March 31, 2025 was immaterial, compared to cost of revenues of $1.5 million for the three-month period ended March 31, 2024. The cost of revenues in 2025 reflects sub-license fees on royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. The cost of revenues in 2024 primarily reflects sub-license fees on a milestone payment received under the Gloria license agreement and royalties on net product sales of APHEXDA in the U.S., as well as amortization of intangible assets and cost of goods sold on product sales.
Research and development expenses for the three months ended March 31, 2025 were $1.6 million, a decrease of $0.9 million, or 34.9%, compared to $2.5 million for the three months ended March 31, 2024. The decrease resulted primarily from lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount.
There were no sales and marketing expenses for the three months ended March 31, 2025, compared to $6.3 million for the three months ended March 31, 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid out-licensing transaction.
General and administrative expenses for the three months ended March 31, 2025 were $1.0 million, a decrease of $0.4 million, or 28.6%, compared to $1.4 million for the three months ended March 31, 2024. The decrease resulted primarily from a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses.
Net non-operating income for the three months ended March 31, 2025 was $7.6 million, compared to net non-operating income of $4.5 million for the three months ended March 31, 2024. Non-operating income for both periods primarily relates to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company’s share price.
Net financial expenses for the three months ended March 31, 2025 were $0.1 million, compared to net financial expenses of $0.4 million for the three months ended March 31, 2024. Net financial expenses for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits.
Net income for the quarter ended March 31, 2025 was $5.1 million, compared to $0.7 million for the quarter ended March 31, 2024.
As of March 31, 2025, the Company had cash, cash equivalents, and short-term bank deposits of $26.4 million
Conference Call and Webcast Information

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until May 29, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On May 27, 2025 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and Alzheimer’s disease (AD) through the inhibition of Semaphorin 4D (SEMA4D), reported that it will present new data characterizing the unique mechanism of pepinemab to enhance immune responses to checkpoint therapies in the neoadjuvant setting that are associated with improved pathologic response in patients with head and neck cancer (Press release, Vaccinex, MAY 27, 2025, View Source [SID1234653404]). Lead investigator and collaborator, Conor Steuer, MD from Winship Cancer Center at Emory University, will present results at the 2025 Annual Meeting of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago on June 1, 2025.

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ASCO Conference Information:

Date: Sunday, June 1, 2025

Presentation title: Neoadjuvant biomarker trial of pepinemab to enhance nivolumab or ipilimumab activity in resectable head and neck cancer. Abstract 103.

Time: 9:45-11:15 AM CST/10:45 AM – 12:15 PM EST.

Session Title: Clinical Science Symposium – Turning "Cold" Tumors "Hot"

Previously reported data from our collaboration with Emory University suggest a crucial role of pepinemab treatment in melanoma patients to facilitate immune cell interactions within highly organized and robust centers of immunity, called tertiary lymphoid structures, or TLS. By blocking the SEMA4D inhibitory signal to Dendritic Cells (DC), pepinemab allows productive, coordinated interactions between SEMA4D+ T cells, key effector cells capable of eradicating tumors, and DC, regulatory cells that promote immune cell interactions within TLS so as to amplify mature T cell responses.

New data presented at ASCO (Free ASCO Whitepaper) will characterize the mechanisms of neoadjuvant treatment with pepinemab in patients with resectable head and neck cancer (HNSCC). Standard of care for these patients often involves toxic chemotherapy and/or radiotherapy, in addition to surgery, which can significantly impact their quality of life. Peri-operative treatment with immunotherapy has recently reported promising and potentially practice-changing results. Certain HNSCC with hot beds of immune cells organized into TLS have been shown to correlate with clinical benefit and positive response to immune checkpoint therapy. However, many HNSCC are considered immunologically "cold" tumors, due to exclusion of immune cells from tumor and/or high levels of immune suppressor cells, making them resistant to immune checkpoint therapy.

Pepinemab has potential to be a major advance for HNSCC patients with cold and resistant disease, with capacity of a well-tolerated and effective treatment that can induce formation and harness the power of TLS to optimize the clinical benefit of immunotherapy. Our data demonstrate that the addition of pepinemab to neoadjuvant immune checkpoint treatments did not compound toxicities, yet it enhanced TLS maturity that correlated with improved pathologic response. Collectively, these results highlight the potential of pepinemab to turn immunologically cold tumors, such as HPV-negative head and neck cancer, into hot immune centers by inducing robust and mature TLS.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can otherwise bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton and lead to loss of homeostatic functions of dendritic cells in immune tissue and of astrocytes and other glial cells in the brain. Pepinemab appears to be well-tolerated with a favorable safety profile in multiple clinical trials in different cancer and neurological indications.