On November 13, 2024 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported that it will present three abstracts highlighting significant advancements in the development of a multi-cancer early detection (MCED) test (Press release, Exact Sciences, NOV 13, 2024, View Source [SID1234648275]). The results of a study evaluating a new multi-biomarker class approach showed improved sensitivity for early-stage and overall cancer detection. In addition, new modeling data estimate that adding MCED testing to recommended screening may reduce the incidence of stage IV cancer and, subsequently, cancer mortality over 10 years. Another new analysis from the DETECT-A study suggests that adding MCED testing complements guideline-recommended lung cancer screening without affecting adherence to current standard of care. These findings will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference in Cancer Research: Liquid Biopsy from November 13-16, 2024, in San Diego, Calif.

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"Cancer is on pace to be the leading cause of death in the U.S. by 2030 1 . Currently, only an estimated 14% of all cancers in the U.S. are diagnosed through screening, 2 revealing a glaring gap in patient care," said Tom Beer, M.D., chief medical officer and vice president, multi-cancer early detection, Exact Sciences. "We believe MCED testing is our single biggest opportunity to combat these stark statistics, and the Exact Sciences team is committed to taking a rigorous, comprehensive approach to multi-cancer screening. The new data answer key questions about the impact we can anticipate with MCED testing if integrated into clinical practice."

A new study demonstrates the ability of a multi-biomarker class MCED test to improve early-stage sensitivity by incorporating a DNA mutation reflex approach to methylation and protein (MP) test results. When excluding breast and prostate cancer and at a 98.5% specificity, sensitivity increased by 28% for stage I cancers and 12.5% for early-stage cancers (stages I and II) in a case-control study, underscoring the potential of a three-biomarker class (DNA methylation, protein, DNA mutation reflex, or MP-r) test to improve the detection of cancer in earlier stages.

Cancer stage

MP-r sensitivity

MP sensitivity

% improvement

Stage I

22.1%

17.2%

28.0%

Stage II

54.7%

51.9%

5.5%

Stage I/II

35.9%

31.9%

12.5%

Overall

62.3%

59.3%

5.0%

This new research will help inform the final design of Exact Sciences’ Cancerguard test, which is currently in development and intends to harness the additive sensitivity of multiple biomarker classes to detect more cancers in earlier stages.

The abstracts featured at the AACR (Free AACR Whitepaper) Special Conference: Liquid Biopsy 2024 are as follows:

Title: Performance of multi-biomarker class reflex testing in a prospectively-collected cohort
Poster session: Thursday, November 14, 5:15 – 7:15 p.m. PT (Session A)
Poster number: A056
Key findings: A new analysis from a case-control study demonstrated the ability of a three-biomarker class (DNA methylation, protein, DNA mutation reflex, or MP-r) MCED test approach to increase sensitivity for early-stage detection. When excluding breast and prostate cancer, stage I sensitivity increased by 28%, and stage I/II increased by 12.5%.

Title: The potential of multi-cancer early detection screening for reducing cancer mortality
Oral presentation: Friday, November 15, 9:35 a.m. PT (Plenary Session 4: Early Detection of Primary Cancer and Relapse)
Presenter: Tyson, C
Poster number: PR006, A073
Key findings: New modeling points to the potential to reduce the burden of cancer by demonstrating an estimated 42% reduction in stage IV cancer incidence and a 17% estimated 10-year reduction in cancer mortality with the addition of MCED testing to usual care.

Title: Lung cancer screening adherence among participants in DETECT-A, the first prospective interventional trial of a multi-cancer early detection (MCED) blood test
Poster session: Thursday, November 14, 5:15 – 7:15 p.m. PT (Session A)
Poster number: A064
Key findings: Analysis from the prospective, interventional DETECT-A study showed lung cancer screening adherence was not reduced in participants who received an MCED test compared to controls.

About the DETECT-A study

The DETECT-A (Detecting cancers Early Through Elective mutation-based blood Collection and Testing) study was the first-ever large, prospective, interventional study to use a blood test to detect multiple types of cancer in a real-world setting. The DETECT-A study enrolled more than 10,000 women with no history of cancer to determine if a blood test in combination with standard-of-care screenings could detect cancers before signs and symptoms appeared. The CancerSEEK test, the MCED test studied in DETECT-A, was the forerunner to the Cancerguard test, the MCED test currently in development at Exact Sciences.

About the Cancerguard test

The Cancerguard test, currently in development, is designed to detect multiple cancers in their earliest stages from a single blood draw. Building upon decades of research, Exact Sciences intends to harness the additive sensitivity of multiple biomarker classes to detect more cancers in earlier stages. The Cancerguard test will utilize a streamlined and standardized imaging-based diagnostic pathway, which may result in fewer follow-up procedures. The test is being developed to provide high specificity to help minimize false positives while detecting multiple cancers, including those with the biggest toll on human health. These features describe current development goals. The Cancerguard test has not been cleared or approved by the U.S. Food and Drug Administration or any other national regulatory authority. To learn more, visit View Source

On November 13, 2024 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for cancer based on its unique Mimicry platform, reported that it will be holding a webinar to run through new clinical data from the ongoing Phase 1/2 ‘SIDNEY’ trial of EO2463, for the treatment of patients with either newly diagnosed, previously untreated follicular lymphoma (FL) [EO2463 monotherapy], or FL and marginal zone lymphoma relapsed/refractory disease [EO2463 in combination with lenalidomide/rituximab] (Press release, Enterome, NOV 13, 2024, View Source [SID1234648268]).

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The data is being presented in two posters at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Conference by Jose Caetano (JC) Villasboas Bisneto, MD, PhD, principal study investigator at the Mayo Clinic, and Stephen Smith, MD, hematologist and medical oncologist at the Fred Hutchinson Cancer Center.

Poster details

Abstract #1616 – EO2463 Peptide Immunotherapy in Patients with Indolent NHL: A Phase 1 Exploration of a Response Biomarker for EO2463 Monotherapy and EO2463 in Combination with Lenalidomide/Rituximab

Abstract #4395 – EO2463 Peptide Immunotherapy in Patients with Newly Diagnosed Asymptomatic Follicular Lymphoma Results in Monotherapy Objective Clinical Responses Linked with Anti-Peptide Specific CD8 Memory T Cell Responses: The EONHL1-20/SIDNEY Study
Webinar details are as follows:

Date: 12 December 2024

Time: 9.30am-10.35am PT / 12.30pm-1.35pm ET / 5.30pm-6.35pm UK / 6.30pm-7.35pm CET

Presenters:

Pierre Belichard PhD, CEO, Enterome

Laurent Chene PhD, Head of Drug Discovery, Enterome

Jose Caetano (JC) Villasboas Bisneto, MD, PhD, Mayo Clinic

Jan Fagerberg, MD, PhD, CMO of Enterome will also be present for the Q&A session following the presentation.

To attend, please register your details at [email protected] .

Questions can be submitted at any time during the presentation.

On November 13, 2024 Curium, a world leader in nuclear medicine, reported that its ECLIPSE trial met its primary endpoint (Press release, Curium Pharma, NOV 13, 2024, View Source [SID1234648264]). ECLIPSE is a pivotal Phase 3, multi-center, open-label, randomized clinical trial comparing the safety and efficacy of 177Lu-PSMA-I&T (INN: lutetium (177Lu) zadavotide guraxetan) versus hormone therapy in patients with metastatic castration-resistant prostate cancer.

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The ECLIPSE trial demonstrated a statistically significant and clinically meaningful improvement in the median radiographic progression-free survival (rPFS) of patients with prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with up to 6 doses of 200 mCi (7.4 GBq) of 177Lu-PSMA-I&T in patients previously treated with an androgen receptor pathway inhibitor (ARPI) compared to a change in ARPI.

Sakir Mutevelic, MD, Curium’s Chief Medical Officer said: "This is a significant accomplishment for Curium, demonstrating in the pivotal confirmatory ECLIPSE trial a statistically significant and clinically meaningful benefit of PSMA-targeted radioligand therapy with 177Lu-PSMA-I&T for patients with mCRPC. ECLIPSE is the first Phase 3 trial investigating a 200 mCi (7.4 GBq) dose of 177Lu-PSMA-I&T administered every six weeks for up to six doses, demonstrating clinical benefit, in mCRPC patients before receiving taxane-based chemotherapy. Curium will continue to work with the FDA as the clinical trial data matures, on a regulatory submission plan for this potentially important product for patients, their caregivers, and the healthcare providers treating prostate cancer."

Michael Patterson, CEO, Curium North America added: "The ECLIPSE achievement of its primary endpoint represents an important clinical milestone in the development of our prostate theranostic program. This underscores Curium’s continued commitment and focus on nuclear medicine diagnostics and therapeutics. Further, the announcement of the opening of Curium’s Netherlands facility for the production of 177Lutetium in September 2024, bolsters Curium’s supply chain and ensures manufacturing reliability. Curium will continue to work to fulfill its mission of redefining the experience of cancer through our trusted legacy in nuclear medicine by ensuring unrestricted access to this important product, if approved."

On November 13, 2024 CEL-SCI Corporation reported that it recently reached an agreement with Dr. Nabil F. Saba, MD, FACP to serve as the confirmatory global Phase III clinical trial Lead, as a member of the Study Steering Committee, for CEL-SCI’s upcoming confirmatory registration study for Multikine in newly diagnosed head and neck cancer (Press release, Cel-Sci, NOV 13, 2024, View Source [SID1234648263]).

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Dr. Saba is a nationally and internationally recognized expert in head and neck cancer and is professor and vice chair in the Department of Hematology and Medical Oncology at Emory University School of Medicine, and the Inaugural Lynne and Howard Halpern Chair in Head and Neck Cancer Research at Emory University School of Medicine. He holds a joint appointment as professor in the Department of Otolaryngology at Emory University School of Medicine. He serves as director of the Head and Neck Cancer Medical Oncology Program and is co-leader of the Multidisciplinary Head and Neck Program at Winship Cancer Institute of Emory University.

Dr. Saba’s work is focused on translational research and the study and development of novel therapeutic agents and modalities. He has served as principal investigator in more than 50 clinical trials and chairs national as well as investigator initiated multi-institution studies focusing on novel approaches for treating head and neck and esophageal cancer. Dr. Saba has also been instrumental in establishing the head and neck cancer research working group at Winship Cancer Institute and is the contact principal investigator of the Lead Academic Participating Site (LAPS) grant of the NCI’s National Clinical Trials Network (NCTN).

Dr. Saba has been elected for two terms as chair and chair emeritus of the National Cancer Institute’s task force for recurrent metastatic head and neck cancer and chaired the Rare Tumors Task Force of the National Cancer Institute’s Head and Neck Cancer Steering Committee. He is an active member of the NRG Oncology and Eastern Cooperative Oncology Group Head and Neck Cancer Core Committees, and chairs two NCI cooperative group trials in the field of head and neck oncology under the ECOG-ACRIN group. Dr. Saba has received competitive NIH funding investigating novel genomic approaches in HPV related and unrelated OPCA and is the recipient of intramural funding studying this disease. He has published more than 290 peer reviewed manuscripts and textbook chapters and is editor of two textbooks: "Esophageal Cancer: Prevention, Diagnosis and Therapy" published in two editions and "Sino-Nasal and Skull Base Malignancies". He is associate editor of JNCI, and Head Neck and served as a member of the ASCO (Free ASCO Whitepaper) Guidelines Committee.

On November 13, 2024 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Biotheus ("Biotheus") reported the signing of a definitive agreement for the acquisition of Biotheus, a clinical-stage biotechnology company dedicated to the discovery and development of novel antibodies to address unmet medical needs of patients with oncological or inflammatory diseases (Press release, BioNTech, NOV 13, 2024, View Source [SID1234648262]).

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With the acquisition, BioNTech will obtain full global rights to the late-stage clinical asset BNT327/PM8002, an investigational bispecific antibody targeting PD-L1 and VEGF-A. The transaction is part of BioNTech’s oncology strategy, aimed at enhancing the company’s capabilities to research, develop and commercialize combination therapies using BNT327/PM8002. Clinical trials with BNT327/PM8002 and the PD-(L)1 x VEGF bispecific class of drugs have demonstrated encouraging clinical activity in various tumor types including in patients with PD-L1-low and -negative tumors who have typically been less responsive to current checkpoint inhibitor treatments.

"The acquisition of Biotheus builds on our successful ongoing collaboration on BNT327/PM8002 and other investigational bispecific antibodies," said Prof. Ugur Sahin, M.D., Ph.D., CEO and co-founder of BioNTech. "We believe that BNT327/PM8002 has the potential to set a new standard of care in multiple oncology indications, surpassing traditional checkpoint inhibitors. We are committed to advancing its research and development in combination with our investigational mRNA vaccines, targeted therapies, and immunomodulators with the aim of enhancing outcomes for patients with solid tumors."

"We are thrilled to deepen our bond with BioNTech. We share the goal of advancing the development of BNT327/PM8002 for future combination therapies in the fight against cancer," said Xiaolin Liu, President, CEO, and Co-Founder of Biotheus. "We believe that BNT327/PM8002 holds significant potential across various tumor indications, and we have an exciting pipeline of innovative investigational assets under development including an antibody discovery and development platform. As we move forward, we are committed to leveraging our strengths with the aim of advancing transformative cancer treatments and enhance our ability to develop treatments for patients in need."

BNT327/PM8002 has shown encouraging efficacy and tolerability in patients across various tumor types, with more than 700 patients treated in clinical trials to date. Multiple registrational trials are planned to start in 2024 and 2025, evaluating BNT327/PM8002 plus chemotherapy in various solid tumor indications including in patients with small cell lung cancer, non-small cell lung cancer and triple-negative breast cancer. Additional trials will explore combining BNT327/PM8002 and BioNTech’s proprietary antibody-drug conjugates ("ADCs"). In June 2024, the evaluation of BNT327/PM8002 in combination with BNT325/DB-1305, a Trophoblast Cell-Surface Antigen 2 ("TROP2")-targeted ADC candidate developed by BioNTech in collaboration with Duality Biologics (Suzhou) Co., Ltd. ("DualityBio"), was initiated as part of an ongoing Phase 1/2 clinical trial (NCT05438329).

Under the terms of the agreement, BioNTech will pay Biotheus shareholders an upfront consideration of $800 million, predominantly in cash, with a small portion in American depositary shares ("ADS"), to acquire 100 percent of the issued share capital, subject to customary purchase price adjustments, plus additional performance-based contingent payments of up to $150 million if certain milestones are met. The transaction is expected to close in the first quarter of 2025, subject to the satisfaction of customary closing conditions, including regulatory approvals. The acquisition follows an initial exclusive global license and collaboration agreement between BioNTech and Biotheus, which closed in November 2023, granting BioNTech the rights to develop, manufacture and commercialize BNT327/PM8002 globally ex-Greater China.

Upon closing, BioNTech will gain full rights to Biotheus’ pipeline candidates and its in-house bispecific antibody drug conjugate capability. The acquisition will expand BioNTech’s footprint in China, adding a local research and development hub to conduct clinical trials. In addition, BioNTech will gain a state-of-the-art biologics manufacturing facility to contribute to its future global manufacturing and supply, and more than 300 Biotheus employees in R&D, manufacturing and enabling functions are expected to join the BioNTech workforce.

BioNTech’s Innovation Series R&D Day
BioNTech leadership will present additional details on the Biotheus transaction, as well as updates on the corporate strategy, commercial strategy and clinical progress across its pipeline during an edition of the company’s Innovation Series R&D Day on 14 November. The live webcast of the event will be available via this link and will begin at 4:30 pm CET (3:30 pm GMT, 10:30 am EST). A replay of the webcast will be available shortly after the event’s conclusion and archived on BioNTech’s website for one year.

About BNT327/PM8002
BNT327/PM8002 is an investigational bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization. The checkpoint inhibition is aimed at restoring T cells’ ability to recognize and destroy tumor cells while targeting VEGF-A is aimed at inhibiting tumor angiogenesis, which cuts off the blood and oxygen supply that feeds tumor cells and thus prevents the tumor from growing and proliferating. The combined blockade of the PD-(L)1 pathway and the VEGF-A driven angiogenesis has been shown to deliver synergistically enhanced anti-tumor immune responses in several solid tumor types.1,2 If successfully developed and approved, BioNTech aims to use this bispecific antibody candidate as a new therapeutic backbone in combination with other treatment modalities targeting different oncogenic pathways.