On November 13, 2024 ImmunoPrecise Antibodies Ltd. (the "Company" or "IPA") (NASDAQ: IPA), a leader in AI-driven medical innovation, reported a significant breakthrough in its primary cancer research initiatives (Press release, ImmunoPrecise Antibodies, NOV 13, 2024, View Source [SID1234648277]). This accomplishment not only highlights IPA’s cutting-edge discovery and AI capabilities, but it also strategically places the company in the rapidly growing market for these cancer-combating antibodies, which is projected to reach $20.7 billion by 2028. The TATX-112 program, dedicated to the development of specialized antibodies for cancer treatment, has shown encouraging results, successfully targeting cells that express a protein known as TrkB. This achievement has paved the way for several promising candidates for further development.

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TrkB is a protein commonly found in aggressive cancers. IPA is spearheading two programs that target this protein. The TATX-200 program is centered on developing T cell engagers, which boost the body’s immune response against tumors. The TATX-112 program is focused on creating antibodies that can deliver cancer-killing drugs directly to tumor cells. The recent advancements in the TATX-112 program have led to the discovery of multiple antibodies that can infiltrate and eliminate TrkB-expressing cells in an in vitro surrogate Antibody Drug Conjugate (ADC) assay. This suggests that these antibodies could be used to deliver drugs directly to cancer cells, potentially enhancing the effectiveness and safety of cancer treatments targeting TrkB.

Dr. Jennifer Bath, CEO of ImmunoPrecise Antibodies, expressed her excitement: "Our TATX-112 program has reached a significant milestone, demonstrating our ability to target and eliminate TrkB-expressing cells. This breakthrough accelerates our cancer-fighting antibody development efforts. Our innovative discovery process, combined with validation and AI-driven characterization, has enabled us to identify antibodies with high TrkB specificity. We are confident in our leadership position in AI-guided development and within our cancer program. We look forward to reaching many more significant milestones in our journey to revolutionize cancer treatment."

Talem Therapeutics’ recent development of antibodies potentially suitable for cancer treatment marks a significant step in their mission to transform cancer treatment. Talem’s focus on TrkB-expressing tumors addresses a critical need in cancer treatment. IPA remains committed to driving innovation and creating long-term value, as it continues to advance the Talem pipeline and explore commercialization opportunities in the biopharmaceutical sector.

On November 13, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on the development of first-in-class and best-in-class targeted oncology therapies, reported financial results for the third quarter ended September 30, 2024, and provided a business update (Press release, Immunome, NOV 13, 2024, View Source [SID1234648276]).

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"Immunome continues to advance its pipeline," said Clay B. Siegall, Ph.D., President and Chief Executive Officer. "Topline data for the RINGSIDE Part B trial of AL102 is expected in the second half of 2025, and IND submissions for IM-1021 and IM-3050 are on track."

"Our discovery team is focused on discovering ADCs that effectively pursue the novel targets we believe will define the next generation of transformative cancer therapies. In particular, the differentiated profile of HC74, our proprietary TOP1 payload, offers exciting opportunities for portfolio expansion when combined with our large repertoire of antibodies."

Pipeline Highlights

Full enrollment for the Phase 3 RINGSIDE Part B study of AL102 for the treatment of desmoid tumors was completed in February 2024, and Immunome expects to report topline data for RINGSIDE Part B in the second half of 2025. In parallel, Immunome is performing additional manufacturing and pharmacology work required to support a new drug application filing for AL102.

Immunome also anticipates submitting INDs for IM-1021 and IM-3050 in the first quarter of 2025, as previously disclosed.

Third Quarter 2024 Financial Results

· As of September 30, 2024, cash, cash equivalents and marketable securities totaled $240.1 million. Immunome’s current cash runway is expected to extend into 2026.
· Research and development expenses for the quarter ended September 30, 2024 were $37.2 million, including stock-based compensation costs of $1.8 million.
· In-process research and development expenses for the quarter ended September 30, 2024 were $6.7 million. These expenses were related to Immunome’s business development activity.
· General and administrative expenses for the quarter ended September 30, 2024 were $9.5 million, including stock-based compensation expense of $3.1 million.
· Immunome reported a net loss of $47.1 million for the quarter ended September 30, 2024.

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."