On April 24, 2024 Mercy BioAnalytics, Inc., a pioneer in extracellular vesicle-based liquid biopsy for the early detection of cancer, reported that it will present data at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showing the performance of its Mercy Halo Ovarian Cancer screening test in a large cohort of asymptomatic, postmenopausal women (Press release, Mercy BioAnalytics, APR 24, 2024, View Source [SID1234642310]). The results of the study, which included more than 1,300 women, will be shared in a poster presentation on June 3rd, 2024.

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Ovarian cancer is one of the leading causes of cancer death among women. More than 70% of ovarian cancer is diagnosed in women over 50 years of age, and nearly 80% of ovarian cancer is diagnosed at an advanced stage of disease, when survival is poor. Today, there are no guideline-recommended screening tests for ovarian cancer, which kills nearly 13,000 women each year in the US alone.

"Legacy technologies such as CA125 serum biomarker testing and transvaginal ultrasound imaging have not proven accurate enough to justify their use for population ovarian cancer screening. Unfortunately, no alternative technology has demonstrated superior clinical performance in a screening population since CA125 and transvaginal ultrasound were introduced nearly four decades ago," said Dawn Mattoon, PhD, Mercy’s CEO.

Mercy is developing a highly sensitive and specific screening test designed to help detect ovarian cancer earlier in asymptomatic, postmenopausal women. Mercy analyzed samples from the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) in which 200,000 women were enrolled, randomized to no screening or annual screening, and followed for up to 20 years. All trial participants donated a blood sample at the time of enrollment. Mercy analyzed the blood of more than 1,300 trial participants to assess the sensitivity and specificity of the Mercy Halo test for detecting ovarian cancer up to three years prior to clinical diagnosis.

"This study allowed us to see how far in advance of the presentation of clinical disease our test can detect early-stage ovarian cancer, and at what sensitivity and specificity," Mattoon said. "We’re excited to share the outstanding performance of the Mercy Halo test in this large patient cohort that is representative of our intended patient population."

The Mercy Halo test achieves high sensitivity and specificity through the simultaneous detection of multiple cancer-related biomarkers co-localized on the surface of individual tumor-associated extracellular vesicles. The high abundance of extracellular vesicles in circulation enables the Mercy Halo test to be run on a very small volume of serum or plasma with a simple qPCR-based read-out, unlike cell-free DNA-based tests which typically require a larger volume of blood and next-generation sequencing to generate results.

The Mercy ovarian cancer data will be shared on June 3rd in a poster titled "Evaluation of a novel extracellular vesicle (EV) based ovarian cancer (OC) screening test in asymptomatic postmenopausal women."

On April 24, 2024 Endeavor BioMedicines, Inc. ("Endeavor"), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, reported the closing of a $132.5 million Series C financing, including the conversion of a $5 million convertible instrument (Press release, Endeavor BioMedicines, APR 24, 2024, View Source [SID1234642326]). The oversubscribed round was led by AyurMaya, an affiliate of Matrix Capital Management, with participation from new investors including Fidelity Management & Research Company, Invus, SymBiosis, Velosity Capital, and Woodline Partners; and strong support from existing investors including funds managed by abrdn Inc. (formerly Tekla Capital Management LLC), Ally Bridge Group, Avidity Partners, Eckuity Capital, Longitude Capital, Omega Funds, Perceptive Advisors, Piper Heartland Healthcare Capital, Silver Arch Bio, and T. Rowe Price Associates.

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Endeavor will use the financing proceeds to advance the clinical development of ENV-101, its lead candidate for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF); and to advance ENV-501, a human epidermal growth factor 3 (HER3) antibody-drug conjugate (ADC) for the treatment of HER3-positive solid tumors through clinical proof-of-concept studies.

"We appreciate the support from this group of leading life sciences investors, who recognize the tremendous progress we’ve made since our initial funding rounds as well as the life-changing potential of our therapeutic candidates to reverse the trajectory of relentless diseases," said John Hood, Ph.D., Co-Founder, CEO and Chairman of Endeavor. "Endeavor BioMedicines has the momentum, coupled with the right team and the necessary financing, to advance our mission of delivering transformational medicines to patients who need them."

Advancing potential groundbreaking medicine for fibrotic lung diseases
Endeavor’s lead investigational candidate, ENV-101, has the potential to improve lung function and reverse the fibrotic process in the lungs of individuals with IPF and PPF. ENV-101 blocks a cellular wound-healing pathway known as Hedgehog (Hh) that is abnormally activated in IPF and PPF and causes the buildup of scar tissue in the lungs. Current standard-of-care therapies do not address the underlying cause of IPF or PPF. They minimally slow the decline of lung function, but do not stop or reverse it, and have tolerability issues that limit their long-term use in most patients.

Preliminary results from the recently completed randomized, double-blind, placebo-controlled Phase 2a clinical trial of ENV-101 (NCT04968574) underscore its potential to modify disease and offer treatment outcomes that go beyond slowing disease progression for patients with IPF. Results will be presented at the American Thoracic Society (ATS) International Conference in May. Endeavor plans to initiate a Phase 2b trial in patients with IPF and in parallel a cohort of patients with PPF in 2024.

Pursuing a validated therapeutic target in solid tumors
Endeavor’s second investigational candidate, ENV-501, is a next-generation anti-HER3 ADC that has been engineered to minimize off-target toxicity and has a clear path for differentiation against other HER3 ADCs in development. The HER3 protein is a growth factor receptor related to clinically validated oncology targets. HER3 is overexpressed in many solid tumors and those cancers that are HER3-positive are associated with poor prognosis and resistance to certain types of therapies. ENV-501 incorporates chemical and genetic features designed to improve the delivery of the drug to tumors and thereby increase its potency and reduce the toxicities commonly associated with ADCs. Endeavor intends to initiate a Phase 1/2 trial of ENV-501 in 2024.

"Endeavor BioMedicines’ novel drug candidates have the potential to disrupt the underlying mechanisms that cause serious, life-threatening diseases," said Karan Takhar, Senior Managing Director at Matrix, who will join Endeavor BioMedicines’ Board of Directors as part of the Series C financing. "I look forward to collaborating with Endeavor BioMedicines’ executive team and other members of the board to support the company’s clinical execution as it pursues significant milestones in 2024 and beyond."

On April 24, 2024 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported preliminary topline results from Cohort B of the TACTI-003 (KEYNOTEPNC-34) Phase IIb trial evaluating eftilagimod alpha (efti) in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression (Press release, Immutep, APR 24, 2024, View Source [SID1234642252]).

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The investigational immuno-oncology combination utilizing Immutep’s MHC Class II agonist and MSD’s PD-1 therapy demonstrates an overall response rate (ORR) of 26.9% and disease control rate (DCR) of 57.7% in 26 patients whose tumours do not express PD-L1 (Combined Positive Score [CPS] <1), according to RECIST 1.1, which compares favourably to historical controls.

Dr. Martin Forster of the UCL Cancer Institute and University College London Hospital NHS Foundation, London, UK, and TACTI-003 Investigator, stated, "These preliminary topline results in the first line setting for patients with head and neck squamous cell cancers that do not express PD-L1 are encouraging. Head and neck squamous cell carcinomas are a heterogenous disease that represent a high unmet medical need regardless of PD-L1 expression. This is especially the case for patients with tumours that do not express PD-L1 and those that cannot receive chemotherapy. The ability of efti to work with MSD’s anti-PD-1 therapy KEYTRUDA to potentially improve patients’ clinical responses and expand patient populations that respond to the latter, without using chemotherapy, is promising."

This new data adds to the body of evidence that efti’s novel activation of antigen-presenting cells provides a powerful boost to the immune system, which enhances the potential of immune checkpoint inhibitors. Fundamentally, efti is leading to a significant expansion of memory cytotoxic T cells that anti-PD-(L)1 therapies can act upon. Importantly, as the only MHC Class II agonist in clinical development today, efti is generating a broad anti-cancer immune response in a unique and safe manner across all levels of PD-L1 expression, even in tumours with negative expression (CPS<1).

A total of 33 patients with recurrent or metastatic HNSCC have been enrolled into Cohort B. The 26 patients reported on today represent those currently available with sufficiently long enough follow up time as per protocol and where the data cleaning has sufficiently progressed at the time of data cut-off in February. The final number of evaluable patients in Cohort B is expected to be higher and additional data, including complete response rate, will be released together with Cohort A data.

With respect to the randomized Cohort A of the TACTI-003 trial evaluating the safety and efficacy of efti in combination with KEYTRUDA as compared to KEYTRUDA monotherapy, 138 patients with PD-L1 positive tumours have been enrolled at over 30 centres globally. Patients in Cohort A are stratified by CPS >1, CPS 1- 19, and CPS >20, and the clinical results for these three CPS groups will be evaluated. The cut-off for primary analysis according to the trial protocol is defined as after all subjects have completed at least three cycles of treatment (18 weeks in total) or discontinued the trial. Thereafter data collection and data cleaning need to be completed.

Data collection, cleaning, and analysis continue for TACTI-003, and the Company expects to report the primary endpoint (overall response rate according to RECIST1.1) from Cohorts A & B in H1 CY2024.

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer by incidence worldwide, with 890,000 new cases and 450,000 deaths reported in 2018.1,2,3 It is an aggressive, genetically complex, and difficult to treat cancer.4 Furthermore, HNSCC is associated with high levels of psychological distress and compromised quality of life (QOL).5 As such, HNSCC patients need improved treatment options.

Efti has received FDA Fast Track designation in 1L HNSCC regardless of PD-L1 expression.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

About the TACTI-003 Trial
The TACTI-003 (KEYNOTE-PNC-34) trial is an ongoing Phase IIb study evaluating eftilagimod alpha (efti), Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist, in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The randomized Cohort A portion of the study is evaluating efti in combination with pembrolizumab as compared to pembrolizumab monotherapy in patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumours, whereas Cohort B is evaluating efti in combination with pembrolizumab in patients with PD-L1 negative tumours.

The primary endpoint of the study is Overall Response Rate of evaluable patients according to RECIST 1.1. Secondary endpoints include Overall Survival, Overall Response Rate according to iRECIST, Progression Free Survival, and Duration of Response. The primary analysis according to the trial protocol will be performed after all subjects have completed at least three cycles of treatment (18 weeks in total) or discontinued the trial, and all relevant data for the primary endpoint has been collected, cleaned, and analysed. For more information about the Phase IIb trial, visit clinicaltrials.gov (NCT04811027).

About Eftilagimod Alpha (Efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On April 24, 2024 Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS) reported the first presentation of clinical data for CHS-114, a highly selective cytolytic anti-CCR8 antibody, at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting, which will be held from May 31 to June 4, 2024, at McCormick Place in Chicago (Press release, Coherus Biosciences, APR 24, 2024, View Source [SID1234642277]).

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Presentation Details

Abstract: 2664
Title: Preliminary Results of a Phase 1, First-in-human, Dose Escalation Study of the Anti-CCR8 Cytolytic Antibody, CHS-114 (formerly SRF114) in Patients with Advanced Solid Tumors.
Poster Session– Developmental Therapeutics – Immunotherapy
Date and Time: Saturday, June 1, 2024, 9:00 a.m. – 12:00 p.m. Central Daylight Time

About CHS-114

CHS-114, a human, afucosylated anti-CCR8 monoclonal antibody, is designed to selectively target human CCR8 and preferentially deplete CCR8+ regulatory T cells (Tregs) within the tumor microenvironment, not effector T (Teff) cells in tumors or Tregs in normal tissue. In preclinical studies, CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) to deplete tumoral CCR8+ Tregs. In addition, treatment with CHS-114 alone reduced tumor growth in murine models, and enhanced antitumor activity was observed in combination with anti-PD-1 treatment.

CHS-114 is currently being evaluated in a Phase 1 clinical trial (NCT05635643) as a monotherapy and in combination with toripalimab in advanced solid tumors, including head and neck cancer. As reported in June 2023, early evidence of biological effect has been seen with CCR8+ Tregs depletion in blood following treatment with CHS-114, with no effect observed on non-CCR8+ Tregs. Clinical data from the CHS-114 single agent dose escalation stage of the Phase 1 study will be presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting.

On April 24, 2024 NKGen Biotech, Inc. (Nasdaq: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer ("NK") cell therapeutics, reported an online publication at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held virtually and at the McCormick Place Convention Center in Chicago, Illinois from May 31–June 4, 2024 (Press release, NKGEN Biotech, APR 24, 2024, View Source [SID1234642293]).

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ePublication Details:

Title: Interim analysis of a phase I study using cryopreserved non-genetically modified allogeneic natural killer cells with enhanced cytotoxicity (SNK02) in patients with advanced solid tumors without lymphodepletion

Authors: Victoria Chua, Sant Chawla, Erlinda Gordon, William Feske, Lucia Hui, Hank Lee, Yoonmi Kang, Juan Mata, Katia Betito, Paul Chang, Paul Song

Abstract Number: e14515

Session Type: Publication Only

Session Title: Developmental Therapeutics – Immunotherapy

A copy of the ePublication will be available on the Scientific Publications page of the Company’s website at View Source