On October 9, 2024 LaNova Medicines Ltd. reported that the investigational new drug (IND) for LM-108 in combination with CTTQ’s benmelstobart injection/penpulimab, has been approved by China NMPA (Press release, LaNova Medicines, OCT 9, 2024, View Source [SID1234656018]).

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LM-108 is the targeted monoclonal antibody independently developed by LaNova Medicines; benmelstobart injection is an innovative humanized anti-PD-L1 monoclonal antibody; and penpulimab is a novel differentiated anti-PD-1 monoclonal antibody.

On October 9, 2024 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for women’s cancers, reported that it will be presenting multiple posters during the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2024) taking place October 23-25, 2024, in Barcelona, Spain (Press release, Olema Oncology, OCT 9, 2024, View Source [SID1234649115]).

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Details of the ENA 2024 poster presentations are:

Title: Combining palazestrant, a CERAN, and everolimus, an mTOR inhibitor, enhances tumor suppression in ER+/HER2- breast cancer models
Poster/Abstract: 211
Session: Poster Session 300, Exhibition Hall
Date/Time: Thursday, October 24, 2024, from 09:00 to 17:30 CEST

Title: Combining palazestrant, a CERAN, and capivasertib, a pan-AKT inhibitor, enhances tumor suppression in ER+/HER2- breast cancer models
Poster/Abstract: 212
Session: Poster Session 300, Exhibition Hall
Date/Time: Thursday, October 24, 2024, from 09:00 to 17:30 CEST

Title: Combining OP-3136, a KAT6 inhibitor, with endocrine therapy and CDK4/6 inhibitor enhances anti-tumor activity in ER+/HER2- breast cancer models
Poster/Abstract: 230
Session: Poster Session 300, Exhibition Hall
Date/Time: Thursday, October 24, 2024, from 09:00 to 17:30 CEST

Additional information, including abstracts for these presentations, can be found on the ENA website. Copies of the posters will be made available on the Publications page of Olema’s website in alignment with the Symposium’s embargo policy.

About Palazestrant (OP-1250)
Palazestrant (OP-1250) is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor efficacy along with attractive pharmacokinetics and exposure, favorable tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 1/2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib), a PI3Ka inhibitor (alpelisib), and an mTOR inhibitor (everolimus). For more information on OPERA-01, please visit www.opera01study.com.

On October 9, 2024 Akiram Therapeutics reported that it has developed 177Lu-AKIR001, a new type of targeted radioimmunotherapy (Press release, Akiram Therapeutics, OCT 9, 2024, View Source [SID1234647279]). The therapy holds the potential to become a first-in-class treatment in multiple cancer types, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer. The drug is composed of a target recognition molecule to which therapeutic radioactivity is coupled for effect on tumor cells.

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The presentations at the EANM Congress will focus on the development and optimization of the drug in preparation for upcoming clinical trials. Specifically, the cGMP production process, which ensures the drug can be manufactured according to high-quality standards for clinical studies, will be highlighted.

The presentation on the cGMP development of 177Lu-AKIR001 has been selected as one of the Top-Rated Oral Presentations at the congress:

Title: cGMP development of the 177Lu-AKIR001 for clinical translation in first-in-human studies of CD44v6 expressing cancer patients
Presentation No.: OP-082
Date & Time: October 20, 9:45 AM, Hall X1-X4
Speaker: Klas Bratteby

Additionally, several other key research findings on 177Lu-AKIR001 will be showcased as posters, including:

177Lu-AKIR001 inhibits growth of pancreatic tumour xenografts
Poster No.: EP-0100
Presented by: Amanda Gustafsson
Fractionation of 177Lu-DOTA-AKIR001 results in increased curative rates and favorable hematopoietic toxicities compared to single high dose
Poster No.:EP-0992
Presented by: Anja Mortensen
Biodistribution and in vivo efficacy of 161Tb-labeled AKIR001, a novel anti-CD44v6 antibody
Poster No.: EP-0991
Presented by: Anja Mortensen
"We are thrilled to see the results of our academic collaborations presented at the EANM Congress. 177Lu-AKIR001 has shown great preclinical potential to transform the treatment of CD44v6-expressing tumors. We are looking forward to starting phase 1 studies later this fall, with the goal of offering new, targeted treatment options for patients with hard-to-treat cancers," says Marika Nestor, CEO of Akiram Therapeutics. "The selection of the cGMP production presentation as one of the top-rated talks is a clear recognition of the promising research, and we are excited to share the results with the international scientific community."

EANM – The European Association of Nuclear Medicine
The annual EANM Congress is one of the premier global platforms where leading experts and industry representatives from around the world gather to discuss advancements and future trends in nuclear medicine. Read more: View Source

About Akiram’s Drug Candidate
Developed through antibody phage display and affinity maturation targeting the CD44v6 cancer marker, 177Lu-AKIR001 combines the radiation component lutetium-177 with a targeted molecule. Preclinical studies have demonstrated its potential as a promising, first-in-class radiopharmaceutical therapy for cancers with high CD44v6 expression.

On October 9, 2024 Nona Biosciences, a global biotechnology company providing a total solution from "Idea to IND" (I to ITM), reported a strategic collaboration with OverT Bio, a New York-based biotechnology company (Press release, Nona Biosciences, OCT 9, 2024, View Source [SID1234647117]). The collaboration will focus on developing next-generation cell therapies for solid tumors by leveraging Nona’s proprietary fully human HCAb Harbour Mice platform and its innovative direct CAR-function-based HCAb library screening platform, NonaCarFxTM.

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The fully human heavy chain-only antibodies (HCAbs) generated from Nona’s HCAb Harbour Mice platform provide an ideal modality for CAR-based cell therapies. Unlike traditional methods, fully human HCAbs have the potential to significantly reduce immunogenicity. Their compact size, simplified structure, and precisely calibrated binding properties offer enhanced versatility in CAR design. In the evolving field of cell therapy, fully human HCAbs present significant potential to unlock further therapeutic advancements.

"We are excited to partner with OverT Bio to advance novel cell therapies for solid tumors," said Jingsong Wang, MD, PhD, Chairman of Nona Biosciences. "By combining our fully human HCAb technology with OverT Bio’s innovative approaches, we aim to accelerate the development of transformative therapies that have the potential to significantly improve patient outcomes."

Mat Legut, PhD, CEO of OverT Bio, added, "We are excited to partner with Nona as we are advancing the field of genetically enhanced allogeneic gamma delta T cells. By leveraging Nona’s fully human HCAbs, we are accelerating the development of our first clinical program to demonstrate the safety and efficacy of our differentiated cell engineering platforms."

On October 9, 2024 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that it will present new data related to its DecisionDx-Melanoma and DecisionDx-UM tests for patients with cutaneous melanoma (CM) and uveal melanoma (UM), respectively, at the 21st International Congress of the Society for Melanoma Research (SMR), taking place Oct. 10-13, 2024, in New Orleans (Press release, Castle Biosciences, OCT 9, 2024, View Source [SID1234647126]).

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"In large prospective and retrospective studies, our DecisionDx-Melanoma test has been shown to provide clinical value above and beyond current staging paradigms and other tests currently available for patients with cutaneous melanoma," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Clinical use studies have shown that clinicians act upon these results to improve risk-aligned treatment pathway decisions which are associated with improved outcomes."

Details regarding Castle’s posters at SMR are included below. Posters will be available for viewing starting the evening of Thursday, Oct. 10, through the evening of Saturday, Oct. 12.

DecisionDx-Melanoma

Poster title: In a prospective, multicenter study, the 31-GEP identified patients at increased risk of tumor recurrence and added significant prognostic value to AJCC staging
Poster #: 40
Summary: This study included 876 patients with Stage I-III CM from multiple centers who received DecisionDx-Melanoma testing as part of their clinical care. The data show DecisionDx-Melanoma stratified patients by their risk of recurrence and was a significant predictor of recurrence; patients with Class 1A (lowest risk) test results had significantly higher three-year recurrence-free survival than those with a Class 1B/2A (increased risk) or Class 2B (highest risk) test result (p<0.001). Importantly, the test added significant predictive value to American Joint Committee on Cancer (AJCC) staging, considered the standard of care in melanoma management. These findings provide evidence that use of the test with melanoma patients enables better risk-aligned care decisions, which have been shown to lead to improved patient outcomes.1,2
DecisionDx-UM

Poster title: Confirmation of PRAME status as a risk modifier of 15-gene expression profile class in a large real-world population-based cohort of uveal melanoma patients
Poster #: 134
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2024, DecisionDx-Melanoma has been ordered more than 173,000 times for patients diagnosed with cutaneous melanoma. Learn more at www.CastleBiosciences.com.

About DecisionDx-UM

DecisionDx-UM is Castle Biosciences’ 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with uveal melanoma (UM). DecisionDx-UM is the standard of care in the management of newly diagnosed UM in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for UM include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B and 2 result. DecisionDx-UM is currently the only prognostic test for UM that has been validated in prospective, multi-center studies, and it has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutational status, AJCC stage and cell type. It is estimated that nearly 8 in 10 patients diagnosed with UM in the United States receive the DecisionDx-UM test as part of their diagnostic workup. Learn more at www.CastleBiosciences.com.