On October 10, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported that four abstracts have been accepted for poster presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, to take place in Barcelona, Spain, October 23 – 25, 2024 (Press release, Aprea, OCT 10, 2024, View Source [SID1234647133]). Details on the posters are below.

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"We are very pleased to have these posters featured at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium, showcasing the ongoing progress in our oncology pipeline of DNA damage response (DDR) inhibitors," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "This symposium provides a great opportunity to share updates on our two clinical stage candidates, APR-1051 and ATRN-119, with the international oncology community."

Poster Details

Clinical:
Title: Safety and Preliminary Efficacy of APR-1051, a WEE1 Inhibitor, in a Phase 1 Study of Patients with Cancer-Associated Gene Alterations (ACESOT-1051)
Session date/ time: Wednesday, October 23rd, 12:00 – 19:00 CET
Location: Exhibition Hall
Poster #: 77

Title: ATRN-119, a Novel Macrocyclic ATR Inhibitor, in Patients with Advanced Solid Malignancies: A Phase 1/2a Trial (ABOYA-119)
Session date/ time: Friday, October 25th, 09:00 – 15:00 CET
Location: Exhibition Hall
Poster#: 348

Preclinical
Title: The novel WEE1i, APR-1051, does not substantially off-target PLK1, PLK2, or PLK3 and exhibits favorable in vivo characteristics for treating CCNE1-overexpressing cancers
Session date/ time: Friday, October 25th, 09:00 – 15:00 CET
Location: Exhibition Hall
Poster #: 335

Title: Development and testing of a first-in-class series of macrocyclic ATR inhibitors for cancer treatment
Session date/ time: Friday, October 25th, 09:00 – 15:00 CET
Location: Exhibition Hall
Poster #: 336

Copies of the posters will be available on the "Investor Resources" page of the Aprea corporate website at the conclusion of the meeting

On October 10, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that its first patient with recurrent lung cancer has been treated, in a clinical trial at Hadassah Medical Center in Jerusalem, Israel (Press release, Alpha Tau Medical, OCT 10, 2024, View Source [SID1234647132]).

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The trial is designed to treat up to ten patients with recurrent tumors in the mediastinum area of the chest, and allows for the use of concurrent chemotherapy, targeted therapy, or immunotherapy, if indicated. The study will assess the safety and feasibility of delivering Alpha DaRT sources into the lung using an endobronchial ultrasound (EBUS) procedure, including by observing the rate of successful source placement and any treatment-related adverse events. In addition, the study will also assess the efficacy of Alpha DaRT for this indication by examining tumor response at one and three months after source insertion using RECIST criteria, as well as tumor coverage. Additional information about the trial can be found at View Source

According to the WHO’s International Agency for Research on Cancer, lung cancer is the leading cause of cancer-related deaths worldwide, with almost 2.5 million new cases detected each year, and is often only diagnosed at advanced stages, when treatment options are limited. In the U.S., lung cancer is the third most common cancer, according to the Centers for Disease Control and Prevention, with an estimated 210,000 new cases per year.

"Alpha Tau continues to forge ahead with the application of Alpha DaRT to a broader set of indications, particularly in tumors in visceral organs and other complex cases," said Alpha Tau Chief Executive Officer Uzi Sofer. "As we see continued clinician excitement and demand for use of the Alpha DaRT in an ever-increasing set of cancers, the ability to start treating patients in as terrible and widespread an illness as lung cancer is particularly meaningful."

"The Institute of Pulmonology of Hadassah Medical Center is excited to utilize this groundbreaking EBUS-guided implantable alpha radiation technology to treat a patient with lung cancer for the first time," noted Prof. Neville Berkman, MD, the study principal investigator and Director of the Institute of Pulmonology and Head of Adults and Invasive Pulmonology Unit, Hadassah Medical Center, who treated the patient. "The treatment makes use of bronchoscopic endobronchial ultrasound to insert the Alpha DaRT sources. We look forward to further examining the promise of what the Alpha DaRT treatment can offer lung cancer patients and their families."

"Treating the first lung patient with the Alpha DaRT is a very exciting moment. We have already demonstrated the advantages of the Alpha DaRT technology in a number of other tumor types, but examining its application to an organ such the lung, given its proximity to vital healthy organs, may hopefully open new doors to a global population of patients with otherwise poor treatment options," commented Alpha Tau Chief Medical Officer Robert Den, MD.

"Treating the first patient with lung cancer using Alpha DaRT marks a significant advancement, introducing a novel approach that combines the precision of alpha-emitting particles with the ability to selectively target and destroy tumor cells while minimizing damage to surrounding healthy tissues," added Dr. Philip Blumenfeld, study co-investigator and Senior Radiation Oncologist and Head of Thoracic Radiation Oncology Services at Hadassah Medical Center. "In this specific case, the patient had already undergone conventional radiation therapy to the lung and lymph nodes, and additional radiation would have posed a high risk of serious harm to nearby structures, particularly the esophagus and bronchus."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

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.