On October 18, 2022 TAE Life Sciences (TLS), a biological-targeted radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported the sponsorship of an Industry Education session focused on the future of biologically targeted radiotherapy at the American Society for Radiation Oncology (ASTRO) Annual Meeting, occurring October 22-26, 2022 (Press release, TAE Life Sciences, OCT 18, 2022, View Source [SID1234622150]).

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The Industry Theater session, "A Glimpse into the Future: Biologically Targeted Radiotherapy" will feature presentations by Sunil Krishnan, M.B.B.S., M.D., Professor, Radiation Oncology, UT Health Houston, Minesh P. Mehta, MD., Deputy Director & Chief of Radiation Oncology, Miami Cancer Institute and Art Raitano, Senior Director Protein Sciences, TAE Life Sciences.

Session Title: A Glimpse into the Future: Biologically Targeted Radiotherapy
Location: Theater 2
Date: Sunday, October 23, 4:00 – 5:00 PM

"BNCT is one of the most exciting developments in radiation therapy, and yet it remains inadequately explored in the clinic due to technological and pharmacological limitations. The good news is that we are looking at an extremely bright future with a variety of novel technological solutions that allow in-hospital accommodation of these devices in typical radiotherapy clinics," said Minesh P. Mehta, M.D., Deputy Director & Chief of Radiation Oncology, Miami Cancer Institute. "The utilization of targeted drugs for a variety of malignancies which allow the enrichment of boron concentration in tumors might represent the ultimate frontier for enhancing BNCT into mainstream radiotherapy."

"I believe a resurgence of interest in BNCT via technological advances in the design of accelerator-based BNCT platforms and future development of next-generation boron therapeutics will enable the advancement of genuine biologically targeted therapy," said Sunil Krishnan, Professor, Radiation Oncology, UT Health Houston.

In addition, TAE Life Sciences will be presenting the following posters:

Poster Title: Development of New Targeted Boronated Small Molecule Drugs for Boron Neutron Capture Therapy (BNCT)
Poster Number: 3170
Presenting Author: Art Raitano, Senior Director Protein Sciences, TAE Life Sciences
Date: Monday, October 24, 5:00 PM

Poster Title: Development of a Clinical Neutron Source for Boron Neutron Capture Therapy
Poster Number: 3200
Presenting Author: Charles Lee, Director of Clinical Development, TAE Life Sciences
Date: Wednesday, October 26, 12:30 PM

About BNCT

BNCT is a combination treatment based on the reaction that occurs when a non-toxic compound containing boron-10 is irradiated with a low-energy neutron beam. BNCT differs radically from other radiation therapy and shows promise in becoming the next-generation cancer treatment. Research has shown BNCT has the capability of killing cancer cells that are resistant to traditional radiation therapy with limited harm to healthy tissue. Current advances in both neutron radiation technology and medicinal boron drug targeting are enabling BNCT’s potential to improve patient care while also improving treatment economics. To date, approximately 2,000 patients have been treated with BNCT at research sites worldwide.

On October 18, 2022 Istari Oncology, Inc., a clinical-stage biotechnology company focused on development of the novel immune activator lerapolturev for the treatment of solid tumors, reported a poster presentation of new data from an enhanced dosing cohort within the LUMINOS-102 phase 2 clinical trial, which is assessing the safety and efficacy of lerapolturev (formerly PVSRIPO) alone or in combination with a programmed death receptor-1 (PD-1) inhibitor in patients with metastatic melanoma who have progressed on an anti-PD-1 containing regimen, and BRAF/MEK inhibitors if BRAF mutation positive (Press release, Istari Oncology, OCT 18, 2022, View Source;102-an-ongoing-Phase-2-Trial-of-Lerapolturev-in-anti-PD-1-Refractory-Metastatic-Melanoma-at-the-Society-for-Melanoma-Research-SMR-2022-Congress [SID1234622149]). The presentation is being made at the Society for Melanoma Research (SMR) Congress being held in Edinburgh October 17 – 20, 2022.

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Lerapolturev is a novel viral immunotherapy that activates the innate and adaptive immune system to produce a functional, systemic anticancer CD8+ T cell response. Following positive phase 1 monotherapy results,1 the LUMINOS-102 phase 2 multicenter trial (NCT04577807) was initiated to further explore lerapolturev’s impact on this tough-to-treat population of anti-PD-1 relapsed/refractory metastatic melanoma patients.

"LUMINOS-102 initially used the lerapolturev dose that yielded a 67% (4/6) response rate in the phase 1 single-center trial," said Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. "Following DSMB review and protocol amendment, a new dosing regimen was implemented for LUMINOS-102 in March 2022. Our poster presentation at SMR highlights the exciting responses we’ve seen among subjects treated with the new regimen. We are optimistic that we’ve now optimized the dosing regimen and are continuing to enroll subjects at this dose to confirm these encouraging results."

The dosing regimen now in place comprises a higher dose of lerapolturev with or without an "induction schedule" of weekly injections for seven weeks, followed by maintenance injections dictated by the cadence of anti-PD-1 infusions (every 2 or 3 weeks). Since implementation, seven (7) patients have been treated with the higher lera dose, with 3 subjects (those who were consented from the start of treatment under the protocol amendment) also receiving the induction dosing schedule. Among these patients, a clinical benefit rate (CR, PR or SD > 6 months) of 71% (5/7) has been observed, including a pathologic complete response (pCR). All subjects were heavily pretreated and had previously failed at least one anti-PD-1 therapy. Some participants had also failed anti-CTLA-4 and BRAF/MEK therapies.

"We are pleased to see lerapolturev treatment yield responses, including responses in non- injected lesions", remarked Yana G. Najjar, MD Assistant Professor of Medicine and Director, Clinical and Translational Center at the UPMC Hillman Cancer Center and Principal Investigator for LUMINOS-102. "Metastatic melanoma patients with anti-PD-1 relapsed/refractory disease have limited options and we’ve recently seen multiple investigational therapies fail in this setting. We’re hopeful that the responses seen with the new lera dosing strategy will be validated with additional patients and lead to further development".

LUMINOS-102 remains open to enrollment, with updates to be presented at an oncology congress in 2023. If successful, Istari plans to leverage its Orphan and Fast Track status in unresectable anti-PD-1 refractory melanoma by collaborating with regulators on a registration strategy.

To view the poster and for more information about Istari Oncology and their ongoing clinical trials, visit www.istarioncology.com.

About Lerapolturev

Lerapolturev is an investigational immunotherapy based on the live attenuated Sabin type 1 polio vaccine genetically modified for safety. Lerapolturev has a distinct target (the poliovirus receptor CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, lerapolturev targets tumors with three key mechanisms: 1) engagement and activation of antigen presenting cells (APCs), leading to T cell priming and sustained, systemic anticancer immunity; 2) direct tumor cell killing and antigen release; and 3) amplification of the immune response via recall of polio vaccine-specific T cells. Lerapolturev has been granted Breakthrough Therapy and Orphan Drug Designation status by the U.S. Food and Drug Administration in recurrent glioblastoma, and Fast Track and Orphan Drug Designation status in refractory melanoma.

About Melanoma

There are estimated to be over 12,000 new and recurrent cases of advanced, unresectable melanoma diagnosed in the U.S. each year, and around 7,000 deaths. While immune checkpoint inhibitors have dramatically improved the outlook for advanced melanoma patients today, most patients treated with these immunotherapies are either primary nonresponders or eventually develop immune-refractory progressive disease and require additional options, which are poor.

On October 18, 2022 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat cancer, reported it has entered into a license agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, for a glypican 2 (GPC2) binding domain to be used for the potential development and commercialization of ARTEMIS T cell therapies for patients with neuroblastoma, a rare cancer that affects the developing nervous system (Press release, Eureka Therapeutics, OCT 18, 2022, View Source [SID1234622148]). The therapy also has expansion potential in medulloblastoma and small cell lung cancer, among several other pediatric and adult cancers that express an abundance of the GPC2 protein on their cell surface.

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Neuroblastoma is a rare cancer that affects the development of the nervous system by attacking immature nerve cells as early as the embryonic stage. Each year, about 800 children are diagnosed with neuroblastoma in the U.S., and overall survival rates are lower than 50%. Current chemotherapy options for these patients are limited and highly toxic, which highlights the urgent need for new treatments for this disease to improve overall survival and reduce long-term toxicity.

"GPC2 is an exciting new target for neuroblastoma. In pre-clinical models, anti-GPC2 directed ARTEMIS T cells demonstrated significant tumor-killing activity," said Dr. Mitchell Ho, Deputy Chief of the Laboratory of Molecular Biology and Director of the Antibody Engineering Program at the NCI Center for Cancer Research. "We believe it is beneficial to further evaluate anti-GPC2 directed ARTEMIS T cells as a potential T cell therapy for patients with neuroblastoma and other cancers that express GPC2."

"The expansion of our pipeline with an anti-GPC2 program supports our effort to deliver the potential benefit of ARTEMIS T cell therapies for patients with neuroblastoma. As the field of T cell therapy continues its rapid advancement, we remain committed to pioneering the next generation of T cell therapies." said Dr. Cheng Liu, President and Chief Executive Officer of Eureka Therapeutics.

On October 18, 2022 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat cancer, reported it has entered into a license agreement with the National Cancer Institute (NCI), part of the National Institutes of Health, for a glypican 2 (GPC2) binding domain to be used for the potential development and commercialization of ARTEMIS T cell therapies for patients with neuroblastoma, a rare cancer that affects the developing nervous system (Press release, Eureka Therapeutics, OCT 18, 2022, View Source [SID1234622148]). The therapy also has expansion potential in medulloblastoma and small cell lung cancer, among several other pediatric and adult cancers that express an abundance of the GPC2 protein on their cell surface.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Neuroblastoma is a rare cancer that affects the development of the nervous system by attacking immature nerve cells as early as the embryonic stage. Each year, about 800 children are diagnosed with neuroblastoma in the U.S., and overall survival rates are lower than 50%. Current chemotherapy options for these patients are limited and highly toxic, which highlights the urgent need for new treatments for this disease to improve overall survival and reduce long-term toxicity.

"GPC2 is an exciting new target for neuroblastoma. In pre-clinical models, anti-GPC2 directed ARTEMIS T cells demonstrated significant tumor-killing activity," said Dr. Mitchell Ho, Deputy Chief of the Laboratory of Molecular Biology and Director of the Antibody Engineering Program at the NCI Center for Cancer Research. "We believe it is beneficial to further evaluate anti-GPC2 directed ARTEMIS T cells as a potential T cell therapy for patients with neuroblastoma and other cancers that express GPC2."

"The expansion of our pipeline with an anti-GPC2 program supports our effort to deliver the potential benefit of ARTEMIS T cell therapies for patients with neuroblastoma. As the field of T cell therapy continues its rapid advancement, we remain committed to pioneering the next generation of T cell therapies." said Dr. Cheng Liu, President and Chief Executive Officer of Eureka Therapeutics.

On October 18, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will report its third quarter 2022 financial results after market close on November 8th, 2022 (Press release, Zymeworks, OCT 18, 2022, View Source [SID1234622147]). Following the announcement, management will host a conference call and webcast to discuss financial results and provide a corporate update on November 8th, 2022 at 4:30 p.m. ET.

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Conference Call and Webcast Information

The event will be webcast live with dial-in details and webcast replays available on Zymeworks’ website at View Source