On June 2, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported interim clinical data, including a confirmed PR per mRANO (meaning >50% reduction in tumor measurements) in a glioblastoma (GBM) patient from its ongoing Phase 1-2 study in patients with advanced unresectable and metastatic solid tumors (NCT04478279) (Press release, Sapience Therapeutics, JUN 2, 2022, View Source [SID1234615448]).

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In the Phase 2 expansion portion of the ongoing Phase 1-2 study of ST101, 14 GBM patients have been enrolled to date. Of these 14 patients, one patient has a confirmed PR after 18 weeks of therapy, seven patients have not reached the first on-study assessment, and six patients progressed. In both the Phase 1 and Phase 2 portions of the ongoing study, ST101 has demonstrated a favorable safety profile, with manageable mild-moderate infusion related reactions as the most common adverse event. Based on the confirmed PR announced today, Sapience intends to expand the recurrent GBM cohort to enroll additional patients.

"ST101 is showing promising results in GBM with a PR, which we have confirmed with repeat scans per mRANO and using an independent radiology reviewer. The tumor shrinkage we are seeing is especially encouraging given the significant unmet medical need in this disease and its poor prognosis," said Fabio Iwamoto, Principal Investigator at Columbia University. "Our team at Columbia is thrilled to be a part of this work and to deliver meaningful therapeutic benefit to cancer patients."

Dr. Alice Bexon, Sapience’s Chief Medical Officer, added, "The confirmed response in GBM is very exciting news, which along with the continuing clinical benefit we are seeing from some of the Phase 1 patients, suggests that ST101 could make a major contribution to the treatment of cancer. Based on its novel mechanism of action, ST101 is the first in a new class of peptide therapeutics, and we look forward to advancing our Phase 2 study."

Data from the ST101 Phase 1 study will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Sunday, June 5th, 2022, Abstract #3014.

About ST101 and the Phase 1-2 Study

ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 expansion. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a confirmed partial response in a patient with recurrent GBM. Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, locally advanced or metastatic hormone-receptor positive breast cancer and castration-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

On June 2, 2022 National Resilience, Inc. (Resilience) and The University of Texas MD Anderson Cancer Center reported the launch of a joint venture, the Cell Therapy Manufacturing Center, to accelerate the development and manufacturing of innovative cell therapies for patients with cancer (Press release, National Resilience, JUN 2, 2022, View Source [SID1234615464]). Uniting the strengths of Resilience and MD Anderson, the joint venture will advance its work within a culture of academic innovation alongside industrial expertise.

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The Cell Therapy Manufacturing Center will be based in a state-of-the art 60,000-square-foot manufacturing facility in the Texas Medical Center, with a team of 70 employees focused on process and analytical development as well as early-phase and clinical-stage Good Manufacturing Practices (GMP).

The joint venture combines MD Anderson’s expertise in immunotherapy and cell therapies as well as a leading clinical trials infrastructure, with Resilience’s innovative biomanufacturing technologies, advanced analytics and a national network for developing and producing cell therapies. Together, the parties aim to accelerate the path of cell therapies to the clinic, while enabling scalability and a smooth transition to late-phase clinical and commercial activities.

"Cell therapies have had a dramatic impact for patients with certain cancers, but progress has been hampered by structural challenges," said Jason Bock, Ph.D., Chief Executive Officer of the Cell Therapy Manufacturing Center. "This novel joint venture was conceived to address those challenges by harnessing the complementary capabilities of two world-class organizations, allowing us to advance innovative programs to deliver impactful therapies to patients."

The joint venture will engage with MD Anderson researchers and external industry collaborators to advance new therapies through preclinical and clinical development, ensuring consistent and safe products that can be evaluated rapidly in clinical trials led by MD Anderson physicians. Resilience customers will be able to leverage this offering as part of the company’s growing network of biomanufacturing facilities that are flexible enough to scale projects from small-batch pre-clinical to large-scale commercial production. Resilience has 10 facilities across North America, with more than 1 million square feet of manufacturing space.

"The promise of cell therapies to help patients in need has been limited by a lack of innovation in biomanufacturing," said Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. "This collaboration aims to overcome those hurdles by extending our network with this unique partnership, creating opportunities to incubate innovative ideas and provide cutting-edge biomanufacturing technologies and processes to researchers, with a goal of bringing more cell therapies to patients."

The joint venture will advance the most promising cell therapy modalities to answer unmet clinical needs, including engineered tumor infiltrating lymphocytes (TILs), chimeric antigen receptor (CAR)-modified T cells, endogenous T cells (ETCs), engineered natural killer (NK) cells and other emerging technologies, for patients with hematological and solid tumors. MD Anderson researchers are leaders in the field of cancer cell therapy, responsible for advancing the translational and clinical development of many of the currently approved and experimental cell therapies.

The joint venture is built upon MD Anderson’s Biologics Development platform, formerly part of the institution’s Therapeutics Discovery division. Current strategic collaborations with MD Anderson’s Biologics Development platform will continue; collaborative relationships with MD Anderson’s Therapeutics Discovery division, as well as physicians and scientists across the institution, also will be maintained.

"We believe in the tremendous potential of cell therapies to deliver solutions that offer cures, not merely prolonged survival. Resilience offers unique capabilities that make it an ideal choice for unlocking that potential and accelerating impactful cell therapies," said Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Relations at MD Anderson. "Our mission at MD Anderson is to end cancer, and this joint venture is a strategic step toward realizing that goal."

On June 2, 2022 A scientific team, led by the scientific founders of EtiraRx, reported thatb has identified a small molecule, ERX-41, as a novel oral therapeutic agent that may have utility in treating multiple solid cancers, including triple negative breast cancer, glioblastoma, ovarian and pancreatic cancers (Press release, EtiraRx, JUN 2, 2022, View Source [SID1234615482]). EtiraRx, headquartered in Biolabs Pegasus Park, plans to initiate clinical trials as early as the first quarter of 2023.

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In the work, published in Nature Cancer, the researchers, led by Drs. Jung-Mo Ahn, Ganesh Raj and Ratna Vadlamudi, identified that ERX-41 dramatically enhances endoplasmic reticulum (ER) stress in cancer cells. Since aggressive cancer cells have higher basal levels of ER stress, the enhanced ER stress induced by ERX-41 is not compensated and causes cancer cell death. Normal cells have low basal of ER stress, can compensate for ERX-41 activity and do not undergo cell death after ERX-41 treatment. Using state-of-the-art molecular approaches, the team identified that the molecular target of ERX-41 is the protein encoded by the lysosomal acid lipase A (LIPA) gene and that pharmacologic inhibition of LIPA by ERX-41 enhances ER stress in cancer cells. The study set the foundation for clinical trials with patients with therapy-resistant cancers that are vulnerable to enhanced ER stress.

Said Dr. Raj, "These discoveries are exciting as they represent a novel approach to targeting the Achilles heel of many aggressive cancers- their vulnerability to enhanced ER stress. Our critical finding was that of a new therapeutic target (LIPA) and its undiscovered role in protein folding. By targeting LIPA with ERX-41, protein folding in the cancer cell was disrupted, causing ER stress and promoting cancer cell death. Our findings indicate the potential for an oral agent with a favorable therapeutic index to effectively treat patients with aggressive cancers, for whom options are limited."

EtiraRx is completing necessary preclinical studies and plans to initiate clinical trials with these compounds, which will take place the first quarter of 2023. Russell Hayward, CEO EtiraRx, said, "ERX-41 has the potential to be a first-in-class oral therapy that kills aggressive therapy-resistant cancers. We are committed to moving these drugs forward to clinical trials and make a difference in the lives of patients with lethal cancers."

To access the complete paper from EtiraRx, please visit Nature Cancer at View Source

On June 2, 2022 A scientific team, led by the scientific founders of EtiraRx, reported that it has identified a small molecule, ERX-41, as a novel oral therapeutic agent that may have utility in treating multiple solid cancers, including triple negative breast cancer, glioblastoma, ovarian and pancreatic cancers (Press release, EtiraRx, JUN 2, 2022, View Source [SID1234616455]). EtiraRx, headquartered in Biolabs Pegasus Park, plans to initiate clinical trials as early as the first quarter of 2023.

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In the work, published in Nature Cancer, the researchers, led by Drs. Jung-Mo Ahn, Ganesh Raj and Ratna Vadlamudi, identified that ERX-41 dramatically enhances endoplasmic reticulum (ER) stress in cancer cells. Since aggressive cancer cells have higher basal levels of ER stress, the enhanced ER stress induced by ERX-41 is not compensated and causes cancer cell death. Normal cells have low basal of ER stress, can compensate for ERX-41 activity and do not undergo cell death after ERX-41 treatment. Using state-of-the-art molecular approaches, the team identified that the molecular target of ERX-41 is the protein encoded by the lysosomal acid lipase A (LIPA) gene and that pharmacologic inhibition of LIPA by ERX-41 enhances ER stress in cancer cells. The study set the foundation for clinical trials with patients with therapy-resistant cancers that are vulnerable to enhanced ER stress.

Said Dr. Raj, "These discoveries are exciting as they represent a novel approach to targeting the Achilles heel of many aggressive cancers- their vulnerability to enhanced ER stress. Our critical finding was that of a new therapeutic target (LIPA) and its undiscovered role in protein folding. By targeting LIPA with ERX-41, protein folding in the cancer cell was disrupted, causing ER stress and promoting cancer cell death. Our findings indicate the potential for an oral agent with a favorable therapeutic index to effectively treat patients with aggressive cancers, for whom options are limited."

EtiraRx is completing necessary preclinical studies and plans to initiate clinical trials with these compounds, which will take place the first quarter of 2023. Russell Hayward, CEO EtiraRx, said, "ERX-41 has the potential to be a first-in-class oral therapy that kills aggressive therapy-resistant cancers. We are committed to moving these drugs forward to clinical trials and make a difference in the lives of patients with lethal cancers."

On June 2, 2022 JSR Corporation reported that Medical & Biological Laboratories (MBL) and Crown Bioscience, JSR Life Sciences companies, have formed a joint venture to further extend their preclinical services to Japanese customers (Press release, JSR, JUN 2, 2022, View Source [SID1234615399]). The new company named "Crown Bioscience & MBL", provides preclinical and translational services to biopharmaceutical customers in Japan. MBL is currently a distributor for Crown Bioscience and the establishment of the joint venture marks a significant milestone in the long-standing relationship between the two founding companies.

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The company, established in April 2022, is expected to start service operation from September 2022. For details, please refer to the announcements from Crown Bioscience.