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InnoCare Announces First Adolescent Patient Dosed in Clinical Trial of pan-TRK Inhibitor ICP-723 in China

On October 31, 2022 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the first adolescent patient has been dosed in clinical trial with its second generation pan-TRK inhibitor ICP-723 at the Sun Yat-sen University Cancer Center (Press release, InnoCare Pharma, OCT 31, 2022, View Source [SID1234622642]). This is also the first time that ICP-723 will be evaluated in the clinical study of adolescent (12 to 18 years old) patients after showing good safety and efficacy in adult patients.

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ICP-723 was developed to treat advanced or metastatic solid tumors harboring NTRK fusion genes, including breast cancer, colorectal cancer, lung cancer, thyroid cancer, sarcoma, etc., and for patients resistant to the first generation of TRK inhibitors.

Among the adult patients with NTRK fusion treated at the recommended Phase II dose (RP2D), ICP-723 showed good efficacy and safety. After the clinical study performed in adolescent patients for the first time, InnoCare will also expand ICP-723 to treat pediatric patients (2 to 12 years old).

Based on the Proof-of-Concept (POC) data obtained, InnoCare will promote a registration clinical study of ICP-723 in China. The Company has also conducted a clinical study of ICP-723 in the United States. Currently there was no dose-limiting toxicities (DLTs) observed at the first dose group.

Dr. Jasmine, the Co-founder, Chairwoman and CEO of InnoCare, said, "NTRK gene fusion occurs in adult, adolescent and pediatric cancers, especially among adolescent and pediatric patients. InnoCare will accelerate the clinical trials to meet their unmet clinical needs."

DiaMedica Therapeutics to Present at Credit Suisse 31st Annual Healthcare Conference

On October 31, 2022 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that Rick Pauls, its President and CEO, will present a corporate overview at the Credit Suisse 31st Annual Healthcare Conference, which will take place November 8 – 10, 2022 in Rancho Palos Verdes, California (Press release, DiaMedica, OCT 31, 2022, View Source(Nasdaq%3A%20DMAC)%2C%20a,Conference%2C%20which%20will%20take%20place [SID1234622641]).

Mr. Pauls is scheduled to present at 8:35 a.m. Eastern Time on November 9, 2022. In addition to the presentation, Mr. Pauls will be available for one-on-one investor meetings throughout the conference. Investors that are interested in arranging a meeting should contact their Credit Suisse representative.

Theriva Biologics to Host Key Opinion Leader Webinar on Lead Program, VCN-01 and Advancing Unique Oncolytic Virus Therapeutics

On October 31, 2022 Theriva Biologics, Inc. (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that it will host a key opinion leader (KOL) webinar on Monday, November 7, 2022 at 11:00 a.m. ET to discuss the oncolytic virus landscape and the encouraging data that positions the Company’s novel oncolytic adenovirus (OV) platform at the forefront of development to address devastating cancers with high unmet need (Press release, Theriva Biologics, OCT 31, 2022, View Source [SID1234622640]). The discussion will also include recent findings from independent research highlighting the market opportunities for pancreatic ductal adenocarcinoma (PDAC).

VCN-01, Theriva Biologic’s lead clinical-stage drug candidate, is an intravenous, oncolytic adenovirus designed to break down the tumor stroma. Theriva’s upcoming Phase 2 clinical trial, VIRAGE, will evaluate VCN-01 in combination with standard-of-care chemotherapy gemcitabine/nab-paclitaxel in patients with PDAC.

The webinar will feature the KOLs Michael Aaron Morse, M.D., Professor of Medicine and Professor in the Department of Surgery in Medical Oncology at the Duke University School of Medicine, as well as Arsen Osipov, M.D., medical oncologist and clinical-translational investigator in the Gastrointestinal Disease Research Group and Pancreas Cancer Research Group of the Samuel Oschin Cancer Center at Cedars-Sinai. Dr. Morse is a pioneer in the use of immune therapies to treat various cancers, including gastrointestinal, breast, lung cancers and melanoma. Dr. Osipov focuses on the development of novel immunotherapy-based treatment strategies for gastrointestinal malignancies, with a focus on pancreatic cancer.

A live Q&A session will follow the formal discussion. To register for the event, please click here. An archived webcast will also be accessible in the "Events" section of the company’s website at www.therivabio.com.

Lantern Pharma to Report Third Quarter 2022 Operating & Financial Results on November 7, 2022 at 4:30 p.m. ET

On October 31, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence (A.I.) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it will host its third quarter 2022 financial results webcast on Monday, November 7, 2022 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time (Press release, Lantern Pharma, OCT 31, 2022, View Source [SID1234622639]).

Management intends to discuss the operating and financial results for the third quarter ended September 30, 2022 and provide guidance on upcoming milestones. Panna Sharma, President and Chief Executive Officer of Lantern Pharma, will lead the call and will be joined by other members of the management team.

A replay of the webinar will be available after the call on the investor relations section of the Company’s website at ir.lanternpharma.com.

Instil Bio Announces Voluntary Pause of Enrollment in Ongoing Clinical Trials Related to Manufacturing

On October 31, 2022 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported that it has voluntarily paused enrollment in its ongoing clinical trials of ITIL-168 and ITIL-306 and has notified regulatory authorities in the United States, Canada, and the UK (Press release, Instil Bio, OCT 31, 2022, View Source [SID1234622638]). No regulatory agencies, including the FDA, have notified the Company of a clinical hold in any of its clinical trials.

The voluntary pause by the Company was instituted following a recent decrease in the rate of successful manufacturing of ITIL-168, resulting in the inability to dose some patients whose individual product of ITIL-168 was not successfully manufactured. A pre-specified safety analysis in the DELTA-1 trial has been conducted on patients who received ITIL-168 and did not identify any unexpected safety issues. The Company has commenced an end-to-end analysis of its manufacturing processes and upon completion of this analysis, plans to take corrective actions to improve the rate of manufacturing success and resume the study. Although no manufacturing failures have been observed to date in the ongoing Phase 1 trial of ITIL-306, the Company has also voluntarily paused enrollment in this trial as part of its overall manufacturing analysis.

"We are committed to advancing TIL therapy for the treatment of patients with cancer," said Bronson Crouch, Chief Executive Officer of Instil Bio. "This pause in enrollment provides us an opportunity to refine our processes and enable us to manufacture and deliver TIL therapies to patients with no other treatment options. We have assembled a world-class technical operations organization and leadership team to address the challenges associated with manufacturing these therapies."

"With the quality of our technical operations staff and our significant experience in developing cell therapies, I am confident in our ability to overcome obstacles in manufacturing," said Tim Moore, Chief Operating Officer of Instil Bio. "Our end-to-end manufacturing analysis is being carried out to expeditiously identify contributing causes, design solutions, and implement corrective actions in order to resume clinical manufacturing."

The Company intends to provide an update on the manufacturing analysis by early Q1 2023. The Company confirms its previously disclosed cash runway into 2025 upon the successful completion of a potential sale-leaseback transaction of its Tarzana manufacturing facility.