BioBiz: Experimental rectal cancer immunotherapy successful in small study;

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A paper in the New England Journal of Medicine describes how an early trial for a drug to treat rectal cancer at Memorial Sloan Kettering Cancer Center, led to remission in every participant. The small trial only included just 14 patients, but after taking the drug dostarlimab for six months there was no identifiable cancer in any of the participants, with all of their scans coming back completely clear. “I believe this is the first time this has happened in the history of cancer,” Dr. Luis A. Diaz Jr. of Memorial Sloan Kettering Cancer Center, one of the study authors, told The New York Times. In every case, the rectal cancer disappeared after immunotherapy — without the need for the standard treatments of radiation, surgery, or chemotherapy — and the cancer has not returned in any of the patients, who have been cancer-free for up to two years.

A new study led by iseo, reported that integrated mental healthcare in diabetes patients can improve mental health outcomes, patient engagement with self-management of diabetes, diabetes distress, and quality of life. The results were presented at the 2022 American Diabetes Association (ADA) Annual Conference. The company used an innovative therapeutic approach based on acceptance and commitment therapy principles, which targeted diabetes-specific psychological processes with the aim of improving adherence to diabetes treatment and the ability to cope with diabetes. The study showed that patients who received ieso online cognitive behavioral therapy tailored for patients with Type 2 diabetes reported improvements in depression and anxiety, which resulted in better diabetes management. Additionally, patients also reported reduced levels of distress about having diabetes, increased engagement in managing their condition, and improved quality of life.

Irvine, CA-based CG Oncology recently announced results for their oncolytic immunotherapy CG0070 in combination with Merck’s Keytruda in a global Phase 2 clinical study in patients with bladder cancer at ASCO 2022 this weekend.

Interim results from a global Phase 2 study (CORE1) of CG0070 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG), showed that 92% of patients evaluable for efficacy (n=22/24) achieved complete response (CR) at the initial 3-month timepoint. Of those patients evaluable for CR at additional timepoints, 88% (n=16) have also maintained a CR through 6 months, 82% (n=11) through 9 months and 75% (n=8) at the 12-month assessment.

“Using an oncolytic virus to first engage an immune response and then amplifying that response with immune checkpoint blockade has shown exciting results in bladder cancer,” said Roger Li, MD, lead study investigator and urologic oncologist at Moffitt Cancer Center. “CG0070 may be a potential game changer to combat BCG-unresponsive bladder cancer.”

Los Angeles-based Trethera Corporation recently reported that an independent safety review committee has unanimously recommended further trial advancement following review of the favorable results from the company’s Phase 1a dose-escalation clinical trial of TRE-515, its first-in-class deoxycytidine kinase (“dCK”) inhibitor. The Phase 1a open-label trial was designed to treat up to 24 patients with various solid tumors during the dose-escalation portion and is expected to enroll the final patient before the end of 2022.

The study’s primary endpoints are to determine the safety and maximum tolerability of TRE-515 when administered orally once daily as a single agent. The secondary endpoints are to (i) establish a recommended Phase 2 dose, (ii) characterize the pharmacokinetics/pharmacodynamics, and (iii) evaluate preliminary antitumor activity. The protocol also includes exploratory objectives such as measuring plasma deoxycytidine (dC), the dCK substrate and a potential liquid biomarker, as well as utilizing a specialized PET probe in select cases to measure intracellular dCK as the drug target. In the trial thus far, TRE-515 demonstrated manageable safety and tolerability profile resulting in authorization to increase the daily dose to 240 mg for the fourth cohort.

Guardion Health Sciences, Inc. reported that it has partnered with OmegaQuant Laboratories to provide the clinical nutrition company with analytic testing and laboratory support services for current and future products. Guardion offers a portfolio of science-based, clinically-developed products that are designed to support the health needs of consumers, healthcare professionals and providers and their patients.

OmegaQuant is an independent, CLIA-certified laboratory located in Sioux Falls, South Dakota that offers an extensive suite of clinical tests to researchers, clinicians and the public, including Omega-3 Index, Vitamin D, Prenatal DHA and Mother’s Milk DHA testing. “This relationship with OmegaQuant positions us to conduct a variety of research projects around both our current product lines, as well as to evaluate future products for efficacy,” commented Bret Scholtes, Guardion’s Chief Executive Officer. 

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