On May 31, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported that Markus Renschler, MD, President and Chief Executive Officer will participate in a presentation at the 2022 Jefferies Healthcare Conference (Press release, Cyteir Therapeutics, MAY 31, 2022, View Source [SID1234615277]). The meeting is being held in person in New York City on Friday, June 10, 2022 at 11:00 a.m. ET.

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A live webcast of the presentation will be available in the Investors & Media section of the Cyteir website at www.cyteir.com. A webcast replay will also be available on the website shortly after conclusion of the event for 30 days.

On May 31, 2022 OneCellDx and Genetics Institute of America reported that they have signed a memorandum of understanding for a diagnostics commercialization agreement for the OneCellDx OncoPredikt HRD Assay (Press release, Genetics Institute of America, MAY 31, 2022, View Source [SID1234615295]). Genetics Institute of America will create a laboratory developed test (LDT) based on OneCellDx’s proprietary AI Enabled Algorithm and assay . The OncoPredikt assay identifies Homologous Recombination Deficiency (HRD) in cancer patients with quicker turnaround times and lower costs.

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Current HRD prediction tests are expensive, time-consuming, require multi-technique processes, and often have sample QC rejection due to low DNA quantity. OneCellDx has developed a proprietary AI-enabled tool to predict key genomic signatures. Genetics Institute of America will run a validation study in its CAP Accredited, CLIA certified facility and launch the laboratory developed test upon successful completion and acceptance of the study.

"Our team of scientists and engineers have developed a uniquely impactful solution and are very excited to partner with the team at Genetics Institute of America in bringing OncoPredikt HRD to market," said Mohan Uttarwar, Co-founder and CEO of OneCellDx.

"The ability to positively impact patients’ lives is one of the missions of Genetics Institute of America. Bringing the OncoPredikt HRD test to market will help in accelerating the development of novel pharmaceuticals, improving the care of thousands of patients," said Holly Magliochetti, CEO and Founder of Genetics Institute of America.

OneCellDx will present a poster session on OncoPredikt HRD at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), June 3-7, 2022, Chicago. Genetics Institute of America and OneCellDx will launch the LDT through HRD Pharma Development programs.

On May 31, 2022 Immedica Pharma AB ("Immedica") and Japanese company OrphanPacific, Inc. ("OrphanPacific") reported that they on May 2, 2022, entered an agreement under which OrphanPacific gains the exclusive rights to Ravicti in Japan (Press release, Immedica Pharma, MAY 31, 2022, View Source [SID1234615240]).

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The pharmaceutical drug product Ravicti is approved in Europe and North America for treatment of urea cycle disorders (UCD).

Under the announced partnership, OrphanPacific is granted a license to develop, register and commercialize the product in UCD in Japan. OrphanPacific will initiate a clinical trial for obtaining approval for glycerol phenylbutyrate in Japan. OrphanPacific is already Immedica’s commercial partner in Japan for the commercialization of the drug product Buphenyl.

"It is with great pleasure that we announce this expanded partnership with OrphanPacific, under which we will be able to make Ravicti available to UCD patients also in Japan. The entered agreement also further strengthens Immedica’s geographical footprint, by introducing yet another product collaboration in Japan," says Anders Edvell, CEO of Immedica.

About Urea Cycle Disorders (UCD)

Urea cycle disorders are a group of metabolic diseases that affect a specific enzyme or transporter in the urea cycle leading to elevated ammonia or glutamine levels in the circulation. Symptoms of the disorder can begin at any age, with more severe defects beginning early in life. UCD patients may experience episodes, called hyperammonemic crises, when ammonia levels in the blood become excessively high, which can result in irreversible brain damage, coma or death. In Japan, UCDs occurs in 1 in 8,000 to 44,000 people and is one of the designated intractable diseases.

On May 31, 2022 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, reported updated overall survival (OS) results from its Phase 1/2 study evaluating GRANITE, an individualized vaccine-based immunotherapy, to treat advanced solid tumors (Press release, Gritstone Oncology, MAY 31, 2022, View Source [SID1234615261]). Additionally, the company announced it is presenting a "Trial in Progress" poster summarizing the Phase 2/3 GRANITE-CRC-1L- study (randomized study for first-line maintenance treatment of metastatic, microsatellite stable colorectal cancer) at the 2022 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"The updated OS data from our Phase 1/2 study continue to demonstrate a correlation between molecular response and overall survival, and points to the potentially significant impact GRANITE is having on lives of patients with advanced stage cancer," said Andrew Allen, M.D., Ph.D., Co-founder, President and Chief Executive Officer of Gritstone. "The median overall survival observed in multiple trials of various therapies in the third-line MSS-CRC setting has been around 6-7 months, which is consistent with what we observed in our study in patients who did not have molecular response (median overall survival of 7.8 months). The very different outcome observed in the molecular responder subset, with median overall survival of over 18 months, is all the more striking given how rarely long-term survival is observed in MSS-CRC patients who have been treated with and progressed on two prior therapies. These maturing data, demonstrating long-term clinical benefit, further support moving GRANITE upstream in the treatment of patients with this grim cancer in the ongoing randomized Phase 2/3 study, which has registrational intent."

The Phase 1/2 study is evaluating the safety, immunogenicity, and clinical activity of GRANITE in combination with PD-1 checkpoint inhibitor, Opdivo (nivolumab) and subcutaneous anti-CTLA-4 antibody, Yervoy (ipilimumab) in advanced solid tumors. This study enrolled and treated 26 patients as of ESMO (Free ESMO Whitepaper) 2021 presentation with previously treated, metastatic solid tumors including patients with colorectal cancer, gastroesophageal adenocarcinoma, and non-small cell lung cancer. As presented at ESMO (Free ESMO Whitepaper) 2021, of 9 patients with MSS-CRC who were treated and evaluable for molecular response, 4 experienced a molecular response (as evidenced by a reduction in circulating tumor DNA [ctDNA]) and continue to have an OS advantage compared to those patients who did not have a molecular response.

Opdivo and Yervoy are trademarks of Bristol-Myers Squibb Company.

Updated overall survival data from GRANITE Phase 1/2:

4 of 9 treated patients with MSS-CRC had a molecular response (as reported during the ESMO (Free ESMO Whitepaper) 2021 data presentation) and the observed median overall survival in this group will now exceed 18 months (median OS not yet reached versus 7.8 months in those who did not have a molecular response).
All patients with MSS-CRC assessed for molecular response and alive at the time of the ESMO (Free ESMO Whitepaper) 2021 data presentation remain alive after an additional 35 weeks of follow-up.
ASCO presentation details are as follows:

Abstract TPS3635: Phase 2/3, randomized, open-label study of an individualized neoantigen vaccine (self-amplifying mRNA and adenoviral vectors) plus immune checkpoint blockade as maintenance for patients with newly diagnosed metastatic colorectal cancer (GRANITE)
Date/Time: Saturday 04 June 2022, 8:00am CST
Session: Gastrointestinal Cancer – Colorectal and Anal
Location: Poster 425b

On May 31, 2022 Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) platform, reported that it will present interim data from its Phase 1 clinical study of SQ3370 in advanced solid tumors, at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held at McCormick Place in Chicago, IL, on June 3-7, 2022 (Press release, Shasqi, MAY 31, 2022, View Source [SID1234615278]).

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Presentation details:

Abstract Title: Interim Phase 1 results for SQ3370 in advanced solid tumors
Abstract Number: 3085
Poster Number: 77
Poster Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
Key highlights include:

26 patients received treatment with SQ3370 and as of the data cutoff date, 21 patients were evaluable
77% of patients had metastases with a median number of 2 metastatic sites (1-5); most frequently lung (50%) and more than 50% being previously treated with doxorubicin
Escalating doses of SQP33 protodrug ranging from 0.38x to 12x the molar equivalent of conventional doxorubicin per cycle along with a dose of 10 or 20 mL of SQL70 were administered
SQ3370 was well tolerated with 62% of patients receiving more than 500 mg/m2 cumulative doxorubicin equivalents given as SQP33
The most common treatment emergent adverse events reported were nausea, fatigue, anemia, and constipation
At a median follow-up of 9.2 weeks, of the 21 evaluable patients, 71% had stable disease, with a median duration of 80 days
Dose escalation continues as the maximum tolerable dose has not yet been reached
SQ3370 demonstrates proof of concept for the CAPAC platform
About CAPAC and SQ3370

SQ3370 is the first click chemistry-based treatment to be tested in humans. It utilizes Shasqi’s proprietary CAPAC platform, an approach that activates cancer drugs at a tumor with decreased systemic toxicity. Shasqi is validating its platform with SQ3370, which is designed to activate a powerful chemotherapeutic, doxorubicin, at the tumor site. The investigational product is based on the chemical reaction between a drug protected through a trans-cyclooctene modification (a protodrug) and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Shasqi believes its click-chemistry approach can improve the efficacy and safety of many existing therapeutics across various modalities with a limited therapeutic window.