On May 31, 2022 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global technology-enabled biotech that is transforming drug discovery through innovative AI-driven pharmaco-pheno-multiomic integration, and Cyclica Inc. ("Cyclica"), a neo-biotech with the vision to advance the most robust and sustainable drug discovery pipeline, reported a therapeutic development partnership (Press release, Champions Oncology, MAY 31, 2022, View Source [SID1234615253]).

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The partnership will combine two therapeutic targets identified and validated within Champions’ Lumin platform with Cyclica’s drug discovery platform to establish a new therapeutic program. The planned partnership will initiate with a single program focused on previously unexplored targets present in tumor indications such as non-small cell lung cancer, head and neck cancer, and other solid tumors. The partnership will also leverage the unique experimental platforms available at Champions to ensure rapid and efficient development towards clinical evaluation. Under the terms of this agreement, Champions will co-own the program with Cyclica and take lead in advancing the program, and, upon achievement of specified milestones and events, will be obligated to make milestone and royalty payments to Cyclica. Should Champions decide not to continue development, Cyclica has the option to carry forward the program in exchange for milestone and royalty payments to Champions.

Ronnie Morris, MD, President and CEO of Champions Oncology, said "We’re excited to announce our first partnership in small molecule drug discovery and development, following two development partnerships with other companies involving large molecules. This partnership with Cyclica is a continued validation of the power of our experimental and digital research platforms. With deeply characterized datasets including our world-leading PDX models and Pharmaco-Pheno-Multi Omic (PPMO) workflows, we can better understand what drives growth and survival of a tumor. These specific targets have been interesting ones for Champions, and we are excited to establish a pipeline program in partnership with Cyclica."

Naheed Kurji, President and CEO of Cyclica, shares "Cyclica’s unique ability to address low data targets combined with Champions’ oncology-focused platform has groundbreaking therapeutic potential. Most importantly, by exploiting novel targets with strong disease linkage, we aspire to improve patient outcomes significantly."

On May 31, 2022 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate TSC-101 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation (HCT) (Press release, TScan Therapeutics, MAY 31, 2022, View Source [SID1234615269]). The target of TSC-101 is the minor histocompatibility antigen HA-2, which is a lineage-specific antigen expressed on blood cells. TScan believes that TSC-101 is the first clinical program to target the HA-2 antigen. As previously announced, TScan’s IND for TSC-100, which targets the minor histocompatibility antigen HA-1, was cleared by the FDA in January 2022. TSC-100 and TSC-101 are designed to address different subsets of patients undergoing allogeneic HCT.

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Study start-up activities are now ongoing for all three arms of TScan’s umbrella Phase 1 clinical trial, which includes active treatment arms for TSC-100, TSC-101, as well as a control arm using current standard-of-care for HCT patients. TScan expects to enroll the first patient in the middle of the year.

"This marks TScan’s second IND clearance in our leukemia program. Our TCRs against both HA-1 and HA-2 antigens are aimed at reducing the risk of relapse following HCT, thereby enabling increased use of more tolerable conditioning regimens to allow more leukemia patients to be cured by transplantation," said David Southwell, President and Chief Executive Officer. "With the FDA clearance of TSC-101, we will now proceed with all components of our planned multi-arm Phase 1 clinical trial, with preliminary data from all three arms of the trial expected by the end of 2022."

"We look forward to fully opening the Phase 1 umbrella trial for our leukemia program," said Gavin MacBeath, Chief Scientific Officer. "The trial will include patients positive for either the HA-1 or HA-2 antigens, with remaining patients receiving standard-of-care in the control arm. Importantly, the INDs for TSC-100 and TSC-101 were based on our proprietary T-Integrate cell engineering platform, which includes our advanced non-viral vector and our in-house GMP manufacturing capabilities. We will use this same platform to develop enhanced TCR-T cell therapies for our solid tumor program, with IND filings beginning later this year."

Primary endpoints in TScan’s HCT trial include safety and dose-finding, and secondary and exploratory endpoints include relapse rate versus standard-of-care as well as quantitative biological readouts including minimal residual disease and kinetics of donor chimerism.

On May 31, 2022 Oncomatryx reported that the FDA and the Spanish Drug Agency (AEMPS) have cleared its investigational new drug (IND) application for OMTX705, a First-in-Class antibody-drug conjugate (ADC) targeting the tumor microenvironment (Press release, Oncomatryx, MAY 31, 2022, View Source [SID1234615287]).

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OMTX705 is a pioneering ADC that targets, with a novel, dual mechanism of action, the Cancer-Associated Fibroblasts that enable tumor metastasis, drug resistance and immunosuppression.

OMTX705 has already shown unbeatable safety in non-human primates and tumor regression in murine models of pancreatic, breast, lung and gastric cancer.

Oncomatryx will run a multicenter, dose escalation trial in patients suffering metastatic solid tumors. OMTX705 will be administered as single agent and in combination with immunotherapy.

OMTX705 phase I clinical trial will be run in seven hospitals in USA and Spain.

On May 31, 2022 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it intends to offer and sell 10,000,000 shares of its common stock in an underwritten registered public offering (Press release, Concert Pharmaceuticals, MAY 31, 2022, View Source [SID1234615306]). All of the shares in the offering are to be sold by Concert. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Jefferies and Truist Securities are acting as joint book-running managers for the proposed offering. Concert intends to grant the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock sold in the offering on the same terms and conditions.

The offering is being made only by means of a written prospectus supplement and prospectus forming part of a shelf registration statement previously filed with the Securities and Exchange Commission (SEC) and declared effective on November 16, 2020.

A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, at the SEC’s website at www.sec.gov, or by request at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at (877) 821-7388, or by email at [email protected] or Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, Georgia 30326, by telephone at (800) 685-4786, email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On May 31, 2022 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that it will host an Innovation Day focused on early research and development on Tuesday, June 21, 2022 at 2:00 PM ET (Press release, CRISPR Therapeutics, MAY 31, 2022, View Source [SID1234615254]).

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CRISPR Therapeutics’ Innovation Day will focus on the Company’s differentiated genetic engineering platform technologies, novel approach to cell and gene therapy, and emerging discovery programs.

A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 30 days following the presentation. Please contact [email protected] for any questions regarding the event.