On August 20, 2021 Prescient is a clinical stage oncology company reported that developing personalised medicine approaches to cancer, including targeted therapies, cell therapy enhancements and next generation CAR-T therapies (Press release, Prescient Therapeutics, AUG 20, 2021, View Source;utm_medium=rss&utm_campaign=health-kick-prescient-therapeutics-ytd-share-price-soars-220-after-progress-in-clinical-studies-and-car-t-platform [SID1234586777]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Encouraging progress through clinical trials of Prescient’s foundational assets PTX-100 and PTX-200 (with the PTX-100 trial progressing to expansion cohort last week following successful Phase 1b) and CAR-T safety and manufacturing milestone with OmniCAR.

The company made headlines in late July with news of its strong finish to the June.

On August 20, 2021 Privo Technologies, Inc. ("Privo"), a biopharmaceutical company focused on optimizing state-of-the-art chemotherapies to be "Tough on cancer, Easy on patients", reported that the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (NIH) has awarded Privo approximately $3 million over three years in a Commercialization Readiness Pilot (CRP) grant as part of the Small Business Innovation Research (SBIR) Program (Press release, Privo Technologies, AUG 20, 2021, View Source;utm_medium=rss&utm_campaign=privo-technologies-inc-awarded-3m-nidcr-nih-commercialization-readiness-pilot-grant [SID1234586795]). The grant was awarded on February 3, 2021 and builds upon previous Phase 1 and Phase 2 SBIR awards from the NIDCR to support the late-stage development of PRV111, Privo’s lead asset that allows for locoregional control of chemotherapeutic via topical application.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very grateful to the NIDCR and NIH for their continued support for the late-stage development and commercialization of PRV111," said Manijeh Goldberg, PhD, CEO of Privo Technologies, Inc. and Principal Investigator on the grants. "Here at Privo, we seek to transform the standard of care for patients suffering from mucosal cancers that typically require disfiguring and disabling surgeries. By alleviating the safety concerns with traditional chemotherapies, our lead asset facilitates locoregional sequestration of the chemotherapeutic to the tumor site and has demonstrated superior efficacy and safety profiles in comparison to standard chemotherapies. This grant will be instrumental in developing PRV111 from a clinical to a commercial stage asset."

On August 20, 2021, Athenex, Inc. (the "Company") reported that it entered into a sales agreement (the "Sales Agreement") with SVB Leerink LLC (the "Agent"), in connection with the offer and sale of up to $100,000,000 of shares of the Company’s common stock, par value $0.001 per share ("ATM Shares") (Filing, 8-K, Athenex, AUG 20, 2021, View Source [SID1234586781]). The ATM Shares to be offered and sold under the Sales Agreement will be issued and sold pursuant to a registration statement on Form S-3 (File No. 333-258185), dated July 27, 2021 that was subsequently amended on August 5, 2021 and became effective with the Securities and Exchange Commission (the "Commission") on August 12, 2021. A prospectus supplement relating to the offering of the ATM Shares was filed with the Commission on August 20, 2021 (the "Prospectus Supplement").

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Subject to the terms and conditions of the Sales Agreement, the Agent will use commercially reasonable efforts, consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of the Nasdaq Stock Market, LLC ("Nasdaq"), to sell ATM Shares from time to time based upon the Company’s instructions, including any price, time or size limits or other customary parameters or conditions the Company may impose.

The Company is not obligated to make any sales of ATM Shares, and Agent is not required to sell any specific number or dollar amount of shares of the ATM Shares under the Sales Agreement. The Company or the Agent may suspend or terminate the offering of ATM Shares upon notice to the other party and subject to other conditions.

Under the Sales Agreement, the Agent may sell ATM Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act of 1933, as amended (the "Securities Act"), and the rules and regulations thereunder, including, without limitation, sales made directly on or through Nasdaq, on or through any other existing trading market for the Company’s shares of common stock or to or through a market maker. If expressly authorized by the Company, the Agent may also sell ATM Shares in privately negotiated transactions. The Company agreed to pay the Agent a commission equal to 3.0% of the gross proceeds from the sales of ATM Shares pursuant to the Sales Agreement.

The Sales Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Agent against certain liabilities, including for liabilities under the Securities Act, and termination provisions. The provisions of the Sales Agreement, including the representations and warranties contained therein, are not for the benefit of any party other than the parties to such agreement and are not intended as a document for investors and the public to obtain factual information about the current state of affairs of the Company. Rather, investors and the public should look to other disclosures contained in the Company’s filings with the Commission.

The foregoing description of the Sales Agreement is a summary of its material terms, does not purport to be complete, and is qualified in its entirety by reference to the Sales Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

On August 20, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical-stage cell therapy company, reported that the US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for CHM 1101 (CLTX CAR T) for patients with recurrent/relapsed Glioblastoma (Press release, Chimeric Therapeutics, AUG 20, 2021, View Source [SID1234586748]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CHM 1101 (CLTX CAR T) is a novel CAR T cell therapy that uniquely utilizes Chlorotoxin as its tumour targeting domain. CHM 1101 has shown promising preclinical safety and efficacy and is currently being studied in a single site phase 1 clinical trial.

"The FDA clearance of our IND is a critical milestone for Chimeric as it enables us to expand the development program for CHM 1101 (CLTX CAR T)," said Jennifer Chow, COO Chimeric Therapeutics. "Our first step will be to open new phase 1 clinical trial sites under the current study protocol. This will allow us to accelerate the phase 1 CHM 1101 clinical trial, which will be particularly important as we head towards the expansion phase of the protocol."

With this foundational IND, Chimeric will also further advance plans for a phase 1 basket trial in solid tumours and a phase 2 registration trial in Glioblastoma.

Chlorotoxin is derived from scorpion toxin, which binds preferentially to unique targets on brain cancer cells. CLTX CAR T cells do not target healthy cells and has not elicited adverse side effects when delivered intracranial and through IV routes in brain cancer mouse models. At the same time it has shown to bind to a higher percentage of Glioblastoma tumours than immunotherapies against other targets. Glioblastoma is the most common and aggressive type of brain tumour, with overall survival following first recurrence estimated at only 5-8 months

On August 19, 2021 Coeptis Therapeutics, Inc. (OTC PINK: COEP), a pharmaceutical company focused on the development of innovative technologies designed to disrupt conventional treatment paradigms and improve patient outcomes, reported it has exercised its option to acquire ownership in two technology assets that target CD38 cancers from VyGen-Bio, Inc., a majority-owned subsidiary of Vycellix, Inc (Press release, Coeptis Pharmaceuticals, AUG 19, 2021, View Source [SID1234586749]). These two technology assets will now be co-developed by Coeptis and VyGen-Bio. The technologies, CD38-GEAR-NK, a cell therapy product being developed to protect CD38+ natural killer (NK) cells from destruction by anti-CD38 monoclonal antibodies (mAbs), and CD38-Diagnostic, an in vitro diagnostic tool being developed to help identify cancer patients who may be appropriate candidates for anti-CD38 mAb therapy were both discovered by scientists at the Karolinska Institutet in Stockholm, Sweden.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This transaction follows Coeptis’ initial entry into two separate exclusive option agreements with VyGen-Bio, Inc. as announced on May 18, 2021. Per the option agreements and subsequent amendments, Coeptis paid VyGen-Bio a combination of cash and promissory notes to acquire the rights to the co-development assets.

"Securing the ownership in the co-development assets for CD38-GEAR-NK and CD38 Diagnostic from VyGen-Bio is a critical step in the growth of Coeptis Therapeutics and in the development of these potentially groundbreaking technologies targeting CD38-related cancers," said Dave Mehalick, President and CEO, Coeptis Therapeutics. "Our vision is to co-develop CD38-GEAR-NK and CD38 Diagnostic to provide safer and more targeted administration of anti-CD38 mAbs in the treatment of cancers that are known to be associated with CD38, including multiple myeloma, chronic lymphocytic leukemia and acute myeloid leukemia. We view this agreement as a significant value driver for the company and plan to soon initiate development programs that leverage these technologies, with the first indication expected to be multiple myeloma."

"By partnering with Coeptis, we are accelerating the development of a new class of natural killer cells, which we envision to be capable of enabling optimized combination therapy with monoclonal antibodies to maximize patient response rates, as well as advancing first-in-class companion diagnostic approaches to ensure optimal patient selection," said Arnika Wagner, Ph.D., Assistant Professor, Gene and Cell Therapy Group, Karolinska Institutet (KI), and Chief Scientific Officer for VyGen-Bio. "We are also privileged to be collaborating on these projects with distinguished faculty at KI via partnership with NextGenNK, an international Competence Center for the development of next-generation NK cells coordinated by KI and funded by Sweden’s Innovations Agency, Vinnova." For more information about NextGenNK, please visit: View Source

CD38-GEAR-NK is a NK cell-based investigational therapeutic engineered to enable combination therapy with anti-CD38 mAbs, potentially minimizing the risks and side effects from CD38-positive NK cell fratricide. The first indication is expected to be multiple myeloma, an incurable cancer of plasma cells.

CD38-Diagnostic is an investigational in vitro screening tool to potentially pre-determine which cancer patients are most likely to benefit from targeted anti-CD38 mAb therapies, either as monotherapy or in combination with CD38-GEAR-NK.