On March 17 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, reported orphan drug status has been granted for lead product OmnImmune for use in Acute Myeloid Leukemia ("AML") (Press release, TC Biopharm, MAR 17, 2022, View Source [SID1234610290]). After reviewing the Phase 1b/2a trial results in relapse/refractory AML patients the FDA approved the Company’s application for Orphan Drug Status.

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 is another milestone achieved by TC BioPharm, further strengthening our leadership position in Gamma Delta therapies for oncology," stated CEO Bryan Kobel. "The granting of orphan drug status provides us a seven-year window post approval of exclusive marketing rights for allogeneic gamma delta use in AML, another added layer of protection around our lead product in a commercial setting beyond our existing strong IP. We look forward to the advancement of OmnImmune in the Phase 2b/3 trial and to helping patients with AML in the near future."

Orphan drug status is a designation granted by the Federal Drug Administration for therapies targeting rare diseases. The status allows for a seven-year exclusive marketing window post approval of the drug, certain lowered application fees and tax incentives, broadly.

About OmnImmune
OmnImmune an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells. The trial, for treatment of patients suffering from relapse/refractory Acute Myeloid Leukemia (AML), OmnImmune comprises GDT cells sourced from healthy donors, expanded and activated in large numbers before being purified and formulated for infusion into patients. OmnImmune is a frozen and thawed product, now "banked" from donor derived cells. Phase 2/3 trials will begin enrollment in the first quarter of 2022 in the UK with expansion into the US in 2022.

On March 17, 2022 Manhattan Scientifics Inc. (OTCQB: MHTX ), reported that positive early results from Imagion Biosystems Cancer Diagnostic human study (Press release, Manhattan Scientifics, MAR 17, 2022, View Source [SID1234610289]).

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!

Imagion Biosystems Ltd. (IBX.AX) shares were up 46% trading 71 million shares.

Manhattan Scientifics Inc., initially funded and is the current owner of more that 50 million shares of Imagion Biosystems Ltd.

On March 17, 2022 Nanjing Bioheng Biotech Co., Ltd reported that China National Drug Administration Drug Review Center (CDE) approved first Universal Chemeric Antigen Receptor T (UCAR-T) cell drug (Acceptance No. : CXSL2101509). CTA101 is independently developed by targeting CD19 and CD22, for the indication of adult recurrent or refractory B-cell acute lymphoblastic leukemia ( r / r B-ALL ) (Press release, Bioheng Biotech, MAR 17, 2022, View Source;301505078.html [SID1234610288]).

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!

"The approval of CTA101 product IND is an important milestone for Bioheng in developing innovative immuno-cell therapies", said Xiaohong He, CEO of Bioheng."It will further accelerate the development and commercialization of "off-the-shelf" allogeneic CAR-T, which potentially offers greater benefits to patients over autologous CAR-T. We look forward to pushing more such disruptive products to clinical and providing more choices to solve the unmet medical needs and treatment accessibility".

On March 17, 2022 Biological Dynamics, Inc. reported the publication of its study, Early-Stage Multi-Cancer Detection Using an Extracellular Vesicle Protein-Based Blood Test, published in Nature Communications Medicine (Press release, Biological Dynamics, MAR 17, 2022, View Source [SID1234610287]). The test correctly identified 71 percent of stage 1 cancers in a combined cohort of pancreatic, ovarian, and bladder cancers with pancreatic stage 1 cancer detection at 96%.

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!

"The results are remarkable and highlight exosomal protein markers as a viable candidate for early-stage cancer detection," said Scott Lippman, M.D., co-senior author of this report and Director of UC San Diego Moores Cancer Center. "Specifically, pancreatic cancer is notoriously difficult to detect at an early stage, when surgery, the only curative therapy, is possible. Biological Dynamics’ assay is demonstrating the potential for early-stage cancer detection to be included in the standard of care."

The case-controlled pilot study explored a cohort of 139 pathologically staged patients with stage 1 and stage 2 pancreatic, ovarian, and bladder cancers. While other liquid biopsy approaches have shown high sensitivity in the later stages of cancer progression, they have been relatively unsuccessful in detecting cancers in earlier stages. Results from the study demonstrate that the company’s unique proprietary Verita platform can rapidly isolate extracellular vesicles (EVs) from 250 microliters of plasma and provide a multi-marker, protein-based analysis that clearly discriminates early-stage cancer cases from healthy controls. The method enables a unique, rapid, multiomic assessment from a single small blood draw.

"Our study shows effective use of EVs isolated by the Verita platform for early cancer detection," said Dr. Paul R. Billings, Biological Dynamic’s CEO and Director. "In addition to delivering the current exo-protein analysis, the platform can provide data on other exo-proteins, exosomal nucleic acids, and circulating DNA biomarkers. With our own development and in partnership, we intend to rapidly improve cancer detection and management."

Publication of this study follows Breakthrough Device Designation granted by the U.S. Food and Drug Administration (FDA) in October 2021. It reviewed Biological Dynamic’s liquid biopsy assay, Exo-PDAC, which delivers early-stage detection of pancreatic ductal adenocarcinoma (PDAC), an aggressive and lethal form of cancer growing in incidence worldwide.

On March 17, 2022 Shasqi, a clinical-stage biotechnology company developing precision click chemistry-activated oncology therapeutics, reported that it will present updated data from its ongoing Phase 1 clinical study of SQ3370 in patients with advanced solid tumors as well as preclinical data highlighting the activity of its click chemistry-modified protodrug version of monomethyl auristatin E (MMAE), at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, Shasqi, MAR 17, 2022, View Source [SID1234610286]). Presentations and posters will be available for registered attendees for on-demand viewing on the AACR (Free AACR Whitepaper) website on April 8, 2022, after 1:00 pm ET.

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 continue to be encouraged by initial data observed from our ongoing Phase 1 study of SQ3370 in heavily pre-treated patients with high disease burden, and we are advancing the development of SQ3370 as a treatment for patients with advanced solid tumors where an anthracycline-containing regimen is appropriate," said José M. Mejía Oneto, M.D., Ph.D., founder and CEO of Shasqi. "We’ve also demonstrated that our click chemistry platform can activate high doses of MMAE, a commonly used antibody-drug conjugate payload, at the tumor. Our MMAE protodrug achieved good plasma stability, attenuation of cytotoxicity, and was tolerated at doses up to 50-fold higher than the conventional MMAE maximum tolerated dose. We also present the anti-tumor effect of MMAE protodrugs activated at the tumor site using a biopolymer injection. We look forward to studying the anti-tumor efficacy of MMAE protodrugs when targeted to the tumor using biologic approaches."

Preclinical Poster Title: Click Activated Protodrugs Against Cancer (CAPAC): A modular platform for tumor-directed oncology therapeutics
Session Title: New Technologies for Drug Discovery
Session Date and Time: Monday, April 11, 1:30-5:00 pm CST
Abstract Number: 1894/25
Poster Number: ET01/02

Trial-In-Progress Poster Title: SQ3370 in advanced solid tumors: Interim phase 1 results
Session Title: Phase 1 Clinical Trials 2
Session Date and Time: Tuesday, April 12, 9:00 am -12:30 pm CST
Abstract Number: CT177/2
Poster Number: CT01/02

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 that have a limited therapeutic window.