On July 25, 2022 HanX Biopharmaceuticals reported that Anti-PD-1 monoclonal antibody – PuyouhengTM (HX-008, pucotenlimab injection), was conditionally approved by the National Medical Products Administration (NMPA) for marketing in China to treat patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors, specifically (Press release, HanX Biopharmaceuticals, JUL 25, 2022, View Source [SID1234616920]):

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!

Patients with advanced colorectal cancers have progressed following previous treatment with a fluoropyrimidine, oxaliplatin and irinotecan;
Patients with other advanced solid tumors that have progressed following at least previous first-line therapy with no satisfactory alternative treatment options.
The approval is based on a multi-center, open-label, phase II clinical study with a primary study endpoint of the objective response rate (ORR) assessed by the Independent Review Committee (IRC) according to the RECIST1.1. As of December 4, 2021, a total of 100 patients with histologically confirmed advanced solid tumors that are identified as having MSI-H/dMMR by the central Laboratory were enrolled in the study. They were given 200 mg of pucotenlimab by intravenous drip every 3 weeks (Q3W). The median follow-up duration for the ITT population was 22.5 months. And the ORR for the ITT population was 49.0% (95% CI: 38.86%, 59.20%), with 9 cases of complete response (CR) and 40 cases of partial response (PR). In the subgroup of patients with colorectal cancers who had failed previous triplet therapy (a fluoropyrimidine, oxaliplatin, and irinotecan), the ORR was 50.0% (95% CI: 31.30%, 68.70%). The results of the study showed that pucotenlimab monotherapy was safe and effective in patients with unresectable or metastatic MSI-H/dMMR advanced solid tumors who have failed previous standard therapy. The expected clinical endpoints were achieved, indicating that patients can benefit significantly from the therapy. The results of the clinical study were first published at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

"We are thrilled to see the approval of pucotenlimab, which validates our years of collaboration with Lepu Biopharma", said Dr. Faming Zhang, Chairman of Hanx Biopharmaceuticals, Inc., "I’m very glad to see the first indication of pucotenlimab was approved in China. The clinical research data of pucotenlimab for MSI-H/ dMMR solid tumors is outstanding and the approval brings new hope to better meet the demands of clinical treatment. Pucotenlimab is the first product launched by Lepu Biopharma as well as a significant milestone in the company’s evolution towards Biopharma", commended by Dr. Sui Ziye, CEO of Lepu Biopharma.

About Puyouheng (HX-008, pucotenlimab injection)

Puyouheng (pucotenlimab injection) is a humanized IgG4 monoclonal antibody against human PD-1 discovered by HanX Biopharmaceuticals, It can bind to PD-1 with high affinity to restore the ability of immune cells to kill cancer cells by blocking the binding of PD-1 to its ligands PD-L1 and PD-L2. Puyouheng (pucotenlimab injection) adopts an innovative molecular design to prolong its half-life, showing strong clinical anti-tumor activity and good safety. The innovative use of antibody engineering technology to introduce triple mutations in the Fc region improves the binding affinity of FcRn, thereby prolonging the drug’s half-life significantly, showing its promising clinical efficacy and drug compliance in patients [5]. Compared with all rival anti-PD-1 antibodies that have been marketed or entered phase III clinical trials, the mean half-life of Puyouheng (pucotenlimab injection) is 21.8 days (single dosing) and 38.2 days (steady-state). In addition, the prolonged half-life does not cause additional adverse events, indicating the excellent clinical efficacy of the drug.

On July 25, 2022 Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, reported the signing of a definitive agreement for the previously announced transaction with Bayer to expand Ginkgo’s platform capabilities in agricultural biologicals (Press release, Bayer, JUL 25, 2022, View Source [SID1234616918]). These capabilities will be built pursuant to a transaction in which Ginkgo will acquire Bayer’s 175,000-square-foot West Sacramento Biologics Research & Development site, team, and internal discovery and lead optimization platform for approximately $83.0 million in consideration. The proposed transaction is projected to close in the fourth quarter of 2022, subject to regulatory approvals and customary closing conditions. Ginkgo will also integrate the R&D platform assets from Joyn Bio, a joint-venture between Ginkgo and Leaps by Bayer formed in 2017.

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!

While chemical and plant trait products are currently the dominant offerings on the market to improve crop performance, agricultural biologicals are a rapidly growing category of solutions that have the potential to offer tremendous sustainability and performance benefits. Bayer will be the first major partner of Ginkgo’s expanded agricultural biologicals platform, entering into a new collaboration focused on the advancement of Joyn’s marquee nitrogen fixation program, as well as new programs in areas such as crop protection and carbon sequestration.

As part of a three-year strategic partnership, Ginkgo will provide research services to Bayer in the field of agricultural biologicals with the potential to earn downstream value in the form of royalties on net sales from products developed under the partnership. As previously disclosed, it is expected that the cash proceeds from this collaboration with Bayer will significantly offset the operating expenses acquired through the transaction. In addition to this collaboration with Bayer, Ginkgo expects to engage with other customers in supporting the development of their agricultural biological programs.

"To ensure sustainable food security for an ever growing population, we need to invest in biological solutions," said Jason Kelly, CEO and co-founder of Ginkgo Bioworks. "By acquiring one of the premier R&D sites for agricultural biologicals worldwide and partnering with the best-in-class teams at Bayer and Joyn, we are demonstrating our commitment to developing breakthrough products for growers around the world. We are excited to be able to make this platform accessible to innovative companies and teams who may otherwise not have the resources or expertise to develop these capabilities in house."

"Through this strategic research partnership with Ginkgo and by tapping into the open innovation ecosystem, Bayer is accelerating innovation in our biologicals pipeline and continuing to lead in the development of effective and reliable solutions," said Bob Reiter, Head of R&D for Bayer’s Crop Science Division. "Agricultural biologicals have the potential to boost crop yields while simultaneously offering environmental benefits to growers, and Ginkgo’s technologies will help to deliver on biologicals’ potential."

On July 25, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System ( "ProSense") that destroys tumors by freezing as an alternative to surgical tumor removal, reported the submission of a regulatory filing with the Canadian governmental agency, Health Canada, for approval of IceCure’s ProSense System and its cryoprobes for the treatment of numerous indications including (Press release, IceCure Medical, JUL 25, 2022, View Source [SID1234616917]):

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!

Oncology – ablation of benign and malignant breast tumors as well as benign and malignant tumors of the lung, liver, and musculoskeletal system, and for palliative intervention;
Urology – ablation of renal cell carcinoma;
Thoracic surgery – ablation of cancerous lesions in the lung tissue; and
Other indications and for general surgery.
The ProSense System currently has regulatory approval for various indications in 14 countries, including in the U.S. and Europe.

According to statistics from the Canadian Cancer Society, an estimated 28,600 women will be diagnosed with breast cancer in Canada in 2022, while an estimated 30,000 people will be diagnosed with lung cancer. Furthermore, breast cancer is the most common cancer among Canadian women. About 1 in 8 women will be diagnosed with the disease in their lifetime.

"We have been contacted by multiple Canadian healthcare providers, including hospitals, with requests to purchase and implement ProSense for treating a range of indications, with malignant breast tumors being the most pressing need," stated IceCure CEO, Eyal Shamir. "We believe demand is being driven by a combination of ProSense’s rising prominence in the global market and health care providers discovering, over the past two years during the pandemic, that they needed minimally invasive solutions that can be administered in an outpatient setting outside of an operating room. The benefits of minimally invasive procedures have become clearer than ever, driving demand in a post-pandemic environment. We hope to receive Health Canada’s approval, further expanding ProSense’s global regulatory and commercial footprint."

On July 25, 2022 Theralink Technologies, Inc. (OTC: THER) ("Theralink" or the "Company"), a precision oncology company with a novel phosphoprotein-based assay for breast cancer, reported that it has acquired licenses for two new U.S. patents relating to methods for treating breast cancer: US 10,823,738 and US 10,690,672, expanding the Company’s patent portfolio to nine (Press release, Theralink Technologies, JUL 25, 2022, View Source [SID1234616916]).

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!

Theralink has licensed the patents from George Mason University, strengthening and extending the current Theralink IP family that covers specific "predictive" biomarkers. Predictive biomarkers are used to identify patients with cancer that require specific, personalized therapeutics. In essence, they define what are called "companion diagnostics" wherein the biomarker is used to identify classes of patients that will best respond to a specific drug. Theralink has issued IP on specific predictive biomarkers that cover a range of therapeutic classes.

Emanuel Petricoin, Ph.D., Chair of Theralink’s Science Advisory Board, stated, "These new patents are a significant addition to Theralink’s biomarker collection, greatly enhancing our existing CLIA Theralink Assay portfolio. Together, these two new patents immediately synergize with the commercially available CLIA Theralink Assay for Breast Cancer since the specifically claimed biomarkers, protected by the new issued patents, are part of the 32-biomarker panel that is commercially available today."

Mick Ruxin, M.D., President & CEO of Theralink, added, "These two important patents, along with the existing seven patents in our portfolio, create a substantial IP moat surrounding our patented Reverse Phase Protein Array Technology and provide Theralink with the exclusive commercial license to bring our predictive assay to all cancer patients within the category of intended use. Significantly, physicians can now order the Theralink Assay for Breast Cancer and use it to expand the use of PARP inhibitors and HER2-EGFR inhibitors to breast cancer patients, by identifying patients who will respond to these powerful therapeutics currently missed by existing genomics-based approaches."

New Patent Details:

Issued patent 10,823,738: A Method for Treating Breast Cancer, relates to the use of specific predictive biomarkers that can be used to identify which patients with HER2 negative disease, including the hard-to-treat "triple negative" breast cancer, will respond to the powerful new class of therapeutics called PARP inhibitors. HER2 negative breast cancer represents 80% of all breast cancers, so this subtype is by far the most prevalent type. While PARP inhibitors represent a tremendously exciting new class of therapies in cancer and are known to be effective in HER2- breast cancer, nearly 40% of these HER2 negative patients do not respond, and this patent covers specific biomarkers that predict which patients will and will not respond to PARP inhibitors, effectively, a predictive marker for PARP inhibitors. Moreover, the patent covers the use of specific biomarkers for any type of PARP inhibitor-based therapy.

Issued patent 10,690,672: A Method for Treating Breast Cancer, covers the use of specific predictive biomarkers that can be used to identify which breast cancer patients will respond to therapies that target the HER2 and EGFR proteins in ALL types of breast cancer. While anti-HER2 therapeutics and HER2-EGFR dual therapeutics together represent the largest class of breast cancer therapeutics on the market, amounting to billions of dollars a year in revenue for the pharmaceutical industry, identification of patients who will respond relies on the use of measuring HER2 first, which means that currently only 20% of all breast cancers are treated with this class of therapies. Theralink’s new powerful IP centers on novel biomarkers that can be used for 100% of breast cancers and may identify many patients who will respond to anti-HER2-EGFR agents missed entirely by current HER2 measurement techniques.

On July 25, 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 treatment, reported that several key executives will speak at The 3rd Gamma Delta T Therapies Summit, which will take place on July 26-28, 2022 in Boston, MA (Press release, TC Biopharm, JUL 25, 2022, View Source [SID1234616915]).

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!

TC BioPharm will participate in five separate conference sessions
Emilio Cosimo, Product Development Manager, will participate in a workshop, "Characterizing Gamma Delta Subsets to Interrogate Function & Therapeutic Application," on July 26, 2022 at 11am EDT.
Dr. Michael Leek, Co-Founder & Executive Chairman, will hold a session, "Gamma Delta T Therapies – From ‘Last Chance’ to Surrogate Front Line Treatment (Vd2)," on July 27, 2022 at 4:30pm EDT.
Angela Scott, Co-Founder & COO, will participate in a panel discussion, "Defining a ‘Super-Donor’ & Discussing Cell Source Considerations to Maximize Off-the-Shelf Product Quality," on July 28, 2022 at 12pm EDT.
Dr. Leek will participate in a panel discussion, "Sharing Perspectives on the Application & Attractiveness of Gamma Delta T Therapy in a Competitive Treatment Landscape," on July 28, 2022 at 12pm EDT.
Scott will hold a session, "Developing Allogeneic Manufacturing Processes to Scale GMP-Compliant, Freeze-Thaw Products (Vd2)," on July 28, 2022 at 2:30pm EDT.
The 3rd Gamma Delta T Therapies Summit will take place in-person for the first time and bring together over 120 leaders in the field. For more information, visit the conference’s website.