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.

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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]):

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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]).

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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]).

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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.

On July 25, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported a significant milestone for the Company’s DecisionDx-Melanoma gene expression profile test, surpassing 100,000 tests ordered (Press release, Castle Biosciences, JUL 25, 2022, View Source [SID1234616914]). From the launch of DecisionDx-Melanoma through June 30, 2022, the test has been ordered more than 105,000 times by more than 10,200 providers for patients diagnosed with cutaneous melanoma.

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"Since I founded the Company, a cornerstone of our strategy has been a keen focus on improved patient care and for DecisionDx-Melanoma, transforming the management of cutaneous melanoma," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Today, we celebrate reaching this milestone of more than 100,000 clinical orders, which has allowed us the opportunity to make a significant impact in the lives of patients diagnosed with cutaneous melanoma. As we look to tomorrow, we believe that DecisionDx-Melanoma will continue to help clinicians and their patients make improved treatment decisions."

DecisionDx-Melanoma is designed to inform two clinical treatment questions in the management of cutaneous melanoma:

a patient’s individual risk of sentinel lymph node (SLN) positivity and
a patient’s personal risk of recurrence and/or metastasis.
Integrating a patient’s tumor biology and their clinicopathologic features, DecisionDx-Melanoma provides comprehensive and actionable results to guide risk-aligned patient care.

DecisionDx-Melanoma’s clinical utility is supported by more than 35 peer-reviewed publications, including two meta-analyses, which the Company believes represents the largest body of data for a cutaneous melanoma prognostic test. The test has been independently validated and studied in more than 9,000 patient samples, including an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on cutaneous melanoma cases. In a recent study in collaboration with the NCI, patients diagnosed with cutaneous melanoma and tested with DecisionDx-Melanoma had a 27% improvement in melanoma-specific survival compared to untested patients, suggesting that DecisionDx-Melanoma test results can aid in providing more risk-aligned treatment plans for improved patient outcomes.1

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 9,000 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration resulted in a study to evaluate melanoma-specific survival and overall survival, where patients tested with DecisionDx-Melanoma had better survival rates than untested patients. This data shows that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. DecisionDx-Melanoma has been validated in four archival risk-of-recurrence studies of more than 900 patients and six prospective risk-of-recurrence studies including more than 1,600 patients. Impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Through June 30, 2022, DecisionDx-Melanoma has been ordered 105,239 times for patients with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.