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Jemincare Out-licenses Prostate Cancer Drug to Roche in $650 Million Deal

On October 11, 2022 Jinxi Jemincare, a China pharma formed in 1999, reported that out-licensed global rights for its androgen receptor degrader to Roche in a $650 million agreement (Press release, Shanghai Jemincare Pharmaceutical, OCT 11, 2022, View Source [SID1234621924]). JMKX002992 is being developed to treat prostate cancer patients who have developed resistance to current therapies. The oral small molecule candidate, which was developed in Shanghai Jemincare’s 500-scientist R&D center, is currently in preclinical testing. Jemincare will receive $60 million upfront and the rest in milestones, plus royalties. Roche said the agreement was the first global in-licensing between its Genentech subsidiary and a China biopharma. The deal was originally announced in August.

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Ginkgo Bioworks Announces Collaboration with Merck to Improve Active Pharmaceutical Ingredient Manufacturing

On October 11, 2022 Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, reported a collaboration with Merck, known as MSD outside the United States and Canada, to engineer up to four enzymes for use as biocatalysts in Merck’s active pharmaceutical ingredient (API) manufacturing efforts (Press release, Ginkgo Bioworks, OCT 11, 2022, View Source [SID1234621923]). Through this collaboration, Ginkgo will leverage its extensive experience in cell engineering and enzyme design, as well as its capabilities in automated high throughput screening, manufacturing process development/optimization, bioinformatics and analytics to deliver optimal strains for expression of targeted biocatalysts.

Biocatalysis is a sustainable and often more effective alternative to some chemical synthesis steps in industrial chemical synthesis. The inherent stereospecificity of enzyme biocatalysts can reduce costly synthesis and purification steps, thereby decreasing production costs. Through this collaboration, Ginkgo aims to optimize several biocatalysts by leveraging its world-class proprietary fungal strains, cell line development, enzyme engineering and optimization, and multiomics expertise.

"Ginkgo’s fungal strains present a major opportunity for improving biocatalysis. E. coli is currently the mainstay host for expressing enzymes, but a large number of enzymes will not express properly in E. coli, and those that do express in E. coli may have better homologs that only express in fungal strains," said Behzad Mahdavi, Senior Vice President of Biopharma Manufacturing and Life Sciences Tools at Ginkgo. "This enzyme optimization project with Merck has the potential to help reduce the cost of goods and enable a more robust supply chain for APIs."

"Merck is a pioneer in biocatalysis, improving manufacturing of crucial medicines. We’re thrilled to be partnering with Merck, and to be leveraging our platform capabilities for improved enzyme activity and production" said Jason Kelly, co-founder and CEO at Ginkgo. "Ginkgo’s platform model enables us to identify improved enzymes and develop powerful fungal strains and fermentation processes for enzyme manufacturing, empowering downstream API production for our customers."

Under the terms of the collaboration, Ginkgo will earn an upfront research and development fee and is eligible for success-based research and development milestone payments. In addition, Ginkgo is eligible to earn commercial milestone payments for each of a specified number of biocatalysis targets, which have the potential to total, in the aggregate, up to $144 million. To learn more about Ginkgo’s work in enzyme discovery, visit ginkgobioworks.com/our work/enzyme-discovery.

Caris’ Precision Oncology Alliance Welcomes The Cancer Institute at The University of Tennessee Medical Center

On October 11, 2022 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize health care, reported that The University of Tennessee Medical Center’s (UTMC) Cancer Institute has joined Caris’ Precision Oncology Alliance (POA) (Press release, Caris Life Sciences, OCT 11, 2022, View Source [SID1234621921]). The POA is a growing network of leading cancer centers across the globe that collaborate to advance precision oncology and biomarker-driven research. POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients.

UTMC, a Magnet recognized hospital, Level I Trauma Center and regional academic medical center, serves as a major referral center for East Tennessee, Southeast Kentucky and Western North Carolina. As the largest provider of cancer care in the region, the Cancer Institute offers the broadest spectrum of cancer specialists and services to care for the local adult population, with research as its cornerstone of knowledge.

"We are proud to join the Caris Precision Oncology Alliance," said John L. Bell, M.D., Director of the Cancer Institute at The University of Tennessee Medical Center. "As cancer treatments become more sophisticated and personalized, having access to the most recent, ever-changing molecular testing helps our providers choose the best cancer treatment for each patient. It is truly an honor to join this prestigious group of institutions and make this testing available to patients in East Tennessee and beyond through cutting-edge precision oncology research."

"We’re excited to welcome The University of Tennessee Medical Center’s Cancer Institute into the growing Caris Precision Oncology Alliance network and look forward to collaborating with its clinicians and investigators to advance clinical and translational research," said Chadi Nabhan, M.D., MBA, FACP, Chairman of the Caris Precision Oncology Alliance. "The University of Tennessee Medical Center’s addition to the POA advances our precision oncology research portfolio aiming to improve the outcomes of patients with cancer."

The Caris Precision Oncology Alliance includes 73 cancer centers and academic institutions. These institutions have early access to the extensive database and artificial intelligence platform within Caris to establish evidence-based standards for cancer profiling and advance research in cancer precision medicine. By leveraging the comprehensive genomic, transcriptomic and proteomic profiling available through Caris molecular profiling, Caris seeks to provide this network with the ability to prioritize therapeutic options and determine which clinical trial opportunities may benefit their patients. POA members are also able to integrate with a growing portfolio of biomarker directed trials sponsored by biopharma. Additionally, as a member of the POA, institutions have access to Caris CODEai, the most comprehensive data solution in the industry with cancer treatment information and clinical outcomes data for over 275,000 patients covering over 1 million data points per patient.

HanAll’s Licensed Partner in China Enters Sublicense Agreement with CSPC to Further Accelerate Development of Batoclimab

On October 11, 2022 HanAll Biopharma (KRX: 009420.KS), a global biopharmaceutical company developing innovative medicines, reported that its licensed partner in greater China, Harbour BioMed, has signed an exclusive sublicense agreement with CSPC NBP Pharmaceutical Co., Ltd. (NBP Pharma), a wholly-owned subsidiary of CSPC, a RBM 28 billion 2021 sales company based in China, for HanAll’s FcRn inhibitor batoclimab (Press release, HanAll Biopharma, OCT 11, 2022, View Source [SID1234621920]). The deal grants NBP Pharma the exclusive rights to develop and commercialize batoclimab in Greater China including mainland of China, Hong Kong, Macau, and Taiwan. Under the agreement Harbour BioMed will receive a total of over RMB 1 billion, including the RMB 150 million worth upfront payment along with the potential milestone payments.

"We are pleased to have reached this agreement with Harbour BioMed," said Cuilong Zhang, CEO of CSPC through the press release by Harbour BioMed. "Batoclimab is a promising innovative drug, and we hope to accelerate its clinical development, manufacturing, registration and commercialization in China, so as to benefit the patients in China better and earlier," he added.

"HanAll welcomes CSPC to join our journey to develop innovative medicines for patients in China. With its strong track records of R&D and commercialization, CSPC is expected to even further accelerate and expand the clinical development of batoclimab to contribute to autoimmune patients in China," said Sean Jeong, M.D., CEO of HanAll Biopharma.

ImpediMed Expands Use of SOZO in Leading Cancer Centers Focused on Reducing the Impact of Lymphedema after Breast Cancer

On October 11, 2022 ImpediMed Limited (ASX.IPD) reported the recent expansion of the use of its SOZO Digital Health Platform at leading cancer centers dedicated to reducing the impact of lymphedema on breast cancer patients (Press release, ImpediMed, OCT 11, 2022, View Source [SID1234621919]). Several key customers, including City of Hope, Mayo Clinic, University of Pittsburgh Medical Center, and US Oncology, added new SOZO devices or software licenses to expand access to SOZO testing for their breast cancer patients.

In 2019, ImpediMed launched its comprehensive Lymphedema Prevention Program, with the goal of ending cancer-related lymphedema. Routine lymphedema testing of cancer survivors uses the company’s FDA-cleared SOZO Digital Health Platform with L-Dex technology, which helps detect lymphedema at the subclinical stage, before noticeable swelling.

We are excited that these prestigious organizations are expanding access to SOZO testing for breast cancer patients.

Since the launch of the Lymphedema Prevention Program, ImpediMed has announced multiple partnerships with leading institutions globally. Publication of ImpediMed’s PREVENT Trial three-year primary endpoint results, which demonstrated that routine monitoring with L-Dex combined with at-home intervention resulted in a 92% reduction in lymphedema progression, also contributed to further adoption of SOZO for lymphedema prevention.

"It is well established that early detection and intervention reduces the burden of lymphedema on breast cancer patients," commented Frank Vicini, MD, radiation oncologist and ImpediMed’s Chief Medical Officer. "ImpediMed’s L-Dex technology, which is available on SOZO, has the most extensive evidence of efficacy for early detection of breast cancer-related lymphedema. Continued improvement in breast cancer treatment has increased the focus on quality of life in survivorship."

"We are excited that these prestigious organizations are expanding access to SOZO testing for their patients," said David Anderson, Interim CEO of ImpediMed. "This is aligned with our commitment to the goal of ending cancer-related lymphedema by delivering research, technology, and workflows to guide clinicians in the use of SOZO for lymphedema prevention. Every day, our team works closely with our customers to ensure successful implementation of SOZO for the benefit of patients."

ImpediMed offers clinicians multiple channels for education about SOZO and lymphedema prevention including online resources at View Source, the ImpediMed Webinar Series, and in-person training. ImpediMed’s website, www.preventlymphedema.com, offers quick and easy access to extensive information about lymphedema prevention including videos and educational materials for surgeons, cancer centers, caregivers and patients.

About Lymphedema
Lymphedema is a side effect of cancer treatment. It currently affects about 1-in-3 patients who have undergone surgery, radiation, or chemotherapy, each of which may compromise the lymphatic system. Lymphedema is characterized by abnormal swelling that generally occurs in one of the arms or legs, and sometimes both arms and both legs. Patients with lymphedema also have a greater risk of getting infections. Cuts or small breaks in the skin can lead to serious complications and hospitalizations. Currently, no cure for lymphedema exists. By the time patients experience swelling, the condition is typically irreversible. However, extensive research indicates that prevention is possible if lymphedema is caught early and ImpediMed’s L-Dex technology, which is available on SOZO, has the most extensive evidence of efficacy for early detection. For more information, visit www.preventlymphedema.com.