On November 1, 2020 LifeArc reported that it initiated a new strategic collaboration with Cleveland Clinic that aims to accelerate the translation of promising scientific discoveries into new tests and treatments for patients (Press release, LifeArc, NOV 1, 2020, View Source [SID1234573196]).

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The relationship begins with LifeArc sponsoring two new post-doctoral fellowships at Cleveland Clinic’s centre for Therapeutics Discovery located on the main campus within the Lerner Research Institute in Cleveland, Ohio. LifeArc will provide funding for the researchers’ salaries and laboratory supplies over two years.

The fellows will carry out investigative research on early-stage innovative projects in therapeutic areas that closely align with the strategic priorities of both organisations. These include infectious disease; cancer, with a focus on early detection and precision medicine; and neurological disorders, including epilepsy and neuropathic pain. Other key shared areas of interest include diagnostics and biomarker development, to create new tests that enable doctors to tailor treatments to patients.

The Fellows program will be led by Dr. Andy Merritt, director for medicinal chemistry at LifeArc, and Dr. Shaun Stauffer, director of Cleveland Clinic’s Centre for Therapeutics Discovery.

"We are delighted to kick-off this new long-term collaboration with Cleveland Clinic with our shared goal of advancing the translation of early-stage innovative discoveries into new life-changing medicines and diagnostics," said Dr. Merritt.

"Our new funding will help accelerate the fruition of exciting innovative ideas that are currently stuck at the lab bench but have huge potential to make a difference to patients.

"We hope this will help projects to reach a key tipping point, creating new opportunities to collaborate on future research programs where we can contribute our expertise in medicinal chemistry, antibody engineering or diagnostics within LifeArc laboratories."

This new funding aims to foster early-stage research that has high potential to benefit patients but requires further validation before it can be taken into larger research programs. LifeArc will be given the first option to initiate new collaborations with the Cleveland Clinic to advance the most promising discoveries and move them closer towards the clinic.

Cleveland Clinic’s Centre for Therapeutics Discovery, established in 2018, promotes the translation of basic science discoveries by Cleveland Clinic researchers into new therapeutics. Under Dr. Stauffer’s leadership, the centre’s team has established a pipeline of innovative drug discovery research programs directed toward improving patient care with a true bench-to-bedside vision.

"We are extremely excited to work with LifeArc," said Dr. Stauffer. "Their vision for how we discover innovative therapies in the future recognizes that this vision starts with discovery teams truly putting patients first with an emphasis on diagnostics and detection.

"It is our shared goal that by establishing this long-term relationship we will empower translational teams, investigators and clinicians to ask the most compelling questions between basic science and human investigation." (Press release, LifeArc, NOV 1, 2020, View Source [SID1234573196])

On November 1, 2020 China Grand Pharmaceutical and Healthcare Holdings Limited ("GP (HK)" or the "Company", together with its subsidiaries, the "Group", stock code: 00512) reported that the Group has entered into several agreements with Telix Pharmaceuticals Limited (ASX:TLX) ("Telix", together with its wholly owned subsidiaries, the "Telix Group"), Jiangsu Institute of Nuclear Medicine, and Beijing Puer Weiye Biotechnology Co., Ltd. ("Puer Weiye") in the field of radionuclide-drug conjugates ("RDC"), focusing on highly innovative and high-barrier radiological diagnostic and therapeutic drugs (Press release, China Grand Pharmaceutical, NOV 1, 2020, View Source [SID1234569743]).

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The Group has entered into a share Subscription Agreement with Telix Group, pursuant to which the Group will invest US$25 million to subscribe approximately 7.6% equity interests of Telix after fulfilling the relevant conditions stipulated in the Subscription Agreement. Furthermore, the Group has entered into a Licensing Agreement with Telix Group, with upfront prepayment and milestones payments of up to US$225 million in aggregate, and a royalty fee for each licensed product as a percentage of annual net sales amount in the licensed region, pursuant to which the Group will obtain the exclusive development, manufacturing and commercialization rights in Mainland China, Hong Kong SAR, Macau SAR and Taiwan (the "Greater China Region") for Telix Group’s innovative RDC TLX591, TLX250 and TLX101 that have the potential to become First in Class therapy for prostate cancer, clear cell renal cell carcinoma ("ccRCC") and glioblastoma. Lastly, the Group has entered into a Partnership Agreement with Telix Group, pursuant to which the Group will obtain the exclusive commercialization rights in the Greater China Region for Telix Group’s innovative RDC TLX591-CDx, TLX250-CDx and TLX599-CDx ("Licensed Products") that have the potential to become First in Class diagnostic method for cancer detection, and the Group will purchase related products from Telix Group pursuant to the Partnership Agreement. In addition, within a certain future period, the Group will have the first right of negotiating exclusive development, manufacturing and commercialization rights in the Greater China Region for future pipeline products of Telix Group.

Headquartered in Melbourne, Australia, Telix is a biopharmaceutical company focused on the development of innovative cancer diagnostic and therapeutic RDC, using Molecularly Targeted Radiation (MTR) and conjugation technology platform to carry out the development and application of RDC. Telix Group’s pipeline covers a variety of cancer types with high morbidity and mortality. At present, Telix Group is conducting over ten clinical trials globally. Three of its pipeline products (TLX101, TLX101-CDx and TLX102) have been granted orphan drug designation, and one product (TLX250-CDx) has been granted breakthrough therapy designation by the United States Food and Drug Administration ("FDA").

In terms of project status, Telix Group has completed phase II clinical trial for TLX591 and is currently planning to start phase III clinical trial in Australia and the United States, and it has submitted New Drug Application ("NDA") to the FDA for TLX591-CDx in September of this year. Telix Group is preparing to commence two phase II clinical trials to assess the efficacy of TLX250 in combination with current immuno-oncology therapies for ccRCC. TLX250-CDx has been granted breakthrough therapy designation and is currently being studied in a phase III clinical trial. The combination of TLX101 and external beam radiation is currently being studied in a phase I/II clinical trial at several hospital locations across Europe and Australia.

The Group and Jiangsu Institute of Nuclear Medicine have entered into a memorandum of strategic cooperation to reach an agreement on the development, manufacturing, testing and standard formulation, preclinical research and intellectual property of RDC; the Group and Puer Weiye has entered into a share purchase agreement, pursuant to which the Group will acquire 100% equity interest in Puer Weiye for a consideration of not more than RMB10 million subject to conditions precedent. Upon the completion of this acquisition, the Group will obtain the "Radioactive Pharmaceutical Production License", "Radioactive Pharmaceutical Trading License" and "Permit for Radiation Safety". After the acquisition of Puer Weiye, the Group will become the second Hong Kong listed company permitted to engage in the production, commercialization and development of radioactive pharmaceuticals.

According to data released by Statista, the size of the global nuclear medicine/radiopharmaceuticals market was around US$3.98 billion in 2018 and is expected to reach US$5.06 billion by 2023. Frost & Sullivan’s forecast predicted that the CAGR of China’s radiopharmaceuticals market is about 18.6%, and the total domestic market size is expected to reach RMB9 billion by 2021. Telix Group’s innovative radionuclide conjugation technologies enable molecular targeted drug or antibody to carry radiation, and enhance the imaging diagnostics and treatment for multiple cancer types. By leveraging the radionuclide conjugation technologies of Telix Group, the Group will be able to provide Chinese patients with integrated diagnostic and treatment solutions for multiple cancer types.

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: "The Group is insightful in the growth opportunities and future development of the radiopharmaceutical industry. Entering into the agreements with well-known companies and institutes to obtain the commercial rights of related products in the Greater China Region and the qualification licenses for trading radioactive pharmaceuticals in China, is another important strategic step for the Group in the expansion of radiopharmaceutical planning. Upon entering the agreements mentioned above, the Group will initiate the clinical trials application of the six licensed products in the Greater China Region. And together with the SIR-Spheres Y-90 resin microsphere that was approved to file NDA in August of this year, in the field of anti-tumor RDC, the Group has owned a total of seven products for the diagnostics and treatment of colorectal liver metastases, prostate cancer, ccRCC and glioblastoma. The Group will continue to increase the investment in RDC and to introduce world-class innovative products, so as to build an integrated supply chain including R&D, production, sales and supervision, and to establish a world-leading RDC platform."

"The Group has been dedicated to the research and development of anti-tumor therapy for many years. It has 11 innovative products globally, of which 10 products are in clinical trials across different locations in the globe, covering 8 major solid tumors (including hepatocellular carcinoma, colorectal cancer, ccRCC, prostate cancer, glioblastoma, metastatic melanoma, triple negative breast cancer and squamous cell carcinoma). The variety and quantity of the Group’s product pipeline are at the leading level in this industry.

"The Group adopts the strategy of ‘global expansion and dual-cycle operation’ and will continue to optimize product structure and enrich the pipeline in anti-tumor field by introducing international advanced products and technologies, in order to provide cancer patients with more treatment options and solutions, forming a new pattern of domestic and international cycles that synergize with each other. In the future, the Group will continue to focus on the R&D of innovative products and be actively involved in activities such as global in-licensing, investment and acquisition of high-quality products and assets in core therapeutic areas, in order to enrich product lines and innovative products pool and to bring better returns for the shareholders of the Company."

On November 1, 2020 Astellas reported financial results for the first six months of the fiscal year 2020 (FY2020) (Presentation, Astellas, NOV 1, 2020, View Source [SID1234569642]).

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On November 1, 2020 Samsung Biologics (207940.KS) reported that it has entered into a strategic partnership with GeneQuantum Healthcare, a China biotech company, to jointly develop an antibody drug conjugate (ADC) for the treatment of non-small-cell lung carcinoma (NSCLC), triple-negative breast cancer (TNBC), and other solid tumors (Press release, Samsung BioLogics, NOV 1, 2020, View Source [SID1234569613]). The agreement signals Samsung Biologics’ accelerated entry into the China market.

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GeneQuantum Healthcare recently received the US FDA’s Investigational New Drug (IND) Good to Proceed Letter in May this year for its first anti-HER2 ADC asset, which was manufactured via GeneQuantum’s patented intelligent ligase-dependent conjugation (iLDC) technology platform.

Samsung Biologics’ approach to entering the Chinese market is strategic. The Chinese biopharmaceutical market was worth 38.5 billion USD in 2019 and is expected to a grow at a rate of 14.4% annually. This new collaboration with a Chinese company follows Samsung Biologics’ recent development partnership with an innovative biotech, APRINOIA Therapeutics, further marking the company’s strategic entry and presence in the market. GeneQuantum had previously signed its CDO contract with a CDMO partner for its first asset, however has notably chosen Samsung Biologics for its second antibody candidate. As a result of Samsung Biologics’ recognized capabilities to achieve best-in-class client satisfaction, the company is currently having extensive discussions with a vast number of potential Chinese clients in the market.

Samsung Biologics has showcased a record of achievements in recent years. The company has dramatically reduced the time required for development stage, taking 6 months to DS manufacturing, and 7 months to DP manufacturing. Samsung Biologics has also recently announced its proprietary cell line technology, S-CHOice, in August this year, which shows improved titers up to two-fold from the industry average and maintains over 90% of cell viability.

Owing to these proven features, the company’s CDO business unit has acquired nearly 60 contracts within a 2-year period, gaining recognition in the global market. Through these extended partnerships, especially with leading Chinese biotech companies, Samsung Biologics aims to further demonstrate its high-quality CDO capabilities and technology in the Chinese market to provide greater accessibility to breakthrough treatments for patients.

"GeneQuantum is excited to collaborate with Samsung Biologics, a global leading partner with proven development capabilities in the market," said Dr. Gang Qin, CEO of GeneQuantum. "One of the decision-making aspects for this partnership was Samsung Biologics’ dedication and commitment to providing high-quality services. With this mutually beneficial partnership, we aim to further expand on this development scope to bring innovative treatments for patients."

"We are extremely proud that our CDO capabilities are continuously being recognized in the Chinese market, especially amid the current global climate," said Dr. Tae Han Kim, CEO of Samsung Biologics. "By joining forces with a leading biotech company with a distinguished reputation in the market, we hope to further expand on the partnership to provide effective and affordable treatments for patients with unmet medical needs."

On November 1, 2020 LabCorp (NYSE: LH), a leading global life sciences company that is focused on advancing health and guiding patient care decisions, and BML, a leading Japanese provider of clinical laboratory testing services, reported an expanded agreement to provide development and delivery of companion diagnostics in Japan (Press release, LabCorp, NOV 1, 2020, View Source [SID1234569597]). This collaboration broadens the potential network of laboratories used by pharmaceutical and biopharmaceutical companies to support companion diagnostic development and commercialization. The collaboration is intended to increase access to healthcare providers in Japan, and further accelerate the adoption of companion diagnostics that are used in drug development and clinical trials.

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The collaboration will initially focus on the commercial availability of assays that have been developed and validated both analytically and clinically at LabCorp’s drug development business, Covance. The companies expect the first application of the new agreement will address unmet needs in oncology.
LabCorp is an established leader in the development, validation, and commercialization of companion diagnostics, which are key enablers of precision medicine. The company has been involved in the development of drugs and their associated companion diagnostics for more than 20 years, and has more U.S. Food & Drug Administration-approved companion diagnostics than any other company. BML, a leader in clinical diagnostic testing in Japan, has more than 53 laboratories and 116 customer service locations, and processes more than 1.5 billion diagnostic tests per year.

"Companion diagnostics are a key component of our precision medicine strategy, enabling healthcare providers to identify the patients who are most likely to benefit from targeted and novel therapies," said Steve Anderson, Ph.D., chief scientific officer of Covance and senior vice president at LabCorp. "This partnership with BML further expands our reach to Japan and benefits our biopharmaceutical clients who need global solutions for precision medicine, with the ultimate goal of improving health and improving lives for patients around the world."

"Our collaboration with LabCorp allows BML to provide our clients with robust companion diagnostics services for the patients who need them in Japan. It builds on our trusted relationship with Covance, which has provided clinical trials testing services to our pharmaceutical partners for over 10 years," said Dr. Kensuke Kondo, president of BML. "Our combined ability to bridge the time gaps between the development phase and drug approval through to national reimbursement, along with the benefit of having a centralized laboratory testing facility, gives our respective customers the advantage of early adoption of their drug. BML’s experience with local testing requirements, quality standards and logistical expectations will ensure instant access to high-quality testing."

BML has collaborated with LabCorp’s drug development business Covance for a decade across over a thousand projects. The collaboration created the Covance-BML Trial Laboratory to manage the growing demand for in-country laboratory testing services that support drug development and clinical trials for pharmaceutical companies. Terms of the new agreement have not been disclosed.