On January 11, 2021 Novartis reporrted that it has signed a strategic collaboration agreement to in-license tislelizumab from BeiGene, Ltd. in major markets outside of China, accelerating the potential for Novartis to enter the large and growing checkpoint inhibitor field (Press release, Novartis, JAN 11, 2021, View Source [SID1234573815]). Tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.

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Under the terms of the agreement, Novartis will obtain the development and commercialization rights to tislelizumab in the United States, Canada, Mexico, the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan in exchange for an upfront payment of USD 650 million plus royalties and milestone payments. BeiGene will retain the rights to tislelizumab in China and other countries. The transaction has been approved by the Boards of Directors of both companies.

More than 7,700 patients have been enrolled in 15 potentially registration-enabling clinical trials with tislelizumab in a dozen indications, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma, gastric cancer and nasopharyngeal carcinoma. The first ex-China regulatory filing is expected in 2021. In addition, Novartis and BeiGene have identified multiple tislelizumab plus Novartis therapy combination clinical trial opportunities in solid tumors.

"Novartis has a bold ambition to reimagine medicine and find new cures for cancer and blood disorders. This agreement expands on our strategy as the only company pursuing four different approaches to treating cancer: targeted therapy, radioligand therapy, cell and gene therapy, and immunotherapy. No other company has this range of therapeutic approaches, and the opportunity to combine them to offer the best outcomes for each patient," said Susanne Schaffert, PhD, President, Novartis Oncology. "We are excited about collaborating with BeiGene, a leading global biotechnology company with roots in China, to bring tislelizumab to patients around the world, and pair it with our extensive portfolio and pipeline to develop transformative combination therapies for patients."

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for certain patients with classical Hodgkin’s lymphoma and metastatic urothelial carcinoma. In addition, BeiGene has filed three supplemental new drug applications for tislelizumab in China for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable HCC.

Closing of the transaction is subject to expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

On January 11, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported a strategic collaboration with Illumina, Inc. (NASDAQ: ILMN) for Illumina to create a kit-based version of the myChoice companion diagnostic (CDx) test for international markets (Press release, Myriad Genetics, JAN 11, 2021, View Source [SID1234573814]).

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"Increasing access to our products and better serving patients and healthcare providers are critical components of our mission to improve outcomes and our transformation plan to drive growth. The agreement between Myriad and Illumina combines companion diagnostics and next-generation sequencing to advance comprehensive genomic profiling of tumor samples and drive improved outcomes in oncology," said Paul J. Diaz, president and CEO, Myriad Genetics. "This collaboration reflects our increasing focus on partnering with high-caliber healthcare leaders like Illumina to bring innovative solutions to the oncology market."

Strategic Partnership with Illumina
The strategic partnership with Myriad and Illumina consists of a time-limited exclusive agreement for Illumina to provide a kit-based version of the myChoice CDx test for international markets. Illumina will leverage its sequencing instrument install base and knowledge from increasing market adoption of its TruSight Oncology 500 next-generation sequencing assay to develop and commercialize distributed kits globally for the assessment of homologous recombination deficiency (HRD) along with other proprietary biomarkers while Myriad expands access and extends the reach of myChoice CDx through Myriad’s services offering.

"Illumina is committed to offering innovative diagnostic tools that power precision oncology," said Dr. Phil Febbo, M.D., Chief Medical Officer of Illumina. "The growing use of PARP inhibitor therapeutics to broader populations of patients with HRD is paramount in our work with Myriad Genetics as the future of healthcare looks to molecular-based testing to improve patient outcomes through standardized, best in class testing with myChoice CDx."

The myChoice CDx offering – through Myriad’s world-class laboratory – is the only companion diagnostic test extensively validated in clinical trials to predict response to poly-ADP ribose polymerase (PARP) inhibitor drugs commonly used in the treatment of ovarian, breast, pancreatic and prostate cancer. It utilizes proprietary technologies to measure genomic instability within tumors and help predict drug response. myChoice CDx test recently received both European CE Marking and Japanese regulatory approval for use as a companion diagnostic with Lynparza (olaparib) for first-line maintenance treatment in ovarian cancer in conjunction with bevacizumab. Lynparza is a PARP inhibitor jointly developed and commercialized by AstraZeneca and Merck.

On January 11, 2021 Aadi Bioscience (Aadi), a biopharmaceutical company focusing on precision therapies for genomically defined cancers and EOC Pharma (EOC), a leading oncology specialty biopharmaceutical company in China, repoted an exclusive license agreement for the development and commercialization of ABI-009 (FYARRO) in Greater China including mainland China, Hong Kong, Macau and Taiwan (Press release, Aadi, JAN 11, 2021, View Source [SID1234573813]).

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Under the terms of the agreement, EOC Pharma will obtain exclusive rights to develop and commercialize ABI-009 in Greater China. Aadi will receive an upfront payment, regulatory and sales-based milestone payments totaling up to $271M as well as tiered royalties based on annual net sales of ABI-009. EOC will be responsible for development, regulatory submissions, and commercialization in the territory. Aadi Bioscience retains full worldwide rights outside of the partnered territory.

"We are very excited to partner with the experienced team at EOC Pharma. Through this collaboration, we will work together to bring ABI-009, a potential best-in-class mTOR inhibitor targeted to inactivating mutations in tumor-suppressor genes in the mTOR pathway such as TSC1, TSC2 or PTEN, to patients globally including in Greater China", said Neil Desai, Ph.D., CEO and Founder of Aadi Bioscience.

"The mTOR pathway plays a major role in multiple critical cellular processes and mTOR activation is associated with specific mutations across a broad range of cancers and other diseases. We are happy to work with Aadi to advance ABI-009 to address unmet medical needs for Chinese patients with malignant PEComa, specific mutation-driven solid tumors and other mTOR driven conditions", said Xiaoming Zou, Ph.D., CEO of EOC Pharma

About ABI-009 (FYARRO)

FYARRO (ABI-009, sirolimus albumin-bound nanoparticles) is an mTOR inhibitor complexed with human albumin that has demonstrated significantly higher tumor accumulation, mTOR target suppression and superior efficacy over other mTOR inhibitors in preclinical models (Hou 2019, AACR (Free AACR Whitepaper) Abstract 348).

Aadi recently initiated a rolling NDA submission for ABI-009 to the FDA for treatment of advanced malignant PEComa, a rare type of sarcoma with high frequency of mutations in the TSC1 or TSC2 genes and no previously approved treatments. Long-term data on the AMPECT registrational trial in PEComa was presented at ASCO (Free ASCO Whitepaper) and CTOS (Wagner 2020, Abstract 11516 and Wagner 2020, Abstract 3463014 respectively). The study met its primary endpoint response rate with a manageable safety profile and durable responses on long-term follow-up. ABI-009 has received Breakthrough Therapy, Fast Track, and Orphan Designations from the FDA.

Based on emerging data for ABI-009 in other solid tumors with TSC1 or TSC2 mutations and following discussions with the FDA, Aadi is proceeding with a tumor-agnostic registrational trial in solid tumors harboring TSC1 or TSC2 pathogenic, inactivating mutations with planned initiation in 2021. TSC1 and TSC2 mutations occur across a broad range of cancers at an average frequency of 1-2% and are further enriched in specific types of cancer including bladder cancer, kidney cancer, melanoma, breast cancer and hepatocellular carcinoma.

On January 11, 2021 EXUMA Biotech Corp., a clinical-stage biotechnology company discovering and developing chimeric antigen receptor (CAR)-T products and delivery solutions for liquid and solid tumors, reported that the company has entered into a strategic collaboration with Moffitt Cancer Center to develop EXUMA’s first rapid point-of-care, or "rPOC", subcutaneous (SC) product for the treatment of B cell malignancies (Press release, EXUMA Biotechnology, JAN 11, 2021, https://exumabio.com/news/2021/01/exuma_moffitt_collaboration/ [SID1234573808]). EXUMA’s first product using rPOC technology targeting CD19 and CD22 has the potential to complete treatment within a six-hour time frame from blood draw to injection, without preparative chemotherapy. Moffitt will provide regulatory support, gene product characterization, and analytical testing to support first-in-human studies.

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"For cancer’s most vulnerable patients, the time it takes to receive CAR-T is often the first hurdle. We look forward to our new collaboration with Moffitt Cancer Center, and the development of our rPOC CAR-T product. This partnership allows us to accelerate our potential treatment for cancer patients from the lab to the clinic, with our combined teams of internationally renowned scientists," said Sid Kerkar, M.D., Vice President Oncology R&D at EXUMA Biotech.

The collaboration enables EXUMA and Moffitt to further characterize and validate the rPOC technology and qualify analytical testing for product and patient screening to support IND submission. EXUMA will tech transfer its rPOC gene vectors to Moffitt’s Cell Therapy Facility. Moffitt will then perform engineering runs using blood from healthy donors and validation runs using blood from lymphoma patients. Moffitt will also participate in FDA meetings with EXUMA, assist with CMC documentation, and perform product characterization.

EXUMA’s rPOC Platform

EXUMA’s next-generation rapid point-of-care, or "rPOC", platform is being developed for subcutaneous CAR-T administration in a matter of hours following blood draw, with the potential to make same-day autologous CAR-T a reality for cancer patients. The long-term vision is for rPOC to be administered in the community oncology infusion clinic without the need for lymphodepleting chemotherapy or long-term immunosuppression.

On January 11, 2021 Tiziana Life Sciences plc (NASDAQ: TLSA / AIM: TILS) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, reported that it is participating in Biotech Showcase 2021 and providing an on-demand company presentation (Press release, Tiziana Life Sciences, JAN 11, 2021, View Source [SID1234573807]). Registered attendees to Biotech Showcase can now access recorded company presentations prior to the actual event. 24×7 on-demand access allows attendees to view presentations at their convenience, avoiding conflicts with busy meeting schedules during the main event week.

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Dr. Kunwar Shailubhai, CEO and CSO of Tiziana Life Sciences, commented, "I look forward to sharing our exciting story with conference attendees. With topline data from our COVID-19 trial expected this month, multiple Phase 2 trial launches expected in 2021, and the potential application of Foralumab in a wide range of autoimmune and inflammatory diseases longer-term, we are well positioned to achieve a series of important milestones that can provide a positive and lasting impact on our valuation in the months and quarters ahead."

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry’s largest gatherings and busiest weeks.

"We are delighted that Tiziana Life Sciences will be presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is a prime occasion for life science entrepreneurs and investors to come together to discover the potential of innovative technologies that will drive the future of drug discovery."