Portonbio announced strategic cooperation with KAEDI to accelerate the R&D and production of CAR-T drugs

On June 2, 2021 Porton Biologics Ltd. (hereinafter referred to as Portonbio) reported a strategic cooperation with Nanjing KAEDI Biotech, Inc. (hereinafter referred to as KAEDI). Portonbio will offer CMC services for KAEDI’s CAR-T cell therapies with its end-to-end CDMO platform for gene and cell therapies to help accelerate their development process (Press release, Porton Biopharma, JUN 2, 2021, View Source [SID1234583427]).

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According to the agreement, Portonbio, as an exclusive CDMO partner, will provide KAEDI with CMC services for multiple CAR-T projects, including the process development and manufacturing of plasmids, viral vectors and CAR-T cells and IND filling (CMC part) support services. The indication of the first project of our collaboration, KD-025 CAR-T, is liver cancer and glioma. The results of its preclinical research have been published in the leading international journal of tumor immunotherapy and ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology). At present, a multi-center clinical trial of KD-025 CAR-T POC is being carried out and a number of cases of clinical infusion have been completed with no obvious toxicities and side effects being observed. At the same time, the product is being applied for IND at home and abroad.

Dr. Hongjiu Dai, Chairman and CEO of KAEDI, said: "We are very pleased to have a strategic cooperation with Portonbio. KAEDI has successfully developed a pipeline of several CAR-T new drug candidates for malignant solid tumors. We believe that Portonbio’s excellent technical team and professional CDMO platform can help KAEDI quickly and efficiently promote the drug candidates in our pipeline and accelerate the development process of our cell therapy drugs."

"We are very honored to contribute to KAEDI’s innovative research in the field of cell therapy", said Mr. Nianfeng Ju, Chairman and CEO of Portonbio, "Portonbio has established an integrated CDMO service platform for plasmids, viral vectors and cell therapy products, and has an experienced expert team and unique technical advantages. We hope to accelerate the marketing process of KAEDI CAR-T products through this cooperation, jointly promote the breakthrough of cell therapy products in the field of solid tumor, and enable the patients’ early-access to the therapies."

Cytokinetics to Participate in Upcoming Investor Conferences

On June 2, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that Robert I. Blum, President and Chief Executive Officer, is scheduled to participate in three virtual fireside chats at the following investor conferences (Press release, Cytokinetics, JUN 2, 2021, View Source [SID1234583461]):

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42nd Annual Goldman Sachs Healthcare Conference on Wednesday, June 9, 2021 at 3:00 PM EDT
JMP Securities Life Sciences Conference on Wednesday, June 16, 2021 at 4:00 PM EDT
Raymond James Human Health Innovation Conference on Monday, June 21, 2021 at 2:00 PM EDT
Interested parties may access the live webcasts of each presentation by visiting the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The replay of each presentation will be archived on the Presentations page within the Investors & Media section of Cytokinetics’ website for 90 days following the conclusion of the event.

Lyra Therapeutics and LianBio Announce Strategic Partnership and Exclusive License Agreement to Develop and Commercialize LYR-210 in Greater China and Other Asian Markets

On June 2, 2021 Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company leveraging its proprietary XTreo platform to enable precise, sustained, and local delivery of medications to ear, nose and throat (ENT) passages and other diseased tissues, and LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, reported a strategic partnership and exclusive license agreement for the development and commercialization of LYR-210 in Greater China (mainland China, Hong Kong, Taiwan, and Macau), South Korea, Singapore and Thailand (Press release, LianBio, JUN 2, 2021, View Source [SID1234583510]). LYR-210 is an anti-inflammatory, intra-nasal drug matrix in late-stage development that is designed to treat chronic rhinosinusitis (CRS), a debilitating inflammatory disease of the nasal passages.

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Under the terms of the agreement, Lyra will receive an upfront payment of $12 million and is eligible to receive up to $135 million in future payments based upon the achievement of specified development, regulatory and commercialization milestones. Upon commercialization on a region-by-region basis, Lyra also will be entitled to receive low double-digit royalties based on net sales of LYR-210 in the licensed territories. LianBio will be responsible for the clinical development and commercialization of LYR-210 in the licensed territories, and Lyra will retain all rights to LYR-210 in all other geographies. As part of the agreement, LianBio will also have the first right to obtain development and commercial rights in the licensed territories to Lyra’s LYR-220, an anti-inflammatory, intra-nasal, drug matrix in development for the treatment of CRS patients who have undergone a prior sinus surgery but continue to have persistent disease.

"We are delighted to enter into this strategic alliance with LianBio to expand the global reach of LYR-210 for millions of CRS patients who need new and innovative treatment alternatives to surgery," said Maria Palasis, Ph.D., CEO of Lyra. "The LianBio team has deep expertise in drug development and is well positioned to successfully commercialize LYR-210 in these Asian territories. The introduction of our novel, integrated ENT drug and delivery solution to the large patient populations in Asian markets supports our planned global commercialization strategy."

"CRS patients who have failed medical management are currently left with limited and invasive options to manage their disease," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "In clinical studies conducted to date, LYR-210 has demonstrated six months of clinically meaningful symptom improvement following a single administration in patients with and without polyps. With an estimated 88 million adult CRS patients in China alone, we believe LYR-210 has the potential to address a significant unmet medical need and meaningfully improve the standard of care for patients in Asia."

About LYR-210

LYR-210 is an investigational product candidate that utilizes Lyra’s proprietary XTreo platform to enable six months of local anti-inflammatory therapy from a single treatment for chronic rhinosinusitis (CRS). LYR-210 is designed as a non-invasive alternative to sinus surgery for the millions of CRS patients who have failed medical management. In the LANTERN Phase 2 clinical trial, LYR-210 (7500mcg) demonstrated rapid, clinically meaningful and durable symptom improvement in symptom scores over six months.

Sorrento Completes Acquisition of ACEA Therapeutics, Creating a Major Oncology Franchise

On June 2, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported that it has completed the acquisition of ACEA Therapeutics Inc. ("ACEA") (Press release, Sorrento Therapeutics, JUN 2, 2021, View Source [SID1234583395]).

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The merger was completed on June 1, 2021 and at such time, ACEA became a wholly owned subsidiary of Sorrento. The total value of the consideration payable to the holders of securities of ACEA in the merger was $38,000,000, subject to certain adjustments for interest expenses, indebtedness, transaction expenses and cash. In total, 5,519,469 shares of Sorrento common stock were issued at closing in satisfaction of certain outstanding indebtedness of ACEA. In addition to the foregoing consideration, and subject to the achievement of certain clinical and sales milestones (as described below), Sorrento will pay the ACEA equity holders (i) up to $450,000,000 in additional payments, subject to the receipt of certain regulatory approvals and achievement of certain net sales targets with respect to the assets acquired in the merger and (ii) with respect to specified royalty-bearing products, five to ten percent of the annual net sales thereof, in each case in accordance with the terms of an earn-out agreement. The amount referenced in clause (i) of the preceding sentence includes the amounts that would have otherwise been due to ACEA under that certain License Agreement, dated July 13, 2020, which agreement terminated in its entirety at the effective time of the merger.

"This is a value-inflection acquisition for Sorrento as we bring in multiple NCE drug product candidates, including the previously licensed Abivertinib as an anchoring small molecule drug product for treating many different cancers and autoimmune diseases," said Henry Ji, Ph.D., Chairman and Chief Executive Officer of Sorrento. "With broad-spectrum and synergistic infrastructures and expertise in pharmaceutical and biological drug discovery, development and manufacturing, and expanded geographic coverage in China and North America, we envision Sorrento becoming a leading biopharmaceutical company to develop and commercialize innovative medicines that will save and improve lives globally."

"With perfectly aligned missions, ACEA and Sorrento are both committed to developing innovative drugs and providing therapeutic solutions for unmet medical needs. The successful integration of ACEA small molecule drug pipelines to Sorrento large molecule and cell therapy platforms will significantly strengthen and facilitate the innovative drug development in the field of cancer and autoimmune diseases," said Xiao Xu, M.D, President of ACEA Therapeutics.

Agilent Announces New SureSelect Human All Exon V8

On June 2, 2021 Agilent Technologies Inc. (NYSE: A) reported the release of SureSelect Human All Exon V8 – a new exome design that provides comprehensive content and up-to-date coverage of protein coding regions from RefSeq, CCDS, and GENCODE (Press release, Agilent, JUN 2, 2021, View Source [SID1234583412]). It also covers the TERT promoter and hard-to-capture exons that are omitted by other exomes on the market. The new design is available in three options – routine exome sequencing (Exome v8), clinical research sequencing (v8 Clinical Plus), and translational research (v8 UTR Plus) – allowing for content flexibility to meet our customer’s needs.

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"The SureSelect exome has been widely adopted in both clinical and translational research, and it has played an important role in shaping the rise of exome sequencing as a routine genomics technique"

Powered by machine learning-based probe design and an improved probe-printing process, the SureSelect Human All Exon V8 spans a 35.1 Mb target region of the human genome, with an efficient end-to-end design size of only 41.6 Mb. The panel delivers excellent enrichment performance for more uniform coverage, as well as efficient and cost-effective exome sequencing.

Kevin Meldrum, vice president and general manager for Agilent’s Genomics Division, discussed the impact of the release. "The SureSelect exome has been widely adopted in both clinical and translational research, and it has played an important role in shaping the rise of exome sequencing as a routine genomics technique," he said. "The SureSelect Human All Exon V8 provides best-in-class enrichment performance and sequencing efficiency, and it shows our commitment to exceed customer expectations and continue our legacy as the benchmark exome to the genomics community."

This new exome design is already delivering promising results in genetics by supporting virtual analysis of targeted genes important in germline investigations through seamless integration with Alissa Interpret for variant interpretation and reporting. In cancer, exome sequencing is commonly used to identify mutations that contribute to tumor progression, and the sequencing efficiency and coverage achieved with this new design will enable customers to get more out of each exome capture than ever before to identify critical genomic targets. In addition, large-scale manufacturing ensures the panel will provide consistent results for many years, another critical need in clinical research laboratories.

These new Exome designs can be automated on the Bravo automated liquid handling platform for high throughput applications and the Magnis NGS Prep System for complete, walkaway automation. The complete, pushbutton automation provided by the Magnis system will allow laboratories to efficiently deploy exome sequencing while reducing labor and operational expenses.