On September 26, 2017 Glythera Limited (Glythera), the next generation antibody drug conjugate (ADC) development company, and Cancer Research UK* reported an agreement giving Glythera exclusive, worldwide rights to the charity’s novel CDK11 inhibitor payload series for the development of multiple ADCs conjugated using Glythera’s proprietary PermaLink conjugation platform (Press release, Cancer Research Technology, SEP 26, 2017, View Source [SID1234523160]).

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According to the agreement, Glythera and Cancer Research UK will select and optimise toxins from the inhibitor payload series for development in ADCs. Glythera will then progress multiple ADCs, optimised according to cancer cell-kill profiles, for difficult-to-treat tumours. Glythera is currently evaluating a range of clinically important antibody targets and intends to identify its first clinical ADC candidate by 2019.

This agreement follows a successful period of collaboration between the parties during which the viability of selected low molecular weight CDK11 molecules was demonstrated in relevant ADC models.

The CDK11 inhibitor programme has identified a series of low molecular weight, synthetically tractable compounds which potently inhibit and are selective against other kinase targets. The series demonstrates highly potent anti-proliferative activity in dividing and non-dividing tumour cells and represents an exciting approach for ADCs.

Under the Terms of the agreement, Cancer Research UK will receive an undisclosed up-front fee, milestone payments on programme success for each resulting ADC, and royalties on worldwide product sales. Glythera is responsible for the development, manufacturing and commercialisation of any ADC products resulting from the agreement.

Dr Hamish Ryder, Director of Cancer Research UK’s Therapeutic Discovery Laboratories, said: "This collaboration highlights the success of our drug discovery approach in translating the most promising early stage research into new cancer treatments."

"We’re excited to work with Glythera to identify and advance the very best novel agents and develop targeted treatments for cancer patients. By continuing to bring together industry and world leading academics in this field, we hope to transform the outlook for people with cancers that are the hardest to treat."

Dr Dave Simpson, Chief Executive Officer, Glythera, said: "I am delighted that Glythera is working with Cancer Research UK as we look to identify and develop CDK11 inhibitor payloads and antibody conjugates to combat difficult-to-treat solid tumours and improve the lives of patients living with cancer."

On September 26, 2017 Amgen (NASDAQ: AMGN) and Simcere Pharmaceutical Group reported the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China (Press release, Amgen, SEP 26, 2017, View Source;p=RssLanding&cat=news&id=2302973 [SID1234520648]). The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology.

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Under the terms of the agreement, Amgen will remain responsible for the co-development, marketing approval applications and manufacturing of the biosimilars. Simcere will be responsible for distribution and commercialization in China, while Amgen will have a limited right to co-promote the products. The biosimilars included in the agreement are a part of Amgen’s existing biosimilars portfolio.

"We are pleased to enter this strategic collaboration with Simcere as we continue to enhance patient access through broader adoption of more competitive therapeutic options worldwide," said Scott Foraker, vice president and general manager of Biosimilars at Amgen. "This agreement brings together Amgen’s long-standing development and biologics manufacturing expertise with Simcere’s local development experience and strong commercial presence in China in the areas of inflammation and oncology."

"This agreement furthers Amgen’s efforts to reach more patients in Asia by bringing high quality biosimilars medicines to patients suffering from debilitating and potentially life-threatening conditions," said Penny Wan, regional vice president and general manager of Amgen’s Japan and Asia-Pacific Region. "We look forward to working with Simcere on these four biosimilar programs where we can build on their network and experience in China to make a big difference for patients."

"This strategic partnership between a world-renowned biotechnology company and a leading Chinese pharma will help to accelerate development and launch of United States and European approved biosimilars in China. By leveraging our sales network, it will also help to improve the accessibility of high quality therapeutic antibodies for Chinese patients," said Honggang Feng, president of Simcere. "This collaboration will allow both companies to further penetrate inflammation and oncology markets in China."

Dr. Hua Mu, chief scientific officer of Simcere said, "Recently, China Food and Drug Administration (CFDA) has formally joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and implemented major reforms on drug evaluation and approval systems, encouraging and supporting research and development of innovative, high quality medicines. This strategic alliance combines Amgen’s leading global research and development capabilities in biosimilars and Simcere’s domestic drug development and registration experience. It aims to bring more high quality and effective medicines to Chinese patients to meet the pressing unmet medical needs. It is also another important milestone in our international collaboration strategy to enrich Simcere’s biologics pipeline."

Specific financial terms of the agreement were not disclosed.

On September 26, 2017 UCL Business spinout company, Autolus Limited, a clinical-stage biopharmaceutical company focused on the development and commercialisation of next-generation engineered T-cell therapies, reported that it closed on a US$80 million (£59 million) Series C financing (Press release, UCLB, SEP 26, 2017, View Source [SID1234520650]).

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New investors Cormorant Asset Management, Nextech Invest and others joined founding investor Syncona Ltd, Woodford Investment Management and Arix Bioscience in this Series C round.

The funds will enable Autolus to establish clinical proof of concept for three programs: AUTO2 in multiple myeloma, AUTO3 in diffuse large B cell lymphoma and paediatric acute lymphoblastic leukaemia and AUTO4 in T-cell lymphoma. In addition, building on its advanced cell programming technologies Autolus plans to advance its pre-clinical pipeline products for solid tumour indications, and will set up the infrastructure required for bringing a CAR-T cell therapy rapidly and successfully to market.

Dr Christian Itin, Chairman and CEO of Autolus, commented:
"We welcome our new shareholders and the continued support of our existing investors, and are looking forward to delivering on the exciting promise of our growing pipeline of engineered T cell product candidates. Since our inception three years ago, Autolus has made substantial progress with two dual targeting programs in three clinical studies, a novel program for T-cell lymphoma’s clinic ready and a unique suite of cell programming technologies established for use in haematological and solid cancers. With the new financing we are well on our way to building a premier fully integrated Oncology Company that harnesses the unique power of T cells to combat cancer."

Bihua Chen, CEO Cormorant Asset Management, commented:
"The upcoming commercial launches of the first generation of CAR-T products herald an important advance in the treatment of cancer. We are excited to be part of a company that is poised to be at the forefront of the next revolution in this field. We are impressed by Autolus’ advanced cell programming and manufacturing capabilities, and a team which we believe has the ability to deliver the full potential of these potentially life-changing therapies in both haematological and solid cancers."

Dr. Martin Murphy, CEO Syncona Ltd., commented:
"Autolus is delivering on world class science with a mission to build a leading oncology business. As a founding shareholder of Autolus we are excited about the remarkable potential of T-cell therapies for the treatment of patients with cancer. Unlocking that potential requires deep innovation in all areas, from cell programming to manufacturing and supply chain, in order to deliver these potentially transformative treatments to patients. Success in this space requires building a new type of biopharma business, which we are excited to be part of."

Joe Anderson, CEO of Arix Bioscience, commented:
"CAR-T is a proven new approach and represents a substantial advance in the treatment of cancer. Autolus has the science and the team to develop the next generation of CAR-T therapies, with a differentiated technology and approach that has the potential to transform patients’ lives. Arix is privileged to be part of this and I look forward to working with my colleagues on the Autolus Board and our co-investors to help achieve these goals."

The Series C follows the £70 million Series A and B financings.

On September 25, 2017– BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases, reported that its Board of Directors has approved a distribution of some or all of the shares of AgeX Therapeutics, Inc. owned by BioTime to BioTime’s shareholders (Press release, BioTime, SEP 25, 2017, View Source;p=RssLanding&cat=news&id=2302486 [SID1234520622]). The Board also authorized management to work with investment banks and other financial institutions to finalize and implement the strategy for taking AgeX public, which may include a tax-free distribution.

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"Asterias BioTherapeutics and OncoCyte Corporation, two companies founded by BioTime, were successfully transitioned into independent, publicly-traded companies that created significant value for BioTime and its shareholders," said Alfred Kingsley, BioTime’s Chairman of the Board. "We believe the formation and independent funding of AgeX, and a subsequent distribution to BioTime shareholders, will similarly unlock the significant value of the previously embedded BioTime assets related to the treatment of aging and age-related diseases, such as diabetes, obesity, heart disease, stroke and cancer."

AgeX Therapeutics focuses on technologies relating to cellular immortality and the regenerative biology of aging. Aging and age-related diseases have recently garnered significant investor interest, as evidenced by the formation of companies such as Calico, Human Longevity Inc., Unity Biotechnology, and Samumed, as well as others. These companies have attracted major financial supporters, many of whose investments were made at multibillion-dollar market valuations. AgeX’s initial investors similarly include institutions and accomplished business leaders, whose support creates a foundation for the company’s potential future success.

AgeX closed its initial $10 million equity financing in August of 2017 with a post-money valuation of approximately $68 million. BioTime currently owns approximately 85% of the outstanding shares of AgeX, with a post-money valuation of approximately $58 million, or 50 cents per BioTime share. The equity financing is expected to fund AgeX’s general operations and product development well into 2019, while saving BioTime more than $5 million annually on these programs and associated operational expenses.

Building on the recent success of the formation, funding and launch of AgeX, BioTime’s management and Board are now exploring all options for making AgeX a publicly-traded company, including a potential tax-free distribution of all AgeX shares to BioTime shareholders. Once BioTime’s management completes its discussions with investment banks and other financial firms, and its analysis of remaining tax, legal, commercial and regulatory issues, BioTime will announce further details of the resulting plan.

(Filing, 10-K, Palatin Technologies, 2017, SEP 25, 2017, View Source [SID1234520832])

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