On June 20, 2017 Merck, a leading science and technology company, reported its corporate venture arm Merck Ventures created iOnctura SA, Geneva, Switzerland. This immuno-oncology spin-out company was formed around two assets from the Healthcare R&D portfolio of Merck and three assets from Cancer Research Technology (CRT) (Press release, Cancer Research Technology, 20 20, 2017, View Source [SID1234523165]). CRT is the commercial arm of Cancer Research UK, London, UK. Merck Ventures will manage the investment and will be represented on iOnctura’s board of directors.

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"Our goal is to modulate key culprits of immunosuppression in the tumor microenvironment to maximize the therapeutic potential of checkpoint inhibitors for patients," said Catherine Pickering, CEO and co-founder of iOnctura. "Through our key alliances with CRT and Merck, we are optimally positioned to explore novel combination therapies and advance them quickly to cancer patients."

iOnctura aims to develop a pipeline of selected assets that target and modulate mechanisms that drive immunosuppression in the tumor microenvironment (TME). Such immunosuppression has been shown to be one of the main causes behind a significant number of patients not responding to first generation checkpoint inhibitors. iOnctura, through its alliances with Merck and CRT, has already built a pipeline of promising programs and entered a research collaboration with CRT Discovery Laboratories. In exchange for the exclusive global option to license three immuno-oncology assets from CRT, iOnctura will provide CRT with an initial equity holding in the company and will make further payments for the achievement of late development and approval milestones as well as royalties on net sales. iOnctura has also secured access to future supply of avelumab, being co-developed and co-commercialized by Merck and Pfizer, which will enable acceleration into initial clinical proof of concept studies.

Stuart Farrow, CRT’s director of biology, said: "We’re delighted that these three potential new cancer treatments, partly developed by our drug discovery laboratories alongside leading Cancer Research UK-funded scientists, have been prioritized for further development through the formation of this new company. The ongoing support by our drug discovery laboratories will hopefully help build a strong development pipeline for iOnctura."

Merck Ventures, the strategic venture investment arm of Merck, is providing the initial seed funding to iOnctura. Hakan Goker, Senior Investment Director at Merck Ventures, and Keno Gutierrez will represent Merck Ventures on iOnctura’s board of directors.

On July 17, 2017 Takeda Pharmaceutical Company Limited (TSE: 4502) and Schrödinger Inc., a privately-held company dedicated to revolutionizing drug discovery through advanced computational methods, reported the formation of a multi-target research collaboration directed to diseases that align with Takeda’s core therapeutic areas of interest (Press release, Takeda, JUN 20, 2017, View Source [SID1234539393]). The unique collaboration will combine Schrödinger’s in silico platform-driven drug discovery capabilities with Takeda’s deep therapeutic area knowledge and expertise in structural biology. With a focus on simplicity, speed and agility, Schrödinger will lead the multi-target discovery effort with Takeda providing protein crystal structures to aid Schrödinger in using its computational platform to guide the design of new chemical entities. Schrödinger will be responsible for its discovery costs.

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"Schrödinger’s agility, drug discovery track record and revolutionary computational chemistry platform are key strengths that attracted Takeda to Schrödinger as a strategic partner," said Stephen Hitchcock PhD, Head of Research for Takeda. "Takeda’s business model is focused on creating mutually beneficial partnerships that capitalize on the complementary capabilities of both parties in order to accelerate the discovery of new therapies for patients. In this case, Schrödinger is taking the lead role in discovery, with Takeda playing a supporting role, leveraging its in-house structural biology team and therapeutic area expertise."

Under the terms of the collaboration, Takeda will have the option to exclusively license the programs from Schrödinger later in discovery at established economic terms, including pre-clinical, clinical, and commercial milestones of up to $170M per program, as well as royalties on future sales. Additional financial details are not being disclosed.

"We are very much looking forward to partnering with Takeda and marshalling its biology and development expertise with our world class computational chemistry and drug discovery capabilities to advance these programs," said Ramy Farid, Ph.D., Schrödinger’s president and chief executive officer. "This alliance allows us the opportunity to fully exploit the power of our platform to accelerate the delivery of novel therapeutics to patients."

On June 20, 2017 Almac Discovery (www.almacgroup.com/discovery), a biopharmaceutical company focused on discovering and identifying innovative therapeutics for the treatment of cancer, and Debiopharm International SA (Debiopharm – www.debiopharm.com), a Switzerland based specialty pharma company, reported a collaboration to pursue the development of Almac Discovery’s Wee-1 kinase inhibitor program (Press release, Debiopharm, JUN 20, 2017, View Source [SID1234525171]).

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Under the terms of the license agreement, Almac Discovery has granted exclusive global rights to its Wee-1 patent families and related subject matter expertise to Debiopharm International SA. Almac Discovery is eligible to receive an upfront payment with further development and commercial milestone payments in addition to receiving royalties from Debiopharm.

The area of DNA damage response and cell cycle regulation has seen notable activity from the pharmaceutical industry recently, including some high profile drug approvals for cell cycle kinase inhibitors. Many cancer treatments such as radiation, antimetabolites, alkylating agents, DNA topoisomerase inhibitors and platinum compounds damage DNA in cells. The cellular response is to arrest the cell cycle temporarily to allow for DNA repair, hence reducing the efficacy of chemotherapy.

The Wee-1 kinase is a key regulator of a number of cell cycle checkpoints and inhibition of Wee1 can force arrested cells through the cell cycle leading to cell death. The Almac Discovery Wee-1 inhibitors exhibit good drug-like properties, high potency, excellent selectivity and demonstrate potent anti-proliferative activity in vitro and in vivo, both as single agents and in combination with genotoxics, in several cancer models.

"We are thrilled to pursue the outstanding work of Almac Discovery on this promising target." said Dr. Bertrand Ducrey, CEO of Debiopharm International SA, who added "Almac Discovery’s compelling expertise in medicinal chemistry and drug discovery is very complementary with Debiopharm business model and we look forward to developing these compounds to offer an innovative treatment for patients with high medical need."

Dr Stephen Barr, Managing Director & President, Almac Discovery commented "We are extremely pleased to announce this agreement with Debiopharm who have proven expertise and an impressive track record of developing drug candidates. The professionalism, dedication and commitment of their team is aligned perfectly with our own core values making them the number one choice to develop our Wee-1 inhibitor. Agreements of this nature enable both companies to continue to strive to improve human health worldwide and we look forward to working with them."

On December 18, 2017 Pharmaceuticals, Inc. (NASDAQ: REGN) and ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, reported a clinical collaboration to advance ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, in combination with cemiplimab (REGN2810), a PD-1 (programmed cell death protein 1) antibody (Press release, Regeneron, DEC 18, 2017, View Source [SID1234522678]). Regeneron and ISA will jointly fund and conduct clinical trials of the combination treatment in cervical cancer and head-and-neck cancer.

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Expression of HPV oncoproteins contributes to the development of cervical and head-and-neck cancers, and approximately 55 percent of cervical cancers and over 60 percent of head-and-neck cancers are HPV16 positive.1

Regeneron and ISA will share clinical trial costs and exchange product supply. In addition, Regeneron will provide an upfront payment and an equity investment in exchange for an option to an exclusive, global license for ISA101. If Regeneron exercises its option to commercialize ISA101, there is potential for various milestone payments and tiered royalty payments to ISA contingent on regulatory approvals, sales and additional indications. Further financial details were not disclosed.

"Regeneron continues to expand and advance our immuno-oncology program by studying multiple combination therapies in order to fully explore the scientific possibilities in this relatively new field," said Israel Lowy, M.D., Ph.D., Vice President Clinical Sciences, Head of Translational Science and Oncology at Regeneron. "Early clinical results with ISA101 in HPV16-positive indications have been promising, and we’re eager to investigate the impact of adding cemiplimab with the goal of further enabling the body’s immune system to attack the cancer."

"This collaboration with Regeneron is a strong validation of our proprietary SLP (Synthetic Long Peptides) platform and know-how," added Ronald Loggers, Chief Executive Officer of ISA Pharmaceuticals. "We are proud to work with Regeneron, a science- and technology-driven biotechnology company, and aim to further strengthen our pioneering role in the development of innovative treatment options for oncology indications with a high unmet medical need."

Cemiplimab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement for immuno-oncology therapeutics, and was developed using Regeneron’s proprietary VelocImmune technology that yields optimized fully-human antibodies. Cemiplimab is currently being studied as a monotherapy in multiple cancers – including cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), non-small cell lung cancer (NSCLC) and cervical cancer – and in various therapeutic combinations. Cemiplimab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

ISA101 is an SLP immunotherapy based on the delivery of oncogenic antigens in the form of synthetic long peptides and targets HPV-induced diseases. This innovative concept was discovered by emeritus professor Cornelis J. M. Melief and his team at the Leiden University Medical Center and has been the subject of multiple studies and peer-reviewed publications. It is ISA´s most advanced clinical-stage immunotherapeutic and is in clinical development in advanced and recurrent cervical cancer and incurable HPV16-positive solid tumors (such as squamous cell carcinoma of the head and neck). The first proof-of-concept data on ISA101 as a monotherapy treatment were published in the New England Journal of Medicine2 and initial results from the recently completed ISA101 combination trials in advanced cervical cancer and head-and-neck cancer were presented at ASCO (Free ASCO Whitepaper)-SITC and ESMO (Free ESMO Whitepaper), respectively, in 2017.

On June 19, 2017 WILEX AG (ISIN DE000A11QVV0 / WL6 / FSE) reported its subsidiary, Heidelberg Pharma GmbH, Ladenburg, Germany, has signed an exclusive multi-target research agreement with Takeda Pharmaceutical Company Limited (TSE: 4502) for the joint development of antibody drug conjugates (ADCs) that use Amanitin as the payload (Press release, Wilex, JUN 19, 2017, View Source [SID1234526974]).

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Under the terms of the exclusive multi-target research agreement, Heidelberg Pharma will produce Antibody Targeted Amanitin Conjugates (ATACs) using antibodies from Takeda’s proprietary portfolio for up to three undisclosed targets. Takeda has an option for an exclusive license for global development and commercialization rights to each of the product candidates resulting from the research collaboration. If it exercises the option, Takeda would be responsible for further preclinical and clinical development, as well as potential commercialization, of any product candidate it licenses.

Professor Andreas Pahl, Chief Scientific Officer of WILEX AG and Heidelberg Pharma GmbH, commented: "We are delighted about the collaboration with Takeda, which has broad expertise in oncology and is a leading ADC company. We believe this partnership provides further validation of our technology. Working with Takeda will allow us to jointly test and expand the application of the ATAC technology to selected antibodies."

Heidelberg Pharma will receive an upfront technology access fee and payments for research services. In the event Takeda exercises its option for an exclusive license, Heidelberg Pharma would receive an option fee. Under the exclusive license agreement, Heidelberg Pharma would be eligible to receive clinical development, regulatory and sales-related milestone payments of up to USD 113 million for each product candidate, as well as royalties.

The expected financial impact of this partnership is already reflected in WILEX’s financial outlook for the current fiscal year provided in March 2017.

"We see significant potential for Heidelberg Pharma’s ATAC technology, combined with our deep oncology expertise, to develop ADC therapies for patients with unmet medical needs," said Christopher Arendt, PhD, Head, Oncology DDU & Immunology Unit, Takeda. "We are excited about this relationship with Heidelberg Pharma, as partnerships such as this one are integral for us to achieve our aspiration of curing cancer."

Takeda signed the agreement with Heidelberg Pharma through its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc.

About Heidelberg Pharma’s proprietary ATAC technology
Antibody-drug conjugates (ADCs) combine the high affinity and specificity of antibodies with the potency of cytotoxic small molecules for the treatment of cancer and inflammatory diseases. Antibody Targeted Amanitin Conjugates (ATACs) are ADCs whose active ingredient is made up of amatoxin molecules. Amatoxins are small bicyclic peptides naturally occurring in the death cap mushroom. They inhibit mRNA transcription by binding to RNA polymerase II, a mechanism that is crucial for the survival of eukaryotic cells. In preclinical testing, ATACs have been shown to be highly efficacious, overcoming frequently encountered resistance mechanisms and combating even quiescent tumor cells.