On October 3, 2017 Vium reported the selection of OncoSynergy, a UCSF oncology therapeutics spinout, as the first recipient of its "Next Generation Disease Model Grant" of $100,000 worth of research services (Press release, OncoSynergy, OCT 3, 2017, View Source [SID1234520773]). The companies will collaborate on a study of OncoSynergy’s lead drug candidate OS2966 to facilitate development of an optimized and clinically relevant experimental model of malignant ascites (MA), a complication of metastatic ovarian cancer (OC) associated with poor prognosis. The study will be the first to collect in-depth quality of life (QOL) metrics using an established experimental model of MA.

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OncoSynergy has already demonstrated efficacy of OS2966, its lead monoclonal antibody therapeutic candidate designated as an Orphan Drug by the U.S. Food and Drug Administration (FDA), in multiple models of OC, including alleviation of clinical signs of MA. The new study will therefore use Vium’s Smart Housing to increase the therapeutic window to more closely model disease progression in humans, thereby yielding more accurate measurement of disease metrics and improved tracking of QOL measures.

"We are pleased to collaborate with OncoSynergy and to fund this innovative study in a disease area with high unmet research and treatment needs," said Vium Chief Scientific Officer David Hutto, Ph.D, DVM, DACVP. "It’s a great match for Vium, as it allows us to apply our fully automated, low-touch technology and novel digital metrics to continuously assess changes in ovarian cancer-related malignant ascites — signs that would be difficult to evaluate using traditional methods."

"We believe the ability to continuously collect multimodal data noninvasively will be a game-changer for oncology studies, in which the current standard for decades has been binary," commented W. Shawn Carbonell, MD, Ph.D, co-founder and CEO of OncoSynergy. "We are excited to work with Vium to develop this novel and more humane approach to studying animal models of orphan malignancies such as ovarian cancer and glioblastoma, as these diseases are our main focus."

On October 3, 2017 Nimbus Therapeutics, a biotechnology company applying deep computational expertise throughout drug discovery and development, reported the initiation of a long-term strategic alliance with Celgene Corporation (NASDAQ: CELG) in immunology (Press release, Nimbus Therapeutics, OCT 3, 2017, View Source [SID1234527305]).

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Under the terms of the agreement, Celgene will receive an option to acquire each program in the alliance up through a clinical inflection point. Nimbus will receive an upfront payment and potential downstream milestone payments for each program Celgene chooses to acquire. Nimbus will retain full control of research and development activities for each program prior to the program’s option point. Financial terms will remain undisclosed until Celgene acquires a program.

The Nimbus programs covered under the alliance include a preclinical effort targeting Tyk2 (tyrosine kinase 2), a signal-transduction kinase for key pro-inflammatory cytokine receptors, including IL-23, IL-12 and type-I interferons. Because of its central role in the inflammatory response, Tyk2 is a high-potential target for the treatment of autoimmune disorders including rheumatoid arthritis, lupus, Crohn’s disease, psoriasis and multiple sclerosis. The alliance also covers Nimbus’ preclinical small-molecule STING (stimulator of interferon genes) antagonist program, which seeks to block the role played by STING in the activation of the innate immune system in lupus and other interferonopathies. Nimbus will continue to own and develop its small-molecule STING agonist program for immuno-oncology, which is not part of the agreement.

"Celgene is committed to the continued growth of our expanding immunology and inflammation pipeline, and believes that the Nimbus immunology programs, including their efforts on Tyk2 and STING antagonists, represent important additions as we work to create the next generation of drug candidates for patients with autoimmune disorders," said Rupert Vessey, F.R.C.P., D.Phil., Executive Vice President and President, Global Research and Early Development, of Celgene.

Robert Plenge, M.D., Ph.D., Vice President, Research and Early Development, and Head, Inflammation and Immunology Thematic Center of Excellence, of Celgene, added, "We are excited about the potential of the Nimbus immunology targets, which are based on compelling human genetic data. Moreover, Nimbus’ robust in silico-based approach is very promising."

"We are thrilled to partner with Celgene and its world-renowned inflammation and immunology team to fuel the rapid advancement of these important potential therapeutic programs for patients," said Donald Nicholson, Ph.D., Chief Executive Officer of Nimbus. "In addition, our agreement with Celgene accelerates our growth as a company back into the clinic, while also expanding the breadth of our pipeline."

On October 3, 2017 Cullinan Oncology, LLC reported a $150 million Series A financing co-led by the UBS Oncology Impact Fund (OIF) managed by MPM Capital, a worldwide leader in oncology investing, and F2 Ventures (Press release, Cullinan Oncology, OCT 3, 2017, https://www.cullinanoncology.com/2017/10/03/cullinan-oncology-secures-150-million-series-a-financing-to-build-innovative-development-company/ [SID1234520759]). Created by MPM Capital, Cullinan was formed to develop high-value oncology therapeutics with a unique, cost-efficient business model.

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"MPM continues to seek innovative ways to finance and develop new therapies in the increasingly dynamic oncology marketplace," said Ansbert Gadicke, Chairman of Cullinan and MPM Co-Founder. "We have assembled a diverse team of seasoned executives, and we have confidence in their ability to generate novel therapies and strong returns."

Cullinan Co-founder and Chief Scientific Officer and MPM Managing Director Patrick Baeuerle stated, "We look forward to capitalizing on recent scientific breakthroughs across a broad range of cancer targets and therapeutic modalities. The pace of discovery in oncology is nearly unmatched, and will continue to drive better outcomes for patients."

Led by an accomplished team of oncology researchers, biopharma executives and experienced entrepreneurs, Cullinan is a company predicated on distributing risk while maximizing optionality through the construction of a diversified portfolio of internally developed as well as externally sourced oncology assets. Cullinan’s scalable model minimizes the fixed costs and inefficiencies of many traditional development approaches through strategic partnerships and a shared services platform.

"This capital infusion, coupled with the talent and structural advantages of Cullinan, positions us well to execute our vision of building a portfolio of assets geared towards dramatically improving the standard of care for those living with cancer," stated Owen Hughes, Cullinan CEO and MPM Managing Director.

World Class Management

CEO Owen Hughes joined Cullinan from Intarcia Therapeutics, where he served as the Chief Business Officer and Head of Corporate Development. While at Intarcia, he was responsible for business development, M&A, and financing, including one of the largest ex-US licensing deals to date. In addition, he helped raise approximately $1.8 billion in private capital through various equity, debt and royalty structures. Prior to Intarcia, Hughes accumulated over 16 years of Wall Street experience, most notably as a director at Bain Capital Public Equity.

Having played key roles in multiple breakthrough oncology therapies, Cullinan’s highly distinguished scientific management team includes:

Patrick Baeuerle, PhD, Cullinan’s Co-founder and Chief Scientific Officer, Biologics, and MPM Managing Director. An immune oncology pioneer, Baeuerle has co-founded MPM oncology start-ups Harpoon, TCR², iOmx, and Maverick, and led the development of BiTE antibody Blincyto, which was approved within three months by the U.S. FDA for relapsed/refractory acute lymphoblastic leukemia (ALL). Prior to Cullinan and MPM, Baeuerle served as Vice President, Research and General Manager of Amgen Research Munich GmbH, and Chief Scientific Officer of Micromet from 1998-2012. To date, he has published 238 PubMed-listed papers that have been cited more than 64,000 times.
Leigh Zawel, PhD, Cullinan’s Chief Scientific Officer, Small Molecules and MPM Managing Director. Zawel is an oncology expert with significant pharmaceutical experience over-seeing large and small molecule projects at Pfizer, Merck, Sanofi-Aventis and Novartis. Most recently, Zawel was Vice President and East Coast Site Head for Pfizer’s Centers for Therapeutic Innovation where he managed a portfolio of large and small molecule projects spanning oncology, immunology and rare disease from which five clinical stage programs emerged in five years.
Briggs Morrison, MD, Clinical Advisor to Cullinan and MPM Managing Director. Dr. Morrison is also the CEO of Syndax Pharmaceuticals (NASDAQ: SNDX), an MPM portfolio company. His distinguished career includes leading roles at AstraZeneca, Pfizer and Merck, with direct involvement in the development of oncology drugs Zolinza, Lynparza, Iressa & Tagrisso.
Complementing the clinical leadership is a team of business development and financial executives that provide deep industry experience to guide Cullinan’s future progress, including:

Corinne Savill, PhD, Cullinan’s Chief Business Officer. An accomplished pharmaceutical executive, Savill was most recently at Novartis, where she was Head of Business Development and Licensing for the Pharma Division, and previously led Pricing and Market Access and the European Transplant Business Unit for Novartis. Savill started her career in research roles at AstraZeneca and Imutran Ltd. in the UK.
Kristen Laguerre, MBA, Cullinan’s CFO and MPM Managing Director, Finance. With 18 years of financial leadership and management experience in the venture industry, Laguerre was most recently Partner and CFO at Flare Capital Partners and, previously, at Atlas Venture and SoftBank Capital. She began her early career at Arthur Andersen LLP.
About Cullinan

On October 2, 2017 KSQ Therapeutics reported that they emerged with $76 million in financing and a world-class executive team to advance the development of drugs empowered by the unique biological insights of its proprietary CRISPRomics drug discovery engine (Press release, KSQ Therapeutics, OCT 2, 2017, View Source [SID1234520709]). With CRISPRomics, KSQ is pioneering high-confidence drug development utilizing a suite of CRISPR-based technologies that industrialize, for the first time, a high-throughput, systematic way to elucidate the precise function that each human gene plays across a multitude of diseases. Based on this deep and comprehensive approach, KSQ is advancing a pipeline of oncology and immunology drug development programs against novel therapeutic nodes to create a new set of disease-tailored medicines. KSQ was founded in 2015 by David Sabatini, MD, PhD, of the Whitehead Institute and MIT, William Hahn, MD, PhD, of the Broad Institute and Dana-Farber Cancer Institute, Jonathan Weissman, PhD, of UCSF, and Tim Wang, PhD, of MIT, along with founding investors Flagship Pioneering and Polaris Partners.

KSQ also announced today the appointment of David Meeker, MD, as Chief Executive Officer. Dr. Meeker most recently served as Head of the Specialty Care Business Unit of Sanofi-Genzyme and previously was Chief Executive Officer and President of Genzyme, a Sanofi Company. He brings more than 20 years of industry leadership experience, from leading-edge R&D programs to global operational roles.

"We have a clear goal with CRISPRomics: empower the drug development process to strategically focus on high-confidence, patient-tailored, novel drug candidates," said Dr. Meeker. "There is a compelling need to improve the quality of drug targets and to identify patients most likely to respond because our industry and our health care systems are challenged by the sheer volume of potential new medicines. With our proprietary CRISPRomics engine, KSQ is positioned to play a leading role in shortening drug development timelines, increasing the rate at which meaningful medicines can reach patients, and ultimately, improving the sustainability of our health care systems."

KSQ also announced Frank Stegmeier, PhD, as Chief Scientific Officer and George Golumbeski, PhD, as Executive Advisor and Board Member. Dr. Stegmeier is a leading expert in industrialized functional genomics who led Oncology Target Discovery at Novartis prior to joining KSQ. He has led KSQ’s platform development and R&D efforts since the company’s formation in 2015, demonstrating the early productivity of CRISPRomics. Dr. Golumbeski is a business development executive with an outstanding track record of success in the pharmaceutical industry. During his more than 25-year career, he has identified and evaluated innovative technologies and drug candidates from early-stage biotech companies and accelerated their drug innovation potential through creative partnerships.

"The human genome harbors more than 20,000 genes, however for most diseases we have yet to discern which genes represent the best therapeutic targets. For the first time, CRISPRomics allows us to systematically pinpoint the optimal nodal targets of disease with extraordinary precision and speed," said Dr. Stegmeier. "The genome-scale insights that are possible with CRISPRomics are enabling KSQ to most efficiently focus our drug discovery efforts on the development of medicines with the greatest potential to intervene in disease and, therefore, impact the lives of patients."

KSQ’s financing is led by Flagship Pioneering; Polaris Partners, ARCH Venture Partners, and Alexandria Equities also participated. Since the company’s formation in 2015, KSQ has deployed its CRISPRomics engine to complete the functional assessment of each gene in more than 600 tumor and immune models. The company has compiled new insights in disease biology to identify novel drug targets and new drug combinations designed to elicit maximal impact on disease. This approach has produced KSQ’s initial pipeline of drug development programs, and will serve as a product engine across a wide range of disease areas for the company and future collaborators. KSQ has grown to a team of more than 40 employees.

"KSQ is a pioneering company, unleashing high-confidence drug development for the first time — a step change in the way drugs are discovered and developed," said David Berry, General Partner, Flagship Pioneering. "Led by proven industry leaders, KSQ is uniquely positioned to translate its breakthrough biological insights into therapeutics that can impact the core of many important diseases."

High-Confidence Drug Development
Powered by CRISPRomics, KSQ has elucidated the function that each human gene plays in a multitude of diseases providing a unique and more comprehensive understanding of disease biology. The quality of these insights enables KSQ to identify a multitude of high-confidence, patient-tailored, novel programs for drug development and rapidly rule-out thousands of less relevant targets from the outset; thereby, focusing R&D investment on the development of medicines with the greatest potential to meaningfully impact the treatment of human disease.

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On October 2, 2017 Southern Research and Bionetix Inc., a South Korea-based biotech firm, reported that they have signed a research and license agreement to develop a new anti-cancer drug that affects a key genetic switch associated with suppression and regulation of the growth of certain types of cancer (Press release, Bionetix, OCT 2, 2017, View Source [SID1234525825]).

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The goal of the research is to develop a novel drug that would block, or inhibit, certain epigenetic processes linked to changes in tumor cell DNA that allow those cells to survive and begin spreading. A new drug that inhibits these processes could also be useful against chemotherapy-resistant tumors in combination with targeted cancer therapeutics and as an adjunct therapy for cancer immunotherapies.

This collaboration is based on the extensive expertise of Southern Research in the discovery of novel cancer therapeutics including promising research on the regulation of tumor growth by controlling how genes are turned on and off in the cell

"The collaborative effort with Bionetix will allow us to accelerate our exploration of an epigenetic approach that could produce life-saving anti-cancer agents as well as continue our commitment to the identification of novel therapeutics," said Mark J. Suto, Ph.D., vice president of Southern Research’s Drug Discovery Division.

Doo Young Jung, CEO of Bionetix, said the teams seek to develop new epigenetic enzyme inhibitors that are more effective than existing drugs so their use can be expanded to successfully treat a broader range of cancers.

"I believe that this collaborative research program will help to expedite the development of novel inhibitors into the clinic so that we can contribute benefits to cancer patients," he said.

Under the Bionetix agreement, Southern Research will conduct studies to identify and optimize new inhibitors of methyl transferases as potential drug candidates. In collaboration with Bionetix, Southern Research will also define the overall development strategy for the new compounds.

"What we are looking at in this exploratory effort is a wide range of specific genes and biomarkers," Suto added. "That will help us identify the types of tumors that should be targeted and which patients would be most likely to benefit from the treatment based on this epigenetic approach."

Southern Research and Bionetix plan to complete the collaborative research program and begin preclinical and clinical development programs by early 2019.

As part of the arrangement, Bionetix can exercise an option to acquire the global exclusive commercialization rights for the optimized inhibitors and the application technologies, and will develop them further independently.

The deal with Bionetix represents the first licensing agreement signed by Southern Research in a decade. Bionetix, based in Suwon, South Korea, is a start-up company backed by venture capital investments.

Bionetix is providing research support for Southern Research, which will provide its extensive expertise in biology and chemistry to move the drug discovery research program forward.