On January 6, 2016 NextCure, Inc., a newly formed biopharmaceutical company focused on the discovery and development of new immuno-oncology products, reported that it has raised a $67 million Series A financing (Press release, NextCure, JAN 6, 2016, View Source [SID1234523240]). Major investors in the financing Canaan Partners, Lilly Asia Ventures, OrbiMed Advisors, Pfizer Inc. and Sofinnova Ventures, were joined by Alexandria Venture Investments.

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NextCure was founded in 2015 by Michael Richman, who will serve as its President and Chief Executive Officer, and Lieping Chen, M.D., Ph.D., United Technologies Endowed Professor of Cancer Research, Professor of Immunobiology, Dermatology, and Medicine at the Yale School of Medicine. The Company plans to develop product candidates licensed from Dr. Chen’s laboratory and has entered into a multi-year agreement with Yale University under which it will sponsor research and hire new scientists in Dr. Chen’s laboratory. In 2014, Dr. Chen received the William B. Coley Award for outstanding achievements in Basic and Tumor Immunology for his discovery of the PD-1/PD-L1 pathway as target for cancer immunotherapy. This pathway is targeted by two cancer immunotherapy drugs in current clinical use (Opdivo, Keytruda) and by many other products in clinical development.

"Immuno-oncology drugs are making a big impact on the survival of many cancer patients. Our research is targeted to finding new cures for those patients and tumor types which do not adequately respond to available therapy," said Dr. Chen.

"The NextCure management team is honored to once again collaborate with Dr. Chen and we are gratified by the support of our Series A investors in funding our ambitious target discovery and product development plans," said Mr. Richman. "The Company has begun recruiting scientists and will commence operations in the coming months."

Mr. Richman was previously President and Chief Executive Officer of Amplimmune, Inc., a biologics company focused on cancer and autoimmune diseases that was acquired by AstraZeneca plc. Three other former members of the Amplimmune management team will join Mr. Richman on the NextCure management team: Solomon Langermann, Ph.D., who will serve as senior vice president of research; James Bingham, Ph.D., senior vice president of development and manufacturing and Linda Liu, Ph.D., vice president of translational research. David Kabakoff, Ph.D., executive partner of Sofinnova Ventures, who was a co-founder of and Chairman of Amplimmune, will serve as Chairman of NextCure. Dr. Chen was also a scientific co-founder of Amplimmune and inventor of key programs developed by the company.

On January 6, 2016 Singapore-based biotech firm Aslan Pharmaceuticals (Nasdaq: ARRY) reported under a new agreement with partner Spanish pharma company Almirall (ALM: MC) it now has gained rights to develop and market its compound ASLAN003 (Press release, ASLAN Pharmaceuticals, JUN 6, 2016, View Source [SID:1234512875]).

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Under the terms of the broadened deal, Almirall has granted Aslan global rights to develop and market ASLAN003 for all non-topical and non-dermatological indications including oncology.

Dr Mark McHale, chief operating officer of Aslan, said: "ASLAN003 is an exciting compound and the promising preclinical data we have observed in various tumor models suggest that it has the potential to become an important novel therapy in the emerging area of cancer metabolism with application to a range of different tumor types. This broadened agreement is a strong endorsement of the success of our collaborative work with Almirall to date and is reflective of both teams’ confidence in each other’s complementary expertise in the research and development of new medicines."

Almirall is eligible to receive development and regulatory based milestone payments and tiered-royalty payments on global sales of ASLAN003 upon successful commercialisation.

ASLAN003 is a small molecule inhibitor of DiHydroOrotate DeHydrogenase (DHODH), an enzyme which catalyses the key rate-limiting step in the synthesis of pyrimidines in mammalian cells, originally licensed to Aslan in 2012 as a treatment for rheumatoid arthritis.

On January 6, 2016 Akebia Therapeutics, Inc. (NASDAQ:AKBA) reported the pricing of an underwritten public offering of 7,250,000 shares of common stock at a price to the public of $9.00 per share (Press release, Akebia , JAN 6, 2016, View Source [SID:1234508692]). In addition, Akebia has granted the underwriters a 30-day option to purchase up to an additional 1,087,500 shares of common stock in connection with the offering. All shares are being sold by Akebia. The net proceeds of the offering are expected to be approximately $61.0 million (or approximately $70.2 million if the underwriters exercise their option to purchase additional shares in full), after deducting underwriting discounts and commissions and other estimated offering expenses payable by Akebia. The offering is expected to close on January 12, 2016, subject to the satisfaction of customary closing conditions.

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Morgan Stanley and UBS Investment Bank are acting as joint book-running managers for the offering. JMP Securities is acting as lead manager, and Needham & Company and Brean Capital are acting as co-managers for the offering.

Akebia intends to use the net proceeds from the offering to fund continued clinical development of vadadustat in patients with anemia secondary to chronic kidney disease (CKD), including to prepare, initiate and conduct its PRO2TECT Phase 3 program and to prepare and initiate its planned INNO2VATE Phase 3 program, to advance AKB-6899 through Phase 1 development in oncology, and the remainder for working capital and other general corporate purposes.

The shares of common stock described above are being offered by Akebia pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a free writing prospectus, prospectus supplement and accompanying prospectus, which have been filed with the SEC. You may obtain these documents for free by visiting the SEC’s website at www.sec.gov. Copies of the free writing prospectus, prospectus supplement and accompanying prospectus relating to the offering may also be obtained, when available, from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 or UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

On January 6, 2016 The Cell Therapy Catapult, the UK organisation dedicated to the growth of the UK cell and gene therapy industry by bridging the gap between scientific research and commercialisation, the University of Birmingham and Cancer Research Technology, the commercialisation arm of Cancer Research UK, reported the launch of a collaboration to develop a new immuno-oncology cellular therapy based on gene modifying T cells to target solid tumours (Press release, Cancer Research Technology, JUN 6, 2016, View Source [SID1234523190]).

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The project is aimed at translating an academic discovery programme funded by Cancer Research UK and developed by Dr Steven Lee and Prof Roy Bicknell at the University of Birmingham into a commercially viable cell therapy.

The collaborating partners have launched a new company, Chimeric Therapeutics Ltd. This new company will hold all future IP rights to the resultant discoveries.

The project is based on a new generation chimeric antigen receptor T-Cell (CAR-T) immuno-oncology therapy for solid tumours. This involves directing the CAR-T cell towards a new, highly specific marker of tumour angiogenesis, CLEC14a. This therapy will act as a vasculature disruptive agent compromising oxygen supply to the tumours and inhibiting tumour growth. The technology is currently undergoing the final stages of preclinical development, and is planned to enter into clinical trials soon after.

Cancer Research Technology and the University of Birmingham have partnered with The Cell Therapy Catapult to bring their extensive regulatory, clinical, analytical and manufacturing process development expertise into the program, utilising their experience in developing immunotherapies for cancer. The Cell Therapy Catapult will specifically be involved in the project to accelerate the translation of the academic discoveries made in Birmingham with Cancer Research Technology around CAR-T immunotherapies for solid tumours and the CLEC14a target towards a commercially available cell therapy.

"The Cell Therapy Catapult has extensive experience in working with early stage cell and gene therapies to develop them for clinical trial and commercialisation. We are delighted to assist Cancer Research Technology and Birmingham University to form this new company, Chimeric Technologies and apply this new CAR-T target to address solid tumours for the benefit of patients," said Keith Thompson, CEO, the Cell Therapy Catapult. "The Cell Therapy Catapult look forward to developing partnerships with other Cancer Research UK supported academic groups."

"Scientists at University of Birmingham have demonstrated that these new engineered CAR-T cells exhibit anti-tumour effects and therefore have considerable potential as a therapy," said David Coleman, Head of Spinout Portfolio, University of Birmingham. "We’re delighted to be working with Cancer Research Technology and the Cell Therapy Catapult, through this new spinout company, Chimeric Therapeutics Limited, in order to develop the technology further and into clinical trials."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re very pleased to partner with the Cell Therapy Catapult and bring their extensive experience to bear on this project. This new partnership builds on a very successful relationship with the University of Birmingham. Immunotherapy is an exciting area in cancer treatment and this technology could provide a powerful route to harness the power of the immune system to block the development of blood vessels, and stop tumours growing."

On January 6, 2016 The Stanford Cancer Institute (SCI) and SRI Biosciences, a division of the independent research center SRI International, reported that they are partnering up to enhance drug development efforts in response to a lack of innovative new treatments for cancer and other diseases (Press release, SRI International, JAN 6, 2016, View Source [SID:1234508782]).

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According to PR Newswire, this collaboration, which is being called the SRI Biosciences-Stanford Drug Discovery and Development Program, brings together scientists from SRI and researchers and physicians from SCI to pursue the development of new compounds that can lead to cures.
The partnership builds on previous collaborations between the two institutions. For example, the development of Tirapazamine, an experimental cancer therapy, was made possible by the teamwork of SRI and SCI researchers.

Researchers and experts from both institutions see the program as the ideal support system to coordinate and catalyze diverse efforts to discover and refine novel substances that can be used for treatment. The program will provide access to necessary infrastructure that promotes understanding of disease mechanisms, drug discovery and drug development.

The Drug Discovery and Development Program will be coordinated by Sanjay V. Malhotra, associate professor of radiation oncology at Stanford, and Nathan Collins, executive director of the Pharmaceutical and Chemical Technologies Section in SRI Biosciences.

"The SCI-SRI Biosciences collaboration provides a fully integrated engine for taking ideas to the investigational new drug (IND) stage and beyond," Collins said. "Our focus is on developing ‘first-in-class’ drugs and delivering improved outcomes for patients."