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SRI Biosciences and Stanford Cancer Institute Launch Drug Discovery Program

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."

Akebia Prices Public Offering of Common Stock

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.

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.

Navidea Biopharmaceuticals Enrolls First Patient in Pediatric Trial of Lymphoseek®

On January 6, 2016 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), reported that the first pediatric patient was enrolled in a clinical study comparing Lymphoseek (technetium Tc 99m tilmanocept) injection and vital blue dye (VBD) in a pediatric population of patients with melanoma, rhabdomyosarcoma, or other solid tumors (Press release, Navidea Biopharmaceuticals, JAN 6, 2016, View Source;p=RssLanding&cat=news&id=2126657 [SID:1234508674]). The study is designed to investigate how Lymphoseek compares with VBD in identifying lymph nodes as well as evaluate safety and tolerability in the pediatric population. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer and is approved for adult use only. Enrollment is currently planned at approximately six sites throughout the U.S. The first patient has been enrolled by the Nationwide Children’s Hospital in Columbus, OH.

"We are pleased to participate in this important clinical study of Lymphoseek in the pediatric patient population where no lymph node mapping agents have yet been approved," said Jennifer Aldrink, M.D., Assistant Professor of Clinical Surgery, The Ohio State University College of Medicine and Director of Surgical Oncology, Division of Pediatric Surgery at Nationwide Children’s Hospital in Columbus, OH. "Intraoperative Lymphatic Mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB) are standards of care in adult and pediatric patients in several forms of cancer, and Lymphoseek is a new agent being used in many adult centers as an alternative to sulfur colloid formulation. Lymphoseek may have the potential to aid physicians in evaluating lymph nodes in children that are necessary for accurate disease staging and optimal post-surgical treatment."

"This study will provide further data on the overall clinical value of Lymphoseek, which has already shown to be a highly effective immunodiagnostic tool in adult patients. Medical literature supports the importance of lymph node evaluations in pediatric patients with rhabdomyosarcoma and melanomas noting that lymph node metastases are highly associated with poorer survival," said Michael Tomblyn, M.D., Chief Medical Officer of Navidea. "Until now, there have been few studies of ILM and SLNB in children. We look forward to the opportunity to evaluate Lymphoseek’s use in pediatric populations."

This study (NAV3-18) is a prospective, open-label, multicenter study comparing Lymphoseek and VBD as lymphoid tissue targeting agents in pediatric patients with melanoma, rhabdomyosarcoma, or other solid tumors who are undergoing lymph node mapping. Primary goals of this study are to evaluate safety and tolerability of Lymphoseek in this subject population and determine the concordance of in vivo detection rates of Lymphoseek and of VBD in tissue excised and histologically confirmed as lymph nodes. In addition, the study will measure other efficacy signals including assessment of the identified lymph node(s) to confirm: the presence/absence of tumor metastases; agent localization per tumor type; degree of localization (nodes per subject both intraoperatively and with preoperative SPECT/CT); reverse concordance parameters; change of subject stage based on histopathology and descriptive assessment on change in treatment plan; number of lymph nodes detected with Lymphoseek intraoperatively compared with preoperative SPECT/CT imaging.

NextCure, Inc., New Immuno-Oncology Firm, Announces $67 Million Series A Financing

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.

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.

Cancer Research Technology, Cell Therapy Catapult and University of Birmingham launch new collaboration for CAR-T cell immuno-oncology therapy development

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]).

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."