On January 7, 2016 BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS, reported the presentation of complete data from its phase 2 clinical trial of BIND-014, a PSMA-targeted ACCURIN containing docetaxel, in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC) who either were or were not exposed to anti-androgens (abiraterone acetate and/or enzalutamide) (Press release, BIND Therapeutics, JAN 7, 2016, View Source [SID:1234508681]). BIND-014 was clinically active and well-tolerated and the study met its primary endpoint with 71 percent of patients achieving rPFS of at least 6 months. The complete data are being presented on January 7, 2016 during a poster session at the 2016 Genitourinary Cancers Symposium held in San Francisco.

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"We are encouraged by the safety and activity profile of BIND-014 in this phase 2 trial, which support its potential to be a nanomedicine alternative superior to conventional docetaxel," said Hagop Youssoufian, M.D., M.Sc., chief medical officer, BIND Therapeutics. "Although these data are encouraging, recent advances with anti-androgen therapy limit our ability to compare BIND-014 data to historical benchmarks. At this time, we are not planning further development of BIND-014 in mCRPC given the evolving treatment landscape. We anticipate additional BIND-014 data from both the iNSITE 1 trial in squamous histology non-small cell lung cancer and the iNSITE 2 trial in multiple tumor types during the first quarter of 2016, which we expect to determine our next steps in the clinical development of BIND-014."

In addition to the primary endpoint, data presented from the trial included measurements of safety and tolerability, objective response rates (ORR), prostate-specific antigen (PSA) response, changes in circulating tumor cells (CTC) and overall survival (OS). Key results include:

BIND-014 administered at 60 mg/m² on day 1 of a 21-day cycle was clinically active and well-tolerated when administered to patients (n=42) with chemotherapy-naive mCRPC, including the 74% of patients with prior exposure to abiraterone acetate and/or enzalutamide.

Median rPFS of 9.9 months (95% CI, 7.1 – 12.6) was achieved (n=42 with 8 censored).
A confirmed ORR of 21% was observed in patients with measurable disease (n=19).
A 50% reduction in PSA was observed in 30% of PSA evaluable patients (n=40).
CTC conversion from ≥ 5 cells/7.5 mL blood at baseline to < 5 cells/7.5 mL blood was observed in 50% of patients.
Median OS was 13.4 months (95% CI, 9.9 – 18.6 months [n=42 with 10 censored]).

On January 6, 2016 January 6, 2016 Accelerator Corporation, a leading life science investment and management firm, reported the Series A financing of Petra Pharma Corporation to develop small molecule inhibitors for the treatment of cancer and metabolic diseases in alliance with Weill Cornell Medicine (Press release, Petra Pharma, JAN 6, 2016, View Source [SID:1234508672]). The investors participating in the $48 million Series A investment in Petra Pharma include Accelerator New York’s investment syndicate partners: AbbVie, Alexandria Venture Investments, ARCH Venture Partners, Eli Lilly and Company, Harris & Harris Group, Inc., Innovate NY Fund, Johnson & Johnson Innovation – JJDC, Inc., The Partnership Fund for New York City, Pfizer Venture Investments, Watson Fund and WuXi PharmaTech.

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"Following the launch of Accelerator in New York in 2014, we are delighted to now be financing our first startup life science company here in New York City," said Thong Q. Le, chief executive officer of Accelerator. "We believe that the scientific advancements pioneered by co-founders Drs. Lewis Cantley and Nathanael Gray, combined with an alliance with Weill Cornell Medicine in New York and our management team’s operational capabilities, provide a tremendous platform for a biotech company with significant growth potential in the City. This first launch is illustrative of the kind of support we expect to continue to bring to the local life sciences community in the months ahead."

Founders and Research Alliance

Petra Pharma’s co-founders include two world-leading researchers who have contributed to numerous breakthrough advances in cancer:

• Lewis Cantley, Ph.D., a foremost expert in understanding the biochemical pathways linking cancer and energy metabolism, discovered the signaling pathway phosphoinositide 3-kinase (PI3K) in 1984. Dr. Cantley is the Director of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and a member of the National Academy of Sciences, the Institute of Medicine of the National Academies and American Academy of Arts and Sciences.

• Nathanael Gray, Ph.D., responsible for the discovery of numerous first-in-class kinase inhibitors, also pioneered the use of synthetic chemistry and functional small molecule discovery to modulate biological pathways important in cancer. Dr. Gray is a professor of biological chemistry and molecular pharmacology at Harvard Medical School and Dana-Farber Cancer Center.

"Petra Pharma’s approach interrogates the novel enzyme targets responsible for a variety of important cellular processes, including cell division, growth, trafficking and signaling to develop therapies to improve patient health," stated Dr. Cantley, co-founder of Petra Pharma, who owns equity in Petra Pharma. "The support of Accelerator at the seed stage, coupled with an expanded syndicate financing offered by Accelerator New York’s investors, puts Petra Pharma in a strong position to advance this promising research avenue, translate critical discoveries into next-generation treatments and ultimately make a difference in the clinic."

Petra Pharma has entered into a multiyear research alliance with Weill Cornell Medicine, a stakeholder in the company, to further examine and elucidate certain biological pathways related to the targets being researched in Dr. Cantley’s lab. Weill Cornell Medicine’s Office of BioPharma Alliances and Research Collaborations is dedicated to proactively generate, structure and market translational research alliances with industry in order to advance promising research projects that have commercial potential.

"Accelerator’s collaborative investing model brings to New York City an attractive opportunity to translate the early-stage, innovative science coming out of our medical college into new therapies for patients," said Larry Schlossman, managing director of BioPharma Alliances and Research Collaborations at Weill Cornell. "We are delighted to be the first institution to partner with Accelerator New York and launch Petra Pharma under Weill Cornell’s unique biopharma alliance program."

Unique Model of Business Operations

Under Accelerator’s unique and proven investment and operations management model, the early operations of Petra Pharma will be overseen by Accelerator’s core management team. Accelerator has assembled a team of talented professionals with deep investment, operational and scientific expertise to build high-quality life science startup companies. By leveraging Accelerator’s capabilities, Petra Pharma will be highly focused on achieving key value-building scientific milestones, while the Accelerator management team will handle all aspects of business management and scientific oversight.

"Accelerator has a unique incubation strategy that helps mitigate the challenges associated with early-stage discovery efforts, leading to the creation of innovative new companies," said Greg Plowman, M.D., Ph.D., vice president of oncology research at Eli Lilly and Company. "As an investor in Accelerator and Petra Pharma, we are excited about Accelerator’s first New York City-based startup and the opportunities that Petra Pharma will bring to the City’s life science ecosystem."

Petra Pharma’s office and lab headquarters will be located within Accelerator’s facilities at the Alexandria Center for Life Science, New York City’s first and only premier life science park. Since its establishment, The Alexandria Center for Life Science has become the leading commercial destination in New York City for world-class life science entities to translate innovative discoveries into breakthrough products for patients with significant unmet medical needs.

About Accelerator Corporation

Accelerator Corporation, established in 2003 with operations in Seattle and New York City, is a biotechnology investment and management company. Formed by a syndicate of top-tier venture capital investors and a world-class research institution, Accelerator identifies, evaluates, finances, and manages the development of emerging biotechnology opportunities. Accelerator has built a unique solution that addresses many of the key problems associated with investing in early-stage biotechnology by providing access to venture capital, management, scientific expertise, and facilities. For more information, please go to: www.acceleratorcorp.com.

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 Caladrius Biosciences, Inc. ("Caladrius" or the "Company") (NASDAQ: CLBS), a cell therapy company combining an industry-leading development and manufacturing services provider with a therapeutic development pipeline, announces an increased focus of its strategic priorities and provides 2016 revenue guidance based on growth at its PCT subsidiary.

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Following a comprehensive review of the Company’s existing operations and development pipeline, as well as an updated assessment of current market dynamics, current and expected future competitive therapies, and the Company’s financial resources, Caladrius has decided to shift greater focus and resources to its growing cell therapy process development, optimization and manufacturing services business at its PCT subsidiary. The rapidly developing cell therapy industry, with several cell-based therapies approaching market approvals which are expected to generate additional demand for commercial manufacturing infrastructure, along with PCT’s continued trend of strong revenue growth, supports the Company’s commitment to focus on growth opportunities for PCT. The Company has also reconfirmed its commitment to pursue further development of its immune modulation platform, with a Phase 2 proof-of-concept clinical trial for a T regulatory cell therapy as the primary focus, while choosing to discontinue the current Phase 3 study of CLBS20 as monotherapy for metastatic melanoma.

"Moving forward, we strongly believe PCT represents a compelling opportunity for near- and long-term shareholder value creation and we intend to continue to invest resources in expanding that business, where we are already experiencing noteworthy year-over-year revenue growth," stated David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius.
"For nearly 17 years, PCT has been an integral partner to the regenerative medicine industry by leveraging its cell therapy-focused, bicoastal development and manufacturing infrastructure to support biotechnology and cell therapy companies," said Robert A. Preti, Ph.D., Chief Technology Officer of Caladrius and President of PCT. "We continue to focus on the design and implementation of sustainable, scalable, reliable and well-controlled manufacturing processes with optimized cost-of-goods as these are all critical success parameters in bringing new cell therapy and immunotherapy treatments to market. We are looking forward to further acceleration of these activities."
Dr. Mazzo continued, "The treatment paradigm in metastatic melanoma was transformed during the course of 2015 by the accelerating adoption of multiple immune checkpoint inhibitors used as monotherapy and in combination treatments. These new drugs have significantly improved outcomes in metastatic melanoma and therefore have altered the opportunity for a monotherapy such as CLBS20 in a landscape that is quickly converting to combination therapies. Therefore, we have concluded that, as designed, our current program in metastatic melanoma will not optimally leverage this asset and we will therefore discontinue the ongoing Phase 3 clinical study with CLBS20 as a monotherapy for the treatment of recurrent Stage III or Stage IV metastatic melanoma. As a result, we will reduce associated staff by approximately 40 employees at our Irvine, California facility. That said, we continue to believe in the potential of CLBS20 as a life-prolonging immunotherapeutic and will pursue licensing or partnership opportunities for its continued development as part of a combination therapy and in different oncology indications. The emphasis will be on collaborating with a company that will allow us to exploit the novel antigen presentation and T cell activation approach of CLBS20."

On the development front, Caladrius will focus its efforts on its T regulatory (Treg) cell therapy product candidate, CLBS03. CLBS03 is based on the Company’s novel immune modulation approach that seeks to restore immune balance by enhancing Treg cell number and function. The Company is planning to commence enrollment in a Phase 2 study for adolescents with recent-onset type 1 diabetes in the first quarter of 2016, in collaboration with Sanford Research, a non-profit research organization that supports an emerging translational research center focused on finding a cure for type 1 diabetes.

"The opportunity provided by polyclonal T cells in the treatment of autoimmune diseases is compelling and we are excited to be at the forefront of this technology’s development and to be working with recognized leaders in the field, such as Drs. Jeffrey Bluestone and Stephen Gitelman of the University of California, San Francisco and Dr. Kevan Herold of Yale University. We believe CLBS03 has the potential to be paradigm-changing in the treatment of recent-onset diabetes and, potentially, other autoimmune diseases. We look forward to initiating our Phase 2 clinical program in conjunction with Sanford Research in the first quarter of 2016," concluded Dr. Mazzo.

Financial Guidance
For 2015, Caladrius expects total revenue to be approximately $23 million, representing an increase of approximately 28% compared with 2014. For 2016, Caladrius expects total revenue to exceed $30 million, representing an increase of greater than 30% compared with the expected results for 2015. In order to accommodate this projected growth, Caladrius has budgeted to spend $6 million in capital improvements to increase PCT’s Allendale, NJ clean room capacity by 60%, and expects to complete the build-out in 2016. Caladrius also estimates that it will incur restructuring charges of approximately $1.0 million in connection with one-time employee termination costs, including severance and other benefits, in the first quarter of 2016. The Company estimates that the staff reduction will result in over $4 million in annualized compensation-related savings, and anticipates significant cost savings associated with terminating the CLBS20 study, which had been estimated to cost $35 million through its completion. In addition, with a narrowed focus on research and development initiatives, as well as a re-sizing of the Company’s general and administrative infrastructure, Caladrius expects to lower R&D, G&A and overall cash burn in 2016 compared to 2015. The Company also expects to incur significant non-cash intangible asset and goodwill impairment charges associated with the termination of the CLBS20 study and will assess the impact as of December 31, 2015 during its annual intangible asset impairment review process.

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.