On December 2, 2014 TESARO and AnaptysBio reported an expansion of their immuno-oncology collaboration and exclusive license agreement to include development of a novel bispecific antibody candidate designed to target two undisclosed immune checkpoints (Press release TESARO, DEC 2, 2014, View Source [SID:1234501050]).

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AnaptysBio and TESARO first initiated their collaboration in March of 2014, and have together focused on the development of monospecific antibody drug candidates targeting TIM-3, LAG-3 and PD-1 and dual reactive antibody drug candidates targeting PD-1/TIM-3 and PD-1/LAG-3. Since the beginning of this partnership, Investigational New Drug (IND) enabling preclinical studies of TSR-042 (anti-PD-1 antibody candidate) have been initiated, and additional clinical candidates have been identified, including lead candidates targeting TIM-3 and LAG-3.

"Through our collaboration with AnaptysBio, we are employing a variety of approaches, including monospecific, bispecific and dual specific antibodies, to address some of the most validated and promising immune checkpoint targets," said Mary Lynne Hedley, Ph.D., president and COO of TESARO. "We are committed to advancing the science of immuno-oncology in order to potentially transform the care of patients with cancer. Our team looks forward to continued collaboration with AnaptysBio on these programs and to the presentation of data describing our anti-TIM-3 antibody candidate at the AACR (Free AACR Whitepaper) conference later today in Orlando."

"AnaptysBio continues to focus on the development of therapeutic antibodies for unmet medical needs in immuno-oncology, inflammation and fibrosis. Our strategic advantage is the ability to rapidly discover and develop therapeutic antibodies against emerging biological targets using the natural somatic hypermutation mechanism encoded within the human immune system," said Hamza Suria, president and CEO of AnaptysBio. "We are pleased to expand our collaboration with TESARO, and look forward to advancing multiple immuno-oncology antibodies into the clinic."

Under the terms of this expansion, TESARO will pay AnaptysBio an undisclosed upfront fee and will provide funding for all costs incurred by AnaptysBio related to the development of a clinical antibody candidate. For each program within the collaboration, AnaptysBio is eligible to receive milestone payments if certain research and development events are achieved and additional payments for achievement of certain U.S. and ex-U.S. regulatory submissions and approvals in multiple indications. AnaptysBio will also be eligible to receive royalties related to worldwide net sales of products developed under the collaboration, and may earn certain commercial milestone payments if specified levels of annual worldwide net sales are attained. AnaptysBio and TESARO will together complete preclinical development of the antibody candidates, with TESARO being solely responsible for all clinical development, manufacturing, regulatory and commercial activities.

On December 2, 2014 Oncolytics Biotech reported that it has submitted applications for Orphan Drug Designation to the U.S. Food and Drug Administration ("FDA") for REOLYSIN for the treatment of pancreatic and ovarian cancers (Press release Oncolytics Biotech, DEC 2, 2014, View Source [SID:1234501052]).

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The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval. For more information, please visit:
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REOLYSIN is Oncolytics’ proprietary isolate of the reovirus. Its primary mode of activity is to infect and selectively target tumours with activating Ras pathway mutations and/or over-expressions of Ras pathway elements including, amongst others, EGFR, BRAF, and KRAS. Up to 70% of pancreatic cancers have activating Ras pathway mutations and/or over-expressions.

"Many patients with either pancreatic or ovarian cancer are not diagnosed until after their disease has progressed to its later stages, which reduces their survival outcomes," said Dr. Brad Thompson, President and CEO of Oncolytics. "The development of more targeted treatment options, in this case an agent targeting cancers with Ras pathway defects, will allow patients to access the most suitable treatment for their specific case."

On December 2, 2014 PMV Pharmaceuticals, Inc., a leader in the discovery and development of p53 targeted small molecule drugs for the treatment of cancer, reported the completion of a $30 million Series A financing. This financing is being led by OrbiMed, with participation by Osage University Partners, and supported by founding investor, InterWest Partners (Press release, PMV Pharma, DEC 2, 2014, View Source [SID1234520735]).

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Founded by p53 thought leader Arnold Levine and world-renowned virologist Thomas Shenk, PMV Pharma possesses unique insights into p53 biology and the discovery of selective modulators of p53 and its pathways. p53’s importance in human biology is profound: it is the most commonly mutated protein in human cancers with more than half of all tumors containing mutant p53. The proceeds of this financing will support the advancement of the Company’s rapidly emerging pipeline of p53 focused therapeutics.

"We are pleased to have OrbiMed, a leader in healthcare investing, lead this financing that will help progress our novel first-in-class programs towards delivering fundamentally new medicines to cancer patients", commented David Mack, Ph.D., President and CEO of PMV Pharmaceuticals. "The enthusiasm and confidence from our new and existing investors underscore the strengths of our approach to drug discovery and development based upon our p53 platform and insights."

"PMV Pharma is leading what is truly one of the last greenfield opportunities in oncology – drugging the ‘guardian of the genome’. PMV Pharma’s approach, could yield breakthrough therapies to treat large segments of the cancer patient population" said Peter Thompson, M.D., Orbimed Private Equity Partner. In conjunction with the Series A financing, Dr. Thompson will be joining PMV’s Board of Directors.

Dr. Arnold Oronsky, InterWest Partners founding investor added "We are pleased to have such quality investors join us in backing PMV Pharma and our pursuit of revolutionary cancer drugs. This financing is an important step toward reaching the potential of the next generation of cancer therapeutics".
About PMV Pharma

PMV Pharma is developing first-in-class p53 and p53 pathway modulators for the treatment of cancer. Bringing together leaders in the field to utilize over three decades of p53 biology, PMV Pharma combines unique biological understanding with pharmaceutical development focus. PMV Pharma has corporate operations in Redwood City, California and Research and Development in Doylestown, Pennsylvania.
About OrbiMed

OrbiMed is a leading investment firm dedicated exclusively to the healthcare sector, with approximately $12 billion in assets under management. OrbiMed invests globally across the spectrum of healthcare companies, from venture capital start-ups to large multinational companies. OrbiMed’s team of more than 80 employees manages a series of private equity funds, public equity funds, royalty/debt funds and other investment vehicles. OrbiMed maintains its headquarters in New York City, with additional offices in San Francisco, Shanghai, Mumbai and Herzliya.
About InterWest

For more than 30 years, InterWest has partnered with exceptional entrepreneurs to build winning technology and Healthcare companies. With more than 200 years of combined operating and investing experience, the firm’s investing team has raised $2.8B, completed more than 78 IPOs, and participated in nearly 75 upside acquisitions. As the firm invests InterWest X, a $650M fund, the InterWest team continues to believe that providing capital is just the beginning of a long-term collaboration with entrepreneurs to turn their vision into a thriving company.

On December 1, 2014 Unum Therapeutics, a company developing a universal cellular immunotherapy to treat multiple cancers, announced today that recruitment has begun in the first clinical trial of the ATTCK20 therapy (Press release, Unum Therapeutics, DEC 1, 2014, View Source!2014dec01-unum-starts-phase-1/cyn5 [SID:1234505419]). The Phase I study will examine the feasibility, safety and potential efficacy of infusing the ATTCK20 combination therapy in patients with B-cell malignancies and persistent disease following standard therapy. The clinical program commences shortly after the company’s official launch in October 2014.

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"Despite recent advances in cancer treatments, there are still far too many individuals with B-cell malignancies who die from their disease," said Chuck Wilson, PhD, President & CEO of Unum Therapeutics. "With these unmet medical needs fueling our efforts, we are excited to see the start of clinical testing for ATTCK20. This novel therapy leverages two of the strongest immunotherapy technologies in modern medicine – engineered T-cells and monoclonal antibodies – to target cancer."

ATTCK20 Clinical Trial

Antibody-Targeted Tumor Cell Killing (ATTCK) happens when T-cells expressing an antibody-coupled T-cell receptor (ACTR) engage a tumor-targeting antibody on the surface of a cancer cell. ATTCK20 is a combination of a patient’s ACTR T-cells administered with rituximab, a monoclonal antibody targeting CD20. The first Phase I dose escalation study for ATTCK20 is taking place in Singapore at National University Hospital (NUH) and Singapore General Hospital (SGH). T-cells from patients in the study are processed at the Tissue Engineering & Cell Therapy (TECT) Laboratory at NUH. The Hematology-Oncology Research Group Trial Unit within the National University Cancer Institute, Singapore (View Source) manages and supports all aspects of the clinical trial. At present, the unit is conducting over 60 clinical trials, many of which are Phase I and II studies. The Hematopoietic Progenitor Cell Transplant Program is the only one in Asia accredited by the Foundation for the Accreditation of Cellular Therapy (FACT).

"This study is designed to translate recent laboratory findings into clinical application," said Unum’s Scientific Founder Dario Campana, MD, PhD. "The efficacy of ACTR T-cells shown in our preclinical studies, together with the demonstrated feasibility of infusing autologous T-cells, forms a compelling rationale for the clinical testing of this novel approach. We look forward to enrolling patients in the ATTCK20 study and will continue to plan for additional clinical studies to leverage our ACTR technology with tumor-targeting antibodies in other types of cancer."

ACTR AND ATTCK20

ACTR is a chimeric protein that combines components from receptors normally found on two different human immune cell types – natural killer (NK) cells and T-cells – to create a novel cancer cell killing activity. As reported earlier this year in the journal Cancer Research[1], T-cells bearing the ACTR receptor can be armed to attack a tumor by combining with a monoclonal antibody that binds antigens on the cancer cell surface. CD20 is expressed on cancer cells from many patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Rituximab, an antibody specific for CD20, is currently part of standard therapy for these indications. Studies carried out in Dr. Campana’s laboratory show remarkable enhancement in the activity of rituximab when it is armed with ACTR T-cells.

Unum has built a platform for cancer treatment based upon ACTR. In contrast to other approaches that are limited to a single target and treat a narrow set of tumors, Unum’s approach is not restricted by antigen and may have applications for treating many types of cancers. The ATTCK20 study will be the first clinical trial to assess clinical candidates engineered with the ACTR technology.

On Decemebr 1, 2014 ImmunoCellular Therapeutics reported that the European Medicines Agency (EMA) has provided scientific advice supportive of advancing ICT-107 to a registrational phase III program in patients with newly diagnosed glioblastoma (GBM) (Press release ImmunoCellular Therapeutics, DEC 1, 2014, View Source [SID:1234501034]). The EMA guidance is consistent with the positive feedback the Company received from the US FDA relative to the scope, design and endpoints of the program and the inclusion of patients based on HLA and MGMT status. ImmunoCellular intends to finalize the design of the phase III program, ensuring harmony between US and EU trial protocols, with the goal of being in position to initiate the phase III program. The Company now is evaluating options for funding the phase III program, which may enable the initiation in 2015.

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"We appreciate the EMA’s support for conducting a phase III program with ICT-107, and for their detailed guidance on the treatment design and statistical elements of the program," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "The encouragement we have received from both the US and EU regulatory authorities, and from the global neuro-oncology community, increase our confidence in ICT-107’s therapeutic potential for patients with this lethal disease. We intend to complete the design of a high quality phase III program, and to explore appropriate funding alternatives to enable next steps."

Earlier this year, ICT-107 was designated as an Advanced Therapy Medicinal Product by the EU Committee for Advanced Therapies, which should provide access in Phase III to valuable services and incentives offered by the EMA, should the Company conduct the phase III program in the EU.