TRACON PHARMACEUTICALS RECEIVES SPECIAL PROTOCOL ASSESSMENT (SPA) AGREEMENT FROM FDA FOR PHASE 3 CLINICAL TRIAL OF TRC105 IN ANGIOSARCOMA

On January 3, 2017 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration (AMD) and fibrotic diseases, reported that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the Company’s Phase 3 study evaluating TRC105 for the treatment of patients with advanced angiosarcoma (Press release, Tracon Pharmaceuticals, JAN 3, 2017, View Source [SID1234517251]).

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"The SPA agreement represents a significant milestone for TRACON, as it provides us with a clearly defined development and regulatory pathway for TRC105, our lead clinical program, for the treatment of angiosarcoma," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We appreciate the FDA’s engagement and guidance during the SPA process and look forward to dosing the first patients in the trial during early 2017."

TRACON intends to conduct the Phase 3 TAPPAS trial (a randomized Phase 3 trial of TRC105 And Pazopanib versus Pazopanib alone in patients with advanced AngioSarcoma) at sites in both the United States and Europe. This one-to-one randomized trial of TRC105 in combination with Votrient (pazopanib) versus Votrient alone will initially enroll 124 patients. The trial features an adaptive design that, based on an interim analysis, can allow for sample size re-estimation up to a maximum of 200 patients, as well as possible enrichment of more responsive patients with cutaneous angiosarcoma. The primary endpoint of the trial is progression-free survival (PFS), with overall survival (OS) as a secondary endpoint.

Further details of the Phase 3 clinical trial are available on www.clinicaltrials.gov under NCT02979899.

About Special Protocol Assessment (SPA)

The SPA process is one in which a sponsor asks the FDA to evaluate the proposed design and size of Phase 3 clinical trials that are intended to form the primary basis for determining a drug product’s efficacy. An SPA agreement indicates concurrence with the adequacy and acceptability of specific critical elements of protocol design, endpoints and analysis. Additionally, it provides a binding agreement with FDA’s review division with respect to the elements agreed to in the SPA process that are considered critical to ensuring the trial has the potential to support a future marketing application. However, final marketing approval depends upon the results of efficacy, the safety profile, and an evaluation of the risk/benefit of treatment demonstrated in the Phase 3 clinical trial, among other requirements, and the FDA may revoke or alter its agreement under certain circumstances. For further information regarding the SPA process, please visit the FDA website at www.fda.gov.

About TRC105 (carotuximab)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in multiple Phase 2 clinical trials sponsored by TRACON or the National Cancer Institute (NCI) for the treatment of solid tumor types in combination with VEGF inhibitors. The ophthalmic formulation of TRC105, DE-122, is currently in a Phase 1/2 trial for patients with wet AMD. TRC205, a second generation antibody to endoglin, is undergoing preclinical testing in models of fibrosis.

About Angiosarcoma

Angiosarcoma is an aggressive form of soft tissue sarcoma (STS) of endothelial cell origin that is associated with poor prognosis. Angiosarcoma has a 5-year survival rate of less than 12%, which highlights the aggressive nature of this tumor when compared to a 5-year survival rate of approximately 56% for all STS. Angiosarcoma can arise in any soft tissue structure. About half of patients present with a primary cutaneous lesion. Risk factors include prior radiation exposure as well as inflammatory damage in chronically sun exposed skin. Angiosarcoma has also been associated with chronic lymphedema. Although resection with curative intent followed by adjuvant radiotherapy is the treatment of choice for localized disease amenable to surgery, approximately 50% of these patients will develop metastases and die from the disease. Furthermore, metastases are frequently present at diagnosis, and resection of metastases is rarely feasible.

Angiosarcoma is an extremely rare disease and meets the definition for an orphan disease in the US and European Union (EU), the two regions for which the Phase 3 TAPPAS study is planned. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the US and EU. The annual incidence of angiosarcoma in the US was reported by the NCI in 2015 to be 475 cases. In the EU the incidence of angiosarcoma is 0.01 per 10,000, accounting for an estimated 508 cases annually.

Kite Pharma Submits Investigational New Drug (IND) Application for KITE-718, an Investigational Next Generation T-Cell Receptor (TCR) Therapy Targeting Cancer Antigens MAGE A3 and MAGE A6

On January 3, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 trial of KITE-718, a T cell therapy engineered to express T cell receptors (TCRs) that target MAGE A3 and MAGE A6 (Press release, Kite Pharma, JAN 3, 2017, View Source [SID1234517250]). MAGE A3/A6 are frequently found in common tumors including bladder, esophageal, head and neck, lung and ovarian cancers. KITE-718 recognizes the MAGE A3 and MAGE A6 fragments bound to a Class II HLA (DPB1*04:01) and therefore has the potential to kill tumor cells both directly and indirectly through activation of the immune system given it incorporates a class II TCR. Class II HLA (DPB1*04:01) is found in 50 percent to 70 percent of Caucasians. The trial is designed to assess the safety and anti-tumor effect of KITE-718 on these solid tumors.

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"Submission of this IND is an important milestone for our solid tumor strategy utilizing engineered T cell therapy based on both TCR and CAR platform technology," said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. "TCRs have the potential to access a broad spectrum of tumor targets and we have incorporated our next generation cell manufacturing technologies into KITE-718 to exploit targets naturally expressed in common solid tumors for which there is a great unmet medical need."

KITE-718 is built on the proof of concept data established by the National Cancer Institute’s (NCI) MAGE A3/A6 TCR program (NCT02111850). No off-target toxicity was observed in the NCI study, and evidence of tumor regression was seen in patients with multiple types of solid tumors. KITE-718 has been optimized from the foundational work at the NCI by streamlining the manufacturing process through advanced technologies and next-generation cell manufacturing conditions.

Eagle Pharmaceuticals’ Pemetrexed NDA Submitted for Review

On January 3, 2016 Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) ("Eagle" or "the Company") reported that the 505(b)(2) New Drug Application (NDA) for its novel pemetrexed drug product has been submitted to the U.S. Food and Drug Administration (FDA) (Press release, Eagle Pharmaceuticals, JAN 3, 2017, View Source [SID1234517249]).

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This 505(b)(2) NDA requests FDA approval of Eagle’s ready-to-dilute (RTD) Pemetrexed Injection product for the treatment of Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer, and Mesothelioma (in combination with cisplatin).

"We look forward to the FDA’s decision on this NDA this year, and to continuing to work closely with the FDA through the review process. We believe our RTD liquid formulation will be well received, adding to Eagle’s growing commercial portfolio of improved formulations, benefiting patients and shareholders alike," said Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Eagle’s RTD Pemetrexed Injection product is administered as an IV infusion.