-- New Capital Funds: Development of Rolapitant through Phase 3 Trials and Potential Regulatory Submissions; Initial Clinical Trial for ALK Inhibitor Program; and Oncology Product Pipeline Expansion --
BOSTON, Jun 21, 2011 (BUSINESS WIRE) -- TESARO, Inc., an oncology-focused biopharmaceutical company, today announced that it has secured $101 million in a Series B financing to advance and expand the Company's cancer product portfolio. Kleiner Perkins Caufield & Byers (KPCB) led the Series B round with participants including founding investor New Enterprise Associates (NEA) and new investors: InterWest Partners, T. Rowe Price, Pappas Ventures, Oracle Partners, Deerfield Management and Leerink Swann.
TESARO was co-founded by former executives of MGI PHARMA, an oncology and acute-care focused biopharmaceutical company that was acquired by Eisai Co., Ltd. in 2008 for $3.9 billion. NEA and TESARO management funded an initial $20 million Series A financing in May 2010 to facilitate the Company's acquisition, development and commercialization of a portfolio of oncology and supportive care products. NEA is the largest investor in the Series B financing.
In the thirteen months since founding, TESARO has made substantial progress toward building a leading oncology-focused pipeline. In December 2010, the Company announced that it had in-licensed its first product, rolapitant, from OPKO Health, Inc. Rolapitant is a Phase 3-ready neurokinin-1 (NK1) receptor antagonist being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV). In March 2011, TESARO announced that it had in-licensed small molecule inhibitors of Anaplastic Lymphoma Kinase (ALK) from Amgen Inc. The ALK program represents a molecularly targeted approach to treating certain cancer sub-populations with compounds that have promising potency, selectivity and pharmaceutical properties. TESARO plans to develop one or more compounds for oncology indications, including the treatment of patients with non-small cell lung cancer (NSCLC) whose tumors express an ALK fusion protein; recent clinical proof-of-concept has been demonstrated for ALK inhibition in this patient population. The Series B financing will fund further development of these programs and expansion of the pipeline.
"We are very pleased to have this superb group of new investors join management and NEA in financing the development and expansion of our pipeline of oncology product candidates," said Lonnie Moulder, Chief Executive Officer. "This new capital will fully fund the development of rolapitant through Phase 3 clinical trials and potential regulatory submissions, and advance the ALK inhibitor program into a clinical trial assessing safety and activity in cancer patients. It will also allow us to continue to leverage the experience and competencies of our team to acquire and develop promising drug candidates with the goal of commercializing meaningful products for the treatment and support of cancer patients."
In connection with the financing, Beth Seidenberg, M.D., Partner, KPCB and Arnold Oronsky, Ph.D., General Partner, InterWest Partners have joined the TESARO Board of Directors. They join board members Lonnie Moulder, Chief Executive Officer; Mary Lynne Hedley, Ph.D., President and Chief Scientific Officer; David Mott, General Partner, NEA; and Paul Walker, Partner, NEA.
Rolapitant, a potent and selective neurokinin-1 (NK1) receptor antagonist with an extended plasma half-life, has completed Phase 2 clinical testing for prevention of chemotherapy induced nausea and vomiting (CINV), post-operative nausea and vomiting (PONV), and chronic cough. Phase 2 testing in cancer patients treated with highly emetogenic chemotherapy demonstrated promising five-day activity in CINV prevention following the administration of a single dose. The safety and tolerability of single and repeat doses of rolapitant has been assessed in over 1000 healthy volunteers and patients. Rolapitant is an investigational agent and has not been approved by regulatory agencies.
About Chemotherapy Induced Nausea and Vomiting (CINV)
CINV is estimated to afflict over 70% of cancer patients undergoing chemotherapy and, if not prevented, may possibly result in a delay or even discontinuation of chemotherapy treatment. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition as well as hospitalization.
NK1 receptors are highly concentrated in the brain and bind the neurokinin substance P. Activation of NK1 receptors plays a central role in nausea and vomiting induced by emetogenic stimuli, including certain cancer chemotherapies. NK1 receptor antagonists have been demonstrated to improve the management of nausea and vomiting experienced by cancer patients undergoing chemotherapy.
About Anaplastic Lymphoma Kinase (ALK) and Non-Small Cell Lung Cancer (NSCLC)
ALK gene fusions and mutations that result in constitutive activation of ALK are associated with sub-sets of certain cancers including NSCLC. ALK is thought to be a key driver of certain types of cancers, including a sub-population of NSCLC as demonstrated in recent clinical trials of an ALK inhibitor. Abnormal ALK proteins are also associated with sub-populations of other cancers including lymphoma and neuroblastoma. ALK is generally not expressed or is expressed at low levels in normal adult tissue and therefore represents a promising molecular target for the development of a cancer therapeutic.
Worldwide, over 1.3 million new lung cancer cases are identified annually. Lung cancer is the leading cause of cancer death in men and the second leading cause of cancer death in women. NSCLC is responsible for approximately 85% of all lung cancer cases with 75% of these patients being diagnosed with metastatic or advanced disease, for which the five-year survival rate is approximately 5%. ALK is believed to be a key driver of tumor development in approximately 5% of all NSCLC patients.
About TESARO, Inc.
Founded in 2010, TESARO is a privately held oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients. The Company intends to leverage the experience and competencies of its management team to identify, acquire and develop promising drug candidates; and to commercialize safer and more effective products for the treatment and support of cancer patients. TESARO is developing rolapitant, a potent, selective neurokinin-1 receptor antagonist that has completed Phase 2 clinical testing for the prevention of chemotherapy induced nausea and vomiting, and is advancing its ALK inhibitor program for oncology indications. Phase 3 clinical testing of rolapitant is planned to commence during 2011 and the first ALK inhibitor clinical trial is targeted to begin in 2012. TESARO was co-founded by former executives of MGI PHARMA, an oncology and acute-care focused biopharmaceutical company that Eisai Co., Ltd. acquired in 2008 for $3.9 billion. TESARO is headquartered in Waltham, Massachusetts. For more information, visit www.tesarobio.com .