PMV Pharma Announces $30 million raised in Series A Financing

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.

New Drug Application for IRESSA accepted by US Food and Drug Administration

On December 2, 2014 AstraZeneca reported that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for IRESSA (gefitinib) as a targeted monotherapy for the first line treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), as identified through a companion diagnostic test (Press release AstraZeneca, DEC 2, 2014, View Source;new-drug-application-for-iressa-accepted [SID:1234501059]). The Prescription Drug User Fee Act goal date for IRESSA will be in the third quarter 2015.

IRESSA is an EGFR tyrosine kinase inhibitor that acts by blocking the transmission of signals involved in the growth and spread of tumours. AstraZeneca’s NDA submission for IRESSA was based on data from the Phase III IFUM1 (IRESSA Follow-Up Measure) clinical trial, providing evidence of IRESSA’s efficacy in Caucasian patients. This was supported by results from the IPASS2 (IRESSA Pan-ASia Study) clinical trial, as well as other collaborative group studies.

IRESSA is already approved in 90 countries for the treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of the EGFR tyrosine kinase.

ENZALUTAMIDE (XTANDI) NOW APPROVED IN EUROPE FOR THE TREATMENT OF MEN WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO ARE CHEMOTHERAPY-NAÏVE

On December 2, 2014 Astellas Pharma reported that the European Commission (EC) has granted a variation to amend the Marketing Authorisation for enzalutamide (trade name XTANDI) (Press release Astellas, DEC 2, 2014, View Source [SID:1234501049]). Enzalutamide is now approved for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy in whom chemotherapy is not yet clinically indicated.

The approval of the variation is based on results from the pivotal phase III PREVAIL study which demonstrate that enzalutamide improves outcomes for men with advanced prostate cancer who have not received chemotherapy.

Compared with placebo, enzalutamide reduced the risk of death by 29% (HR=0.71; p<0.001) and the risk of radiographic progression or death by 81% (HR=0.19; p<0.001). Men treated with enzalutamide experienced a 17-month delay in the time to initiation of chemotherapy compared to placebo (28.0 months versus 10.8 months, respectively; HR=0.35; p<0.001). Astellas expects to launch enzalutamide in the pre-chemotherapy setting in the first European countries, including the UK, from January 2015. The approval of this new indication for enzaltamide triggers $45 million in milestone payments to Medivation (NASDAQ: MDVN) under its collaboration agreement with Astellas. The impact has been accounted in Astellas’ financial forecasts for fiscal year ending March 2015.

Glutaminase Inhibitor CB-839 Synergizes with Pomalidomide in Preclinical Multiple Myeloma Models

On December 1, 2014 Calithera Biosciences presented the corporate presentation (Poster, ASH (Free ASH Whitepaper) 2014, Calithera Biosciences, DEC 1, 2014, View Source [SID1234535307]).

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iomarkers of Response to the Glutaminase Inhibitor CB-839 in Multiple Myeloma Cells

On December 1, 2014 Calithera Biosciences presented the corporte presentation (Presentation, Calithera Biosciences, DEC 1, 2014, View Source [SID1234535306]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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