On June 7, 2018 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor infiltrating lymphocyte (TIL) technology, reported that the first patient was dosed in the ongoing C-144-01 Phase 2 trial of LN-144 (lifileucel) for the treatment of patients with metastatic melanoma at a clinical trial site in the United Kingdom (Press release, Iovance Biotherapeutics, JUN 7, 2018, View Source;p=RssLanding&cat=news&id=2353696 [SID1234527218]).

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"The dosing of the first patient with lifileucel in Europe for the treatment of metastatic melanoma marks an important milestone for Iovance and our global development plans as our European Union (EU) manufacturing is now able to support enrollment in that region," said Dr. Maria Fardis, PhD, MBA, president and chief executive officer of Iovance Biotherapeutics. "This is a major step forward and we are excited by the opportunity to offer more patients TIL therapy around the world."

In December 2017, the company announced that the Generation 2 manufacturing process, with a duration of 22 days, was selected and all studies were shifted to utilize that method of manufacturing. The company has manufacturing capability in both the US and EU. This is the first patient treated with TIL developed in an EU-based manufacturing facility.

C-144-01 is a Phase 2 multicenter study evaluating the safety and efficacy of autologous tumor infiltrating lymphocytes (lifileucel), Iovance’s lead product candidate for treatment of patients with metastatic melanoma. The study is currently enrolling in the United States and Europe. To date, Iovance has over 25 active clinical sites in the United States and Europe. The sample size for enrollment was increased to 85 for this study. Additional information on this study is available at www.clinicaltrials.gov using the identifier number NCT02360579.

On June 7, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported it will announce results for the second quarter of 2018 on Thursday, July 26, 2018 (Press release, Bristol-Myers Squibb, JUN 7, 2018, View Source [SID1234527217]). During a conference call at 10:30 a.m. EDT on July 26, company executives will review financial information and will address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 323-794-2093 or international 866-548-4713, confirmation code: 4235170. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 1:30 p.m. EDT on July 26 through 1:30 p.m. EDT on, August 9, 2018. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 4235170.

On June 6, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical stage biotechnology company focused on the development of novel cancer therapeutics, reported Susan M. Molineaux, Ph.D, founder, CEO and President and Keith Orford, M.D., Ph.D., Senior Vice President of Clinical Development will participate in the following two investment conferences in June (Press release, Calithera Biosciences, JUN 6, 2018, View Source [SID1234535238]):

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The Jefferies 2018 Healthcare Conference at the Grand Hyatt in New York City. Calithera will present at the conference today, June 6, 2018 at 8:00 a.m. Eastern time. A live webcast of this presentation will be accessible via the media and investors page of www.calithera.com. An archived replay of the webcast will be available on the Company’s website for 30 days following the conference.

The JMP Securities 2018 Life Sciences Conference at the St.Regis in New York City. Calithera will participate in a panel discussion on June 20, 2018 at 3:30 p.m. Eastern time.

On June 6, 2018 Advanced Proteome Therapeutics Corporation ("APC" or the "Company") (TSXV:APC) (FSE:0E8) is pleased to reported the appointment of Mr. Bill Dickie as Chief Executive Officer, President and Director of the company, effective June 6, 2018 (Press release, Advanced Proteome Therapeutics, JUN 6, 2018, View Source [SID1234527225]). Mr. Dickie brings with him more than 30 years of exceptionally qualified experience in business leadership, development and execution of growth strategies within the healthcare and pharmaceutical sectors.

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Mr. Dickie joins APC after serving as Co-founder, President, CEO and Director of Atreus Pharmaceuticals, a radiopharmaceutical development company in Phase II clinical trials with a medical imaging product licensed from Stanford University. Under Bill’s leadership, Atreus raised $1 million in seed capital and negotiated a $6 million strategic investment, followed by a full acquisition by Advanced Accelerator Applications International, currently a Novartis company.

Previously Bill served as President, CEO and Director of Liponex Inc., (TSX:LPX) a Phase 2 company developing a novel cardiovascular drug based on technology licensed from the University of Ottawa Heart Institute. During his time as CEO, Liponex raised $10.5 Million in an IPO. Bill also spent over 25 years in management and executive roles with MDS Nordion, a large Canadian health care company. Bill’s extensive experience provides Advanced Proteome with the necessary guidance, leadership and expertise during this next, important phase of its development.

"We are delighted to welcome Bill to the Advanced Proteome team and are extremely fortunate to have his services," said Dr. Allen Krantz, founder and Chief Scientific Officer of Advanced Proteome Therapeutics. "We are confident that his keen intelligence, high standards, and strong work ethic along with his experience in leadership roles within the healthcare sector qualify him to enable our universal linker technology to realize its full potential. We look forward to his leadership and will consolidate our operations around his vision."

"I am honored to join the Advanced Proteome Therapeutics team and help lead the efforts to develop this proprietary and groundbreaking linker technology that will create superior versions of antibody-drug conjugates in the fight against cancer," said Bill Dickie, CEO and President of Advanced Proteome Therapeutics. "This proprietary approach has tremendous value and potential. I am confident we will implement a strategy for APC based on joint ventures, collaborations and licensing agreements with leading pharmaceutical companies which will bring significant value to the company and its shareholders."

On June 6, 2018 Peloton Therapeutics, Inc., reported dosing of the first patient in a Phase 2 trial evaluating the efficacy and safety of lead investigational oncology agent , PT2977, to treat von Hippel-Lindau (VHL) disease-associated kidney cancer (Press release, Peloton Therapeutics, JUN 6, 2018, View Source [SID1234527212]). PT2977 is a once-daily, oral inhibitor of HIF-2α, a transcription factor that has been implicated in the development and progression of renal cell carcinoma (RCC).

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"The initiation of this Phase 2 trial is an important milestone for Peloton and a critical step towards helping patients with this rare condition which can have serious lifelong health consequences," said Mohammad Hirmand, M.D., Peloton’s Chief Medical Officer. "The safety, pharmacokinetics, and clinical activity that we have observed in a Phase 1 trial of PT2977 provides insights into its potential to improve outcomes for patients with kidney cancer. We look forward to continuing clinical evaluation of this novel oral HIF-2α inhibitor."

The primary objective of the Phase 2 trial is to evaluate the efficacy of PT2977 for the treatment of VHL disease-associated renal tumors as measured by overall response rate. Secondary objectives include duration of response, time to response, progression free survival, and time to surgery for VHL disease-associated renal tumors. The trial will also evaluate the efficacy of PT2977 in other VHL disease-associated tumor types as well as the safety and pharmacokinetics of PT2977. Patients will be evaluated radiologically approximately every 12 weeks while continuing in the study.

"Unfortunately, there are no approved systemic therapies available for VHL disease. Currently, the only option is surgery, sometimes required multiple times which can be devastating for patients and does not cure the disease," said Eric Jonasch, M.D., Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine; Director, VHL Clinical Center, The University of Texas MD Anderson Cancer Center. "We are excited about the opportunity to study PT2977 which may offer a new option as an orally available agent that could reduce the need and frequency of surgical intervention for patients with VHL-associated kidney disease."

Peloton’s drug discovery and development efforts focus on identifying novel compounds capable of modulating complex protein-protein interactions that drive disease which have eluded conventional small molecule approaches. Peloton has the only clinical stage small-molecule inhibitors of HIF-2α, and PT2977 has demonstrated a favorable profile in a Phase 1 study in patients with advanced solid tumors including RCC.

The study will enroll 50 patients at clinical trial centers across the United States and Europe. More information about the trial is available at www.clinicaltrials.gov, identifier NCT NCT03401788.

About VHL Disease

Von Hippel-Lindau (VHL) disease is a rare, hereditary cancer syndrome in which affected individuals have a mutation and/or deletion of the tumor suppressor VHL gene, and are at risk for the development of multiple tumors including renal cell cancer. The global incidence of VHL is estimated to be one in 36,000 people.

About PT2977

Peloton has succeeded in creating a series of orally-available small molecules that bind to HIF-2α and inhibit its transcription of disease-promoting genes. PT2977 is a once-daily, orally-active agent that blocks hypoxia-inducible factor-2α (HIF-2α). It is a structurally-related compound designed to be more potent with less pharmacokinetics variability compared to PT2385. PT2977 has demonstrated anti-tumor activity with a favorable safety profile in an early-stage clinical study in patients with solid tumors. Given its superior profile, PT2977 is the lead agent being developed in oncology by Peloton. In addition to the international Phase 2 trial of PT2977 in VHL disease-associated RCC, Peloton is evaluating the agent in a Phase 1 clinical trial for the treatment of advanced RCC.