Sorrento and 3SBio Announce CAR-T Joint Venture in China

On June 7, 2016 Sorrento Therapeutics, Inc. (NASDAQ: SRNE) ("Sorrento"), an antibody-centric, clinical-stage biopharmaceutical company developing new treatments for cancer and other unmet medical needs, reported its subsidiary TNK Therapeutics, Inc. ("TNK") has entered into a joint venture agreement ("JVA") with Shenyang Sunshine Pharmaceutical Company Ltd ("3SBio") to develop and commercialize proprietary immunotherapies, including those developed from, including or using TNK’s chimeric antigen receptor T cell ("CAR-T") technology targeting carcinoembryonic antigen ("CEA") positive cancers (Press release, Sorrento Therapeutics, JUN 7, 2016, View Source [SID:1234513131]). 3SBio is a leading China-based biotechnology company focused on discovering, developing, manufacturing, and commercializing biopharmaceutical products.

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Under the terms of the JVA, 3SBio will make total contributions of $10 million to the joint venture and TNK will grant the joint venture an exclusive license to the CEA CAR-T technology and two additional CARs for cellular therapy for the Greater China market, including Mainland China, Hong Kong and Macau. 3SBio will initially own 51% of the joint venture while TNK will initially hold the remaining 49%.

"We are pleased that 3SBio, a leading biotechnology company in China, has recognized the value of our CAR-T technologies and we look forward to working with them to advance the development of our novel anti-cancer cellular therapies," said Dr. Henry Ji, President and CEO of Sorrento.

"3SBio is committed to introducing innovative biologic medicines for unmet medical needs in China and we look forward to collaborating with Sorrento to advance our CAR-T program into clinical trials in China. CAR-T technology is an important and promising approach to treating cancers, particularly for patients in advanced or metastatic stages of the disease. Our first candidate is aimed at CEA-positive cancers, which include colorectal, lung, liver and breast cancers," commented Dr. Jing Lou, Chairman and CEO of 3SBio.

MabVax Therapeutics Expands Patient Enrollment in Phase I Trial for Treatment of Pancreatic Cancer to Memorial Sloan Kettering Cancer Center

On June 7, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported the initiation of patient enrollment at Memorial Sloan Kettering Cancer Center (MSK) in the Phase I clinical trial evaluating its leading clinical development product MVT-5873 (HuMab-5B1) as a therapeutic treatment for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies (Press release, MabVax, JUN 7, 2016, View Source [SID:1234513112]). This is the second investigational site in the Phase I trial with patient recruitment currently underway at the Sarah Cannon Research Institute in Nashville, TN. MabVax previously announced receipt of authorization to proceed on the Investigational New Drug (IND) application filed from U.S. Food and Drug Administration (FDA).

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The open-label, dose-escalation Phase I therapeutic trial is evaluating the safety, tolerability and pharmacokinetics of MVT-5873. The first group of patients are being enrolled to assess safety and determine the recommended phase II dose of the antibody. A second patient group will establish the safety and dose of the antibody when administered with a standard-of-care chemotherapy. Eileen O’Reilly, MD, Associate Director for Clinical Research at MSK’s David M. Rubenstein Center for Pancreatic Cancer Research, is serving as the lead investigator at the investigational site.

"We are very fortunate to have an established and productive relationship with MSK," said David Hansen, MabVax President and CEO. "With the addition of this investigational site, we are now recruiting patients in our Phase I therapeutics trial at two highly respected institutions. We continue on track to announce interim results from this trial in the third quarter of 2016."

About HuMab-5B1:

MabVax’s HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer. MabVax’s two lead antibody clinical programs utilize HuMab-5B1 as a naked antibody (MVT-5873) and as an immuno-PET imaging agent (MVT-2163).

Valeant Pharmaceuticals Reports First Quarter 2016 Financial Results

On June 7, 2016 Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) ("Valeant" or the "Company") reported first quarter 2016 financial results and updated 2016 guidance (Press release, Valeant, JUN 7, 2016, http://ir.valeant.com/news-releases/2016/06-07-2016-110324216 [SID:1234513132]).

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"The first quarter’s results reflect, in part, the impact of significant disruption this organization has faced over the past nine months," said Joseph Papa, chairman and chief executive officer. "This has been a difficult period for Valeant and its stakeholders, and while there are some challenges to work through in certain business operations in 2016, such as our U.S. dermatology unit, the majority of our businesses are performing according to expectations.

"While we recognize that we did not meet the timeline for filing our first quarter results, with our filing expected this week, we will be current in our financial reporting," continued Papa. "We have made progress toward stabilizing the organization over the past few months, and we expect to file our financial results in a timely manner going forward. Valeant has a portfolio of world class brands, a strong new product pipeline and dedicated leaders who are committed to doing what is right and what is necessary to turn this company around by re-engaging our workforce, rebuilding our relationships with prescribers, patients and payors, and regaining the trust of our debtholders and shareholders."

Total Revenues
Total revenues increased $202 million, or 9%, to $2.37 billion in the first quarter of 2016, primarily due to the effect of acquisitions completed in 2015 and their subsequent growth under Valeant’s ownership. This increase was primarily offset by a negative foreign currency impact of $52 million and a negative impact from divestitures and discontinuations of $22 million. On an organic basis, total revenues declined $289 million in the first quarter of 2016 from the remainder of the existing business.

In the Developed Markets segment, revenues increased $186 million primarily from the acquisitions of Salix Pharmaceuticals, Ltd. (Salix) and certain assets of Dendreon Corporation and their subsequent growth under Valeant’s ownership of $513 million, primarily offset by declining volumes in the neurology portfolio and lower volumes in dermatology of $208 million.

In the Emerging Markets segment, revenues increased $15 million, primarily from the acquisition of Amoun Pharmaceutical Company S.A.E. of $59 million, partially offset by a negative foreign currency exchange impact.

Operating Expenses
Cost of goods sold, excluding amortization, as a percentage of product sales, increased to 27% for the first quarter of 2016 as compared to 24% for the first quarter of 2015 (restated) primarily due to an unfavorable foreign currency exchange impact in the first quarter of 2016, lower high-margin dermatology revenues due to changing market dynamics and the addition of lower margin products acquired in 2015, partially offset by increased margins in the neurology and other portfolio, as well as the addition of the Salix portfolio acquired in 2015.

Selling, general and administrative expenses ("SG&A") increased $239 million, or 42%, to $813 million in the first quarter of 2016. As a percentage of revenue, SG&A was 34% in the first quarter of 2016, as compared to 26% in the first quarter of 2015 (restated). SG&A in the first quarter of 2016 was impacted primarily by higher expenses related to acquisitions completed in 2015, as well as expenses related to share-based compensation costs and contractually required termination benefits for the Company’s former Chief Executive Officer, higher expenses to support the U.S. operations, and increased professional fees.

Investment in research and development increased $47 million, or 85%, to $103 million in the first quarter of 2016, primarily due to the development programs related to the Company’s dermatology product portfolio, including IDP-118, as well as brodalumab, an IL-17 receptor monoclonal antibody for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis, and programs acquired in the Salix acquisition.

Net Income (Loss)
Net loss was $373.7 million, or a loss of $1.08 per diluted share for the first quarter of 2016 as compared to net income of $97.7 million, or $0.28 per diluted share in the first quarter of 2015 (restated). Adjusted net income (non-GAAP) was $442.6 million, or $1.27 per diluted share for the first quarter of 2016 as compared to adjusted net income (non-GAAP) of $704.2 million, or $2.05 per diluted share in the first quarter of 2015 (restated).

Cash Flow
GAAP cash flow from operations was $558 million in the first quarter of 2016 as compared to $491 million in the prior year, an increase of 14%.

2016 Guidance
The Company is updating its full year 2016 guidance. Total revenue is expected to be in the range of $9.9 – $10.1 billion. Adjusted EPS (non-GAAP) is expected to be in the range of $6.60 – $7.00. Adjusted EBITDA (non-GAAP) is expected to be in the range of $4.80 – $4.95 billion.

Trillium Therapeutics Announces Presentation on TTI-621 Immune Checkpoint Inhibitor Targeting CD47 at European Hematology Association 21st Annual Congress

On June 7, 2016 Trillium Therapeutics Inc. (NASDAQ: TRIL; TSX: TR), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it will present its TTI-621 (SIRPaFc) immune checkpoint inhibitor program at the European Hematology Association (EHA) (Free EHA Whitepaper) 21st Annual Congress, to be held in Copenhagen from June 9- 12 (Press release, Trillium Therapeutics, JUN 7, 2016, View Source [SID:1234513089]).

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Details of Trillium’s presentation are as follows:

Presentation Type: Electronic Poster
Abstract #: E1373
Title: The CD47-blocking Cancer Immunotherapeutic TTI-621 has Anti-Tumor Effects Across a Broad Range of Hematological Malignancies

Provectus Biopharmaceuticals Announces Publication of Article on PV-10 for In-Transit Melanoma in Journal of Surgical Oncology

On June 7, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that an article on the use of PV-10 for in-transit melanoma has been published by the Journal of Surgical Oncology (Press release, Provectus Pharmaceuticals, JUN 7, 2016, View Source [SID:1234513114]). It expands on a presentation on the same topic given at the Royal Australasian College of Surgeons 85th Annual Scientific Congress, which was held 2-6 May 2016, in Brisbane, Australia.

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Titled "Intralesional PV-10 for In-Transit Melanoma – A Single Centre Experience," the article reports on use of PV-10 in the management of in-transit melanoma at the Peter MacCallum Cancer Centre, in East Melbourne, Victoria, Australia. The article was authored by Jocelyn Lippey et al. using retrospective analysis of data from nineteen patients receiving PV-10 at the center between 2010 and 2014.

Dr. Lippey reported, "After a median follow up of 11.7 months, disease control was achieved in 63% of patients. Five patients (26%) achieved a complete response, another five (26%) patients achieved a partial response, and two patients had stable disease (11%) at the time of last follow-up. Seventy-four percent (14/19) of patients had a clinical response at time of first follow-up (median time 21 days); range 8–91 days. Younger patients and those with smaller lesions were more likely to respond to treatment." The median age of patients in this series was 80 years.

Dr. Lippey also noted, "Ten patients did not have all lesions injected, primarily due to the number of lesions present. A bystander response was noted in un-injected lesions in 50% of patients who did not have all their lesions directly injected."

Eric Wachter, CTO of Provectus commented, "The results reported here are consistent with other evaluations of PV-10 in melanoma, and highlight both the rapid ablative properties and the immunologic features of PV-10 as an investigational ablative immunotherapy."

The article can be found at View Source

About the Peter MacCallum Cancer Centre

Peter MacCallum Cancer Centre is Australia’s only public hospital solely dedicated to cancer treatment, research and education. The hospital treats more cancer patients each year than any other hospital and the highly skilled medical, nursing and allied health team is backed by the largest cancer research group in Australia. Peter Mac has five locations across the state and provides services to patients from across Victoria and Australia and overseas. Multi-disciplinary teams, consisting of medical, surgical and radiation oncologists, nurses, radiation therapists and allied health professionals, develop comprehensive and coordinated treatment plans, ensuring patients get treatment and a team tailored to their individual needs. For more information, visit View Source