On July 14, 2016 Panther Biotechnology, Inc. (OTC PINK: PBYA) (Panther), a biotechnology company specializing in the development of enhanced therapeutics for the treatment of neoplastic and autoimmune disorders reported that it has initiated the formal drug development process for its lead compound, Transferrin Doxorubicin (TRF-DOX) (Press release, Panther Biotechnology, JUL 14, 2016, View Source [SID1234517416]). In April 2015, Panther entered into a definitive agreement with privately held Faulk Pharmaceuticals, Inc. to acquire Faulk’s pharmaceutical technology assets which included TRF-DOX. The transaction provided Panther with a proprietary, multi-nationally patent protected, ligand-drug conjugate technology platform as well as a pipeline of drug product candidates that address unmet medical needs in oncology, autoimmune, antiviral and other disease indications. Panther was particularly interested in the TRF-DOX conjugate as it has shown promising safety and preliminary efficacy in a randomized controlled study of ovarian cancer outside the US.

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Panther has executed an agreement with Dr. Patricia D. Williams of IND Directions, LLC in Washington DC to lead all aspects of the drug development process for TRF-DOX including regulatory, preclinical, manufacturing and clinical development activities. Dr. Williams has over 30 years of experience designing and implementing high quality drug development programs for small molecules, biologics, and gene therapies. Dr. Williams has held various positions of increasing responsibilities at major pharmaceutical and biotechnology companies (Bristol-Myers, Eli Lilly, American Cyanamid, Ligand, Biochem Pharma) as well as contract research and consulting organizations (SRA Life Sciences, TherImmune, Gene Logic and Summit Drug Development Services). In addition, Dr. Williams has already worked on TRF-DOX with Faulk Pharmaceuticals in the past. Teams under Dr. Williams’ leadership have advanced over 50 small molecules and biologics into clinical development. Under Dr. Williams’ leadership, Panther has initiated the preparation of a formal Pre-Investigational New Drug (IND) submission to the US Food and Drug Administration (FDA). This step will result in FDA’s input into Panther’s Phase II clinical plans with TRF-DOX as well as the preclinical and manufacturing data that will support clinical trials with TRF-DOX.

"We are very excited to work with Dr. Williams to initiate clinical development of the Faulk Pharmaceutical technology, which we see as complementary to our efforts to develop and commercialize innovative pharmaceutical approaches for the treatment of cancer. Not only does Dr. Williams provide enormous experience, her previous work on the TRF-DOX will be invaluable to our efforts," stated Evan Levine, Chief Executive Officer of Panther. "The goal of this next phase is to present a clinical plan to the FDA that has the opportunity to generate a statistical signal over the reference drug and progress Transferrin Doxorubicin towards commercialization. We will continue to inform the public as critical milestones are achieved."

TRF-DOX is a combination of the iron-binding glycoprotein, transferrin, and Doxorubicin resulting in targeted delivery to tumors with the reduction of serious side effects. TRF-DOX leverages the targeting ability of the plasma glycoprotein transferrin to deliver a powerful chemotherapeutic payload to cancerous cells which have elevated levels of transferrin receptors. In vitro assays demonstrate growth inhibition of cancer cells that are resistant to other chemotherapies including Doxorubicin itself. Cytotoxicity studies demonstrate that a doxorubicin dose reduction of ten to one hundred-fold kills all cancer cells in multiple cancer types. In vivo studies demonstrate that TRF-DOX selectively binds tumors, inhibits tumor growth better than unmodified Doxorubicin, and increases survival. This improved therapeutic index suggests that further improvements in efficacy without added toxicity can be achieved.

On July 14, 2016 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by delivering high quality biological products through its contract development and manufacturing organization (CDMO) services and by advancing its novel R&D pipeline, reported that the company has entered into an exclusive licensing agreement with University of Texas (UT) Southwestern Medical Center for a novel exosome technology that has potential application as a simple blood test to detect or monitor cancer (Press release, Peregrine Pharmaceuticals, JUL 14, 2016, View Source [SID:1234513872]). The company intends to develop a novel cancer test utilizing internal expertise and then pursue revenue-generating partnering opportunities at an early stage of development.

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Tumor exosomes represent small pieces of tumor cells that are released into the blood as tumors grow. Tumor derived exosomes have phosphatidylserine (PS) on their surface as a detectable marker. It is believed that even small tumors begin to release PS-positive exosomes and thus the ability to detect these exosomes in the blood may be an indicator of the presence of a tumor.

The licensing agreement is the result of the long-standing sponsored research agreement between Peregrine and UT Southwestern focused on PS, a highly immunosuppressive signaling molecule. The new technology licensed by Peregrine relates to assays that are able to detect small amounts of PS-exosomes in a patient blood sample as a way to potentially detect cancer at a very early stage of development. Preliminary studies have demonstrated that the levels of PS-positive exosomes present in the blood of cancer patients are higher than levels found in the blood of healthy volunteers. Furthermore, study findings also suggest that there is a correlation between the level of PS-positive exosomes detected in the blood of cancer patients and disease burden.

"We are excited to enter into this licensing agreement with our long-term collaborators at UT Southwestern. This technology offers a promising product development opportunity and aligns directly with the company’s expertise with our proprietary PS-targeting platform and our longstanding CDMO capabilities around the development, qualification, and validation of in vitro analytical assays. As such, there are significant opportunities to use this technology as both a complementary tool in bavituximab’s ongoing development, as well as more broadly as the basis for novel cancer detection and monitoring tests that can be the focus of partnering efforts," said Jeff T. Hutchins, Ph.D., Peregrine’s vice president, preclinical research. "It is important to note that this development program will require minimal capital investment and has the potential to create significant value over the next 18 months, including potential partnering opportunities. As a result, we feel that today’s licensing deal provides yet another important driver in our ongoing efforts to achieve profitability."

Together, the Peregrine and Avid Bioservices teams have the existing infrastructure, staff and expertise to develop, optimize and validate a functional assay capable of detecting PS-positive exosomes from a blood sample. Given the company’s extensive experience in developing assays of this type, Peregrine does not anticipate the need to add personnel or any specialized equipment for this project. The company intends to establish clinical proof-of-concept for the test and expects to initiate partnering discussions for the program in 2017.

"One of the most exciting aspects of this technology is the potential synergy that it offers with our ongoing bavituximab clinical development program. Through our ongoing work with bavituximab, we have gained significant understanding of PS-mediated immunosuppression in cancer," said Joseph Shan, MPH, vice president, clinical and regulatory affairs of Peregrine. "The availability of a PS-specific biomarker which can be implemented in our planned future bavituximab clinical trials aligns nicely with our refocused bavituximab development strategy aimed at generating the most meaningful data possible from small, early stage clinical trials to support partnering efforts."

On July 13, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that data on PV-10 as a treatment for melanoma was presented June 30, 2016 at the 6th European Post-Chicago Melanoma/Skin Cancer Meeting in Munich, Germany (Press release, Provectus Pharmaceuticals, JUL 13, 2016, View Source [SID:1234513864]).

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Sanjiv Agarwala, MD, Professor of Medicine at Temple University, Chief, Oncology & Hematology at St. Luke’s Cancer Center in Bethlehem, Pennsylvania and Global Lead Investigator for the phase 3 study of PV-10 in locally advanced cutaneous melanoma (protocol PV-10-MM-31), participated in a symposium, "Current Clinical Trials I." His presentation covered the status of clinical trials of leading oncolytic agents for the treatment of soft tissue and skin metastases, including the ongoing phase 3 study of PV-10 and the phase 1b study of PV-10 in combination with pembrolizumab (Keytruda).

During his presentation, Dr. Agarwala noted that "systemic therapy is not always possible or appropriate" for patients with locally advanced disease, and that "local-regional control of soft tissue/skin metastases is clinically important." Touching on six different types of oncolytic therapy, he highlighted key efficacy and safety data for PV-10 when used for direct ablation of dermal and soft tissue metastases, and noted that PV-10 is the only one currently being studied as both monotherapy and in the combination setting (with pembrolizumab). With regard to combination therapy, he noted that newer intralesional therapies like PV-10 are the "backbone for future combinations" since they are capable of producing a systemic anti-tumor immune response complementary to that of immune checkpoint inhibitors.

To view his presentation, please visit
http://www.pvct.com/presentation/EuropeanPostChicago-2016.

For more information about the meeting visit: View Source

On July 13, 2016 Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) reported a new collaboration on a Phase 1b study that will evaluate the safety and tolerability of BI 836845, Boehringer Ingelheim’s insulin-like growth factor (IGF)-1/IGF-2 ligand neutralising antibody, in combination with abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase (CDK) 4 and 6 inhibitor, in patients diagnosed with HR+/HER2- mBC (Press release, Boehringer Ingelheim, JUL 13, 2016, View Source [SID:1234513868]). Based on the Phase 1b trial results, the collaboration has the potential to expand to Phase 2 trials in patients with HR+/HER2- mBC and other solid tumours. Enrolment is scheduled to begin in late 2016 and Boehringer Ingelheim will be the sponsor of the study programme.

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"We are pleased to join with Boehringer Ingelheim to study the potential of their molecule in combination with Lilly’s abemaciclib, for which we have an active Phase 3 development programme underway," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "For patients living with metastatic breast cancer, the limited treatment options available make this an important area of focus for our efforts to advance the most innovative treatments."

Dr. Mehdi Shahidi
Dr. Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim commented, " Boehringer Ingelheim is excited about initiating this collaboration with Lilly to investigate a novel combination of two compounds that have individually shown promising results in metastatic breast cancer and have a complementary mode of action. We hope that this study will lay foundations for making much needed new therapies available to patients with metastatic breast cancer."

Boehringer Ingelheim’s BI 836845 is an IGF ligand-neutralising antibody that binds to both IGF-1 and IGF-2 preventing activation of the respective receptor resulting in decreased growth-promoting signalling, which may decrease tumour growth. In a Phase Ib/II trial BI 836845 has shown promising preliminary efficacy and good clinical safety in combination with everolimus and exemestane in patients with HR+ mBC.1 Lilly’s abemaciclib is designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6. In many cancers, uncontrolled cell growth arises from a loss of control in regulating the cell cycle due to increased signalling from CDK 4 and 6.

The rationale for the collaboration is based upon the hypothesis that these two agents, in combination, could offer a more complete pathway interference and could potentially prolong cell cycle arrest. For HR+/HER2- mBC patients, this could translate to a reversal of resistance to hormone therapy.

About Metastatic Breast Cancer
Breast cancer is the most common cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012.2 In the U.S. this year, approximately 246,600 new cases of invasive breast cancer will be diagnosed and about 40,450 women will die from breast cancer.3 Of all early stage breast cancer cases diagnosed in the U.S., approximately 30 percent will become metastatic, spreading to other parts of the body, with an estimated six to 10 percent of all new breast cancer cases initially being stage IV, or metastatic.4 Approximately 75% of breast cancers are hormone receptor-positive and are typically managed with endocrine therapies, including aromatase inhibitors and selective oestrogen receptor modulators.5 Metastatic breast cancer is considered incurable, but is generally treatable.

About BI 836845
BI 836845 is an investigational compound in Phase II clinical development. It is a humanised antibody that binds to insulin-like growth factor (IGF) signalling pathways, which may play a role in the development or spread of cancer by providing a growth mechanism for tumours. BI 836845 specifically binds to IGF-1 and IGF-2. It is being studied in combination with other agents for use in patients with advanced solid tumours.

On July 12, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that the European Society for Medical Oncology’s Scientific Committee has accepted an abstract for a poster presentation detailing the use of PV-10 as a treatment for stage III and IV melanoma as part of ESMO (Free ESMO Whitepaper)’s 2016 Congress (Press release, Provectus Pharmaceuticals, JUL 12, 2016, View Source [SID:1234513829]).

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The exact date and time of the presentation, titled "Intralesional Rose Bengal for Stage III and IV Melanoma," has yet to be decided. When the schedule is set, the details for this abstract, #3438, will be available at View Source

In addition, the abstract will also be published in the ESMO (Free ESMO Whitepaper) 2016 Congress Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Annals of Oncology. ESMO (Free ESMO Whitepaper) has not yet announced the final publication number. The ESMO (Free ESMO Whitepaper) 2016 Congress will be held in Copenhagen, Denmark, from October 7-11, 2016.