Scientific Data on PYK2 Inhibition by VS-4718 in Multiple Myeloma Published in the Journal Blood

On November 7, 2014 Verastem reported that a paper, titled "PYK2 Promotes Tumor Progression in Multiple Myeloma," has been published in Blood (2014 Oct 23;124(17):2675-86), a peer-reviewed medical journal published by the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release Verastem, NOV 7, 2014, View Source;p=RssLanding&cat=news&id=1987281 [SID:1234500939]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"These data demonstrate that PYK2 is a promising therapeutic target in multiple myeloma," said Jonathan Pachter, Ph.D., Verastem Head of Research. "These results build upon prior scientific findings demonstrating the activity of dual FAK/PYK2 inhibitors across multiple types of cancer and support the ongoing clinical development of VS-4718."

The paper describes the finding that patients with multiple myeloma have a higher expression of proline-rich tyrosine kinase 2 (PYK2), a member of the focal adhesion kinase (FAK) family, compared to healthy individuals, and that PYK2 plays a tumor-promoting role in myeloma progression. The FAK family is composed of just two members, FAK and PYK2, which are highly homologous. In the published study, it was demonstrated that inhibition of PYK2 led to reduction of myeloma tumor growth in vivo as well as decreased cell proliferation, cell cycle progression, and adhesion ability in vitro. In contrast, overexpression of PYK2 was shown to promote the malignant phenotype, as evidenced by enhanced tumor growth and reduced survival. The paper further describes how administration of Verastem’s FAK/PYK2 inhibitor, VS-4718, effectively inhibited myeloma cell growth in both in vitro and in vivo models.

"In addition to this work recently published by our collaborators at the Dana Farber Cancer Institute, we have been conducting further research and collaborating with scientific leaders to understand the potential of cancer stem cell inhibitors in hematological malignancies", continued Dr. Pachter. "We believe that inhibitors of FAK and PYK2, such as VS-4718, may be useful in the treatment of many types of cancer, particularly where there is minimal residual disease with enrichment of cancer stem cells following chemotherapy. We and our collaborators will be presenting additional research at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) in December."

"VS-4718 is currently being evaluated in a Phase 1 dose escalation clinical trial in patients with advanced solid tumors," said Robert Forrester, President and Chief Executive Officer of Verastem. "A new Phase 1 trial of VS-4718 in hematological malignancies is currently planned to begin in the first quarter of 2015."

(Press release, CanTx, NOV 6, 2014, View Source [SID:1234505853])

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!


MacroGenics Announces Pre-clinical Data to be Presented at ASH 2014 Annual Meeting

On November 6, 2014 MacroGenics reported that pre-clinical data on MGD011, a humanized CD19 x CD3 Dual-Affinity Re-Targeting (DART) protein, will be highlighted in a poster presentation at the 56th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), to be held December 6-9, 2014 in San Francisco, CA (Press release MacroGenics, NOV 6, 2014, View Source [SID:1234501246]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

MGD011 is designed to redirect T-cells to eliminate CD19-expressing cells found in many hematological malignancies and has been engineered to address half-life challenges posed by other programs targeting CD19 and CD3. Moreover, MGD011 and other DART molecules are manufactured using a conventional antibody platform without the complexity of having to genetically modify T cells from individual patients as required by approaches such as chimeric antigen receptor (CAR) T cells. MGD011 has a modified Fc domain, which allows for extended pharmacokinetic properties and convenient dosing at a once-a-week or longer interval. It is one of two new oncology-based DART candidates for which MacroGenics intends to initiate clinical studies in 2015.

"This represents another important milestone for our DART platform," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "CD19-targeted therapies have generated much excitement, and, based on our pre-clinical data, we believe that MGD011 has great potential in the treatment of patients with certain types of hematological malignancies. We look forward to initiating clinical development in 2015."

Provectus Biopharmaceuticals Submits PV-10 Phase 3 Melanoma Protocol to FDA

On November 6, 2014 Provectus Biopharmaceuticals reported that it has submitted its phase 3 protocol for evaluation of PV-10 for treatment of locally advanced cutaneous melanoma to the FDA (Press release Provectus Pharmaceuticals, NOV 6, 2014, http://www.pvct.com/pressrelease.html?article=20141106.3 [SID:1234500938]). The FDA is expected to review the submission and comment on the proposed study population, clinical endpoints, and statistical analyses within 30 to 45 days. Provectus believes details of the protocol will be available publicly on www.clinicaltrials.gov within the next few days.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The submission of the protocol follows completion of the due diligence audit of Provectus’ regulatory documents for PV-10 and PH-10. The purpose of the audit was to ensure that all the regulatory documents were in order.

Provectus anticipates few, if any, significant issues to arise from review of the protocol based on the substantive contact it has had with the FDA since the Company had its Type C meeting with the Agency on December 16, 2013. In particular in its letter of May 16, 2014 to the Company, the FDA gave guidance on assessment methods and endpoints that Provectus has incorporated into its phase 3 submission.

Shareholders received a letter from the CEO dated July 8, 2014 that detailed these interactions with the FDA. The letter read in part, "The primary endpoint of the study is progression-free survival (PFS) assessed using standard RECIST 1.1 criteria. Secondary endpoints are complete response rate and overall survival. Progression-free survival and overall survival are standard endpoints for oncology approvals. With these assessment methods and endpoints we’re following what the FDA has suggested to document the clinical benefit to patients after intralesional injection. And, we’ll measure patient reported outcomes to better characterize the relationship between complete response and symptoms of locally advanced cutaneous melanoma, such as pain and bleeding."

Pipeline

B-701 is a human IgG1 monoclonal antibody that is highly specific for FGFR3 which is under development by BioClin Therapeutics for the treatment of cancer (Company Pipeline BioClin Therapeutics, NOV 6, 2014, View Source [SID:1234500934]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!