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]).

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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."

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.

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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."

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]).

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CYP0150 is a recombinant protein consisting of a human IL-15 linked to the Sushi+ domain of the human alpha chain receptor (transpresentation) which is under development by Cytune Pharma for the treatment of cancer (Company Pipeline Cytune Pharma, NOV 6, 2014, View Source [SID:1234500931]).

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On November 6, 2014 Genmab reported additional data from the interim analysis of the ofatumumab (Arzerra) Phase III study, PROLONG (OMB112517) (Press release Genmab, NOV 6, 2014, View Source [SID:1234500929]). The study evaluated ofatumumab maintenance therapy versus no further treatment (observation) in patients with a complete response (CR) or partial response (PR) after 2nd or 3rd line treatment for chronic lymphocytic leukemia (CLL). The improvement in the study’s primary endpoint, progression free survival (PFS), met the prespecified statistical significance level for the interim analysis.

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A total of 474 patients were included in the interim analysis. Patients who received ofatumumab maintenance treatment lived 13.4 months longer without their disease worsening (median PFS) than patients who received no further treatment. Median PFS was 28.6 months for the ofatumumab treatment arm and 15.2 months for the observation arm (Hazard Ratio 0.48; p<0.0001).

The amount of time until patients started their next therapy was significantly longer in the ofatumumab treatment arm than in the observation arm (median 38.0 months vs 27.4 months, Hazard Ratio 0.63; p=0.0076).

There were no unexpected safety findings. Adverse events occurred in 87% of patients in the ofatumumab treatment arm versus 75% in the observation treatment arm. In the ofatumumab treatment arm, 25% of patients experienced grade 3-4 adverse events compared to 17% in the observation arm. Grade 3-4 infections were 18% in the ofatumumab arm and 13% in the observation arm. The two most common grade 3-4 adverse events were neutropenia (22% in ofatumumab arm vs 9% in observation arm), and pneumonia (7% in ofatumumab arm vs 4% in observation arm). The death rate was similar in both arms (14%).

"The interim results of this study show that ofatumumab maintenance therapy significantly extended the amount of time the patients in the study lived without their CLL symptoms getting worse," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

These data will be presented in an oral session at the 56th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in San Francisco, California on December 6 from 12 Noon to 1:30PM PST.