On September 21, 2015 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported that data from ongoing phase 1 trials of Endocyte’s SMDC EC1456 will be presented at the European Cancer Congress 2015, being held Sept. 25 – 29, 2015, in Vienna, Austria (Press release, Endocyte, SEP 21, 2015, View Source [SID:1234507511]).

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The presentation materials will be available on Endocyte’s website following presentation at the conference.

Presentation is as follows:

Poster Presentation: An ongoing Phase 1 dose-escalation study of the folic acid-tubulysin in small-molecule drug conjugate (SMDC) folate-tubulysin EC1456
When: Sunday, Sept. 27, 16:45 – 18:45 p.m. CEST
Poster Session: Early Drug Development
Presenter: Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore

About EC1456

EC1456 is an investigational proprietary, injectable, SMDC consisting of folate (vitamin B9) linked to a potent cytotoxic agent, tubulysin B hydrazide (TubBH). EC1456 is wholly owned by Endocyte. TubBH is a member of the tubulysin class of anti-neoplastic agents that inhibit the polymerization of tubulin into microtubules, a critical component during cell division. The targeting ligand folate, essential for cell division, has been investigated with vintafolide. EC1456 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT01999738).

On September 21, 2015 Deciphera Pharmaceuticals, a clinical-stage biotechnology company focused on developing advanced kinase inhibitor treatments targeting the tumor cell and the tumor microenvironment, reported that it has closed a $75 million Series B financing led by New Leaf Venture Partners and joined by Deciphera’s existing investors (Press release, Deciphera Pharmaceuticals, SEP 21, 2015, View Source [SID:1234507509]). The proceeds will enable Deciphera to advance its pipeline of proprietary switch control kinase inhibitors through multiple key clinical milestones. Concurrent with the financing, Liam Ratcliffe, M.D., Ph.D., Managing Director at New Leaf Venture Partners, will join Deciphera’s board of directors.

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"We are very pleased to have secured significant funding from one of the preeminent life science investors, New Leaf Venture Partners, whose commitment to Deciphera reflects the strong potential of our unique switch control kinase inhibitors to address the unmet needs of patients with cancer," said Michael D. Taylor, Ph.D., President and CEO of Deciphera Pharmaceuticals. "The proceeds of this financing will be used to advance our lead candidates, altiratinib and DCC-2618, through clinical proof- of-concept and further develop our strong pipeline including rebastinib and DCC-3014."

Altiratinib is currently in a late Phase 1 dose escalation study with Phase 1 expansion trials in patients with actionable MET genomic alterations expected to start early in 2016. DCC-2618 is expected to enter a first-in-human Phase 1 dose escalation trial before the end of the year.

"New Leaf Venture Partners is excited to support the Deciphera team as they develop multiple promising drug candidates that address the continued need for effective and safe medicines in the treatment of cancer," said Dr. Ratcliffe. "We believe that Deciphera has developed an exceptional pipeline of unique switch control kinase inhibitors that will provide the foundation for building a substantial oncology company."

Deciphera’s proprietary switch control kinase inhibitor technology platform has enabled the development of advanced small molecule kinase inhibitor therapeutics that provide robust and durable kinase binding and block key cancer signaling mechanisms and mutational resistance. Deciphera’s product pipeline includes four product candidates in Phase 1 clinical development including altiratinib (DCC-2701), a MET/TIE2/VEGFR2/TRK inhibitor; DCC-2618, a pan-KIT inhibitor; rebastinib, a TIE2 kinase inhibitor; and a pan-RAF inhibitor (LY-3009120) being developed by partner Eli Lilly. In addition, DCC-3014, Deciphera’s selective inhibitor of CSF1R, is currently in preclinical development.

On September 18, 2015 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, reported that the Phase 1a/1b clinical trial combining FPA008 with OPDIVO (nivolumab) in multiple tumor types was featured today in a trial-in-progress poster at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in New York City (Press release, Five Prime Therapeutics, SEP 18, 2015, View Source [SID:1234507502]). FPA008 is Five Prime’s monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R). OPDIVO is Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor. The poster entitled "A Phase 1a/1b Study of FPA008 in Combination with Nivolumab in Patients with Selected Advanced Cancers" was presented by F. Stephen Hodi, Jr., M.D., of Dana-Farber Cancer Institute.

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The comprehensive design of the study, which is being conducted by Five Prime under a clinical collaboration with Bristol-Myers Squibb, will allow the company to explore the potential of FPA008 in immuno-oncology, both as a monotherapy and in combination with anti-PD-1 therapy. During Phase 1a, Five Prime will evaluate the safety, pharmacokinetics and biomarkers of escalating doses of FPA008 alone, and in combination with the approved 3 mg/kg dose of nivolumab. Approximately 30 patients with advanced cancers are expected to be enrolled during Phase 1a and both drugs will be administered every two weeks. In Phase 1b, Five Prime will evaluate the safety, tolerability and preliminary efficacy of the selected dose of FPA008 in combination with nivolumab in approximately 240 patients across eight tumor settings:

Second- or third-line non-small cell lung cancer (NSCLC, anti PD-1 therapy naïve)
Anti PD-1 therapy resistant NSCLC (either de novo or acquired)
Previously untreated melanoma (anti PD1 therapy naïve)
Anti PD-1 therapy resistant melanoma (de novo)
Second-line squamous cell carcinoma of the head and neck
Second-line pancreatic cancer
Third-line colorectal cancer
Second-line glioblastoma multiforme (GBM)

Tumor biopsies will be obtained both pre-treatment and one month post-treatment in all patients enrolled in the Phase 1a portion and in a subset of patients enrolled in the Phase 1b portion to analyze the immune response within the tumor microenvironment. Five Prime will use this analysis to further guide FPA008’s development in oncology.

"We are pleased to now have patient dosing underway and to be evaluating the FPA008/nivolumab immunotherapy combination in the original six tumor settings we’ve communicated, as well as in two additional settings, anti-PD1 resistant non-small cell lung cancer and melanoma," said Julie Hambleton, M.D., Executive Vice President and Chief Medical Officer of Five Prime. "We remain on track to complete Phase 1a dose escalation and expand into Phase 1b across the eight tumor settings in late 2015 or early 2016."

About FPA008

FPA008, Five Prime’s antibody that inhibits colony stimulating factor-1 receptor (CSF1R), targets macrophages and monocytes, which are activated or elevated in multiple disease settings. In cancer, tumor-associated macrophages suppress the immune system’s ability to kill cancer cells. In joint diseases, such as PVNS and RA, synovial macrophages play a central role in the disease process. Five Prime is evaluating the immunotherapy combination of FPA008 and OPDIVO (nivolumab), Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor, in six tumor types in a Phase 1a/1b clinical trial. Five Prime is also conducting a Phase 1/2 trial of FPA008 in pigmented villonodular synovitis (PVNS), a joint tumor driven by the CSF1 pathway and an orphan disease, and a Phase 1 study in rheumatoid arthritis.

On September 18, 2015 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer immunotherapies, reported the presentation of clinical and preclinical data from the Company’s Ad-RTS-IL-12 program in various malignancies at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) taking place September 16-19, 2015 in New York City (Press release, Ziopharm, SEP 18, 2015, View Source [SID:1234507506]). Ad-RTS-IL-12 is a novel gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T cell immune response.

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The first poster presentation, titled, "Demonstration of Systemic Antitumor Immunity via Intratumoral Regulated Expression of IL-12 in Advanced Breast Cancer and Melanoma Patients," highlights additional evidence of systemic immune activation with AD-RTS-hIL-12 and veledimex in advanced melanoma and breast cancer patients. The data were drawn from two previously completed open-label Phase II clinical studies: one which enrolled 12 patients with metastatic advanced stage breast cancer, and one which enrolled 26 patients with metastatic melanoma, both exploring the immune-mediated local and systemic anti-tumor effects of Ad-RTS-hIL-12 and veledimex. Among other findings, treatment with Ad-RTS-hIL-12 and veledimex in patients with melanoma was found to increase in the immune cytokine IL-12 and downstream cytokines, IFNg, IP-10 and IL-10, resulting in a significant increase in tumor infiltrating lymphocytes both locally, in injected lesions, and systemically, in non-injected lesions.

The second poster presentation, titled "Demonstration of Systemic Antitumor Immunity via Intratumoral Regulated Expression of IL-12 as a Gene Therapy Approach to Treatment of Cancer," demonstrates the anti-tumor effects and tolerability of Ad-RTS-mIL-12 in murine models of glioblastoma (brain cancer), colon cancer and melanoma. The data demonstrated dose-related increases in veledimex in both plasma and brain tissue, leading to an increase in expression of IL-12 mRNA and in-tumor IL-12p70 expression with minimal increase in serum IL-12. Ad-RTS-mIL-12 + veledimex also demonstrated systemic memory upon rechallenge in multiple syngeneic mouse models, providing further evidence of systemic anti-tumor immunity elicited by Ad-RTS-mIL-12.

Both posters are available under "Presentations and Publications" on the Company’s website at www.ziopharm.com. In addition to the poster presentations, Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM, is scheduled to deliver an oral presentation titled "Non-viral gene transfer to redirect T cell specificity" on Saturday, September 19.

"Clinical and preclinical data from our Ad-RTS-IL-12 program continue to demonstrate the ability to achieve both local anti-tumor effect and systemic effects across a variety of malignancies," said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. "We look forward to understanding how these results translate to our ongoing, multicenter Phase 1 gene therapy study in malignant glioma as well as our Phase 1b/2 Study in locally advanced or metastatic breast cancer. These data also provide support for our integration of both the RTS gene switch and cytokines into our broader adoptive cell therapy programs."

On September 18, 2015 Heron Therapeutics, Inc. (NASDAQ: HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs, reported that the U.S. Food and Drug Administration (FDA) has accepted for review Heron’s New Drug Application (NDA) resubmission for SUSTOL (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens (Filing, 8-K, Heron Therapeutics, SEP 18, 2015, View Source [SID:1234507497]). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016.

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The NDA filing includes data from the MAGIC study, Heron’s recently completed, multi-center, placebo-controlled, Phase 3 study of SUSTOL for the prevention of delayed CINV in more than 900 patients receiving HEC regimens. Data from an earlier Phase 3 study of more than 1,300 patients, which were previously submitted to the FDA, demonstrated SUSTOL’s efficacy in the prevention of acute and delayed CINV associated with MEC regimens and acute CINV associated with HEC regimens.

"We believe that the MAGIC study has demonstrated SUSTOL’s superior ability to improve the lives of patients suffering from the debilitating effects of nausea and vomiting associated with chemotherapy compared to the current standard-of-care," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "We look forward to working closely with the FDA during the review of the SUSTOL NDA and moving forward with commercial planning in anticipation of SUSTOL’s potential launch early next year."

About SUSTOL for Chemotherapy-Induced Nausea and Vomiting

SUSTOL (granisetron) Injection, extended release, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is Heron’s novel, long-acting formulation of granisetron for the prevention of chemotherapy-induced nausea and vomiting (CINV). Granisetron, an FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist was selected due to its broad use by physicians based on a well-established record of safety and efficacy. SUSTOL has been shown to maintain therapeutic drug levels of granisetron for five days with a single subcutaneous injection. SUSTOL is being developed for the prevention of both acute (day 1 following the administration of chemotherapy agents) and delayed (days 2-5 following the administration of chemotherapy agents) CINV associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). While other 5-HT3 antagonists are approved for the prevention of CINV, SUSTOL is the first agent in the class to demonstrate efficacy in reducing the incidence of delayed CINV in patients receiving HEC, a major unmet medical need, in a randomized Phase 3 study.

Affecting 70-80% of patients undergoing chemotherapy, CINV is one of the most debilitating side effects of such treatments, often attributed as a leading cause of premature discontinuation of cancer treatment. 5-HT3 receptor antagonists have been shown to be among the most effective and preferred treatments for CINV. However, an unmet medical need exists for patients suffering from CINV during the delayed phase, which occurs on days 2-5 following the administration of chemotherapy agents. Only one 5-HT3 receptor antagonist is approved for the prevention of delayed CINV associated with MEC, and no 5-HT3 receptor antagonists are approved for prevention of delayed CINV associated with HEC.

SUSTOL was the subject of a recently completed, multi-center, placebo-controlled, Phase 3 clinical study in patients receiving HEC regimens known as MAGIC. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the corticosteroid dexamethasone. The MAGIC study, which was conducted entirely in the U.S. using the 2011 ASCO (Free ASCO Whitepaper) guidelines for classification of emetogenic potential, is the only Phase 3 CINV prophylaxis study in a HEC population performed to date to use the currently recommended, standard-of-care, three-drug regimen as a comparator: a 5-HT3 receptor antagonist, fosaprepitant, and dexamethasone. The study’s primary endpoint was achieved. Specifically, the percentage of patients who achieved a Complete Response in the delayed phase was significantly higher in the SUSTOL arm compared with the comparator arm (p=0.014). Adverse events reported in the study were generally mild to moderate in severity and of short duration, with the most common being injection site reactions (ISRs). In July 2015, Heron resubmitted its New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA), and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016. SUSTOL is not approved by the FDA or any other regulatory authority.