On March 07, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported dose administration for the first patient in the expansion phase of an ongoing Phase 2 clinical trial of its lead Lm immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) (Press release, Advaxis, MAR 7, 2016, View Source [SID:1234509384]). Schedule your 30 min Free 1stOncology Demo! The interventional, open-label, non-randomized dose-escalation study is designed to evaluate the safety, efficacy and immunological effect of AXAL administered at doses up to 1 x 1010 colony forming units (CFU) in repeat cycles of treatment in approximately 25 women with cervical cancer whose disease recurred after receiving one prior cytotoxic treatment regimen. The study is being led by principal investigator Sharad Ghamande, M.D., Director of Gynecology Oncology at GRU Cancer Center, Augusta University in Augusta, Ga.
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Launch of the expansion phase follows a poster presentation of preliminary data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2015 Annual Meeting, where data from 9 patients showed that AXAL could be safely administered with prophylactic antibiotics up to 1 x1010 CFU, a tenfold increase from prior dosing regimens at 1 x 109. Adverse events at this high dose were consistent with previous experience with predominately grade 1 or grade 2, transient events that self-resolved or were resolved with anti-inflammatory agents (NSAIDS) and antiemetics. The high dose expansion phase will include 15 patients.
"The launch of the expansion phase of this clinical study is an important next step in AXAL’s development program. This study will further explore what our research has shown to date – that a higher dose drives an increase in protein expression in the cytosol and results in greater generation of T cells to the HPV target," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "AXAL holds the potential to fill an unmet treatment gap for women with recurrent cervical cancer."
About Cervical Cancer
Cervical cancer is the fourth most common cancer in women worldwide. In the United States, nearly 13,000 new cases are diagnosed and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.
About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’ lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology. Axalimogene filolisbac has Orphan Drug Designation in the U.S. for the treatment of invasive cervical cancer, head and neck, and anal cancer.
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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]
vTv Therapeutics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, vTv Therapeutics, 2017, MAR 4, 2016, View Source [SID1234521320]).
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20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]
(Filing, Annual, Sanofi, 2016, MAR 4, 2016, View Source [SID:1234509376])
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Karolinska Development portfolio company Akinion Halts Further Development of AKN-028 due to Safety Concerns
On March 4, 2016 Karolinska Development AB (Nasdaq Stockholm: KDEV) reported that Akinion, a KDev Investments portfolio company, has halted further development of its lead product candidate AKN-028, which was being evaluated in a Phase I/II clinical study for acute myeloid leukemia (AML), due to a small number of patients experiencing severe liver toxicity (Press release, Akinion Pharmaceuticals, MAR 4, 2016, http://www.karolinskadevelopment.com/?cID=551&pid=875351&did=699813&y=2016&m=03 [SID:1234512168]). As a consequence, Karolinska Development’s portfolio Net Fair Value will decrease by SEK 78 million.
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Jim Van heusden, CEO of Karolinska Development, said: "Today´s announcement is obviously very disappointing news for patients with acute myeloid leukemia given the great need for improved treatment options for this difficult-to-treat cancer. It’s unfortunate, but also illustrates the risks inherent in investing in the development of novel drug candidates."
SRI International Receives $19.8 Million National Cancer Institute Contract for PREVENT Cancer Program
On March 10, 2016 SRI International reported that it has been awarded a contract of up to $19.8 million from the National Cancer Institute (NCI) PREVENT Cancer Preclinical Drug Development Program to support the development of potential cancer preventive agents or vaccines (Press release, SRI International, MAR 4, 2016, View Source [SID:1234509760]). Under the contract, SRI Biosciences, a division of SRI International, will conduct preclinical studies to assess the efficacy of specific compounds or vaccines for preventing invasive-cancer development. Researchers will also identify biomarkers to help quantify the effectiveness of the experimental compounds and vaccines.
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The PREVENT Cancer Drug Development Program is an NCI-supported pipeline to bring new cancer PREVENTing interventions and biomarkers through preclinical development towards clinical trials. PREVENT enables the milestone-driven progression of novel cancer PREVENTive chemical or biological agents (singly or in combination), and biomarkers from the lab bench towards proof-of principle preclinical and clinical testing and registration or validation.
"The discovery and development of cancer preventative agents is an area that is underserved, primarily because the length of required clinical trials can be resource-prohibitive for many companies. Our work in biomarker discovery may provide validated surrogate endpoints that can help to shorten clinical trials in cancer prevention," said Lidia Sambucetti, Ph.D., senior director of Cancer Biology, Center for Discovery Technologies, SRI Biosciences, and principal investigator for the NCI contract. "The PREVENT program is an opportunity to identify and advance novel strategies for cancer prevention."
Under the three-year contract, SRI Biosciences will conduct detailed preclinical pharmacological studies to determine the efficacy of experimental agents, as well as test biomarkers that may parallel the effectiveness of response to these agents.
Under the PREVENT program, for efficacy and biomarker testing, two NCI task orders in the area of cancer prevention have already been awarded to SRI Biosciences: The first to develop a mesothelin-based vaccine against ovarian cancer, and another to develop novel models for testing preventative agents against ovarian cancer.
For the ovarian cancer program, SRI Biosciences optimized a vaccine strategy designed to mount both antibody-based and cellular immunity against mesothelin tumor antigen. SRI researchers are currently testing whether the vaccine can help prevent ovarian cancer. In addition, SRI generated encouraging data supporting the development of a new model that will be used to test experimental drugs for ovarian cancer prevention.
"Efforts toward cancer prevention are the best long-term investments to protect the health of society as a whole while also reducing the healthcare costs," said Nathalie Scholler, M.D., Ph.D., director Cancer Immunology, Center for Cancer, SRI Biosciences and lead on the ovarian cancer program.
SRI has broad experience with similar studies for NCI and for many other divisions of the National Institutes of Health, as well as for private sponsors.
This project has been funded in whole or in part with Federal funds from the National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN261201500041I & HHSN261201200014I"
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. – See more at: View Source#sthash.Gwxi65Wc.dpuf