On September 1, 2015 Vaxin Inc., a clinical stage immunotherapy and vaccine company, reported that it has changed its corporate name to Altimmune, Inc. Vaxin was founded in 1997 to pioneer new-generation vaccine technologies and products (Press release, Altimmune, SEP 1, 2015, View Source [SID1234517080]). Since then, the company has achieved steady success, developing promising vaccine candidates for biodefense and other public health needs, as well as animal health. In a strategic growth move earlier this year, the company acquired UK-based Immune Targeting Systems (ITS) and added prominent new investors to its syndicate. The acquisition vaulted Vaxin into the immunotherapeutics sector, growing its therapeutics expertise, expanding its market, and broadening its global footprint. The new name marks the next chapter for the newly combined company.

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"The Vaxin brand has served as a superb ambassador of our vaccine product family, but the expansion of our product platform calls for a new brand," said president and CEO, Bill Enright. "The name Altimmune reflects the novel solutions we bring to the broader biotech marketplace today. Bold emphasis on the immune system is intentional; it speaks to alternative therapies that stimulate immune responses for prevention and treatment of diseases. With some of today’s most exciting research discoveries happening in this area, our new name conveys a promise to deliver essential innovation to the space."

Beyond a Vaccine Company

The company name change marks a high point for Altimmune. Last month, the company initiated a first-inman phase I clinical trial of HepTcell (FP-02.2), an immunotherapeutic compound to treat and potentially cure, people chronically infected with the hepatitis B virus (HBV). Patient enrollment has begun for the multicenter trial to be conducted at seven sites in the United Kingdom. The study aims to recruit 72 patients with chronic HBV infection. The clinical trial initiation augments rising momentum for Altimmune’s vaccine products. In its latest success, the company demonstrated in pre-clinical studies that a single intranasal vaccination with its NasoShield anthrax vaccine was non-inferior to the protection conferred by two vaccinations of the currently licensed Anthrax Vaccine Absorbed (AVA; BioThrax). Intranasal delivery is generally believed to be a superior vaccination route because the mucosal immune response has been shown to be important for protection, particularly against respiratory pathogens. Importantly, NasoShield produced protective immunity with earlier onset and greater persistence than AVA, suggesting that NasoShield may offer both rapid and long-lasting protection with just a single dose. The study results were published in the April 2015 issue of the prestigious journal, Clinical Vaccine Immunology. 2 Altimmune is headquartered in Gaithersburg, Maryland, with operating sites in the UK and France.

On August 31, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported that final clinical data from Stage 1 of the ongoing two-stage Phase 2 study (GOG-0265) of Advaxis’s lead Lm Technology immunotherapy, axalimogene filolisbac (ADXS-HPV), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), will be presented at the American Gynecological & Obstetrical Society (AGOS) annual meeting in Half Moon Bay, Calif. by Tom Hertzog, M.D., Clinical Director at the University of Cincinnati Cancer Institute, on September 17, 2015, at 11:15 a.m. PDT (Press release, Advaxis, AUG 31, 2015, View Source [SID:1234507360]).

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"There are limited therapies available in metastatic cervical cancer, particularly for patients who have failed at least one line of therapy," said Dr. Hertzog. "We see the potential for axalimogene filolisbac to fill a significant unmet need in the treatment of this disease and look forward to presenting these Stage 1 data at the AGOS annual meeting."

GOG-0265 is an open-label, single-arm, two-stage Phase 2 study designed to evaluate the safety, tolerability and efficacy of axalimogene filolisbac in approximately 67 patients with PRmCC who have received at least one prior line of systemic therapy. The primary efficacy endpoint is 12-month overall survival rate, with secondary efficacy endpoints of progression-free survival, overall survival and objective tumor response. The primary safety endpoints are the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

The trial is being conducted in the United States by the Gynecologic Oncology Group (GOG), now part of NRG Oncology, under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). Further information about the study can be found on ClinicalTrials.gov, using Identifier NCT01266460.

About Cervical Cancer

Cervical cancer is the fourth most common cancer and the most common cause of mortality 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’s 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.

On August 31, 2015 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX) aclinical stage oncology drug development company reported that the Company’s lead antibody, HuMab 5B1, will be garnering major attention as the subject of five separate presentations during the upcoming World Molecular Imaging Congress (WMIC) being held in Hawaii September 2-5, 2015 (Press release, MabVax, AUG 31, 2015, View Source [SID:1234507361]). Researchers from the Department of Radiology at Memorial Sloan Kettering Cancer Center (MSK) will present results on the use of MabVax’s lead antibody as a PET imaging agent and as a radioimmunotherapy agent targeting pancreatic cancer.

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Presenters at the WMIC include Jacob Houghton, Ph.D. of MSK, who will present results from two preclinical in vivo studies using the HuMab 5B1 antibody as an ImmunoPET imaging agent in the context of circulating antigen as well as new pretargeted methods for the immunoPET imaging of CA19.9 in murine models of pancreatic cancer. Dalya Abdel-Atti will present the results of using HuMab5B1 in ImmunoPET imaging with newly developed murine organoid models of pancreatic cancer. A third presenter, Jan-Philip Meyer, Ph.D., will present results of using HuMab 5B1 as a pre-targeting agent followed by administration of the short-lived (18F)-NOTA-labeled tetrazine radioligand for PET imaging and in vivo coupling, examining the efficiency of HuMab5B1 in imaging and the reduction in exposure to the radiolabel. All four presentations illustrate the potential utility of the antibody as a next generation imaging agent for pancreatic cancer. Lastly, Ryan Lanning, M.D. Ph.D., will present the results of using HuMab 5B1 as a radioimmunotherapy agent for treatment of pancreatic cancer.

Because five-year survival rates in pancreatic cancer are only 5% and more than half of all patients initially diagnosed already have metastatic disease, the difficulties in identifying distant metastases that often go undetected as well as developing advanced therapeutics to treat this difficult cancer are significant unmet medical needs. These researchers at MSK are on the cutting edge of this technology and may well help develop a new generation of diagnostic and therapeutic agents using HuMab 5B1. Continuing studies of HuMab 5B1 could further demonstrate the utility of a broad technology platform useful both as a imaging and therapeutic agent.

About HuMab 5B1
The fully human antibody HuMab 5B1 was recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center. The HuMab 5B1 has demonstrated high specificity, affinity, and lack of cross-reactivity with similar antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon, and small cell lung cancers. Ongoing toxicology results continue to demonstrate an acceptable profile in acute and repeat dose studies in animals. MabVax plans to initiate two complementary Phase I clinical trials in the first quarter of 2016. One clinical trial is aimed at determining the safety and potential utility of HuMab 5B1 as a therapeutic agent in subjects with metastatic pancreatic cancer. The second clinical trial is aimed at demonstrating the utility of 89Zr-HuMab 5B1, the Company’s radio-labeled HuMab 5B1 antibody, as a next-generation PET imaging agent for the diagnosis, staging, and management of pancreatic cancer.

On August 31, 2015 Diffusion Pharmaceuticals LLC reported that Company CEO David G. Kalergis, MBA/JD, will be a guest speaker at the 2015 American Cancer Society CAN Virginia Research Breakfast, to be held September 17, 2015 at the Hilton Garden Inn, Glen Allen, Virginia (Press release, Diffusion Pharmaceuticals, AUG 31, 2015, View Source [SID:1234507363]). His topic will be the possible impact of the Company’s transformative new drug trans sodium crocetinate (TSC) on the treatment of cancer in years to come.

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The other speakers will be Dr. Gordon D. Grinder, Director, Massey Cancer Center, VCU; Dr. Thomas P. Loughran, Director, UVA Cancer Center; and Dr. Harold Sontheimer, Director Glial Biology, Disease and Cancer Center, VT Carilion Research Center.

Diffusion Pharmaceuticals recently announced results from its recently completed Phase 1/2 TSC GBM study in 59 patients with newly diagnosed glioblastoma (GBM), the most common and aggressive form of primary brain cancer. The results demonstrated that people who received TSC plus radiotherapy and chemotherapy benefited from an improvement in overall survival compared to the historical control group who received radiotherapy and chemo alone.

TSC plus radiotherapy and chemotherapy increased the patients’ chance of survival at two years by 37 percent compared to the control group. In the subgroup of patients considered inoperable, the chance of survival at two years for those who received TSC was increased by over 100 percent. No negative safety findings were observed in the TSC GBM study and no serious adverse events were attributed to TSC in any patient.

TSC currently has FDA Orphan Designations in GBM and metastatic brain cancer. In August 2015, agreement was reached with the FDA on a proposed single Phase 3 GBM study design which, if successful, could support TSC’s approval. Diffusion plans to initiate the study in 1H 2016.

In addition to moving TSC forward for the treatment of GBM, the Company is preparing it for clinical trials in other solid tumor cancer indications.

On August 28 2015 Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) reported that it has received its BLA Filing Notification for MCNA from the U.S. Food and Drug Administration (FDA). This formal letter communicates that the FDA has completed its initial review of Telesta’s Biologics License Application (BLA) submitted on June 29, 2015 and has accepted it for filing (Press release, Telesta Therapeutics, AUG 28, 2015, View Source [SID:1234507865]). In the same letter, the FDA communicated that it has designated the file for 6 month Priority Review and has set February 27, 2016 as the review goal date for MCNA. The FDA has also advised that it will be organizing an advisory committee to discuss the BLA application.

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Commenting on the FDA letter, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist noted: "Today is a historic day for Telesta Therapeutics and for all of our staff and collaborators who have worked so diligently to advance our new treatment for non-muscle invasive bladder cancer towards potential regulatory approval early next year. While we recognize that the FDA must complete its full review of our BLA filing before rendering its ultimate decision, we are working extremely hard, at all levels, to prepare for commercial launch in the United States."

About MCNA

MCNA is a biologic therapy developed to provide high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy with a therapeutic alternative to surgery. MCNA is derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects. MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line bacillus Calmette-Guérin (BCG) therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety data from MCNA’s pivotal Phase 3 trial was recently published in The Journal of Urology. The FDA has set February 27, 2016 as its review goal date for MCNA’s potential approval.

About Telesta Therapeutics Inc.

Telesta Therapeutics Inc. is a late stage therapeutics company with near term commercial potential focused on the manufacturing, marketing and licensing/acquisition of proprietary and innovative therapies for the global health market. The Company’s primary goal is to develop and commercialize products that advance human health and increase shareholder value. For more information, please visit www.telestatherapeutics.com