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Advaxis Unveils State-of-the-art Manufacturing Facility, Laboratory to Produce and Develop Novel Immuno-Oncology Therapeutics

On September 12, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that it has welcomed New Jersey Governor Christopher J. Christie and BioNJ President and Chief Executive Officer Debbie Hart on Sept. 9 to celebrate the completion of its new state-of-the-art manufacturing facility and laboratory with a ribbon-cutting event before close to 200 people (Press release, Advaxis, SEP 12, 2016, View Source [SID:SID1234515095]).

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A photo accompanying this release is available at View Source

Advaxis built out the 30,000-square-foot expansion at its College Road East headquarters to include a clean-room manufacturing and laboratory facility to develop and manufacture clinical-grade products to support Advaxis’ clinical trials and future commercialization of its immuno-oncology therapeutics.

"I’m proud Advaxis is increasing its footprint and investment in the Garden State and specifically the Princeton Corridor, which in the past several years has grown as a beacon for world-renowned biotech and life sciences accomplishments," Governor Christie said. "For the benefit of New Jerseyans, Advaxis is emerging as a leading innovator in the biotech industry, rapidly developing state-of-the-art cancer treatment for patients in need, creating great private-sector jobs and attracting private investments from global companies who want to be a part of its budding successes."

Advaxis is conducting several clinical trials evaluating its proprietary Lm Technology using bioengineered live attenuated Listeria monocytogenes (Lm) bacteria to activate the immune system to attack cancer cells. In addition, the company announced a global collaboration agreement with Amgen for its My Immunotherapy Neo-Epitopes or MINE program for the development of ADXS-NEO, which will enter phase 1 trials in 2017.

"The Advaxis team believed in this technology and believed that it could help patients in need even when the company was struggling a few years ago, but just this year, the company has reported two complete responses in patients who have received AXAL in clinical trials, meaning the cancer in these two patients has disappeared," said Ms. Hart during the event. "Advaxis is a true New Jersey success story."

AXAL, or axalimogene filolisbac, is being tested in a Phase 3 clinical study called AIM2CERV to evaluate safety and efficacy in patients with high-risk, locally advanced cervical cancer. The U.S. Food and Drug Administration (FDA) has granted AXAL orphan drug designation as well as Fast Track designation for adjuvant therapy and a Special Protocol Assessment for the Phase 3 AIM2CERV trial. The trial is set to dose its first patient this year.

"Governor Christie’s administration has worked to help life science companies like Advaxis and many others succeed here in New Jersey, and his leadership in this field has benefited our state with jobs and economic development, and, more importantly, has facilitated Advaxis’ opportunity to develop its immunotherapies with the goal of helping cancer patients around the world for years to come," said Daniel J. O’Connor, president and CEO of Advaxis.

IntelGenx Announces Development and Commercialization Agreement for Three Products with Chemo Group, A Global Pharmaceutical Company

On September 12, 2016 IntelGenx Corp., (TSXV: IGX) (OTCQX: IGXT), reported that they have entered into a licensing, development and supply agreement with Chemo Group ("Chemo") granting Chemo the exclusive license to commercialize two generic products for the USA market and one product on a worldwide basis (Filing, 8-K, IntelGenx, SEP 12, 2016, View Source [SID:SID1234515092]).

The Chemo Group is a privately held global pharmaceutical company with over 5,000 employees and operations in over 40 countries and revenues over $1.2 billion annually.

Under the terms of the agreement, Chemo has obtained certain exclusive rights to market and sell IntelGenx’ products in exchange for upfront and milestone payments, together with a share of the profits of commercialization. Chemo also has a right of first refusal to obtain the exclusive commercialisation rights for two of the products to include any country outside the USA.

"We are pleased to have established a partnership with a significant global pharmaceutical company," commented Dr. Horst Zerbe, President and CEO of IntelGenx. "This is the first step into a long term strategic alliance. We see the completion of this deal as further validation of our oral delivery platforms and our ability to attract high quality partnerships. This partnership is the beginning of what we believe will lead to further product agreements in expanding our global reach of our innovative product pipeline."

Aptose Submits Formal Response to Clinical Hold for APTO-253

On September 12, 2016 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, reported that it has submitted a formal response to the U.S. Food and Drug Administration (FDA) regarding the previously announced clinical hold of Aptose’s Phase 1b clinical trial of APTO-253 in patients with hematologic cancers (Press release, Aptose Biosciences, SEP 12, 2016, View Source;p=RssLanding&cat=news&id=2201082 [SID:SID1234515091]). Aptose provided responses to all of the questions cited in the clinical hold letter issued by the FDA.

"This submission represents months of disciplined labor to resolve a manufacturing matter related to APTO-253 that arose during our Phase 1b Trial in patients with AML and high-risk MDS," commented Dr. William G. Rice, Chairman, President and Chief Executive Officer. "Although the FDA will make the ultimate decision whether our clinical trial may resume, all of their questions have been addressed."

During a Phase 1b clinical trial with APTO-253, a clinical site experienced stoppage of the infusion pump during an IV infusion caused by back pressure as a result of clogging of the in-line filter. The Company determined the root cause was a chemistry-based issue with the molecule, and the Company is now working with a drug product that does not cause filter clogging or pump stoppage during mock infusion studies performed to confirm the acceptability of the updated product through the clinical infusion procedures. Such improvements to the APTO-253 manufacturing process required to address the filter clogging event will be incorporated into a Chemistry, Manufacturing and Control (CMC) amendment to our Investigational New Drug application.

CytRx to Present Data at the European Society for Medical Oncology 2016 Congress from Aldoxorubicin Plus Ifosfamide/Mesna Combination Clinical Trial

On September 12, 2016 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that results from its on-going Phase 1b/2 trial of aldoxorubicin in combination with ifosfamide/mesna in patients with advanced sarcomas will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress being held in Copenhagen, Denmark, from October 7-11, 2016 (Press release, CytRx, SEP 12, 2016, View Source;p=RssLanding&cat=news&id=2201143 [SID:SID1234515090]).

"Presenting the results from this trial at the ESMO (Free ESMO Whitepaper) Congress underscores the continued anti-tumor activity of aldoxorubicin across a variety of treatment settings for patients with advanced sarcomas," said Sant Chawla, M.D., F.R.A.C.P., the trial’s principal investigator and Director of the Sarcoma Oncology Center in Santa Monica, California. "The data show that aldoxorubicin can successfully be combined with ifosfamide and mesna, which are regularly given with doxorubicin to patients with first-line soft tissue sarcomas. Based on encouraging results, the trial was expanded to 50 patients and continues to enroll."

The Phase 1b/2 clinical trial has enrolled 38 patients to date with locally advanced, unresectable, and/or metastatic soft tissue sarcoma, intermediate-grade or high-grade chondrosarcoma or osteosarcoma. In the dose escalation phase, patients received either 170mg/m2 or 250mg/m2 of aldoxorubicin in combination with up to a 14-day continuous infusion of ifosfamide (1g/m2/day) plus mesna over a 28-day cycle. The expansion phase will enroll patients at the 250mg/m2 dose of aldoxorubicin and will allow for patients that had received prior chemotherapy to be included. The primary endpoint of the study is safety, and secondary endpoints include overall response rates and progression-free survival.

About Aldoxorubicin

Aldoxorubicin is a rationally-engineered cytotoxic which combines doxorubicin, a widely used chemotherapeutic agent, with a novel linker molecule that binds directly and specifically to circulating albumin, the most abundant protein in the bloodstream. Protein-hungry tumors concentrate albumin, which facilitates the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. Typically, doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Using this acid-sensitive linker technology, aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4 times). To date, there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2. Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized clinical trial in first-line STS.

RedHill Biopharma Announces Research Collaboration with Stanford University for YELIVA™

On September 12, 2016 RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported a research collaboration with Stanford University School of Medicine ("Stanford") for the evaluation of RedHill’s proprietary Phase II-stage drug, YELIVA (ABC294640) (Press release, RedHill Biopharma, SEP 12, 2016, View Source [SID:SID1234515076]).

The research collaboration is intended to complement RedHill’s planned Phase Ib clinical study to evaluate YELIVA as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy.

As part of the collaboration, Stanford will evaluate the effect of YELIVA on mucositis reduction and tumor control in a murine model of head and neck cancer. YELIVA will be administered in combination with a chemotherapy agent and radiotherapy, similar to the design of RedHill’s planned radioprotectant Phase Ib clinical study with YELIVA, expected to run in parallel with the Stanford research collaboration. Results from the research collaboration are expected in mid-2017.

The Stanford research collaboration is led by Dr. Quynh-Thu Le, MD, a radiation oncologist, Chair of the Stanford Radiation Oncology Department, Co-Director of the Radiation Biology Program of the Stanford Cancer Institute and the Chair of the Head and Neck Cancer Committee of the NRG Oncology Group, part of the National Cancer Institute (NCI) supported National Clinical Trial Network (NCTN).

YELIVA is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anti-cancer and anti-inflammatory activities. By inhibiting the SK2 enzyme, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid signaling molecule that promotes cancer growth and pathological inflammation.

RedHill is pursuing with YELIVA multiple clinical programs in oncology, inflammatory and gastrointestinal indications. RedHill is evaluating potential clinical studies for additional oncology and inflammatory indications, as well as potential collaboration opportunities to evaluate YELIVA as an add-on therapy.

Results from the Phase I study with YELIVA in patients with advanced solid tumors confirmed that the study, conducted at the Medical University of South Carolina (MUSC), successfully met its primary and secondary endpoints, demonstrating that the drug is well- tolerated and can be safely administered to cancer patients at doses that provide circulating drug levels that are predicted to have therapeutic activity.

Among the 16 subjects that were assessable for response by RECIST 1.1 criteria (Response Evaluation Criteria in Solid Tumors), one subject had a partial response with a progression-free survival of 16.9 months, and six subjects had stable disease with a progression-free survival of between 3.5 and 17.6 months. Of the three patients with cholangiocarcinoma, one had a partial response and the other two had stable disease, one for over a year. YELIVA was well-tolerated over a prolonged period at doses inducing the expected pharmacodynamic effects.

A Phase Ib/II study with YELIVA for the treatment of refractory or relapsed multiple myeloma has recently been initiated at Duke University Medical Center. The study is supported by a $2 million grant from the National Cancer Institute (NCI) Small Business Innovation Research Program (SBIR) awarded to Apogee Biotechnology Corp. (Apogee), in conjunction with Duke University, with additional support from RedHill.

A Phase II study with YELIVA for the treatment of advanced hepatocellular carcinoma is planned to be initiated in the coming weeks. The study will be conducted at MUSC Hollings Cancer Center and additional clinical centers in the U.S. It is supported by a $1.8 million grant from the NCI awarded to MUSC, intended to fund a broad range of studies on the feasibility of targeting sphingolipid metabolism for the treatment of a variety of solid tumor cancers, including the Phase II study with YELIVA and will be further supported by additional funding from RedHill.

A Phase I/II clinical study evaluating YELIVA in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL) was initiated at the Louisiana State University Health Sciences Center (LSUHSC) in New Orleans in June 2015 and is expected to resume later this year following administrative hold and pending a protocol amendment aimed at improving overall recruitment. The study is supported by a grant awarded to Apogee from the NCI as well as additional support from RedHill.

The studies with YELIVA (ABC294640) are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

About YELIVA (ABC294640):
YELIVA (ABC294640) is a Phase II-stage, proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anti-cancer and anti-inflammatory activities. RedHill is pursuing with YELIVA multiple clinical programs in oncology, inflammatory and gastrointestinal indications. By inhibiting the SK2 enzyme, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid signaling molecule that promotes cancer growth and pathological inflammation. SK2 is an innovative molecular target for anticancer therapy because of its critical role in catalyzing the formation of S1P, which is known to regulate cell proliferation and activation of inflammatory pathways. YELIVA was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI and radioprotection models, as well as the ABC-101 Phase I clinical study in cancer patients with advanced solid tumors. The development of YELIVA was funded to date primarily by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including the U.S. National Cancer Institute, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Defense and the FDA Office of Orphan Products Development.