On September 5, 2018 DiaMedica Therapeutics Inc. (the "Company" and "DiaMedica") (TSX-V:DMA) (OTCQB:DMCAF) reported the recent appointment of Harry Alcorn Jr. Pharm.D. as Chief Medical Officer where he will oversee global clinical development and regulatory initiatives for DiaMedica (Press release, DiaMedica, SEP 5, 2018, View Source [SID1234529333]). Dr Alcorn has over 30 years of clinical research experience working with public and private biotech and pharmaceutical companies in studies of kidney diseases and diabetic, hepatic and cardiovascular patients. He has designed, authored and been a consultant to a multitude of companies in the industry on protocol development, clinical execution and regulatory guidance. He has served as Principal Investigator or Sub Investigator in over 450 clinical studies and has assisted many biotech and pharmaceutical companies in negotiating protocols and presenting results to the FDA. Dr. Alcorn has presented at numerous international meetings and industry seminars discussing the critical challenges in conducting patient studies.

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Prior to joining DiaMedica, Dr. Alcorn served as Chief Scientific Officer at DaVita Clinical Research (DaVita), a company that provides clinical research services for pharmaceutical and biotech companies. During this time, he also served on the Board of Directors for The Association of Clinical Pharmacology Units and on the Board of Directors of MedTox Laboratories. In 2000 Dr. Alcorn started the US Renal Network, the first organization to coordinate clinical trial sites for the conduct of kidney studies. Prior to DaVita he held the position of Executive Director and led the clinical trials at GalaGen Inc, a biopharmaceutical company developing therapeutics to target life-threatening and emerging pathogens.

Dr. Alcorn obtained his Bachelor of Pharmacy from Creighton University and his Doctor of Pharmacy from University of Nebraska Medical Center. He currently holds clinical faculty appointments with the University of Minnesota, Creighton University, University of Nebraska Medical Center, Virginia Commonwealth and the University of Colorado, Denver.

"We are thrilled that Harry is bringing to DiaMedica his strong industry and operational leadership at a time when we are preparing to initiate clinical research in patients with Chronic Kidney disease" commented Rick Pauls, President and CEO of DiaMedica. "His knowledge, experience in patient trials, along with his work as a subject matter expert for both industry and the FDA, complements our team."
I am very excited to join DiaMedica at this stage of its development," said Dr. Alcorn. "DiaMedica is leading the investigation of the KLK1 protein and has the opportunity to significantly improve the lives of patients suffering from chronic kidney disease and neurological disorders. I look forward to helping the company accelerate the development of DM199 for these patients."

About DM199

DM199 is a recombinant (synthetic) form of the human protein known as "KLK1". The KLK1 protein plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostacyclin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as chronic kidney disease, retinopathy, stroke, vascular dementia and treatment resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke and DiaMedica is preparing to initiate a clinical study in patients with chronic kidney disease.

On September 5, 2018 ITUS Corporation (NASDAQ: ITUS) and its research partner, Moffitt Cancer Center, reported that a pre-IND meeting with the US FDA has been scheduled on Tuesday, October 16, 2018 (Press release, Anixa Biosciences, SEP 5, 2018, View Source [SID1234530493]). The meeting is to discuss numerous aspects of the planned clinical trial of their CAR-T therapy for ovarian cancer.

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Dr. Amit Kumar, CEO of ITUS stated, "We are pleased to be meeting with the FDA this fall, as anticipated. We have submitted pre-clinical data, as well as a series of questions, to the FDA. Coming out of this meeting, our goal is to have a good understanding of the design for the clinical trial in our Investigational New Drug (IND) application. Assuming the FDA does not require additional animal studies, we hope to file the IND application in early 2019, with human testing potentially beginning shortly thereafter."

Dr. Jose Conejo-Garcia, Co-head of Immunology at Moffitt Cancer Center, the inventor of the technology, and the Principal Investigator of the team developing the therapy, added, "We are heading towards the first in human trial of our hormone receptor based Chimeric Antigen Receptor T-cell technology, which internally we refer to as Chimeric Endocrine Receptor T-cell technology (CER-T). Our unique approach, could create a whole new platform for CAR-T that takes advantage of hormone-receptor combinations. To date CAR-T therapy has only shown efficacy in certain liquid tumors. We hope our approach will enable chimeric receptors expressed on T cells to work on the vastly larger numbers of solid tumors relative to hematological malignancies".

On September 5, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that it will present data on its investigational anti-PD-1 antibody tislelizumab at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC), which takes place September 23-26 in Toronto, Canada (Press release, BeiGene, SEPT 5, 2018, View Source;p=irol-newsArticle&ID=2366246 [SID1234529293]). Discovered by BeiGene, tislelizumab is being studied as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumors and hematologic cancers.

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Poster Presentations:

Title: Tislelizumab Combined with Chemotherapy as First-Line Treatment in Chinese Patients with Advanced Lung Cancer
Session 1: JCSE01 – Perspectives for Lung Cancer Early Detection
Location: Room 202 BD
Date: Sunday, September 23
Time: 07:30-11:15 EDT
Presenter: J. Wang

Poster: P1.04-36
Session 2: P1.04 Immuno-oncology
Date: Monday, September 24
Time: 16:45-18:00 EDT
Presenter: J. Wang

Title: Preliminary Results with Tislelizumab in Chinese Patients with Non-Small Cell Lung Cancer (NSCLC)
Poster: P2.04-29
Session: P2.04 Immuno-oncology
Date: Tuesday, September 25
Time: 16:45-18:00 EDT
Presenter: Y-L. Wu

About Tislelizumab
Tislelizumab (BGB-A317) is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. Discovered by BeiGene scientists in Beijing, tislelizumab is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is potentially differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells, based on preclinical data. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for the development of tislelizumab in solid tumor cancers outside of Asia (except Japan).

On September 5, 2018 Iovance Biotherapeutics, Inc presented the Corporate Presentation (Presentation, Iovance Biotherapeutics, SEP 5, 2018, View Source [SID1234529316]).

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On September 5, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported new interim poziotinib data from the MD Anderson Phase 2 non-small cell lung cancer (NSCLC) study which appeared in an online abstract as part of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (Press release, Spectrum Pharmaceuticals, SEPT 5, 2018, View Source [SID1234529294]). The interim results, which include data from the EGFR cohort and, for the first time, the HER2 cohort, are preliminary and based on data through May 3, 2018. More robust and updated data will be presented in an oral session on September 24 at the conference in Toronto, Canada.

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"These results add to a growing body of evidence supporting the role of poziotinib in patients with EGFR and HER2 exon 20 mutations, and are a real advance for these patients for whom no targeted therapies have been effective so far," said John Heymach, M.D., Ph.D., Chairman and Professor, Department of Thoracic/Head and Neck Medical Oncology, University of Texas, MD Anderson Cancer Center. "I am highly encouraged by these results and the evolution of poziotinib data. Our study is the single largest data set in this high unmet need patient population and I am excited to present updated data during an oral session at the IASLC World Conference on Lung Cancer."

Data appearing in the abstract were current as of May 3, 2018. 40 patients of the 50 patient EGFR cohort had data available for the efficacy analysis. In the 40 patients, poziotinib continued to show robust efficacy with an objective response rate (ORR) of 58% in this heavily pre-treated population. Median progression free survival (PFS) was 5.6 months (95%-CI 5.06-NA). The disease control rate was 90%. In the HER2 cohort the ORR was 50% and the disease control rate was 83%. The most common adverse events were skin-rash (27.5%), diarrhea (12.5%), and paronychia (7.5%). 45.0% of patients required dose reduction to 12mg, while 17.5% of patients required dose reduction to 8mg. Updated data will be presented at the conference and will include data into September.

"We are thrilled with the data presented in the abstract and look forward to a more robust data set on September 24th," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Additionally, we believe the treatment potential of poziotinib may go well beyond the previously treated lung cancer setting. We are actively expanding the poziotinib clinical program to explore poziotinib in new areas including first-line treatment of NSCLC, treatment of other solid tumors with EGFR or HER2 mutations, and combination therapies."

Spectrum Pharmaceuticals will be hosting a live webcast on September 24 following the oral presentation.

Abstract: A Phase II Trial of Poziotinib in EGFR and HER2 exon 20 Mutant Non-Small Cell Lung Cancer

Background

Insertions/mutations in exon 20 of EGFR and HER2 occur in ~1% and ~3% of all lung adenocarcinomas, respectively. These alterations are characterized by primary resistance to approved tyrosine kinase inhibitors (TKIs) with response rates of <12%. We have previously shown that exon 20 insertions restrict the size of the drug-binding pocket, limiting binding of large inhibitors. However, poziotinib can circumvent these steric changes and is a potent inhibitor of EGFR and HER2 exon 20 mutants (Robichaux et al. Nat Med). Herein, we report the results of an investigator-initiated study of poziotinib in EGFR and HER2 exon 20 mutant NSCLC (NCT03066206).

Methods

Patients ≥18yrs with locally advanced/metastatic NSCLC bearing mutations/insertions in EGFR or HER2 exon 20 (except EGFR T790M) were eligible. Unlimited prior systemic and targeted therapies were permitted. Poziotinib 16mg PO daily was administered until progression, death, or withdrawal. The primary endpoint was objective response rate (ORR) based on RECIST v1.1. Response was evaluated every eight weeks. A Bayesian design was used with a plan to enroll patients in cohorts of 10 and to terminate the study if ORR was ≤20%. Secondary endpoints included disease control rate (DCR); progression-free survival (PFS); overall survival; and safety.

Results

As of May 3, 2018, the planned EGFR cohort of 50 patients was fully enrolled, and 40 patients were evaluated for response. Median age was 55yrs (range 29-78). 65.1% of patients had received at least two prior lines of therapy for metastatic disease. 60% of patients had ≥grade 3 adverse events; most common were skin-rash (27.5%), diarrhea (12.5%), and paronychia (7.5%). 45.0% of patients required dose reduction to 12mg, while 17.5% of patients required dose reduction to 8mg. One patient stopped the treatment due to grade 3 skin rash. The ORR at eight weeks was 58% (95%-CI 40.9-73.0) and the DCR was 90% (95%-CI 76.3-97.2). Among 23 patients who achieved partial response, 15 responses were confirmed, five responses were unconfirmed, and three patients are pending confirmation. Responses were observed in 8/13 (62%) patients that were previously treated with TKI. Median PFS was 5.6mo (95%-CI 5.06-NA). Furthermore, 13 patients were enrolled in the HER2 cohort. Observed toxicities were similar to the EGFR cohort except one case of grade 5 pneumonitis, assessed to be possibly drug related. Twelve patients were evaluated for response with an ORR of 50% (95% CI 21.1-78.9) at eight weeks and a DCR of 83%.

Conclusion

The trial exceeded the stopping boundary of ORR of 20%. In a heavily pre-treated population with EGFR and HER2 exon 20 mutant NSCLC, poziotinib provides a high ORR, an encouraging PFS, and a manageable toxicity profile.

Conference Call Details:

Monday, September 24, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 1993267
International: (973) 796-5077, Conference ID# 1993267

The conference call will also be webcast live. To access the webcast and additional documents related to the call, please visit the Investor Relations page of the Spectrum Pharmaceuticals website at View Source

For interested individuals unable to join the call, a replay will be available from September 24, 2018 @ 7:00 p.m. ET/4:00 p.m. PT through October 1, 2018, until 7:30 p.m. ET/4:30 p.m. PT.

Domestic Replay Dial-In: (855) 859-2056, Conference ID# 1993267
International Replay Dial-In: (404) 537-3406, Conference ID# 1993267

About Poziotinib

Poziotinib is a novel, orally available Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize worldwide excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumor indications.

The poziotinib NSCLC clinical program for patients with EGFR or HER2 exon 20 insertion mutations currently consists of a Phase 2 investigator-initiated study at The University of Texas MD Anderson Cancer Center and a Phase 2 pivotal, Spectrum-sponsored, multi-center, global study (ZENITH20) with active sites in the United States and future centers planned in Canada and Europe.