On October 15, 2019 CEL-SCI Corporation (NYSE American: CVM) reported that the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its recent review of the Phase 3 study data (Press release, Cel-Sci, OCT 15, 2019, View Source [SID1234542272]). The IDMC meets periodically to review the safety and efficacy of the ongoing Phase 3 study.

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The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study. At the most recent IDMC meeting in October 2019 the IDMC reviewed "progression free and overall survival and limited demographic and safety data available for the aforementioned protocol."

The IDMC made the following recommendation:

The IDMC recommendation "is to continue the trial until the appropriate number of events has occurred".
IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients and the integrity of the study data in ongoing trials, especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time.

On October 15, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that the results of a metanalysis of 13 clinical studies of the Company’s systemically delivered oncolytic reovirus, pelareorep, were presented during a podium presentation at the annual International Oncolytic Virus Conference (IOVC), hosted at the Mayo Clinic in Rochester, MN on October 9-12, 2019 (Press release, Oncolytics Biotech, OCT 15, 2019, View Source [SID1234542254]). The analyses examined the effectiveness of viral replication within the tumors of patients treated systemically with pelareorep. The data demonstrated that, unlike other oncolytic viruses that require intra-tumoral delivery, intravenous (IV) systemic delivery of pelareorep resulted in 81% of patient tumor samples across multiple types of cancer testing positive for virus replication, with no infection in normal tissue. These results are from studies across a broad range of solid and liquid tumors, including metastatic disease.

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"This metanalysis across multiple clinical studies provides definitive proof that pelareorep can effectively be delivered intravenously, further demonstrating pelareorep’s ability to avoid neutralization, reach primary and metastatic disease and be a valuable therapy and immune adjuvant across a wide range of cancers," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "By effectively and selectively targeting and replicating within tumor cells, systemically delivered pelareorep causes inflammation, labelling the tumor microenvironment with viral RNA priming the patient’s immune system. Combined with PD-1/PD-L1 checkpoint inhibition to enhance the anti-tumor immune response, pelareorep is uniquely positioned to become a backbone for many leading immuno-oncology combination regimens."

Key Findings from the Metanalysis

After IV delivery, 81% of patient tumor samples are positive for replicating reovirus (the average increases to 96% when melanoma and skin biopsies are excluded)
Tumor types that showed a high proportion of active viral replication: breast cancer, pancreatic adenocarcinoma, multiple myeloma, colorectal cancer patients with liver metastases and high-grade glioma
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On October 15, 2019 Aro Biotherapeutics Company reported that co-founder and Chief Scientific Officer Karyn O’Neil, PhD, debuted ABX300, the company’s lead Centyrin-pan-KRAS siRNA program, during a presentation today at the 2019 Oligonucleotide Therapeutic Society (OTS) meeting in Munich, Germany (Press release, Aro Biotherapeutics, OCT 15, 2019, View Source [SID1234542274]).

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In her presentation entitled, "Cell Specific Centyrin Targeting of Oligonucleotides for Cancer," Dr. O’Neil highlighted preclinical data demonstrating ABX300’s efficacy in treating KRAS-driven epithelial tumors. ABX300 comprises the Company’s proprietary Centyrin protein scaffold technology, conjugated to a pan-KRAS small-interfering RNA (siRNA).

KRAS has been one of the most elusive and difficult to drug targets in cancer. Various point mutations can occur in the KRAS oncogene, resulting in persistent KRAS activation, which drives tumor growth. Recent reports on preclinical and clinical results with small molecule KRAS G12C mutant inhibitors have shown promise; however, this mutant represents only about 12 percent of all KRAS mutations. In contrast, ABX300 is designed to address all known KRAS mutations identified in human tumors.

"Tumor cells treated with ABX300 internalized the Centyrin-siRNA conjugate and exhibited potent, sustained knockdown of mutant KRAS RNA and protein that persisted for days, resulting in complete inhibition of proliferation," said Dr. O’Neil. "This long-term intracellular activity reflects the unique stability and biochemical properties of Centyrins inside the cellular microenvironment."

ABX300 contains two Centyrin-based binding domains that allow for selective targeting of the KRAS siRNA to epithelial-derived tumor cells. ABX300 was shown in preclinical studies to selectively reduce KRAS mRNA levels in cell lines with KRAS G12C, G12D, G12S and G12V mutations, providing proof of concept for broad KRAS inhibition with a single therapeutic.

Sue Dillon, PhD, co-founder and Chief Executive Officer of Aro, commented, "Dr. O’Neil’s presentation at the OTS Meeting is an important milestone for Aro Biotherapeutics. As demonstrated by ABX300 in our research to date, Centyrin-siRNA targeting is a powerful approach to addressing disease target genes in specific cell types, broadly expanding opportunities for RNA medicines."

Building a Pipeline of Life Changing Therapies

Centyrins are small, structurally simple, ultra-stable, highly soluble proteins. These characteristics enable the discovery of medicines with new mechanisms of action for cancer and other devastating diseases. This first-of-its-kind combination of properties is designed to address unmet medical needs by targeting drug payloads in high concentration to the site of disease, while lowering the toxicity to non-target organs. The company holds an exclusive worldwide license for research, development, manufacturing and commercialization of Centyrin protein therapeutics.

On October 15, 2019 Perrigo Company plc (NYSE; TASE: PRGO), reported that it will release its third quarter calendar year 2019 financial results on Wednesday, November 6, 2019 (Press release, Perrigo Company, OCT 15, 2019, View Source [SID1234542255]). The Company will host a conference call beginning at 8:00 a.m. (EDT).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID 9864625. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EDT) Wednesday, November 6, 2019 until midnight, November 13, 2019. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10135743.

On October 15, 2019 Abalos Therapeutics reported a EUR 12 million Series A financing round establishing its operations and leadership (Press release, Abalos Therapeutics, OCT 15, 2019, View Source [SID1234542275]). The Company’s objective is to develop new immuno-oncology therapeutics based on a specific arenavirus strain that preferentially infects and proliferates in cancer cells generating a strong anti-tumor immune response. The Series A round was co-led by Boehringer Ingelheim Venture Fund (BIVF) and Gruenderfonds Ruhr, with participation from NRW.BANK and High-Tech Gruenderfonds (HTGF). Representatives from all investors will join the company’s newly formed Supervisory Board.

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Concurrent with the financing, Abalos announced the appointment of experienced entrepreneurs Dr. Marcus Kostka as Chief Executive Officer and Dr. Jörg Vollmer as Chief Scientific Officer.

"Abalos’ goal is to capture the potent immune activation and highly specific tumor tropism of the arenavirus to propel a differentiated immuno-oncology approach towards clinical evaluation," said Dr. Marcus Kostka, CEO of Abalos Therapeutics. "After funding and supporting a range of biotechnology companies over the years, this promising technology and the chance to build a company with Jörg as a highly-experienced immunology expert made this opportunity extremely attractive."

The proceeds from the financing will be used to advance Abalos’ arenavirus-based lead candidates towards clinical testing. The Company will develop the initial product candidates using its proprietary Fast Evolution platform, which will generate virus strains with optimized anti-tumoral properties. These candidates will be selected based on their ability to re-program the immune system to specifically and efficiently eliminate the malignant tumor tissue. The approach is based on the innovative research of immunologists Prof. Dr. Karl Lang, Chair of Immunology at the Medical Faculty, University Duisburg-Essen and Prof. Dr. Philipp Lang, Director of the Department of Molecular Medicine II, University Düsseldorf. Abalos builds on a close collaboration with the Universities Duisburg-Essen and Düsseldorf.

Dr. Aristotelis Nastos from Gruenderfonds Ruhr commented: "Immuno-oncology continues to make very exciting progress, however, developing drug candidates that can more fully harness the power of the immune system remains a challenge, in particular, addressing not only the main tumor but also distant metastases. We look forward to supporting Abalos’ experienced management team and its dedicated researchers to work on an arenavirus-based solution."

Dr. Marcus Kostka is a highly seasoned industry expert bringing over 20 years and a range of experiences from Boehringer Ingelheim (BI), where he held positions defined by the ability to locate and advance innovation. Most recently, he was Venture Fund Partner at BI and held board positions at several companies and participated in the successful exits of Rigontec and ICD Therapeutics.

In his role as CSO, Dr. Jörg Vollmer brings to Abalos Therapeutics significant knowledge and experience in the areas of immunology, oncology and infectious diseases, which he obtained in various R&D and executive positions over the course of his career. Most recently, Jörg was CSO at Rigontec where he helped advance a novel immuno-oncology treatment approach into the clinic and led the company’s R&D efforts until the acquisition by MSD in 2017.