Market Overview

Biotechs Endeavour to Increase Access to Cancer Treatments

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NEW YORK, Oct. 1, 2019 /PRNewswire/ -- Cancer is the second leading cause of death globally and was responsible for approximately 9.6 million deaths in 2018, according to the World Health Organization (WHO). Statistically, cancer is the cause of about 1 in 6 deaths worldwide. Predominantly, 70% of cancer-related deaths occur in low- and middle-income countries. The WHO highlights that about a third of cancer-related deaths are tied to behavioral and dietary risk factors. Specifically, the top five risks are: high body mass index, low fruit and vegetable intake, lack of physical activity, tobacco use, and alcohol use. Notably, tobacco is one of the highest risk factors for cancer and is responsible for 22% of cancer deaths. Moreover, cancer-causing infections such as hepatitis and human papilloma virus (HPV) are also common occurrences and are responsible for 25% of cancer cases in low- and middle-income countries. Overall, the low and middle-income classes are severely devastated by cancer due to their lack of access to proper healthcare. In 2017, it was reported that only 26% of low-income countries had access to pathology services. On the other hand, 90% of high-income countries reported having treatment services. The polar difference between low-income and high-income nations represents a medical disparity. As a result, many biotechnology companies have begun to develop alternative cancer treatments in order to reduce the rising cost of cancer. According to data compiled by Transparency Market Research, the global anticancer drug market is estimated to expand to USD 155.6 Billion by 2025 while registering a CAGR between 6% to 7% during the forecast period from 2017 to 2025. Oncology Pharma Inc. (OTC:ONPH), Agenus Inc. (NASDAQ:AGEN), Inovio Pharmaceuticals, Inc. (NASDAQ:INO), Geron Corporation (NASDAQ:GERN), Acasti Pharma Inc. (NASDAQ:ACST).

In 2018, the most common cancer cases were lung, breast, colorectal, and prostate. In particular, lung cancer had the most deaths with 1.76 million. And while there were many breast cancer cases, colorectal was actually the second leading cause of death with 862,000 lives claimed. Although breast cancer accounts for the second-largest occurrence of cancer cases, it is actually just the fifth leading cause of cancer-related deaths. Breast cancer is highly common because most cases are inherited through mutated genes. The WHO reported a total of 2.09 million breast cancer cases in 2018. Among that group, 627,000 patients passed away. To note, breast cancer has a much higher survivability rate when compared to lung cancer or stomach cancer. There were a reported 2.09 million lung cancer cases and 1.03 million stomach cancer cases in 2018. Among those numbers, 1.76 million people passed away from lung cancer, while 782,000 passed away from stomach cancer. The possibility of passing away from breast cancer is much smaller compared to other cancers because of early detection treatments. In the early stages of breast cancer, patients have an increased likelihood to survive. Specifically, if patients receive anticancer drugs such as chemotherapies, hormone therapies, and biological therapies, their chances of survival get a boost. Generally, anticancer drugs are aimed at killing cancerous cells, which can either spread or grow. Typically, medical professionals recommend these therapies depending on the characteristics of the cancer cells. Oncologists will likely recommend anticancer drugs in order to alleviate symptoms, improve quality of life, extend life expectancy, and make side effects more manageable. "Today new avenues for cancer diagnostics and therapeutics present themselves. The choices include specific diagnostics, such as the rapidly evolving use of liquid biopsies that analyze cells and molecules spawned by the tumor and found in bodily fluids such as blood or urine, a more focused analysis of non-responders, the financial implications of future therapies, and an advocacy for a return to basic scientific research. The result of exploring these options will be a wider range of treatment choices for oncologists and a more positive outcome for patients," said Steve Brozak, President of WBB Securities, LLC, an investment bank and research firm that specializes in the biotechnology, specialty pharmaceutical and medical device sectors.

Oncology Pharma Inc. (OTC:ONPH) announced yesterday that, "Kalos Therapeutics' lead compound, KTH-222, can produce a reduction in the attachment of newly seeded cells to a solid-phase by an average of 39%.  These non-clinical results suggest that KTH-222 disrupt tubulin formation and attachment to the solid-phase in a similar way to most of the commonly used tubulin disrupting chemotherapeutic drugs. However, the mechanism of action by KTH-222 may be different than the most commonly used tubulin-disrupting therapies and needs further investigation. Mr. George Colberg (CEO, Kalos Therapeutics) stated: 'Synergistic therapies based on pairing of two or more drugs such as KTH-222 and doxorubicin have the potential of being more efficacious with higher durable response, and the treatment will be safer than most treatments because the dose of the more toxic drugs can be reduced to mitigate the adverse effects and thus benefit the cancer patients.'

A further goal of the drug combination development through the teaming of Oncology Pharma's resources and the Kalos technology would include the likely reduction of resistance and the potential for creating a new approach to reducing or preventing metastatic disease. Kalos, in tandem with Oncology Pharma, will utilize the in-licensed NanoSmart Technology and their approach to reducing the toxicity of doxorubicin.  By combining NanoSmart's anti-nuclear antibody targeted liposomes with the safety profile of the Kalos compound KTH-222, a new and potentially powerful therapeutic combination is created that may dramatically reduce toxicity and tumor resistance. This synergistic work will also lead to the long-term treatment of cancer patients with KTH-222 as a monotherapy and/or poly-therapy combined with therapies such as immunotherapy or "check-point-inhibitors."

About Oncology Pharma, Inc: Oncology Pharma, Inc. (OTCPK: ONPH) (the "Company") is a pioneering oncology company dedicated to developing, manufacturing, and commercializing therapeutics.  The Company has licensed Tulynode's patent pending Autologous Immuno-therapy for durable therapy response using an extracorporeal device. The Company is currently engaging in research and development of therapeutics for oncology, and prides itself for having a world-class Advisory Board that keeps the Company in the forefront of developing technologies in cancer research, biotechnology, and healthcare."

Agenus Inc. (NASDAQ:AGEN) is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer. Agenus Inc. recently announced a manufacturing agreement with Gilead for the supply of GS-1423, a bi-functional molecule licensed to Gilead. This supply represents a second clinical batch for an ongoing Phase 1 clinical trial of GS-1423. Agenus is providing clinical supply at standard industry rates. The collaboration between the two companies was announced in December 2018. Under the terms of the agreement, Agenus received USD 150 Million in an upfront cash payment and equity investment and is eligible for approximately USD 1.7 Billion in potential future fees and milestones. "Our state-of-the-art facility in Berkeley, California and experienced staff have delivered more than 50 antibodies into the clinic2," said Al Dadson, Chief Manufacturing Officer of Agenus. "In the last 18-20 months, we have set path-breaking records with the development and manufacture of 8 compounds including two bi-specific compounds with 7 accepted INDs and one pending acceptance."

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) is an innovative biotechnology company focused on the discovery, development, and commercialization of its synthetic DNA technology targeted against cancers and infectious diseases. Inovio Pharmaceuticals, Inc. recently announced that the company and its collaborator The Wistar Institute have received a USD 4.6 Million National Institutes of Health (NIH) grant in support of innovative research to tackle antimicrobial resistance (AMR) employing Inovio's DNA-encoded monoclonal antibodies (dMAb®) platform. Inovio is advancing a ground-breaking approach to combat multidrug-resistant infections based on Inovio's dMAbs. In a recent study, Inovio developed a targeted dMAb approach for AMR and demonstrated that these dMAbs can effectively control multidrug-resistant infection in animal models. Dr. Laurent Humeau, Executive VP and Chief Scientific Officer, said, "Antimicrobial resistance represents an expanding global public health concern and a tremendous market opportunity for Inovio. While antibiotic-resistant organisms are appearing at an alarming rate, there has been a 30-year hiatus in the development of novel classes of effective antibiotics for combatting these infections. Our ultimate goal is to create a paradigm shift approach to monoclonal antibody technology that results in a pipeline of high impact dMAb products, which can be developed with corporate partnerships, external funding, and collaborations. This grant from the NIH will further this goal."

Geron Corporation (NASDAQ:GERN) is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. Geron Corporation recently announced the opening of patient screening and enrollment for the Phase 3 portion of IMerge to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS). IMerge is a two-part Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with lower risk MDS who are relapsed after or refractory to erythroid stimulating agents (ESAs). The Phase 3 portion is planned to enroll approximately 170 patients in a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that imetelstat improves the rate of red blood cell transfusion independence (TI). The trial is planned to be conducted at multiple medical centers globally, including North America, Europe, Middle East and Asia. The primary efficacy endpoint is 8-week TI rate, which is defined as the proportion of patients achieving transfusion independence during any consecutive eight weeks since entry into the trial. Key secondary endpoints include the rate of transfusion independence lasting at least 24 weeks, or 24-week TI rate, durability of transfusion independence and the amount and relative change in transfusions. "The start of the Phase 3 portion of IMerge is a significant milestone for Geron and imetelstat," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "We are hopeful that the Phase 3 will confirm the encouraging results from the Phase 2 portion, and that imetelstat could become a much-needed treatment alternative for patients with lower risk MDS."

Acasti Pharma Inc. (NASDAQ:ACST) is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Acasti Pharma Inc. recently announced that the Company's TRILOGY 2 trial studying CaPre in patients with severe hypertriglyceridemia had achieved 100% patient randomization.  This follows the Company's prior announcement on April 2019 that the Company's TRILOGY 1 trial had achieved 100% patient randomization. The Company also announced that its two on-going Phase 3 TRILOGY trials (TRILOGY 1 and TRILOGY 2) have exceeded the target of a combined 500 randomized patients, and more than 60% of the patients in both trials have already completed their 6-month treatment plan. Pierre Lemieux, Ph.D., Chief Operating Officer and Chief Scientific Officer of Acasti, commented, "Both of our TRILOGY Phase 3 trials remain on track and are proceeding according to plan. Consistent with our prior disclosures, there have been no severe adverse events associated with our product to date, and we continue to experience a lower than expected drop-out rate, supporting the high safety profile and patient acceptability of CaPre. Importantly, we are encouraged by the growing excitement within the industry as we eagerly await the results of our TRILOGY program.  We appreciate the on-going support of all of the investigators involved with these trials at more than 150 clinical sites across the U.S., Canada, and Mexico." 

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