Patients Turn to Assistance Programs for Aid in the Fight Against Chronic Diseases

NEW YORK, Oct. 4, 2019 /PRNewswire/ -- With the advancement of the cancer therapy market, new forms of treatment are now being studied and manufactured. Additionally, demand is expected to keep growing for currently effective treatments. Not just because various cancer conditions are quite common, but also due to the fact than 45 million Americans do not have health insurance and millions more are underinsured. Notably, 8 out of 10 uninsured people are from working families. Among those with health insurance, 1 out of 10 individuals, 65 years old or younger, and one in three persons over 65 years do not have prescription drug coverage. Hence, Patients Assistance Programs (PAPs) have emerged in an effort to help patients who are lacking health insurance or prescription drug coverage get the medication they need. Now, several large pharmaceutical companies have started these programs to help uninsured patients who are suffering from chronic diseases. As such, a large number of uninsured patients, most suffering from cancer, can now undergo cancer therapies, further augmenting the growth of the market. Overall, the global cancer therapy market was valued at USD 136,254.35 Million in 2018, and is estimated to be valued at USD 220,701.26 Million in 2024 while witnessing a CAGR of 8.37%, according to Mordor Intelligence. Oncology Pharma Inc. (OTC: ONPH), Curis, Inc. (NASDAQ: CRIS), Immunomedics, Inc. (NASDAQ: IMMU), Agenus Inc. (NASDAQ: AGEN), ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP)

Cancer immunotherapy has emerged as a promising new treatment for cancer. Overall, increasing investments in R&D related to cancer immunotherapy as well as the increases in the number of approvals for new immune therapeutic drugs are expected to drive the market. Notably, new immunotherapeutic options include immunomodulators and CAR-T cell therapy, which are in the pipeline and are being tested for their ability to provide better cancer treatment. The immunotherapy market application segment itself is broken up by various forms of cancer such as lung cancer, breast cancer, and prostate cancer, which are among the most common forms. Overall, the market will see strong growth due to the prevalence of cancer and the rising demand for treatment options. "The potential of immunotherapies is huge. I would say that immunotherapies are the most important change in oncology treatment in the past 10 years, and now they are expanding into other disease areas," said Etienne Drouet, Vice President of Strategic Development at SynteractHCR. "Immunotherapy is the new star in the life sciences. Compared to chemotherapy they have less adverse events, and also show positive long-term effects in overall survival rates."

Oncology Pharma Inc. (OTC: ONPH) announced earlier this week 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."

Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, recently highlighted a publication titled "U2AF1 mutations induce oncogenic IRAK4 isoforms and activate innate immune pathways in myeloid malignancies" in Nature Cell Biology.1 The study findings demonstrate that a cancer-causing splicing variant of IRAK4 (IRAK4-L) is dominant in the majority of cases of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Additionally, specific mutations of the U2AF1 splicing factor induce IRAK4-L, which has potential therapeutic targetability by CA-4948, the Company's small molecule inhibitor of IRAK4. "We are encouraged by these findings in Nature Cell Biology, which support that CA-4948's unique target profile may be beneficial to patients with myeloid malignancies and, in particular, those with IRAK4-L and U2AF1 mutations," said Jim Dentzer, President and Chief Executive Officer of Curis. "There is a large unmet need for further treatment options among this patient subgroup and we look forward to assessing the potential of CA-4948 to address this significant medical issue."

Immunomedics, Inc. (NASDAQ: IMMU)  a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), announced earlier in September that its TROPHY-U-01 late-breaking abstract on interim results of sacituzumab govitecan in patients with metastatic urothelial cancer (mUC) has been selected for oral presentation at the ESMO 2019 Annual Congress, taking place from  September 27 to October 1, 2019, at the Fira Barcelona, Spain. "We look forward to presenting, for the first time, interim data for sacituzumab govitecan in metastatic urothelial cancer patients who are relapsed or refractory to platinum-based and checkpoint inhibitor therapies," commented Dr. Behzad Aghazadeh, Executive Chairman. "Completion of target enrollment of 100 patients is expected by the end of this year."

Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, adoptive cell therapies and cancer vaccines, announced earlier this summer that the FDA has accepted the company's IND filing for AGEN2373, a milestone in its partnership with Gilead Sciences, Inc. This milestone triggers a cash payment of $7.5M. Agenus is eligible to receive additional milestone payments this year and beyond. "This IND clearance underscores our continued commitment to delivering novel and best-in-class therapies to patients with cancer with the utmost urgency," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "AGEN2373 has unique binding properties and is designed to mitigate the toxicity observed with competitor molecules; we believe that this molecule has great potential for patients with cancer."

ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced earlier this summer completion of enrollment of the third cohort of a phase 1 clinical trial evaluating Controlled IL-12 (Ad-RTS-hIL-12 plus veledimex, Ad+V), in combination with the PD-1 inhibitor OPDIVO® (nivolumab) for the treatment of recurrent or progressive glioblastoma multiforme (rGBM) in adults. 

Investigators from this multi-center trial, conducted at Northwestern University in Chicago, Brigham and Women's Hospital in Boston, and The University of Texas MD Anderson Cancer Center in Houston, have indicated interest in expanding the study and the Company now expects to enroll additional patients at the highest dosing level, subject to final agreement by the Data and Safety Monitoring Board. "We are pleased to complete enrollment of the dose escalation of Ad-RTS-hIL-12 + veledimex and nivolumab and explore the potential to expand this combination trial to further enrich our clinical experience," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "The enthusiasm for combining PD-1 inhibitors with IL-12 in the current study is evident, and we also look forward to initiating a phase 2 trial with Ad-RTS-hIL-12 plus veledimex and cemiplimab in the coming days."

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