Chronicle Journal: Finance

Technological Advancements Aid Medical Practitioners in Combatting Cancer

NEW YORK, Aug. 21, 2019 /PRNewswire/ -- In 2018, there was an estimated 1.73 million new cancer cases diagnosed and 609,640 cancer deaths in the U.S., according to the American Cancer Society. The ACS does not expect cancer rates to slow down and instead projects 1.76 million new cancer cases diagnosed with a slightly lower number of deaths at 606,880 in the U.S. in 2019. The shocking projection has stirred concern among the public, as well as with companies dabbling within the industry. In an effort to prevent cancer, many people have shielded themselves from carcinogenic influences such as smoking and avoided environments that are prone to cause cancer. However, cancer can also be caused because of hereditary issues. Many biotechnology companies have been actively developing innovative medicines to effectively decrease the rate of cancer cases and over the past two decades, U.S. cancer-related deaths have significantly declined. As of 2015, the death rate for both men and women declined by 26% from its peak in 1991. Overall, the number of cancer-related deaths is decreasing due to advancements made in technology and treatment. For instance, the emergence of early detection has prevented numerous deaths because medical professionals were able to stop the spread of cancerous cells before it reached later stages. However, despite the dwindling number of deaths, the number of cases is still anticipated to gradually grow. As a result, biotechnology companies are aggressively developing new treatments and therapies to prevent the formation of cancer cells and ultimately limit the number of deaths. According to data compiled by Allied Market Research, the global oncology and cancer drugs market was valued at USD 97.40 Billion in 2017 and is expected to reach USD 176.51 Billion by 2025. Additionally, the market is also projected to grow at a CAGR of 7.6% from 2018 to 2025. Oncology Pharma Inc. (OTC: ONPH), United Health Products, Inc. (OTC: UEEC), AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), Aptevo Therapeutics Inc. (NASDAQ: APVO), SELLAS Life Sciences Group, Inc. (NASDAQ: SLS)

With the advancement of the cancer therapy market, new forms of treatment are now being studied and manufactured. Predominantly, chemotherapy is one of the most common cancer treatments. However, with the expansion of the market, new therapies such as personalized medicine, immunotherapy, CAR T-cell therapy, radiation therapy, and targeted therapies have become highly popular. In particular, the targeted therapies market is one of the fastest treatment segments. Targeted therapies are drugs that block the growth and spread of cancer by interfering with specific molecules involved in the growth, progression, and spread of cancerous cells, according to the National Cancer Institute. Eventually, the drug can completely eliminate cancerous cells or make them dormant. However, not all anticancer drugs are solely related to slowing or eradicating cancer. For example, some drugs are used to alleviate symptoms associated with cancer such as chronic pain, nausea, and lack of appetite. Specifically, drugs such as opioids or appetite stimulants are commonly used among cancer patients. "Everything today is becoming more and more personalized. With cancer treatments, the genomic information on the tumor is increasingly becoming available as the cost of sequencing continues to drop. We can expect a future where we will have much more precise treatments based upon the genomic signature of the patient," said Sean Marett, Chief Brand Officer and Chief Commercial Officer of German immuno-oncology company BioNTech. "A pharmacy will no longer be selling tablets off the shelf. We're going to be delivering a specific treatment only for the patient."

Oncology Pharma Inc. (OTC: ONPH) announced yesterday that, "it signed a Letter of Intent with Kalos Therapeutics (Phoenix, AZ) for a world-wide license and co-development of Kalos's lead anti-cancer drug, KTH 222. The expected license and co-development of KTH 222 as a monotherapy and/or in combination with NanoSmart's ANA-conjugated liposomal doxorubicin targeted delivery is licensed exclusively worldwide by Oncology Pharma. Doxorubicin is one of the most commonly used chemotherapies for treating a wide variety of cancers such as breast, ovarian, lung, bladder, lymphoma, and Kaposi's sarcoma. The KTH 222 combined with the NanoSmart's targeted delivery of doxorubicin provides an excellent synergy between the two therapies while offsetting further the potential cardiotoxicity inherent with doxorubicin. 

Kalos Therapeuticsis developing a platform of drugs containing multiple array of natriuretic peptide which have demonstrated a broad spectrum of anti-tumor activity with negligible or no known adverse effects. In a Pre-IND Study using the parent drug involving a total of eighty-eight patients, including 22 healthy patients, the study demonstrated safety and therapeutic efficacy. Kalos's leading drug candidate, KTH 222, regulates cell growth via inhibition of the mitogen-activated protein kinase (MAPK) pathway. Kalos is looking to change the care paradigm for treating cancer patients as KTH 222 can be a lead therapy, or used in combination with existing therapies to improve efficacy and reduce toxicity, and mitigate resistance or reverse it. There are nearly 17 million patients living with a cancer diagnosis without a safe nontoxic maintenance therapy; Kalos believes it will attain this lofty goal and become the Holy Grail for "cancer tune up," and a therapeutic option to a drug Holiday.

About Kalos Therapeutics: Kalos is pursuing a multiphase strategy to reorient today's therapeutic approach to cancer patients while driving changes to transform therapeutic approaches for unmet and rare medical conditions. Kalos has a lead compound KTH 222 which is more promising than "standard of care" drugs with difficult to treat tumors. Kalos[gc1]. Therapeutics, Inc. CEO, George Colberg, announced, "The collaboration with the Oncology Pharma has provided new opportunities for Kalos to advance its drug development program changing how cancer patients can be treated with safer, nontoxic approaches improving the patient's quality of life. The possibility of bringing to market a safer more promising version of the Oncology Pharma product line is extremely exciting!"

Kalos is devoted to treating the unmet needs of people living with incurable diseases, while doing so with less toxic and debilitating side effects commonly associated with chemotherapies. Kalos believes that by leveraging nature and all of the body's mechanisms, they have created new, safer approaches to cancer and diseases that affect the eye as well. Kalos has several applications for animal health based on both its 8 amino acid and a 15 amino acid drug KTV-111. Kalos aims to treat dangerous and debilitating diseases and improve the quality of life for the patient and their families.

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."

United Health Products, Inc. (OTC: UEEC) develops, manufactures, and markets patented hemostatic gauze, for the healthcare and wound care sectors. United Health Products, Inc. recently announced that it had received the pathology results of a preclinical animal study to assess the effect of HemoStyp on the bone. The company conducted the animal study to evaluate the suitability of HemoStyp in contact with bone in the chronic swine model, and to validate HemoStyp for this application. This study and indication is independent of the current PMA application and will potentially allow UHP acess to a new and significant market opportunity. The study results determined that there was no adverse pH effect on the bone and surrounding tissue. UHP believes that these preliminary results demonstrate the safe application of HemoStyp in orthopedic procedures. These results need to be confirmed by human clinical trial in order to confirm safety and efficacy prior to obtaining FDA approval.  The study was completed by Dr. Clay Robinson, DVM at Mt. Sterling Bio Medical in Willard Bay, Utah and pathology performed by Dr. Tom Baldwin at the Utah State University Diagnostic Laboratory. Dr. Gerard Abate, Chief Medical Officer, UHP commented, "HemoStyp is easy to apply, dissolves completely within 24 hours; and, will be an effective adjunct to stop cancellous bone bleeding while not interfering with the healing process. This data supports our development plan as we move forward with additional human trials to seek other surgical indications."

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) is a biopharmaceutical company seeking to advance targeted medicines for oncology and other unmet medical needs. AVEO Oncology recently announced results from an investigator-sponsored Phase Ib expansion cohort of ficlatuzumab, AVEO's potent hepatocyte growth factor (HGF) inhibitory antibody product candidate, in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML). The results were presented in a poster session at the American Association for Cancer Research (AACR) 2019 Annual Meeting. Elevated serum HGF level is an adverse prognostic factor associated with worse survival in AML and other cancers. Pre-clinical models have shown that myeloid blasts produce HGF and that blocking the HGF/c-Met pathway sensitizes blasts to cell death. The Phase Ib trial, which was funded by Gateway for Cancer Research and is being conducted at the UCSF Medical Center under the direction of Charalambos Andreadis, M.D., Associate Professor of Clinical Medicine, Director, Clinical Research Support Office, UCSF Helen Diller Family Comprehensive Cancer Center, was designed to assess the safety, tolerability and preliminary efficacy of ficlatuzumab with cytarabine in AML patients who are refractory to first line therapy (7+3) or have relapsed within one year of induction, a population known to have poor outcomes. "Patients with AML who are refractory to induction therapy or relapse within one year have poor outcomes," said Dr. Andreadis. "Elevated serum HGF level is an adverse prognostic factor, and these results demonstrate that the anti-HGF antibody ficlatuzumab combined with cytarabine holds potential to affect outcomes in patients with relapsed or refractory AML. We look forward to potentially evaluating ficlatuzumab in larger outcome studies in AML."

Aptevo Therapeutics Inc. (NASDAQ: APVO) is a clinical-stage biotechnology company focused on developing novel oncology, autoimmune and hematology therapeutics to meaningfully improve patients' lives. Aptevo Therapeutics Inc. recently announced that new preclinical data for two ADAPTIR bispecific candidates, APVO436, a bispecific antibody candidate targeting CD123 and CD3, and ALG.APV-527, a bispecific antibody candidate targeting 4-1BB and 5T4, were presented at the American Association for Cancer Research (AACR) 2019 Annual Meeting. In a poster presentation entitled "APVO436, a Bispecific anti-CD123 x anti-CD3 ADAPTIR Molecule for Redirected T-cell Cytotoxicity with Limited Cytokine Release, is Well Tolerated in Repeat Dose Toxicology Studies," Aptevo scientists presented new preclinical data demonstrating that APVO436: Induces the generation of functional memory T cells with cytolytic function from naïve T cells; Has good tolerability, antibody-like clearance and volume of distribution parameter; Has an extended serum half-life of 4.5 days in a relevant non-clinical species. "The reduction in cytokine release we've observed in preclinical studies with APVO436, vis-à-vis a competitor molecule, is a particularly interesting finding," said Jane Gross, Ph.D., Chief Scientific Officer for Aptevo. "The possibility that APVO436 could stimulate an effective immune response against CD123-positive tumors, but with a more controlled cytokine release profile is especially intriguing, offering the potential for reduced toxicities compared to other CD123 x CD3 T-cell engagers at comparable or higher doses. We also show new data demonstrating the differentiation of a memory T cell population by APVO436 in preclinical studies which can potentially contribute to a more sustained clinical response. We are excited to have commenced our Phase 1/1b clinical trial of APVO436 in patients with AML and MDS and are hopeful that the emerging clinical data will validate our preclinical safety hypothesis. We look forward to reporting a preliminary ADA read-out for APVO436 in the third quarter of 2019 and reporting preliminary Phase 1 safety data in the fourth quarter of 2019."

SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a clinical-stage biopharmaceutical company focused on novel cancer immunotherapeutics for a broad range of cancer indications. SELLAS Life Sciences Group, Inc. recently announced the dosing of the first patient in its Phase 1/2 open-label study of GPS in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab), in patients with selected WT1-positive advanced cancers, including both solid tumors and hematologic malignances. "This is an important milestone as this study allows us to potentially enhance our safety and activity profile of GPS in combination with anti-PD-1 therapies, particularly in combination with KEYTRUDA® in multiple malignances, following intriguing initial combination clinical data with OPDIVO®," said Angelos M. Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS. "We are confident this study will build on our body of clinical evidence in support of the use of GPS in combination with PD-1 inhibitors to benefit cancer patients with limited treatment options. We believe that our innovative WT1 immunotherapeutic, GPS, in combination with anti-PD-1 immunotherapy agents, may provide therapeutic benefit for patients with WT1 expression. These beliefs are shared by the renowned U.S. oncologists who are undertaking this work. We look forward to studying this combination in patients with a wide range of cancers and expect to provide the first clinical data from this study in the first quarter of 2020."

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