Palm Beach, FL – December 15, 2021 – FinancialNewsMedia.com News Commentary – Acute Myeloid Leukemia (AML) is a type of blood cancer which usually affects white blood cells (WBCs), however, it can also start in other types of blood-forming cells. In AML, there is a fast production of the abnormal WBCs that get accumulated in the bone marrow and affect the production of normal blood cells. The major factors that drive the market growth include advantages of biopharmaceuticals over conventional medicines, rise in geriatric population, unhealthy lifestyle, strong biopharmaceutical pipeline, and development of combination therapies that can treat diseases that were previously untreated. However, high cost of the therapeutic process, and its safety concerns, is expected to hinder the growth of the market. Moreover, ongoing researches have led to discovery of more efficient therapies for cancer treatment, which pose attractive opportunities for the key market players.  A report from iHealthcare Analyst projected that: “The global market for acute myeloid leukemia expected to reach $2.6 billion by 2027, growing at CAGR 15.2% over the forecast period, driven by introduction of high-priced products and strong pipeline of upcoming drugs. During the forecast period, the marketed drugs, pipeline drugs and others are predicted to contribute 55%, 35%, and 10% market share of the global AML market, respectively. Acute myeloid leukemia (AML) is the second most common type of leukemia diagnosed in adults and children.”   Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Galera Therapeutics, Inc. (NASDAQ: GRTX), Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), Alzamend Neuro, Inc. (NASDAQ: ALZN), CTI BioPharma Corp. (NASDAQ: CTIC).

However, another report from ReportsAndData was even more optimistic, saying: “The Global Acute Myeloid Leukemia Therapeutics Market is expected to be valued at USD 3.56 Billion in 2027 from USD 1.46 Billion in 2019, registering a CAGR of 13.1% through the forecast period. The industry is gaining traction due to rising cases of acute myeloid leukemia globally.  Reinforcing the demand for forwarding therapeutics is considered as the high-impact rendering operator in this sector. The rising acute myeloid leukemia therapeutics occurrences are related to several administrators including unhealthy lifestyles, genetic variations, and exposure to harmful chemicals like benzene as well as radiation exposure. Additionally, the growing population base and the increasing healthcare needs are further propelling the sector’s growth.  Furthermore, roadblocks in the drug therapies for myeloid leukemia are responsible for escalating the demand for effective and enhanced treatments, also augmenting market growth. The advantages of such therapies, including enhanced safety, long-term survival rates, and improved quality. Additionally, a high chance of early detection of leukemia cells, and targeted therapy are providing several lucrative avenues in the industry.  North America is currently controlling the market for acute myeloid leukemia and is required to maintain its center for a few more years. The United States operates the largest share of the market.”

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech^® Announces the Presentation of Preclinical Data Demonstrating the Synergistic Anti-Leukemic Effects of Pelareorep Combined with Azacitidine at the 2021 American Society of Hematology Annual Meeting – Oncolytics Biotech^® announced preclinical data demonstrating the synergistic anti-leukemic effects of pelareorep combined with the chemotherapeutic agent azacitidine. The data were featured in a poster presentation at the 2021 American Society of Hematology (ASH) Annual Meeting, which took place from December 11-14, 2021, in Atlanta, Georgia.

• Preclinical studies featured in the poster evaluated pelareorep in combination with azacitidine in acute myeloid leukemia (AML) cells in vitro and in a leukemia xenograft mouse model. Key data and conclusions from the poster include:

• Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant reduction (p<0.01) in tumor burden in a leukemia xenograft mouse model

• Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant (p<0.001) synergistic enhancement of anti-leukemic activity against AML cell lines, a benefit that was confirmed in AML patient samples in vitro

• The combination of pelareorep and azacitidine dramatically upregulated multiple genes known to drive anti-cancer immune responses such as IFNβ1, BATF2, IL-12β, CCL2, TLR3, and PD-L1

“These compelling preclinical findings, together with previously reported data demonstrating clinical proof-of-concept in multiple myeloma, indicate that pelareorep’s immunotherapeutic effects extend across multiple hematological malignancies. They also further highlight pelareorep’s potential to enhance the efficacy of a wide range of cancer therapeutics and have stimulated interest in investigator-sponsored clinical studies of pelareorep in leukemia,” said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. “Given its ability to be administered intravenously without special handling procedures, pelareorep exerts a systemic effect that is uniquely suited to address liquid tumors compared to other oncolytic viruses. We look forward to leveraging collaborative relationships to continue evaluating pelareorep in hematological malignancies, which will allow us to potentially broaden its therapeutic impact while maintaining our primary focus on our lead breast cancer program.”  CONTINUED… Read this full press release and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/    

Other recent developments in the biotech industry of note include:

Galera Therapeutics, Inc. (NASDAQ: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy (RT) in cancer, recently announced that corrected results from its Phase 3 ROMAN trial of avasopasem for the treatment of RT-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) achieved statistical significance on the primary endpoint of reduction in the incidence of SOM. Avasopasem has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the reduction of SOM induced by RT.

The Company previously announced the Phase 3 ROMAN trial of avasopasem in SOM did not achieve statistical significance on the primary endpoint. Upon further analysis, an error by the contract research organization (CRO) was identified in the statistical program. Correction of this error resulted in improved p-values for the primary and secondary endpoints.

Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, recently reported its financial results for the quarter ended September 30, 2021.  The Company also provided an update on its development programs, ADAIR and ADMIR, which leverage the Company’s proprietary technology that is designed to resist manipulation for snorting and provide barriers to injection.

Recent Highlights Were: Presented at the American Academy of Child & Adolescent Psychiatry (AACAP) 68^th Annual Meeting the results from a survey, led by researchers at the University of Kentucky, of nearly 500 people who misuse or abuse prescription stimulants; Continued to advance the Company’s pivotal intranasal abuse study, Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (SEAL study) toward completion of patient enrollment and treatment; Completed selection of the final formulation for the Company’s second development program ADMIR, an abuse-deterrent formulation of methylphenidate (Ritalin^®); Entered into an agreement with Catalent, a leading global provider of advanced delivery technologies, development, and manufacturing, to support the development and manufacturing of ADMIR; and Announced the formation of its Scientific Advisory Board (SAB) and initial appointments of Stephen V. Faraone, PhD, Jeffrey Newcorn, MD, and Anthony Rostain, MD.

Alzamend Neuro, Inc. (NASDAQ: ALZN), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, recently announced that it has received confirmation that topline data for its Phase 1 clinical trial for AL001 for dementia related to Alzheimer’s will be delivered mid- to late-December 2021. The Phase 1 first-in-human study is for the purpose of determining potential clinically safe and appropriate dosing for AL001 in a planned Phase 2 multiple ascending dose study. AL001 is a lithium-delivering ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer’s.

“We are very excited about this important milestone for Alzamend,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We believe these data will confirm AL001’s potential as a replacement of the current lithium-based treatments and may provide a treatment to the over 40 million Americans suffering from Alzheimer’s and other neurodegenerative diseases and psychiatric disorders. We look forward to utilizing these data to move swiftly into a Phase 2 multiple ascending dose study involving Alzheimer’s patients in the first quarter of 2022.”

CTI BioPharma Corp. (NASDAQ: CTIC) recently announced five scientific poster presentations on the pacritinib clinical program at the recent 63^rdAmerican Society of Hematology (ASH) Annual Meeting & Exposition, meeting in Atlanta, Georgia.

“We are pleased with the growing body of clinical evidence supporting the potential of pacritinib’s unique place in treating cytopenic myelofibrosis, specifically in patients with moderate or severe thrombocytopenia, a notable challenge in light of the significant limitations of approved therapies,” said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. “Importantly, today we presented data demonstrating that in patients with cytopenic myelofibrosis, full-dose pacritinib yielded higher response rates and a similar safety profile to lower doses of ruxolitinib.

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