On June 11, 2020 AVM Biotechnology reported that it has been awarded a National Cancer Institute Small Business Innovation Research (SBIR) Grant from the National Institutes of Health (NIH) to study the use of their lead molecule AVM0703 as a preconditioning agent to allow safe and efficient delivery of therapeutic immune cells for cancer treatment (Press release, AVM Biotechnology, JUN 11, 2020, View Source [SID1234561017]). This novel solution could offer clinical advantages to any cell-based immunotherapy, improving access to potentially life-saving therapies by all cancer patients, including those too frail to receive chemotherapy.

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Cellular immunotherapy has the potential to become a crucial solution for cancer. However, toxic chemotherapy is currently required as preconditioning treatment to impair graft rejection and maintain therapeutic cells in the bloodstream where they can target cancer cells. Chemotherapy is hardly tolerated by frail cancer patients, and it fuels the side effects of immunotherapy such as toxic cytokine releases (CRS) and neuroedemas. AVM0703, which could be easily administered to increase efficient delivery of adoptive cellular immunotherapy, induces safe lymphodepletion in only 24 hours, sparing platelets, stem cells and red blood cells in animal models. AVM0703 can safely deplete monocytes, known to be a key inducer of CRS. CRS toxicities occur as frequently as 90% with half of them determined as severe. Severe CRS complications can be life threatening if not treated in a timely manner. Unlike chemotherapy, AVM0703 could safely deplete monocytes reducing the risk of CRS and making cellular immunotherapy accessible to high-risk individuals.

This Phase I grant will be used to validate the efficacy and safety of preconditioning by AVM0703 in an established tumor mouse models of multiple myeloma (MM). The proposal was regarded as very significant in addressing a clinical need of better ways for improving efficacy and reducing toxicity of cellular therapies. Moreover, preconditioning using AVM0703 was seen as well supported by a good rationale and strong preliminary data. AVM0703 mode of action could offer an exemplary preconditioning regimen.

Named one of the top 10 best Biotech and Pharma companies to keep your eye on in 2019 by Mirror Review Online Magazine, AVM Biotechnology was founded in 2008 by Dr. Theresa Deisher, Ph.D. With over 30 years of successful pharmaceutical research experience and holding over 47 patents, Dr. Deisher leads a team of scientists dedicated to changing what a diagnosis of cancer, autoimmunity, or chronic infectious disease means to patients and their loved ones. AVM received FDA IND approval in April 2020 to test AVM0703 for treatment of relapsed/refractory lymphoid malignancies. AVM’s passion is to deliver drugs that work rapidly and that are safe, effective, and affordable, to treat serious worldwide illness like cancer, autoimmunity, and life-altering infectious disease. They develop products that improve outcomes without additional suffering because they believe that side effects from treatments of cancers or infections should never be worse than the diseases themselves.

AVM is the only company to receive homologous use designation for a patient’s own bone marrow used for an indication outside of blood disorders. Additionally, in 2019 AVM Biotechnology was awarded an SBIR grant for targeted lympho-ablation as an alternative to cure Type I Diabetes by the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK).

This award was granted by the National Institutes of Health under Award Number R43CA246896. The content of this press release is solely the responsibility of the author and does not necessarily represent the official views of the NIH.

On June 11, 2020 Invitae reported that New recommendations from a large, multidisciplinary consensus conference published this week in the Journal of Clinical Oncology suggest expanding use of genetic testing to guide treatment for men with prostate cancer, including the use of panel testing and testing patients with early stage disease (Press release, Invitae, JUN 11, 2020, View Source [SID1234561384]). Taken together with research recently presented by Invitae (NYSE: NVTA), a leading genetics company, the publications underscore the utility of increased access to genetic testing for men with prostate cancer across all stages of disease.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

Invitae was among the non-voting sponsors of the conference, which gathered more than 100 experts across a number of specialties with the goal of developing recommendations for how clinicians can use genetic testing to help patients benefit from precision medicine approaches to prostate cancer.

"Inherited prostate cancer is starting to get the attention it deserves, but we have a long way to go to catch up to the research and testing that has been done in other cancers, such as breast cancer," said Sarah Nielsen, M.S., L.C.G.C. a medical affairs liaison now at Invitae who previously participated in the conference. "This framework provides a very thoughtful approach to implementing genetic testing for prostate cancer treatment, screening and family testing. Importantly, the framework recognizes that changes in a number of different genes can increase prostate cancer risk and therefore encourages greater use of panel testing for men with metastatic disease. With new precision therapies linked to specific genetic changes, increased genetic testing can help identify patients who could benefit from these approaches."

Among the consensus conference recommendations:

Larger panels are useful for patients with metastatic disease

Large germline panels and somatic testing were recommended for patients with metastatic prostate cancer. Of the approximately 12-17% of men with metastatic prostate cancer who harbor germline variants, the majority are found in DNA damage repair (DDR) genes such as BRCA1, BRCA2, ATM, CHEK2, PALB2, and the DNA mismatch repair (MMR) genes. Large panels provided information across these and other genes of significance, information which is increasingly informing options for PARP inhibitors, immune checkpoint inhibitors, platinum chemotherapy, and clinical trials.

Genetic information can support early diagnosis and inform disease surveillance

Germline test results are increasingly important for early detection, as men with BRCA2 variants exhibit higher rates of prostate cancer, often with a younger age at diagnosis and more clinically significant disease. Among patients with early-stage disease, emerging data suggest that men with germline BRCA2 mutations and possibly ATM mutations have higher rates of upgrading of prostate biopsies while on active surveillance, suggesting the utility of genetic information in shaping surveillance strategies after diagnosis.

Importance of using genetic information requires novel strategies to increase access to counseling resources

The guidelines recommend broad access to genetic counseling support but shortages of genetic counselors and wait times for traditional genetic counseling workflows will require development of alternate models for timely and responsible delivery of genetic testing for men and their families. The consensus framework provides suggestions for clinicians on how to counsel and provide alternatives to traditional in-person appointments for patients across a number of issues related to testing, including using pretest education materials and the use of telehealth genetic counseling sessions.

"This framework provides an important step in helping clinicians incorporate genetic testing into care for a wide range of prostate cancer patients," said Robert Nussbaum, M.D., chief medical officer of Invitae. "Research has shown that narrow testing criteria will miss men with clinically relevant variants that could inform their care. Providing a framework for more clinicians to expand their use of genetic testing will increase the number of patients who benefit from precision medicine approaches."

Research underscores frequency of clinically important variants that may be missed by narrow testing criteria

In addition, a study presented recently at the American College of Medical Genetics and Genomics online annual meeting that further underscored the frequency of actionable variants expanded testing can help uncover.

The study of 2,252 men who participated in Invitae’s Detect Prostate Cancer program found an overall positive rate of 13% with no statistical differences in rates among stages of disease. Only half of patients with an actionable variant reported a family history suggestive of increased risk. Nearly three-quarters (71%) of positive patients were eligible for management guidelines and/or potentially eligible for approved precision therapies or clinical trials. These data suggest that broader testing criteria and greater access to testing leads to better informed care for patients and their families.

The consensus conference noted the need for additional research into the associations between genetics and prostate cancer in African-American men, who are 1.8 times more likely to be diagnosed with and 2.2 times more likely to die from prostate cancer. Importantly, this study included 16% participation among African-Americans, which is greater participation than previous similar studies, aligning to the consensus conference research priorities.

The full consensus statement can be found in the Journal of Clinical of Oncology.

On June 11, 2020 OncBioMune Pharmaceuticals, Inc. (OTC: OBMP) ("OncBioMune") reported the successful completion of its purchase of all the assets of Avant Diagnostics, Inc. ("Avant"), a commercial-stage, molecular profiling company (Press release, Oncbiomune, JUN 11, 2020, View Source [SID1234561002]). OncBioMune is currently trading on the OTC Markets under the symbol ‘OBMP’, but intends to file the necessary applications to change the stock symbol to ‘THER’ and its name to Theralink Technologies, Inc. in the near future.

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Avant Diagnostics provides personalized medicine data through its Theralink assays, initially for breast cancer, to assist the treating physician in a data-driven process for treatment decision support and to help enable predictive biomarker-based patient therapy selection. Avant is the leading developer of phosphoproteomic technologies for measuring the activation state of therapeutic targets and signaling pathways, a key metric for biopharmas, with applications across multiple cancer types, including breast, non-small cell lung, colorectal, gynecologic and pancreatic, among others.

Theralink was developed to empower physicians with potentially actionable information to help them make time-sensitive treatment decisions for their patients. Theralink is designed to provide new predictive biomarkers for biopharmas through the direct measurement of drug target activation mapping, making Theralink instrumental in the development of molecular targeted therapies. The information gathered through the measurement of developed biomarkers has the potential to help physicians make molecularly rationalized treatment decisions that might improve treatment outcomes and may reduce side effects by foregoing ineffective therapy.

As consideration for the assets of Avant, OncBioMune issued to Avant shares of its Series D-1 Convertible Preferred Stock. Upon the filing of an amendment to OncBioMune’s Articles of Incorporation to increase its authorized common stock, which is expected to occur within 45 days, the shares of preferred stock issued to Avant shall automatically convert into approximately 4.4 billion shares of OncBioMune’s common stock. As a condition of the closing of the acquisition, the Company raised $1,075,000 in a private placement of its Series C-2 Convertible Preferred Stock from two institutional investors, the Cavalry Fund and Lincoln Park Capital. The Company does not have institutional debt and no longer has convertible debt or variable rate warrants.

On June 11, 2020 CNS Pharmaceuticals, Inc., (Nasdaq: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its lead product Berubicin for the treatment of malignant gliomas (Press release, CNS Pharmaceuticals, JUN 11, 2020, View Source [SID1234561018]).

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"We are pleased to receive Orphan Drug Designation for Berubicin, our lead candidate. The designation provides Berubicin with a special status that can accelerate its development to treat malignant gliomas, and provides CNS with the potential for market exclusivity upon the drug’s approval," stated John Climaco, CEO of CNS Pharmaceuticals. "In the Phase 1 trial of Berubicin to treat glioblastoma, one of the world’s most aggressive cancers, under a prior developer, 44% of the patients demonstrated a significant improvement in progression free survival, and one patient experienced a complete response. We look forward to continuing to execute on our strategic plan and initiating a Phase II trial evaluating the effect of Berubicin on patients with glioblastoma later this year."

Chief Medical Officer of CNS, Dr. Sandra Silberman, stated, "We are excited to continue to drive the development of Berubicin and work towards addressing a critical unmet medical need. Glioblastoma currently has a dismal survival rate of only 14.6 months from its diagnosis. We believe Berubicin, which based on limited clinical data appears to be the first anthracycline to cross over the blood brain barrier in adults, provides a potentially novel therapy for the treatment of malignant gliomas."

The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Due to small patient numbers, treatment for these rare diseases would not be considered economically feasible without government programs to support their economic viability. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trials costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.

On June 11, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that its Chief Executive Officer, Nancy Simonian, M.D., will participate in a fireside chat at the JMP Hematology and Oncology Forum (Press release, Syros Pharmaceuticals, JUN 11, 2020, View Source [SID1234561003]). Details are as follows:

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JMP Securities Hematology and Oncology Forum
Date: Thursday, June 18
Presentation Time: 4:00 p.m. ET

A live webcast of the presentation will be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay will be available for approximately 30 days following the fireside chat.