On June 25, 2020 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported positive preclinical findings published in Frontiers in Immunology regarding the prospect of MN-166 (ibudilast) as an adjunct treatment for glioblastoma (Press release, MediciNova, JUN 25, 2020, View Source [SID1234561500]).

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The publication, entitled "Glioblastoma myeloid-derived suppressor cell subsets express differential macrophage migration inhibitory factor receptor profiles that can be targeted to reduce immune suppression", was a collaborative effort between MediciNova and the Cleveland Clinic, led by Tyler Alban (doctoral candidate) and Dr. Justin Lathia, Co-Director of the Brain Tumor Research and Therapeutic Development Center of Excellence at the Lerner Research Institute, Cleveland Clinic, and Associate Professor, Department of Molecular Medicine at Case Western Reserve University. Dr. Lathia, Dr. Michael Vogelbaum (previously at the Cleveland Clinic, now at Moffitt Cancer Center in Tampa, FL) and colleagues previously reported on findings that GBM patients had higher levels of immune suppressive myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment and they tended to be resistant to and dependent on macrophage migration inhibitory factor (MIF). In this research publication, in collaboration with Dr. Richard Bucala (Yale University), they report the monocytic subset of MDSCs (M-MDSCs) expressed high levels of the MIF cognate receptor CD74 in the tumor microenvironment. This finding is meaningful in that targeting M-MDSCs with ibudilast, a brain penetrant MIF-CD74 interaction inhibitor, resulted in decreased MDSC function and enhanced CD8 T cell activity in the tumor microenvironment. They note that clinical trial results to date suggest that treatment with an immune stimulatory therapy alone is not effective in treating GBM and hypothesized that better clinical outcomes will be seen when an immune stimulatory therapy is combined with ibudilast, which has been shown to reverse tumor-induced immune suppression.

Dr. Justin Lathia commented, "We found that the receptor CD74 may play a greater role in GBM MDSC biology because the subset of MDSCs primarily found in the tumor microenvironment were M-MDSCs, which predominantly express CD74 as a MIF receptor. These findings are significant for treating patients diagnosed with GBM. Among multiple anti-MIF agents we tested, ibudilast was most potent with reducing M-MDSCs. Ibudilast readily crosses the blood-brain barrier, an advantage over other agents, and has a strong safety profile. Our hope is that combining ibudilast and immune stimulatory therapy will translate to decreased disease progression in clinical trials."

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We have an ongoing clinical trial evaluating MN-166 in combination with temozolomide for the treatment of GBM at the Dana-Farber Cancer Institute, Harvard Medical School. Recently, we expanded our target population to include patients with either recurrent or newly diagnosed GBM. A recently published GBM animal model study showed that median survival was longer in the group treated with MN-166 plus temozolomide than in the group treated with temozolomide alone. The new findings reported by Dr. Lathia and his colleagues may lead to the use of MN-166 as combination therapy with immune stimulatory treatment and may offer a new treatment option to patients with GBM, one of the most serious refractory cancers."

About Glioblastoma

According to the American Association of Neurological Surgeons, glioblastoma is an aggressive brain cancer that often results in death within 15 months of diagnosis. Glioblastoma develops from glial cells (astrocytes and oligodendrocytes), grows rapidly, and commonly spreads into nearby brain tissue. Glioblastoma is classified as Grade IV, the highest grade, in the World Health Organization (WHO) brain tumor grading system. The American Brain Tumor Association reports that glioblastoma represents about 15% of all primary brain tumors and approximately 10,000 cases of glioblastoma are diagnosed each year in the U.S. Despite decades of advancements in neuroimaging, neurosurgery, chemotherapy and radiation therapy, only modest improvements have been achieved and the prognosis has not improved for individuals diagnosed with glioblastoma. Median survival is approximately 11-15 months for adults with more aggressive glioblastoma (IDH-wildtype) who receive standard treatment of surgery, temozolomide, and radiation therapy.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. Our earlier human studies demonstrated significant reductions of serum MIF level after treatment with MN-166 (ibudilast). It also attenuates activated glial cells, which play a major role in certain neurological conditions. MN-166 (ibudilast)’s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical studies, which provide the rationale for treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (MS) and other neurological diseases such as glioblastoma (GBM), and substance abuse/addiction. MediciNova is developing MN-166 for ALS, progressive MS and other neurological conditions such as degenerative cervical myelopathy (DCM), glioblastoma, substance abuse/addiction, and chemotherapy-induced peripheral neuropathy. MediciNova has a portfolio of patents which covers the use of MN-166 (ibudilast) to treat various diseases including ALS, progressive MS, and drug addiction.

On June 25, 2020 AnchorDx, a Guangzhou diagnostics company, reported progress on its next-gen blood-based DNA cancer test that will screen for six types of cancer at a cost as low as $100 (Press release, AnchorDx, JUN 25, 2020, View Source [SID1234561494]). The test, named Aurora, uses the company’s ctDNA methylation detection technology to test for lung, breast and digestive system cancers (colorectum, stomach, esophagus and liver), which together account for 65% of new cancer cases in China. AnchorDx said the one-tube DNA test offers high sensitivity and specificity, short turn-around time and low cost.

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On June 25, 2020 Nurix Therapeutics, Inc., a company developing targeted protein modulation drugs, reported the formation of a new adoptive cell therapy company, DeCART Therapeutics, which has been initially formed as a wholly owned subsidiary of Nurix (Press release, Nurix Therapeutics, JUN 25, 2020, View Source [SID1234561493]). DeCART plans to combine the use of Nurix’s proprietary targeted protein modulation drugs with the latest T cell genetic engineering technologies to create a drug-enhanced chimeric antigen receptor T cell (CAR T) process for cancer. DeCART has been founded by Nurix in partnership with Carl June, M.D., the Richard W. Vague Professor in Immunotherapy and director of the Center for Cellular Immunotherapies in the Abramson Cancer Center of the University of Pennsylvania,. Dr. June will lead the DeCART founding team and also serve as the chairman of DeCART’s scientific advisory board.

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"On behalf of the founding team, we are very excited to launch DeCART and begin implementing our first drug-enhanced CAR T process with a goal of rapidly advancing towards clinical development," said Dr. June, "We are encouraged by the preclinical results using CBL-B inhibitors to improve T cell phenotype in a manner that is consistent with delivering anti-tumor activity."

DeCART’s first program is expected to use Nurix’s small molecule CBL-B inhibitor, NX-0255, for ex vivo enhancement of T cell biology throughout the processing and engineering of CAR T cells. CBL-B is an E3 ligase target that functions as an intracellular immune checkpoint that regulates T cell activation and immune response. DeCART will explore development and commercialization of CAR T cell therapies for both hematologic and solid tumors.

"We are very pleased to work with leaders from the powerful research, clinical, and management team that have made history at the University of Pennsylvania with the first regulatory approval and commercialization of CART19 therapy," said Arthur T. Sands, M.D., Ph.D., chief executive officer of Nurix. "Together with DeCART, we plan to introduce a new generation of drug-enhanced CAR T products for patients by integrating pharmacologic control of protein levels within T cells."

DeCART Therapeutics plans to establish operations in Cellicon Valley in the Philadelphia area and will be managed by Ms. Dana Hammill as its chief operating officer. Ms. Hammill is the former director of strategy and business development at the Center for Cellular Immunotherapies at the Perelman School of Medicine at the University of Pennsylvania where she co-managed Penn-Novartis alliance for commercialization of CART19. Dr. Sands will serve as chairman of the board of directors of DeCART.

On June 25, 2020 GNS Healthcare, an AI-driven precision medicine company, reported the launch of GeminiTM, the in silico multiple myeloma patient (Press release, GNS Healthcare, JUN 25, 2020, View Source [SID1234561492]). The in silico patient is a highly accurate computer model of disease progression and drug response at the individual patient level. Clinical development applications include discovering markers of response/nonresponse for clinical trial design, predicting optimal combination therapies, and running head-to-head in silico trials. Market access applications include generating evidence for line of therapy switching and optimizing treatment sequencing.

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Drawing from large quantities of molecular, genomic, and clinical data, this in silico patient represents a culmination of almost a decade of research and development in collaboration with several biopharmaceutical companies, academic medical centers, and the Multiple Myeloma Research Foundation (MMRF). GNS and MMRF recently announced a five-year collaboration which seeks to answer key questions for multiple myeloma patients. GeminiTM includes the drug mechanisms most commonly used to treat multiple myeloma – such as proteasome inhibitors, IMIDs, corticosteroids, alkylating agents, anti-SLAMF7, anti-CD38, and others, connecting the impact of these drugs to clinical endpoints including progression free survival (PFS) and overall survival (OS). Previous results from the in silico multiple myeloma patient have been presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and recently published in Leukemia.

"Over the past decade there have been a dozen treatments approved for multiple myeloma but there is still a lack of evidence to ensure patients receive optimal treatments in first line and subsequent lines of therapy," said GNS Chairman and CEO, Colin Hill. "Creating Gemini, the in silico patient, allows us to break the bottleneck of understanding what treatments work for which patients, driving better clinical trial design, generating real-world evidence for market positioning and ultimately creating better outcomes for patients."

"We are reaching a tipping point where patient data is becoming rich and multi-layered enough to power AI models that can help predict patient response at the individual level. This announcement represents a true step forward in personalizing cancer treatment," said Dr. Ravi Parikh, an Oncologist and instructor of Medical Ethics and Health Policy in the Perelman School of Medicine at the University of Pennsylvania.

To support the future formation of in silico patients, GNS recently convened an in silico patient advisory board to guide development and commercialization strategy. The in silico patient for multiple myeloma represents the first of several poised to expand the world’s understanding of causal response to therapeutics across a range of diseases within oncology, immunology, and neurology.

On June 25, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on developing products to diagnose and treat life and organ threatening diseases, reported financial results for its fiscal year ended March 31, 2020 and provided an update on recent developments (Press release, Aethlon Medical, JUN 25, 2020, View Source [SID1234561491]).

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Company Updates

Aethlon Medical, Inc. (Company or Aethlon) is continuing the development of its proprietary Hemopurifier, which is a first in class therapeutic device designed for the single use depletion of cancer-promoting exosomes and circulating viruses. The Hemopurifier has previously been designated a Breakthrough Device by the FDA for the treatment of glycosylated viruses, including Ebola and other hemorrhagic fever viruses, and in late 2018 was additionally designated as a Breakthrough Device "…for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease…".

Aethlon is currently preparing for the initiation of clinical trials in patients with advanced and metastatic cancers. The Company is initially focused on the treatment of solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers. Under an Investigational Device Exemption (IDE) application approved by FDA in October 2019 the Company is initiating an Early Feasibility Study (EFS – the device equivalent of a phase 1 study) in patients with advanced and/or metastatic head and neck cancer at the UPMC Hillman Cancer Center in Pittsburgh, PA. The EFS will enroll 10-12 subjects and will investigate the combination of the Hemopurifier with standard of care pembrolizumab (Keytruda) in the front line setting.

On June 17, 2020, the FDA approved a supplement to the Company’s existing IDE for the use of the Hemopurifier in life threatening viral infections, to allow for the treatment of patients with SARS-CoV-2/COVID-19 infection. This will allow for up to 40 of these patients to be treated under a New Feasibility Study protocol at up to 20 clinical sites in the U.S.

In other news, the Company announced that Thomas L. Taccini has joined the Aethlon management team as Vice President, Manufacturing and Product Development. Mr. Taccini has over 35 years of experience in leading teams in engineering, product development, project management, quality systems and regulatory affairs for multiple different classes of medical devices.

Financial Results for the Fiscal Year Ended March 31, 2020

The Company recorded government contract revenue of $650,187 in the fiscal year ended March 31, 2020. This revenue resulted from work performed under the Company’s Phase 2 Melanoma Cancer Contract with the National Institutes of Health, or NIH. The Company recorded government contract revenue of $229,625 in the fiscal year ended March 31, 2019.

Operating expenses for the fiscal year ended March 31, 2020 were approximately $6.58 million, compared to $6.23 million for the fiscal year ended March 31, 2019. This increase of approximately $350,000, or 6%, in the fiscal year ended March 31, 2020 was due to increases in professional fees of $537,000 and in general and administrative expense of $595,000, which were partially offset by a decrease of $781,000 in payroll and related expenses.

The $537,000 increase in our professional fees in the fiscal year ended March 21, 2020 was primarily due to a $694,000 increase in our legal fees and a $111,000 increase in our accounting fees, which were partially offset by decreases of $245,000 in consulting fees. The increase in legal and accounting fees related to increased activity in our registration statement filings and in intellectual property actions, among other matters.

The $595,000 increase in general and administrative expenses in the fiscal year ended March 21, 2020 was primarily due to the combination of a $316,000 increase in our clinical trial expenses, a $198,000 increase in subcontracting and other costs related to our government contracts, and an increase of $87,000 in laboratory supplies.

The $781,000 decrease in payroll and related expenses in the fiscal year ended March 21, 2020 was due to a combination of a decrease in our stock-based compensation of $475,000 and a decrease of $306,000 in cash-based compensation, primarily due to the termination of consulting and severance payments to our former chief executive officer and former president.

Other expense in the fiscal year ended March 21, 2020 consisted of a non-cash loss on debt extinguishment, interest expense and a gain on share for warrant exchanges, and in the fiscal year ended March 21, 2019, consisted of interest expense only. Other expense for the fiscal year ended March 21, 2020 was approximately $450,000, compared to other expense of approximately $220,000 for the fiscal year ended March 21, 2019.

As a result of the changes in revenues and expenses noted above, our net loss before noncontrolling interests increased to approximately $6,380,000 for the fiscal year ended March 31, 2020, from $6,220,000 for the fiscal year ended March 31, 2019.

At March 31, 2020, we had a cash balance of approximately $9.6 million.

In June 2020, we raised additional cash through the sale of 2,685,600 shares of common stock under our ATM facility at an average price of $2.70 per share of net proceeds. The aggregate net proceeds to us were approximately $7.3 million.

The unaudited condensed consolidated balance sheet for March 31, 2020 and the unaudited condensed consolidated statements of operations for the fiscal years ended March 31, 2020 and 2019 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Thursday, June 25, 2020 at 4:30 p.m. Eastern Time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source Please note that registered participants will receive their dial in number upon registration.

Interested parties without internet access or unable to pre-register may dial in by calling:

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through July 2, 2020. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10145174.