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New Study Demonstrates the Ability of myPath® Melanoma to Accurately Classify Lesions Ruled Indeterminate by Standard Pathological Assessment

On June 25, 2020 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, reported that a new study published in Future Medicine demonstrates the ability of myPath Melanoma to accurately classify skin lesions ruled indeterminate by standard pathological review (Press release, Myriad Genetics, JUN 25, 2020, View Source [SID1234561738]).

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"This validation study for myPath Melanoma demonstrates the ability of the test to accurately classify lesions which are ruled indeterminate by an expert dermatopathologist," said Nicole Lambert, president of Myriad International, Oncology and Women’s Health. "Importantly, this accuracy was linked to the gold standard endpoint of real world clinical outcomes demonstrating the accuracy of the myPath Melanoma test result for patients and physicians concerned about this deadly cancer."

The study evaluated 181 skin lesions of which 125 were ruled indeterminate by at least one of seven blinded dermatopathologists who reviewed the samples. The samples were linked to known real world outcomes with 43 percent of samples representing malignant melanomas. Importantly, myPath Melanoma demonstrated 90.4 percent sensitivity and 95.5 percent specificity in the indeterminate sample cohort and 93.8 percent sensitivity and 96.2 percent specificity when evaluating the entire sample cohort. This data is consistent with multiple other clinical validation studies for myPath Melanoma which have demonstrated the ability of the test to delineate melanoma from benign skin lesions with high diagnostic accuracy.

About Melanoma
According to the American Cancer Society, approximately 100,350 Americans are expected to be diagnosed with melanoma this year. Early and accurate diagnosis of melanoma is critical for long-term survival.

About Myriad myPath Melanoma
Myriad myPath Melanoma is a clinically validated test to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. The test measures the expression of 23 genes and accurately distinguishes melanoma from benign nevi. For more information visit: View Source

Entry into a Material Definitive Agreement

On June 24, 2020 (the "Closing Date"), HTG Molecular Diagnostics, Inc. (the "Company") reported that it entered into a Loan and Security Agreement (the "Loan Agreement"), by and among the Company and Silicon Valley Bank ("SVB"), as lender, which provides a secured term loan in the principal amount of $10.0 million (the "Term Loan") (Filing, HTG Molecular Diagnostics, JUN 25, 2020, View Source [SID1234561674]).

The proceeds from the Term Loan were fully funded on the June 25, 2020. The proceeds from the Term Loan, together with cash on hand, were used to repay in full all outstanding amounts and fees due under the (i) Credit and Security Agreement (Term Loan), dated as of March 26, 2018, by and among the Company, as borrower, the lenders party thereto from time to time and MidCap Financial Trust, as agent (the "MidCap Term Loan"), in the aggregate amount of approximately $7.5 million, (ii) Credit and Security Agreement (Revolving Loan), dated as of March 26, 2018, by and among the Company, as borrower, the lenders party thereto from time to time and MidCap Funding IV Trust (together with MidCap Financial Trust, "MidCap"), as agent (the "MidCap Revolving Loan"), in the aggregate amount of approximately $22,000 and (iii) Subordinated Convertible Promissory Note, dated as of October 26, 2017, issued by the Company to Qiagen North American Holdings, in the aggregate amount of approximately $3.2 million.

The Term Loan bears interest at a floating rate equal to the greater of 2.50% above the Prime Rate (as defined in the Loan Agreement) and 5.75%. Interest on the Term Loan is due and payable monthly in arrears. The Term Loan has interest-only payments through June 30, 2021. The interest only period may be extended for six months upon the achievement of an equity milestone as more fully described in the Loan Agreement. The ultimate interest-only period will be followed by equal monthly payments of principal and interest through the maturity date of January 1, 2024.

Prepayments of the Term Loan, in whole or in part, will be subject to early termination fees in an amount equal to 3.0% of principal prepaid if prepayment occurs on or prior to the first anniversary of the Closing Date, 2.0% of principal prepaid in prepayment occurs after the first anniversary of the Closing Date but on or prior to the second anniversary of the Closing Date, and 1.0% of principal prepaid if prepayment occurs after the second anniversary of the Closing Date and prior to the maturity date.

Upon termination of the Loan Agreement, the Company is required to pay an exit fee equal to 8.00% of the principal amount of the Term Loan.

The Company’s obligations under the Loan Agreement are secured by a security interest in substantially all of its assets, excluding intellectual property (which is subject to a negative pledge). Additionally, the Company’s future subsidiaries, if any, may be required to become co-borrowers or guarantors under the Loan Agreement.

The Loan Agreement contains customary affirmative covenants and customary negative covenants limiting the Company’s ability and the ability of the Company’s subsidiaries, if any, to, among other things, dispose of assets, undergo a change in control, merge or consolidate, make acquisitions, incur debt, incur liens, pay dividends, repurchase stock and make investments, in each case subject to certain exceptions. The Company must also comply with a financial covenant requiring the Company to maintain unrestricted cash at an account with SVB of not less than the greater of (i) $12.5 million and (ii) an amount equal to six (6) times the amount of Company’s average trailing three (3) month Cash Burn (as defined in the Loan Agreement), tested monthly as of the last day of each month.

The Loan Agreement also contains customary events of default relating to, among other things, payment defaults, breaches of covenants, a material adverse change, delisting of the Company’s common stock, bankruptcy and insolvency, cross defaults with certain material indebtedness and certain material contracts, judgments, and inaccuracies of representations and warranties. Upon an event of default, SVB may declare all or a portion of the Company’s outstanding obligations to be immediately due and payable and exercise other rights and remedies provided for under the agreement. During the existence of an event of default, interest on the obligations could be increased by 5.0%.

Warrant

In connection with the Loan Agreement, the Company granted to SVB a warrant to purchase up to 643,413 shares of the Company’s common stock at a purchase price of $0.7771 per share (the "Warrant"). The Warrant will

expire on June 24, 2030 and may be exercised for cash or at the election of the holder on a cashless, net exercise basis.

The foregoing is only a summary of the material terms of the Loan Agreement and the Warrant and does not purport to be complete and is qualified in its entirety by reference to the full text of the Loan Agreement and the Warrant, copies of which are filed as Exhibit 10.1 and Exhibit 4.1 to this report, respectively.

$30M for Cancer-Focused TAE Life Sciences

On June 25, 2020 TAE Technologies Inc. of Foothill Ranch races to solve the world’s energy problems via nuclear fusion,reported that its 3-year-old biologically-targeted radiation therapy offshoot is inching closer to its own world-changing target: treating and curing cancer patients (Press release, TAE Life Sciences, JUN 25, 2020, View Source [SID1234561517]).

TAE Life Sciences LLC recently announced a $30 million investment to support its drug development program, which when combined with its neutron beam accelerator technology could unlock a new generation of targeted cancer therapy.

The Series B initial funding is among the largest in Orange County in the first half of the year.

The amount of funding is indicative of the company’s high expectations, officials tell the Business Journal.

"TAE Technologies doesn’t shy away from some pretty ambitious goals. We have the same culture at our company," said Bruce Bauer, chief executive of TAE Life Sciences, or TLS.

"We believe we have a technology that is going to change the world of cancer therapy. That’s an ambitious goal and a challenging area, but we have a culture of solving big problems. We’re not shying away from the magnitude of it."

Tumors Targeted

TLS publicly launched in March 2018 with some $40 million in funding at a $100 million valuation. Its combined $70 million of reported investments to date is a relatively small amount of funding compared to the $700 million its parent company has raised over the past 18 years; TAE Technologies backers have included Google and the late Paul Allen, co-founder of Microsoft Corp.

The PhD-heavy parent company, which is aiming to commercialize its space-age fusion technologies in the next three years or so, is reported to have a $3 billion valuation.

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TLS exclusively licensed its parent company’s accelerator technology, built on more than two decades of research that originated at the University of California-Irvine. The parent company’s goals are to provide an abundant source of energy that produces fewer pollutants.

TLS is using that same base of technology for medical applications: it aims to build a neutron delivery system for an emerging type of radiation therapy called Boron Neutron Capture Therapy or BNCT. BNCT is a radiation therapy technique that offers noninvasive treatment options for cancers of the head and neck, brain tumors and other aggressive and recurrent cancers.

TLS’ delivery system, called the AlphaBeam, produces low-energy neutrons that neutralize tumors containing accumulated boron-10, a nontoxic type of isotope that when given to a patient via a drug collects in tumor cells.

The radiation therapy is designed to spare healthy tissue. Because the boron-10 carrier drug is highly targeted to accumulate cancer cells, a patient could in theory be treated in just one or two treatment sessions, without many of the side effects of traditional radiation therapy.

Testing Underway

The technology is still in the testing phase.

The company’s first commercial system is currently on its way to a site in China, where its partner Neuboron Medtech Ltd. plans to launch Phase II clinical trials with TLS’ accelerator-based neutron system and a boron-10 target drug called BPA, which has been used to treat about 2,000 patients to date.

In the meantime, TLS is finalizing construction plans with an Italian-based partner, which will kick off clinical trials for CE markings in 2022. U.S. clinical trials will follow with at least three or more clinical sites.

On the drug development side, Bauer said research will continue for several years before clinical trials can begin.

"We’re bringing together everything from particle acceleration technology to pharmaceutical development. It takes time and perseverance, and that’s what we’re bringing to the table."

$100M Mission

TLS announced the $30 million initial close of its Series B round of financing on June 2.

More’s in store. Bauer—whose résumé includes stints in the private equity and medical imaging industries—said TLS ultimately wants to raise $100 million in its Series B round.

San Francisco-based Artis Ventures, which led TLS’ $40 million Series A round in 2018, participated in the deal.

R&D

Funds from the latest funding round will support drug development, which takes place at the company’s new R&D facility in Santa Monica. The building was previously occupied by Japan’s Stella Pharma Corp., which has experience in creating boron compounds for BNCT.

TLS subleased the 16,000-square-foot lab and recruited a core team of researchers from Stella, Bauer said.

The new round of funding will also support growing teams in R&D, manufacturing, quality control, software and systems engineering in Foothill Ranch.

TLS currently has 30 employees, though more than 70 people including contractors and TAE Technologies employees are working on the project, Bauer said.

Bauer declined to comment on future job openings, saying the subsidiary is "performing very well" occupying one of the four buildings at TAE Technologies’ Foothill Ranch headquarters.

Bright Future

Amid COVID-19, Bauer said TLS has transitioned to work from home and, he joked, "given everyone a chance to catch up on their paperwork, given the regulatory environment we operate in."

Joking aside, "we’ve had very productive continuity on the device side and drug development side."

The biggest challenge for the business has been maintaining its international partnerships amid travel restrictions, which have prevented teams from traveling to sites in Russia and China.

"The good news is we have strong partnerships in these locations and we’ve been relying on local assets to continue our work. It’s slowed us down a bit, but we’re working it out. Our teams will travel when they can."

Bauer is no stranger to patience and persistence, and he’s keeping his ambitions high.

"OC has a history of companies that have undertaken big challenges in healthcare, and succeeded, and really made an impact.

MediciNova Announces Positive Preclinical Results Regarding MN-166 (ibudilast) in Glioblastoma (GBM) Published in Frontiers in Immunology

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]).

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.

AnchorDx Developing $100 Diagnostic Test for Six Types of Cancer

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.