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]).

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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.

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.