Tosk Drug Demonstrates Proof of Concept in Head and Neck Cancer Clinical Study

October 3, 2019

Tosk Drug Demonstrates Proof of Concept in Head and Neck Cancer Clinical Study

Mountain View, CA, October 3, 2019. Tosk, Inc., reported today that its drug, TK-90, has successfully completed a Phase 2a, placebo-controlled, clinical study in 22 head and neck cancer patients receiving chemotherapy. TK-90 demonstrated almost complete prevention of mucositis, a painful and potentially fatal adverse side effect of many cancer drugs and radiation therapy.

In the study, patients were dosed once per week for four weeks. Half of the patients were given TK-90 with chemotherapy and half were given placebo with the same chemotherapy. Initial results from the study suggest highly significant prevention of mucositis in the TK-90 patients compared to placebo based upon two widely recognized measures of mucositis. These findings confirmed results from a previous study in 25 patients who received increasing doses of TK-90 along with a higher dose of chemotherapy.

Dr. William Garland, Vice President of Research and Development atTosk, said “It is unusual to get such unambiguous results from a small study in patients. Generally, patient numbers must be much higher in order to yield such favorable statistics.The study suggests that TK-90 has the potential to become a standard part of cancer therapy for treatments that cause mucositis in the GI tract.”

Dr. Garland also noted, “The findings also demonstrate that our proprietary fruit fly-based drug screening technology can be used to discover clinically useful agents. This augurs well for the other Tosk drug candidates discovered using fruit flies to prevent serious adverse effects, such as doxorubicin-induced cardiomyopathy.”

Tosk, Inc. is a privately held biopharmaceutical company that discovers and develops new drugs to improve outcomes for cancer patients by preventing the adverse side effects of existing, widely-used cancer therapies and by blocking the proteins produced by cancer genes.

Leading Cancer Pharmacologist Joins Tosk’s Scientific Advisory Board

September 12, 2019

Leading Cancer Pharmacologist Joins Tosk’s Scientific Advisory Board

Mountain View, California, September 12, 2019 – Dr. Giuseppe Pizzorno, an expert in cancer pharmacology research, has joined Tosk, Inc.’s Scientific Advisory Board, according to Brian Frenzel, Tosk’s CEO.

“Dr. Pizzorno brings to Tosk a deep understanding of clinical and pre-clinical pharmacology, experimental therapeutics, and translational research garnered over 30 years in the field,“ Frenzel said. “We are honored to have him as a member of our SAB.”

Dr. Pizzorno has held leadership positions in academia, National Cancer Institute cancer centers, and other prominent research institutions, and has made significant contributions in drug discovery and development.

“Tosk developed its reputation as an innovative pharmaceutical research and development company by using fruit flies to rapidly identify new drugs to improve outcomes for cancer patients,” Frenzel said. “Dr. Pizzorno’s expertise in cancer pharmacology and drug mechanisms of action will support Tosk’s work both in drug development and in the clinic. We have a number of human trials underway and planned over the next several years, and we look forward to Dr. Pizzorno’s support in this important effort.”

Dr. Pizzorno has held increasingly senior positions in institutions of higher education. At the Yale University School of Medicine, he directed the Clinical Pharmacology program at the school’s Comprehensive Cancer Center, and later directed the research component of the Yale Pediatric Pharmacology Research Unit, a network of university-based pediatric clinical pharmacologists. This network is supported by the National Institute of Child Health and Human Development (NICHD) and is dedicated to performing pediatric studies for the pharmaceutical industry.

He was one of three founders and served as Vice President of Research Operations and Deputy Director of the Nevada Cancer Institute (NVCI), where he led and coordinated Translational Research group activities and mentored young investigators. He also supervised the Institute’s Phase 1 clinical research program and its Clinical Trial Office, and participated in the implementation of a number of clinical studies, including four first-in-human studies of new pharmaceutical entities. During his tenure at NVCI, he was also the co-PI and member of the steering committee for the Nevada IDeA Network of Biomedical Research Excellence (INBRE), a National Institutes of Health initiative to promote biomedical research and education by supporting faculty development and research infrastructure in states that have historically received low levels of support from NIH.

Recently, Dr. Pizzorno joined the University of Tennessee College of Medicine as the Associate Dean for Research and the Chief Research Officer for the Erlanger Health System.

Dr. Pizzorno has published over 100 research articles and book chapters and obtained funding for more than 25 individual and institutional research projects. He earned a Doctor of Pharmaceutical Chemistry and Technology degree in 1983 from the University of Genova, Italy, and a year later, a Doctor of Pharmacy degree from the same university, graduating both programs summa cum laude.

Tosk, Inc. is a privately held biopharmaceutical company that discovers and develops new drugs to improve outcomes for cancer patients by preventing the adverse side effects of existing, widely-used cancer therapies and by blocking the proteins produced by cancer genes.

Leading Cancer Expert Joins Tosk’s Medical Advisory Board

September 3, 2019

Leading Cancer Expert Joins Tosk’s Medical Advisory Board

Mountain View, California, September 3, 2019 – Tosk, Inc. announced today that Dr. Joel Epstein, a specialist in oral medicine and in cancer diagnosis with particular expertise in the treatment and prevention of the adverse side effects of common cancer therapeutics, has joined its Medical Advisory Board.

“We are honored that one of the nation’s most distinguished experts in head and neck and maxillofacial cancer diagnosis and treatment has joined our Advisory Board,” Tosk’s CEO, Brian Frenzel said. “Joel’s extensive experience in understanding, diagnosing, and treating the complications of cancer will be invaluable as we continue in our mission to prevent the toxic effects of front-line cancer drugs and to block the activity of cancer genes.”

Dr. Epstein has published over 500 papers and participated in over 30 clinical studies in the field. He has taught and practiced at a number of respected universities and hospitals, including the British Columbia Cancer Agency, the University of Washington, and the University of Illinois, where he was Head of the Interdisciplinary Program in Oral Cancer Biology, Prevention and Treatment.

Dr. Epstein has earned many fellowships and awards during his career, the latest in 2018, when he was presented the Distinguished Service Award of the International Society of Oral Oncology.  He’s also well known for his writings and presentations on maxillofacial cancer and other oral/dental diseases. Dr. Epstein holds a DMD degree from the University of Saskatchewan and an MSD degree from the University of Washington, where he also served as a Resident in Oral Medicine.

Dr. Epstein currently serves as Professor and Director of Cancer Dentistry at the Samuel Oschin Comprehensive Cancer Institute, part of the Cedars-Sinai Health System, in Los Angeles, CA, and as Medical Director of Dental Oncology Services at the City of Hope Comprehensive Cancer Center in Duarte, CA.

“Joel’s work with head and neck cancer patients, as well as his understanding of treatments that can often cause painful and life-threatening adverse side effects, will be of immediate benefit to our company as our drug candidate TK-90 moves through clinical testing to prevent the mucositis caused by cancer therapies,” Frenzel said. “This will be particularly relevant as we review clinical results, apply for accelerated approval pathways with the FDA, and design and implement additional clinical trials.”

Tosk, Inc. is a privately held biopharmaceutical company that discovers and develops new drugs to improve outcomes for cancer patients by preventing the adverse side effects of existing, widely used cancer therapies and by blocking the activity of cancer genes.

 

First Drug Discovered in a Fruit Fly Used in Patients

May 30, 2019

First Drug Discovered in a Fruit Fly Used in Patients

Tosk, Inc. announced today that its patented drug, TK-90, which prevents the adverse side effects of frontline cancer therapies, succeeded in human clinical studies involving 25 head-and-neck cancer patients. TK-90 is the first drug discovered through screening using the common fruit fly (Drosophila melanogaster) to be tested in patients. The drug prevents mucositis, a painful, dose limiting, side effect suffered by many cancer patients undergoing chemotherapy and radiation therapy.

“Fruit flies have played an important role in scientific research for generations,” said Brian Frenzel, Tosk’s CEO, pointing out that six Nobel prizes in medicine or physiology have been awarded to scientists based on their research using the fruit fly, the latest in 2017. “However,” he added, “Drosophila have not been widely used for drug discovery and development by the pharmaceutical industry. Tosk is an exception. Our scientists have developed two proprietary drug discovery platforms that use fruit flies to identify new drugs to combat cancer and other diseases.”

Tosk, like the Nobel prize winners, uses the fruit fly because it has surprising similarities to humans at the genetic and molecular levels. Adult fruit flies, for example, have body parts that mimic mammalian hearts, kidneys, digestive tracts, and lungs. Nearly 70 percent of human disease-related genes have analogs in the fruit fly. “Because the life cycle of a fruit fly is short, only 50 days from birth to death and only two weeks from birth to adulthood, drug discovery in flies can be done quickly and cost effectively,” Frenzel says. “Using non-mammals as a discovery tool may yield new drugs that could not have been found using other, more traditional methods.”

Tosk selected TK-90 out of tens of thousands of compounds using what the company calls the Side Effect Fly™. Tosk incubates test compounds with a toxic chemo-therapeutic that would otherwise prevent eggs from hatching and developing. Compounds that increase survival and result in larvae or mature fruit flies are “hits.” Hits are tested in cell culture models using human cancer cells to select “leads” that do not affect the cancer killing efficacy of the chemotherapy. Tosk’s researchers then move to traditional drug development models to confirm safety, adverse effect prevention, and non-interference with the beneficial effects of the cancer therapy.

Frenzel said, “Instead of picking a target and fitting compounds to match, as most pharmaceutical companies do, our scientists let the fruit fly tell us which compounds are safe and effective. We then work backward to identify the molecular target or targets through which the drug works, opening what we believe is an exciting new vista on the process of drug discovery.”

Tosk has innovated a second, perhaps even more important, drug discovery platform, which it calls the Genetically Modified Fly™. Tosk integrates a human disease gene into Drosophila and then tests compounds for their ability to block the activity of the disease gene. This model is designed to discover drugs for disease targets that have previously been considered “undruggable.”

In addition to TK-90, Tosk has three other new drugs in its pharmaceutical development pipeline. The most advanced is TK-39, which prevents the dose-limiting, permanent, and potentially fatal damage to the heart caused by doxorubicin and other widely used, frontline cancer therapies. Another side effect preventing drug is TK-88, which prevents permanent kidney damage caused by platinum-based drugs such as carboplatin and cisplatin. Both were discovered using the Side Effect Fly.

Tosk’s cancer gene activity blocking program addresses a top priority for the U.S. National Cancer Institute (NCI) – developing a drug to block the activity of the human kRAS cancer gene. Funded by a $2 million grant from NCI, Tosk has used its Genetically Modified Fly for this purpose. The mutant kRAS gene drives as many as 30 percent of all cancers, including 90 percent of pancreatic, 45 percent of colon, and 35 percent of lung cancers.

Tosk’s fruit fly-based drug screening technologies afford a new method to find small molecule, inexpensive drugs for difficult targets. “We think our fly models give us an advantage, a way to succeed where others have failed,” Frenzel says.Tosk’s first drug candidate, TK-90, has confirmed this in human clinical studies. Tosk believes that this is just the beginning, and plans to deliver many more drugs to improve outcomes for cancer patients.

Preclinical Efficiency Testing in a Rat Model of Doxorubicin-induced Cardiotoxicity Demonstrates Statistically Significant Protection

January 28, 2019

Preclinical Efficiency Testing in a Rat Model of Doxorubicin-induced Cardiotoxicity Demonstrates Statistically Significant Protection

Tosk announces today that, TK-39, Tosk’s second patented product, which blocks damage to the heart resulting from a widely used class of cancer drugs known as the anthracyclines, has demonstrated preclinical efficacy testing in a well-accepted rat model. The rat model was developed by US FDA to study heart function.

The experiment examined the pumping capacity of the heart following treatment with doxorubicin. Survival also was substantially better in the animals dosed with TK-39.Tosk’s CEO, Brian Frenzel said, “This model of functional protection from doxorubicin-induced cardiotoxicity confirms previous work using biomarkers. We are ready to begin the final GLP toxicity testing needed to file an IND with the US FDA to initiate human clinical studies.”

Tosk’s Drug to Prevent Mucositis Proves Safe and Effective

December 17, 2018

Tosk’s Drug to Prevent Mucositis Proves Safe and Effective

Privately held biotechnology company, Tosk, Inc., announced today the successful completion of the Company’s human clinical study testing the safety and efficacy of its patented drug, TK-90, to prevent the painful and dose-limiting mucositis caused by widely used cancer therapies.

TK-90 was administered to 25 head and neck cancer patients receiving methotrexate to determine the optimal dose of treatment as well as to confirm safety. TK-90 proved effective in preventing virtually all of patients’ mucositis at the two higher doses tested. No TK-90 related side effects were observed in any patient group. A follow-up study is planned to confirm these results using the optimal dose and will be completed within the first half of 2019.

“Tosk’s mission is to improve the quality of life of cancer patients worldwide by providing them with highly effective, inexpensive drugs that eliminate toxic side effects and make certain drugs effective in patients that do not currently benefit from treatment,” Tosk’s CEO, Brian Frenzel, said. “Though side effect reduction is one of the 10 areas of emphasis in the U.S. government’s Cancer Moonshot initiative, it tends to be under appreciated. Side effects suffered by cancer patients not only reduce their quality of life but can force physicians to limit cancer treatment. Also, side effects are often expensive to treat, increasing the cost of care. Some cancer therapy side effects are permanent and reduce lifespan, even if the cancer is in remission. Our team at Tosk is dedicated to addressing these important, unmet medical needs.”

Tosk has two other promising side-effect-reducing drugs in the pipeline. TK-39 is a patented drug that blocks the cardiotoxicity caused by a class of widely-used cancer drugs known as the anthracyclines. These drugs are used to treat breast, bladder, and lung cancers, as well as lymphomas and leukemias. The damage to heart tissue from these drugs is permanent and limits the lifetime dosage of an otherwise effective cancer treatment. Tosk’s other side-effect-reducing drug, TK-88, is designed to block adverse effects caused by widely used platinum-based drugs, such as cisplatin and carboplatin. These side effects can include loss of kidney function, peripheral neuropathy, and hearing loss.

“The results of the TK-90 clinical study fully met our expectations,” said Frenzel. “The company has initiated a partner search to identify companies that would be a good fit for TK-90. We plan to grow and add other products to our pipeline using our proprietary discovery technologies, but we’ll let others take our drugs to market. These could include big pharma, specialty pharma, and supportive care oncology companies.”

Tosk Presents Jointly with NCI on kRAS Project at Research Meeting in San Diego

December 11, 2018

Tosk Presents Jointly with NCI on kRAS Project at Research Meeting in San Diego

Tosk, Inc., announced today a joint presentation with the US National Cancer Institute (NCI) Frederick National Laboratory and the Texas Tech Health Sciences Center (TTHSC) at a meeting this week in San Diego, CA. The meeting, entitled “Targeting RAS-Driven Cancers,” was sponsored by the American Association for Cancer Research (AACR). The presentation was entitled “kRAS and Metabolism: An Interesting Interplay.”

Mutations in the human kRAS gene drive 90% of pancreatic cancers, 45% of colon cancers, and 35% of lung cancers. Patients with certain mutated kRAS genes also do not benefit from treatment with a widely-used class of cancer drugs known as EGFR inhibitors, such as Erbitux®. An effective inhibitor of mutated kRAS would address these unmet medical needs and provide an important, new treatment for cancer.

Tosk features proprietary discovery technology using the common fruit fly to discover potential kRAS-inhibiting drugs. This discovery platform uses fruit files with a mutated human kRAS gene integrated into their genome, causing the fly’s wings to be crimped. Tosk screens for drugs which reverse this wing crimping by inhibiting the protein produced by the mutated kRAS gene.

The presentation discussed how a small molecule discovered by Tosk, partially restored normal wing development in the kRAS mutated flies and inhibited growth and signal transduction in multiple, oncogenic kRAS-driven cell lines. The goal of the successful collaboration between Tosk, NCI’s Frederick Laboratory, and TTHSC was to establish the mechanism-of-action of the discovered inhibitor. The work at Tosk and TTHSC was funded by an SBIR grant from NCI.

Dr. William Garland, Vice President of Research and Development at Tosk stated, “This innovative work on the discovered inhibitor provided important information on the previously, not fully appreciated, interplay between mutated kRAS and a metabolic process. The information gained will help future work at Tosk. The results demonstrate the power of collaboration among a small research company, academia, and a large public research institute. None of the groups alone could have achieved the advance reported in our joint presentation.”

National Cancer Institute Renews Grant for Tosk’s kRAS Cancer Program

September 13, 2018

National Cancer Institute Renews Grant for Tosk’s kRAS Cancer Program

Tosk, Inc. announced today that the US National Cancer Institute (NCI) has renewed Tosk’s Phase II SIBR grant to support the drug company’s promising kRAS oncogene drug development program, a high priority for the NCI. The renewal provides an additional $1 million of grant funding for the program over a period of one year.

Cancer patients with a mutant kRAS gene – approximately 40 percent of all cancer patients – are unable to benefit from EGFR-inhibitor cancer therapies, such as Erbitux®️. Furthermore, mutant kRAS has been estimated to drive 90 percent of pancreatic cancers, 45 percent of colon cancers, 35 percent of lung cancers, and a smaller percentage in other cancers.

Tosk’s scientists are focused on breakthrough therapies that address so-called difficult-to-modulate targets, such as oncogenic kRAS. Tosk’s CEO, Brian Frenzel said, “kRAS is characterized as an ‘undruggable’ target, since many research efforts targeting it have failed. We have a different approach to discovering such a drug by using our Genetically Modified Fly™ technology.” Tosk will collaborate with Scientific Advisory Board member, Prof. Jeff Thomas, at the Texas Tech Health Sciences Center, and with the NCI in pursing the goal of finding a drug to block the activity of the most virulent subtype of the human kRAS gene.

The NCI-supported kRAS program is one of a number of Tosk initiatives. The company currently has three active programs designed to block the painful, debilitating and potentially fatal adverse side effects caused by common cancer treatments. One patented drug, TK-90, has completed trials in head and neck cancer patients with favorable results. TK-90 is designed to prevent mucositis, the inflammation and ulceration of the mucosal membranes lining the digestive tract, a painful, dose-limiting side effect of certain cancer therapies. The company also has programs targeting the cardiotoxicity and kidney toxicity caused by cancer drugs.