CohBar Reports Fourth Quarter 2018 Financial Results and Provides Business Update

On March 18, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported its financial results for the fourth quarter ended December 31, 2018 (Press release, CohBar, MAR 18, 2019, View Source [SID1234534465]).

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"We continue to focus on getting CB4211 back into the clinic as soon as possible, and have engaged in direct discussions this month with the FDA about our revised clinical plan," said Philippe Calais, CohBar’s interim chief executive officer. "At the same time, our increased investment in research is enabling significant progress in evaluating our new peptides in an expanded range of disease models, and uncovering mechanisms that open new potential opportunities for additional therapeutic targets. We also continue to make progress optimizing novel peptides as potential therapeutics for type 2 diabetes and cancer. These developments on multiple fronts reinforce our belief in the therapeutic potential of our portfolio of mitochondrial peptides to treat multiple age-related diseases."

Fourth Quarter 2018 and Recent Clinical, Research and Business Highlights:

CB4211 Clinical Study Update. The company retained Dr. James Leyden, Professor Emeritus of Dermatology at University of Pennsylvania, a well-respected expert and advisor to U.S. and European regulatory agencies, who reviewed the clinical data related to the mild but persistent indurations observed in the company’s temporarily-suspended Phase 1a/1b clinical trial. Dr. Leyden reported his conclusions that there were no significant safety issues and participated in the company’s call with the FDA in early March. The company is submitting additional information to the FDA, with the goal of resuming clinical activities as soon as possible.

CohBar Pipeline Update. During the fourth quarter and more recently, the company continued to advance its optimization and evaluation of novel analogs of its previously discovered peptides, and the identification of potential mechanisms and disease targets. In the area of type 2 diabetes research, the company recently discovered the interaction between a family of novel peptide analogs with effects on glucose tolerance in animals and a key cell surface receptor. This receptor plays an important role in a number of age-related diseases. CohBar submitted an abstract on this discovery for presentation at a major scientific meeting scheduled for later this year.

Appointed Dr. Philippe Calais as Interim CEO. Dr. Calais became interim CEO in December, bringing to the company more than 30 years of large and small-cap biopharmaceutical experience in product development and commercialization, partnerships, collaborations and financings. He most recently served as Chief Executive Officer of Isarna Therapeutics B.V., after having led several clinical stage biopharmaceutical companies in Canada and in Europe, and Univalor LTD, a large technology transfer organization in Canada. Earlier in his career, he served in multiple roles at F. Hoffmann-La Roche.

Expanded the Company’s Board of Directors. Dr. Phyllis Gardner joined the CohBar Board in February 2019, adding broad and deep expertise in academia, medicine, pharmacology, drug delivery, biotechnology and corporate investing and governance to the CohBar board. Dr. Gardner’s background includes roles as a senior scientist at ALZA Corporation, a partner at Essex Woodland Health Ventures and over 30 years as a distinguished professor of medicine at Stanford University School of Medicine.

Investment Community Outreach. During the fourth quarter, CohBar presented an overview of the company and its clinical development program at The BIO Investor Forum. The company also met with investors, bankers and analysts during the JP Morgan Healthcare conference in January 2019, and presented at the BIO CEO and Investor Conference in February. At BIO CEO, Dr. Calais was featured on a panel entitled "Attacking Biological Mechanisms of Aging to Extend Healthspan."

Media Coverage. An article entitled "CohBar Develops Targeted Mitochondria Based Therapeutics for Metabolic Disorders that Cause Age-Related Diseases," and an interview with Dr. Calais, were published in the February 15, 2019 issue of Beikoku Seiyaku Gyokai Shuho. Beikoku Seiyaku Gyokai Shuho is a weekly report covering the U.S. pharmaceutical market. Its subscribers include some of Japan’s largest pharmaceutical and other life sciences companies.
During the fourth quarter and more recently, CohBar’s founders, Dr. Pinchas Cohen and Dr. Nir Barzilai, continued to be recognized as international leaders in the study of aging, age-related diseases and mitochondrial science.

Dr. Cohen was featured as a keynote speaker at "The Barshop Symposium on Exercise Regulation of Biological Aging" in San Antonio, Texas and at "The Gerontological Society of America" in Boston, Massachusetts. Dr. Cohen also co-authored three studies related to mitochondrial peptides published during the quarter and recently: "Characterizing the Protective Effects of SHLP-2, a Mitochondrial Derived Peptide, in Macular Degeneration," in Nature Scientific Reports (October 2018), "Humanin is a Novel Regulator of Hedgehog Signaling and prevents Glucocorticord-induced Bone Growth Impairment," in FASEB Journal (January 2019), and "MOTS-c, an Equal Opportunity Insulin Sensitizer," Journal of Molecular Medicine (February 2019).

Dr. Barzilai was awarded the prestigious international Fondation IPSEN Longevity Prize during the 22nd Geriatric Society of America meeting held on November 17, 2018 in Boston, Massachusetts. Dr. Barzilai also delivered keynote lectures at the "Happy Aging Day," in Brussels, Belgium, "The Cristofalo Annual Lectureship," at The University of Pennsylvania, "Endokrinologisches Symposium," in Berlin, Germany, "The Longevity Therapeutics Summit," in San Francisco, California, "The Science and Business of Aging," Boston, Massachusetts, and "The Taft Lectureship at the Nutrition Center," also in Boston, Massachusetts. Dr. Barzilai also authored four published articles: "Effects of FOXO3 Polymorphisms on Survival to Extreme Longevity in Four Centenarian Studies," in The Journals of Gerontology, "Sarcosine is Uniquely Modulated by Aging and Dietary Restriction in Rodents and Humans," in Cell Reports, "PopCluster: an Algorithm to Identify Genetic Variants with Ethnicity-dependent Effects," in Bioinformatics, and "Models and Studies of Aging: Executive Summary of a Report from the U13 Conference Series," in the Journal of American Geriatrics Society.
Fourth Quarter 2018 Financial Highlights

Cash and Investments. CohBar had cash and investments of $22,182,768 on December 31, 2018, compared to $8,452,459 on December 31, 2017.

R&D Expenses. Research and development expenses were $2,085,662 in the three months ended December 31, 2018, compared to $1,791,212 in the prior year quarter. The increase was primarily due to the transition of our lead MBT Candidate from preclinical to clinical stage, resulting in an increase in clinical activity costs incurred in the current year quarter partially offset by a decrease in preclinical activity costs incurred in the prior year quarter.

G&A Expenses. General and administrative expenses were $2,009,604 for the three months ended December 31, 2018, compared to $1,059,565 in the prior year quarter. The increase in general and administrative expenses was primarily due to severance and non-cash stock-based compensation costs related to the termination of our former CEO, recruiting costs, and increased director fees.

Net Loss. For the three months ended December 31, 2018, net loss was $4,190,125, or $0.10 per basic and diluted share, compared to a net loss of $2,833,396, or $0.07 per basic and diluted share, for the three months ended December 31, 2017.
Fourth Quarter Investor Call and Slide Presentation:

Date: March 18, 2019
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

Dial-in U.S. and Canada: (800) 289-0438
Dial-in International: (323) 794-2423
Conference ID No.: 8144256
Slide Presentation

Go to www.webex.com, click on the ‘Join’ button and enter Meeting Number 923 629 679 and Password CWBR, or
Go to www.cohbar.com and click on Q4 Shareholder Presentation at top of homepage.
We kindly request that you please call into the conference audio and log into WebEx approximately 10 minutes prior to the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on March 18, 2019, through 11:59 p.m. Eastern Time on April 8, 2019. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 8144256. The audio replay along with the slide presentation will also be available on the homepage at www.cohbar.com from March 18, 2019 through April 8, 2019.

About CB4211

CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. In July 2018, CB4211 entered a Phase 1a/1b clinical trial which includes a potential activity readout relevant to NASH and obesity. In November 2018, the company announced the temporary suspension of the trial to address mild injection site reactions that were unexpectedly persistent. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.

Mogrify Awarded $555,000 USD (£420,000 GBP) Innovate UK Funding to Accelerate Regenerative Cell Therapies

On March 18, 2019 Cell Mogrify Ltd (Mogrify), a UK company aiming to transform the future development of cell therapies, reported that it has been awarded $555,000 USD (£420,000 GBP) funding from Innovate UK, the UK’s innovation agency, through the investment accelerator for innovation in precision medicine (Press release, Mogrify, MAR 18, 2019, View Source [SID1234553931]). This funding will support the application of Mogrify’s bioinformatic approach to transition three cell therapy products to preclinical stage, with potential application in wound healing, and oncology immunotherapy.

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Mogrify will utilize its patented systematic big-data approach (Rackham et al., Nature Genetics, 2016) to identify, from next-generation sequencing and gene-regulatory networks, the sets of highly influential and non-redundant transcription factors (in vitro) or small molecules (in vivo), needed to drive the direct conversion of one mature cell type (e.g. fibroblasts) into another (e.g. T cells). The reprogramed cells will then be subjected to a number of functional tests to demonstrate bioequivalence and potential as cell therapies, such as CAR-T for the treatment of cancers.

At present, cells used in cell therapies either need to be extracted and sorted from the patient themselves or a donor, or derived via experimental protocols that can take several years to develop, all of which can delay cell therapies reaching the clinic. Mogrify aims to accelerate this process by using its novel, bioinformatic platform to deliver an efficient, safe and scalable source of cells for the development of multiple personalized regenerative cell therapy products.

Dr. Darrin M. Disley, OBE, CEO, Mogrify, said: "Mogrify’s mission is to place ourselves, and as a result the UK, at the forefront of the next generation of cell therapy companies. By embracing systematic data science approaches built on large-scale transcriptomic, cell regulatory network and epigenetic data we believe better cell therapies can be developed at a lower cost across all therapeutic areas. The funding from Innovate UK will enable Mogrify to expand its portfolio of cell types and extend its reach into new therapeutics areas to address the global cell therapy opportunity, worth an estimated $30 billion USD."

Professor Julian Gough, PhD, Co-founder and CSO, Mogrify, said: "We have already used our bioinformatic-approach to produce chondrocytes and microvascular endothelial cells by transdifferentiation and speed up the protocols for acquiring astrocytes, neurons and chondrocytes from induced pluripotent stem cells. We are already engaging with companies that would like us to support development of autologous and allogeneic T-cell therapies, and are confident that our technology has the potential to provide a platform technology on which any cell for cell therapy can be developed."

Rackham OJL et al. A predictive computational framework for direct reprogramming between human cell types. Nature Genetics. 2016 Mar;48(3):331-5. doi: 10.1038/ng.3487. Epub 2016 Jan 18.

Puma Biotechnology Presents Interim Results from the Phase II SUMMIT Trial of Neratinib for HER2 (ERBB2) Mutant, Metastatic Cervical Cancer at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting

On March 18, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that updated results from the cervical cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the efficacy of neratinib in HER2-mutated cancers, were reported at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting in Honolulu, Hawaii (Press release, Puma Biotechnology, MAR 18, 2019, View Source [SID1234534416]). "Neratinib in patients with HER2-mutant, metastatic cervical cancer: findings from the phase II SUMMIT ‘basket’ trial," was presented during the Scientific Plenary Session by Anishka D’Souza, M.D., Assistant Professor of Clinical Medicine, Keck School of Medicine of University of Southern California (USC). SGO selected this abstract as the recipient of the 2019 SGO Presidential Award. Slides from the presentation are available on the Puma Biotechnology website.

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The Phase II SUMMIT ‘basket’ trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating, somatic HER2 mutations. The cervical cancer cohort was comprised of 11 patients with advanced and/or metastatic disease treated with neratinib monotherapy. Patients received a median of 2 (range 1–4) prior regimens in the recurrent or metastatic setting before entering this trial. Six patients (54.5%) had been previously treated with bevacizumab prior to entering the study; 7 patients (63.6%) had received prior surgery; and 9 patients (81.8%) received prior radiation therapy. The objective response rate was 27.3% (95% CI: 6.0%–61.0%). The clinical benefit rate was 54.5% (95% CI: 23.4%–83.3%) and included 3 patients with confirmed partial responses and 3 patients with stable disease that lasted greater than 16 weeks. The median progression free survival was 7.0 months (95% CI: 0.7–20.1 months).

The safety profile observed in neratinib-treated cervical cancer patients in SUMMIT was consistent with that reported for HER2-amplified metastatic breast cancer. The most frequently observed adverse event was diarrhea, any grade (n=9, 81.8%) including 1 (9%) grade 3 diarrhea event. The duration of grade 3 diarrhea was 1 day. None of the diarrhea events resulted in dose reduction, dose discontinuation or hospitalization.

"Somatic HER2 mutations represent a distinct class of oncogenic driver mutations that appear to be clinically actionable for metastatic cervical cancers. Treatment with neratinib led to durable responses and disease control in metastatic patients with HER2-mutant cervical cancer," said Dr. D’Souza, who practices oncology at the USC Norris Comprehensive Cancer Center.

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are very pleased with the activity seen with neratinib in this cohort of patients with HER2-mutated cervical cancer. We look forward to the further development of neratinib in this patient population."

Novavax Reports Fourth Quarter and Year-End 2018 Financial Results

On March 18, 2019 Novavax, Inc. (Nasdaq: NVAX) reported its financial results and operational highlights for the fourth quarter and twelve months ended December 31, 2018 (Press release, Novavax, MAR 18, 2019, View Source [SID1234534467]).

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"In 2018, we committed to focus on our two lead programs, ResVax and Nanoflu, and reflecting on last year’s activities, I am proud to say we have achieved significant results for both," said Stanley C. Erck, President and CEO of Novavax, Inc. "Although we were disappointed to miss the primary endpoint of our Prepare trial, ResVax is the first RSV vaccine to demonstrate efficacy for the prevention of RSV disease in a Phase 3 clinical trial. In addition, the successful Phase 2 results for our NanoFlu vaccine provide an opportunity to now confirm with the FDA the use of accelerated approval for licensure. We are now prepared to make meaningful advances on these programs during 2019."

Fourth Quarter 2018 and Subsequent Operational Highlights

ResVax Program

In February 2019, Novavax announced top-line data from the Prepare trial, which was initiated in December 2015 to determine the efficacy of ResVax against medically significant RSV-positive lower respiratory tract infection (LRTI) in infants. Although the Prepare trial results did not meet the pre-specified primary efficacy endpoint, they demonstrate efficacy against a secondary objective (RSV LRTI hospitalizations). In addition, other pre-specified exploratory endpoints and post-hoc analyses highlight ResVax’ potential to improve global health against serious RSV disease.
NanoFlu Program

In January 2019, Novavax announced positive top-line results of its Phase 2 clinical trial of NanoFlu comparing various quadrivalent formulations, with or without Novavax’ Matrix-M adjuvant, with two U.S.-licensed influenza vaccines in older adults. These results show that NanoFlu with Matrix-M generated enhanced immune responses compared to the unadjuvanted formulation, and importantly, showed superior hemagglutination inhibition antibody (HAI) responses against wild-type A(H3N2) viruses, including drifted strains, when compared to Fluzone High-Dose, the leading flu vaccine in older adults.
Key Upcoming Events

Continue ongoing discussions with the FDA, European regulatory agencies, and potentially other national regulatory agencies, to assess opportunities for submission of marketing license applications for ResVax.
Reach agreement with the FDA during the second quarter of 2019 on a proposed Phase 3 study design for NanoFlu utilizing accelerated approval criteria.
Present ResVax Phase 3 trial data at the 37th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) on May 7, 2019.
Financial Results for the Three and Twelve Months Ended December 31, 2018

Novavax reported a net loss of $49.3 million, or $0.13 per share, for the fourth quarter of 2018, compared to a net loss of $50.8 million, or $0.16 per share, for the fourth quarter of 2017. For the twelve months ended December 31, 2018, the net loss was $184.7 million, or $0.50 per share, compared to a net loss of $183.8 million, or $0.63 per share, for the same period in 2017.

Novavax revenue in the fourth quarter of 2018 was $6.1 million, compared to $10.4 million in the same period in 2017. This 41% decrease was driven by the completion of enrollment of participants in the Prepare trial in the second quarter of 2018.

Research and development expenses decreased 13% to $43.4 million in the fourth quarter of 2018, compared to $49.7 million for the same period in 2017. This decrease was primarily due to decreased development activities of ResVax and lower employee-related costs, partially offset by increased development activities of NanoFlu.

General and administrative expenses increased 8% to $9.2 million in the fourth quarter of 2018, compared to $8.5 million for the same period in 2017. The increase was primarily due to higher professional fees.

Interest income (expense), net for the fourth quarter of 2018 was ($2.8) million, compared to ($3.1) million for the same period of 2017.

As of December 31, 2018, Novavax had $103.9 million in cash, cash equivalents, marketable securities and restricted cash, compared to $186.4 million as of December 31, 2017. Net cash used in operating activities for the fourth quarter of 2018 was $45.3 million, compared to $43.4 million for same period in 2017.

Conference Call

Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 9559037. A replay of the conference call will be available starting at 7:30 p.m. ET on March 18, 2019 until 7:30 p.m. ET on March 25, 2019. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 9559037.

A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "Investor Info"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until June 18, 2019.

About RSV in Infants

Globally, RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children.1 It is the second leading cause of death in children under one year of age.2 Estimated annual hospitalizations of 1.4 million and an estimated 27,300 in-hospital deaths were due to RSV acute lower respiratory infection in children under six months of age.3 RSV results in a total global economic burden of $6.2 billion annually.

In the U.S., RSV is the leading cause of hospitalization of infants.4 Estimated annual hospitalizations are up to 76,000.5,6 While RSV can impact all infants, babies under six months of age are among those at highest risk, as approximately 77% of all first-year RSV infections occur before six months. In the U.S., the total economic burden is $2.7 billion annually.

About ResVax

ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. In February 2019, Novavax announced top-line data from Prepare, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom have received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

About Influenza

Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths globally each year are attributed to influenza.7 Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S., Japan, France, Germany, Italy, Spain and UK), show a potential increase from approximately $3.2 billion in 2012-13 season to $5.3 billion by the 2021-22 season.8

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1 Nair, H., et al. (2010) Lancet. 375:1545-1555
2 Losano R., et al. (2012/Dec15) Lancet. 380: 2095
3 Ting S/Nair H. Lancet. 2017/Sep2;390:946
4 Leader S., et al. (2003) J Pediatr. 143: S127
5 Hall CB. N Engl J Med 2009;360:588
6 CDC-Stockman LJ. Pediatr Infect Dis J 2012;31:5
7 Resolution of the World Health Assembly. (2003) WHA56.19.28
8 Influenza Vaccines Forecasts. Datamonitor (2013)

About NanoFluand Matrix M

NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA protein amino acid sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax’ patented saponin-based Matrix-M adjuvant, which is potent and well- stimulates both high quality and durable antibody responses as well as multifunctional CD4 and CD8 T-cell responses. In January 2019, Novavax announced positive top-line data from its Phase 2 clinical trial in older adults of quadrivalent formulations of NanoFlu in 1,375 healthy older adults across clinical sites in the U.S.

About Accelerated Approval

Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments. Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered for accelerated approval, a biologics license application for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.

Latest ONC201 Clinical Efficacy to Be Presented in Oral Abstract Session at ASCO

On March 17, 2019 Oncoceutics, Inc. reported that the latest efficacy data for the use of ONC201 in adult recurrent H3 K27M-mutant glioma will be presented in an Oral Abstract Session at the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago (Press release, Oncoceutics, MAR 17, 2019, View Source [SID1234558354]). In addition, there will be an update on ONC201 in previously irradiated pediatric H3 K27M-mutant glioma that will be presented in a poster session.

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The oral abstract session presentation, entitled "Single agent ONC201 in adult recurrent H3 K27M-mutant glioma" will describe the clinical experience of ONC201, in adults with recurrent H3 K27M-mutant glioma. It will be presented on Monday, June 3rd from 9:24 am to 9:36 am (Abstract 3005) as part of the Developmental Therapeutics and Tumor Biology (nonimmune) session by Isabel Arrillaga, MD, PhD, Associate Clinical Director of Neuro-Oncology at MGH Cancer Center. The presentation will discuss a cohort of adults with H3 K27M-mutant glioma patients who have received ONC201 after failure of available therapies. The results will include assessments of radiographic response, progression-free survival, and overall survival, as well as safety and clinical benefit. This presentation was selected for review by a panel of discussants.

A second data set to be presented is entitled "ONC201 in previously-irradiated pediatric H3 K27M-mutant glioma," and will be presented as a poster by Sharon Gardner, MD, Associate Professor in the Department of Pediatrics at NYU Langone Cancer Center, on Saturday, June 1, from 8:00 am to 11:00 am (Abstract 10046, Poster 428). Dr. Gardner will discuss the emerging safety, pharmacokinetics, and outcome data available from the first arm of the first pediatric clinical trial with ONC201. This trial is currently evaluating the compound in children with DIPG, or other forms of H3 K27M-mutant glioma, who have no meaningful treatment options.

"As someone who was involved from the very beginning in Oncoceutics’ development programs, I am delighted to see the progress in the development of ONC201 for brain tumors that have challenged our abilities in oncology for a long time", said Joseph Bertino, MD, FAACR, Founding Member of the Scientific Advisory Board of Oncoceutics, Past President of ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper), and, amongst the numerous accolades given to him, recipient of the 2018 Award for Lifetime Achievement in Cancer Research. "I am encouraged that the therapeutic concept of addressing GPCRs with imipridones for applications in oncology will materialize as a new paradigm to treat cancer. ONC206 is the next compound from the imipridone portfolio that will enter the clinic, and based on the preclinical profile, including the well characterized binding target and mechanism of action, I expect an efficient translational program."

A team of Oncoceutics team members will be present at the conference. If you have any questions, please contact us at [email protected].

The abstracts are listed below:

Single agent ONC201 in adult recurrent H3 K27M-mutant glioma. Presented Monday, June 3, 2019. View Source
ONC201 in previously-irradiated pediatric H3 K27M-mutant glioma. Presented Saturday, June 1, 2019. View Source