On November 6, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that abstracts for both fimepinostat and CA-4948 were accepted for presentation at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) which will be held December 7-10, 2019, in Orlando, FL (Press release, Curis, NOV 6, 2019, View Source [SID1234550454]).

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"We are pleased to announce that abstracts for two of our first-in-class cancer therapeutics, fimepinostat and CA-4948, were accepted for presentation at ASH (Free ASH Whitepaper)," said James Dentzer, President and Chief Executive Officer of Curis. "In addition to the data published in the abstracts this morning, we look forward to providing updated clinical data on both programs at ASH (Free ASH Whitepaper)."

Curis’ abstracts are listed below and are available on the ASH (Free ASH Whitepaper) conference website: www.hematology.org/Annual-Meeting/.

Poster Presentation:

Presentation Title:

A Multi-Center Dose-Finding Study to Assess Safety, Tolerability,
Pharmacokinetics and Preliminary Efficacy of Fimepinostat (CUDC-907) in
Combination with Venetoclax in Patients with Relapsed/Refractory (R/R)
Lymphoma

Session:

626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive
B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical
Trials: Poster III

Viewing Date/Time:

Monday, December 9, 2019, 10:00 a.m. – 8:00 p.m. ET

Presentation Date/Time:

Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. ET

Location:

Hall B, Orange County Convention Center

Online Abstract:

Abstract Title:

Phase 1 Dose-Finding Study Investigating CA-4948, an IRAK4 Kinase
Inhibitor, in Patients with R/R NHL: Report of Initial Efficacy and Updated
Safety Information

Poster Presentation:

Presentation Title:

SF3B1 Mutations Induce Oncogenic IRAK4 Isoforms and Activate
Targetable Innate Immune Pathways in MDS and AML

Session:

636. Myelodysplastic Syndromes—Basic and Translational Studies: Poster
III

Viewing Date/Time:

Monday, December 9, 2019, 10:00 a.m. – 8:00 p.m. ET

Presentation Date/Time:

Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. ET

Location:

Hall B, Orange County Convention Center

On November 6, 2019 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its third-quarter and nine-month 2019 financial results (Press release, Constellation Pharmaceuticals, NOV 6, 2019, View Source [SID1234550453]).

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"Our clinical programs continued to advance during the third quarter," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "We are particularly pleased with new MANIFEST data on CPI-0610 in myelofibrosis published today in abstracts by the American Society of Hematology (ASH) (Free ASH Whitepaper). The data in the abstracts show signs of encouraging clinical activity in both JAK-inhibitor-naïve patients and ruxolitinib-refractory or -intolerant patients. Based on this activity, we have expanded the MANIFEST trial in first-line patients and in second-line transfusion-dependent patients to look more closely at these signals of activity. We plan to provide a further update on CPI-0610 in oral and poster presentations and at an investor event at the ASH (Free ASH Whitepaper) meeting on December 9. Additionally, we have begun planning for a randomized Phase 3 clinical trial for CPI-0610 in JAK-inhibitor-naïve patients that we expect to begin in 2020."

Program Updates

CPI-0610

Two abstracts with preliminary data from the MANIFEST clinical trial from 59 enrolled patients as of June 27, 2019, the data cutoff date, were published today in association with ASH (Free ASH Whitepaper). The following are highlights from the abstracts:

In Arm 3, in which we are evaluating CPI-0610 in combination with ruxolitinib in a first-line setting in JAK-inhibitor-naïve patients, all four evaluable patients experienced at least a 35% spleen volume reduction and at least a 50% reduction in total symptom score, which are the primary endpoints for these patients.
In Arms 1 and 2, in which we are evaluating CPI-0610 in combination with ruxolitinib and as a monotherapy in a second-line setting in ruxolitinib-resistant or -intolerant patients, additional preliminary data showed continuing signs of activity across a broad range of parameters, including spleen volume reduction, patient-reported symptom improvement, hemoglobin increases, conversion to transfusion independence in transfusion-dependent patients, and bone marrow fibrosis score improvement, consistent with preliminary data presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) in June.
In Arms 1 and 2, conversions to transfusion independence increased from two as of April 17, 2019, to four as of June 27, 2019. Data from 12 additional patients are being monitored for possible additional conversions.
CPI-0610 was generally well-tolerated, both as a monotherapy or in combination with ruxolitinib. One ruxolitinib-resistant or -intolerant patient discontinued due to serious adverse event(s), which were reported as unlikely related to CPI-0610. No JAK-inhibitor-naïve patients discontinued due to adverse events. Please review the abstracts here for more details.
The Company will present updates of clinical data from MANIFEST in oral and poster presentations at the ASH (Free ASH Whitepaper) annual meeting on December 9 and will also host an investor meeting. Please read here for additional information.
We expanded Arm 3 of MANIFEST for JAK-inhibitor-naïve patients from 43 to up to approximately 100 patients. We expanded Cohort 2A for TD ruxolitinib-refractory or -intolerant patients being treated with CPI-0610 + ruxolitinib, and we may expand Cohort 1A for TD ruxolitinib-refractory or -intolerant patients being treated with CPI-0610 monotherapy, from 16 to up to approximately 60 patients in each cohort.
We have started planning for a potential pivotal trial with CPI-0610 for MF in the first-line setting, and we expect the trial to begin in 2020.
CPI-1205

Constellation provided a program update on CPI-1205:

Enrollment in the Phase 2 portion of ProSTAR is nearly complete.
An endpoint accepted by regulatory authorities for pivotal clinical trials in prostate cancer is radiographic progression-free survival (rPFS). In addition, we learned from a study presented by the Kim Chi lab at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting that median responses to second-line therapy generally last only a few months.
Data from the Phase 1b portion of ProSTAR provided preliminary evidence of deep and durable effects of CPI-1205 in certain metastatic castration-resistant prostate cancer patients. We are shifting our focus in this study to durability of clinical activity with CPI-1205.
We are gathering data on time to progression (TTP) of CPI-1205 in ProSTAR, a metric that may serve as a surrogate for rPFS and may guide future development of the compound. Determining TTP will require additional time for the data set to mature, and we expect to report these data from ProSTAR in mid-2020. Plans for any potential Phase 3 program for CPI-1205 will depend on our assessment of the Phase 2 data.
CPI-0209

Enrollment of patients in a Phase 1/2 clinical trial of CPI-0209 continues according to plan. Dosing began in September 2019.
CPI-0209 is a second-generation and potentially best-in-class EZH2 inhibitor that has been designed to achieve comprehensive target coverage through extended on-target residence time. The compound has demonstrated more robust anti-tumor activity compared to first-generation EZH2 inhibitors in preclinical models of multiple cancer types. We believe that CPI-0209 may enable us to address additional patient populations beyond those that we are targeting with CPI-1205 or that have been targeted by other EZH2 inhibitors.
Third Quarter 2019 Financial Results

Cash, cash equivalents, and marketable securities as of September 30, 2019, were $89.1 million, a decline of 22.3% compared to December 31, 2018, primarily due to operating expenses. On October 3, 2019, the Company raised gross proceeds of $65 million in a private placement of its stock.
Research and development (R&D) expenses increased 27.6% year over year to $16.2 million in the third quarter of 2019 mainly due to increased clinical trial expenses.
General and administrative (G&A) expenses grew 30.7% year over year to $4.8 million in the third quarter of 2019, primarily due to building out the organization of the company.
The net loss increased 32.7% year over year to $21.1 million for the third quarter of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders increased 1.2% to $0.82 per share due to the increased net loss, offset in part by an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
Nine Month 2019 Financial Results

Research and development (R&D) expenses increased 48.9% year over year to $47.9 million in the first nine months of 2019, mainly due to increased clinical trial expenses.
General and administrative (G&A) expenses grew 66.8% year over year to $14.1 million in the first nine months of 2019, primarily due to building out the organization of the company.
The net loss increased 53.4% year over year to $61.3 million for the first nine months of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 56.3% to $2.38 per share due to an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
Financial Guidance

Constellation expects that its cash, cash equivalents, and marketable securities as of September 30, 2019, plus the $65 million of proceeds from a private placement completed on October 3, 2019, will enable the Company to fund planned operating expenses and capital expenditure requirements into the first half of 2021.

On November 6, 2019 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS),reported financial results for the quarter ended September 30, 2019 (Press release, Coherus Biosciences, NOV 6, 2019, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third-0" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-third-0" rel="nofollow">View Source [SID1234550452]).

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Third Quarter 2019 Company Highlights

UDENYCA (pegfilgrastim-cbqv) continues as the U.S. market-leading pegfilgrastim biosimilar, achieving approximately 19% of unit market share at the end of September 2019, delivering on the promise of biosimilars for patients, providers and payers.
Net product revenue for the third quarter of 2019 was $111.7 million, and net income was $47.0 million, or $0.63 per share on a fully diluted basis for the third quarter. Net income was $50.6 million or $0.69 per share on a fully diluted basis for the nine months ending September 30, 2019. Cash flow from operations was $55.0 million for the quarter. Cash, cash equivalents and investments in marketable securities was $170.5 million at September 30, 2019.
The company completed two business development transactions:
The Company acquired exclusive rights from Bioeq IP AG, ("Bioeq") a Swiss biopharmaceutical joint venture, to commercialize Bioeq’s Lucentis (ranibizumab) biosimilar candidate in the United States. Bioeq plans to file a Biologics License Application ("BLA") with the U.S. Food and Drug Administration ("FDA") in the fourth quarter of 2019 and Coherus plans to launch the product in the United States in 2021, applying its proficiencies and infrastructure developed for the oncology therapeutic commercial environment to the ophthalmology therapeutic commercial environment.
Coherus and Pfizer entered into a license and settlement agreement relating to Coherus’ patents and applications for patents directed to Humira (adalimumab) formulations.
The Company further advanced its internal ophthalmology product candidate, CHS-2020, a biosimilar candidate to Eylea (aflibercept).
Third Quarter 2019 Financial Results

Net product revenue for third quarter of 2019 was $111.7 million. Cost of goods sold for the third quarter of 2019 was $6.4 million, resulting in a gross profit margin of 94% for the third quarter of 2019.
Research and development (R&D) expense for the third quarter of 2019 was $21.6 million compared to $31.6 million for the same period in 2018. R&D expenses for the nine months ended September 30, 2019 were $59.2 million, as compared to $83.6 million for the same period in 2018. The decrease in R&D expense in both periods was primarily due to the capitalization of UDENYCA manufacturing costs since the approval of UDENYCA on November 2, 2019 and a decrease in costs related to impairment loss, facilities, supplies and materials.
Selling, general and administrative (SG&A) expense for the third quarter of 2019 was $31.8 million, as compared to $25.4 million for the same period in 2018. SG&A expense for the nine months ended September 30, 2019 was $101.0 million, as compared to $60.3 million for the same period in 2018. The increase in SG&A expense in 2019 was primarily attributable to the costs related to commercializing UDENYCA in the United States, which included personnel and third-party services costs for commercial and marketing initiatives.
Cash, cash equivalents and investments in marketable securities for the third quarter totaled $170.5 million at September 30, 2019, as compared to $111.9 million at June 30, 2019 and $72.4 million at December 31, 2018.
Net income attributable to the Company for the third quarter of 2019 was $47.0 million, or $0.63 per share on a fully diluted basis, compared to a net loss of ($58.8) million, or ($0.87) per share on a basic and fully diluted basis for the same period in 2018.
Guidance for the Next Twelve Months from September 30, 2019

UDENYCA (pegfilgrastim-cbqv) biosimilar to Neulasta (pegfilgrastim)
Maintain market position as the leading pegfilgrastim biosimilar of choice, continuing the validated biosimilar-specific strategy of offering a robust value proposition across all key customer segments including ample product supply.
Achieve 2019 exit unit market share of 20% or greater and gain additional market share beyond 20% through 2020.
Continue to increase penetration against all Neulasta dosage forms.
CHS-1420, biosimilar candidate to Humira (adalimumab)
Complete certain development and regulatory objectives to support a BLA filing in 2020.
Ophthalmology pipeline
Facilitate the Bioeq filing of a BLA with the FDA for the biosimilar candidate to Lucentis (ranibizumab) in the United States in the fourth quarter of 2019.
Advance the development of CHS-2020, a biosimilar candidate to Eylea (aflibercept).
Conference Call Information

Date: Wednesday, November 6, 2019 starting at 4:30 p.m. ET
Connect: Dial 844.452.6826 (toll free) or 765.507.2587 (international)
Enter: Conference ID: 8589299
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

About UDENYCA

UDENYCA (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

Indication

UDENYCA IS A LEUKOCYTE GROWTH FACTOR INDICATED TO DECREASE THE INCIDENCE OF INFECTION, AS MANIFESTED BY FEBRILE NEUTROPENIA, IN PATIENTS WITH NON-MYELOID MALIGNANCIES RECEIVING MYELOSUPPRESSIVE ANTI-CANCER DRUGS ASSOCIATED WITH A CLINICALLY SIGNIFICANT INCIDENCE OF FEBRILE NEUTROPENIA.

Limitations of Use

UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Contraindication

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

Warnings and Precautions

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Adverse Reactions

MOST COMMON ADVERSE REACTIONS (≥ 5% DIFFERENCE IN INCIDENCE COMPARED TO PLACEBO) ARE BONE PAIN AND PAIN IN EXTREMITY.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On November 6, 2019 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases and extend healthy lifespan, reported its financial results for the third quarter ended September 30, 2019 (Press release, CohBar, NOV 6, 2019, View Source [SID1234550451]).

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"Our recently announced completion of Phase 1a and the start of recruitment for Phase 1b of our CB4211 clinical study is a key step in the examination of the tolerability and pharmacokinetics of CB4211, and a significant milestone for the first clinical study of a mitochondria based therapeutic in humans," said Steven Engle, Chief Executive Officer. "In parallel, we continued to move our preclinical programs forward by evaluating novel peptides in new animal studies of fibrotic diseases, cancer, and type 2 diabetes. We believe that CB4211 is the first of a number of candidates that our mitochondria-based technology platform will identify for advancement into the clinic."

Business Highlights

●Completed CB4211 Phase 1a and intiated Phase 1b patient recruitment: CohBar recently completed the Phase 1a stage of the Phase 1a/1b clinical trial. Patient recruitment has started for the Phase 1b stage that includes an evaluation of biological activity relevant to nonalcoholic steatohepatitis (NASH) and obesity. Results from both stages of the study are anticipated in mid-2020.

●Advanced peptides targeting cancer and fibrotic diseases: The company initiated additional preclinical studies evaluating novel peptides in animal models of fibrotic diseases, cancer, and type 2 diabetes. Preliminary evidence of anti-fibrotic activity was previously observed in an animal model of idiopathic pulmonary fibrosis. Fibrotic disease is a major unmet medical need contributing to approximately one-third of deaths worldwide. Previous preliminary in vitro data demonstrated the potential for CohBar peptides to enhance the killing of cancer cells by human immune cells. The market for cancer immunotherapy is projected to grow significantly to over $100 billion by 2023.

●Expanded Board of Directors: Biotech veteran Misha Petkevich joined the CohBar board of directors in October. Mr. Petkevich brings to the company more than three decades of financial and investment experience with life sciences companies in senior managment roles at V2M Capital, Robertson Stephens & Co. and Hambrecht & Quist.

●Presented at the Cantor Healthcare Conference and BIO Investor Forum: CohBar CEO Steven Engle presented and met with investors at the Cantor conference in New York, which featured more than 200 innovative public and private companies and a large audience of healthcare focused investors. A recording of the presentation is available at www.cohbar.com. He also presented at the BIO Investor Forum in San Francisco, which featured investment trends and opportunities in life sciences with emphasis on emerging public companies.

●Outreach to analysts and investors: During the quarter, CohBar management introduced the company’s technology and programs to a number of biotechnology analysts. The company also met with biotech focused institutional investors and existing shareholders in New York, Boston, Tel Aviv, London and California.

●Strengthened patent portfolio: The company received notification of the issuance of patents for MOTS-c in China and for a method of use in treating diabetes in the U.S. Notice of Allowance was also issued by the USPTO for the CohBar trademark.

During the third quarter and more recently, Dr. Pinchas Cohen and Dr. Nir Barzilai continued to be recognized as international leaders in the study of mitochondrial science, aging and age-related diseases:

·Dr. Cohen delivered a keynote presentation on "Systems Biology of the Mitochondria: Tools for Discovery of Aging Targets" at the International Perspectives on Geroscience, Weizmann Institute, in Rehoboth, Israel, in September 2019. In addition, Dr. Cohen co-authored "Effects of air pollution on mitochondrial function, mitochondrial DNA methylation, and mitochondrial peptide expression," published in Mitochondrion, and "Metabolomic profile of diet-induced obesity mice in response to humanin and small humanin-like peptide 2 treatment," published in Metabolomics. This summer, Dr. Cohen was elected as a fellow of the Gerontological Society of America.

·Dr Barzilai delivered opening remarks and a presentation entitled "Improving healthspan of the elderly: Not science fiction anymore," at the International Geroscience Meeting in Rehoboth, Israel, in September 2019. Dr. Barzilai also delivered presentations on improving healthspan and aging research at the 6th Aging Research, Drug Discovery and AI Forum during the Basel Life Congress, in Basel, Switzerland, in September 2019, at The International European Geroscience Meeting in Madrid, Spain, in September 2019 and was a featured speaker the Metabesity conference in Washington, D.C., in October 2019. In addition, Dr. Barzilai was an honored guest at the Global Leader Symposium in August 2019, in Venice, Italy and at the Milken Institute, as a participant on the Panel on Aging in Washington, D.C. In October 2019, Dr. Barzilai authored an article published in the Journal of Alzheimers Disease entitled "Frailty and Risk of Incident Motoric Cognitive Risk Syndrome" and co-authored the article entitled "A meta-analysis of genome-wide association studies identifies multiple longevity genes," published in Nature Communications.

Financial Highlights

●Cash and Investments. CohBar had cash and investments of $14.4 million as of September 30, 2019, compared to $22.2 million as of December 31, 2018. The cash burn for the quarter ended September 30, 2019, was approximately $2.5 million.

●R&D Expenses. Research and development expenses were $1.9 million for the three months ended September 30, 2019, compared to $3.4 million in the prior year quarter. The decrease was primarily due to lower preclinical, clinical and stock-based compensation costs in the quarter, partially offset by an increase in costs associated with our research programs focused on the continuing development of peptides.

●G&A Expenses. General and administrative expenses were $1.3 million for the three months ended September 30, 2019, compared to $1.1 million in the prior year quarter. The increase was primarily due to increased investor relations and insurance premium costs and director fees.

●Net Loss. For the three months ended September 30, 2019, net loss, which included $0.7 million of non-cash expenses, was $3.3 million, or $0.08 per basic and diluted share. For the three months ended September 30, 2018, net loss, which included $1.7 million of non-cash expenses, was $4.6 million, or $0.11 per basic and diluted share.

Third Quarter Investor Call and Slide Presentation:

Date: November 6, 2019

Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio

-Dial-in U.S. and Canada: (877) 451-6152
-Dial-in International: (201) 389-0879
-Conference ID No.: 13694507

Slide Presentation

-Go to www.webex.com, click on the ‘Join’ button and enter meeting number 920 124 970 and Password CWBR, or
-Go to www.cohbar.com and click on Q3 2019 Shareholder Presentation at top of homepage.

For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Webex approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on November 6, 2019, through 11:59 p.m. Eastern Time on November 27, 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# 13694507. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

About CB4211

CohBar’s lead clinical program is based on CB4211, a first-in-class mitochondria based therapeutic, 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, which has been shown to play a significant role in the regulation of metabolism, and was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators. In 2018, CB4211 entered a Phase 1a/1b clinical trial which includes an evaluation of biological activity relevant to NASH and obesity. NASH is a chronic and silent disease in its early stages that can progress to more serious disease stages, such as advanced fibrosis, cirrhosis, liver failure or liver cancer. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is no approved treatment for the disease.

On November 6, 2019 Cofactor Genomics, leaders in RNA-based technologies and diagnostics, reported they will provide early access to a new feature in their Predictive Immune Modeling platform which enables cell-state characterization within FFPE tissue samples (Press release, Cofactor Genomics, NOV 6, 2019, View Source [SID1234550450]). Measuring cell-states, such as T cell exhaustion, has been cited as integral to improving the accuracy of patient selection for immune checkpoint inhibitors. The field has previously failed to reach consensus on a short list of individual analytes that effectively characterize exhaustion using incumbent technologies, leading Cofactor to address this challenge using multidimensional biomarker models.

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Cofactor is offering access to the technology through the "Functional to FFPE" Early Access Grant Program, which will support solid tumor or engineered cell therapy exploratory studies, with up to $100,000 in reagents, sequencing, and analysis support covered by the company.

Cofactor’s platform is underpinned by the industry’s first database of Health Expression Models, built using machine learning to identify multidimensional gene expression patterns that enable highly-sensitive characterization of cell types in heterogenous tissue or cell samples. With this new feature, the database has been expanded to include validated models for unstimulated T cells, activated T cells, and exhausted T cells.

The presence of terminally exhausted T cells has been shown to negatively predict success with anti-PD-1 checkpoint inhibitor therapies. As a result, the ability to detect cell state – such as exhaustion – has garnered significant interest, but has proved difficult with clinical archives. Previously, only viable tissue and laborious functional assays were able to generate difficult-to-interpret rough approximations of cell state.

"The ability of RNA-based models to accurately characterize these important cell states in FFPE tissue samples is exactly the reason why Cofactor has invested in Predictive Immune Modeling. No other technology – genomic or proteomic – has been able to accomplish this in FFPE," stated Cofactor’s Chief Scientific Officer Jon Armstrong. "We have to move beyond just detecting cells, and better characterize how those cells are influenced by their microenvironment."

In addition to today’s announcement, Cofactor will be presenting early results using these new cell state models, sharing data from collaborative studies via poster presentations, and releasing other product updates this month at the Annual Meetings for the Association for Molecular Pathology (Booth #2319) and Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Booth #535).