Syndax Pharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Clinical and Business Update

On November 7, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the third quarter ended September 30, 2019. In addition, the Company provided a clinical and business update (Press release, Syndax, NOV 7, 2019, View Source [SID1234550614]). As of September 30, 2019, Syndax had $72.2 million in cash, cash equivalents and short-term investments.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased to have passed the final interim futility analysis of overall survival for E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, and anticipate the final overall survival readout in the second quarter of 2020," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "Supported by highly compelling survival data from the Phase 2b ENCORE 301 trial, leading to Breakthrough Therapy designation for entinostat in HR+ breast cancer, we believe the combination of entinostat and exemestane has the potential to improve outcomes for patients with this difficult to treat disease."

Pending a positive overall survival (OS) assessment in E2112, Syndax intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for entinostat plus exemestane for the treatment of HR+, HER2- breast cancer.

Dr. Morrison added, "Beyond entinostat, patient dosing is now underway in the Phase 1/2 open-label AUGMENT-101 trial of SNDX-5613, our potent, highly selective, oral Menin inhibitor, in adults with relapsed/refractory acute leukemias. We look forward to establishing a safe dose that provides the appropriate target coverage to advance into the Phase 2 portion of the trial. We are committed to bringing this promising therapeutic option to patients, and expect to report initial data from this trial in 2020."

Pipeline Updates

Entinostat

In October 2019, Syndax reported that the E2112 trial passed its fifth and final interim OS analysis. E2112 is Syndax’s NCI-sponsored, ECOG-ACRIN-led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer.

The Company continues to anticipate the trial will reach 410 death events in 2Q20, which will trigger the final E2112 OS analysis. A positive OS assessment at that time would enable the Company to file for full regulatory approval in the U.S. The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat’s Breakthrough Therapy designation in HR+ breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a strong OS benefit.

SNDX-5613

Earlier this week, the Company announced that the first patient has been dosed in the Phase 1/2 open-label AUGMENT-101 trial of orally administered SNDX-5613. The Phase 1 dose escalation portion of AUGMENT-101 will enroll adults with relapsed/refractory acute leukemias, including patients with MLL-rearrangements and NPM1c mutations, and establish a recommended Phase 2 dose. The Phase 2 portion will evaluate efficacy, as defined by Complete Response rate (per International Working Group response criteria), across three expansion cohorts: MLL-rearranged (MLL-r) acute lymphoblastic leukemia (ALL), MLL-r AML and NPM1 mutant AML. The Company expects to report initial clinical data from the trial in 2020.

SNDX-6352

Syndax reported that the FDA has agreed to a recent request to amend enrollment criteria for its ongoing Phase 1 dose escalation trial of SNDX-6352, the Company’s anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease (cGVHD). Consistent with the evolving treatment paradigm for this patient population, the majority of patients will no longer be required to have progressed on prior IMBRUVICA (ibrutinib) therapy in order to enroll in the study. In addition, the FDA has agreed to expand enrollment to include adolescents.

Enrollment in this trial is ongoing, and Syndax continues to anticipate results in the second half of 2020. The trial is designed to evaluate the safety and preliminary efficacy of SNDX-6352 in cGVHD and to identify a recommended Phase 2 dose and schedule.

Third Quarter 2019 Financial Results

As of September 30, 2019, Syndax had cash, cash equivalents and short-term investments of $72.2 million and 31.6 million shares of common stock and prefunded warrants issued and outstanding.

Third quarter 2019 research and development expenses decreased to $9.9 million from $14.1 million for the prior year period. The decrease was primarily due to decreased activity in the ENCORE and SNDX-6352 clinical programs, decreased CMC activities for SNDX-6352, and decreased professional expenses and stock compensation, partly offset by increased activity in the Menin clinical program.

General and administrative expenses for the third quarter 2019 decreased to $3.6 million from $4.1 million for the prior year period. The decrease was primarily due to decreased legal and professional fees and decreased compensation expenses.

For the three months ended September 30, 2019, Syndax reported a net loss attributable to common stockholders of $12.8 million or $0.41 per share compared to $17.3 million or $0.68 per share for the prior year period.

Financial Guidance

For the fourth quarter and full year 2019, research and development expenses are expected to be $11 to $12 million and $45 to $46 million, respectively, and total operating expenses are expected to be $15 to $16 million and $60 to $62 million, respectively.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, November 7, 2019.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 9065948
Domestic Dial-in Number: 855-251-6663
International Dial-in Number: 281-542-4259
Live Webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

Aclaris Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Highlights and an Update on R&D Programs

On November 7, 2019 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory diseases, reported its financial results for the third quarter of 2019 and provided business highlights and an update on its research and development programs (Press release, Aclaris Therapeutics, NOV 7, 2019, View Source [SID1234550613]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Business Highlights:

Announced the completion of the strategic review of its business in September 2019, as a result of which Aclaris is refocusing its resources on its immuno-inflammatory development programs and is actively seeking partners for its commercial products and certain clinical development assets.
Divested RHOFADE (oxymetazoline hydrochloride) cream, 1% (RHOFADE) to EPI Health, LLC in October 2019 for up to $55.0 million, consisting of:
Upfront payment of $35.0 million; and
Potential sales milestone payments of up to $20.0 million in the aggregate upon the achievement of specified levels of net sales of products covered by the agreement; as well as
A high single-digit royalty on net sales, on a product-by-product and country-by-country basis; and
25% of any upfront, license, milestone, maintenance or fixed payment received by EPI Health from a licensee or sublicensee in any territory outside of the United States, subject to specified exceptions.
Seeking partners to:
Commercialize A-101 45% Topical Solution, an investigational compound being developed as a potential treatment for common warts (verruca vulgaris);
Further develop and commercialize ATI-501 (oral) and ATI-502 (topical), which are investigational Janus Kinase (JAK) 1/3 inhibitor compounds, as potential treatments for alopecia; and
Commercialize ESKATA (hydrogen peroxide) topical solution, 40% (w/w).
R&D Program Updates:

Recently announced positive results from THWART-1 (WART-301) and THWART-2 (WART-302), Aclaris’ two pivotal Phase 3 clinical trials of A-101 45% Topical Solution as a potential treatment for common warts.
Announced in August that the first subject in its Phase 1 clinical trial of ATI-450, an investigational oral MK2 inhibitor compound, has been dosed. ATI-450 is Aclaris’ first internally developed novel compound to enter the clinical phase of development.
"We are excited with the progress we have made toward executing on our new business strategy, with our first step being the divestiture of RHOFADE," said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. "With the success of our two pivotal Phase 3 trials for A-101 45% Topical Solution, which has the potential to be the first FDA-approved prescription treatment for common warts, we believe this program will be of interest to potential commercial partners. In September, we presented our new focus on immuno-inflammatory diseases at our R&D day. We look forward to reporting the results of our Phase 1 trial for ATI-450 by the end of the first quarter of 2020 and providing further updates on the execution of our new strategy," said Dr. Walker.

Clinical Pipeline Update:

A-101 45% Topical Solution:
A-101 45% Topical Solution met the primary and all secondary efficacy endpoints in both THWART-1 and THWART-2, Aclaris’ pivotal Phase 3 clinical trials for the treatment of common warts.
The majority of adverse events (AEs) in THWART-1 and THWART-2 were application site reactions, which were predominantly mild or moderate. No treatment-related serious adverse events were observed in the trials. Only one subject in the Phase 3 program had an AE that led to treatment discontinuation. The most common AEs occurring in more than 5% of subjects in the A-101 45% Topical Solution group were AEs at the application site such as pain, scabbing, erythema, pruritus, pallor and erosion.
An open-label safety extension Phase 3 clinical trial (WART-303) evaluating the long-term safety of A-101 45% Topical Solution as a potential treatment for common warts, has completed enrollment of 425 patients. Aclaris expects WART-303 to be completed in the first half of 2020.
ATI-450:
ATI-450-PKPD-101 – This is an ongoing Single Ascending Dose / Multiple Ascending Dose (SAD/MAD) safety, pharmacokinetic and pharmacodynamic Phase 1 clinical trial of approximately 60-80 subjects. If successfully completed, Aclaris expects to initiate a Phase 2 clinical trial for ATI-450 in subjects with rheumatoid arthritis in the first half of 2020. Aclaris is also considering developing ATI-450 for an additional inflammatory indication.

ATI-1777:
ATI-1777 is an investigational topical soft-JAK inhibitor compound that Aclaris is developing as a potential treatment for moderate-to-severe atopic dermatitis.
Aclaris expects to submit an IND/regulatory filing for ATI-1777 in mid-2020.
If the IND/regulatory filing is allowed, Aclaris expects to initiate a Phase 1/2 clinical trial in the second half of 2020.
Financial Highlights:
Liquidity and Capital Resources

As of September 30, 2019, Aclaris had aggregate cash, cash equivalents and marketable securities of $91.4 million compared to $168.0 million as of December 31, 2018. For the quarter and nine months ended September 30, 2019, net cash used in operating activities was $23.4 million and $76.1 million, respectively. As of September 30, 2019, Aclaris had approximately 41.4 million shares of common stock outstanding.

Aclaris anticipates that its cash, cash equivalents and marketable securities as of September 30, 2019, after giving effect to both the upfront payment from the sale of RHOFADE and the full repayment of the loan facility with Oxford Finance LLC, will be sufficient to fund its operations into the third quarter of 2021, without giving effect to any potential new business development transactions or financing activities.

Third Quarter 2019 and Year-to-Date Financial Results

As described above, on September 5, 2019, Aclaris announced the completion of a strategic review and its decision to refocus its resources on its immuno-inflammatory development programs and to actively seek partners for its commercial products. The accompanying condensed consolidated statements of operations and selected condensed consolidated balance sheet data have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to Aclaris’ commercial products as discontinued operations. The accompanying financial statement data are generally presented in conformity with Aclaris’ historical format. Aclaris believes this format provides comparability with its previously filed financial statements.

Contract research revenues decreased to $1.0 million and $3.1 million for the quarter and nine months ended September 30, 2019, compared to $1.1 million and $3.4 million for the quarter and nine months ended September 30, 2018. Cost of revenue was $0.8 million and $3.0 million for the quarter and nine months ended September 30, 2019, compared to $1.1 million and $3.1 million for the quarter and nine months ended September 30, 2018. These amounts included non-cash stock-based compensation, and amortization and depreciation expenses, of $0.2 million and $0.8 million for the quarter and nine months ended September 30, 2019, respectively, and $0.3 million and $0.8 million for the quarter and nine months ended September 30, 2018, respectively.

Research and development expenses were $16.2 million and $53.3 million for the quarter and nine months ended September 30, 2019, respectively, compared to $15.2 million and $41.5 million for the quarter and nine months ended September 30, 2018, respectively. The increases were mainly the result of a $4.0 million milestone payment made by Aclaris to Rigel Pharmaceuticals, Inc. for the achievement of a specified development milestone, and activities associated with preclinical development and the recently initiated Phase 1 clinical trial for ATI-450. These increases were offset in part by decreases in expenses for several Phase 2 clinical trials of ATI-501 and ATI-502 and two Phase 3 clinical trials of A-101 45% Topical Solution, which reached or neared completion in the third quarter of 2019.

General and administrative expenses were $6.7 million and $21.1 million for the quarter and nine months ended September 30, 2019, respectively, compared to $6.1 million and $20.5 million for the quarter and nine months ended September 30, 2018, respectively.

Total costs and expenses from continuing operations for the third quarter of 2019 were $23.8 million, compared to $22.5 million for the third quarter of 2018. For the nine months ended September 30, 2019, total costs and expenses were $96.6 million, compared to $65.1 million for the same period in 2018. These amounts included non-cash stock-based compensation expenses of $4.0 million and $12.9 million for the quarter and nine months ended September 30, 2019, respectively, compared to $4.0 million and $12.4 million for the prior year periods, respectively. For the nine months ended September 30, 2019, there was also an $18.5 million non-cash charge for the impairment of goodwill. There was no such charge in the prior year.

Loss from continuing operations was $23.1 million for the third quarter of 2019, compared to $20.6 million for the third quarter of 2018. Loss from continuing operations was $94.1 million for the nine months ended September 30, 2019, compared to $58.5 million for the nine months ended September 30, 2018.

Loss from discontinued operations was $32.2 million for the third quarter of 2019, compared to $12.1 million for the third quarter of 2018, and was $48.7 million for the nine months ended September 30, 2019, compared to $35.6 million for the nine months ended September 30, 2018.

Net loss, which combines loss from continuing and discontinued operations, was $55.3 million for the third quarter of 2019, compared to net loss of $32.7 million for the third quarter of 2018, and was $142.8 million for the nine months ended September 30, 2019, compared to $94.2 million for the nine months ended September 30, 2018.
2019 Financial Outlook and Cash Runway

As a result of Aclaris’ new strategic direction announced on September 5, 2019, which resulted in the reclassification of expenses related to its commercial products, Aclaris’ prior full-year 2019 estimated operating expense guidance no longer represents an accurate estimate of its anticipated operating expenses, and Aclaris does not believe that updated full-year guidance for 2019 would be meaningful.

Aclaris now anticipates that its cash, cash equivalents and marketable securities as of September 30, 2019, after giving effect to both the upfront payment from the sale of RHOFADE and the full repayment of the loan facility with Oxford Finance LLC, will be sufficient to fund its operations into the third quarter of 2021, without giving effect to any potential new business development transactions or financing activities.
Company to Host Conference Call
Management will conduct a conference call at 5:00 PM ET today to discuss Aclaris’ financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 2698128 prior to the start of the call.

IntelGenx Reports Third Quarter 2019 Financial Results

On November 7, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, reported financial results for the third quarter ended September 30, 2019 (Press release, IntelGenx, NOV 7, 2019, View Source [SID1234550612]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

2019 Third Quarter Financial Summary:

Revenue was $61,000, compared to $700,000 in the third quarter of 2018
Adjusted EBITDA was ($2.3 million), unchanged from Q3-2018
Cash and short-term investments totaled $4.3 million as at September 30, 2019 compared to $2.2 million as at September 30, 2018
Recent Developments:

Received approval for prototype cannabis-infused VersaFilm product from co-development partner, Tilray (NASDAQ:TLRY), and initiated manufacturing scale-up work
Announced that its 505(b)(2) New Drug Application ("NDA") for RIZAPORT VersaFilm for the treatment of acute migraines was accepted for review by the U.S. Food and Drug Administration ("FDA") and that the FDA assigned a March 26, 2020, Prescription Drug User Fee Act ("PDUFA") goal date for completion of the review
Received a positive Data Safety Monitoring Board recommendation that the Company’s Montelukast VersaFilm Phase 2a (BUENA) clinical trial in patients with mild to moderate Alzheimer’s Disease continue
Presented an overview of the Company’s business at the H.C. Wainwright 21st Annual Global Investment Conference
"In many respects, we are now just nearing the starting line with the anticipated commercialization of our two lead VersaFilm products," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "The initiation of scale-up work for the cannabis-infused VersaFilm product we are co-developing with our worldwide partner, Tilray, and receipt of a PDUFA goal date for completion of the FDA’s review of the RIZAPORT NDA, mark important milestones. We are looking forward to unveiling details about our cannabis-infused oral film as we approach product launch, and as always, to updating our stakeholders as we continue to make progress toward bringing our VersaFilm products to market."

Financial Results:

Total revenues for the three-month period ended September 30, 2019 amounted to $61,000, compared to $700,000 for the three-month period ended September 30, 2018. The decrease is mainly attributable to a $639,000 decrease in Research and Development ("R&D") revenues.

Operating costs and expenses were $2.6 million for the third quarter of 2019, versus $3.3 million for the corresponding three-month period of 2018. The decrease for the three-month period ended September 30, 2019 is mainly attributable to a $610,000 decrease in R&D expenses and a $153,000 decrease in Selling, General and Administrative expenses.

For the third quarter of 2019, the Company had an operating loss of $2.5 million, compared to an operating loss of $2.6 million for the comparable period of 2018.

Net comprehensive loss for the three-month period ended September 30, 2019 was $2.9 million, or $0.03 on a basic and diluted per share basis, compared to $3.0 million, or $0.04 on a basic and diluted per share basis, for the comparable period of 2018.

As of September 30, 2019, the Company’s cash and short-term investments totalled $4.3 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2019 third quarter financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (833) 231-8269 (Canada and United States) or (647) 689-4114 (International), conference ID 5068946. A live and archived webcast of the call will be available on IntelGenx’s website at www.intelgenx.com under "Presentations" in the Investors section.

Spectrum Pharmaceuticals Reports Third Quarter 2019 Financial Results and Pipeline Update

On November 7, 2019 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period ended September 30, 2019 (Press release, Spectrum Pharmaceuticals, NOV 7, 2019, View Source [SID1234550611]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Spectrum has an expanding pipeline, significant near-term milestones, solid capitalization and a highly focused team," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "In December, we look forward to results from Cohort 1 of our ZENITH20 study investigating poziotinib in lung cancer patients with hard-to-treat mutations. We recently submitted our BLA for ROLONTIS to the FDA, a key milestone, as we continue to execute on our strategic priorities."

Pipeline Updates

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

Topline results from the EGFR previously treated non-small cell lung cancer cohort (Cohort 1) in the ZENITH20 trial are expected in December. These data could potentially support a New Drug Application (NDA) filing with the FDA.
The HER2 previously-treated non-small cell lung cancer cohort (Cohort 2) of the ZENITH20 trial is fully accrued and is expected to have topline results by mid-year 2020. This cohort also has the potential to support an NDA filing with the FDA in the future.
A basket study has been initiated to investigate poziotinib in patients with EGFR or HER2 mutation-positive malignant solid tumors in an investigator-led study, with the first patient enrolled at The University of Texas MD Anderson Cancer Center.
In September, new preclinical data from The University of Texas MD Anderson Cancer Center, was presented during the IASLC 2019 World Conference on Lung Cancer in Barcelona, Spain. These scientific data support the recently announced expansion of the ZENITH20 trial.
ROLONTIS (eflapegrastim), a novel long-acting GCSF

Spectrum submitted the ROLONTIS BLA to the FDA on October 24, 2019.
In October, Spectrum presented a poster at the ASCO (Free ASCO Whitepaper) Supportive Care in Oncology Symposium in San Francisco, CA, highlighting integrated efficacy data from the Phase 3 ROLONTIS clinical trials, ADVANCE and RECOVER which studied more than 600 patients combined and met all primary and secondary endpoints.
Integrated safety data from the ROLONTIS studies will be presented at the San Antonio Breast Cancer Symposium meeting in December.
Three-Month Period Ended September 30, 2019 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a loss of $26.6 million, or $0.24 loss per basic and diluted share, in the three-month period ended September 30, 2019, compared to net loss of $69.2 million, or $0.66 loss per basic and diluted share, in the comparable period in 2018. Total research and development expenses were $17.2 million in the quarter, as compared to $15.3 million in the same period in 2018. Selling, general and administrative expenses were $13.1 million in the quarter, compared to $13.1 million in the same period in 2018.

The company ended the quarter with cash, cash equivalents, restricted cash, and marketable securities of $252 million.

Non-GAAP Results

Spectrum recorded a non-GAAP loss of $24.5 million, or a non-GAAP loss of $0.22 per basic and diluted share, in the three-month period ended September 30, 2019, compared to a non-GAAP loss of $25.3 million, or a non-GAAP loss of $0.24 per basic and diluted share, in the comparable period in 2018. Non-GAAP research and development expenses were $16.1 million, as compared to $14.7 million in the same period of 2018. Non-GAAP selling, general and administrative expenses were $9.9 million, as compared to $11.1 million in the same period in 2018.

Conference Call:

Thursday, November 7, 2019 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 1469173
International: (973) 796-5077, Conference ID# 1469173

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on November 7, 2019 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

Enterome enters research collaboration with major cancer center focused on new microbiome-derived immunotherapies

On November 7, 2019 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the key functional and molecular interactions between the gut microbiome and the human body to develop targeted therapeutics, reported that has entered into a research collaboration with Memorial Sloan Kettering Cancer Center (MSK) in New York City to evaluate the potential of gut microbiome-derived antigens for development as cancer immunotherapies (Press release, Enterome, NOV 7, 2019, View Source [SID1234550610]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Enterome is pioneering an innovative approach to cancer immunotherapy based on the concept of "molecular mimicry", whereby microbiome-derived bacterial antigens that show molecular similarity with Tumor-associated Antigens (TAAs) and Tumor-specific Neoantigens (TSNAs) are used to trigger tumor-specific cytotoxic T cell immune responses. The Company refers to these bacterial antigens as "onco-mimics."

Enterome has developed its proprietary Onco-Mimics discovery platform to identify such antigens from the human gut microbiome and has advanced EO2401 as its first clinical candidate. EO2401 comprises several microbiome-derived antigens that mimic those that are selectively over-expressed by a number of solid tumors. The Company aims to develop EO2401 as a potential new immunotherapy for several indications, with an initial focus on recurrent glioblastoma multiforme (GBM), a devastating cancer for which no curative treatments exist. The first clinical trial is targeted to start by the end of 2019.

This new research collaboration aims to generate further evidence to support Enterome’s Onco-Mimics immunotherapy platform and will look at validating its application in several tumor types including melanoma, lung and pancreatic. Enterome will bring its ability to identify potential TAAs and TSNAs as well as to generate onco-mimics derived from the microbiome for the selected TAAs and TSNAs and will work with leading cancer experts within the Ludwig Center for Cancer Immunotherapy and the David M. Rubenstein Center for Pancreatic Cancer Research, both at MSK.

"We are excited to initiate this new collaboration with Memorial Sloan Kettering Cancer Center, which following the start of our collaboration with Dana-Farber Cancer Institute earlier this year, means we are now working closely with experts at two of the world’s leading cancer research centers to further the understanding of our immunotherapy approach and validate our unique Onco-Mimics discovery platform," said Christophe Bonny, CSO of Enterome. "We believe that this cutting-edge research will provide a solid scientific foundation that will enable us to further develop our pipeline of new immunotherapy candidates for multiple cancer indications."

Taha Merghoub PhD Biologist at MSK commented, "The microbiome concept presents an exciting new approach to the development of cancer immunotherapies and our understanding of how the microbiome works keeps improving with emerging data highlighting the important link between the microbiome and the effectiveness of immunotherapies."