FMTX Forma Therapeutics Holdings Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
FT-4202
Sickle cell disease
|
Phase 1
Phase 1
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
|
FT-7051
Prostate cancer (CRPC)
|
Phase 1
Phase 1
|
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Olutasidenib FT-2102
Acute myeloid leukemia
|
Phase 2
Phase 2
|
Phase 2 interim data released October 26, 2020. CR+CRh (complete remission plus complete remission with partial hematologic recovery) rate of 33.3% (30% CR and 3% CRh).
|
|
FT-2102
Glioma
|
Phase 1
Phase 1
|
Phase 1 trial ongoing.
|
Latest News
-
View Full Article Hide Full Article
Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that company management will participate in three upcoming investor conferences:
- The SVB Leerink 10th Annual Global Healthcare Conference taking place Feb. 22-26. Forma will present on Wednesday, Feb. 24 at 1:40 p.m. Eastern Standard Time (EST).
- The H.C. Wainwright Global Life Sciences Conference taking place March 9-10. Forma will present on Tuesday, March 9 at 7:00 a.m. EST.
- The Oppenheimer 31st Annual Healthcare Conference taking place March 16-17. Forma will present on Wednesday, March 17 at 8:40 a.m. EST.
Webcasts of the conference presentations will be available in the "News & Investors" section of Forma's website at www.formatherapeutics.com.
About Forma Therapeutics
Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210217005230/en/
-
View Full Article Hide Full Article
Phase 1 study includes late-line patients and patients with AR-v7 splice variants for whom there are no approved therapies
FT-7051 is a selective inhibitor of CREB-binding protein/E1A binding protein p300 (CBP/p300) and a co-activator of androgen receptor
In prostate cancer cell lines in vitro, FT-7051 demonstrated inhibition of AR-dependent gene expression and a reduction in androgen receptor expression; also demonstrated antiproliferative activity in AR-positive prostate cancer cell lines, including resistance variant AR-v7 positive models
Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that the first patient has been dosed in a Phase 1 clinical trial evaluating FT-7051, a selective inhibitor of CBP/p300, a known co-activator of the androgen receptor (AR) in men with metastatic castration-resistant prostate cancer (mCRPC).
"While a patient with mCRPC may initially respond to standard anti-androgen therapies, a significant unmet need persists since nearly all patients ultimately become resistant to these treatments," said David N. Cook, Ph.D., chief scientific officer of Forma Therapeutics. "Initiating enrollment in this Phase 1 trial is an important step toward our goal of providing mCRPC patients with an additional therapeutic option to treat this severe illness."
Study Design
The Phase 1 trial is a multicenter, open-label evaluation of the safety and tolerability, preliminary anti-tumor activity (PSA and radiographic responses), and pharmacokinetics/pharmacodynamics (PK/PD) of FT-7051 in men with mCRPC who have progressed despite prior therapy and have been treated with at least one potent anti-androgen therapy. This is an adaptive trial design, intended to accelerate the escalation to potentially therapeutic doses and yield important safety information. More information about this trial may be accessed at Clinicaltrials.gov (identifier: NCT04575766).
About FT-7051
FT-7051 is a selective inhibitor of CREB-binding protein/E1A binding protein p300 (CBP/p300) and a co-activator of androgen receptor (AR). In prostate cancer cell lines in vitro, FT-7051 demonstrated inhibition of AR-dependent gene expression and reductions in androgen receptor expression. FT-7051 also demonstrated antiproliferative activity in AR-positive prostate cancer cell lines, including resistance variant AR-v7 positive models.
About Metastatic Castration-resistant Prostate Cancer
Prostate cancer is the second leading cause of cancer death for men in the U.S., and mCRPC is the most advanced form of this disease. Prostate cancer cell growth is driven by activity of the androgen receptor (AR). Primary treatments of mCRPC include therapies that reduce androgen synthesis or inhibit androgen binding and activation of the AR. Studies have shown that approximately 20% to 40% of mCRPC patients demonstrate primary resistance to enzalutamide and abiraterone acetate, two commonly used therapies, and virtually all patients who demonstrate initial clinical responses eventually acquire resistance. There are currently no approved therapies specifically aimed at mCRPC over-expressing AR variants, including AR-v7; therefore, a novel inhibitor of AR co-activator CBP/p300 may play a role in the suppression of mCRPC driven by AR aberrations.
About Forma Therapeutics
Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding: our guidance regarding our business plans and objectives for FT-7051, including the therapeutic potential and clinical benefits thereof as well as the planned study design, the timing and success of ongoing clinical trials, our growth as a company, and the potential impact of COVID-19 on patient retention, strategy, future operations and clinical trials. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical programs, our ability to execute on our strategy, that positive interim results from a clinical study may not be necessarily predictive of the results of future or ongoing clinical studies, the regulatory developments in the United States, the risks related to the competitive landscape, and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210120005136/en/
-
View Full Article Hide Full Article
Strong pipeline progress in 2020 positions company well for 2021
Established proof of concept in SCD for FT-4202
Potential transformative treatment profile for IDH1 inhibitor olutasidenib in R/R/ AML
Enrolling Phase 1 FT-7051 trial for prostate cancer - including patient with AR-v7 splice variants
Completed successful IPO and follow-on equity offering
Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today provided a review of corporate highlights from 2020 and outlined anticipated key clinical program milestones for 2021.
"While 2020 was marked by tremendous challenges due to the COVID-19 pandemic, Forma made important strides due to the courage of patients and the dedication of our employees. We reported promising results our from our clinical programs including FT-4202 in sickle cell disease, olutasidenib in both AML and glioma, and FT-7051 in prostate cancer, and also raised approximately $695 million in public equity offerings," said Frank Lee, president and chief executive officer of Forma. "In this coming year, we anticipate continued progress, and look forward to advancing drug candidates that we believe have the potential to significantly impact patients living with rare hematologic diseases and cancers."
Clinical Program Highlights and Milestones
PKR Program in Sickle Cell Disease (SCD):
FT-4202 is a novel investigational selective red blood cell pyruvate kinase R (PKR) activator Forma is actively evaluating in a multi-center, placebo-controlled Phase 1 trial in individuals with sickle cell disease ages 12 years and older.
- In June 2020, encouraging single dose cohort data were reported at the 25th European Hematology Association (EHA) Annual Congress. Initial findings from Forma's Phase 1 trial of FT-4202 in patients with SCD demonstrated a favorable tolerability profile and biologic effects, with evidence of pharmacodynamic activity.
- In December 2020, clinical proof-of-concept data were presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. Forma presented data from a multi-dose cohort of its Phase 1 trial of FT-4202 in patients with SCD, showing that 86% of patients dosed with 300 mg of FT-4202 for 14 days achieved a hemoglobin increase of greater than 1 g/dL from baseline. The observed reduction in hemolysis in conjunction with the biomarker analysis showing improved deformability and hydration of RBCs supports the hypothesis that pyruvate kinase activation may have an impact on vaso-occlusive crises (VOCs).
- Additional clinical data anticipated from the ongoing Phase 1 randomized placebo-controlled trial in SCD patients. Data from the MAD2 600 mg cohort of the Phase 1 trial is expected to be reported in the first quarter of 2021, followed by results from the 12-week open-label extension in the second quarter of 2021.
- Expanding FT-4202 development program. Forma has initiated a global pivotal Phase 2/3 trial of FT-4202 in SCD patients, with plans to initiate a Phase 2 trial in thalassemia in the second half of 2021, and a pediatric SCD trial in the first half of 2022.
IDH1 Program in AML and Glioma:
Olutasidenib (FT-2102) is a selective inhibitor for cancers with IDH1 mutations Forma is evaluating for the treatment of acute myeloid leukemia (AML) and glioma. Olutasidenib is currently being studied in a registrational Phase 2 trial for relapsed/refractory (R/R) AML and an exploratory Phase 1 trial for glioma.
- In May 2020, positive data for olutasidenib in glioma was announced at the American Society of Clinical Oncology (ASCO). Forma announced positive preliminary Phase 1 data for olutasidenib in refractory, enhancing glioma at ASCO 2020, suggesting the potential for response and prolonged disease control in relapsed/refractory IDH1-mutated glioma patients.
- In October 2020, positive data for olutasidenib in a registrational trial for R/R AML was announced. Forma announced positive results from the planned interim analysis of the Phase 2 registration trial of olutasidenib in R/R AML patients with IDH1 gene mutations. Olutasidenib as a monotherapy demonstrated a favorable tolerability profile and achieved a composite complete remission (CR/CRh) rate of 33.3% (30% CR and 3% CRh), the primary efficacy endpoint. While a median duration of CR/CRh has not yet been reached, a sensitivity analysis indicated the median duration of CR/CRh to be 13.8 months. Further data analysis indicates an estimated 87% survival rate at 18 months in patients who respond to treatment with olutasidenib. Olutasidenib's potential transformative treatment profile is based upon three key indicators: durability of response and increased survival for responders, favorable tolerability suggesting ability to combine with other therapies, and properties to support indication expansion to other IDH1 mutated cancers.
- Forma has begun preparing for a new drug application for olutasidenib in R/R AML.
CPB/p300 Program in Prostate Cancer:
FT-7051 is a potent and selective CBP/p300 inhibitor Forma is evaluating for the treatment of metastatic prostate cancer resistant to androgen receptor (AR) signaling inhibitor therapy.
- In April 2020, preclinical data on FT-6876 (a research compound related to FT-7051) in breast cancer was presented at the American Association for Cancer Research (AACR). Forma presented preclinical data that demonstrated antitumor activity of FT-6876 in AR-dependent breast cancer cell lines, suggesting that FT-6876 could serve as a treatment for patients with other AR-dependent tumors, such as prostate cancer.
- Phase 1 underway in 2021. In December 2020, Forma initiated recruitment in a Phase 1 trial of FT-7051 in men with metastatic castration-resistant prostate cancer including those with AR-v7 splice variants. Dosing in this trial is anticipated to begin in early in the first quarter of 2021. Forma plans to disclose initial safety, tolerability and preliminary response data in the second half of 2021.
About Forma Therapeutics
Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding our beliefs and expectations regarding its: our business plans and objectives; future plans for FT-4202, FT-7051, and olutasidenib, including expectations regarding timing and success of the current ongoing clinical trials as well as planned future clinical trials, therapeutic potential and clinical benefits thereof, and upcoming milestones for our other product candidates; the planned timing and potential submission of new drug applications for olutasidenib in R/R AML, growth as a company and the anticipated contribution of our employees and the members of our board of directors to our operations and progress; presentation of additional data at upcoming scientific conferences, and other preclinical data in 2021; the potential commercial and collaboration opportunities, including potential future collaborators and parties, as well as value and market, for our product candidates; uses of capital, expenses and other 2021 financial results or in the future, and the potential impact of COVID-19 on patient retention, strategy, future operations, clinical trials or IND submissions. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical programs and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210111005249/en/
-
View Full Article Hide Full Article
Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced that Selwyn M. Vickers, M.D., F.A.C.S., has been elected to serve on the company's board of directors.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210107005057/en/
(Photo: Business Wire)
Dr. Vickers is a world-renowned surgeon, pancreatic cancer researcher and pioneer in health disparities research. He currently serves as senior vice president of medicine and dean of the School of Medicine at The University of Alabama at Birmingham (UAB). As dean, Dr. Vickers leads the medical school's main campus in Birmingham and the regional campuses in Montgomery, Huntsville and Tuscaloosa. He is a practicing clinician and conducts research with a focus on pancreatic cancer. Dr. Vickers is a member of the National Academy of Medicine.
"I am pleased to welcome Selwyn to our board at this exciting stage of growth for Forma," said Peter Wirth, chair of Forma's board of directors. "Selwyn's expertise in addressing disparities in access to health care resources, especially among minority populations, will inform Forma's work not only to develop drugs that meet the needs of specific patient populations but also to help create systems so that patients can access the drugs developed."
"In addition to his deep medical knowledge, Selwyn's understanding of the importance of diversity will provide valuable insight as we advance our pipeline of programs through the clinic," said Frank Lee, president and chief executive officer of Forma. "I'm delighted he's decided to be part of our important mission."
"I am honored to join the board of Forma, whose distinctive patient-driven and culturally-competent approach to impacting disease aligns with my own passion," said Dr. Vickers. "I look forward to sharing my clinical and research expertise to support the company's mission to truly transform the lives of patients."
Dr. Vickers will serve on the board's audit committee.
About Forma Therapeutics
Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the advancement of our clinical programs, our expectations of the therapeutic benefits related thereto, and our growth as a company and the anticipated contribution of the members of our board of directors to our operations and progress. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the advancement of our clinical program, the expected impact and contribution of our board of directors and executives to our business, and other risks identified in our SEC filings, including those risks discussed under the heading "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as well as other risks detailed in our subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210107005057/en/
-
View Full Article Hide Full Article
Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, today announced the closing of an underwritten public offering of 6,095,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 795,000 shares of common stock, at a public offering price of $45.25 per share. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $275.8 million. All of the shares in the offering were offered by Forma.
Jefferies, SVB Leerink and Credit Suisse acted as joint book-running managers for the offering. Oppenheimer & Co acted as lead manager for the offering.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
Registration statements relating to these securities became effective on December 10, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].
About Forma Therapeutics
Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201215006042/en/