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Verastem Oncology | |
Company type | Public |
Industry | Pharmaceutical Industry |
Founded | 2010 |
Headquarters | Needham, Massachusetts, United States |
Key people | |
Products | Pharmaceuticals |
Number of employees | 100-200 |
Website | verastem |
Verastem, Inc., doing business as Verastem Oncology, is an American pharmaceutical company that develops medicines to treat certain cancers. [2] Headquartered and founded in Boston, Massachusetts, the firm is a member of NASDAQ Biotechnology Index. [3]
Verastem Oncology (Verastem Inc) was co-founded in 2010 by entrepreneur Christoph H. Westphal and venture capitalist Michelle Dipp, who provided seed funding and initial office space in Cambridge, MA. The company was formed to commercialize the work of the three other co-founders, MIT biologists Robert F. Weinberg, Eric S. Lander and Piyush Gupta, by discovering and developing drugs to treat cancer by targeting cancer stem cells. [4]
The company raised $16 million in the initial Series A financing. [5]
Westphal served as CEO and chairman of the board from 2010 to 2013. Under his leadership, the company raised $55 million through an IPO in 2012. [6] Mr. Robert Forrester succeeded Christoph Westphal as Verastem's president and CEO in 2013. [7] In July 2019, Brian Stuglik was appointed to chief executive officer (CEO) of Verastem Oncology. [8]
Their leading investigational drug is defactinib (VS-6063), is a small-molecule focal adhesion kinase (FAK) inhibitor designed to kill cancer stem cells, intended for the treatment of malignant pleural mesothelioma. [9] In October 2015, they announced the premature termination of the company's late-stage clinical trial for defactinib after data analysis of the Phase II COMMAND trial found no significant differences in efficacy versus placebo. . [10] [11] [12] Following the failure of the study, the company had to cut 50% of its workforce. [13]
In November 2016, Verastem Oncology licensed global rights from Infinity Pharmaceuticals to duvelisib (IPI-145), a novel inhibitor of PI3K delta and gamma. [14] [15] In April 2018, Verastem filed a New Drug Application (NDA) for duvelisib for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for relapsed or refractory follicular lymphoma (FL). The results of the clinical study DUO were published in Blood Journal. [16]
Verastem Oncology received FDA approval for duvelisib on September 24, 2018, as a treatment for adults with 3rd-line chronic lymphocytic leukemia/small lymphocytic lymphoma, and an accelerated approval as a 3rd-line treatment for follicular lymphoma, contingent on the results of a confirmatory trial. [17] The drug label carries a black box warning due to the risk of potentially fatal or serious toxicities: infections, diarrhea or colitis, cutaneous reactions and pneumonitis. [18]
In July 2019, Verastem Oncology signed an exclusive agreement with Sanofi for the commercialization of duvelisib in Russia and CIS, Turkey, the Middle East and Africa. [19]
Chronic lymphocytic leukemia (CLL) is a type of cancer in which the bone marrow makes too many lymphocytes. Early on, there are typically no symptoms. Later, non-painful lymph node swelling, feeling tired, fever, night sweats, or weight loss for no clear reason may occur. Enlargement of the spleen and low red blood cells (anemia) may also occur. It typically worsens gradually over years.
Bruton's tyrosine kinase, also known as tyrosine-protein kinase BTK, is a tyrosine kinase that is encoded by the BTK gene in humans. BTK plays a crucial role in B cell development.
Richter's transformation (RT), also known as Richter's syndrome, is the conversion of chronic lymphocytic leukemia (CLL) or its variant, small lymphocytic lymphoma (SLL), into a new and more aggressively malignant disease. CLL is the circulation of malignant B lymphocytes with or without the infiltration of these cells into lymphatic or other tissues while SLL is the infiltration of these malignant B lymphocytes into lymphatic and/or other tissues with little or no circulation of these cells in the blood. CLL along with its SLL variant are grouped together in the term CLL/SLL.
An anti-CD22 immunotoxin is a monoclonal antibody linked to a cytotoxic agent. They are being studied in the treatment of some types of B-cell cancer.
Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund. The company is based in Copenhagen, Denmark – internationally, it operates through the subsidiaries Genmab B.V. in Utrecht, The Netherlands, Genmab U.S., Inc. in Princeton, USA, and Genmab K.K. in Tokyo, Japan. Genmab is a dual-listed company with shares traded on both the Copenhagen Stock Exchange in Denmark and the NASDAQ Global Select Market in the US.
Obinutuzumab, sold under the brand name Gazyva among others, is a humanized anti-CD20 monoclonal antibody used as a treatment for cancer. It was originated by GlycArt Biotechnology AG and developed by Roche.
Phosphoinositide 3-kinase inhibitors are a class of medical drugs that are mainly used to treat advanced cancers. They function by inhibiting one or more of the phosphoinositide 3-kinase (PI3K) enzymes, which are part of the PI3K/AKT/mTOR pathway. This signal pathway regulates cellular functions such as growth and survival. It is strictly regulated in healthy cells, but is always active in many cancer cells, allowing the cancer cells to better survive and multiply. PI3K inhibitors block the PI3K/AKT/mTOR pathway and thus slow down cancer growth. They are examples of a targeted therapy. While PI3K inhibitors are an effective treatment, they can have very severe side effects and are therefore only used if other treatments have failed or are not suitable.
The PI3K/AKT/mTOR pathway is an intracellular signaling pathway important in regulating the cell cycle. Therefore, it is directly related to cellular quiescence, proliferation, cancer, and longevity. PI3K activation phosphorylates and activates AKT, localizing it in the plasma membrane. AKT can have a number of downstream effects such as activating CREB, inhibiting p27, localizing FOXO in the cytoplasm, activating PtdIns-3ps, and activating mTOR which can affect transcription of p70 or 4EBP1. There are many known factors that enhance the PI3K/AKT pathway including EGF, shh, IGF-1, insulin, and CaM. Both leptin and insulin recruit PI3K signalling for metabolic regulation. The pathway is antagonized by various factors including PTEN, GSK3B, and HB9.
Ibrutinib, sold under the brand name Imbruvica among others, is a small molecule drug that inhibits B-cell proliferation and survival by irreversibly binding the protein Bruton's tyrosine kinase (BTK). Blocking BTK inhibits the B-cell receptor pathway, which is often aberrantly active in B cell cancers. Ibrutinib is therefore used to treat such cancers, including mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström's macroglobulinemia. Ibrutinib also binds to C-terminal Src Kinases. These are off-target receptors for the BTK inhibitor. Ibrutinib binds to these receptors and inhibits the kinase from promoting cell differentiation and growth. This leads to many different side effects like left atrial enlargement and atrial fibrillation during the treatment of Chronic Lymphocytic Leukemia.
Abexinostat is an experimental drug candidate for cancer treatment. It was developed by Pharmacyclics and licensed to Xynomic. As of 2013, it was in Phase II clinical trials for B-cell lymphoma. Pre-clinical study suggests the potential for treatment of different types of cancer as well.
Idelalisib, sold under the brand name Zydelig, is a medication used to treat certain blood cancers. Idelalisib acts as a phosphoinositide 3-kinase inhibitor; more specifically, it blocks P110δ, the delta isoform of the enzyme phosphoinositide 3-kinase. It was developed by Gilead Sciences. It is taken orally.
Copanlisib, sold under the brand name Aliqopa, is a medication used for the treatment of adults experiencing relapsed follicular lymphoma who have received at least two prior systemic therapies.
Venetoclax, sold under the brand names Venclexta and Venclyxto, is a medication used to treat adults with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or acute myeloid leukemia (AML).
Acalabrutinib, sold under the brand name Calquence, is a medication used to treat various types of non-Hodgkin lymphoma, including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic Lymphoma (CLL/SLL). It may be used both in relapsed as well as in treatment-naive settings.
Duvelisib, sold under the brand name Copiktra, is a medication used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma after other treatments have failed. It is taken by mouth. It is a PI3 kinase inhibitor.
Umbralisib, sold under the brand name Ukoniq, is an anti-cancer medication for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). It is taken by mouth.
Zanubrutinib, sold under the brand name Brukinsa, is an anticancer medication used for the treatment of mantle cell lymphoma (MCL), Waldenström's macroglobulinemia (WM), marginal zone lymphoma (MZL), and chronic lymphocytic leukemia (CLL). Zanubrutinib is classified as a Bruton's tyrosine kinase (BTK) inhibitor. It is given by mouth.
Indolent lymphoma, also known as low-grade lymphoma, is a group of slow-growing non-Hodgkin lymphomas (NHLs). Because they spread slowly, they tend to have fewer signs and symptoms when first diagnosed and may not require immediate treatment. Symptoms can include swollen but painless lymph nodes, unexplained fever, and unintended weight loss.
BeiGene, Ltd. is a China-based drug developer. It specializes in the development of drugs for cancer treatment. Founded in 2010 by chief executive officer John V. Oyler and Xiaodong Wang, the multinational company headquartered in Cambridge, Massachusetts has offices in North America, Europe, South America, Asia and Australia. BeiGene has a large presence in Chinese market. BeiGene has developed several pharmaceuticals, including tislelizumab, a checkpoint inhibitor, and zanubrutinib, a Bruton's tyrosine kinase inhibitor.
Nemtabrutinib is a small molecule drug that works as a reversible Bruton's tyrosine kinase (BTK) inhibitor; unlike other BTK inhibitors it also works against some mutated forms of BTK. Merck paid $2.7 billion to acquire the company ArQule and the drug, which is being investigated as a cancer treatment.