NEW YORK (PRWEB)
December 15, 2021
Novita Pharmaceuticals, Inc. (“Novita” or the “Company”), a privately held clinical-stage pharmaceutical company dedicated to developing novel cancer drugs based on its proprietary fascin inhibitor technology, today announced that the first patient has been dosed with its first-in-class fascin-inhibitor NP-G2-044 in a Phase 2A clinical trial.
The primary objectives of the open-label study in patients with advanced or metastatic solid tumor malignancies is to define the recommended phase 2 doses (RP2Ds) of NP-G2-044 monotherapy and when given in combination with anti-PD-(L)1 therapy and to evaluate the safety, tolerability, and preliminary anti-tumor efficacy of NP-G2-044. Approximately 100 patients are anticipated to be enrolled in this study at multiple cancer centers across the United States. Pharmacokinetic and pharmacodynamic data will also be evaluated from the study.
“This fascin inhibitor has the potential to treat multiple cancer types through direct blocking of tumor metastasis and simultaneous activation of intra-tumoral dendritic cells to synergize with anti-PD1 immunotherapy,” said Edward Garmey, M.D., acting CMO of Novita, adding, “The results from the first-in-human Phase 1 clinical trial of NP-G2-044 presented at ASCO last June showed excellent safety as well as robust preliminary signals of both anti-tumor activity and prolonged metastasis-free time. We look forward to further elucidating the potential of this first-in-class drug when administered as both monotherapy and in combination.”
“The initiation of this Phase 2A study marks a major milestone for Novita. We are proud of the tremendous progress we have made since last year and excited as we move forward to the next stage in the development of NP-G2-044 as a novel cancer therapy,” said Jillian Zhang, Ph.D., President and Chief Scientific Officer of Novita.
About Novita Pharmaceuticals, Inc.
Novita Pharmaceuticals, Inc. (“Novita” or the “Company”) is a privately held clinical-stage biopharmaceutical company dedicated to developing ground-breaking drugs based on its proprietary fascin inhibitor technology to prevent and treat cancer metastasis and at the same time to boost anti-cancer immune responses. Cancer metastasis is the primary cause of over 90% of deaths of cancer patients and yet there is no drug specifically and directly targeting metastasis on the market today. In addition, Immuno-Oncology (IO) with anti-PD-1 immune checkpoint inhibitors has made a significant impact on the treatment of many types of cancer. However, most cancer patients do not respond to current IO treatments. Novita aims to address both these important medical needs by developing inhibitors of fascin, a key protein critically involved in tumor cell motility and highly expressed in tumor cells and in antigen-presenting cells in the tumor tissues. The Company’s lead asset, a small-molecule fascin inhibitor NP-G2-044 has been shown in preclinical studies to block tumor cell migration, invasion, and metastasis. In animal models, NP-G2-044 in combination with immune checkpoint inhibitors demonstrated synergistic efficacy that tripled overall survival rates in comparison to IO alone. The multicenter Phase 2A clinical trial of NP-G2-044 titled “NP-G2-044 as Monotherapy and Combination Therapy in Patients with Advanced or Metastatic Solid Tumor Malignancies.” is currently ongoing and open for patient enrollment.
For more clinical trial information, please go to:
https://clinicaltrials.gov/ct2/show/NCT05023486
Cautionary Note Regarding Forward-Looking Statements
This press release contains certain forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. These statements are based on a number of assumptions and estimates that are inherently subject to significant uncertainties and contingencies, many of which are beyond the Company’s control, and reflect future business decisions, which are subject to change. Among those factors that could cause actual results to differ materially from those described in the forward-looking statements are the risks associated with the Company’s being a development stage company with uncertain revenue streams; uncertain results or outcomes during clinical trials; certain rights owned by others over the Company’s intellectual property; failure to raise necessary capital in the future; the loss of key personnel; competition from other larger, better-capitalized peers; the Company’s reliance on incorrect assumptions regarding the market for its products, the costs of developing, manufacturing and marketing the Company’s products, and the timing and receipt of regulatory approval for the Company’s products; adverse economic conditions; and other risks. In light of the significant uncertainties inherent in the forward-looking statements, the inclusion of any such statement should not be regarded as a representation by Novita or any other person that the Company’s objectives or plans will be achieved.
Contact Info:
Christy Shue
cshue@novita-pharm.com
(914)-912-4135
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