fascin

NEW YORK, Feb. 25, 2025 /PRNewswire/ -- Novita Pharmaceuticals, Inc. ("Novita"), a privately held, clinical-stage pharmaceutical company dedicated to developing novel cancer drugs through its proprietary fascin inhibitor technology, today announced additional results from its Phase 2 study (NCT05023486) evaluating NP-G2-044 in combination with SOC anti-PD-1 therapy in patients with advanced solid tumors resistant to prior anti-PD-1 therapy at the American Association for Cancer Research Immuno-oncology (AACR IO) Annual Meeting. The data was presented in a poster presentation titled "Phase 2 Study of NP-G2-044, a Novel Fascin Inhibitor, in Combination with Anti-PD-1 Therapy in Patients with Solid Tumors Resistant to Prior Anti-PD-1 Therapy." Findings indicate that NP-G2-044 provides a novel therapeutic opportunity when combined with ICIs. "We are very pleased with the findings generated to date in our Phase 2 trial of NP-G2-044 both as a monotherapy and in combination with anti-PD-1 immune checkpoint inhibitors (ICIs) in ICI-resistant patients with advanced and metastatic solid tumors," said Jillian Zhang, Ph.D., President & Chief Scientific Officer of Novita. "The strong safety and durable efficacy we have observed with our first-in-class fascin inhibitor further support the simultaneous inhibition of metastasis and enhancement of cancer immunotherapy as a promising and innovative approach in cancer treatment with broad applications for many solid tumors. We look forward to sharing additional data from the Phase 2 expansion cohort of NP-G2-044 in combination with ICI in the second half of 2025." Among the 45 patients treated with NP-G2-044 as of the last data cutoff (Oct. 2024), 80% had progressed on prior anti-PD-(L)1 therapies. The anti-PD-1 Combination RP2D for NP-G2-044 was 1600 mg QD with 4-week cycles. The primary endpoint was objective response rate (ORR), and secondary endpoints included progression-free survival (PFS), metastasis-free interval (MFI), overall survival (OS), safety, and tolerability. Key highlights include: A Disease Control Rate of 76% (includes patients with Stable Disease and Objective Responses) An ORR of 21% (95% CL 9-38.9%) including 4 patients with Partial Response (PR) and 3 patients with Complete Responses (CR) including Pathologic Complete Response Results indicate durable responses and tumor control in a significant proportion of patients across at least seven cancer types, including cases converted from ICI-non-responsive to ICI-responsive. Long lasting objective responses have been observed. Notable outcomes include a CR in a cervical cancer patient, target lesion CR in an endometrial cancer patient, pathological CRs in a pancreatic cancer patient and a patient with gastroesophageal junction adenocarcinoma and PRs in cutaneous squamous cell carcinoma, non-small cell lung cancer, and cholangiocarcinoma. Seven patients are still on treatments, with the longest duration of 18+ months in an endometrial cancer patient and a patient with pancreatic cancer. An amendment to the study is underway to open additional cohorts. These new cohorts aim to further evaluate the combination of NP-G2-044 with anti-PD-1 therapy across patient populations and solid tumor subtypes, providing a broader understanding of its therapeutic potential. Future analysis will also explore biomarkers for response prediction and mechanisms of resistance, guiding personalized approaches in treatment-resistant cancer. Novita is on track to begin enrollment in its pivotal Phase 3 study of NP-G2-044 + PLD in platinum resistant ovarian cancer in the third quarter of 2025. About Novita's Pioneering Research in Fascin Inhibition Cancer metastasis is the primary cause of over 90% of cancer-related deaths, yet there is currently no drug on the market specifically targeting metastasis. Furthermore, while Immuno-Oncology (IO) therapies, particularly immune checkpoint inhibitors, have made significant strides in cancer treatment, a large proportion of patients do not respond to existing IO treatments. Novita aims to address both of these critical medical needs by developing fascin inhibitors, which target a key protein involved in tumor cell motility and highly expressed in tumor cells and antigen-presenting cells within tumor tissues. The Company's lead asset, NP-G2-044, is a small-molecule fascin inhibitor that has demonstrated the ability to block metastasis in both preclinical and clinical studies. Additionally, when combined with immune checkpoint inhibitors, NP-G2-044 has shown potential to reinvigorate anti-tumor immune responses. Novita's multicenter Phase 2 clinical trial, titled "NP-G2-044 as Monotherapy and Combination Therapy in Patients with Advanced or Metastatic Solid Tumor Malignancies," is currently ongoing. About Novita Pharmaceuticals, Inc. Novita Pharmaceuticals, Inc. is a privately held, clinical-stage biopharmaceutical company focused on developing groundbreaking therapies using its proprietary fascin inhibitor technology to prevent and treat cancer metastasis while simultaneously enhancing anti-cancer immune responses. For more information, visit 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 respect 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; 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. Media Contact: Argot Partners (media) David Rosen 212.600.1902 [email protected] Investor Contact: Argot Partners (investors) Noor Pahlavi 212.600.1902 [email protected] SOURCE Novita Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEW YORK, Feb. 13, 2025 /PRNewswire/ -- Novita Pharmaceuticals, Inc., a privately held, clinical-stage pharmaceutical company dedicated to developing novel cancer drugs through its proprietary fascin inhibitor technology, today announced that the Company will present additional data from the Phase 2 trial of its novel fascin inhibitor, NP-G2-044, at the American Association for Cancer Research Immuno-Oncology Conference 2025 (AACR IO), being held February 23-26, 2025 in Los Angeles, California. Details of the poster presentation are below. Title: Phase 2 Study of NP-G2-044, a Novel Fascin Inhibitor, in Combination with Anti-PD-1 Therapy in Patients with Solid Tumors Resistant to Prior Anti-PD-1 Therapy Session: Poster Session B Date and Time: Tuesday, February 25, 2025 at 1:45-4:00 p.m. PT Presenting Author: Anup Kasi, M.D., M.P.H., University of Kansas Medical Center The poster will be available on Novita's website following the presentation. For more details about the AACR IO Annual Meeting, please visit their website here. About Novita's Pioneering Research in Fascin Inhibition Cancer metastasis is the primary cause of over 90% of cancer-related deaths, yet there is currently no drug on the market specifically targeting metastasis. Furthermore, while Immuno-Oncology (IO) therapies, particularly immune checkpoint inhibitors, have made significant strides in cancer treatment, a large proportion of patients do not respond to existing IO treatments. Novita aims to address both of these critical medical needs by developing fascin inhibitors, which target a key protein involved in tumor cell motility and highly expressed in tumor cells and antigen-presenting cells within tumor tissues. The Company's lead asset, NP-G2-044, is a small-molecule fascin inhibitor that has demonstrated the ability to block metastasis in both preclinical and clinical studies. Additionally, when combined with immune checkpoint inhibitors, NP-G2-044 has shown potential to reinvigorate anti-tumor immune responses. Novita's multicenter Phase 2 clinical trial, titled "NP-G2-044 as Monotherapy and Combination Therapy in Patients with Advanced or Metastatic Solid Tumor Malignancies," is currently ongoing and approaching completion. About Novita Novita Pharmaceuticals, Inc. ("Novita" or the "Company") is a privately held, clinical-stage biopharmaceutical company focused on developing groundbreaking therapies using its proprietary fascin inhibitor technology to prevent and treat cancer metastasis while simultaneously enhancing anti-cancer immune responses. For more information, visit . Media Contact: Argot Partners (media) David Rosen 212.600.1902 [email protected] Investor Contact: Argot Partners (investors) Noor Pahlavi 212.600.1902 [email protected] SOURCE Novita Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

In C. elegans worms, a single neuron named HSN uses multiple chemicals and connections to orchestrate egg-laying and locomotion over the course of several minutes. A new MIT study that focuses on a single cell in one of nature's simplest nervous systems provides an in-depth illustration of how individual neurons can use multiple means to drive complex behaviors. In the C. elegans worm, which only has 302 nerve cells, the neuron HSN releases several chemicals and makes multiple connections along its length to not only control the animal's instantaneous egg laying and locomotion, but also to then slow the worm down for several minutes after the eggs are laid. To control that latter phase of the behavior, HSN transfers the neurotransmitter serotonin to a fellow neuron, which re-releases it to influence behavior minutes later. "Our results reveal how a single neuron can influence a broad suite of behaviors over multiple timescales and show that neurons can 'borrow' serotonin from one another to control behavior," the researchers wrote in Current Biology. The study's senior author is Steven Flavell, Associate Professor in The Picower Institute for Learning and Memory and the Department of Brain and Cognitive Sciences. Postdoc Yung-Chi Huang is the study's first author. A busy neuron Heading into the study, HSN's connections to other neurons had already been mapped (C. elegans is the only animal where the full connectome among neurons is known). It had also been associated with egg-laying. Flavell's lab, meanwhile, has observed that when the worms lay eggs, they speed across patches of food a bit like a farmer will drive a tractor to disperse seeds throughout fertile soil. Moreover, scientists had observed that when HSN is ablated, worms don't engage in a characteristic feeding behavior of slowing down to dine on patches of food. But how this single neuron had these seemingly paradoxical effects on behavior (egg laying, speeding up to do that, and slowing down after) remained a mystery. Flavell and Huang's team employed a wide variety of techniques and experiments to discover how HSN does its many jobs. To establish that HSN indeed has a causal role in controlling these behaviors, they manipulated the neuron's activity using optogenetics, a technique in which cells are genetically engineered to be controlled by flashes of light. In addition to confirming HSN's key role in egg laying, these and other genetic manipulation experiments also confirmed that HSN causes the worm to speed up and then, after a bout of roaming and egg laying, to slow down for several minutes. The lab also tracked the electrical activity of HSN during these behaviors (by tracking the flow of calcium ions within the cell as animals freely moved) and saw that specific patterns of the cell's activity were associated with egg laying and locomotion. Many molecular means Having established that HSN causes the three related behaviors, the lab then zeroed in on how it does so. HSN is known to release a wide variety of neurotransmitter chemicals including serotonin, acetylcholine and numerous peptides. Its release of serotonin and a neuropeptide called NLP-3 is known to drive egg-laying. To determine how the neuron drives speedy locomotion, the team systematically knocked out each HSN neurotransmitter and then stimulated HSN to see whether the worms could still speed up when HSN couldn't produce one chemical or the other. The experiments revealed that HSN drives increased locomotion via the release of two neuropeptides, called FLP-2 and FLP-28. Knocking out serotonin in HSN, meanwhile, disabled the worm's slowing behavior. Further experiments showed how. Flavell's team has previously studied the neuron NSM, showing that it uses serotonin when a worm is feeding to inhibit motor circuits and slow the worm down for the meal. In this study, the team showed that NSM's action depended on a supply of serotonin coming from HSN. When HSN couldn't produce serotonin, for instance, NSM couldn't slow the worms down as well. The team further showed that NSM uses the serotonin transporter SERT (called MOD-5 in C. elegans) to take up HSN's serotonin and re-release it. This showed that serotonergic neurons can pool and share serotonin with one another, with a direct impact on the animal's behavior, Flavell said. Turning to HSN's anatomy, the team discerned that control of locomotion and control of egg laying occurred along different points of HSN's axon. HSN's cell body is in the midbody of the animal. It forms synapses with the egg-laying circuit in the midbody and then its axon projects to the head to make synapses with other neurons. Cutting HSN's axon between the midbody and head did not disrupt the animal's egg-laying, but did prevent the coordination of egg-laying and locomotion, suggesting that HSN's projection to the head coordinates HSN's action on the egg-laying circuit with its action on the locomotion circuit. In all, the study showed how HSN uses many parallel neurotransmitter outputs in different ways to control the animal's behavior. "Our results illustrate how cellular morphology, multiple transmitter systems, and non-canonical modes of transmission like neurotransmitter "borrowing" endow a single neuron with the ability to orchestrate multiple features of a behavioral program," the authors wrote. Meanwhile, the finding that neurons can take up and re-release serotonin produced by other neurons to control behavior reveals a novel feature of serotonin signaling that could have important medical implications, Flavell said. The molecule that takes up the serotonin, SERT/MOD-5, is the target of serotonin-specific reuptake inhibitors (SSRIs) like Prozac. This study raises the possibility that SSRIs may influence how neurons share serotonin with one another, which could be relevant for their mode of action in treating a wide variety of psychiatric disorders. In addition to Huang and Flavell, the paper's other authors are Jinyue Luo, Wenjia Huang, Casey Baker, Matthew Gomes, Bohan Meng, and Alexandra Byrne. The National Institutes of Health, the National Science Foundation, the McKnight Foundation, The Alfred P. Sloan Foundation, The Picower Institute for Learning and Memory and The JPB Foundation contributed funding for the study.