On February 27, 2024 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to NVL-520 for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with two or more ROS1 tyrosine kinase inhibitors (TKIs) (Press release, Nuvalent, FEB 27, 2024, View Source [SID1234640548]).

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ROS1 rearrangements occur in up to approximately 3% of metastatic NSCLCs. At the time of diagnosis, up to 40% of these patients present with accompanying brain metastases, and approximately 40% of patients develop resistance mutations following current front-line treatment. There remains no clear standard of care for patients who have been previously treated with two or more ROS1 TKIs.

NVL-520 is a novel brain-penetrant ROS1-selective tyrosine kinase inhibitor (TKI) created with the aim to simultaneously overcome the clinical challenges of emergent treatment resistance, brain metastases, and off-target central nervous system (CNS) adverse events associated with inhibition of the structurally-related tropomyosin receptor kinase (TRK) family that may limit the use of currently available ROS1 TKIs.

"In line with our commitment to bringing new potential best-in-class medicines to patients with cancer as quickly as possible, we are always looking for opportunities to further accelerate our programs," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "We’re very encouraged by today’s announcement of FDA breakthrough therapy designation for NVL-520, as it recognizes the continued need for innovation for patients with ROS1-positive NSCLC who have exhausted available therapies. We look forward to providing an update from the ARROS-1 trial of NVL-520 at a medical meeting later this year."

BTD is designed to expedite the development and review of therapies intended to treat a serious or life-threatening condition and whose preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over existing available therapies. Under the designation, the FDA provides intensive guidance, organizational commitment involving senior managers, and eligibility for rolling review and other actions to expedite review.

The BTD for NVL-520 is based on the preliminary safety and activity of NVL-520 in heavily pretreated patients with advanced ROS1-positive NSCLC in the Phase 1 portion of the Phase 1/2 ARROS-1 clinical trial. Enrollment in the Phase 2 portion of the trial is ongoing, and the company expects to share updated data from the trial at a medical meeting in 2024.

About NVL-520
NVL-520 is a novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. NVL-520 is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, NVL-520 is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally-related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. NVL-520 has received orphan drug designation for ROS1-positive non-small cell lung cancer (NSCLC) and is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors.

On February 27, 2024 Curve Therapeutics ("Curve" or the "Company"), a private biotechnology company pioneering a revolutionary intracellular screening platform addressing complex and challenging disease targets, reported the close of its successful £40.5 million Series A financing (Press release, Curve Therapeutics, FEB 27, 2024, View Source [SID1234640547]). Pfizer Ventures led the round with participation from Columbus Venture Partners and British Patient Capital, which join founding investor Advent Life Sciences and co-lead from the seed round, Epidarex Capital.

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Curve’s powerful Microcycle platform enables the direct discovery of biologically active molecules against targets that have been difficult to address using conventional drug discovery methods. Curve has built a discovery pipeline of assets including a first-in-class dual-inhibitor of HIF-1 and HIF-2 that addresses survival mechanisms in more than half of solid tumours, and a first-in-class inhibitor of ATIC dimerization that targets an important vulnerability in multiple cancers. The financing will enable the Company to progress development of these assets rapidly towards clinical development and to expand the discovery platform beyond challenging and complex intracellular protein targets.

Simon Kerry, PhD, MBA, Chief Executive Officer of Curve Therapeutics, said: "This financing will enable us to expand our team, progress our lead assets into the clinic and to expand our drug discovery platform. We welcome our new investors alongside our existing strong syndicate and look forward to working together to take Curve to its next stage of growth."

Professor Ali Tavassoli, Chief Scientific Officer of Curve Therapeutics, added: "Curve’s Microcycle platform is a powerful tool for drug discovery, enabling an unparalleled advantage in the discovery of functional hits and leads. We look forward to maximising the potential of our platform to further develop a rich pipeline of programmes with the potential to treat unmet clinical needs in a diverse range of diseases, including cancer."

Dr. Marie-Claire Peakman, Partner at Pfizer Ventures, commented: "We are delighted to have led this financing and to work with great co-investors and leadership team. Curve’s platform provides an exciting new approach designed to tackle tough, high priority targets which have been difficult to progress in the past. We are eager for the Company to progress the platform with the goal of identifying new therapeutics for challenging diseases."

Curve’s platform allows functional screening and enrichment of highly diverse, gene-encoded, Microcycle libraries within the cytoplasm of mammalian cells to identify library members that have a desired biological activity against a therapeutic target. Importantly, the compact size of Microcycles enables their transformation to non-peptide small molecules for lead optimisation and development, an unparalleled advantage compared to other cyclic peptide technologies.

Curve occupies state of the art laboratories at the Southampton Science Park, a move prompted by the expansion of the Company’s research team which included the recent appointments of Dr Monika Ermann as Vice President of Drug Discovery, and Dr Sally Price as Vice President of Biology. With four regional Universities and pioneering medical institutions such as the Centre for Cancer Immunology in Southampton, Hampshire is an attractive location for life science companies, and just an hour from key biotech centres in Oxford and London.

On February 27, 2024 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its self-developed novel ADC drug targeting Nectin-4 (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (hereinafter referred to as "ESCC") (Press release, Mabwell Biotech, FEB 27, 2024, View Source [SID1234640546]).

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As of February 20, 2024, for the indication of esophageal cancer (EC), 9MW2821 has shown an ORR and DCR of 30% and 73.3%, respectively, in a Phase II clinical study at a dose of 1.25 mg/kg in 30 patients with advanced EC who have received monotherapy and completed at least one tumor assessment. Of those, 28 patients have undergone chemotherapy and immunotherapy. The study is still ongoing with further enrollment and evaluation. 9MW2821 is the world’s first Nectin-4-targeting drug to disclose clinical efficacy data for the indication of EC.

9MW2821 is a site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell’s ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first clinical stage Nectin-4-targeting ADC developed by Chinese company.

The drug achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.

In addition to EC, Mabwell is conducting clinical studies for multiple indications such as urothelial cancer (UC), Cervical Cancer (CC), with monotherapy for UC entering Phase III clinical study, combination therapy with PD-1 entering Phase I/II clinical study, and monotherapy for CC entering Phase II clinical study. As of now, more than 280 patients have been enrolled. 9MW2821 is also the first to disclose preliminary clinical efficacy data for the indication of CC among drugs with the same target in the world.

About EC

According to the global cancer burden data released by the International Agency for Research on Cancer (IRAC), there were 604 thousand new cases of EC worldwide in 2020, with 544 thousand deaths. In 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on JNCC, showing that there were 224 thousand new cases of EC in China (167.5 thousand in men, 56.5 thousand in women), with 187.5 thousand deaths (140.4 thousand in men, 47.1 thousand in women), ranking 7th and 5th, respectively, in terms of new cases and deaths. According to the statistics from the American Cancer Society, it is estimated that there will be 22,370 new cases of EC (17,690 in men, 4,680 in women), and 16,130 deaths (12,880 in men, 3,250 in women) in the United States in 2024. In China, ESCC is the most common histological type, accounting for about 85.79% of EC cases, while esophageal adenocarcinoma (EAC) and other types account for 11.00% and 3.21%, respectively. In the United States, EAC is the most common type of EC among White population, accounting for about 70% of EC cases, with ESCC accounting for about 30%, and ESCC is more common among African Americans.

Furthermore, according to IQVIA’s report, in 2022, the number of prevalent patients with EC in China was 742 thousand, with approximately 70% being cases of advanced metastatic EC, of which about 80% (approximately 416,000 cases) were eligible for systemic treatment. The guidelines of the Chinese Society of Clinical Oncology (CSCO) recommends that PD-1 monoclonal antibody combined with platinum-based chemotherapy is the standard first-line treatment, and PD-1 or monotherapy chemotherapy is an optional second-line treatment. In actual clinical practice, there is a significant unmet clinical need after first-line treatment failure, since no preferred options are available.

On February 27, 2024 Accuray Incorporated (NASDAQ: ARAY) reported its participation in the Oppenheimer 34th Annual Healthcare MedTech & Services Conference taking place March 12-13, 2024 (Press release, Accuray, FEB 27, 2024, View Source;services-conference-302073376.html [SID1234640545]). The management team is scheduled to participate in a fireside chat on Tuesday, March 12, 2024 at 7:00am PST / 10:00am EST.

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A live webcast of the fireside chat can be accessed on the Accuray website at investors.accuray.com. A replay will be available on the company’s website following the event. The webcast replay of the presentation will begin about one hour after the conclusion of the live presentation and will be available for 90 days.

The Oppenheimer Conference will connect institutional investors to a wide variety of public and private healthcare companies spanning all major sectors of the healthcare industry.

On February 27, 2024 Nektar Therapeutics (Nasdaq: NKTR) reported that management is scheduled to present at the upcoming TD Cowen 44th Annual Health Care Conference in Boston on Tuesday, March 5, 2024 at 2:10 p.m. Eastern Time (Press release, Nektar Therapeutics, FEB 27, 2024, View Source [SID1234640544]).

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The presentation and Q&A session will be accessible via a webcast through a link posted on the Investor Events section of the Nektar website: View Source This webcast will be available for replay until April 5, 2024.