A Phase 1/1b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of KIN-3248 in Participants With Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-3248, an oral small molecule FGFR inhibitor, in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.

开始日期2022-04-18

申办/合作机构

Kinnate Biopharma, Inc.

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项与 Kinnate Biopharma, Inc. 相关的文献（医药）

2024-07-19·ORGANIC PROCESS RESEARCH & DEVELOPMENT

Efficient, Scalable Synthesis of Functionalized Pyrrolo[2,1-f][1,2,4]triazines

作者: Chen, Ce ; Li, Zhongzhen ; Feng, Lei ; Pack, Shawn K.

An efficient, scalable synthesis of functionalized 5-fluoropyrrolo[2,1-f][1,2,4]triazines was developed from readily available starting materials.The synthesis is highlighted by a safe, Cu mediated difluoroacetate addition to vinyl TMS, selective formylation of 3-fluoropyrrole and sequential imine formation followed by cyclization to the triazine core.Addition of other electrophiles to 3-fluoropyrrole was also shown to be equally selective.

2022-12-01·Bioorganic & medicinal chemistry

The discovery of (1R, 3R)-1-(3-chloro-5-fluorophenyl)-3-(hydroxymethyl)-1,2,3,4-tetrahydroisoquinoline-6-carbonitrile, a potent and selective agonist of human transient receptor potential cation channel subfamily m member 5 (TRPM5) and evaluation of as a potential gastrointestinal prokinetic agent

Article

作者: Myers, R ; Raveglia, L F ; Aldegheri, L ; Virginio, C ; Ton-Nu, T ; Bianchi, F ; Feriani, A ; Tassini, S ; Wang, H ; Miura, J ; Piccoli, L ; Brault, L ; Barilli, A ; Sabat, M ; Lingard, I ; Tyhonas, J ; Brodbeck, D

This publication details the discovery of a series of selective transient receptor potential cation channel subfamily M member 5 (TRPM5) agonists culminating with the identification of the lead compound (1R, 3R)-1-(3-chloro-5-fluorophenyl)-3-(hydroxymethyl)-1,2,3,4-tetrahydroisoquinoline-6-carbonitrile (39). We describe herein our biological rationale for agonism of the target, the examination of the then current literature tool molecules, and finally the process of our discovery starting with a high throughput screening hit through lead development. We also detail the selectivity of the lead compound 39 versus related family members TRPA1, TRPV1, TRPV4, TRPM4 and TRPM8, the drug metabolism and pharmacokinetics (DMPK) profile and in vivo efficacy in a mouse model of gastrointestinal motility.

2022-06-01·Journal of the American College of Radiology : JACR2区 · 医学

A Coordinated Approach to Implementing Low-Dose CT Lung Cancer Screening in a Rural Community Hospital

2区 · 医学

Article

作者: Sharman, Kent ; Bertoldi, Margaret ; Baden, Derek ; Howes, Deb ; Shannon, Jackilen ; Cook, Bret ; Farris, Paige E ; Currier, Jessica ; Cox, Cherie ; Stoller, Wesley

PURPOSE:

The authors describe a rural community hospital's approach to lung cancer screening using low-dose CT (LDCT) to address the high incidence of lung cancer mortality.

METHODS:

An implementation project was conducted, documenting planning, education, and restructuring processes to implement a lung cancer screening program using LDCT in a rural community hospital (population 64,917, Rural-Urban Continuum Code 5) located in a region with the highest lung cancer mortality in Oregon. The hospital and community partners organized the implementation project around five recommendations for an efficient and effective lung cancer screening program that accurately identifies high-risk patients, facilitates timely access to screening, provides appropriate follow-up care, and offers smoking cessation support.

RESULTS:

Over a 3-year period (2018-2020), 567 LDCT scans were performed among a high-risk population. The result was a 4.8-fold increase in the number of LDCT scans from 2018 to 2019 and 54% growth from 2019 to 2020. The annual adherence rate increased from 51% in 2019 to 59.6% in 2020. Cancer was detected in 2.11% of persons scanned. Among the patients in whom lung cancer was detected, the majority of cancers (66.6%) were categorized as stage I or II.

CONCLUSIONS:

This rural community hospital's approach involved uniting primary care, specialty care, and community stakeholders around a single goal of improving lung cancer outcomes through early detection. The implementation strategy was intentionally organized around five recommendations for an effective and efficient lung cancer screening program and involved planning, education, and restructuring processes. Significant stakeholder involvement on three separate committees ensured that the program's design was relevant to local community contexts and patient centered. As a result, the screening program's reach and adherence increased each year of the 3-year pilot program.

项与 Kinnate Biopharma, Inc. 相关的新闻（医药）

2024-10-02

·Pharmaceutical Technology

Shattuck Labs stock craters following pipeline and job cuts

Following the restructuring news, Shattuck’s stock was down by 44.99% at market close on 1 October, compared to market close on the previous day. Shutterstock: paper cut design / Shutterstock. Shattuck Labs has dropped by nearly 45% after it announced plans to reduce its headcount and discontinue its lead cancer therapy programme, SL-172154. The restructuring decision was made after interim data from a Phase Ib trial (NCT05275439) showed a lack of a definitive overall survival (OS) benefit in patients receiving SL-172154. The company added that the ‘modest’ improvements in the OS seen in Phase I would likely erode in larger late-stage studies. Following the announcement, Shattuck’s stock was down by 44.99% at market close on 1 October, compared to market close on the previous day. The company’s market cap currently stands at $81.6m. SL-172154 is a cluster of differentiation 47 (CD47) inhibitors, which were investigated as a treatment for myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML). In February, Shattuck licensed out multiple potential drug candidates, including SL-172154, to Ono Pharmaceuticals in a deal worth more than $227m. As part of the restructuring, the companies have mutually terminated the agreement and Shattuck is “no longer required to satisfy any remaining performance obligations and will not receive any future research activity reimbursements or upfront, milestone, or royalty payments from Ono”. See Also: ImmunoPrecise and Biotheus partner on bispecific antibodies to treat cancer Novaliq and Laboratoires Théa announce EC approval for dry eye disease therapy The cost-saving measures also cull 40% of the workforce by the end of the year and will cost between $1.5m and $1.75m. Shattuck reported cash reserves of $105.3m as of 30 June, as per the latest SEC filing by the company. The company plans to funnel its remaining resources into developing its antibody therapy, SL-325. The DR3 antagonist acts by modulating adaptive immunity, as DR3 is expressed on the cell surface of various immune cells. Shattuck is developing SL-325 as a treatment for inflammatory autoimmune diseases, including inflammatory bowel disease (IBD). The company plans to file an investigational new drug application (IND) for SL-325 in Q3 2025. Shattuck noted that it has sufficient funds to finance beyond its planned Phase I clinical trial of SL-325 and into 2027. Following the recent round of lay-offs, Shattuck joins the list of pharmaceutical companies, including Atreca , Candel Therapeutics , Cidara Therapeutics , Kinnate Bio , and NexImmune , which have cut their workforces to reallocate funds into their clinical development pipelines in the last few months.

临床1期免疫疗法引进/卖出临床申请

2024-09-13

·Pharmaceutical Technology

Cidara axes 30% of staff to focus on flu prevention drug

Cidara reacquired the rights to the therapy from J&J for $85m in April. Image credit: gguy / Shutterstock. Cidara Therapeutics is axing nearly a third of its workforce to find funds to continue advancing clinical development of its reacquired flu candidate. The US-based biotech plans to lay off approximately 30% of its workforce, amounting to 20 positions, as per the company’s recent SEC filing. The reduction is expected to cost the company $1.2m in severance and benefit payments and will conclude by 1 November 2024. Cidara plans to focus its resources on advancing its influenza prevention therapy, CD388. The company also announced it plans to start a Phase IIb trial of CD388 for the prevention of influenza A and B in Q3 this year during the Northern Hemisphere’s flu season. After originally selling the rights to the drug to Johnson & Johnson (J&J) in 2021, the company reacquired the rights to the therapy for $85m in April after the pharma giant announced plans to deprioritise the development of the drug. Despite Cidara now being responsible for all development and marketing costs for CD388, J&J is eligible to receive additional milestone-based payments. CD388 received fast track designation by the US Food and Drug Administration (FDA) in June 2023. The drug has been evaluated in two Phase I studies (NCT05285137 and NCT05619536) and one Phase IIa (NCT05523089) trial. See Also: Bavarian Nordic promises two million mpox vaccines for Africa by end of 2024 IBA venture PanTera gains €134m in funding to scale up actinium-225 production In the Phase IIa data, despite a numerical decrease in influenza virus replication after a single dose of CD388, the reduction was not statistically significant. The CD388 treatment group also reported reduced influenza incidence rates compared to the placebo arm but again this was not statistically significant. Cidara also has cancer therapeutics as part of its pipeline, its most advanced candidate in the indication is CBO421. In July 2024, the company received investigational new drug application (IND) clearance to start a Phase I trial for evaluating CBO421 in solid tumours. However, Cidara’s SEC filing noted that it “does not currently plan to initiate clinical trials for any other product candidate”. The company has started multiple strategic measures to raise capital this year, including the sale of its rezafungin programme to Mundipharma and a $240m private investment in a public equity financing deal. Both efforts were expected to fund the Phase IIb trial of CD388. Following the recent round of lay-offs, Cidara joins a list of pharmaceutical companies, including Atreca , Candel Therapeutics , Kinnate Bio , and NexImmune , that have fired workers to funnel more money into their clinical development pipelines.

临床1期临床2期快速通道疫苗临床申请

2024-06-06

·美通社

皮尔法伯实验室宣布提交关于一种针对实体瘤（包括伴 MET 异常的非小细胞肺癌）患者的潜在治疗 PFL-002/VERT-002 的 IND 申请

法国卡斯特尔 2024年6月6日 /美通社/ -- 皮尔法伯实验室于今日宣布向美国食品药品监督管理局（"FDA"）提交一份新药临床试验（"IND"）申请，以启动 PFL-002/VERT-002 治疗实体瘤（包括非小细胞肺癌 (NSCLC)）的首次人体 (FIH) I/II 期临床试验。 PFL-002/VERT-002 I/II 期试验是一项多中心国际研究，旨在评估 PFL-002/VERT-002 在伴 MET 异常的 NSCLC 患者，包括对其他治疗产生耐药机制的患者中的安全性、耐受性、药代动力学 (PK)、药效学 (PD) 和初步疗效。FDA 将审查该申请并确定其可接受性。皮尔法伯实验室医疗保健研发部主管 Francesco Hofmann 表示："我们期待在今年下半年启动 PFL-002/VERT-002 的首次人体试验。该新药是一种具有差异化作用机制的新型治疗方案，用于治疗包括 NSCLC 在内的伴 MET 异常实体瘤患者，我们坚信它拥有广阔前景。" 关于 PFL-002/VERT-002 PFL-002/VERT-002 是由 Vertical Bio 开发的一种单克隆抗体，其具有独特的差异化作用机制，能够降解已知存在于实体瘤（包括伴 MET 突变或扩增的非小细胞肺癌 (NSCLC)）患者体内的疾病驱动因素： c-MET 。Vertical Bio 已被皮尔法伯实验室收购，并已完成该抗体的临床前优化工作。皮尔法伯实验室正在推进 PFL-002/VERT-002 的临床开发，并希望于 2024 年底之前为 FIH 试验招募到首例患者。关于皮尔法伯研发管线和产品组合皮尔法伯实验室在其研发管线中新增了几项资产，从而扩大了在精准肿瘤学领域的投入。该实验室将与 Scorpion Therapeutics 合作开发两种用于治疗 EGFR 驱动性非小细胞肺癌 (NSCLC) 患者的突变选择性 EGFR 抑制剂：PFL-241/STX-241 和 PFL-721/STX-721。通过收购 Vertical Bio，皮尔法伯实验室将针对 PFL-002/VERT-002 治疗 MET 基因异常驱动性实体瘤开展临床试验。最近，该实验室从 Kinnate Biopharma 购得泛 RAF 抑制剂 exarafenib，旨在扩展 RAS/RAF 驱动性实体瘤的靶向治疗方案。这些新增的临床开发产品组合分别通过 encorafenib、binimetinib 和来那替尼补充了皮尔法伯实验室现有的靶向 BRAF、MEK、HER2 的精准肿瘤学产品组合。 PDF - https://mma.prnewswire.com/media/2430129/Pierre_Fabre_filing.pdf Press contact: Laurence Marchal laurence.marchal@pierre-fabre.com

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