Delving into the Latest Updates on Famitinib Malate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Famitinib, Famitinib maleate, SHR 1020

+ [1]

Target

FGFRs x PDGFR x VEGFR x VEGFR2 x c-Kit

Mechanism

FGFRs antagonists(Fibroblast growth factor receptors antagonists), PDGFR antagonists(Platelet-derived growth factor receptor antagonists), VEGFR antagonists(Vascular endothelial growth factor receptor antagonists)

Therapeutic Areas

NeoplasmsUrogenital DiseasesRespiratory Diseases+ [3]

Active Indication

Uterine Cervical CancerTriple Negative Breast CancerPD-L1 positive Non-Small Cell Lung Cancer+ [19]

Inactive Indication

Advanced Colorectal AdenocarcinomaAdvanced Lung Non-Small Cell CarcinomaAdvanced Lung Non-Squamous Non-Small Cell Carcinoma+ [22]

Originator Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Active Organization

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Fudan University

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationBreakthrough Therapy (CN)

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Structure/Sequence

Molecular FormulaC27H33FN4O7

InChIKeyJNDRBKCNKMZANY-QLTVYZEUSA-N

CAS Registry1256377-67-9

This study is a prospective, open-label, multi-center, phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene (gBRCA1/2) that were indicated for neoadjuvant chemotherapy. The characteristics of this study are a precision treatment scheme without chemotherapy, the scheme of HRS-1167 combined with famitinib neoadjuvant therapy for patients with gBRCA mutations is explored, and the efficacy of combined immunotherapy is further explored according to the efficacy of the combination of the two drugs.

Start Date30 Sep 2024

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Famitinib Malate

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100 Translational Medicine associated with Famitinib Malate

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100 Patents (Medical) associated with Famitinib Malate

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43

Literatures (Medical) associated with Famitinib Malate

01 Jan 2025·The Innovation

Famitinib plus camrelizumab in patients with advanced colorectal cancer: Data from a multicenter, basket study

Article

Author: Yang, Mudan ; Qu, Song ; Zhang, Shilong ; Yu, Yiyi ; Xiu, Peng ; Yang, Xinfeng ; Cheng, Ying ; Pan, Yueyin ; Lu, Jin ; Yuan, Ying ; Gao, Shegan ; Wang, Xicheng ; Feng, Jifeng ; Zhang, Xizhi ; Ai, Luoyan ; Yi, Shanyong ; Li, Jin ; Liu, Tianshu ; Li, Qian ; Dong, Yu ; Wang, Junsheng ; Wang, Shuni

Concurrent inhibition of angiogenesis and immune checkpoints represents a potent therapeutic approach. We conducted a phase 2, multicenter, basket study to assess the efficacy and safety of combination therapy of famitinib (anti-angiogenic agent) plus camrelizumab (PD-1 antagonist) in patients with metastatic solid tumors across 11 cohorts (this study was registered at Clinicaltrials.gov [NCT04346381]). This report focuses on the cohort of patients with metastatic or advanced colorectal cancer. Eligible patients, who had previously received ≥2 lines of systemic treatments for their metastatic disease, were treated with famitinib (20 mg once daily) in combination with camrelizumab (200 mg intravenously every 3 weeks). The primary endpoint was the objective response rate, with secondary endpoints encompassing progression-free survival, overall survival, duration of response, safety and exploratory biomarkers. A total of 44 patients were enrolled and treated. With a median follow-up time of 9.46 months (range 2.0-22.5 months), objective responses were observed in 6 patients (13.6%; 95% confidence interval [CI], 5.2%-27.4%), all of whom had rectal cancer. The median duration of response is 6.2 months (95% CI, 2.3-10.6 months). Median progression-free survival was 3.3 months (95% CI, 2.1-4.1 months), and median overall survival was 10.9 months (95% CI, 7.6-15.2 months). Among the 44 patients, 29 (65.9%) experienced grade 3 or 4 treatment-related adverse events, predominantly hypertension and proteinuria. In conclusion, the combination of famitinib and camrelizumab demonstrates promising antitumor activity with a manageable safety profile in metastatic colorectal cancer patients. Further research is warranted to confirm and extend these ﬁndings.

01 Jan 2025·Therapeutic Advances in Medical Oncology

Efficacy and safety of camrelizumab plus famitinib in patients with previously treated non-small-cell lung cancer: a single-arm, phase II trial

Article

Author: Ma, Junxun ; Wang, Lijie ; Zhang, Xia ; Zhao, Changhong ; Yan, Huan ; Sun, Decong ; Ju, Yanfang ; Yang, Xuejiao ; Yuan, Fang ; Liu, Zhefeng ; Tao, Haitao ; Zhao, Yan ; Tian, Luyuan ; Gao, Ming ; Hu, Yi

Background::

For non-small-cell lung cancer (NSCLC) patients who progressed after first-line chemotherapy, immunotherapy targeting programmed cell death (ligand) 1 has shown promising activity. However, the activity is relatively limited in patients harboring epidermal growth factor receptor (EGFR) mutations.

Objectives::

This study aimed to evaluate the efficacy and safety of camrelizumab plus famitinib in previously treated patients with locally advanced and metastatic NSCLC.

Design::

A single-center, single-arm, phase II study.

Methods::

Previously treated patients with locally advanced and metastatic NSCLC were enrolled to receive camrelizumab (200 mg, administered intravenously every 3 weeks) and famitinib (20 mg, administered orally once daily). Patients harboring EGFR mutation genes had received at least one EGFR tyrosine kinase inhibitor and no more than two lines of chemotherapy regimen before the enrollment. The other patients had progressed on first-line chemotherapy with or without immunotherapy before the enrollment. The primary endpoint was the objective response rate (ORR) per RECIST v1.1 by the investigator.

Results::

Our study encompassed 23 NSCLC patients between October 2019 and October 2022. For all patients, the confirmed ORR was 30.4%, and the disease control rate was 95.7%. The median progression-free survival (PFS) was 6.9 months (95% CI: 4.9 months–not reached). The median overall survival (OS) was not reached. 1- and 2-year OS rates were 85.6% (95% CI: 71.8%–100.0%) and 56.8% (95% CI: 37.7%–85.7%). Especially, for the 6 patients with EGFR genetic aberrations, the confirmed ORR was 33.3%, the median PFS was 10.3 months (95% CI: 1.8–18.8 months), and the median OS was 20.3 months (95% CI: 0.8–39.8 months). The most common grade 3 and above treatment-related adverse events were platelet count decreased, white blood cell count decreased, and hypertension. No unexpected adverse events were reported.

Conclusion::

Camrelizumab plus famitinib demonstrated encouraging clinical activity with a manageable safety profile in previously treated patients with locally advanced and metastatic NSCLC. The results warranted further validation.

Trial registration::

Chinese Clinical Trial Registry identifier: ChiCTR1900026641.

01 Sep 2024·EUROPEAN JOURNAL OF CANCER

Heterogeneity in advanced pulmonary sarcomatoid carcinoma and its efficacy to immune checkpoint inhibitors

Article

Author: Wu, Lin ; Chu, Tianqing ; Wang, Huijuan ; Wang, Jialei ; Yao, Yu ; Ye, Feng ; Chu, Qian ; Cai, Xiuyu ; Zhu, Bo ; Xie, Mengqing ; Zhou, Caicun ; Su, Chunxia ; Dong, Xiaorong

BACKGROUND:

Immune checkpoint inhibitors (ICIs) have improved the prognosis of patients with non-small cell lung cancer but rarely been explored in pulmonary sarcomatoid carcinoma (PSC). This multicenter study aimed to evaluate the effectiveness of ICIs for PSC and its underlying mechanism.

METHODS:

Advanced PSC who received ICIs between August 2018 and May 2022 from 11 centers in China were included. Clinical characteristics and treatment information were collected. Whole-exome sequencing (WES) and whole transcriptome sequencing were conducted on pre-treatment samples to explore the mechanism.

RESULTS:

113 patients with PSC were enrolled, the median PFS for patients receiving ICIs therapy was 8.77 months (95 % confidence interval, 4.21 to 13.32). Combining ICIs with anti-angiogenic agents significantly increased PFS (p = 0.04). Liver metastasis and combination therapy with anti-angiogenic agents were independent risk factors for PFS (Hazard Ratio [HR] = 3.652, p = 0.019 and HR = 0.435, p = 0.017, respectively). WES showed that PSC presented with a TMB of 6.3 mutations per million base pairs. High expression of TNFα signaling and glycolysis related gene showed a better prognosis.

CONCLUSIONS:

ICIs showed promising benefits for advanced PSC, and the addition of anti-angiogenic therapy might be a more effective treatment strategy for this disease.

2

News (Medical) associated with Famitinib Malate

23 Jan 2024

·papyrustherapeutics.com

Papyrus Therapeutics Receives Approval of New Patent Claims for Multi-Cancer Tumor Suppressor Therapy Platform

January 23, 2024 WEST CHESTER Pa — Papyrus Therapeutics Inc., a biotechnology platform company for the development of potent, multi-cancer, tumor suppressor precision therapies for solid cancers, is pleased to announce that the United States Patent and Trademark Office (USPTO) granted approval of all 20 claims in Papyrus’ submitted Patent. That the USPTO approved all 20 claims is distinguishing given the infrequency patent grants are awarded without prior art being cited against the claims. The nature of the expanded patent recognizes the groundbreaking novelty and potential of Papyrus’ platform’s science, knowledgebase, and AI enablement to streamline the discovery of naturally occurring tumor suppressor proteins like OPCML as therapeutics. Such proteins, when identified as silenced in human cancer, can be restored in those cancers by Papyrus’ recombinant-OPCML (r-OPCML) protein replacement therapy through intravenous delivery. Unlike chemotherapy and other oncogene-focused therapeutics, r-OPCML targets only cancer cells deficient in this protein without damaging healthy cells that normally express it. Further, the data-to-date points to the therapeutic being a well-tolerated and effective treatment. According to Papyrus’ co-founder / chief scientific officer, and renowned translational medical oncologist Hani Gabra, PhD FRCP, “Preclinical studies of Papyrus’ lead clinical asset PYTX-004, the r-OPCML-Fc fusion tumor suppressor analog, have demonstrated a high degree of tumor suppressor efficacy as a monotherapy and as a combination therapy in ovarian cancer with no adverse toxicities noted thus far. This, in concert with USPTO’s approval of all 20 claims reinforces the transformational potential of the Papyrus tumor suppressor discovery platform to enable a pipeline of novel, cancer-targeted protein-replacement tumor suppressor therapeutics.” Similar results for this suppressor replacement therapy have been observed for HER2+ breast cancer and are projected for other cancers, with loss of this tumor suppressor noted in at least half of all human solid cancers. OPCML, a member of the IgLON family of proteins, is a naturally occurring tumor suppressor protein. PYTX-004 is Papyrus’ r-OPCML-Fc lead tumor suppressor biotherapeutic in development that is outlined in the patent application. The Company expects to have continued success with upcoming patent filings based on unique synthetic alterations of OPCML and other related IgLON family members that will enable the development of a pipeline of pioneering unique synthetic tumor suppressor biotherapeutics with novel specificities for monotherapy and combination therapies in differing indications. About Papyrus Therapeutics Inc.: Papyrus Therapeutics, Inc. (https://papyrustherapeutics.com/) is a biotherapeutics platform company developing novel tumor suppressor-based therapies. Papyrus ́ lead therapeutic is a modified, recombinant analogue of Opioid Binding Protein/Cell Adhesion Molecule-like (r-OPCML-Fc), PYTX-004. PYTX-004 is a native engineered OPCML protein replacement therapy designed to suppress tumor growth. OPCML is a broadly acting tumor suppressor that is epigenetically silenced in many cancers, leading to tumor invasion and metastasis through deregulation of apoptosis, epithelial-to-mesenchymal transition (EMT) and cellular migration. Delivery of OPCML, which works at the cell surface, can overcome the challenge of RTK inhibitor resistance by reconstituting normal RTK signaling in the tumor. Contact Dr. Paul Blake pblake@pytxi.com

Patent Expiration

10 Feb 2021

·www.biospace.com

Targovax and Papyrus Therapeutics enter research collaboration to develop novel ONCOS viruses with receptor tyrosine kinase (RTK) inhibitor functionality

The parties will explore the feasibility and effect of combining their respective oncolytic virus and receptor tyrosine kinase (RTK) inhibitor technologies Targovax retains the right to develop and commercialize novel drug candidates emerging from the pre-clinical collaboration OSLO, Norway, Feb. 10, 2021 /PRNewswire/ -- Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, today announces that it has entered into a research collaboration agreement with Papyrus Therapeutics to assess the potential of combining their respective proprietary technology platforms to develop a first-in-class oncolytic virus concept with RTK inhibitor functionality. Papyrus Therapeutics, Inc. (West Chester, PA, USA) is an emerging biopharma company developing novel tumor suppressor therapies. Papyrus's lead therapeutic is a modified, recombinant version of Opioid Binding Protein/Cell Adhesion Molecule-like (OPCML), which is an extra-cellular, upstream regulator of RTK activity. OPCML is a broadly acting tumor suppressor that is epigenetically silenced in many cancers, leading to tumor invasion and metastasis through deregulation of apoptosis, epithelial-to-mesenchymal transition (EMT) and cellular migration. Classic RTK inhibition using small molecules has proven highly effective in many cancers, but treatment resistance remains a significant challenge. Delivery of OPCML can overcome this challenge by reconstituting normal RTK signaling in the tumor. Under the agreement, Targovax and Papyrus will run a joint pre-clinical research project to evaluate the technical feasibility and anti-cancer activity of combining the ONCOS oncolytic virus platform and recombinant OPCML technology. Targovax retains an exclusive option to develop and commercialize novel ONCOS-OPCML drug candidates emerging from the pre-clinical research collaboration. Dr. Paul Blake, Co-Founder and Chief Executive Officer of Papyrus Therapeutics said: "We are excited by the potential of including our modified, recombinant OPCML with the clinically validated ONCOS platform, thereby extending the scope of our tumor suppression strategy to adenoviral gene therapy. Targovax has demonstrated the broad immunomodulatory power of their oncolytic immunotherapy in a variety of solid tumors, and we believe this serves as an ideal environment to reconstitute the extra-cellular tumor suppressor capabilities of OPCML". Dr. Victor Levitsky, Chief Scientific Officer of Targovax added: "The tumor deploys two core strategies to avoid detection by the immune system and to enable it to grow and spread; local immunosuppression and inhibition of biochemical processes that prevent cellular migration and invasion into surrounding healthy tissue. By combining ONCOS and OPCML we can deal with both of these issues in parallel, and thereby establish a first-in-class immunotherapy concept that couples the power of oncolytic adenoviruses with the clinically validated principle of RTK inhibition." CONTACT: For further information, please contact: Renate Birkeli, Investor Relations Phone: +47 922 61 624 Email: renate.birkeli@targovax.com Media enquires: Andreas Tinglum - Corporate Communications (Norway) Phone: +47 9300 1773 Email: andreas.tinglum@corpcom.no IR enquires: Kim Sutton Golodetz - LHA Investor Relations (US) Email: kgolodetz@lhai.com Phone: +1 212-838-3777 This information was brought to you by Cision View original content: SOURCE Targovax Company Codes: Bloomberg:TRVX@NO, ISIN:NO0010689326, Oslo:TRVX, RICS:TRVX.OL

CollaborateGene TherapyImmunotherapyFirst in ClassSmall molecular drug

100 Deals associated with Famitinib Malate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB11741

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Uterine Cervical Cancer	NDA/BLA	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	06 Dec 2023
Triple Negative Breast Cancer	Phase 3	CN	Fudan University	17 Mar 2023
PD-L1 positive Non-Small Cell Lung Cancer	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Aug 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	09 Dec 2021
Non-squamous non-small cell lung cancer	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Feb 2021
Gastrointestinal Stromal Tumors	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	07 Sep 2020
Recurrent Lung Non-Squamous Non-Small Cell Carcinoma	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jun 2016
Advanced Colorectal Adenocarcinoma	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jan 2015
Colorectal cancer recurrent	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jan 2015
Metastatic Colorectal Carcinoma	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jan 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04346381 (Literature) Manual	Phase 2	Colorectal Cancer Third line	44	Famitinib + camrelizumab	nundvvbkjn(kohcvsqgfk) = uxcvufemfw klhsaipcsi (sueeaiuqya, 5.2 - 27.4) View more	Positive	06 Jan 2025
NCT04346381 (phase 2, multicenter, basket study, Pubmed \| Innovation (Camb))	Phase 2	Colorectal Cancer	44	Famitinib 20 mg	scpkeehbaf(yypbsjejqe) = 29 (65.9%) experienced grade 3 or 4 treatment-related adverse events, predominantly hypertension and proteinuria mpcihhlcob (xcwopxrhtx )	Positive	01 Jan 2025
ChiCTR2000037927 (Pubmed \| NEWS) Manual	Phase 2	Pancreatic Ductal Adenocarcinoma \| Advanced biliary tract cancer	51	SHR-1701 + famitinib (BTC)	ryckuhuaxg(nkjpcczftv) = kmijvdpyld ghsugvcuup (hexqvyggfy, 12.1 - 49.4) View more	Positive	13 Dec 2024
ChiCTR2000037927 (Pubmed \| NEWS) Manual	Phase 2		51	SHR-1701 + famitinib (PDAC)	ryckuhuaxg(nkjpcczftv) = ilwfiqnexi ghsugvcuup (hexqvyggfy, 3.2 - 37.9) View more	Positive	13 Dec 2024
SHR-1210-II-217 (NEWS) Manual	Phase 2	Uterine Cervical Cancer	194	卡瑞利珠单抗+法米替尼	hntuigbpin(qujhrhmhve) = mwdjzyztzb shzheebuxq (aljfmlckzm )	Positive	07 Dec 2023
SHR-1210-II-217 (NEWS) Manual	Phase 2	Uterine Cervical Cancer	194	卡瑞利珠单抗	-	Positive	07 Dec 2023
NCT04129996 (FUTURE-C-PLUS, ESMO 12023 \| ESMO 22023) Manual	Phase 2	Triple Negative Breast Cancer First line CD8 expression \| HER2 Negative \| ER Negative ... View more	48	Famitinib + Camrelizumab + nab-paclitaxel	vnbwagmbue(rydijyhtpz) = hczfmcuojb irvkqyyalz (eohzbmjeho, 70.2 - 92.3) View more	Positive	21 Oct 2023
NCT04129996 (FUTURE-C-PLUS, ASCO2023) Manual	Phase 2	Triple Negative Breast Cancer First line ER Negative \| PR Negative \| HER2 Negative	48	Famitinib + Camrelizumab + Nab-paclitaxel	wzkgqedlbc(eczzwcwjjs) = The most common treatment-related grade 3 or 4 adverse events were neutropenia (16 [33.3%]), anemia (5 [10.4%]), febrile neutropenia (5 [10.4%]), and thrombocytopenia (4 [8.3%]). gvyxgaxajc (vsbmwxvsys )	Positive	31 May 2023
NCT05051865 (ASCO 12023 \| ASCO 22023) Manual	Phase 2	Acral Lentiginous Malignant Melanoma	18	famitinib+Camrelizumab (pts experienced ICI)	kflmvszisc(lznimbabil) = kshjcbfzif cozczdrazj (laymslcskf ) View more	Positive	31 May 2023
ASCO2023	Not Applicable	Adenomatous Polyposis Coli	11	Famitinib 20 mg QD	qmceawwmre(lcurkeegsa) = lxzbsmohnk mixmesicuv (fmlyevstrl ) View more	Positive	31 May 2023
NCT04346381 (ESMO_ELCC2023) Manual	Phase 2	Non-Small Cell Lung Cancer First line	41	Camrelizumab+Famitinib	poxsbknjsf(toalonzjnw) = ijufqkxuym lowpmkluvs (whwjjntncp, 37.4 - 69.3) View more	Positive	31 Mar 2023
NCT04494659 (Pubmed \| Cancer Chemother Pharmacol)	Phase 1	-	21	Famitinib 25 mg	ttmtmottge(cdkrdswzvu) = ilprodefat usfkfnqdjs (kkqteeszwf )	-	15 Sep 2022
NCT04494659 (Pubmed \| Cancer Chemother Pharmacol)	Phase 1	-	21	Rifampin 600 mg	ttmtmottge(cdkrdswzvu) = yghycecncq usfkfnqdjs (kkqteeszwf )	-	15 Sep 2022