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- ||| axatilamab (SNDX-6352) / Syndax Pharma, Incyte
Watching @StephanieLeeMD present on the Lee symptom scale 👀measured during #axatilimab study for chronic #GVHD. Superhero! ♥️♥️ #ASH21 #bmtsm (Twitter) - Dec 11, 2021
- axatilamab (SNDX-6352) / Syndax Pharma, Incyte
Safety, Tolerability, and Efficacy of Axatilimab, a CSF-1R Humanized Antibody, for Chronic Graft-Versus-Host Disease after 2 or More Lines of Systemic Treatment (Salt Palace Convention Center Ballroom D) - Dec 3, 2021 - Abstract #TCTASTCTCIBMTR2022TCT_ASTCT_CIBMTR_178;
P1/2
The Ph1/2 study demonstrates the safety and efficacy of Axa in heavily pre-treated pts with active cGVHD. In the pivotal study AGAVE-201, efficacy of 3 doses of Axa (1mg/kg Q2W, 3mg/kg Q4W and 0.3mg/kg Q2W) will be defined in the cGVHD pt population.
- axatilamab (SNDX-6352) / Syndax Pharma, Incyte
Safety, Tolerability, and Efficacy of Axatilimab, a CSF-1R Humanized Antibody, for Chronic Graft-Versus-Host Disease after 2 or More Lines of Systemic Treatment (GWCC - B304-B305, Level 3) - Nov 5, 2021 - Abstract #ASH2021ASH_1575;
Data from this Ph 1/2 study demonstrate the safety and clinical activity of Axa in heavily pre-treated pts with active cGVHD, particularly those with fibrotic manifestations. A randomized pivotal study (AGAVE-201) has started enrolling a similar pt population, evaluating doses of 1 mg/kg Q2W and 3mg/kg Q4W, along with a lower dose of 0.3mg/kg Q2W.
- ||||| axatilamab (SNDX-6352) / Syndax Pharma
Clinical: Syndax Pharmaceuticals and Incyte Announce Global Collaboration to Develop and Commercialize Axatilimab for Chronic Graft-Versus-Host Disease and Other Fibrotic Diseases https://t.co/8TTkIhupBa (Twitter) - Sep 28, 2021
- | Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment closed, Trial completion date, Trial primary completion date: SNDX-6352-0503: A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD (clinicaltrials.gov) - May 14, 2021
P1/2, N=37, Active, not recruiting, Sponsor: Syndax Pharmaceuticals
A randomized pivotal study (AGAVE-201) has started enrolling a similar pt population, evaluating doses of 1 mg/kg Q2W and 3mg/kg Q4W, along with a lower dose of 0.3mg/kg Q2W. Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> May 2022 | Trial primary completion date: Dec 2020 --> Nov 2021
- | Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Trial completion date, Combination therapy, Monotherapy, Metastases: A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors (clinicaltrials.gov) - May 6, 2021
P1, N=45, Active, not recruiting, Sponsor: Syndax Pharmaceuticals
Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> May 2022 | Trial primary completion date: Dec 2020 --> Nov 2021 Trial completion date: Feb 2021 --> Aug 2021
- | Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy: Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - Mar 10, 2021
P2, N=30, Recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Trial completion date: Feb 2021 --> Aug 2021 Trial completion date: Mar 2025 --> Sep 2025 | Trial primary completion date: Mar 2025 --> Sep 2025
- |||| Jakafi oral (ruxolitinib) / Novartis, Incyte, axatilamab (SNDX-6352) / Syndax Pharma, KD-025 CAR T-cells / KAEDI
Clinical: Axatilimab randomized study upcoming. Look for AGAVE-201, will be open to patients age 6+. In phase I, responses observed after prior ibrutinib, ruxolitinib, and KD025: (Twitter) - Feb 15, 2021
- ||| axatilamab (SNDX-6352) / Syndax Pharma
Novel therapy targeting #macrophages in with axatilimab chronic #GHVD: (Twitter) - Feb 15, 2021
- ||||| Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
New P2 trial: AGAVE-201: A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) (clinicaltrials.gov) - Jan 13, 2021
P2, N=210, Recruiting, Sponsor: Syndax Pharmaceuticals
- || Imfinzi (durvalumab) / AstraZeneca
Enrollment open, Combination therapy: Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - Jan 13, 2021
P2, N=30, Recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Trial completion date: Mar 2025 --> Sep 2025 | Trial primary completion date: Mar 2025 --> Sep 2025 Not yet recruiting --> Recruiting
- ||||| axatilamab (SNDX-6352) / Syndax Pharma
#ASH20 #bmtsm Arora: CSF1 regs macrophage infiltration and differentiation. Axatilimab (SNDX-6352) is a CSF1R mAb which inhibits monocyte activation/differntiation, here a Ph1/2 study in cGVHD after 2+ prior treatments. (Twitter) - Dec 6, 2020
- axatilamab (SNDX-6352) / Syndax Pharma
[VIRTUAL] Phase 1 Study of Axatilimab (SNDX-6352), a CSF-1R Humanized Antibody, for Chronic Graft-Versus-Host Disease after 2 or More Lines of Systemic Treatment (Channel 23 (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_3084;
These data demonstrate that axatilimab is clinically active with acceptable safety profile and responses observed in heavily pretreated pts with active cGVHD. Enrollment continues in the Phase 1 study at 3 mg/kg q4w and Phase 2 study at a dose of 1 mg/kg q2w.
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors (clinicaltrials.gov) - Sep 10, 2020
P1, N=45, Active, not recruiting, Sponsor: Syndax Pharmaceuticals
Enrollment continues in the Phase 1 study at 3 mg/kg q4w and Phase 2 study at a dose of 1 mg/kg q2w. Recruiting --> Active, not recruiting | Trial completion date: Feb 2019 --> Feb 2021 | Trial primary completion date: Feb 2019 --> Feb 2021
- ||||| Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Trial suspension: A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19 (clinicaltrials.gov) - Aug 10, 2020
P2, N=186, Suspended, Sponsor: Syndax Pharmaceuticals
Recruiting --> Active, not recruiting | Trial completion date: Feb 2019 --> Feb 2021 | Trial primary completion date: Feb 2019 --> Feb 2021 Recruiting --> Suspended
- |||| axatilamab (SNDX-6352) / Syndax
Clinical: SNDX-6352 (Syndax is sponsor) on a clinical trial? Is that a possible option for the patient? (Twitter) - Aug 7, 2020
- | Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy: Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - Jul 13, 2020
P2, N=30, Not yet recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Recruiting --> Suspended Trial completion date: Jun 2024 --> Sep 2024 | Trial primary completion date: Jun 2024 --> Sep 2024
- |||| Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
New P2 trial: A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19 (clinicaltrials.gov) - Jun 3, 2020
P2, N=186, Recruiting, Sponsor: Syndax Pharmaceuticals
- axatilamab (SNDX-6352) / Syndax, Imfinzi (durvalumab) / AstraZeneca, BMS
[VIRTUAL] SNDX-6352-0502: A phase 1, open-label, dose escalation trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of SNDX-6352 in combination with durvalumab in patients with unresectable, recurrent, locally-advanced, or metastatic solid tumors (Virtual Meeting: All Session Times Are U.S. EDT) - Apr 13, 2020 - Abstract #AACRI2020AACR-I_423;
SNDX-6352 is a potent CSF1R antagonist that demonstrates tolerability and robust PD biomarker modulation in combination with durvalumab. The recommended phase 2 dose of 3 mg/kg administered q2wk in combination therapy will be explored in future studies.
- axatilamab (SNDX-6352) / Syndax
[VIRTUAL] SNDX-6352-0502 - A phase 1, open-label, dose escalation trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic activity of SNDX-6352 monotherapy in patients with unresectable, recurrent, locally-advanced, or metastatic solid tumors (Virtual Meeting: All Session Times Are U.S. EDT) - Apr 13, 2020 - Abstract #AACRI2020AACR-I_149;
SNDX-6352 demonstrates tolerability at the highest dose level evaluated (6 mg/kg) with robust PD biomarker modulation at doses as low as 1 mg/kg. A RP2D of 6mg/kg q4wks will be explored in future solid tumor studies.
- || Imfinzi (durvalumab) / AstraZeneca
New P2 trial, Combination therapy: Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - Mar 10, 2020
P2, N=30, Not yet recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- ||| Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Phase classification, Enrollment change, Trial completion date, Trial primary completion date: SNDX-6352-0503: A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD (clinicaltrials.gov) - Feb 6, 2020
P1/2, N=52, Recruiting, Sponsor: Syndax Pharmaceuticals
A RP2D of 6mg/kg q4wks will be explored in future solid tumor studies. Phase classification: P1 --> P1/2 | N=30 --> 52 | Trial completion date: Dec 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Dec 2020
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment change: SNDX-6352-0503: A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD (clinicaltrials.gov) - Dec 5, 2019
P1, N=30, Recruiting, Sponsor: Syndax Pharmaceuticals
Phase classification: P1 --> P1/2 | N=30 --> 52 | Trial completion date: Dec 2020 --> Jun 2021 | Trial primary completion date: Jun 2020 --> Dec 2020 N=132 --> 30
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment change, Trial completion date, Trial primary completion date: SNDX-6352-0503: A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD (clinicaltrials.gov) - Nov 15, 2019
P1, N=132, Recruiting, Sponsor: Syndax Pharmaceuticals
N=132 --> 30 N=30 --> 132 | Trial completion date: Mar 2020 --> Dec 2020 | Trial primary completion date: Oct 2019 --> Jun 2020
- | Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment open: SNDX-6352-0503: A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD (clinicaltrials.gov) - Nov 21, 2018
P1, N=30, Recruiting, Sponsor: Syndax Pharmaceuticals
N=30 --> 132 | Trial completion date: Mar 2020 --> Dec 2020 | Trial primary completion date: Oct 2019 --> Jun 2020 Not yet recruiting --> Recruiting
- | Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
New P1 trial: SNDX-6352-0503: A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD (clinicaltrials.gov) - Jul 26, 2018
P1, N=30, Not yet recruiting, Sponsor: Syndax Pharmaceuticals
- || Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors (clinicaltrials.gov) - Jun 27, 2018
P1, N=48, Recruiting, Sponsor: Syndax Pharmaceuticals
Not yet recruiting --> Recruiting N=24 --> 48 | Trial completion date: Jul 2018 --> Feb 2019 | Trial primary completion date: May 2018 --> Feb 2019
- Niktimvo (axatilimab-csfr) / Syndax Pharma, Incyte
Enrollment open, Combination therapy, Monotherapy, Metastases: A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors (clinicaltrials.gov) - Sep 13, 2017
P1, N=24, Recruiting, Sponsor: Syndax Pharmaceuticals
N=24 --> 48 | Trial completion date: Jul 2018 --> Feb 2019 | Trial primary completion date: May 2018 --> Feb 2019 Not yet recruiting --> Recruiting