Study to Assess Safety and Preliminary Efficacy of Orally Administered JBI-802 in Subjects with Myeloproliferative Neoplasms (MPN) and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) with Thrombocytosis

Start Date21 Oct 2024

Sponsor / Collaborator

Jubilant Therapeutics, Inc.

[+1]

NCT05268666

/ RecruitingPhase 1/2

A First-in-Human, Open-label, Dose Escalation and Expansion Study of Orally Administered JBI-802 in Patients With Advanced Solid Tumors

The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JBI-802 in patients with Advanced Solid Tumors.The efficacy of the RP2D will be evaluated in phase 2 in patients with solid tumors of neuroendocrine differentiation.

Start Date08 Apr 2022

Sponsor / Collaborator

Jubilant Therapeutics, Inc.

100 Clinical Results associated with Jubilant Therapeutics, Inc.

0 Patents (Medical) associated with Jubilant Therapeutics, Inc.

Literatures (Medical) associated with Jubilant Therapeutics, Inc.

21 Apr 2025·Cancer Research

Abstract 3827: Chronic alcohol consumption promotes pancreatic cancer liver metastasis in mice through PAD4-mediated pre-metastatic niche formation

Author: Seki, Ekihiro ; Kazmi, Syed ; Kim, Jieun ; Pandol, Stephen J. ; Kim, So Yeon ; Fert-Bober, Justyna

Liver metastasis is a critical determinant of prognosis for patients with pancreatic ductal adenocarcinoma (PDAC). The liver microenvironment, shaped by underlying liver diseases such as alcohol-associated liver disease (ALD), significantly influences the progression of liver metastasis. However, the molecular mechanisms underlying liver metastasis in the context of ALD remain poorly understood. Steatosis and neutrophil infiltration, common features of ALD, are known to alter the hepatic microenvironment. Peptidylarginine deiminase 4 (PAD4), an enzyme primarily expressed in neutrophils, catalyzes citrullination, a post-translational modification that impacts protein structure and function. Here, we investigated the impact of chronic alcohol consumption on liver metastasis progression using animal models and explored the role of PAD4 in this process. Female C57BL/6 wild-type and neutrophil-specific PAD4-deleted mice were fed either an isocaloric diet or 5% ethanol Lieber-DeCarli diet for 6 weeks. Liver metastases were induced via intrasplenic injection of Pan02 mouse PDAC cells, followed by two additional weeks of diet. Neutrophil-specific PAD4-deleted mice were generated by crossing PAD4-floxed mice with MRP8-Cre mice. JBI-1044, a novel PAD4 inhibitor developed by Jubilant Therapeutics Inc., was administered via orally twice daily. Chronic alcohol consumption exacerbated metastatic tumor growth, correlating with increased PAD4 expression, neutrophil infiltration, and collagen deposition. Our single-cell RNA sequencing confirmed that tumor-associated neutrophils are the primary source of PAD4. Immunohistochemical staining for peptidyl-citrulline revealed its accumulation within metastatic tumors and enhanced citrullination in the livers of alcohol-fed mice compared to controls. Our proteomics analysis identified a significant increase in PAD4-mediated citrullination in the metastatic tumors of alcohol-fed mice, targeting vimentin and extracellular matrix proteins. Chronic alcohol-fed mice showed reduced survival. In contrast, PAD4 deletion in neutrophils suppressed metastatic tumor growth in the livers of alcohol-fed mice, accompanied by reduced neutrophil infiltration, collagen deposition, and citrullination. Treatment with JBI-1044 significantly improved survival and decreased the tumor growth in alcohol-fed mice by reducing neutrophil infiltration and collagen deposition. In conclusion, PAD4 plays a pivotal role in pre-metastatic niche formation and remodeling of the liver tumor microenvironment in PDAC liver metastasis associated with ALD. By regulating neutrophil activity and collagen deposition, PAD4 contributes to the progression of liver metastases. Selective inhibition of PAD4 with JBI-1044 represents a promising therapeutic strategy for managing PDAC liver metastasis in the context of ALD.Citation Format:Jieun Kim, So Yeon Kim, Justyna Fert-Bober, Syed Kazmi, Stephen J. Pandol, Ekihiro Seki. Chronic alcohol consumption promotes pancreatic cancer liver metastasis in mice through PAD4-mediated pre-metastatic niche formation [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 3827.

21 Apr 2025·Cancer Research

Abstract 4388: Novel small molecule on state inhibitor for GTP bound pan-KRAS (G12) mutations

Author: Sadhu, Naveen M. ; Rajagopal, Sridharan ; Sivanandhan, Dhanalakshmi ; Gajendran, Chandru ; Zainuddin, Mohammed ; Gosu, Ramachandraiah

AbstractIntroduction:KRAS is part of the RAS family of small GTPases. They act as molecular switches by cycling between an active GTP-bound (ON) state and an inactive GDP-bound (OFF) state in response to extracellular signals. KRAS is frequently mutated in nearly 30% of cancers, with the G12, G13, and Q61 hotspots being the most common [1]. Among these, G12 mutations account for 83% of KRAS mutations, being one of the most prevalent drivers of cancers [2]. Active KRAS triggers effector pathways like MAPK and PI3K, promoting cellular proliferation and survival. Oncogenic KRAS remains constitutively active due to defective GTP hydrolysis [3]. Therefore, inhibitors that target the “ON” state can effectively interrupt the signaling pathways that promote cancer cell growth and survival. Recently pan-KRAS tricomplex inhibitor, which inhibits KRAS ON state, has entered the clinic. Therefore, targeting the KRAS in ON state could be of high clinical value in cancers with defects in G12 mutations and in overcoming resistance. In this regard, we are developing a series of novel pan-KRAS ON state inhibitors.Methods:Fragment screening with SPR and structure-based drug design were used to identify novel pan-KRAS (G12) mutant “ON” state inhibitors. Over 20 scaffolds were synthesised and screened using the AlphaLISA and Nucleotide exchange assay. Binding was assessed using thermal shift assay. To assess in vitro potency and to drive the structure-activity relationship, an AlphaLISA assay that measures the disruption of active KRAS:C-Raf interaction and for the inactive GDP bound state Nucleotide exchange assay was used. The cell-based activity of these inhibitors was assessed by measuring the pERK levels and 2D/3D cell proliferation assays. PK-PD assessment was performed in A427 lung cancer and AGS gastric cancer xenograft models in mice.Results:Based on in vitro screening, we identified a novel series of potent pan-KRAS ON inhibitors targeting (G12) mutations. These early hit compounds demonstrated differential anti-proliferative activity between wild type and G12 mutant KRAS cell lines under 2D and 3D culture conditions. Accordingly, significant reductions in PD biomarker, pERK was demonstrated in KRAS mutant cell lines. PK-PD correlation was also established in a tumor bearing mice models, showing dose-dependent reductions in pERK level. The early data with these compounds show good ADME properties, and oral bioavailability, making them suitable for in vivo profiling and further SAR exploration.Conclusion:Our findings highlight the potential of these novel pan-KRAS ON state inhibitors as promising therapy approach for cancers harbouring KRAS (G12) mutations. Further SAR optimization, mechanistic studies, in vivo studies and toxicity evaluations are warranted to fully establish their efficacy and safety.Citation Format:Chandru Gajendran, Naveen M. Sadhu, Ramachandraiah Gosu, Mohammed Zainuddin, Dhanalakshmi Sivanandhan, Sridharan Rajagopal. Novel small molecule on state inhibitor for GTP bound pan-KRAS (G12) mutations [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4388.

05 Nov 2024·Blood

JBI802 a Highly Potent Corest Inhibitor Demonstrated Anti-Tumor Activity at Low Dose, Thrombocytopenia at Higher Dose NOW Leading to an Opportunity to Treat ET Myeloproliferative Neoplasms (MPN) /Essential Thrombocythemia [ET]) and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) with Thrombocytosis

Author: Dolan, Melda ; G, Chandru ; Rajagopal, Sridharan ; Baruah, Abhijit ; Zainuddin, Mohd. ; Mittal, Deepak ; Sadhu, Naveen

Background and Significance: Epigenetic alterations have emerged as hallmarks of cancer. Post-translational modifications (PTM) of histones have been implicated in several diseases including cancer. JBI-802 is a highly potent LSD1/HDAC6 selective CoREST inhibitor with superior anti-tumor activity in several pre-clinical models compared to LSD1 or HDAC6 inhibitors.JBI-802 in its first-in-human study in patients with solid tumors showed a dose dependent, reversible decrease in platelets which at the highest dose resulted in thrombocytopenia but did not show any other toxicities, particularly a lack of effect on haemoglobin. Based on these data, there is a strong scientific rationale to test the activity of JBI-802 in diseases such MPN and MDS/MPN with thrombocytosis where platelet reduction without anemia induction would represent an advantage over currently available therapies.Two treatment resistant lung cancer patients displayed improvement in tumor-related symptoms with confirmed and durable partial response (PR) in one patient, and significant improvement in cancer related pain and symptoms. Overall, JBI-802 was well tolerated with good safety profile, with grade 3/4 thrombocytopenia as the only adverse event observed at the highest dose. Dose-dependent decrease in platelets as a part of MOA of LSD1 inhibition demonstrated that JBI-802 is pharmacologically active and provided an opportunity to treat patients with hematological malignancies like essential thrombocythemia (ET) and other myeloproliferative neoplasms (MPN) and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) characterized by thrombocytosis.Study Design and Methods: Herein we are initiating a phase 1/2 clinical trial to assess the safety and preliminary efficacy of orally administered JBI-802 in ET, PV and MDS/MPN patients with thrombocytosis (Trial ID: ACTRN12624000478516) with two phases:Part 1: Dose Escalation Phase with objectives of both determining the recommended phase 2 dose (RP2D) of JBI-802 in subjects with ET, MPN and MDS/MPN neoplasms with thrombocytosis in all patients and evaluating the overall safety and tolerability of JBI-802 as a single agent.Part 2: Dose Expansion Phase with primary objective of obtaining preliminary evidence of efficacyat the RP2D in subjects with ET, MPN and MDS/MPN.Conclusion: JBI-802 in its first-in-human study in patients with solid tumors demonstrated a dose dependent, reversible decrease in platelets which at the highest dose resulted in thrombocytopenia but did not show any other toxicities. Based on these data, there is a strong scientific rationale to test the activity of JBI-802 in diseases such MPN and MDS/MPN with thrombocytosis representing an advantage over currently available therapies. As the study progress, interim data from the phase 1/2 clinical trial of ET and MPN patients will be presented.

News (Medical) associated with Jubilant Therapeutics, Inc.

25 Oct 2024

·pipelinereview.com

Jubilant Therapeutics Inc. announces First Patient Dosing in Global Clinical Trials for JBI-802, a CoREST Inhibitor and JBI-778, a PRMT5 Inhibitor

MORRISVILLE, NC, USA I October 25, 2024 I Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced the dosing of first patients in global clinical trials involving two pipeline programs: Phase I/II clinical trial of JBI-802 in heme-oncology and Phase I clinical trial for JBI-778 in solid tumors. “We are excited to take this significant step forward in our mission to transform the lives of patients through the development of easy to administer precision oral medicines with enhanced safety and therapeutic efficacy,” said Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. JBI-802 is a first-in-class, orally administered, small-molecule dual inhibitor of LSD1 (Lysine-specific histone demethylase 1A) and HDAC6 (Histone deacetylase 6) within the CoREST (Co-repressor of Repressor Element-1 Silencing Transcription) complex. In the earlier Phase I study conducted in advanced solid tumor patients, JBI-802 showed a dose-proportional increase in exposure across cohorts and a strong correlation between exposure and the on-target effect of platelet decrease. There were no reports of Dysgeusia and Anemia, typical adverse events seen with LSD1only inhibitors. The Phase I trial also showed anti-tumor activity in Non-Small Cell Lung Cancer (NSCLC) patients including a confirmed partial response. Overall, the study results provided human proof-of-principle for expanding the development of JBI-802 in Essential Thrombocythemia and Myelodysplastic Syndrome/Myeloproliferative Neoplasms (MDS/MPN) with thrombocytosis. Essential Thrombocythemia is a chronic disease of excessive platelets with over 100,000 patients in the United States for whom the primary treatment is hydroxyurea, a therapy that poses severe limitations for patients in terms of both safety and efficacy. The second clinical trial is to assess both safety and the recommended Phase II dose for JBI-778, an oral brain-penetrant inhibitor of PRMT5 (Protein arginine N-methyltransferase 5) in mEGFR Tyrosine Kinase Inhibitor (TKI) resistant NSCLC, IDH+ high-grade glioma (HGG) and Adenoid Cystic Carcinoma (ACC). PRMT5, although a proven pathway for multiple cancers, has produced mixed results in terms of drug development due to safety concerns surrounding SAM competitive approach to PRMT5 inhibition and patient segment limitations of MTAP null tumor-focused approach PRMT5 inhibition. JBI-778 is a unique substrate competitive brain penetrant PRMT5 inhibitor that has shown no adverse effects in preclinical setting and can address both MTAP null and wild type tumors as well as brain tumors, catering to a larger patient segment including those with brain metastases. “The two most advanced novel drug candidates at Jubilant Therapeutics Inc. were discovered in-house using our TIBEO (Therapeutic Index and Brain Exposure Optimization) Discovery Engine. It is our unique approach of structure-based drug design to generate novel pharmacophores with improved therapeutic index compared to existing agents. We are excited to advance both JBI-802 and JBI-778 in genetically-defined subsets of patients with select hematological and solid tumor indications with high unmet medical needs. Initial clinical data are expected to read out in 2025,” said Syed Kazmi, Chief Executive officer, Jubilant Therapeutics Inc . About JBI-802 JBI-802 is novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior compared to either target alone and with a favorable safety profile. JBI-802 is under evaluation in both hematological cancers such as acute myeloid leukemia, myelodysplastic syndrome and other myeloproliferative cancers as well as solid tumors, such as non-small cell lung cancer and small cell lung cancer. About JBI-778 JBI-778 is novel, oral, potent and brain penetrant inhibitor of PRMT5. JBI-778 targets the substrate site and stabilizes SAM bound to PRMT5, providing high biological selectivity and has shown a superior safety profile as seen in animals. Preclinical research has demonstrated significant activity in Tyrokinase-Inhibitor resistant cell lines, brain tumor and NSCLC. JBI-778 is under evaluation in solid tumors such as NSCLC, High Grade Glioma and Adenoid Cystic Carcinoma. About Jubilant Therapeutics Inc. Jubilant Therapeutics Inc. is a clinical stage biopharmaceutical company developing precision oral medicines with enhanced therapeutic index to address unmet medical needs in oncology and autoimmune diseases for genetically defined patients. Its advanced structure-based discovery engine, TIBEO (Therapeutic Index and Brain Exposure Optimization), has been validated through successful partnerships. The Company’s clinical pipeline consists of a first-in-class dual CoREST modifier, JBI-802, currently in a Phase I/II clinical trial in multiple tumors and a novel brain-penetrant modulator of PRMT5, currently in Phase I clinical trial. Additional pre-clinical programs include brain penetrant and gut restrictive PDL1 inhibitors, as well as PAD4 inhibitors for oncology and inflammatory indications. The Company is headquartered in Pennsylvania and guided by globally renowned scientific advisors. For more information, please visit www.jubilanttx.com or follow us on Twitter @JubilantTx and LinkedIn . SOURCE: Jubilant Therapeutics

Phase 1Clinical Result

25 Oct 2024

·www.prnewswire.com

Jubilant Therapeutics Inc. announces First Patient Dosing in Global Clinical Trials for JBI-802, a CoREST Inhibitor and JBI-778, a PRMT5 Inhibitor

JBI-802 is a first-in-class, orally administered, inhibitor of CoREST complex JBI-778 is a potential best-in-class, orally administered, brain penetrant inhibitor of PRMT5 MORRISVILLE, N.C., Oct. 25, 2024 /PRNewswire/ -- Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced the dosing of first patients in global clinical trials involving two pipeline programs: Phase I/II clinical trial of JBI-802 in heme-oncology and Phase I clinical trial for JBI-778 in solid tumors. "We are excited to take this significant step forward in our mission to transform the lives of patients through the development of easy to administer precision oral medicines with enhanced safety and therapeutic efficacy," said Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. JBI-802 is a first-in-class, orally administered, small-molecule dual inhibitor of LSD1 (Lysine-specific histone demethylase 1A) and HDAC6 (Histone deacetylase 6) within the CoREST (Co-repressor of Repressor Element-1 Silencing Transcription) complex. In the earlier Phase I study conducted in advanced solid tumor patients, JBI-802 showed a dose-proportional increase in exposure across cohorts and a strong correlation between exposure and the on-target effect of platelet decrease. There were no reports of Dysgeusia and Anemia, typical adverse events seen with LSD1only inhibitors. The Phase I trial also showed anti-tumor activity in Non-Small Cell Lung Cancer (NSCLC) patients including a confirmed partial response. Overall, the study results provided human proof-of-principle for expanding the development of JBI-802 in Essential Thrombocythemia and Myelodysplastic Syndrome/Myeloproliferative Neoplasms (MDS/MPN) with thrombocytosis. Essential Thrombocythemia is a chronic disease of excessive platelets with over 100,000 patients in the United States for whom the primary treatment is hydroxyurea, a therapy that poses severe limitations for patients in terms of both safety and efficacy. The second clinical trial is to assess both safety and the recommended Phase II dose for JBI-778, an oral brain-penetrant inhibitor of PRMT5 (Protein arginine N-methyltransferase 5) in mEGFR Tyrosine Kinase Inhibitor (TKI) resistant NSCLC, IDH+ high-grade glioma (HGG) and Adenoid Cystic Carcinoma (ACC). PRMT5, although a proven pathway for multiple cancers, has produced mixed results in terms of drug development due to safety concerns surrounding SAM competitive approach to PRMT5 inhibition and patient segment limitations of MTAP null tumor-focused approach PRMT5 inhibition. JBI-778 is a unique substrate competitive brain penetrant PRMT5 inhibitor that has shown no adverse effects in preclinical setting and can address both MTAP null and wild type tumors as well as brain tumors, catering to a larger patient segment including those with brain metastases. "The two most advanced novel drug candidates at Jubilant Therapeutics Inc. were discovered in-house using our TIBEO (Therapeutic Index and Brain Exposure Optimization) Discovery Engine. It is our unique approach of structure-based drug design to generate novel pharmacophores with improved therapeutic index compared to existing agents. We are excited to advance both JBI-802 and JBI-778 in genetically-defined subsets of patients with select hematological and solid tumor indications with high unmet medical needs. Initial clinical data are expected to read out in 2025," said Syed Kazmi, Chief Executive officer, Jubilant Therapeutics Inc. About JBI-802 JBI-802 is novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior compared to either target alone and with a favorable safety profile. JBI-802 is under evaluation in both hematological cancers such as acute myeloid leukemia, myelodysplastic syndrome and other myeloproliferative cancers as well as solid tumors, such as non-small cell lung cancer and small cell lung cancer. About JBI-778 JBI-778 is novel, oral, potent and brain penetrant inhibitor of PRMT5. JBI-778 targets the substrate site and stabilizes SAM bound to PRMT5, providing high biological selectivity and has shown a superior safety profile as seen in animals. Preclinical research has demonstrated significant activity in Tyrokinase-Inhibitor resistant cell lines, brain tumor and NSCLC. JBI-778 is under evaluation in solid tumors such as NSCLC, High Grade Glioma and Adenoid Cystic Carcinoma. About Jubilant Therapeutics Inc. Jubilant Therapeutics Inc. is a clinical stage biopharmaceutical company developing precision oral medicines with enhanced therapeutic index to address unmet medical needs in oncology and autoimmune diseases for genetically defined patients. Its advanced structure-based discovery engine, TIBEO (Therapeutic Index and Brain Exposure Optimization), has been validated through successful partnerships. The Company's clinical pipeline consists of a first-in-class dual CoREST modifier, JBI-802, currently in a Phase I/II clinical trial in multiple tumors and a novel brain-penetrant modulator of PRMT5, currently in Phase I clinical trial. Additional pre-clinical programs include brain penetrant and gut restrictive PDL1 inhibitors, as well as PAD4 inhibitors for oncology and inflammatory indications. The Company is headquartered in Pennsylvania and guided by globally renowned scientific advisors. For more information, please visit or follow us on Twitter @JubilantTx and LinkedIn. Logo: SOURCE Jubilant Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Clinical Result

25 Oct 2024

·www.biospace.com

Jubilant Therapeutics Inc. announces First Patient Dosing in Global Clinical Trials for JBI-802, a CoREST Inhibitor and JBI-778, a PRMT5 Inhibitor

JBI-802 is a first-in-class, orally administered, inhibitor of CoREST complex JBI-778 is a potential best-in-class, orally administered, brain penetrant inhibitor of PRMT5 MORRISVILLE, N.C. , Oct. 25, 2024 /PRNewswire/ -- Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced the dosing of first patients in global clinical trials involving two pipeline programs: Phase I/II clinical trial of JBI-802 in heme-oncology and Phase I clinical trial for JBI-778 in solid tumors. “We are excited to take this significant step forward in our mission to transform the lives of patients through the development of easy to administer precision oral medicines with enhanced safety and therapeutic efficacy,” said Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. JBI-802 is a first-in-class, orally administered, small-molecule dual inhibitor of LSD1 (Lysine-specific histone demethylase 1A) and HDAC6 (Histone deacetylase 6) within the CoREST (Co-repressor of Repressor Element-1 Silencing Transcription) complex. In the earlier Phase I study conducted in advanced solid tumor patients, JBI-802 showed a dose-proportional increase in exposure across cohorts and a strong correlation between exposure and the on-target effect of platelet decrease. There were no reports of Dysgeusia and Anemia, typical adverse events seen with LSD1only inhibitors. The Phase I trial also showed anti-tumor activity in Non-Small Cell Lung Cancer (NSCLC) patients including a confirmed partial response. Overall, the study results provided human proof-of-principle for expanding the development of JBI-802 in Essential Thrombocythemia and Myelodysplastic Syndrome/Myeloproliferative Neoplasms (MDS/MPN) with thrombocytosis. Essential Thrombocythemia is a chronic disease of excessive platelets with over 100,000 patients in the United States for whom the primary treatment is hydroxyurea, a therapy that poses severe limitations for patients in terms of both safety and efficacy. The second clinical trial is to assess both safety and the recommended Phase II dose for JBI-778, an oral brain-penetrant inhibitor of PRMT5 (Protein arginine N-methyltransferase 5) in mEGFR Tyrosine Kinase Inhibitor (TKI) resistant NSCLC, IDH+ high-grade glioma (HGG) and Adenoid Cystic Carcinoma (ACC). PRMT5, although a proven pathway for multiple cancers, has produced mixed results in terms of drug development due to safety concerns surrounding SAM competitive approach to PRMT5 inhibition and patient segment limitations of MTAP null tumor-focused approach PRMT5 inhibition. JBI-778 is a unique substrate competitive brain penetrant PRMT5 inhibitor that has shown no adverse effects in preclinical setting and can address both MTAP null and wild type tumors as well as brain tumors, catering to a larger patient segment including those with brain metastases. “The two most advanced novel drug candidates at Jubilant Therapeutics Inc. were discovered in-house using our TIBEO (Therapeutic Index and Brain Exposure Op timization) Discovery Engine. It is our unique approach of structure-based drug design to generate novel pharmacophores with improved therapeutic index compared to existing agents. We are excited to advance both JBI-802 and JBI-778 in genetically-defined subsets of patients with select hematological and solid tumor indications with high unmet medical needs. Initial clinical data are expected to read out in 2025,” said Syed Kazmi , Chief Executive officer, Jubilant Therapeutics Inc . About JBI-802 JBI-802 is novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior compared to either target alone and with a favorable safety profile. JBI-802 is under evaluation in both hematological cancers such as acute myeloid leukemia, myelodysplastic syndrome and other myeloproliferative cancers as well as solid tumors, such as non-small cell lung cancer and small cell lung cancer. About JBI-778 JBI-778 is novel, oral, potent and brain penetrant inhibitor of PRMT5. JBI-778 targets the substrate site and stabilizes SAM bound to PRMT5, providing high biological selectivity and has shown a superior safety pro seen in animals. Preclinical research has demonstrated significant activity in Tyrokinase-Inhibitor resistant cell lines, brain tumor and NSCLC. JBI-778 is under evaluation in solid tumors such as NSCLC, High Grade Glioma and Adenoid Cystic Carcinoma. About Jubilant Therapeutics Inc. Jubilant Therapeutics Inc. is a clinical stage biopharmaceutical company developing precision oral medicines with enhanced therapeutic index to address unmet medical needs in oncology and autoimmune diseases for genetically defined patients. Its advanced structure-based discovery engine, TIBEO (Therapeutic Index and Brain Exposure Optimization), has been validated through successful partnerships. The Company’s clinical pipeline consists of a first-in-class dual CoREST modifier, JBI-802, currently in a Phase I/II clinical trial in multiple tumors and a novel brain-penetrant modulator of PRMT5, currently in Phase I clinical trial. Additional pre-clinical programs include brain penetrant and gut restrictive PDL1 inhibitors, as well as PAD4 inhibitors for oncology and inflammatory indications. The Company is headquartered in Pennsylvania and guided by globally renowned scientific advisors. For more information, please visit or follow us on Twitter @JubilantTx and LinkedIn . Logo: View original content to download multimedia: SOURCE Jubilant Therapeutics Inc.

Phase 1Clinical Result

100 Deals associated with Jubilant Therapeutics, Inc.

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Drug(Targets)	Indications	Global Highest Phase

JBI-802 ( HDAC6 x KDM1A )	Locally Advanced Malignant Solid Neoplasm More	Phase 2 Clinical
JBI-778 ( PRMT5 )	EGFR Mutation Lung Cancer More	Phase 1
CK-103 ( BET x BRD4 )	Neoplasms More	IND Application
JBI-589 ( PAD4 )	Neoplasms More	Preclinical
JBI-1527 ( PDL1 )	Neoplasms More	Preclinical

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