A Phase 3, Open-Label, Randomized, Multinational Study to Investigate the Anti-tumor Efficacy of Golidocitinib versus Investigators Choice in Adult Patients with Relapsed/Refractory Peripheral T-cell Lymphoma

Start Date01 May 2025

Sponsor / Collaborator

Dizal (Jiangsu) Pharmaceutical Co., Ltd.

NCT06630091

/ RecruitingPhase 2

A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study

To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL.

Start Date21 Feb 2025

Sponsor / Collaborator-

NCT06855823

/ RecruitingPhase 1/2IIT

A Phase I/II, Open-Label Clinical Trial to Evaluate the Efficacy and Safety of Golidocitinib As Monotherapy or in Combination with Pomalidomide for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

This is a phase I/II clinical trial to evaluate the efficacy and safety of Golidocitinib combined with Pomalidomide for relapsed/refractory peripheral T-cell lymphoma.

Start Date14 Jan 2025

Sponsor / Collaborator

Sun Yat-Sen University

100 Clinical Results associated with Golidocitinib

100 Translational Medicine associated with Golidocitinib

100 Patents (Medical) associated with Golidocitinib

153

Literatures (Medical) associated with Golidocitinib

01 May 2025·CLINICAL IMMUNOLOGY

JAK inhibitor ameliorates inflammatory bowel disease in a patient with IKZF1 haploinsufficiency

Article

Author: Hoshino, Yuki ; Tagami, Yuji ; Moriya, Kunihiko ; Nambu, Ryusuke ; Nakazawa, Atsuko ; Inoue, Shota ; Kyushiki, Masashi ; Kojima, Ryo ; Kanegane, Hirokazu ; Imai, Kohsuke ; Isoda, Takeshi ; Ikai, Masaatsu ; Hoshino, Akihiro ; Ichimura, Kayoko

IKAROS, encoded by IKZF1, is a crucial transcription factor regulating hematopoiesis and B cell development. While IKZF1 haploinsufficiency variants are associated with various immunological disorders, inflammatory bowel disease (IBD) has been rarely reported. We report a case of IKZF1 haploinsufficiency presenting with an atypical IBD phenotype and its response to filgotinib. The patient was previously diagnosed with IKZF1 haploinsufficiency and presented with chronic diarrhea, fatigue and anemia. Laboratory findings indicated folate deficiency-induced megaloblastic anemia and malabsorption syndrome. Endoscopic examination showed inflammation with erythema in the colon and extensive villous blunting of the small intestine. Immunohistochemical analysis revealed increased pSTAT3/5 in the colon. Considering the clinical features and increased JAK-STAT cascade, treatment with filgotinib was initiated. At 10 weeks post-treatment, we observed improvement in endoscopic findings and suppression of pSTAT3/5. This case extends the clinical spectrum of IKZF1 haploinsufficiency. A JAK1 inhibitor is considered to be useful for IKZF1 haploinsufficiency-associated IBD.

08 Apr 2025·JCI Insight

Sequential JAK inhibition enhances antitumor immunity after combined anti–PD-1 and anti-CTLA4

Article

Author: Wolters, Rachel M ; Goodearl, Andrew ; Chen, PeiXi ; Arias-Badia, Marcel ; Ritacco, Wendy ; Srinath, Aahir ; Fan, Zenghua ; Gorman, Jacob V ; Setayesh, Ali ; Clark, Matthew ; Harding, Fiona A ; Fong, Lawrence ; Lwin, Yee May ; Kwek, Serena S ; Luong, Diamond N ; Lyu, Aram ; Sakamoto, Mason ; Lea, Averey

While immune checkpoint inhibition (CPI) has reshaped cancer treatment, the majority of patients with cancer do not benefit from this approach, which can also cause immune-related adverse events. Induction of IFN-γ responses is thought be necessary for antitumor immunity, but growing evidence also implicates IFN-γ as a tumor-intrinsic mediator of CPI resistance. CPI-induced IFN-γ mediates activation-induced cell death in T cells as an immune-intrinsic mechanism of resistance. In this study, we found that transient block of IFN-γ signaling through administration of the JAK1 inhibitor ABT-317 enhanced antitumor T cell responses with CPI in preclinical models. Importantly, sequential but not concomitant ABT-317 treatment led to significantly reduced toxicity and improved tumor efficacy. Sequential treatment reduced activation-induced T cell death and enhanced expansion of tumor-reactive T cell subsets with increased effector function in vivo and ex vivo. Only CPI in combination with ABT-317 also enhanced memory responses by protecting mice from tumor rechallenge. These results demonstrate that JAK inhibition within a discrete time window following CPI addresses an immune-intrinsic mechanism of therapeutic resistance.

01 Apr 2025·BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY

Filgotinib Improves Experimental Pulmonary Fibrosis by Modulating JAK1/STAT3/SOCS3/IL‐17A Signalling

Article

Author: Kong, Dexin ; Zhang, Guanghua ; Lv, Yunying ; Jiang, Wanglin

ABSTRACT:

Background:

Regulatory agencies in Europe and Japan have approved filgotinib, a selective JAK1 inhibitor, for use in treating rheumatoid arthritis, but its effect and mechanism of action in treating pulmonary fibrosis remain unclear.

Methods:

We performed an in vivo investigation in rats on filgotinib's effect on pulmonary fibrosis resulting from the intratracheal infusion of bleomycin (BLM). Then, we focused on the mechanisms by which filgotinib inhibits experimentally induced pulmonary fibrosis in vitro by determining its effect on TGF‐β1‐induced proliferation of mouse lung fibroblasts.

Results:

Continuous gavage of filgotinib at 20 mg/kg for 14 days elicited protective effects in the BLM‐induced rat experimental pulmonary fibrosis model, as reflected in changes in Hounsfield units as an indicator of overall pulmonary function and in the lung coefficient and lung microscopic pathology scores as indicators of gross pulmonary pathology. Protein expression levels of IL‐17A, phosphorylated tyrosine kinase (p‐JAK1), p‐STAT3 and cytokine signal transduction inhibitor 3 (SOCS3) were also changed. In in vitro studies, filgotinib at 1 μM reduced TGF‐β1‐induced fibroblast proliferation and produced lower levels of IL‐17A, p‐JAK1 and p‐STAT3, but higher SOCS3.

Conclusions:

Filgotinib appeared to alleviate experimental pulmonary fibrosis by reducing fibroblast proliferation via inhibition of the JAK1/STAT3/SOCS3/IL‐17A pathway.

News (Medical) associated with Golidocitinib

20 Mar 2025

·www.prnewswire.com

Dizal's Golidocitinib in Combination with Anti-PD-1 Shows Promise in IO Resistant Non-Small Cell Lung Cancer

Golidocitinib is a JAK1 only inhibitor approved for the treatment of relapsed or refractory PTCL The combination of golidocitinib and PD-1 antibody showed synergistic anti-tumor effects in anti-PD-1-resistant NSCLC SHANGHAI, March 20, 2025 /PRNewswire/ -- Dizal (SSE: 688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, today announced new findings on golidocitinib, a first-in-class Janus kinase 1 (JAK1) only inhibitor, in combination with PD-1 antibodies for patients who have progressed on anti-PD-1 therapy. The details of the trial design and clinical results will be presented at the 2025 European Lung Cancer Congress (ELCC 2025) in Paris, March 26-29. Recent studies showed that the dysregulated activation of the JAK/STAT pathway, which leads to the prolonged release of IFN-γ, is a significant contributor to the resistance to immune checkpoint inhibitors in cancer immunotherapy. Preclinical and clinical studies have demonstrated that the combination of JAK inhibitors with PD-1 immunotherapy can reverse or delay onset of immunotherapy resistance by modulating the JAK/STAT pathway in Hodgkin's lymphoma and NSCLC. Golidocitinib has shown excellent clinical benefits by effectively inhibiting the JAK/STAT pathway, leading to its approval for the treatment of relapsed/refractory peripheral T-cell lymphoma (r/r PTCL) in China. Preclinical studies also show that the combination of Golidocitinib and PD-1 antibody has synergistic potentials for anti-tumor effects. Building on these findings, an exploratory phase Ib clinical study combining golidocitinib with PD-1 antibodies was designed to explore the synergistic effects of this combined regimen in NSCLC patients who have failed from anti-PD-1 containing regimens. This study will enroll 30 locally advanced or metastatic NSCLC patients who have previously received anti-PD-1 monotherapy or anti-PD-1 therapy with platinum-containing chemotherapy regimens. "Immunotherapy alone or with chemotherapy is commonly used as front line treatment for NSCLC patients without driver mutations. Unfortunately, resistance is inevitable and once the disease progresses, the prognosis is poor and treatment option is limited." said Xiaolin Zhang, PhD, CEO of Dizal. "The findings we are presenting at ELCC 2025 highlight the potential for Golidocitinib-based combination regimen to delay or overcome the resistance. The preliminary results are very promising and justify further clinical validation." In addition to the golidocitinib-based combination therapy, positive results from a Phase II study of sunvozertinib in combination with Anlotinib will also be presented. Sunvozertinib combined with anlotinib was well tolerated and demonstrated encouraging antitumor activity in NSCLC patients with EGFR mutations who had failed prior EGFR-TKI therapies. As of December 25, 2024, the objective response rate (ORR) and the disease control rate (DCR) were 33.3% and 100%, respectively, in this heavily pre-treated patient population. Enrollment is ongoing and detailed results will be updated at the congress. Dizal presentation details during ELCC 2025 About golidocitinib (DZD4205) Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, mDoR reached 20.7 months. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) was published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) was published in The Lancet Oncology (Impact Factor: 54.4). About sunvozertinib (DZD9008) Sunvozertinib is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. In August 2023, sunvozertinib received approval from NMPA to treat advanced NSCLC with EGFR exon20ins after platinum-based chemotherapies. The approval is based on the results of WU-KONG6 study, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. In addition, sunvozertinib also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1 Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR exon20ins. Pre-clinical and clinical results of sunvozertinib were published in peer-reviewed journals Cancer Discovery and The Lancet Respiratory Medicine. About Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development, and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with two approved drugs and multiple assets in global pivotal studies. To learn more about Dizal, please visit , or follow us on Linkedin or Twitter. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect. Contacts Investor Relations: [email protected] Business Development: [email protected] Media Contact: [email protected] SOURCE Dizal Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyPhase 1Fast TrackDrug Approval

17 Mar 2025

·www.fiercebiotech.com

Incyte posts phase 3 skin condition wins but details disappoint, sinking stock

While Incyte called the data positive, investors were unconvinced and sent the biotech’s share price down.\n Incyte has delivered a pair of pivotal wins for an oral JAK inhibitor in an inflammatory skin condition. But with the placebo-adjusted response rate down on phase 2, the results drew unfavorable comparisons to rival data and triggered a 15% drop in the biotech’s share price. The JAK1 inhibitor, povorcitinib, could offer an oral alternative to biologics in multiple indications and, if approved, partly offset the loss of exclusivity of Incyte\'s JAKi Jakafi later this decade. Incyte took the candidate into phase 3 trials in the skin condition hidradenitis suppurativa (HS) after seeing (PDF) placebo-adjusted response rates of up to 27.7% in a mid-stage study. Asked by analysts at recent investor events, Incyte executives declined to name the number they were targeting in the phase 3 trials but did say they expected to see a profile that is consistent with the earlier trial. The primary endpoints looked at the number of patients who had a 50% or greater reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count. In the first study, around 40% of patients on both the low and high dose met the criteria, versus around 30% on placebo. The drug and placebo figures in the second trial were around 42% and 29%, respectively. Adjusted for placebo, the response rates at the low and high dose were 10.5% and 10.9%, respectively, in the first trial. The figure for both doses was 13.7% in the second trial. In the earlier phase 2 trial, Incyte reported placebo-adjusted results of 17.3% and 27.7%, respectively, at the low and high doses used in the pivotal studies. Incyte saw higher placebo-adjusted results in a predefined subgroup of phase 3 patients who previously took a biologic. The biotech also found more people on povorcitinib had a 75% or greater improvement, experienced a reduction in flares and reported a more than three-point improvement on a pain scale. The overall safety profile of povorcitinib was consistent with previous data, according to Incyte.While the biopharma called the data positive, investors were unconvinced and sent the biotech’s share price down around 15% to just $58 in early premarket trading. The drop may reflect unfavorable comparisons between the phase 3 data and both Incyte’s midphase results and the evidence on rival biologics. UCB won approval for Bimzelx in HS after linking the biologic to placebo-adjusted response rates of 19% and 20% after 16 weeks in two phase 3 trials. Novartis’ biologic Cosentyx is also approved in the indication. Povorcitinib has the advantage of oral administration but the data leave scope to question the size of the opportunity that will be open to the small molecule.

Clinical ResultPhase 3Phase 2Drug Approval

17 Mar 2025

·endpts.com

Incyte's stock sinks as pivotal skin disease data disappoint

Incyte’s topline pivotal data for its oral therapy for a painful inflammatory skin condition appear somewhat disappointing, with efficacy falling short of analysts’ expectations and in comparison with marketed drugs like UCB’s Bimzelx. The company’s shares $INCY fell about 10% on Monday morning. Incyte said Monday that the STOP-HS1 and STOP-HS2 studies of povorcitinib met their primary endpoints in patients with moderate-to-severe hidradenitis suppurativa (HS). After three months of treatment, significantly more patients given the JAK1 inhibitor than those given placebo had a reduction of at least 50% in the number of abscesses and inflammatory nodules, with no increase in abscess or draining tunnel count. This measure is known as HiSCR50. But the improvements over placebo were not as extensive as some had hoped. With the lower dose of povorcitinib — 45 mg once daily — the HiSCR50 delta was 10.5 percentage points in STOP-HS1 and 13.7 points in STOP-HS2. The differences versus placebo seen with the higher dose — 75 mg per day — were almost identical. That’s an odd finding, since a higher dose would be expected to work better. “We’ll have to wait for longer-term follow-up to see if there’s a separation of the 45 and 75 [mg doses],” Incyte head of R&D Pablo Cagnoni said during an analyst call to discuss the data. He added that Incyte plans to provide more data on this point later this year. Incyte also said the drug’s efficacy was better in patients who had previously been treated with biologics. Here the deltas over placebo were larger, but the p-value for the difference between the 45 mg dose and placebo in the HS-1 trial was 0.096, missing the generally accepted threshold for significance. William Blair analysts pointed out that the data came in well below the Phase 2 results, which showed placebo-adjusted HiSCR50 response rates of 18 to 28 percentage points. They added that even on an absolute basis, the Phase 3 HiSCR50 response rates for povorcitinib were markedly lesser than those seen in Phase 2. Incyte intends to wait for further data from the trial before seeking approval for the pill, and it’s aiming for an NDA submission at the end of this year or early next year. The Phase 3 data might be good enough for approval, with Incyte saying on the call that it believes regulators will greenlight povorcitinib for both biologic-naïve and -experienced patients. But doctors might have little reason to prescribe the pill when several approved injected drugs still look more effective. For example, in the pivotal HS trials for Bimzelx, the HiSCR50 delta was 19 to 26 percentage points. This was after four weeks of treatment, which is slightly longer than Incyte’s STOP-HS1 and STOP-HS2 trials, but the effect size is much greater. Another competitor is not far behind. There are high expectations for the pivotal data on MoonLake Immunotherapeutics’ antibody sonelokimab in HS. Those data should be revealed in the third quarter of this year.

Clinical ResultPhase 3Phase 2Immunotherapy

100 Deals associated with Golidocitinib

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Peripheral T-Cell Lymphoma	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	18 Jun 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
PD-L1 positive Non-Small Cell Lung Cancer	Phase 2	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	01 Jan 2024
T-cell lymphoma recurrent	Phase 2	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	31 May 2022
Mycosis Fungoides	Phase 2	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	23 Dec 2021
Sezary Syndrome	Phase 2	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	23 Dec 2021
EGFR-mutated non-small Cell Lung Cancer	Phase 2	Australia	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	16 Apr 2018
Crohn Disease	Preclinical	China	Dizal (Jiangsu) Pharmaceutical Co., Ltd.	-
Non-Small Cell Lung Cancer	Preclinical	United Kingdom	AstraZeneca PLC	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04105010 (JACKPOT8 Part B \| JACKPOT8, CTgov)	Phase 1/2	Peripheral T-Cell Lymphoma	171	AZD4205 (AZD4205 Group D)	bucgznclsj = yevszruowv hhychghhqe (jbiyeembsn, qttzexyjjm - kwrhfvuljc) View more	-	04 Apr 2025
NCT04105010 (JACKPOT8 Part B \| JACKPOT8, CTgov)	Phase 1/2	Peripheral T-Cell Lymphoma	171	AZD4205 (AZD4205 Group A)	ekfpaorpcz = gqpzvgtpsx thwkyxmjyr (jfkintegum, mvyousmfak - fellksgplh) View more	-	04 Apr 2025
NCT04105010 (JACKPOT8 Part B, Pubmed) Manual	Phase 2	Peripheral T-Cell Lymphoma Second line	104	Golidocitinib 150 mg	saoevsvofs(wzhkpinjtb) = neutrophil count decreased (30 [29%]), white blood cell count decreased (27 [26%]), lymphocyte count decreased (22 [21%]), and platelet count decreased (21 [20%]), which were clinically manageable and reversible. Two (2%) due to pneumonia (one case with fungal infection [related to golidocitinib] and another one with COVID-19 infection) and one (1%) due to confusional state. smbffihmxb (eiikkqhfma )	Positive	01 Jan 2024
CTR20213318 (JACKPOT26, ASH2023)	Phase 2	Peripheral T-Cell Lymphoma Maintenance	48	Golidocitinib 150 mg	pfnbmkgzyi(xlqdzursxx) = ybjefihkff qjtxvoicjt (snxuqwtqsr ) View more	-	11 Dec 2023
NCT04105010 (JACKPOT8, ASH2023) Manual	Phase 2	Peripheral T-Cell Lymphoma Second line	112	Golidocitinib 150 mg	zmtrhaxcmf(lkehkkxpgw) = qmadsicvbx dlfylgvbvo (bhhbvybhli, 33.7 - 55.3) View more	Positive	09 Dec 2023
NCT04105010 (JACKPOT8, ICML2023)	Phase 1/2	Peripheral T-Cell Lymphoma	104	Golidocitinib 150 mg	kifhtyhlxz(bfwjonkbxd) = onrgmvqine npshkqpnlq (mkcbqkzpqq ) View more	Positive	09 Jun 2023
NCT04105010 (JACKPOT8, ASCO 12023 \| ASCO 22023) Manual	Phase 2	Peripheral T-Cell Lymphoma	104	Golidocitinib	hxvoqoxqyg(hheoljflmh) = ymyiagcdff ezfwtuwdkl (gyvbpruehh ) View more	Positive	26 May 2023
NCT04105010 (ASCO2022) Manual	Phase 1/2	Peripheral T-Cell Lymphoma	51	GolidocitinibGolidocitinib 150 or 250 mg QD	wcysedpxry(myhejtoxkt) = ciixqlcdsn lxjocrlqvb (vwlmjnqjse ) View more	Positive	02 Jun 2022
NCT04105010 (EHA2022)	Phase 1/2	Peripheral T-Cell Lymphoma	51	Golidocitinib	eogijlayhv(hjdtgfompj) = rgskstpyge rzniiewkyc (smuzjgwybl ) View more	-	12 May 2022
NCT04105010 (JACKPOT8, ICML2021)	Phase 1/2	Peripheral T-Cell Lymphoma	47	DZD4205 150 mg	wmwggvuzur(qvmrvnhbik) = jbowrdkukb qqhvrruagx (liksswobyr ) View more	Positive	17 Jun 2021
NCT04105010 (JACKPOT8, ICML2021)	Phase 1/2	Peripheral T-Cell Lymphoma	47	DZD4205 250 mg	wmwggvuzur(qvmrvnhbik) = ykbpvcruzd qqhvrruagx (liksswobyr ) View more	Positive	17 Jun 2021

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