On May 17, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that topline and subgroup results from the ESLIM‑01 Phase III study of sovleplenib, as well as new and updated data related to novel investigational hematological malignancy therapies HMPL-306, HMPL-760 and tazemetostat, will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) ("EHA") Hybrid Congress, taking place on June 13-16, 2024 in Madrid, Spain and online (Press release, Hutchison China MediTech, MAY 17, 2024, View Source [SID1234643409]).

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ESLIM-01 is a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in adult patients with primary Immune Thrombocytopenia ("ITP") who have received at least one prior line of standard therapy (NCT05029635). In 188 patients randomized to receive oral sovleplenib or placebo, sovleplenib demonstrated a clinically meaningful early and sustained durable platelet response in patients with primary ITP with durable response rate of 48.4% compared to zero with placebo (p<0.0001). The median time to response was 1.1 weeks with sovleplenib. It demonstrated a tolerable safety profile with grade 3 or above treatment-emergent adverse events (TEAEs) in 25.4% of patients with sovleplenib and 24.2% with placebo. Sovleplenib also significantly improved quality of life in physical functioning and energy/fatigue (p<0.05).

Most patients were heavily pretreated with a median of four prior lines of ITP therapy and a majority (71.3%) of the patients had received prior TPO/TPO-RA[i] treatment. Further post-hoc subgroup analysis of the study demonstrated consistent clinical benefits across ITP patients regardless of prior lines of ITP therapies or prior TPO/TPO-RA exposure, regardless of TPO/TPO-RA treatment types and number of prior regimens.

In addition to the promising data in ITP, results from Phase II part of the ongoing ESLIM-02 Phase II/III study (NCT05535933) of sovleplenib for warm antibody autoimmune hemolytic anemia (wAIHA) will also be presented at the congress demonstrating encouraging hemoglobin (Hb) benefit compared with placebo, with overall response rate of 43.8% vs. 0% in the first 8 weeks, and overall response rate of 66.7% during the 24 weeks of sovleplenib treatment (including patients that crossed over from placebo). A favorable safety profile was also demonstrated.

Details of the presentations are as follows:

Abstract title Presenter / Lead author Presentation details
Efficacy and Safety of The Syk Inhibitor Sovleplenib (HMPL-523) in Adult Patients with Primary Immune Thrombocytopenia in China (ESLIM-01): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study Renchi Yang
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China #S316
Oral Presentation (Platelet disorders in the spotlight: Clinical and translational)
Friday, June 14, 2024
15:00 – 15:15 CEST, Hall Mallo
Sovleplenib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (wAIHA): Results from the Randomized, Double-Blind, Placebo-Controlled, Phase 2 Part of the Study Fengkui Zhang
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China #S297
Oral Presentation (Thalassemias and rare anemias)
Sunday, June 16, 2024
12:00 – 12:15 CEST, Hall Mallo
Sovleplenib In Primary Immune Thrombocytopenia (ITP) Patients by Prior Lines of Therapy: Subgroup Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (ESLIM-01) Xiaofan Liu
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China #P1629
Poster Session
Friday, June 14, 2024
Sovleplenib In Primary Immune Thrombocytopenia (ITP) Pts with Prior TPO/TPO-RA Treatment: Subgroup Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (ESLIM-01) Heng Mei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China #P1631
Poster Session
Friday, June 14, 2024
Safety and Efficacy of Syk Inhibitor Sovleplenib in Heavily Pre-Treated Hodgkin Lymphoma Patients Paolo Strati
The University of Texas MD Anderson Cancer Center, Houston, U.S. #P1102
Poster Session
Friday, June 14, 2024
HMPL-306 in Patients with Relapsed or Refractory Myeloid Hematological Malignancies Harboring IDH1 and/or IDH2 Mutations: Final Result of Dose Expansion in Phase 1 Study Xiaojun Huang
Peking University People’s Hospital, Beijing, China #P532
Poster Session
Friday, June 14, 2024
Phase 1 Study of HMPL-306 in Patients with Advanced Acute Myeloid Leukemia with Isocitrate Dehydrogenase (IDH) Mutations: Preliminary Results of the Dose Escalation Cohorts Pau Montesinos
Hospital Universitario La Fe, Valencia, Spain #P549
Poster Session
Friday, June 14, 2024
Phase II Study of EZH2 Inhibitor Tazemetostat plus Amdizalisib, a PI3K Inhibitor, in Patients with Relapsed/Refractory Lymphomas Mingci Cai
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China #P2080
e-Poster Presentation
Friday, June 14, 2024
Results from a Phase 1 Dose Escalation Study of HMPL-760, a Third Generation, Highly Selective, Reversible BTK Inhibitor in Chinese Patients with Relapsed/Refractory (R/R) Lymphomas Ying Qian
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China #P2054
e-Poster Presentation
Friday, June 14, 2024
A Phase 1b Study to Evaluate the Safety and Preliminary Efficacy of Sovleplenib, a Syk Inhibitor, in Adult Subjects with Immune Thrombocytopenia
Waleed Ghanima
University of Oslo, Oslo, Norway #PB3341
Publication Only

On May 17, 2024 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported its operational and financial results for the first quarter ended March 31, 2024 (Press release, Autolus, MAY 17, 2024, View Source [SID1234643422]).

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"We continue to engage with the FDA in the regulatory review process for obecabtagene autoleucel (obe-cel) in adult ALL as we head towards the PDUFA target action date of November 16, 2024, and are driving commercial readiness activities across the Company," said Dr. Christian Itin, Chief Executive Officer of Autolus. "We’re also delighted that our abstracts from the pivotal FELIX Phase 2 trial have been accepted for oral presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) this year and we look forward to sharing further long-term data and additional subset analyses."

"In addition, the first two patients have been enrolled into our dose confirmation trial (CARLYSLE) of obe-cel in Systemic Lupus Erythematosus (SLE) and the study is on track for initial data by end of 2024."

Key obe-cel updates and anticipated milestones:

Obe-cel in relapsed / refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL) – The FELIX Study
Obe-cel Biologics License Application (BLA) for r/r B-ALL submitted to the FDA in November 2023; PDUFA target action date of November 16, 2024. A marketing authorization application (MAA) to the European Medicines Agency (EMA) was accepted in April 2024. For the UK we are evaluating a filing based on an international recognition procedure.
Pooled analysis of the FELIX Phase 1b/2 study presented at ASH (Free ASH Whitepaper) in December 2023 demonstrated prolonged event free survival and low overall immunotoxicity across all cohorts in r/r B-ALL, and particularly in patients with low leukemic burden at lymphodepletion.
Further long-term data from the FELIX study including additional subset analysis will be presented in oral and poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (ASCO – May 31 – June 4, 2024), and European Hematology Association (EHA) (Free EHA Whitepaper) congress (EHA – June 13 – 16, 2024) respectively.
Obe-cel in B-cell mediated autoimmune diseases
The Phase 1 dose confirmation study (CARLYSLE) in refractory systemic lupus erythematosus (SLE) patients is ongoing. Two patients have been enrolled and Autolus continues to expect initial clinical data in late 2024.
Pipeline clinical trials, in collaboration with University College London (UCL), updates and anticipated milestones:

AUTO8 in Multiple Myeloma – Phase 1 MCARTY Study
AUTO8 is a next-generation product candidate for multiple myeloma, which includes two CARs for the multiple myeloma targets, BCMA and CD19. Initial data from the MCARTY Phase 1 study in multiple myeloma presented at ASH (Free ASH Whitepaper) in December 2023 showed AUTO8 was well tolerated, with responses observed in all patients. Enrollment of the initial cohorts are complete and further updates from the MCARTY study are anticipated in H2 2024.
AUTO6NG in Neuroblastoma – Phase 1 MAGNETO Study
AUTO6NG contains a CAR that targets GD2 alongside additional programming modules to enhance the activity and persistence. A Phase 1 clinical study in children with r/r neuroblastoma was opened for enrollment in the fourth quarter of 2023.
Strategic developments:

In February 2024, BioNTech and Autolus announced a strategic CAR T cell therapy collaboration to advance their pipelines and expand late-stage programs, for $50 million cash upfront and up to $582 million in potential option exercise and milestone payments. Additionally, Autolus sold $200 million of ADSs to BioNTech in a concurrent private placement financing transaction.
In February 2024, Autolus completed an underwritten offering in the United States at a price of $6.00 per ADS, for total gross proceeds of $350 million before underwriting fees and offering expenses.
Operational Updates:

In March 2024, The Nucleus manufacturing facility in Stevenage obtained a Manufacturer’s Importation Authorization (MIA), together with the accompanying GMP certificate. This authorization enables Autolus to manufacture products for global commercial and clinical supply at The Nucleus, effective as of March 18, 2024.
In April 2024, Autolus announced that the European Medicines Agency (EMA) had accepted its Marketing Authorization Application (MAA) for obe-cel for patients with relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL). The MAA submission was based on data from the pivotal Phase 2 FELIX study of obe-cel in adult r/r B-ALL.
In April 2024, Autolus entered into a distribution services agreement with a subsidiary of Cardinal Health to support the ordering and distribution of obe-cel in the United States, following the receipt of regulatory approval.
In April 2024, Autolus announced the appointment of Mike Bonney as Chairman of the Board, and Ravi Rao M.D., as Non-Executive Director. John H. Johnson advised the Board of his decision to step down from his role as Chairman of the Board and Non-Executive Director, effective April 1, 2024.
Scientific Publications:

In January 2024, Autolus announced the publication of a paper in ACS Chemical Biology entitled: ‘Designer small molecule control system based on Minocycline induced disruption of protein-protein interaction’ – Jha et al., ACS Chemical Biology (2024) doi:10.1021/acschembio.3c00521; [Link]
In February 2024, Autolus announced the publication of a paper in Nature Communications entitled: ‘Structure-Guided Engineering of Immunotherapies Targeting TRBC1 and TRBC2 in T Cell Malignancies’ – Ferrari et al., Nat Commun 15, 1583 (2024) doi:10.1038/s41467-024-45854-3; [Link]
In March 2024, Autolus announced the publication of a paper in Blood Cancer Journal entitled: ‘Dual T-cell constant β chain (TRBC)1 and TRBC2 staining for the identification of T-cell neoplasms by flow cytometry – Horna et al., Blood Cancer J. 14, 34 (2024) doi: 10.1038/s41408-024-01002-0; [Link]
2024 Expected News Flow:

Obe-cel FELIX data update at ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper) & ASH (Free ASH Whitepaper) May, June & Dec 2024
Obe-cel Marketing Authorization Application to MHRA Second half 2024
Obe-cel U.S. FDA PDUFA target action date November 16, 2024
Obe-cel in autoimmune disease – initial data from SLE Phase 1 study Late 2024

Financial Results (Unaudited) for the Quarter Ended March 31, 2024

Cash and cash equivalents at March 31, 2024, totaled $758.5 million, as compared to $239.6 million at December 31, 2023.

Total operating expenses, net for the three months ended March 31, 2024, were $38.8 million, as compared to $39.1 million, for the same period in 2023.

Research and development expenses increased from $27.4 million to $30.7 million for the three months ended March 31, 2024, compared to the same period in 2023. This change was primarily due to increases in operating costs related to the Company’s new commercial manufacturing facility, employee salaries and related costs, clinical trial costs related to obe-cel, and a decrease in our U.K. reimbursable R&D tax credits claimable through the U.K. small and medium-sized entity (SME) scheme. These were partially offset by decreases in professional consulting fees, legal fees, manufacturing costs related to obe-cel clinical supply, information technology infrastructure fees and general office expenses.

General and administrative expenses increased from $9.3 million to $18.2 million for the three months ended March 31, 2024, compared to the same period in 2023. This increase was primarily due to salaries and other employment-related costs driven by an increase in general and administrative headcount supporting the overall growth of the business, primarily relating to pre-commercialization activities.

Net loss was $52.7 million for the three months ended March 31, 2024, compared to $39.8 million for the same period in 2023. The basic and diluted net loss per ordinary share for the three months ended March 31, 2024, totaled $(0.24), compared to a basic and diluted net loss per ordinary share of $(0.23) for 2023.

Autolus estimates that, with its current cash and cash equivalents and proceeds received from the strategic alliance with BioNTech and the private placement and underwritten equity financing, it is well capitalized to drive the full launch and commercialization of obe-cel in r/r adult ALL as well as to advance its pipeline development plans, which includes providing runway to data in the first pivotal study of obe-cel in autoimmune disease.

Financial Results for the Quarter Ended March 31, 2024
Selected Unaudited Condensed Consolidated Balance Sheet Data
(In thousands)

March 31 December 31
2024 2023
Assets
Cash and cash equivalents $ 758,529 $ 239,566
Total current assets $ 804,298 $ 275,302
Total assets $ 901,436 $ 375,381
Liabilities and shareholders’ equity
Total current liabilities $ 43,985 $ 44,737
Total liabilities $ 319,406 $ 263,907
Total shareholders’ equity $ 582,030 $ 111,474

Selected Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss Data
(In thousands, except share and per share amounts)

Three Months Ended March 31,
2024 2023
License revenues $ 10,091 $ 1,292
Operating expenses:
Research and development (30,671 ) (27,388 )
General and administrative (18,177 ) (9,284 )
Loss on disposal of property and equipment - (3,768 )
Total operating expenses, net (38,757 ) (39,148 )
Total other expenses, net (13,941 ) (677 )
Net loss before income tax (52,698 ) (39,825 )
Income tax benefit 8 14
Net loss (52,690 ) (39,811 )
Other comprehensive income (loss):
Foreign currency exchange translation adjustment 58 5,641
Total comprehensive loss $ (52,632 ) $ (34,170 )

Basic and diluted net loss per ordinary share $ (0.24 ) $ (0.23 )
Weighted-average basic and diluted ordinary shares 222,170,707 173,825,825

Conference Call
Management will host a conference call and webcast at 08:30 am EDT/13:30 pm BST to discuss the Company’s financial results and provide a general business update. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call.

A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.

On May 17, 2024 Ono Pharmaceutical Co., Ltd. reported that it has received supplemental approvals for BRAFTOVI (generic name: encorafenib) Capsule ("BRAFTOVI"), a BRAF inhibitor, and MEKTOVI (generic name: binimetinib) Tablet ("MEKTOVI"), a MEK inhibitor, when used in combination, in Japan for the two new indications of "unresectable thyroid cancer with a BRAF mutation that has progressed following chemotherapy", and "unresectable anaplastic thyroid cancer with a BRAF mutation" (Press release, Ono, MAY 17, 2024, View Source [SID1234646254]).

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 These approvals are based on the results of a Phase 2 study (ONO-7702/7703-03), conducted in Japan in 22 patients with unresectable BRAFV600-mutant thyroid cancer, including 5 patients with anaplastic thyroid cancer. The study met its primary endpoint of objective response rate (ORR) as assessed by the Independent Central Review in the overall patient population, which was 54.5% (12/22 cases, 95% confidence interval: 32.2 – 75.6%) in the combination therapy of BRAFTOVI and MEKTOVI. The safety profile of the combination therapy of BRAFTOVI and MEKTOVI in the study was consistent with those previously reported in the clinical trials of BRAFTOVI and MEKTOVI.

About Phase 2 study (ONO-7702/7703-03)
 The study is a multi-centre, open-label, uncontrolled Phase 2 study (ONO-7702/7703-03), conducted in Japan, evaluating the efficacy and safety of the combination therapy of BRAFTOVI and MEKTOVI in patients with unresectable BRAFV600-mutant thyroid cancer. Patients received the combination therapy with BRAFTOVI 450 mg once daily, and MEKTOVI 45 mg twice daily, until it was determined that treatment could not be given due to disease progression or safety reasons. The primary endpoint of the study was objective response rate (ORR) as assessed by the Independent Central Review. Secondary endpoints include ORR as assessed by physician of each medical institutes, disease control rate (DCR), overall survival (OS) and progression-free survival (PFS).

About Thyroid Cancer
 Thyroid cancer (TC) is a malignant tumor that develops in the thyroid tissue located around the trachea or in front of the neck. Histologically, it is roughly divided into differentiated carcinoma (approximately 97% of TC), undifferentiated carcinoma (1 – 2%), and medullary carcinoma (1 – 2%). In Japan, it is estimated that approximately 18,700 new cases are diagnosed with TC per year with approximately 1,900 deaths per year resulting from the disease in 2023*. BRAF mutation is reported in 37 – 68% of TC patients.

Cancer Statics in Japan, 2024, The Editorial Board of Cancer Statistics, Foundation for Promotion of Cancer Research (FPCR), March 2024

Overview of BRAFTOVI Capsule 50 mg and 75 mg
Product Name BRAFTOVI Capsule 50 mg and 75 mg
Generic name (JAN) Encorafenib
Indication
Unresectable melanoma with a BRAF mutation
Unresectable advanced or recurrent colorectal cancer with a BRAF mutation that has progressed following chemotherapy
Unresectable thyroid cancer with a BRAF mutation that has progressed following chemotherapy
Unresectable anaplastic thyroid cancer with a BRAF mutation
Dosage and administration

In combination with binimetinib, usually, for adults, administer 450 mg of encorafenib orally once a day. According to patients’ condition, the dose should be reduced.

In combination with cetuximab (genetical recombination) or with binimetinib and cetuximab (genetical recombination), usually, for adults, administer 300 mg of encorafenib orally once a day. According to patients’ condition, the dose should be reduced.

Manufacturer/distributor Ono Pharmaceutical Co., Ltd.
Note: Underlined parts show the revised ones due to this approval.

Overview of MEKTOVI Tablet 15 mg
Product Name MEKTOVI Tablet 15 mg
Generic name (JAN) Binimetinib
Indication
Unresectable melanoma with a BRAF mutation
Unresectable advanced or recurrent colorectal cancer with a BRAF mutation that has progressed following chemotherapy
Unresectable thyroid cancer with a BRAF mutation that has progressed following chemotherapy
Unresectable anaplastic thyroid cancer with a BRAF mutation
Dosage and administration

In combination with encorafenib, usually, for adults, administer 45 mg of encorafenib orally twice a day. According to patients’ condition, the dose should be reduced.

In combination with encorafenib and cetuximab (genetical recombination), usually, for adults, administer 45 mg of binimetinib orally twice a day. According to patients’ condition, the dose should be reduced.

Manufacturer/distributor Ono Pharmaceutical Co., Ltd.
Note: Underlined parts show the revised ones due to this approval.

About BRAFTOVI and MEKTOVI
 BRAFTOVI is a small molecule BRAF kinase inhibitor and MEKTOVI is a small molecule MEK inhibitor. BRAF and MEK are important protein kinases in the MAPK signalling pathway (RAS-RAF-MEK-ERK), which regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many types of cancers including melanoma, colorectal cancer and thyroid cancer. Both BRAFTOVI and MEKTOVI target key enzymes in this pathway.
 In Japan, Ono received a manufacturing and marketing approval of BRAFTOVI and MEKTOVI for the treatment of unresectable melanoma with a BRAF mutation in combination therapy of the products in January 2019 and launched them in February 2019. Thereafter, Ono received additional approval in November 2020 for the treatment of unresectable advanced or recurrent colorectal cancer with a BRAF mutation that has progressed following chemotherapy, in triplet combination treatment of BRAFTOVI, MEKTOVI and cetuximab, an anti-human EGFR monoclonal antibody, as well as in doublet combination treatment of BRAFTOVI and cetuximab.
 Abroad, Array BioPharma Inc. (a wholly owned subsidiary of Pfizer Inc.) and its collaboration partner, Pierre Fabre, received an approval of BRAFTOVI and MEKTOVI for the treatment of unresectable or metastatic melanoma with BRAFV600E or V600K mutation and launched them in 2018 in the US and EU, respectively. Thereafter, the companies received supplemental approval for the treatment of metastatic colorectal cancer with a BRAFV600E mutation following prior therapy in the US and EU in 2020. Additionally, Pfizer received supplemental approval in the US for the treatment of metastatic non-small cell lung cancer with a BRAFV600E mutation in 2023.

About the Ono Pharmaceutical Co., Ltd. and Pfizer Inc. Collaboration
 In May 2017, Ono entered into the license agreement with Array BioPharma Inc. (became a subsidiary of Pfizer Inc. as of July 30, 2019) regarding BRAFTOVI (encorafenib), a BRAF inhibitor and MEKTOVI (binimetinib), a MEK inhibitor and received rights to develop and commercialize both products in Japan and South Korea.

On May 17, 2024 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, reported upcoming scientific presentations at the Gordon Research Conference on Chemotactic Cytokines and at EASL 2024, the Annual Congress of the European Association for the Study of the Liver (Press release, Chemomab, MAY 17, 2024, View Source [SID1234643423]).

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The presentations cover a range of topics, from new preclinical studies further elucidating the roles of the soluble protein target CCL24 and Chemomab’s CCL24 neutralizing antibody CM-101 in fibro-inflammatory disease, to novel translational research designed to support the ongoing clinical development of CM-101 for primary sclerosing cholangitis, a rare and often fatal fibrotic liver disease. The presentations will be made available and described in greater detail post embargo.

Gordon Research Conference: Chemotactic Cytokines – Portland, Maine, USA, June 2-7, 2024

Date: June 2-7, 2024
Format: Poster presentation: Attenuating liver fibrosis and inflammation: blocking CCL24 inhibits recruitment of hepatic stellate cells, monocytes and neutrophils and modulates hepatic stellate cell activation
Presenter: Prof. Amnon Peled, Hadassah University Hospital; Faculty of Medicine, Hebrew University
Information: 2024 Chemotactic Cytokines Conference GRC

EASL Congress 2024 – Milan, Italy, June 5-8, 2024

Date: June 6, 2024
Time: 8:30-18:00 CEST
Format: Poster presentation: Ex-vivo translational assay of hepatic stellate cells using patient-derived serum characterizes the anti-fibrotic activity of CM-101
Presenter: Revital Aricha, PhD, Vice President, Translational Science, Chemomab Therapeutics
Session: Poster – Fibrosis/Stellate cell biology, Abstract #380

Date: June 6, 2024
Time: 8:30-17:00 CEST
Format: Poster presentation: Machine learning-driven identification of serum protein signature for primary sclerosing cholangitis and enhanced liver fibrosis score
Presenter: Ilan Vaknin, PhD, Vice President, R&D, Chemomab Therapeutics
Session: Immune-mediated and cholestatic: Experimental and pathophysiology, Abstract #1032

Date: June 7, 2024
Time: 12:25-13:45 CEST
Format: Poster Tour: Ex-vivo translational assay of hepatic stellate cells using patient-derived serum characterizes the anti-fibrotic activity of CM-101
Presenter: Ilan Vaknin, PhD, Vice President, R&D, Chemomab Therapeutics
Session: Fibrosis/Stellate Cell Biology Poster Tour, Abstract #380
Location: Basic Science Track Hub
Information: EASL Congress 2024

In addition, Chemomab Corporate Development will be in San Diego June 3-6, 2024, participating in the BIO International Convention’s One-on-One Partnering event. Registered attendees can click here to log in and schedule a meeting with Chemomab.

On May 17, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that topline and subgroup results from the ESLIM-01 Phase III study of sovleplenib, as well as new and updated data related to novel investigational hematological malignancy therapies HMPL-306, HMPL-760 and tazemetostat, will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) ("EHA") Hybrid Congress, taking place on June 13-16, 2024 in Madrid, Spain and online (Press release, Hutchison China MediTech, MAY 17, 2024, View Source [SID1234643424]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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ESLIM-01 is a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in adult patients with primary Immune Thrombocytopenia ("ITP") who have received at least one prior line of standard therapy (NCT05029635). In 188 patients randomized to receive oral sovleplenib or placebo, sovleplenib demonstrated a clinically meaningful early and sustained durable platelet response in patients with primary ITP with durable response rate of 48.4% compared to zero with placebo (p<0.0001). The median time to response was 1.1 weeks with sovleplenib. It demonstrated a tolerable safety profile with grade 3 or above treatment-emergent adverse events (TEAEs) in 25.4% of patients with sovleplenib and 24.2% with placebo. Sovleplenib also significantly improved quality of life in physical functioning and energy/fatigue (p<0.05).

Most patients were heavily pretreated with a median of four prior lines of ITP therapy and a majority (71.3%) of the patients had received prior TPO/TPO-RA1 treatment. Further post-hoc subgroup analysis of the study demonstrated consistent clinical benefits across ITP patients regardless of prior lines of ITP therapies or prior TPO/TPO-RA exposure, regardless of TPO/TPO-RA treatment types and number of prior regimens.

In addition to the promising data in ITP, results from Phase II part of the ongoing ESLIM-02 Phase II/III study (NCT05535933) of sovleplenib for warm antibody autoimmune hemolytic anemia (wAIHA) will also be presented at the congress demonstrating encouraging hemoglobin (Hb) benefit compared with placebo, with overall response rate of 43.8% vs. 0% in the first 8 weeks, and overall response rate of 66.7% during the 24 weeks of sovleplenib treatment (including patients that crossed over from placebo). A favorable safety profile was also demonstrated.

Details of the presentations are as follows:

Abstract title

Presenter / Lead author

Presentation details

Efficacy and Safety of The Syk Inhibitor Sovleplenib (HMPL-523) in Adult Patients with Primary Immune Thrombocytopenia in China (ESLIM-01): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study

Renchi Yang

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China

#S316

Oral Presentation (Platelet disorders in the spotlight: Clinical and translational)

Friday, June 14, 2024

15:00 – 15:15 CEST, Hall Mallo

Sovleplenib for the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (wAIHA): Results from the Randomized, Double-Blind, Placebo-Controlled, Phase 2 Part of the Study

Fengkui Zhang

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China

#S297

Oral Presentation (Thalassemias and rare anemias)

Sunday, June 16, 2024

12:00 – 12:15 CEST, Hall Mallo

Sovleplenib In Primary Immune Thrombocytopenia (ITP) Patients by Prior Lines of Therapy: Subgroup Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (ESLIM-01)

Xiaofan Liu

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China

#P1629

Poster Session

Friday, June 14, 2024

Abstract title

Presenter / Lead author

Presentation details

Sovleplenib In Primary Immune Thrombocytopenia (ITP) Pts with Prior TPO/TPO-RA Treatment: Subgroup Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (ESLIM-01)

Heng Mei

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

#P1631

Poster Session

Friday, June 14, 2024

Safety and Efficacy of Syk Inhibitor Sovleplenib in Heavily Pre-Treated Hodgkin Lymphoma Patients

Paolo Strati

The University of Texas MD Anderson Cancer Center, Houston, U.S.

#P1102

Poster Session

Friday, June 14, 2024

HMPL-306 in Patients with Relapsed or Refractory Myeloid Hematological Malignancies Harboring IDH1 and/or IDH2 Mutations: Final Result of Dose Expansion in Phase 1 Study

Xiaojun Huang

Peking University People’s Hospital, Beijing, China

#P532

Poster Session

Friday, June 14, 2024

Phase 1 Study of HMPL-306 in Patients with Advanced Acute Myeloid Leukemia with Isocitrate Dehydrogenase (IDH) Mutations: Preliminary Results of the Dose Escalation Cohorts

Pau Montesinos

Hospital Universitario La Fe, Valencia, Spain

#P549

Poster Session

Friday, June 14, 2024

Phase II Study of EZH2 Inhibitor Tazemetostat plus Amdizalisib, a PI3K Inhibitor, in Patients with Relapsed/Refractory Lymphomas

Mingci Cai

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

#P2080

e-Poster Presentation

Friday, June 14, 2024

Results from a Phase 1 Dose Escalation Study of HMPL-760, a Third Generation, Highly Selective, Reversible BTK Inhibitor in Chinese Patients with Relapsed/Refractory (R/R) Lymphomas

Ying Qian

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

#P2054

e-Poster Presentation

Friday, June 14, 2024

A Phase 1b Study to Evaluate the Safety and Preliminary Efficacy of Sovleplenib, a Syk Inhibitor, in Adult Subjects with Immune Thrombocytopenia

Waleed Ghanima

University of Oslo, Oslo, Norway

#PB3341

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