On June 7, 2023 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a private, clinical-stage oncology company dedicated to the discovery and development of novel biotherapeutics by targeting inhibitory receptors on myeloid cells, reported Phase 1 data for IO-202, a first-in-class humanized IgG1 monoclonal antibody targeting Leukocyte Immunoglobulin-Like Receptor B4 (LILRB4, also known as ILT3) (Press release, Immune-Onc Therapeutics, JUN 7, 2023, View Source [SID1234632571]). Data from the dose escalation part of the Phase 1 study evaluating patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) will be presented during a poster session at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting in Frankfurt, Germany on June 9, 2023.

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"AML is the most common form of acute leukemia in adults in the U.S. and is characterized by high rates of relapsed and refractory disease. Monocytic AML is especially in need of break-through medicine as it is often resistant to standard-of-care treatment. CMML is a rare leukemia overlap syndrome characterized by the accumulation of monocytes in the blood and bone marrow, with both myeloproliferative and myelodysplastic features," said IO-202 Phase 1 investigator, Courtney DiNardo, M.D., MSCE, associate professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, Houston, TX. "These results, showing strong safety and promising clinical activity as both monotherapy and in combination with a standard-of-care chemotherapy for monocytic AML and CMML, suggest that LILRB4 may be an important therapeutic target for hard-to-treat blood cancers."

"We are very encouraged with the efficacy data of IO-202 as a single agent and in combination with azacitidine in heavily pre-treated patients with R/R AML and CMML," said Paul Woodard, MD, chief medical officer of Immune-Onc. "Based on the data, we have developed a patient enrichment strategy for the ongoing dose expansion phase of the study to select AML patients who would most likely respond to IO-202. We are also pleased to receive the FDA Fast Track designation for IO-202 for the treatment of R/R CMML, which follows the R/R AML Fast Track designation received in 2022. We look forward to working closely with the FDA and trial investigators to accelerate the clinical development of IO-202 in hematologic malignancies."

The Phase 1 multicenter, open-label, dose escalation study of IO-202 assessed the safety and tolerability of IO-202 in successive cohorts of patients with R/R AML with monocytic differentiation and R/R CMML as its primary objective. Secondary and exploratory objectives included pharmacokinetics, immunogenicity, pharmacodynamic (PD) biomarker effects, and clinical response rate of IO-202 as a monotherapy and in combination with azacitidine (AZA).

Treatment with IO-202 was well tolerated. There were no dose-limiting toxicities observed and a maximum tolerated dose was not reached. In the monotherapy treatment cohorts, one CMML patient demonstrated clinical benefit for more than one year and one AML patient achieved a partial response (PR). In combination therapy cohorts, Complete Remission (CR) has been achieved and is on-going for over 10 months in an AML patient with high LILRB4 expression. Additionally, 3 out of 5 CMML patients achieved clinical benefit including Optimal Marrow Response.

Based on the promising results of the dose escalation part of the study and utilizing a biomarker driven patient selection strategy, the Company has opened dose expansion cohorts to enroll AML patients with monocytic differentiations and high LILRB4, and CMML patients (IO-202-CL-001; NCT04372433).

Poster presentation details are as follows:

Abstract Number: P536
Title: A first-in-human Phase 1 study of IO-202 (anti-LILRB4 mAb) in Acute Myeloid Leukemia (AML) with monocytic differentiations and Chronic Myelomonocytic Leukemia (CMML) patients.
Presenter: Courtney DiNardo, M.D., MSCE, Associate Professor, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, Houston, TX
Session Title: Acute myeloid leukemia – Clinical
Session Date and Time: Friday, June 9, 6:00 p.m. – 7:00 p.m. CEST

Abstracts and full session details can be accessed through the EHA (Free EHA Whitepaper) Online Program Planner

ABOUT IO-202

IO-202 is a humanized IgG1 monoclonal antibody (mAb) with high affinity and specificity towards LILRB4 (also known as ILT3). It blocks the interaction of LILRB4 with multiple ligands, including ApoE and Fibronectin, and has broad potential in blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 causes depletion of cells expressing high LILRB4 through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of blood cancer cells. In the context of solid tumors, preclinical data presented at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrate that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in an immune competent model in vivo.

IO-202 has two ongoing clinical studies in the U.S.: The Phase 1 trial is currently enrolling expansion cohorts of patients with monocytic (LILRB4 high) acute myeloid leukemia (AML) or chronic myelomonocytic leukemia (CMML) in combination with standard-of-care agents such as azacitidine +/- venetoclax (NCT04372433). The U.S. Food and Drug Administration granted IO-202 Orphan Drug designation for treatment of AML in 2020, as well as Fast Track designations for relapsed or refractory AML in 2022 and relapsed or refractory CMML in 2023. The second Phase 1 trial of IO-202 is currently enrolling patients with advanced solid tumors to evaluate IO-202 as a monotherapy and in combination with an anti-PD-1 (NCT05309187).

On June 7, 2023 Dizal (688192.SH ) reported compelling data of its robust oncology portfolio at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2023, in Chicago (Press release, Dizal Pharma, JUN 7, 2023, View Source [SID1234632570]). Highlights include new or updated findings from Dizal’s leading assets sunvozertinib (a selective EGFR TKI targeting a wide spectrum of EGFR mutations) and golidocitinib (a JAK1 only inhibitor), which have demonstrated superior efficacy in treating advanced non-small cell lung cancer (NSCLC) and relapsed and refractory peripheral T-cell lymphoma (r/r PTCL), respectively.

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Sunvozertinib cemented "Best-in-Class" position for NSCLC patients with EGFR Exon20ins mutations

NSCLC patients with EGFR Exon20 insertion (Exon20ins) mutations have worse clinical outcomes due to the absence of effective targeted therapies. Sunvozertinib is a rationally designed, orally available, best-in-class tyrosine kinase inhibitor (TKI) that specifically targets these mutations. Its new drug application (NDA) has been accepted by the China National Medical Products Administration (NMPA) and granted priority review for the treatment of advanced NSCLC with EGFR Exon20ins mutations following platinum-based chemotherapies.

With longer follow-up, sunvozertinib showed an unprecedented ORR of 60.8% in the second-line setting and beyond

Updated results of WU-KONG6, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR Exon20ins mutations, were presented in an oral session. With longer follow-up, patients treated with sunvozertinib achieved a confirmed objective response rate (cORR) of 60.8% assessed by independent review committee (IRC). Anti-tumor efficacy was observed across a broad range of EGFR Exon20ins subtypes, and tumor response was also observed in patients with pretreated and stable brain metastasis.

Commenting on the findings, Prof. Mengzhao Wang, MD, PhD at Peking Union Medical College Hospital, the leading principal investigator of WU-KONG6, said, "Currently, only two new drugs have been approved in the US for≥2L treatment of EGFR Exon20ins NSCLC. However, their efficacy, particularly in terms of ORR, is significantly inferior to that of EGFR TKIs for EGFR sensitizing mutations. Nevertheless, WU-KONG6 study revealed that sunvozertinib had an impressive increase in ORR, reaching 60.8% in the ≥ second-line treatment of EGFR Exon20ins NSCLC. Additionally, sunvozertinib also demonstrated a high ORR regardless of mutation subtypes and insertion locations, as well as in patients with pre-treated and stable brain metastasis. These findings provide promising evidence for the treatment of EGFR Exon20ins NSCLC, and we are optimistic about sunvozertinib’s potential in a broader realm of NSCLC."

Sunvozertinib showed the "Best-in-Class" potential with an ORR of 77.8% in the first-line setting

According to the pooled analysis from WU-KONG1 part A and WU-KONG15, sunvozertinib monotherapy demonstrated significant efficacy in the treatment-naive EGFR Exon20ins NSCLC patients, achieving a best objective response rate (BOR) of 77.8% in the 300 mg cohort.

"EGFR Exon20ins is a primary resistant mutation, and there are currently no effective targeted therapies available for the first-line treatment. However, sunvozertinib demonstrated impressive efficacy in the ≥ second-line treatment of EGFR Exon20ins NSCLC, indicating its potential to become a superior therapeutic option in this area. Additional research is warranted to further explore its potential in the frontline." said Prof. Yan Xu, MD, PhD at Peking Union Medical College Hospital, the principal investigator of WU-KONG15, "The ASCO (Free ASCO Whitepaper) data revealed that sunvozertinib had an ORR of 77.8% in treatment-naive patients at the recommended Phase 2 dose (RP2D) of 300mg QD, exceeding the ORR of 71.2% observed with gefitinib in the IPASS study for treatment-naive patients with EGFR sensitizing mutations. A global multicenter, randomized phase III study (WU-KONG28) is ongoing to evaluate the efficacy and safety of sunvozertinib as a first-line treatment for NSCLC with EGFR Exon20ins mutations as compared to platinum-based doublet chemotherapy. We look forward to additional data readouts to strengthen the position of sunvozertinib in the EGFR Exon20ins domain."

In addition to expressive antitumor efficacies, sunvozertinib continues showing favorable overall safety profile, similar to other EGFR-TKIs. With its superior efficacy and manageable safety profile, sunvozertinib is poised to become a robust player in the realm of EGFR Exon20ins mutations.

Sunvozertinib showed encouraging anti-tumor efficacy in advanced NSCLC patients after failure of EGFR TKI treatment

While EGFR-targeted therapy can provide a durable survival benefit to NSCLC patients with EGFR mutations, resistance invariably emerges to current generation EGFR inhibitors.

Findings of the pooled analysis from WU-KONG1 Part A, WU-KONG2 and WU-KONG15 revealed that sunvozertinib exhibited encouraging anti-tumor efficacy in NSCLC patients with common EGFR mutations who failed standard EGFR TKI treatment.

A total of 37 heavily pretreated (median 5 lines of prior treatment) patients were treated with sunvozertinib, among whom 70.3% had previously received third-generation EGFR TKI, 91.9% received chemotherapy and 40.5% had baseline brain metastasis. At the data cut-off date of April 3, 2023, the median progression-free survival (mPFS) was 5.8 months, and the median duration of response (mDoR) was 6.5 months. And the safety profile was consistent with previous reports.

"Preclinical studies revealed that sunvozertinib showed potent antitumor activity against EGFR Exon20ins as well as EGFR sensitizing, T790M and uncommon mutations. It is worth noting that in patients with EGFR sensitizing mutations who had failed multiple lines of treatment, sunvozertinib monotherapy achieved a mPFS of 5.8 months, which is comparable to the efficacy of second-line chemotherapy." said Prof. James Chih-Hsin Yang, MD, PhD at National Taiwan University Hospital and National Taiwan University Cancer Center, the leading principal investigator of WU-KONG1, "According to the retrospective studies, re-challenge with EGFR TKIs may be a viable approach. In other words, re-administering EGFR TKIs after chemotherapy may help to overcome resistance that developed during previous EGFR TKI treatment. As chemotherapy and EGFR TKI may target different cell populations, switching to a different EGFR TKI could expand the treatment options for patients who are resistant to existing therapies. Further investigation is warranted to explore the potential of sunvozertinib in this area."

WU-KONG studies refer to clinical trials with sunvozertinib being conducted both as monotherapy and as combination therapy in NSCLC including WU-KONG1, WU-KONG2, WU-KONG6, WU-KONG15, WU-KONG21, and WU-KONG28 etc.

Golidocitinib yielded promising tumor responses in r/r PTCL

Relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) is an aggressive non-Hodgkin lymphoma with a five-year survival rate of less than 30%. Currently there is no consensus on the standard treatment for r/r PTCL. New innovative treatment strategies are needed to improve survival in this patient population.

Dizal identified that JAK/STAT may mediate the pathogenesis of PTCL and launched clinical studies of golidocitinib to test the hypothesis. Golidocitinib is the First-in-Class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a multinational, pivotal study in r/r PTCL (JACKPOT8 Part B). Consistent with earlier data, golidocitinib demonstrated potent and durable anti-tumor efficacy in the pivotal study, with the presentation of clinical data delivered orally at 2023 ASCO (Free ASCO Whitepaper).

A total of 112 r/r PTCL patients were included in the analysis. IRC assessed ORR was 44.3% in 88 patients with PTCL including 21 complete responses (CRR, 23.9%). Anti-tumor efficacy was observed across different PTCL subtypes. The mDoR has not been reached. The longest DoR was 16.8 months, and the patient is still responding.

The safety profile of golidocitinib was benign. The majority of treatment-related adverse events (TRAEs) were hematological in nature and amenable to monitoring and management in the clinical setting. The median relative dose intensity was 100%, and the longest treatment duration was 18 months.

"Patients with r/r PTCL have limited treatment options and a poor prognosis. Golidocitinib has demonstrated superior efficacy compared to current treatment options for r/r PTCL, with an ORR of 44.3% and a complete response rate of 23.9%. These findings validate earlier research results and suggest golidocitinib as a potential therapeutic option to improve patients’ survival outcomes." said Qingqing Cai, MD, PhD at Sun Yat-sen University Cancer Center, the principal investigator of JACKPOT8, "Moreover, the favorable safety profile of golidocitinib suggests that highly selective JAK1 inhibitors may address the limitations of non-selective inhibition of JAK/STAT signaling pathway, thus offering a novel and effective targeted approach for treating PTCL."

Golidocitinib was granted Fast Track Designation by the US FDA in 2022. With promising efficacy and favorable safety profile, golidocitinib could be an innovative approach for this difficult-to-treat disease.

"The data presented at 2023 ASCO (Free ASCO Whitepaper) demonstrated the differentiation of our pipeline." said Xiaolin Zhang, PhD, Chairman and CEO of Dizal, "At Dizal, our focus is on advancing scientific research and development to deliver innovative drugs that can effectively address unmet medical needs and improve patient outcomes worldwide."

About sunvozertinib (DZD9008)

Sunvozertinib was designed with the goal to address the limitations of existing NSCLC therapies. It is a rationally designed, irreversible EGFR inhibitor targeting various EGFR mutations with wild-type EGFR selectivity. The first pivotal study WU-KONG6 of sunvozertinib has achieved its primary objective, demonstrating superior anti-tumor efficacy in pretreated NSCLC patients with EGFR Exon20ins. In January 2023, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) granted priority review status to sunvozertinib and accepted the New Drug Application (NDA) for sunvozertinib for the treatment of advanced NSCLC with EGFR Exon20ins mutations after platinum-based chemotherapies. The confirmed objective response rate (cORR) at 300 mg was 60.8% assessed by IRC (Data cut-off date: October 17, 2022). Anti-tumor efficacy was observed across a broad range of EGFR Exon20ins subtypes, and in patients with pretreated and stable brain metastasis. 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 mutations.

Sunvozertinib showed a well-tolerated and manageable safety profile in the clinic. Two multinational pivotal studies are ongoing in ≥ 2nd line (WU-KONG1) and 1st line setting (WU-KONG28), respectively, in NSCLC patients with EGFR Exon20ins mutations.

Pre-clinical and Phase 1 clinical results of sunvozertinib were published in peer-reviewed journal Cancer Discovery (IF:39.397) in April 2022. The China NMPA has accepted NDA filing and granted priority review for sunvozertinib for the treatment of advanced NSCLC with EGFR Exon20ins mutations after platinum-based chemotherapy.

About Golidocitinib (DZD4205)

Golidocitinib is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study in r/r PTCL. At the data cut-off date of February 16, 2023, Golidocitinib has demonstrated strong and durable anti-tumor activity, with an ORR of 44.3%. Over 50% of the patients with tumor remission achieved complete response. The longest duration of response (DoR) exceeded 16 months. Golidocitinib was granted Fast Track Designation for the treatment of r/r PTCL by US FDA in February 2022.

On June 7, 2023 Hopewell Therapeutics, a biotechnology company with a differentiated lipid nanoparticle platform harnessing unique ionizable lipid chemistry, reported a Seed Financing of up to $25 million to support its operations and growth (Press release, Hopewell Therapeutics, JUN 7, 2023, View Source [SID1234632569]). These funds will enable the Company to advance the development of genomic medicines based on its differentiated ttLNP platform through both internal pipeline programs and external partnerships.

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The Seed Financing has been supported by scientific focused venture investors including Mass Ave Capital, 5Y Capital, HIKE Capital, BOPU Capital, IMO Capital and WS Investments. The Seed Financing has been conducted across multiple tranches, with a majority of funds received by the Company to date in addition to further commitments from existing investors. The Company established operations in 2021 with Scientific Founder Qiaobing Xu, Ph.D., Professor of Biomedical Engineering at Tufts University and Chief Technology Officer at Hopewell, and is led by Louis Brenner, M.D., an experienced biotech industry executive, who serves as the Company’s President and Chief Executive Officer. Hopewell holds exclusive licenses to its ttLNP intellectual property estate from Tufts University for use in a broad field of clinical and commercial applications and has established multiple research relationships with leading industry partners.

"Hopewell Therapeutics seeks to redefine the non-viral delivery space for novel genomic medicines by designing systemically-administered LNPs to specifically target extrahepatic tissues and cells throughout the body. The groundbreaking research and intellectual property in LNP design and delivery established by Professor Xu over the last decade provide a solid foundation for Hopewell to develop our own internal pipeline, initially targeting diseases of the lung, while concurrently exploring the potential of our ttLNP platform for patients with unmet needs in oncology, infectious diseases, rare genetic diseases, and neurological disorders," said Dr. Brenner. "We will also continue to pursue industry partnerships that leverage the full potential of our unique ttLNP platform technology."

"I am delighted with the support we have received from our scientific venture investors who recognize the promising data demonstrating the ability of our ttLNPs to overcome the limitations of existing LNP approaches, including allowing for highly targeted systemic delivery and sustained expression with repeat dosing," said Professor Xu. "I began designing novel LNPs for genetic drug delivery during my post-doctoral work in the laboratory of Professor Robert Langer at MIT and carried it forward as I built my own research group at Tufts. We continue to innovate and expand our ttLNP platform, as we develop LNPs with the potential to bring next generation genomic medicines to patients with high unmet medical needs."

"It has been gratifying to support the establishment and evolution of Hopewell including the coming together of foundational IP, high impact scientific publications, Company-generated data, strategic investment and experienced management, all catalyzed by the Seed Financing. Hopewell’s ttLNP platform and robust portfolio of ionizable lipids have the potential to change the treatment paradigms of multiple diseases," said Howie Rosen, Chairman of the Board of Hopewell Therapeutics.

Technology Platform

Through a decade of peer-reviewed publications, Hopewell’s ttLNPs have been shown to deliver a variety of high impact genomic cargoes, including mRNA, siRNA, DNA, gene editing and gene-writing apparatus, to organs, tissues, and cells throughout the body, with the potential to impact multiple areas of medicine. The Company is developing its proprietary chemistry to create ionizable lipids that can overcome the drug delivery limitations of current LNP approaches in terms of organ and tissue targeting, biocompatibility, and sustained expression with repeat dosing.

Research conducted by Hopewell and industry partners in progressive animal models, including non-human primates (NHP), have demonstrated high translatability for systemic delivery to targeted tissues across species. Hopewell intends to focus its initial internal pipeline efforts on developing therapeutics for diseases of the lung, having recently demonstrated high transfection efficiency for systemic delivery to multiple epithelial cell types in the lung alveoli in multiple species. Furthermore, results from multiple studies of systemic delivery of Hopewell’s LNPs have shown first-ever high transfection of genetic cargoes in the basal epithelial cells of the lung and trachea. Reaching these pulmonary progenitor cells with genomic medicines may unlock the potential to treat a variety of challenging lung diseases.

In addition to its pulmonary programs, Hopewell’s LNPs have shown promise in multiple pre-clinical disease models. Its lymphoid organ-specific LNPs exploit a scientifically validated strategy for developing the next generation mRNA vaccines for cancer immunotherapy. Early preclinical data has demonstrated the LNP-mRNA elicited robust CD8+ T-cell responses to encoded antigens, exhibiting notable protective and therapeutic effects in cancer models. Recent NHP experiments with our LNP-mRNA encoded Bispecific T-cell Engager (BiTE) have demonstrated dose-dependent protein expression and long-lasting and deep B-cell depletion effects, suggesting alternative approaches to injectable antibodies and CAR-T cell therapy to treat B-cell malignancies and autoimmune diseases. Hopewell’s ttLNPs have also been used to deliver multiple therapeutic cargo types including mRNA, oligonucleotides, proteins, and small molecules to the central nervous system via both systemic and local delivery.

On June 7, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s chief executive officer and president, will participate in a fireside at the upcoming Goldman Sachs 44th Annual Global Healthcare Conference on Monday, June 12, 2023, at 3:20 p.m. PT (Press release, Ultragenyx Pharmaceutical, JUN 7, 2023, View Source [SID1234632567]).

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The live and archived webcast of the panel will be accessible from the company’s website at View Source

On June 7, 2023 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that management will participate in a fireside chat at the Goldman Sachs 44th Annual Global Healthcare Conference in Dana Point, CA on Monday, June 12, 2023 beginning at 11:20 a.m. PT / 2:20 p.m. ET (Press release, SpringWorks Therapeutics, JUN 7, 2023, View Source [SID1234632566]).

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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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To access the live webcast, please visit the Events & Presentations page within the Investors & Media section of the company’s website at View Source A replay of the webcast will be available on SpringWorks’ website for a limited time following the conference.