On September 21, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, reported that a Phase I study of the best-in-class anti-CD24 antibody, ATG-031, has been approved by the Institutional Review Board (IRB) of The University of Texas MD Anderson Cancer Center in Houston, Texas, the United States (Press release, Antengene, SEP 21, 2023, View Source [SID1234635323]). This clinical study, codenamed the PERFORM trial and led by MD Anderson, will be conducted in patients with advanced solid tumors or B-NHL.

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The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding study of ATG-031 in patients with advanced solid tumors or B-NHL. The study’s primary objective is to evaluate the safety and tolerability of ATG-031 as a monotherapy, and determine the appropriate dose for Phase II studies. The secondary objective is to characterize the pharmacology, evaluate the immunogenicity, and assess the preliminary efficacy of ATG-031.

Dr. Amily Zhang, Antengene’s Chief Medical Officer said,"We are excited about the progress being made with ATG-031. We look forward to further characterizing the safety, tolerability, and preliminary efficacy of ATG-031. We will begin enrolling patients for the study as soon as possible and plan to release the first batch of preliminary data from the study in 2024."

"Through committed work and unrelenting innovation, our R&D organization successfully advanced the ATG-031 program to the clinical stage in just three years, an achievement that has truly made us proud," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "Based on the robust preclinical data of ATG-031, we are confident that the drug will continue to demonstrate its therapeutic potential in clinical studies. Moving forward, Antengene will press ahead the clinical development of its global rights programs with the aim of serving a broader population of patients."

About ATG-031

ATG-031 is a first-in-class humanized CD24 monoclonal antibody which inhibits the "don’t eat me" signal and enhances macrophage-mediated phagocytosis of cancer cells. Tumor cells evade the surveillance of the human immune system by over-expressing "don’t eat me" surface proteins that signal macrophages to prevent the detection and phagocytosis of cancer cells. CD24 (cluster of differentiation 24) is a prominent "don’t eat me" signal that plays a significant role in tumor immune evasion by suppressing macrophage-mediated phagocytosis. Compared to CD47, another well-known "don’t eat me" target, CD24 has a more restricted distribution in normal tissue and higher expression in cancerous tissue. In addition，unlike CD47，CD24 is not expressed on human red blood cells，allowing for a wider therapeutic window and minimal on-target-off-tumor toxicity as a CD24-targeted therapy.

As a novel innate immune checkpoint, CD24 orchestrates immune evasion through its interaction with the inhibitory receptor Siglec-10 (sialic-acid-binding Ig-like lectin 10) expresses on tumor-associated macrophages (TAMs). Preclinical data presented in 2023 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR 2023) demonstrated that ATG-031 can specifically bind to CD24 with nM affinity and block the interaction of CD24 and Siglec-10. Furthermore, ATG-31 induces efficient phagocytosis with a picomolar EC50 and stimulates the pro-inflammatory cytokines production by macrophages.

On September 21, 2023 Lynk Pharmaceuticals Co., Ltd. (hereinafter referred to as ‘Lynk Pharmaceuticals’), an innovative clinical stage company, reported the successful completion of Series C2 financing (Press release, Lynk Pharmaceuticals, SEP 21, 2023, View Source [SID1234635322]). This round of financing was jointly participated by the Shaoxing Binhai New Area Biomedical Industry Equity Investment Fund managed by China Grand Prosperity Investment, Haibang Venture and Howbuy Primary Fund, while original shareholders, New Alliance Capital and Lilly Asia Ventures (LAV), increased their investment. Following Series C1 financing on May 31, this new funding marks another step in the company’s continuous growth, bringing the total amount raised in the C-round to 322 million RMB. HaoYue Capital acted as the exclusive financial advisor in this transaction.

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Founded in 2018, Lynk Pharmaceuticals is a leading company dedicated to the research and development of FIC and BIC drugs targeting autoimmune diseases, inflammation, and oncology. Leveraging the core team’s extensive background in medicinal chemistry, biology, clinical development, and commercial development, and with an average of more than 20 years of experience in new drug research and development, Lynk Pharmaceuticals focuses on innovative and differentiated pipeline development. The core of the pipeline is centered around the development of second-generation highly selective and third-generation tissue-specific JAK inhibitors, while also exploring the potential of innovative target-based drug development.

Since its establishment, efficient execution has propelled Lynk Pharmaceuticals rapid development. In the past three months, the Phase II clinical trial data for LNK01001 in rheumatoid arthritis, atopic dermatitis, and ankylosing spondylitis have been successively released, with all results demonstrating significant therapeutic effects and a high level of safety. These results highlight the characteristics of small molecule JAK1 inhibitors, that have quick onset action and excellent efficacy. The company has submitted applications for the End of Phase II (EOP2)/Pre-Phase III meeting; several indications are poised to enter Phase III clinical trials, aiming to benefit more patients as soon as possible. Additionally, first patient dosing was achieved in a Phase 1b trial of LNK01004 in both psoriasis and atopic dermatitis in the first half of this year. The early clinical trial data fromLNK01002 and LNK01003 are also promising while the pre-clinical pipeline development is progressing steadily as well.

Lynk Pharmaceuticals innovative research and clinical development capabilities have been continuously validated and enhanced, positioning the company for a crucial stage of rapid value growth. According to Frost & Sullivan’s projections, the market size for JAK1 inhibitors is expected to reach $30.5 billion by 2030, underscoring the significant potential of the future market. Leveraging the considerable market demand in autoimmune diseases and oncology, the company holds substantial commercialization prospects.

Dr. Zhao-Kui (ZK) Wan, Chairman and CEO of Lynk Pharmaceuticals, said, "We are grateful for the support and trust from Shaoxing Binhai New Area Biomedical Industry Equity Investment Fund （managed by China Grand Prosperity Investment）, New Alliance Capital, Fenghua Venture, Howbuy Primary Fund and Lilly Asia Ventures (LAV) for this round of investment. We also thank Tailong Capital and Liando Investment, the series C1 round investment institutions. Together they have helped us successfully complete the C round of financing. As a company focused on the treatment of autoimmune diseases and oncology, Lynk Pharmaceuticals is committed to developing globally competitive FIC/BIC innovative drugs and delivering differentiated and innovative therapeutic solutions to patients worldwide. We are pleased to see that even amidst the current challenges in the biopharmaceutical capital landscape, Lynk Pharmaceuticals continues to gain support from both new and existing shareholders, demonstrating the capital market’s recognition of our team. During this rapid growing stage, we will need to consolidate resources from various aspects, further invest in clinical development, R&D teams, and technology platforms, aiming to provide safer and more effective innovative drugs to patients as early as possible. HaoYue Capital acted as the exclusive financial advisor for this financing, and we sincerely appreciate their professionalism and support."

Mr. Ding Yameng, Founding and Managing Partner and Chief Operating Officer of HaoYue Capital, said, "We are honored to continue assisting Lynk Pharmaceuticals in completing this round of financing. The field of autoimmune diseases is diverse and complex, with significant room for expanding indications and numerous unmet clinical needs, offering distinct opportunities for innovation. Lynk Pharmaceuticals has an internationally competitive and innovative pipeline that is continuously gaining market validation and recognition. We look forward to seeing breakthrough potentials in subsequent clinical validations of multiple highly differentiated candidates from Lynk. We believe that under the guidance of a highly capable and mission-driven team, Lynk Pharmaceuticals will steadily navigate through cycles, embrace the vast blue ocean markets, and provide better choices for patients soon."

On September 21, 2023 Dizal reported that the China National Medical Products Administration (NMPA) has granted priority review status to golidocitinib, Dizal’s investigational JAK1-only inhibitor, for the treatment of relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) (Press release, Dizal Pharma, SEP 21, 2023, View Source [SID1234635321]). In February 2022, golidocitinib received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the same indication, making it the first and only innovative drug in China to receive this recognition for PTCL.

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"Patients with relapsed or refractory PTCL worldwide face limited treatment options and a poor prognosis. We are pleased with the CDE’s decision to grant priority review status to golidocitinib, as it recognizes the potential of this groundbreaking drug to improve survival benefits for this underserved patient population. We are fully committed to expediting the NDA filing process and ensuring that golidocitinib becomes available to Chinese patients as quickly as possible." said Xiaolin Zhang, PhD, Chairman and CEO of Dizal.

Golidocitinib, a JAK1-only inhibitor, aimed to address the r/r PTCL dilemma

PTCL is an aggressive non-Hodgkin lymphoma (NHL) that represents approximately 7% to 10% of NHLs worldwide. Patients with r/r PTCL face a poor prognosis, with a 3-year survival rate ranging from 21% to 28%. Currently, there is no established consensus on the standard approach for treating r/r PTCL. Therefore, there is an urgent need for novel and innovative treatment options to improve survival in this patient population.

The Priority Review designation for golidocitinib’s application was supported by data from the JACKPOT8 PARTB study, a multinational, pivotal study to evaluate the efficacy and safety of golidocitinib in patients with r/r PTCL. The primary endpoint of the study, objective response rate (ORR) assessed by an independent review committee (IRC), reached 44.3%, with a complete response rate (CRR) of 23.9%. Anti-tumor efficacy was observed across different PTCL subtypes and irrespective of the patients’ prior treatment history. The majority of treatment-related adverse events (TRAEs) could be monitored and well managed in the clinic. These findings, highlighting the superior efficacy and safety of golidocitinib, have been widely acknowledged at prestigious conferences such as ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper), ICML, and ASH (Free ASH Whitepaper) with five oral presentations for four consecutive years. Recently, the Phase I clinical data of golidocitinib for the treatment of r/rPTCL (JACKPOT8 PARTA) was published in the esteemed peer-reviewed journal, Annals of Oncology (Impact Factor: 51.8).

Driving innovation through the fundamentals of translational science

Dizal, a spinoff of AstraZeneca’s oncology translational science center, has established a portfolio of five clinical-stage assets with global competitiveness. Among these, golidocitinib represents a major research achievement deeply rooted in the principles of translational science. Dizal was the first to identify and validate the JAK/STAT pathway as a highly promising therapeutic approach for PTCL, leading to the development of golidocitinib as the world’s first and currently the only JAK1-only inhibitor in pivotal trial for T cell lymphoma.

About golidocitinib (DZD4205)

Golidocitinib is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study (JACKPOT8 PARTB) in r/r PTCL. At the data cut-off date of February 16, 2023, Golidocitinib has demonstrated robust and durable anti-tumor activity, with an ORR of 44.3% and a CRR of 23.9%. More than 50% of the patients with tumor remission achieved a complete response. The median relative dose intensity was 100%. 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 the NDA and granted the Priority Review status for the treatment of r/r PTCL. And the Phase I clinical data of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PARTA) was published in Annals of Oncology (Impact Factor: 51.8).

On September 21, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the European Commission (EC) has granted marketing authorization for Enrylaze (JZP458; a recombinant Erwinia asparaginase or crisantaspase) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase (Press release, Jazz Pharmaceuticals, SEP 21, 2023, View Source [SID1234635320]). Enrylaze, approved as Rylaze in the United States and Canada, is a new Erwinia-derived asparaginase developed using a next-generation recombinant technology with a safety profile consistent with that of other asparaginase preparations.1,2,3,4,5

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"Asparaginase is a core component of multi-agent chemotherapeutic regimens for the treatment of ALL, however, up to 30% of patients develop hypersensitivity to E. coli-derived asparaginase, resulting in a delay or disruption in treatment," said Professor Carmelo Rizzari, Department of Pediatrics, University of Milano-Bicocca, Head of the Pediatric Hematology Oncology Unit, Foundation IRCCS San Gerardo dei Tintori, Monza, Italy. "The ability to complete a full course of asparaginase treatment is of critical importance when treating ALL and LBL, as it is strongly linked to improved outcomes for patients. The approval of Enrylaze now provides an important option to support patients in completing their planned asparaginase treatment regimen."

Enrylaze may be given by both intravenous infusion (IV) and intramuscular injection (IM) and is dosed on either alternate days (every 48 hours) or via a Monday/Wednesday/Friday (MWF) dosing schedule.1 The use of recombinant technology to manufacture Enrylaze delivers a scalable supply – able to meet global demand, and a ready-to-use solution that avoids the need for reconstitution in the clinic.2

"This approval is a testament to Jazz’s commitment to developing an Erwinia-derived asparaginase using innovative recombinant technology to deliver a scalable supply, and we look forward to making Enrylaze available to those who need it," said Robert Iannone, MD., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "Healthcare professionals in the European Union will now have access to a new, recombinant Erwinia-derived asparaginase with multiple dosing and administration options to address their patients’ individual needs, which allows them to complete their treatment program as prescribed."

The EC approval is based on data from a Phase 2/3 trial conducted in collaboration with the Children’s Oncology Group (COG) in a cohort of 228 pediatric and adult patients with ALL and LBL who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. The study was conducted in two parts to assess the IV and IM routes of administration.1,3 The determination of efficacy was based on demonstration of the achievement and maintenance of nadir serum asparaginase activity (NSAA) levels ≥ 0.1 U/mL.1

The study showed that for the IV administration of JZP458 (a recombinant Erwinia asparaginase or crisantaspase) (25/25/50 mg/m2 MWF), the proportion of patients maintaining NSAA ≥ 0.1 U/mL at 48 hours after a dose was 89.8% (95% CI: 82.1%, 97.5%) and 40% at 72 hours post-dose (95% CI: 26.4%, 53.6%). The IM administration of JZP458 (25/25/50 mg/m2 MWF) achieved sustained asparagine activity in 95.9% of patients at 48 hours after a dose (95% CI: 90.4%, 100.0%) and 89.8% of patients at 72 hours post-dose (95% CI: 81.3%, 98.3%). The other dosing schedules were based on interpolation from pharmacokinetic (PK) and response rates observed with the very similar investigated regimens.1

Overall, the safety profile of JZP458 was consistent with the reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy.1,3 The most common adverse reactions were anemia, vomiting, thrombocytopenia, neutropenia, nausea, febrile neutropenia, fatigue, pyrexia, decreased appetite, transaminase increased, abdominal pain, white blood cell count decreased, headache, diarrhea, and lymphocyte count decreased. The most frequent serious adverse reactions were febrile neutropenia, pyrexia, vomiting, sepsis, medicinal product hypersensitivity, nausea, and pancreatitis.1

The European Commission approval extends to all European Union Member States, as well as Iceland, Norway, and Liechtenstein.

For a full list of side effects and information on dosage and administration, contraindications, and other precautions when using Enrylaze, please refer to the Summary of Product Characteristics for further information.

About Enrylaze (JZP458) Enrylaze, also known as JZP458 and approved as Rylaze in the United States and Canada, is the only recombinant Erwinia asparaginase or crisantaspase that is derived from a Pseudomonas fluorescens expression platform.2,4,5 It is approved for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase products. JZP458 was approved by the U.S. Food and Drug Administration (FDA) in June 2021 for the treatment of this patient population and became commercially available in July of the same year in the U.S.4

About Study JZP458-201

The EC approval of Enrylaze is based on clinical data from the pivotal Phase 2/3 single-arm, open-label, multicenter, dose confirmation study evaluating 228 pediatric and adult patients with ALL or LBL who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginases and have not previously received Erwinia-derived asparaginase. The study was designed to assess the safety, tolerability, and efficacy of JZP458. The determination of efficacy was measured by serum asparaginase activity (SAA) levels. The Phase 2/3 study was conducted in two parts. The first part investigated the intramuscular (IM) route of administration, including a Monday-Wednesday-Friday dosing schedule. The second investigated the dose and schedule for the intravenous (IV) route of administration.1,3

About Acute Lymphoblastic Leukemia (ALL)
Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that can progress quickly if not treated.6,7 ALL is the most common childhood malignancy, accounting for 80% of leukemia diagnoses in children, compared to 20% of adults.8 Long-term survival rates for pediatric patients have improved significantly over the last few decades, which is in part a result of crafting effective combinations of multi-agent chemotherapeutics with an asparaginase backbone.9 The estimated overall incidence of ALL and lymphoblastic lymphoma (LBL) in Europe is 1.28 per 100,000.10 The number of ALL global cases in children was 59,100 in 2017.11

Asparaginase is a core component of multi-agent chemotherapeutic regimens in ALL,12 however, up to 30% of patients develop hypersensitivity to E. coli-derived asparaginase,13 necessitating treatment discontinuation or a switch to a non-E. coli-derived asparaginase preparation.14 Patients not receiving asparaginase due to hypersensitivities and those not receiving all prescribed doses have been shown to have poor outcomes.2,15

About Lymphoblastic Lymphoma (LBL)

Lymphoblastic Lymphoma (LBL) is a rare, fast-growing, aggressive subtype of non-Hodgkin’s lymphoma (NHL), which is very rare in adults and is most often seen in teenagers and young adults under the age of 35.16,17 LBL is a type of high-grade lymphoma – which means the lymphoma grows quickly with early spread to different parts of the body.17 LBL is the second most common type of NHL in childhood and adolescence, accounting for 25-35% of cases.

On September 21, 2023 Affimed N.V. (Nasdaq: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that its Chief Financial Officer, Angus Smith, will participate in a fireside chat at the Cantor Global Healthcare Conference 2023 on Thursday, September 28, 2023 at 1:15 p.m. Eastern Daylight Time / 19:15 Central European Time (Press release, Affimed, SEP 21, 2023, View Source [SID1234635318]).

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A live webcast of the presentation will be accessible on Affimed’s website at View Source A replay of the call will be archived on Affimed’s website for 30 days after the call.

For more information on the conference or to schedule a one-on-one meeting with Affimed’s management, please contact your Cantor representative or Alex Fudukidis via email at [email protected] or phone at +1 (917) 436-8102.