On September 21, 2023 Leucid Bio ("Leucid" or the "Company"), a privately-held biotechnology company pursuing the development of innovative Chimeric Antigen Receptor T-cell (CAR-T) therapies using the Company’s proprietary Lateral CAR platform, reported that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted clinical trial authorisation (CTA) to commence the Phase 1/2 AERIAL clinical trial evaluating the safety and tolerability of LEU011 for the treatment of adults with relapsed or refractory solid tumours (Press release, Leucid Bio, SEP 21, 2023, View Source [SID1234635326]).

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In September 2022, LEU011 received the innovative medicine designation, the Innovation Passport, as part of the Innovative Licensing and Access Pathway (ILAP) from the MHRA for the treatment of solid tumours expressing NKG2D ligands. Established in 2021, ILAP is a pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.

"The MHRA’s authorisation and the ILAP designation for LEU011 highlight the strong potential of our proprietary lateral CAR T candidate LEU011 for the treatment of solid tumours," commented Filippo Petti, Chief Executive Officer, Leucid Bio. "The development of LEU011 demonstrates our commitment to pushing the boundaries in cell therapy research and underpins our dedicated focus on pursuing novel, durable therapies for cancer patients with limited treatment options."

Dr. John Maher, Chief Scientific Officer, Leucid Bio, stated, "The design of the AERIAL trial, which was inspired by our exciting preclinical data for LEU011, is aimed at assessing the broad potential of the innovative cell therapy across several solid tumours expressing NKG2D ligands. We look forward to initiating the AERIAL study over the next few months and providing preliminary first-in-human data for LEU011 in 2024."

About LEU011 and AERIAL Trial

LEU011 is an autologous, lateral CAR T cell therapy targeting NKG2D ligands. The NKG2D receptor enables immune recognition of one or more of the eight human NKG2D ligands expressed on transformed, infected or damaged cells. LEU011 has the potential for the treatment of multiple cancer indications as NKG2D ligands are reported to be expressed on more than 80% of human tumours.

The Phase 1/2 AERIAL trial will evaluate the safety and clinical activity of LEU011 in patients with relapsed or refractory solid tumours following preconditioning chemotherapy. The Phase 1/2 trial consists of an open-label, single-ascending dose design which will identify the maximum tolerated dose for LEU011. Following the dose-escalation portion of the trial, LEU011 will further be evaluated in a dose expansion open-label segment with enrolment of patients with solid tumours expressing one or more NKG2D ligands.

On September 21, 2023 PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors, and its majority-owned subsidiary Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or "Lucid Diagnostics"), a commercial-stage cancer prevention diagnostics company, reported their participation in the 2023 Cantor Fitzgerald Global Healthcare Conference in New York City (Press release, PAVmed, SEP 21, 2023, View Source [SID1234635325]).

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Lishan Aklog, M.D., PAVmed and Lucid’s Chairman & Chief Executive Officer, and Dennis McGrath, PAVmed’s President and Chief Financial Officer and Lucid’s Chief Financial Officer, will participate in a panel presentation on Wednesday, September 27, 2023, at 8:00 a.m. EDT.

On September 21, 2023 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported the publication of two cases of the treatment of metastatic pancreatic cancer with CARsgen’s CT041, an innovative Claudin (CLDN) 18.2 CAR T-cell Therapy, in Journal of Hematology & Oncology (IF 23.186), titled "CT041 CAR T cell therapy for Claudin18.2–positive metastatic pancreatic cancer" (View Source)[1] (NCT04581473 and NCT03874897) (Press release, Carsgen Therapeutics, SEP 21, 2023, View Source;oncology-301934471.html [SID1234635324]).

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For case 1, a 58-year-old woman was diagnosed with pancreatic cancer with lung and lymph nodes metastasis. First-line nab-paclitaxel plus gemcitabine and second-line irinotecan-liposome plus 5-flurouracil were failed before she was enrolled in CT041 clinical trial, after confirming CLDN18.2 expression as 2+/70%. After lymphodepletion consisting of fludarabine, cyclophosphamide, and nab-paclitaxel, a CT041 dose of 250 × 106 cells was administered to the patient in September 2021. Grade 2 cytokine release syndrome (CRS) occurred, which was later controlled by tocilizumab. Partial response (PR) was achieved according to RECIST v1.1, with great shrinkage of lung metastasis.

For case 2, a 75-year-old woman was diagnosed as pT2N0 pancreatic cancer after she underwent surgery in May 2019. Lung metastasis was found after 5 months during routine post-surgery follow-up. S-1 monotherapy was given as the first-line chemotherapy starting from December 2019. During the surgical area palliative radiation, tumor progression was observed in the lung. Since the CLDN18.2 expression was determined as 3+/60%, the patient was enrolled in CT041 clinical trial. After receiving lymphodepletion consisting of fludarabine, cyclophosphamide and nab-paclitaxel, the patient was infused with a CT041 dose of 250 × 106 cells in July 2021. Patient experienced grade 2 CRS, which was further controlled with tocilizumab. PR was reached since the first evaluation 4 weeks after infusion. Target lesions of lung metastasis subsequently disappeared and achieved complete response. The tumor was still under well control until the last follow-up in July 2023. The peripheral blood CLDN18.2 CAR copy number in both patients exhibited a rapid post-infusion increase, peaking within 2 weeks. Concurrently, fluorescence-activated cell sorting results indicated an increase in peripheral blood CD8+ T cells and Treg cells, alongside a reduction in CD4+ T cells and B cells. These shifts in immune cell phenotypes demonstrated greater persistence compared to alterations in cytokine levels.

Raffaele Baffa, MD, PhD, Chief Medical Officer of CARsgen Therapeutics, remarked that, "I am delighted to see the publication of two cases on our CT041’s treatment of metastatic pancreatic cancer cases in the Journal of Hematology & Oncology. The fact that both patients achieved partial response after receiving CT041 infusion is truly encouraging. Pancreatic cancer remains one of the most challenging malignancies in the field of oncology, with extremely poor prognosis and limited treatment options. Therefore, the development of innovative therapy is crucial in providing hope to pancreatic cancer patients. Our preliminary data from the treatment of pancreatic cancer with CAR T-cell therapy indicate its potential in achieving significant anti-tumor responses, even in patients who have failed multiple previous treatment regimens. We believe that CT041 has the potential to transform the treatment landscape of pancreatic cancer and other solid tumors, offering new hope to patients and their families."

About CT041

CT041 is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. CT041 targets the treatment of Claudin18.2 positive solid tumors with a primary focus on GC/GEJ and PC. Trials in CARsgen include investigator-initiated trials (NCT03874897), a Phase Ib clinical trial for advanced GC/GEJ and PC and a confirmatory Phase II clinical trial for advanced GC/GEJ in China (CT041-ST-01, NCT04581473), a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) Designation by U.S. FDA for the treatment of advanced GC/GEJ with Claudin18.2-positive tumors in January 2022 and was granted PRIME eligibility by the EMA for the treatment of advanced gastric cancer in November 2021. CT041 received Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ and Orphan Medicinal Product designation from the EMA in 2021 for the treatment of advanced gastric cancer.

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."