On April 3, 2022 JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China granted Breakthrough Therapy Designation for Carteyva (relmacabtagene autoleucel injection) in patients with mantle cell lymphoma (MCL) (Press release, JW Therapeutics, APR 3, 2022, View Source [SID1234611376]). Carteyva is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product independently developed by JW Therapeutics.

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The Breakthrough Therapy Designation was supported by the results from the clinical study of Carteyva in relapsed or refractory MCL (r/r MCL), which aimed to assess the efficacy and safety of Carteyva in adults with r/r MCL in China. This is the first clinical result obtained in Chinese patients.

MCL is a non-Hodgkin lymphoma, which is highly aggressive and can’t be cured by the currently approved therapies1. About 80% to 90% of MCL patients were diagnosed at the advanced stage and with poor prognoses2. Despite a few novel mechanism-of-action drugs such as Bruton tyrosine kinase inhibitors (BTKi) have improved outcomes for patients living with this disease, subsets of patients with aggressive disease biology or multiply relapsed disease continue to experience relatively poor outcomes with these currently available therapies. There are still urgent unmet medical needs to develop additional active therapeutic agents for the treatment of r/r MCL.

References

1. The consensus of the diagnosis and treatment of mantle cell lymphoma in China (2016 version) .Chin J Hematol.2016, 37(9):735-741.

2. Herrmann A, Hoster E, Zwingers T, et al. Improvement of Overall Survival in Advanced Stage Mantle Cell Lymphoma[J]. Journal of Clinical Oncology, 2009, 27(4):511-518.

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

About JWCAR029-005 Study (NCT04718883)

This is a phase II, open-label, single-arm, multicenter study which aims to assess the efficacy and safety of Carteyva in adults with r/r MCL in China. This is the first clinical study to evaluate such novel therapy in Chinese MCL patients. The study will be conformance with the Chinese clinical practices and will truly reveal the efficacy and safety data in Chinese patients.

This study will enroll a total of 59 r/r MCL patients either relapsed or refractory to second-line or more line regimens. Prior therapies must include an anti-CD20 monoclonal antibody, anthracycline- or bendamustine-containing chemotherapy, and BTK inhibitor therapy. These patients will be followed up for long-term survival in 2 years or above.

The study is currently ongoing. Preliminary clinical data found Carteyva providing outstanding efficacy and good safety profile for r/r MCL patients. In particular, Carteyva provided clear therapeutic benefits to patient refractory or relapsed to BTK inhibitor therapy.

On April 3, 2022 Kintor Pharmaceutical Limited (Kintor Pharma, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, reported two poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, including proxalutamide to treat COVID-19 and a c-Myc Degrader to treat blood cancer and small cell lung cancers (SCLC) (Press release, Suzhou Kintor Pharmaceuticals, APR 3, 2022, View Source [SID1234611375]). This year’s AACR (Free AACR Whitepaper) annual meeting will be held in the city of New Orleans, United States, on April 8-13, 2022.

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E-Poster
Mechanisms of action (MOA) for proxalutamide, an androgen receptor (AR) antagonist, for the treatment of mild, moderate and severe COVID-19 patients

Abstract#: 5274

Session Title: COVID-19 and Cancer

Session Time: April 8, 2022, 12:00 PM – 1:00 PM

Abstract Link: View Source!/10517/presentation/18533

Discovery and evaluation of GT19630, a c-Myc/GSPT1 cereblon E3 ligase modulator(CELMoD) , for targeting Myc-driven blood cancers and small cell lung cancers(SCLC)

Abstract#: 5479

Session Title: Small Molecule Therapeutic Agents

Session Time: April 8, 2022, 12:00 PM – 1:00 PM

Abstract Link: View Source!/10517/presentation/18624

Please refer to the website of AACR (Free AACR Whitepaper) for more details.

On April 2, 2022 Epsilogen Ltd. reported that it has raised £30.8 million (US$41.5 million) in an oversubscribed series B, after its lead immunoglobulin E (IgE) program delivered positive results in a phase I in advanced solid tumors (Press release, Epsilogen, APR 2, 2022, View Source [SID1234611331]). The money is to fund a phase Ib trial of the product, Mov18 IgE – the first and only IgE antibody to have made it to the clinic – in platinum-resistant ovarian cancer.

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On April 1, 2022 Nykode Therapeutics Presented the Corporate Presentaiton (Presentation, Nykode Therapeutics, APR 1, 2022, View Source [SID1234611373])

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On April 1, 2022 Akeso, Inc. (9926.HK) ( "Akeso" ), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, reported 2021 annual results (Press release, Akeso Biopharma, APR 1, 2022, View Source [SID1234611365]).

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Highlights:

Anniko (Penpulimab, AK105, PD-1) obtained market entry approval from the Chinese National Medical Products Administration (NMPA). Product sales of RMB 212 million was recorded for the year ended December 31, 2021. Licensing fee recognized was RMB128.6 million from our out-licensed product AK107 (CTLA-4) to MSD ("Merck Sharp & Dohme Corp.").
Significant progress of clinical trials made: we submitted 4 marketing applications in 2021, including one for Cadonilimab (AK104, PD-1/CTLA-4) for the treatment of relapsed or metastatic cervical cancer, and three for Penpulimab including treatments for 1L sq-NSCLC and 3L NPC. We also obtained 37 IND approvals, and advanced 2 pre-clinical stage programs into clinical stage. As of the announcement date, we have developed over 30 innovative programs in-house, 15 of which are in clinical stage (including three out-licensed products). And our total number of pivotal or Phase III trials increased to 15. Our total R&D investment for the year was RMB1.07bn (excluding share-based compensation).
As at December 31, 2021, total cash on hand and confirmed via other financing channels amounted to over RMB5bn, which will be sufficient to support research and development in the next two years.
Anniko (PD-1) approved and Cadonilimab (PD-1/CTLA-4) expected to obtain approval

On August 5, 2021, our first oncology immunotherapy product, Anniko (Penpulimab, AK105, PD-1) injection for the treatment of relapsed or refractory classic Hodgkin’s lymphoma obtained market entry approval by the NMPA in China. Product sales of RMB212 million was recorded for the year ended December 31, 2021.

In July 2021, we submitted an NDA of Anniko in combination with chemotherapy for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer ("sq-NSCLC") in China. In August, we submitted another NDA for third-line treatment of patients with metastatic nasopharyngeal carcinoma ("NPC") in China. In September, 2021, we also submitted a BLA for third-line treatment of patients with metastatic NPC to the FDA through the Real-Time Oncology Review ("RTOR") Programme.

Meanwhile, in oncology therapeutic area, we have achieved important breakthroughs on its fully in-house developed innovative products including Cadonilimab (AK104, PD-1/CTLA-4), AK112 (PD-1/VEGF) and AK117(CD47). In September 2021, we submitted another NDA in China for Cadonilimab for the treatment of relapsed or metastatic cervical cancer under priority review. As of this announcement date, Cadonilimab started three Phase III clinical trials for first-line treatment of advanced gastric adenocarcinoma or gastroesophageal junction cancer (GC/GEJ), first-line treatment of recurrent or metastatic cervical cancer, and locally advanced cervical cancer. AK112 (PD-1/VEGF) started two Phase III clinical trials for first-line treatment of PD-L1(+) NSCLC, and advanced NSCLC previously treated with EGFR-mutant Tyrosine Kinase Inhibitor (TKI) treatment. Another core product AK117 (CD47) has also started various combination therapies studies for treatment of solid tumors, and the preliminary data showed promising results.

In non-oncology therapeutic area, AK101 (IL12/23) entered into Phase III clinical study for the treatment of moderate-to-severe plaque psoriasis. AK102 (PCSK9) started Phase III clinical study for hypercholesterolemia, and a pivotal clinical study for heterozygous familial hypercholesterolemia ("HeFH").

An experienced commercialization team is ready to launch the new product

With more innovative drugs pending to obtain approval, we have already established an experienced commercialization team with proven track record of success. As of the end of 2021, our commercialization team has more than 500 team members, and all core members have successful sales and marketing experiences. It has achieved in-depth coverage of 1500+ hospitals, 500+ DTP pharmacies, and 60+ Insurance and Charity across the country.

This professional team will be responsible for the commercialization of Cadonilimab. Based on the superior efficacy and first mover advantage of Cadonilimab in clinical studies for the treatment of cervical cancer, gastric cancer, and liver cancer, we have full confidence in a successful launch of Cadonilimab.

High-quality GMP-compliant manufacturing

As of December 31, 2021, we have developed world-class GMP facilities to support large scale commercialization and R&D plans. We currently have 23,500L GMP compliant production capacity in operation, with more capacity under construction and in planning.