On August 23, 2024 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the "A Randomized, Open-label, Phase III Study to Evaluate 9MW2821 vs Investigator’s Choice of Chemotherapy in Subjects with Recurrent or Metastatic Cervical Cancer Who Progressed on or after Platinum-based Chemotherapy" has been approved (Press release, Mabwell Biotech, AUG 23, 2024, View Source [SID1234646078]). The company will initiate the Phase III clinical study to assess the efficacy and safety of 9MW2821 in patients with recurrent or metastatic cervical cancer (CC) that has progressed on or after platinum-based chemotherapy.

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9MW2821, a novel Nectin-4 targeting ADC developed by Mabwell, is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies. It’s also the first Nectin-4-targeting ADC to enter phase III clinical study for the treatment of CC worldwide. Multiple clinical studies have been conducted for urothelium carcinoma, cervical cancer, esophageal cancer, and breast cancer, and more than 400 subjects have been enrolled. The results of the existing clinical studies have demonstrated outstanding therapeutic efficacy and safety.

Treatment options and outcomes for patients with recurrent or metastatic cervical cancer remain limited. In the cervical cancer expansion cohort of the phase I/II study, the detection rate of Nectin-4 expression was 91.87%, and the detection rate of Nectin-4 IHC 3+ was 73.98%. 53 CC patients received at least one dose of 9MW2821 and were evaluable for efficacy assessment. All of the patients had received doublet platinum-containing chemotherapy, 51% patients had received bevacizumab, and 58% patients had received immune checkpoint inhibitor. ORR and DCR in 53 CC patients were 35.8% and 81.1%, respectively. The median progression-free survival (mPFS) and duration of response (DOR) was 3.9 months and 7.2 months, respectively. Median overall survival (OS) was not reached yet and 12-months OS rate was 74.6%. Among patients with Nectin-4 IHC 3+, the ORR was 43.6%.

The results of the above studies indicate that 9MW2821 has a positive therapeutic effect in patients with cervical cancer. The company is in the process of scientifically evaluating and advancing the conduct of clinical studies on first-line combination therapies.

About Cervical Cancer

Cervical cancer is the 4th most common neoplasm and the 4th leading cause of cancer death in females worldwide (excerpted from "Worldwide trends in cervical cancer incidence and mortality, with predictions for the next 15 years, Cancer 2021"). According to the "World Cancer Report 2020" released by the International Agency for Research on Cancer (IARC), there were 600 thousand new cases of cervical cancer worldwide in 2020 and up to 340 thousand deaths caused by cervical cancer. In February 2024, the National Cancer Center published the Cancer Burden Data in China in 2022 on Journal of the National Cancer Center (JNCC), showing that there were 150.7 thousand new cases of cervical cancer and 55.7 thousand deaths in China, ranking 8th and 9th respectively in terms of new cases and number of deaths. Compared with the 119 thousand new cases and 37 thousand deaths released in February 2022 for the same period in 2016, significant increases are observed.

About 9MW2821

9MW2821 is the first site-specific conjugated novel Nectin-4 targeting ADC developed by Mabwell using ADC platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies, and also the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data of cervical cancer (CC), esophageal cancer (EC) and breast cancer. In 2024, 9MW2821 has been granted Fast Track Designation by FDA for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC), recurrent or metastatic CC progressed on or following prior treatment with a platinum-based chemotherapy regimen, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer (TNBC); 9MW2821 has been granted Orphan Drug Designation by FDA for the treatment of EC, and also Breakthrough Therapy Designation by CDE of NMPA.

9MW2821 achieves site-specific modification of antibody through proprietary conjugation technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.

On August 23, 2024 Antengene Corporation (6996.HK) reported its interim results for the period ending June 30, 2024, along with several significant milestones achieved in recent months (Press release, Antengene, AUG 23, 2024, View Source [SID1234646077]).

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Dr. Jay Mei, Antengene’s Founder, Chairman, and CEO, stated, "In the first half of 2024, the company has made significant progress in both R&D and commercialization. Our four global rights assets — ATG-022 (Claudin 18.2 ADC), ATG-037 (CD73 small molecule), ATG-101 (PD-L1/4-1BB bispecific antibody), and ATG-031 (CD24 monoclonal antibody) have all advanced steadily as planned. Among them, ATG-022, currently in Phase II dose expansion stage, has demonstrated efficacy not only in gastric cancer patients with moderate-to-high Claudin 18.2 expression but also in those with low and ultra-low expression levels. This unprecedented data reinforces our belief that ATG-022 is poised to become a globally best-in-class molecule targeting Claudin 18.2. While we remain focused on building a differentiated and innovative pipeline, the company has also established a robust self-sustaining revenue-generating capability. XPOVIO has achieved three significant milestones within the past six months, including a supplementary new drug approval (NDA) for diffuse large B-cell lymphoma (DLBCL) in the Mainland of China, National Health Insurance Service Approval for Reimbursement in South Korea, and NDA approvals for multiple myeloma (MM) in Malaysia. To date, XPOVIO has been approved for marketing in eight countries and regions across the Asia-Pacific markets and included in the national health insurance of four of these markets, generating product revenue of RMB 60.8 million in the first half of 2024." Dr. Mei continued, "Antengene’s innovative R&D capabilities, strategic approach to drug discovery and development, and rigorous cost-efficiency measures ensure the company is well positioned for sustained operations and growth in the coming years. With a cash and bank balance of RMB 1.024 billion, we have sufficient runway to provide strong support to the continuous growth, development, and operations of Antengene. We look forward to sharing more of our progress in the second half of 2024, with a key highlight being the latest research results of ATG-037, which will be presented in a mini oral presentation at the ESMO (Free ESMO Whitepaper) Annual Meeting on September 16."

1. Global Rights Assets with Advancing Steadily at Clinical Stage

ATG-022 (Claudin 18.2 Antibody-Drug Conjugate, ADC): Currently at Phase II Dose Expansion Stage, Effectively Targeting Gastric Cancer with both High and Ultra-low Claudin 18.2 (CLDN18.2) Expression

ATG-022 is a highly differentiated asset demonstrating activity across a wide range of CLDN18.2 expression levels, including both high and low/ultra-low expression level. ATG-022 has received two Orphan Drug Designations (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer.
The Phase I CLINCH dose escalation study was completed earlier this year, 2.4 mg/kg was selected as the recommended Phase II dose (RP2D). ATG-022 has now progressed to the Phase II monotherapy dose expansion stage.
As of Aug 21st 2024, Data from the on-going Phase II CLINCH dose expansion study, shows that 21 CLDN18.2 positive gastric cancer patients have been treated with ATG-022. Among the 12 patients who at least underwent their first tumor assessment after study treatment, 5 achieved partial response (PR), resulting in an overall response rate (ORR) of 41.7% (including one patient with ultra-low CLDN18.2 expression), and a disease control rate (DCR) of 100%. The Phase II CLINCH study is currently progressing smoothly in China and Australia.
ATG-037 (CD73 Small Molecule Inhibitor): Demonstrated Potential in Reversing Resistance to anti-PD-1 Therapies during Dose Escalation

Inhibiting CD73 is intended to stop the production of adenosine, a key immunosuppressive molecule in the tumor microenvironment. As a small molecule inhibitor of CD73, ATG-037 has demonstrated pre-clinically the ability to overcome the "hook effect" that can limit efficacy and is commonly seen in anti-CD73 antibodies. Antengene entered into a global clinical collaboration with MSD and is currently evaluating this molecule in combination with the anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with locally advanced or metastatic solid tumors.
ATG-037 demonstrated an excellent safety profile during the dose escalation stage. Notably, four partial responses in patients previously treated with a checkpoint inhibitor were observed — two in melanoma patients and two in non-small cell lung cancer patients. With the Phase I dose escalation now complete, the company plans to initiate the Phase II dose-expansion of the STAMINA study in China and Australia in the third quarter of 2024.
ATG-101 (PD-L1/4-1BB Bispecific Antibody): Durable Responses and Preliminary Efficacy in "Cold Tumors" Observed at Low Doses Without Off-target Liver Toxicity

ATG-101’s differentiated approach to targeting PD-L1 resistant cancers incorporates the conditional activation of the T-cell co-stimulatory receptor 4-1BB. The bispecific antibody utilizes high PD-L1 affinity and conditional 4-1BB activation, to reduce the risk of hepatotoxicity.
ATG-101 is currently undergoing dose-escalation studies in the US, the Mainland of China, and Australia. The treatment has demonstrated excellent tolerability, with no significant liver toxicity observed to date. Encouragingly, durable stable disease has been observed even at low dose levels, as along with a partial response in a patient with microsatellite stable (MSS) colorectal cancer. The Phase I dose escalation phase is on track for completion by the first half of 2025.
ATG-031 (Anti-CD24 Monoclonal Antibody): First-in-Class Macrophage Activator Targeting CD24

ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter clinical trials for cancer in the U.S. ATG-031 works by blocking CD24-Siglec10 and enhancing macrophage-mediated phagocytosis of cancer cells. Key study sites of ATG-031 include four renowned cancer centers in the United States: MD Anderson Cancer Center at the University of Texas, University of California, San Francisco (UCSF), University of Colorado, and Yale Cancer Center.
In the Phase I PERFORM study, 19 late-stage cancer patients have been treated with early low doses in the dose escalation segment, with no dose-limiting toxicities (DLTs) observed. Observations include stable disease (SD), objective tumor shrinkage, and clinical improvements among enrolled patients. The company targets a Phase I data readout in the first half of 2025.
Promising Pre-clinical Programs:

Antengene is committed to advancing its proprietary "2+1" T-cell engager platform, AnTenGagerTM. T cell engagers developed from this platform are designed to induce disease-associated antigen (DAA)-dependent T-cell binding and activation, delivering strong therapeutic activity while minimizing the risk of cytokine release syndrome (CRS).
The development of preclinical candidates, including ATG-042, a selective PRMT5 inhibitor targeting MTAP-null tumors, and ATG-201, a CD19 x CD3 T-cell engager, is ongoing.
2. Expanding APAC Presence with Inclusion in Multiple National Health Insurance Programs

In June 2024, South Korea’s National Health Insurance Service (NHIS) has approved the reimbursement of XPOVIO, effective from July 1, 2024. This marks the fourth Asia-Pacific market, following the Mainland of China, Australia, and Singapore, where the company has secured reimbursement/insurance coverage for XPOVIO. The company is actively working to secure health insurance inclusion for XPOVIO in more Asia-Pacific markets.
In July 2024, XPOVIO received approval for a new indication in the Mainland of China, offering a new treatment option for patients with DLBCL. This is the second indication approved for XPOVIO in the Mainland of China, following its approval for relapsed/refractory multiple myeloma (R/R MM).
In August 2024, XPOVIO was officially approved for marketing in Malaysia. To date, XPOVIO has received multiple new drug approvals across eight countries and regions in the Asia-Pacific market (the Mainland of China, Taiwan, Hong Kong, Macau, Australia, South Korea, Malaysia, and Singapore). The company has also submitted NDA for XPOVIO in other ASEAN markets such as Thailand and Indonesia, with approvals expected later this year.
Since being included in the National Reimbursement Drug List (NRDL) in December 2023, XPOVIO has shown impressive revenue performance in the first half of 2024. As of June 30, 2024, XPOVIO sales revenue has reached RMB 60.8 million.
3. Strong Cash and Bank Balance to Support Strategic Objectives

As of June 30, 2024, the company held RMB 1.024 billion in cash and bank balance. The steady growth in revenue, strong cash and bank balance coupled with careful spending, will provide strong support to the continuous growth, development, and operations of Antengene.

For more details on the 2024 interim financial results, please refer to the full announcement available in the "Investor Relations" section of the company’s official website.

On August 23, 2024 GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, reported China’s National Medical Products Administration has approved Dupert（fulzerasib, GFH925/IBI351）for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy (Press release, GenFleet Therapeutics, AUG 23, 2024, View Source [SID1234646076]). Fulzerasib was the first China-developed KRAS G12C inhibitor that had its NDA submission accepted with Priority Review Designation in 2023, and the monotherapy was also granted two Breakthrough Therapy Designations (BTD) for treating advanced KRAS G12C-mutant NSCLC and colorectal cancer (CRC) patients.

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The NDA approval is based on the results from a single-arm registrational study (NCT05005234) intended to evaluate the efficacy and safety of fulzerasib monotherapy in advanced NSCLC patients with KRAS G12C mutation who failed or were intolerant to the standard treatment in China. The updated data from this registration study has been published in full manuscript in the Journal of Thoracic Oncology (JTO) and selected for oral presentation at the 2024 World Conference on Lung Cancer (WCLC) .

As of the data cutoff date (Dec 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable. Fulzerasib was generally well-tolerated and demonstrated encouraging antitumor activity. The confirmed objective response rate (ORR) assessed by the Independent Radiology Review Committee (IRRC) was 49.1% (95% CI: 39.7-58.6). Disease control rate (DCR) was 90.5% (95%CI: 83.7, 95.2). The median duration of response (DoR) was not reached. Median progression-free survival (PFS) was 9.7 months (95%CI: 5.6-11.0), and median overall survival (OS) was not yet reached.

NSCLC comprises approximately 85% of all lung cancer diagnoses, with KRAS being the most frequently mutated driver gene in NSCLC. The rarity of co-mutations with EGFR or ALK in KRAS-mutated scenario, substantially reduces the clinical benefits of approved EGFR or ALK-targeting therapies for KRAS-mutant or driver-gene-negative NSCLC patients. They are confronted with limited later-line therapeutic options upon disease progressing through the current first-line standard of care (SOC).

"KRAS has long been considered an ‘undruggable’ target despite being a common oncogenic driver mutation. The advent of KRAS G12C inhibitors has opened new avenues for precision medicine in cancers harboring this mutation. We are proud to be part of the clinical research and development of Dupert, the first KRAS G12C inhibitor approved in China. We hope that Dupert will soon benefit more patients with advanced lung cancer harboring KRAS G12C mutations, driving the progress of precision treatment for lung cancer." Stated Professor Yi-Long Wu from Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital.

Beyond monotherapy, the combination of KRAS and EGFR inhibitors exhibits a synergistic biological mechanism and thus enables the potential of fulzerasib to serve as a first-line treatment option. In 2023, GenFleet initiated a first-line NSCLC combination study (KROCUS) of fulzerasib and cetuximab in Europe, led by world-renowned Professor Rafael Rosell. The analysis of preliminary phase II data was selected for late-breaking abstract and oral presentation at the ASCO (Free ASCO Whitepaper) conference in June 2024: as of Apr. 19 2024, a total of 33 subjects had at least one post-treatment tumor assessment. The ORR was 81.8% (95% CI: 64.5, 93) and the DCR was 100% (95% CI: 89.4, 100). The ORR was 70% among those with brain metastases (32.5% of enrolled patients).

"Initiated in 2018, the fulzerasib’s development has been moving forward rapidly and yielded positive results. We are delighted at the approval of fulzerasib in China and thankful for the collaborative efforts of Innovent Biologics and the investigators. Given the high G12C prevalence among advanced NSCLC patients in western countries, GenFleet has embarked on the KROCUS study in Europe, a pioneering trial of first-line therapy integrating KRAS and EGFR inhibitors. In specific patient populations, the KROCUS study has demonstrated efficacy and safety potentially comparable or even superior to immunotherapy combined with chemotherapy, positioning the fulzerasib/cetuximab combination as a potentially novel first-line SOC for G12C-mutated NSCLC patients." stated Yu Wang, M.D.,Ph.D., Chief Medical Officer of GenFleet.

Alongside with NSCLC treatment, the efficacy of fulzerasib monotherapy for CRC also outperformed other single-agent KRAS G12C inhibitors in terms of ORR and mPFS; the efficacy was also comparable to combinations of other G12C inhibitors with anti-EGFR antibodies. Notably, the FDA has granted approval in April this year for GenFleet’s phase III study investigating fulzerasib in G12C-mutated refractory, metastatic CRC patients. Furthermore, fulzerasib holds the distinction of being the first G12C inhibitor that received a BTD for CRC treatment in China.

About Dupert (fulzerasib, KRAS G12C Inhibitor)

RAS protein family can be divided into KRAS, HRAS and NRAS categories. KRAS mutations are detected in nearly 90% of pancreatic cancer, 30-40% of colon cancer, and 15-20% lung cancer patients. The occurrence of KRAS G12C mutation subset is more frequently observed than those with ALK, ROS1, RET and NTRK 1/2/3 mutations combined.

Discovered by GenFleet Therapeutics, fulzerasib (GFH925/IBI351) is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest.

In September 2021, Innovent and GenFleet Therapeutics entered into an exclusive license agreement for the development and commercialization of GFH925 in China (including the Chinese mainland, Hong Kong, Macau and Taiwan) with additional option-in rights for global development and commercialization.

In January 2023, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for fulzerasib for the treatment of patients with advanced NSCLC harboring KRAS G12C mutation who have received at least one systemic therapy. In May 2023, the CDE of China’s NMPA granted another BTD for fulzerasib for the treatment of advanced CRC patients with KRAS G12C mutation who have received at least two systemic therapies.

In August 2024, the CDE of NMPA has approved fulzerasib for the treatment of advanced NSCLC patients harboring KRAS G12C mutation who have received at least one systemic therapy.

On August 23, 2024 CanariaBio Inc, a leading late-stage biotechnology company, reported the successful completion of enrollment of 88 patients in a randomized Phase 2 study of oregovomab in combination with chemotherapy (paclitaxel and carboplatin) as neo-adjuvant treatment of patients with newly diagnosed advanced epithelial ovarian cancer (Press release, CanariaBio, AUG 23, 2024, https://www.prnewswire.com/news-releases/canariabio-inc-announces-enrollment-completion-of-randomized-phase-2-study-of-oregovomab-in-combination-with-chemotherapy-as-neo-adjuvant-treatment-of-patients-with-advanced-ovarian-cancer-302228497.html [SID1234646075]).

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This trial, known as FLORA-6 (NCT05605535) is a Phase 2, double-blinded, placebo-controlled, multi centered clinical trial in neo-adjuvant setting in patients with newly diagnosed advanced epithelial ovarian cancer. The study will assess 12 months progression free survival (PFS) rate, PFS, overall survival (OS), disease control rate, the immunological and early humoral response of concomitant oregovomab and chemotherapy.

Ovarian cancer is known for its high recurrence rate. Despite numerous clinical trials conducted, the development of an effective and specific treatment has proven challenging due to treatment resistance, toxicity, and limited efficacy. In this difficult landscape, oregovomab has the potential of emerging as a promising immunotherapeutic agent.

About Oregovomab

Oregovomab is a murine monoclonal antibody against CA 125, a biomarker commonly found in ovarian cancer. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefits as observed in a Phase II trial (Gynecology Oncology (2020) 156:523-529). Oregovomab is currently undergoing multiple clinical trials for the treatment of ovarian cancer in various setting including a Phase 3 study (NCT04498117, NCT05605535, NCT05335993, NCT05407584, NCT04938583)

On August 23, 2024 Abogen Biosciences ("Abogen" or the "Company") reported a publication titled "Efficient circularization of protein-encoding RNAs via a novel cis-splicing system " in Nucleic Acids Research (Press release, Abogen Biosciences, AUG 23, 2024, View Source [SID1234646074]). In the article, Abogen has revealed a highly efficient RNA circularization cis-splicing system (referred to as the "Cis-System") which enables the production of circular RNA ("circRNA") with significantly extended protein expression, reduced innate immune activation, and flexible splice site design that offers substantial market potential.

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In recent years, circular RNA technology has gained significant attention from the biopharmaceutical industry, several circular RNA start-up companies raised a total of over 1 billion dollars in financing. Among the most notable are Flagship-incubated Sail Biomedicines (formed through the merger of Laronde and Senda Biosciences), which has raised nearly $800 million, and Orna Therapeutics, founded by MIT Professor Daniel Anderson, secured over $300 million in funding and recently acquired ReNAgade Therapeutics to accelerate its clinical development.

Abogen’s Cis-System-based circRNA not only has global IP, but also improves over PIE System

The conventional technology for circRNA synthesis is the PIE method (Permuted Introns and Exons), patented by Orna and other companies. However, the Cis-System not only circumvents the patent restrictions by the PIE system, but also simplifies the circularization process and makes it more suitable for industrial production. As described in the publication, the Cis-System embeds a ribozyme core structure at one end of the precursor RNA, rendering the need for additional spacer elements between the ribozyme and the target gene. This invention significantly enhances the circularization efficiency thus offers a "scarless" and highly efficient translation process with less process-related impurities.

The Cis-System-based circRNA shows promising prospects for the future

The Cis-System reported in this study can achieve high circularization efficiency with essentially unrestricted base and sequence composition at the ends of RNA molecules, enabling truly efficient and scarless circularization. Furthermore, the Cis-System is designed to be more flexible, allowing customization based on specific therapeutic needs and compatibility with RNA molecule of different lengths. All these technological advances will lead to more sustained protein expression, reduced innate immune stimulation, and potential tissue-specific expression, which potentially bring more hopes in chronic disease treatment and immunotherapies where repeated dosing may be required.

Dr. Shaojun Qi, Senior Scientist in mRNA Innovation department at Abogen commented:

"I deeply appreciated the innovative culture at Abogen which is crucial for our success in overcoming the key bottlenecks in circular RNA technology. "

Dr. Peng Gao, Vice President of Abogen (corresponding author of the publication), commented:

"After over two years of commitment and continuous efforts, our team has finally overcome the critical technical hurdle presented in circRNA technology. Preliminary results from further studies have reinforced the great value and application potential of this technology. We hope to rapidly translate this achievement into clinical solutions to address the unmet medical needs."

Link for the Original Paper

Shaojun Qi, Huiming Wang, Guopeng Liu, Qianshan Qin, Peng Gao, Bo Ying, Efficient Circularization of Protein-Encoding RNAs via a Novel Cis-Splicing System, *Nucleic Acids Research*, 2024;, gkae711, [View Source]" target="_blank" title="View Source]" rel="nofollow">View Source(View Source)