HONG KONG, Sep 28, 2022 – (ACN Newswire) – Transcenta Holding Limited (06628.HK), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announced that interim safety and efficacy data of dose expansion cohort from the phase I/II study of TST001 (Osemitamab), a humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody, in combination with Capecitabine and Oxaliplatin (CAPOX) as a first line treatment of locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer was presented in a poster at the European Society for Medical Oncology (ESMO) Congress 2022.

In first line treatment of advanced or metastatic G/GEJ cancer, early interim data of the first 15 patients with measurable disease receiving the combination of TST001 with CAPOX demonstrated a partial response rate of 73.3% and a disease control rate of 100% per RECIST1.1. Based on these encouraging data, the TST001 program is further accelerated and Health Authority consultations are being initiated. A global phase III clinical program of TST001 (Osemitamab) for the first line treatment of locally advanced or metastatic Claudin18.2 positive G/GEJ cancer is currently being planned.

1. Claudin18.2 is expected to be the most shining star target in gastric cancer

The European Society for Medical Oncology (ESMO) Congress 2022 was held in person in Paris and virtually between 9-13 September 2022. Around 2000 abstracts and late-breaking abstracts were presented during the congress days. Transcenta's poster with the dose expansion cohort interim data from the TST001 in combination with chemotherapy in first line treatment of locally advanced or metastatic G/GEJ cancer patients with Claudin18.2 expression was presented on Sept 12, 2022.

Data shows that as of August 4, 2022, 51 patients were enrolled and dosed including 36 patients treated with TST001 plus CAPOX at 6mg/kg Q3W in the expansion phase. Among the 15 patients with measurable disease and at least one post-treatment tumor assessment, 11 (73.3%) achieved partial response and four (26.7%) achieved stable disease. All 51 enrolled patients were evaluated for safety and tolerability. Treatment-emergent adverse events regardless of causality were mostly grade 1-2. Twelve (23.5%) patients experienced dose delay, five (9.8%) experienced dose reduction and no patient experienced discontinuation due to treatment related adverse events. In this study, TST001 also demonstrated a clear dose proportional pharmacokinetic profile, is consistent with those observed with TST001 monotherapy and in US patients. These data suggest that TST001 combined CAPOX is well tolerated and with promising efficacy in a broad gastric cancer patient population with tumors expressing Claudin18.2, including medium and high expressors. Furthermore, Transcenta has also developed a proprietary IHC assay to select patients with Claudin18.2 expressing tumors for registration enabling studies.

Despite progresses in the treatment of advanced gastric cancer with HER2, VEGF, VEGFR, or PD-1/PD-L1 targeted therapies, outcomes remain poor for 1st line patients with median overall survival of around 14 months. Claudin18.2 expression is observed at various levels in 50%-70% of gastric cancer patients, and at relatively high percentage in a variety of tumors including pancreatic, cholangiocarcinoma, ovarian and lung cancer. It is one of the hottest targets in cancer treatment. A few Claudin18.2 directed targeted drugs have entered the clinical stage, including monoclonal antibodies, bispecific antibodies, CAR-T and antibody-drug couples (ADCs). TST001, a humanized anti-Claudin18.2 monoclonal antibody, with higher target binding affinity and enhanced ADCC activity than other antibodies, has demonstrated very encouraging preliminary signs of activity in 1st L gastric / GEJ cancers with various levels of CLDN18.2 expression, and a manageable safety and tolerability profile.

Since entering into the clinical stage, Transcenta has attracted the attention of many multinational corporations. It established a global clinical collaboration with Bristol-Myers Squibb to evaluate the combination of TST001 with Opdivo(R) (Bristol-Myers Squibb's anti-PD-1 therapy) for the treatment of patients with unresectable locally advanced or metastatic G/GEJ cancer earlier in March this year. These TST001 data have also generated a lot of excitement from GI cancers investigators who see TST001 as an effective new treatment option to cover the high unmet need of Claudin18.2 medium and high expressors cancers, providing a broader treatment option than other players in the same class. As TST001 data continue to mature, Transcenta progresses TST001 towards phase III trial and has initiated Health authority consultations.

2. Dr. Caroline Germa, former AstraZeneca Oncology's Vice President, is now Transcenta's Chief Medical Officer as the Company accelerates its expansion internationally

In August 2022, Transcenta announced the appointment of Dr. Caroline Germa as the Executive Vice President, Global Medicine Development and Chief Medical Officer. Dr. Caroline Germa was formerly Vice President of AstraZeneca Oncology and has extensive oncology development experience. Prior to joining AstraZeneca, she also worked for a number of world-renowned companies including Pfizer and Bristol-Myers Squibb, and led the late-stage clinical development of a number of key oncology assets, in particular the global registration strategy and approval of blockbuster drugs including Ribociclib (CDK4/6 inhibitor – Kisqali) and Neratinib. She has a deep understanding of the industry and, with her pharmaceutical industry contacts and unique ideas on the business development of the Company, international clinical development and regulatory approvals, the Company is confident that Dr Caroline Germa will be able to lead Transcenta to better global expansion and make a significant contribution to enhancing the Company's shareholder value.

3. TST001 is ranked among the top two most advanced clinical programs for Claudin18.2 worldwide, and the first in China

Zolbetuximab is the first clinical stage anti-claudin18.2 monoclonal antibody. In a phase II, randomized study evaluating Zolbetuximab + epirubicin + oxaliplatin + capecitabine (EOX) for the first-line treatment of CLDN18.2 positive advanced G/GEJ cancer or esophageal adenocarcinoma, zolbetuximab plus EOX chemotherapy showed significant improvements in progression-free survival (PFS) and overall survival (OS) compared to chemotherapy alone in the overall population, padding the Claudin18.2 target's potential for druggability. TST001 of Transcenta is a second generation anti-Claudin18.2 antibody with a differentiated profile relative to Zolbetuximab. It not only has 10-folds higher affinity binding to Claudin18.2, but also has a reduced fucose profile in the Fc of the humanized antibody. Combining these features, the ADCC activity of TST001 is 30-100 folds higher compared to Zolbetuximab analogue in tumor cells expressing various levels of Claudin18.2, which translated into much more potent in vivo anti-tumor activity, in particular, for those tumors expressing medium or low levels Claudin18.2.

TST001 is being developed in parallel in China and the US and is currently in Phase II clinical studies. It is expected to start the global pivotal trial for TST001 during the Mid-2023. In the meantime, Transcenta will continue to evaluate other combination therapies as well as other indications. As the Company continues to accelerate its clinical development and commercialization, Transcenta will eventually better realize more of its potential with its outstanding platform, increase the shareholder value and develop innovative drugs that will benefit patients worldwide.


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HONG KONG, Sep 23, 2022 – (ACN Newswire) – AIM Vaccine Co., Ltd. ("AIM Vaccine" or the "Company", together with its subsidiaries, the "Group", stock code: 06660.HK), the second largest vaccine company in China in terms of 2021 approved lot release volume (excluding COVID-19 vaccines), announced the proposed listing of its H shares on the Main Board of The Stock Exchange of Hong Kong Limited ("SEHK") today.

AIM Vaccine plans to offer an aggregate of 9,714,000 H shares (the "Offer Shares") under the Global Offering (subject to the Over-allotment Option), comprising an international offering (the "International Offering") of 8,742,400 H shares (subject to adjustment and the Over-allotment Option) and Hong Kong public offering (the "Hong Kong Public Offering") of 971,600 H shares (subject to adjustment), at an offer price of HK$16.16 per H share.

The Hong Kong Public Offering will commence at 9:00 a.m. on 23 September 2022 (Friday) and close at 12:00 noon on 28 September 2022 (Wednesday) in Hong Kong. Dealings in H shares of the Company on SEHK are expected to commence at 9:00 a.m. on 6 October 2022 (Thursday), with the stock code 06660.HK in board lots of 200 H shares each.

Goldman Sachs (Asia) L.L.C., China International Capital Corporation Hong Kong Securities Limited, China Securities (International) Corporate Finance Company Limited and Macquarie Capital Limited are the Joint Sponsors, Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers. BOCI Asia Limited, ICBC International Securities Limited, CMB International Capital Limited, Futu Securities International (Hong Kong) Limited, and Tiger Brokers (HK) Global Limited are the Joint Bookrunners and Joint Lead Managers. Livermore Holdings Limited is the Joint Lead Manager.

Empowered by a full spectrum of proven human vaccine platform technologies, covering the full value chain

AIM Vaccine is a major player in the Chinese vaccine industry. According to CIC, the National Medical Products Administration of the PRC ("NMPA") approved lot releases of 623.8 million doses of 46 vaccines against 26 diseases (exclusive of COVID-19 vaccines) in 2021, of which AIM Vaccine contributed 7.4%, or approximately 46 million doses, making AIM Vaccine the second largest vaccine manufacturer group and the largest among all privately-owned vaccine companies in the PRC in terms of approved lot release volume (excluding COVID-19 vaccines). AIM Vaccine covers the full value chain from research and development to manufacturing and to commercialization. According to CIC, AIM Vaccine is the only China-based vaccine player that has all five proven human vaccine platform technologies worldwide, namely bacterial vaccine technologies, viral vaccine technologies, genetically engineered vaccine technologies, combination vaccine technologies and mRNA vaccine technologies, with at least one approved product or one vaccine candidate at CTA or clinical stages under each platform. AIM Vaccine is one of the first two human vaccine companies in the PRC that has been granted permission under the Fourteenth Five Year Plan of the PRC to build a P3 Lab. In response to the current pandemic, AIM Vaccine has taken full advantages of the Group's full-spectrum platform technologies and is developing COVID-19 vaccine candidates spanning multiple technology routes validated by approved vaccines.

AIM Vaccine currently commercializes eight vaccine products against six disease areas, of which the HBV vaccines and human rabies vaccine are its market-leading key commercialized vaccine products. According to CIC, in 2021, AIM Vaccine was the largest supplier of HBV vaccines in the globe and in the PRC, possessing a 45.4% market share in China in terms of approved lot release volume. In 2021, AIM Vaccine was the second largest supplier of human rabies vaccines in the globe and in the PRC, possessing 18.1% and 16.2% market shares of China market, respectively, in terms of approved lot release volume and sales revenue. AIM Vaccine also has 22 vaccine candidates in the Group's pipeline against 13 disease areas, of which five candidates are at clinical stages. AIM Vaccine's comprehensive vaccine product portfolio is empowered by high-quality, commercial-scale manufacturing capabilities of the Group's four individual licensed manufacturing facilities, enabling AIM Vaccine to achieve scalable and quality supply of multiple vaccines. As of 16 September 2022, a total of 45 production permits were granted by the NMPA to 33 vaccine manufacturers or manufacturer groups, and only seven had approved lot releases for four or more products in 2021, including the Group. By obtaining four production permits, the Group is the largest holder of production permits in the PRC among all privately-owned companies, and the second largest holder overall.

Strive to access the best industry resources and innovative technologies to accelerate product development and commercialization

In order to accelerate building up a vaccine portfolio with true market potential, AIM Vaccine is profoundly committed to striving to access the best industry resources. AIM Vaccine currently has four individual licensed manufacturing facilities with differentiated product foci. AIM Vaccine acquired Rong'an Bio, AIM Honesty, AIM Kanghuai and AIM Weixin between 2015 and 2017, together with their vaccine products against human rabies, HBV, HAV, mumps and HFRS. After these acquisitions, AIM Vaccine upgraded the manufacturing infrastructure in each subsidiary to meet the latest GMP standards, improved manufacturing processes and techniques in pursuit of higher product quality and stronger supply capabilities, formulated and executed production plans which closely follow group marketing strategies and consolidated supply chains.

In addition, AIM Vaccine turns science to high-quality vaccine products through a truly interactive R&D and manufacturing process with high efficiency. AIM Vaccine has established dedicated R&D departments in each of the four operating subsidiaries, with a specific focus on developing new vaccine varieties based on their respective leading products and manufacturing specialties. In addition, AIM Explorer, one of the Group's three research institutions, focuses on offering technological support to the four operating subsidiaries with research on early-stage and cutting-edge technologies as its priority. A cross-functional, cross-entity collaboration, which enables AIM Vaccine to consider both biological attributes and sound engineering and manufacturing principles from program inception onwards, could significantly improve R&D success rates and vaccine delivery efficiency. AIM Vaccine realizes a promotive synergy across vaccine R&D and manufacturing. On one hand, AIM Vaccine has ready-for-use commercial-scale manufacturing facilities to harness development of various vaccine candidates. On the other hand, the intensive pilot and scale-up productions of diverse candidates also rapidly refine and improve the Group's process know-how, production facilities, and productivity and skillset of production teams. Such a collaborative development path and culture enable AIM Vaccine to generate 22 vaccine candidates across different development stages.

Leading mRNA COVID-19 vaccine in R&D progress is expected to capture massive market opportunities

The ongoing COVID-19 pandemic has created a massive and sustainable vaccine market in the globe and PRC. To capture such massive and underserved vaccine market opportunities, AIM Vaccine is currently developing vaccines for COVID-19 based on mRNA technology platform and has initiated a global Phase III clinical trial. According to CIC, as of 16 September 2022, there was no approved mRNA COVID-19 vaccine in the PRC. Six PRC vaccine developers were undertaking clinical trials for their respective mRNA COVID-19 vaccine candidates in the PRC or overseas, two of which (including AIM Vaccine) reached Phase III clinical trials. Therefore, AIM Vaccine's mRNA COVID-19 vaccine candidate is expected to be one of the first few to be approved in the PRC. Moreover, AIM Vaccine's mRNA vaccine pilot scale production facility is also among the first one to reach GMP standards in the PRC. In addition, for candidates against variant strains, AIM Vaccine has successfully constructed and produced trial vaccines against different variant strains in preclinical studies, including the Omicron variant strain. AIM Vaccine plans to first obtain NDA approval for and/or launch the Group's mRNA vaccine against the Original Strain in the second quarter of 2023 to address the urgent and near-term market demand. For the longer future, AIM Vaccine plans to launch the broad-spectrum recombinant adenoviral vector vaccine, which is not only effective against COVID-19 variants, but also risks of other coronavirus.

Strong pipeline consisting of market-leading vaccine products and vaccine candidates with large market size

As of 16 September 2022, AIM Vaccine had eight vaccine products against six vaccine-preventable infectious diseases, and 22 vaccine candidates against 13 major vaccine-preventable infectious diseases. According to CIC, the Group's portfolio of vaccine products and vaccine candidates covers all top 10 vaccine products worldwide by 2021 global sales (totaling US$101.9 billion).

Among its vaccine products, HBV vaccines and human rabies vaccines are the Group's key commercialized products, which is the main source of revenue for the Company, and each has a leading position in the corresponding Chinese vaccine market. In addition to these two types of market-leading key commercialized vaccines, AIM Vaccine has other vaccine products against HAV, meningococcal diseases, mumps and HFRS, which diversify the Group's product portfolio and revenue sources.

Among 22 vaccine candidates in the Group's pipeline against 13 disease areas, AIM Vaccine has five candidates at clinical stages, and plans to file over 10 CTAs by the end of 2023 to advance multiple CTA-enabling and preclinical candidates to clinical trial stages. Out of this robust pipeline, AIM Vaccine expects to obtain NDA approvals for and/or launch new vaccine products every year from 2023 to 2025 and 12 other new products in and after 2026, to bring sustainable new growth drivers to the Group's business with a continuously diversifying product portfolio.

Strong R&D capabilities fueled up by the full-spectrum proven human vaccine platform technologies, and mass-scale manufacturing capabilities with proven quality management

AIM Vaccine is the only China-based vaccine company that possesses all five proven human vaccine platform technologies worldwide, namely bacterial vaccine technologies, viral vaccine technologies, genetically engineered vaccine technologies, combination vaccine technologies and mRNA vaccine technologies. As of 16 September 2022, AIM Vaccine operates four individual licensed manufacturing facilities (Rong'an Bio, AIM Honesty, AIM Kanghuai and AIM Weixin), with a designed annual production capacity of 25.0 million doses, 45.0 million doses, 5.3 million doses and 16.0 million doses, respectively, or 91.3 million doses in aggregate. Each licensed manufacturing facility is responsible for producing one or more specific types of vaccines with different production processes and techniques. According to CIC, vaccine quality and safety attributes are highly dependent on the production processes and techniques, which take time to accumulate and are very hard to copy or switch. In addition, vaccine companies in China are generally prohibited from outsourcing manufacturing to CMOs. As a result, these four individual licensed manufacturing facilities create a highly competitive edge for the Group. By equipping AIM Vaccine with extensive hands-on experiences, process know-how and ready-for-use large-scale production capacity for multiple vaccine products, they enable AIM Vaccine to promptly respond to increasing commercial demand and shorten vaccine development cycle.

AIM Vaccine has established a comprehensive quality management from vaccine research, development and manufacturing, with high and consistent quality as the Group's top priority. All the Group's four licensed manufacturing facilities have maintained 100% pass rate in vaccine lot release quality audits by the National Institutes for Food and Drug Control ("NIFDC") under the Group's operation, higher than the industry average level, according to CIC. AIM Vaccine is the only human rabies vaccine manufacturer with 100% pass rate in lot release quality audits by NIFDC over the past five years, and the Group's 10ug HBsAg/0.5ml recombinant HBV vaccine (Hansenula Polymorpha) has maintained 100% pass rate in lot release quality audits for 15 years since commercial launch.

Extensive sales network and highly experienced and efficient commercialization team

The Group's sales and marketing function is centralized, and is specialized and market-oriented. AIM Vaccine's in-house sales and marketing team, consisting of over 100 members with an average of more than 10 years' experience in sales of pharmaceuticals or vaccines. AIM Vaccine's core commercial leadership team has an average of 12 years of experiences in vaccine commercialization in leading multinational pharmaceutical companies, and has excellent track records in marketing international blockbuster vaccines, including global first HPV, IPV and DTaP-IPV-Hib. AIM Vaccine consolidates and integrates quality resources at the Group level instead of dispersing into four operating subsidiaries, which enables AIM Vaccine to achieve a high cost-efficiency, especially in team building and management. Through the sales and marketing centralization, AIM Vaccine has built effective sales channels for and strong CDC recognition of the Group's products, enabling AIM Vaccine to cross-sell existing vaccine products and rapidly ramp up sales of vaccine products. As of 16 September 2022, AIM Vaccine sold vaccine products to all 31 provinces, direct-controlled municipalities and autonomous regions in the PRC, covering all provincial CDCs and over 2,000 county-level CDCs.

Visionary founder with strong support from experienced execution team and industry-leading scientists

AIM Vaccine's core management team comprises a group of seasoned vaccine industry professionals with a strong track record and proven execution capabilities. The industry experience, management expertise, professional knowledge and contributions of key members of the senior management are crucial to the Group's success. AIM Vaccine has leading scientists joining or collaborating with AIM Vaccine to support the Group's vaccine development and manufacturing. Within the group, AIM Vaccine has also established a Group-level vaccine expert panel. In addition, outside the group, AIM Vaccine has established a scientific advisory board that comprises prominent scientists in China's vaccine industry to offer advice and recommendations on the direction of the Group's R&D efforts. These scientists, in together, have and would continue to cultivate their scientific insights, deep industry knowledge and rich experience in the Group's vaccine development and production processes, and have helped to shape a dedicated, quality-forward and market-oriented culture in the Group.

Vaccines have been one of the most important innovations in the science of public health, China has increasing demand from all age groups for high-quality vaccines. Including the COVID-19 vaccine market, the overall PRC vaccine market is expected to increase from RMB303.6 billion in 2021 to RMB431.4 billion in 2030. Leveraging its strong R&D capabilities and mass-scale manufacturing capabilities, to capture opportunities arising from the massive and underserved vaccine market in the PRC, the Group plans to advance R&D of the Group's vaccine candidates and to continue to enrich the Group's vaccine pipeline, construct new production facilities to expand production capacity for new vaccine products, as well as further invest in sales and marketing. Looking forward, AIM Vaccine will continue to realize its mission to "develop and manufacture top quality vaccines to safeguard the health of the world" through a diversified product portfolio, and strive to become a leader in the global vaccine industry.

Copyright 2022 ACN Newswire. All rights reserved. http://www.acnnewswire.com