On August 31, 2022 Genor Biopharma reported its interim results for 2022, sharing the company’s business progress, financial data, and highlights during the period (Press release, Genor Biopharma, AUG 31, 2022, View Source [SID1234618964]).
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Dr. GUO Feng, Chairman of the Board and Chief Executive Officer, Genor Biopharma, said: "Despite the pandemic challenges and the continuing impact of the international situation, Genor Biopharma relied on its passion and power to face difficulties with its profound professional capability in the first half of 2022. It firmly adhered to the "Acceleration, Expansion, Focus and Consolidation" strategy. Turning crises into opportunities, the company achieved a number of important goals much faster than the industry overall. Seven of nine plans for 2022 were completed at a high level of quality. With close cross-departmental cooperation and excellent execution ability, Genor Biopharma will further leverage its results, expand its advantages, successfully reach its annual target, and create steady growth."
With the successful approval of Jiayujian (GB242, infliximab) in February 2022, Genor Biopharma commercialized its first product. In the first half of 2022, the company accelerated multiple key clinical trials and improved its competitive advantage in the industry. It also strengthened its platform for early discovery of global FIC/differential bi-specific/multi-specific antibodies in immune-oncology, expanded business development and cooperation, and continuously built up momentum for sustained and strong development.
The group directed its efforts towards the strategy of global innovation and the research and development of FIC/BIC potential innovative medicine. Fueled by the Company’s strong antibody discovery platform. Currently:
GB261(CD20/CD3) has obtained the preliminary clinical Proof of Concept (POC) data.
GB263T(EGFR/cMET/cMET) has achieved patient dosing in the FIH clinical trial in Australia.
Both GB261(CD20/CD3) and GB263T(EGFR/cMET/cMET) have been approved by the National Medical Products Administration (NMPA) for phase I/II clinical trials.
Nearly 10 tumor therapy projects with global differentiation are in early discovery stage.
The company entered into a cooperative development agreement with Abogen to jointly develop globally innovative mRNA products and related pharmaceuticals.
The regularity applications for clinical trial of the Company’s innovative medicine in its product pipelines have been accelerated to promote the clinical progress, driven by its highly specialized departments and the close collaboration between different departments.
GB491(Lerociclib, a differentiated oral CDK4/6 inhibitor), whose phase III clinical trial for the first line/second line breast cancer indication is progressing rapidly as planned.
GB492(IMSA101, STING agonist), whose clinical trials for monotherapy and in combination with Aibining (GB226, Geptanolimab) have achieved first-patient dosing and are progressing rapidly.
Acceleration – Achieved rapid advancement far beyond the industry overall for a number of key clinical trials
GB491(Lerociclib) – developed for breast cancer patients with better safety and efficacy
GB491(Lerociclib), is a novel, potent, selective oral bioavailable CDK4/6 inhibitor co-developed by Genor Biopharma and G1 Therapeutics, a US based company, for use in combination with endocrine therapy in advanced breast cancer. Based on the data published at European Society for Medical Oncology 2020 conference, GB491(Lerociclib) has demonstrated a better safety and tolerability profile, enabling uninterrupted daily dosing and better long-term benefits, and could potentially be a BIC CDK4/6 drug candidate.
The phase III trials for both first and second line could be continuously accelerating via adaptive and seamless study design, scientific reference and data bridging, seamless registration strategy, and excellent execution. In January 2022, the first patient of phase III clinical trials of GB491(Lerociclib) in combination with Letrozole in first line HR+/HER2- advanced breast cancer was dosed.
GB261(CD20/CD3) is a highly differentiated CD20/CD3 bi-specific antibody developed in-house. GB261(CD20/CD3) is the first T-cell engager with ultra-low affinity to bind CD3 and has Fc functions (ADCC and CDC).
With similar binding affinity to CD20 as rituximab, GB261(CD20/CD3) significantly inhibits rituximab-resistant cancer cell proliferation by in vitro assays and in vivo models. More importantly, GB261(CD20/CD3) induced low levels of cytokine production by Human Peripheral Blood Mononuclear Cell (hPBMC) in monkeys, indicating low occurrences of cytokine release syndrome (CRS). Thus, GB261(CD20/CD3) is a highly promising bi-specific therapeutic antibody for B cell malignancies. It may ultimately provide a concept shift to better and safer T-cell engager antibody drugs for various cancers.
On 18 March 2022, the NMPA accepted GB261(CD20/CD3)’s IND application, and gave an implied permission for its phase I/II clinical trial on 23 May.
Currently, we are in process of the dose escalation up to 10mg in the clinical trial of GB261(CD20/CD3) for the treatment of B-cell non-Hodgkin Lymphoma (B-NHL) in Australia. We have obtained the preliminary clinical Proof of Concept (POC) data and observed objective responses, which were consistent with the molecular design mechanism of GB261(CD20/CD3), indicating a good safety and pharmacokinetic profile.
GB263T(EGFR/cMET/cMET) was the first tri-specific antibody of EGFR/cMET/cMET in the world, targeting EGFR and two different cMET epitopes to enhance its safety and efficacy. Such design has two Fabs to bine EGFR. Its Fc fragment has been mutated to enhance Fc functions.
GB263T(EGFR/cMET/cMET) with highly differentiated sign, exhibits multiple mechanisms of action to inhibit primary and secondary EGFR mutations and cMET signaling pathway simultaneously. The significant anti-tumor activities have been demonstrated by in vitro studies and in vivo animal models.
The EC approval for the FIH clinical trial of GB263T(EGFR/cMET/cMET) was obtained in Australia on 28 March 2022, with the first patient dosed on 18 May.
The research and development of GB263T(EGFR/cMET/cMET) fully demonstrated the advantages of cross-team collaboration and enhanced the Company’s globalization capabilities and innovation practices. By closely working with the globally renowned Key-Opinion-Leaders (KOLs), the clinical trial protocol was finished on the date of obtaining the toxicology data, substantially speeding up the submission to the EC.
The new drug clinical trial application of GB263T(EGFR/cMET/cMET) in China was formally accepted by the NMPA on 28 March 2022, the phase I/II clinical trial of which was approved by the NMPA on 2 June 2022.
GB492(IMSA101)-Potentially Best-In-Class Sting Agonist
GB492(IMSA101) is the major mediator of innate sensing of cancerous cells, which Genor Biopharma exclusively licensed from ImmuneSensor Therapeutic in June 2020. STING agonist, as an immune stimulatory therapy, may further increase the response of immune checkpoint inhibitors for patient. Multiple studies have shown that STING agonists can activate the cGAS-STING signaling and significantly enhance the efficacy of cancer immunity cycle when using in combination with other immune checkpoint inhibitors(ICI), which may become a potential FIC therapy.
In phase I/II clinical trial of GB492(IMSA101) as a monotherapy or in combination with GB226(Aibining, Geptanolimab) in patients with advanced /treatment-refractory malignancies:
In January 2022, monotherapy clinical trials finished.
In January 2022, dose escalation up to 400ug completed.
In January 2022, approval from CDE was obtained to directly conduct a dose-escalating study of GB492 in combination with PD-1 in subjects with advanced malignancy, based on the available data on 400ug dose group in the monotherapy study in China and all data of the monotherapy dose-escalation study in the United States. In this clinical trial, an innovative FIH trial design was employed to combine the dose escalations when GB492 is administered alone and when it is administered with GB226. It is the first STING agonist combination therapy that has obtained clinical trial approval in China.
Expansion – Carried out multi-level strategic cooperation to enhance value creation
In June 2022, the company entered into a cooperative development agreement with Abogen to jointly develop globally innovative mRNA products and related pharmaceuticals. The Company’s antibody development platform will be integrated with Abogen’s mRNA technology platform to enable them to jointly research and develop mRNA drugs for tumor treatment.
Currently, Genor Biopharma is exploring opportunities to conduct cooperative development projects with various innovative technology platforms.
On 23 February 2022, the NMPA has granted marketing approval for Jiayujian(GB242, infliximab) which is used for the treatment of Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriasis, Adult Ulcerative Colitis, Adult and Pediatric Crohn’s Disease and Fistulising Crohn’s Disease. Up to now, Jiayujian(GB242, infliximab) has been obtained for online procurement in more than 20 provinces including Yunnan, Shandong, Hainan, Guangdong Guangzhou, Hubei, Anhui, Shanghai and Tianjin.
Jiayujian(GB242, infliximab) will be commercialized through cooperation with a focus on the development of gastrointestinal indications, such as ulcerative colitis. By doing so, we are able to create a differentiation advantage from other competing products in the market and maximize the value of Inflixib biosimilar.
Focus – Highlighted differentiation and improved operation efficiency
Through paralleled efforts in original innovation and strategic cooperation, Genor Biopharma has successfully established the research and development platform for early discovering global FIC/differential bi-specific/multi-specific antibodies in immune-oncology and therapeutic areas with large unmet medical needs. The R&D team focused on developing targeted antibodies and projects with first-in class (FIC) potential, ad continued to promote the research and development platform for discovering FIC/best in class (BIC) potential bi-specific / multi-specific antibodies in immune-oncology. The company will maximize its existing product portfolio by developing and executing a comprehensive strategy to conduct research on molecular with the best potential to become clinically beneficial and commercially viable drugs, and to address unmet medical needs in China and globally.
As of June 2022, nearly 10 innovative early research projects involving different drug molecular forms have been carried out, focusing on the field of tumor therapy. Genor Biopharma will continue to accelerate the development of clinical trials for several kinds of bi-specific and multi-specific antibody drug candidates in Australia and China, advancing the clinical POC of GB261 and GB263T in the clinical phase I.
At the same time, all departments of the company are unified and clear development priorities, adopt a variety of effective measures, constantly optimize and improve operational efficiency, and do everything possible to reduce unnecessary expenses. In the first half of 2022, "focus" is not only reflected in the optimization of R&D pipeline projects, but also in the organizational structure, operations management, and every aspect of daily business.
Consolidation – Strengthened response to risks and turned crises into opportunities
In the first half of 2022, the Covid-19 situation was severe. As one of the key biomedical enterprises in Zhangjiang area, Genor Biopharma actively proceeded with communication and application, and thus was included in the list of the second batch of enterprises resuming work released in Shanghai on 28 April 2022. Subsequently, Dr. GUO Feng, Chairman of the Board and Chief Executive Officer, immediately served as the leader to set up a project group in person to prepare for the resumption of work, with the active participation by company’s government affairs department, administration department, human resources department, procurement department as well as the EHS (Health, Safety and Environment) team of CMC department. Besides, there were 26 employees stationed at the park on Zhangjiang Road in Pudong, Shanghai during the epidemic, so as to ensure the steady progress of the core projects.
From March to May, Genor Biopharma completed the enrollment of patients with breast cancer in the clinical trial in an efficient manner, while achieving rapid clinical progress beyond the industry level in terms of GB491(Lerociclib).
Total revenue was approximately RMB 3.0 million during the reporting period, primarily generated by providing research and manufacturing services to our customers under fee-for-service contracts.
Research and development expenses were approximately RMB 295.1 million for the reporting period, as compared with approximately RMB 271.5 million for the six months ended 30 June 2021. The spending was mainly attributed to our new drugs development fee and ongoing clinical trials expenses.
Total comprehensive loss was approximately RMB 407.5 million for the reporting period, as compared with approximately RMB 402.9 million for the six months ended 30 June 2021.