FAQs(category)

Drug Research & Development
  • During the institutional investor conference in the second quarter of the year, your company mentioned that in addition to the FB825 2a clinical trial carried out in the United States, it also carried out 20 individual clinical trials in Taiwan to find the effective physiological indicators of FB825 in the use of patients with atopic dermatitis. These indicators should have a great impact on the revenue generated from the sale of FB825 after subsequent authorization. Has your company found this indicator in clinical trials in Taiwan?
    The target of FB825 is CemX of human membrane-bound IgE, which will increase IgE B cell apoptosis after binding. When IgE cells in atopic dermatitis patients are activated, they cause an overreaction in the immune cells, which is positively correlated with the severity of the disease. However, clinically, the physiological indicators of patients with atopic dermatitis are quite complicated. It may be interfered with by multiple antigens and cytokines at the same time, so that the effect of the drug may be inconsistent due to individual differences in patients, leading to a deviation in clinical trials. For this reason, in addition to the 2a trial conducted in the United States, Oneness Biotech also conducted a human trial on 20 persons with FB825 to test their effective responder biomarkers at the National Taiwan University Hospital. At present, FB825 has been found to be an effective response physiological index in patients with atopic dermatitis, and a patent application is now pending approval. As Taiwan has an island-like climate, the dermatitis symptoms are more complicated than those in the United States. Therefore, this physiological index is helpful for the implementation of subsequent international clinical trials.
  • Thank you for your hard effort, Oneness Biotech! I am a clinical physician and a shareholder living in the southern part of Taiwan. Here are my questions for the company:
    1. The global burn care market is expected to grow at a compound annual growth rate of approximately 7.1%. The main reason for the market growth is the increase in the incidence of burns and the increase in demand for minimally invasive treatment. According to the National Center for Biotechnology Information (NCBI) data, 67 million people are burned every year in the world. Is your company prepared for such a huge burn care market?
    2. Although the medical devices on the ON101 new drug/medical devices combo are still confidential, I would like to ask if the company is planning to move towards the development of ON101 medical device combo for burn care. I personally believe that a dressing suitable for large wounds like burns is needed, of which the inner layer can be used to absorb exudate while the outer layer is attached with a waterproof dressing to protect the wound from bacteria; As for the amount of ON101 used, if you follow the method for treating diabetic foot ulcer, the cost should be very unbearable for the family. Is your company planning to study the application of ON101 on a larger area of burn wounds, without using too much cream and also taking into account economic and therapeutic effects? Thank you!
    1. The current goal is to first obtain the drug permit license of ON101 in treating the most hard-to-heal chronic wounds of diabetic foot ulcers (DFU), as well as the access permit for major global markets. This allows the product to enter the market as soon as possible and meet the urgent needs of DFU patients.
    2. In Q4 of 2020, a 30-person exploratory human trial of ON101 on Venous Leg Ulcers (VLU) will be conducted to further expand the indications for the future.
    3. The burn care market and drug demand cannot be met by the drug mechanism and nature of ON101, and it also involves the market positioning of ON101 in the future. Hence, there is currently no consideration for clinical studies on burn wounds.
  • According to the company's previous reply
    1. The results of Phase III Clinical Trials and the improvement of wound healing will be divided into two articles for submission to journals. The submission time for Phase III clinical results is this month (August).
    2. As for the wound healing mechanism, the third animal experiment is currently under specimen analysis. The analysis and statistics must be completed so that a patent application can be filed before submission. It is currently not possible to estimate the time and date of the publication.
    In response to reply 2, can you explain the current progress? Thank you!
    For the third animal experiment performed on the wound healing mechanism, Oneness Biotech has completed the in-house analysis. After receiving the results of the outsourced analysis project at the end of September, Oneness Biotech will proceed with subsequent patent applications and paper writing.
  • The company previously talked about the feasibility assessment of COVID-19 if the first phase of FB704A is successfully unblinded. At what stage has the company's feasibility assessment been carried out? Thank you very much, Oneness Biotech!
    1. FB704A is currently aiming at two indications with more potential, which are severe neutrophilic asthma and systemic sclerosis. Perform phase II exploratory clinical trial first, and then do phase II after seeing the effect to reduce the risk of directly doing phase II.
    2. The use of FB704A in the treatment of COVID-19 has high uncertainty (currently, the effect of Anti-IL6 in the treatment of COVID-19 is not confirmed). At the same time, we must also consider the global competition of vaccines. Therefore, it will be ranked as the secondary endpoints to be developed.
  • Greetings to you, for ON101's third animal test, has your company received the results of the outsourced analysis project? In addition, has ON101 been named? Thank you!
    1. The third outsourced analysis project of repeated verification in the diabetic mouse animal model has generated a final result, where the wound healing of the ON101 group was significantly better than that of the control group. By activating specific chemokines and growth factors in ON101, both M1 and M2 are regulated to promote the mechanism of wound healing in diabetic rats. Starting from the next month (November) onwards, Oneness Biotech will take a further step to enroll trial subjects in the clinical trial to test the mechanism of drug action on the trial subjects. Confirm the mechanism of ON101 in treating animal wounds and its performance in treating human wound tissues, including the changes of immune cells and the regulation of M1 and M2 to complete ON101's action mechanism on the human body.
    2. The 20 naming that meet the drug specifications have been completed with the CRO. Right now, The CRO is conducting interviews with 580 international professionals with experience in the treatment of DFU before the case can be finalized later on.
  • According to the information provided by the company, OB318 is a VEGF inhibitor that inhibits the growth of cancer cell. Does it belong to drugs like tyrosine kinase inhibitors (TKI)? If so, it is difficult to achieve the target tumor response rate with TKI alone according to the current liver cancer treatment mechanism. Therefore, it is advised to consider combining with other immune checkpoint inhibitors in the Phase II clinical trial to meet the current trend of liver cancer treatment.
    1. The mechanism of action of OB318 includes inhibiting the message transmission path of cancer cells, inhibiting the angiogenesis of VEGF and enhancing the expression of tumor suppressor genes/proteins.
    2. Combined medication is the current trend of cancer treatment, with liver cancer being the most difficult to treat. After verifying the anti-cancer effect of OB318 on humans, Oneness Biotech will decide whether to use the single drug alone or in combination with other drugs including immune checkpoint for liver cancer treatment.
  • As mentioned in the previous question, it is incorrect to state that there are no other liver cancer drugs after Nexavar. Currently, the US FDA approves Atezolizumab plus Bevacizumab for the 1st line unresectable HCC, Nivolumab plus ipilimumab for the 2nd line sorafenib-experienced HCC, and even Lenvatinib has obtained the 1st line unresectable HCC indication. Therefore, the Q&A session may need revision. Thank you!
    1. The reply to the above question refers to no single drug approved for the treatment of liver cancer except for Nexavar drugs.
    2. Other drugs currently approved for the treatment of liver cancer, such as levatinib and regorafenib, are similar to Nexavar and are small molecule drugs with multiple kinase inhibitors.
    3. As for the combination of drugs, the US FDA approved the combination of atezolizumab and bevacizumab for the treatment of unresectable or metastatic HCC this year. Although bevacizumab is an antibody-drug, its role of neutralizing VEGF and blocking the message transmission of VEGF are mechanically similar to that of Nexavar drugs.
    4. Another type of combination drug is the US FDA-approved nivolumab plus ipilimumab this year to treat liver cancer for which sorafenib (Nexavar) had no effect. Both of these drugs are immune checkpoint inhibitors, and the actual efficacy after launching for sale is still unclear. There are doubts and concerns over the immune checkpoint inhibitors as having a low response rate to treatment and are currently only used as second-line drugs.
  • Greetings to you, has your company completed the production of investigational products for the Phase IIa FB704A clinical trial? In addition, it was mentioned in the Q&A session yesterday that your company is coming up with a plan for the unmet medical needs and it was also mentioned on the English website of your company that FB704A has great potential for SSc. Will it be evaluated as SSc-ILD in the Phase II exploratory clinical trial? Thank you!
    1.The investigational product for FB704A is in the final filling stage and can support the first phase II exploratory trial as scheduled.
    2.Since FB704A acts on neutralizing IL6 and is closely related to SSc-ILD, Oneness Biotech has already conducted clinical drug preparation and program design. However, the key pulmonary fibrosis problem of SSc still requires a longer treatment period to show any treatment effect. Therefore, in addition to the ongoing evaluation of the Phase II exploratory trial of SSc-ILD, based on factors such as the best indications for FB704A, the possibility of clinical success, and the economic benefits, Oneness Biotech’s upcoming Phase II exploratory trial is aimed at becoming closely related to IL6. And it is still an indication of Neutrophilic Asthma (Neutrophilic Asthma) that has unmet medical needs worldwide.
  • Greetings, Oneness Biotech! Although cytokine storm can kill people in a short period of time, the FB704a study shows that it has a significant effect on il6. With sufficient budget for research and development, can the company conduct a Phase 2a exploratory clinical trial on cytokine storm in addition to the current scheduled disease? Although there may be some challenges in the process of enrolling trial subjects, everyone needs a life-saving shot.
    1.Cytokine Storm is closely related to IL6. To this end, Tocilizumab (trade name: Actemra) developed by Roche and Chugai has been approved for use in CAR-T-induced cytokine storms, and there have been many successful cases in the treatment of severe cases of influenza. The biggest challenge for the clinical trial on the cytokine storm is the unexpected nature of subject enrollment and the requirement of a very long trial period. At present, Oneness Biotech plans to take unmet medical needs and indications with market potential as the primary goal to accelerate the launching of this drug.
    2. Drugs for indications such as cytokine storm can be provided to patients in urgent need with the package insert "off-label use".
  • First of all, congratulations to Oneness Biotech ON101 for the successful unblinding process, and thanks to the team members for their hard works over the years. The month for the submission of "ON101 How to Promote Wound Healing Mechanism" to an internationally renowned journal is in August. Is it a time for submission or publication? If it is a time for submission, when will the paper estimated to be published? Thank you!
    1.Regarding the results of Phase III Clinical Trials and the mechanism of improving wound healing, Oneness Biotech will separate them into two articles for the journal, and the submission time for Phase III clinical results is this month (August).
    2.As to the wound healing mechanism, the third animal experiment is currently under a sample analysis but the analysis and statistics are yet to be completed. After completion, a patent application will be filed before submission. Currently, the publication time cannot be estimated.
  • ON101's mechanism in the Q&A session is described as follows: 2. In the wound healing model of dB/dB diabetic rats, Oneness Biotech found that ON101 can induce the production of specific chemokine in the wound tissues of diabetic rats and promote immune cell infiltration. In particular, the accumulation of M2 macrophage can also inhibit wound inflammation, stimulate blood vessel proliferation, and ultimately achieve a complete wound healing, which is the general wound healing mechanism.
    1.Can this drug/medical device also be used as a simple wound healing drug for general use? Such as the healing of atopic dermatitis wounds caused by scratching or accidental wound caused by trauma. Or does this mechanism of action have to be established upon an environment with specific diseases (such as diabetes)?
    2.If ON101 can promote wound healing, can it also have the effect of scar removal? Or can it reduce the formation of scar tissue?
    3.In the United States, ON101 is applied for marketing in the form of medical devices. Why is it not marketed as a drug? I remembered that the patent protection period and the monopoly period of medical devices and drugs are different. Compared with drugs, are medical devices disadvantageous in patent protection?
    1.ON101 Phase III clinical trials are indicated for diabetic foot ulcers (DFU), which is an unmet medical need worldwide. Since there are many treatment drugs for general wounds, it is not a new target for Oneness Biotech's development. Atopic dermatitis is mainly due to immune disorders and whether ON101 is effective for wounds caused by scratching has not yet been tested. After the drug permit license for diabetic foot ulcer (DFU) is passed, the overall consideration will be given to the new indications.
    2.ON101 does not form excessive tissue proliferation and scars in the treatment of diabetic foot ulcers (DFU). As for the effect of scar removal, it is not included in the clinical evaluation nor is there any relevant data so far.
    3.The patent protection period will not be different depending on whether the product belongs to the drug or medical device. Therefore, the patent protection of medical devices will not be more disadvantageous than the drug.
  • Today (July 20), it was published in the Economic Daily News that your company has additional animal experiments. What kind of testing is that? What is the estimated date of completion?
    In animal experiments, diabetic mice were used as experimental subjects to explore the mechanism of ON101. The dissection of the experimental mice was completed this week, and tissue samples were analyzed.
  • Have you already finished writing research articles and submitting papers to international scientific journals (July 17)? Thank you!
    Since this article is very important for the subsequent development of ON101, Oneness Biotech is very cautious that the analysis of the detailed data in Phase III clinical results has been completed. At the same time, Oneness Biotech’s repeated animal experiment on wound healing of diabetic mice with drug action mechanisms is now nearly complete. These will be combined with the final clinical study report (CSR) written and completed by the British consulting company on July 25, before the data, charts, and final content are verified in detail. The articles are expected to submit to the international journal in August.
  • The company will list varicose ulcers and bedsores as the development targets for the new indications of ON101. Should the above targets go through phase I to phase III of the clinical trial as well? Or are there other ways to speed up the drug in becoming applicable to the new indications?
    ON101 has proven to be clinically effective and safe by the clinical trials for diabetic foot ulcers (DFU). For the redevelopment of indications such as varicose ulcers and bedsores, the efficacy can be directly verified by conducting Phase III Clinical Trials.
  • Can you explain the mechanism of the cancer patent obtained in Japan and published by your company on June 25? What kind of new drugs does it belong to in your company?
    This patent is a patented platform technology, named "cancer-associated fibroblasts for maintaining the stemness of cancer stem cell". The core of the patented technology lies in the production or long-term in vitro culture of cancer stem cells, which can be used to screen drugs that can inhibit cancer stem cells and to develop novel cancer stem-like cell markers as well as the study of related mechanisms of cancer stem cells. SNS01 is the lung cancer stem cell antibody drug developed using this technology platform.
  • Since FB704A is developing in the direction of treating COVID-19, it should be pathologically feasible.
    1.Please tell shareholders why it is feasible from your own medical perspective.
    2.If it is feasible, what is your plan?
    1.The pulmonary infiltration of COVID-19 is mainly caused by cytokine storm. The cause of cytokine storm comes from IL-6 and FB704 is a monoclonal antibody that inhibits IL-6. At present, treatment with IL-6 receptor antibodies has achieved partial therapeutic effects.
    2. After FB704A Phase I Clinical Trials data analysis is completed in July 2020, Oneness Biotech will evaluate the feasibility with reference to the statistics generated from the Phase I Clinical Trials.
  • Is SNS01 also a drug screened by the Fully Human Antibody Library? Is the target "CDX" of the drug first discovered by the company in cooperation with National Taiwan University? Are there any other company currently conducting researches on this target? Thank you!
    1.Yes, SNS01 is to inhibit the specific target (CDX) on lung cancer stem cells to treat the metastasis and recurrence of lung cancer. For this target, Oneness Biotech has used the Fully Human Antibody Library to screen three monoclonal antibodies with a requirement for subsequent modification and optimization of antibody.
    2.Currently, no other company conducts research on this target in the field of oncology.
  • The previous Q&A mentioned that "a pre-clinical study of the new drug and a go/no go evaluation is expected to be conducted for SNS01 in the third quarter of 2020"; In the 2020 shareholder meeting manual, there is already an introduction to the drug available. Does it mean that the company has decided to put SNS01 through the stage of clinical trial? Thank you!
    1.SNS01 is a developmental target of the new drugs when Fountain Biopharma merged with Synovel Sciences. After Oneness Biotech merged with Fountain Biopharma, it was included in the Oneness Biotech development pipeline for the new drug. At present, the monoclonal antibodies under the development of Oneness Biotech include FB825 and FB704A and both of which are subject to clinical trials. It was originally scheduled to choose between SNS01 and FB918 (anti-IL33) for follow-up development as Oneness Biotech could not afford to put four monoclonal antibodies through clinical trials at the same time considering its existing funds. At present, the team chooses to put FB918 through the R&D process first and invest more resources on SNS01 R&D when the funds become sufficient. Both FB918 and SNS01 are monoclonal antibodies developed by Oneness Biotech using its own Fully Human Antibody Library.
    2.At present, Oneness Biotech is continuing to modify and optimize the SNS01 antibody. Since this is a brand-new anti-cancer target, its drug action mechanism is continuously being explored while its research and development are currently on the go.
  • May I ask if ON101’s second midterm analysis fails to meet the standards, what are the subsequent plans in the future?
    The results of the second interim analysis of ON101 are still subject to TFDA’s agreement on whether to unblind. Once the result is confirmed, Oneness will explain the compliance and subsequent plans.
  • According to the review article of JAMA. 2020;323(18):1824-1836, if a cytokine storm occurs in COVID-19 critically ill patients, the use of anti-IL6 agent will reduce the damage of the patient’s immune system to the lungs and help the patients to overcome the difficulties. There are also many ongoing trials (Tocilizumab, Clazakizumab). The company’s FB704A has completed the Phase Ia trial to prove its safety in humans. In theory, can it be applied for the clinical trial of COVID-19 patients? For the company, are the current resources and manpower sufficient for such planning? Has the company considered cooperating with international pharmaceutical companies to launch similar clinical trials? Thank you!
    1.Anti-IL6 drugs have been used in the patients with acute and severe infections, and some do see relief effects. But so far, no anti-IL6 drugs have passed for this type of indications worldwide, mainly because of the difficulty in designing such a large-scale clinical trial and performing proper subject enrollment.

    2.The pharmacological mechanism of anti-IL6 drugs is to reduce the release of cytokine by suppressing the immune response, but at the same time, it may also lead to a decrease in the inhibition of the virus. Whether it is clinically applicable to patients with acute and severe infections requires more supportive evidence and strict verification.

    3.At present, the clinical trials of anti-IL-6 drugs in the treatment of COVID-19 are described as follows:
    a.For Sanofi’s marketed drug, Kevzara (sarilumab, anti-IL6 receptor), it was announced at the end of last month that it showed no consistency in the use of drugs (200 mg) on a trial of 457 people. At present, the drugs of 200 mg were replaced by the drugs of 400 mg but only on the critically-ill patients. According to the judgment, its response rate to COVID-19 still falls short of expectation.
    b.For Roche’s marketed drug Actemra (Tocilizumab, anti-IL6 receptor), although the clinical trials have seen a significant reduction in mortality rate and dependence on the respirator, the deterioration of IL-6 and CRP in patients also occurred in different trials.

    4.Since the COVID-19 is a global pandemic, it is the most convenient for international pharmaceutical companies to put their launched drugs into anti-epidemic clinical trials from the perspective of public health. Even if it fails, it will not detract from its originally-approved indications. Although these launched IL-6 drugs have accumulated enough experience in human trials, they still show inconsistent efficacy in the treatment of COVID-19. Since FB704A is a drug under research and development, it is not appropriate to hurriedly put the drugs into anti-pandemic clinical trials and treat the severely infected patients as trial subjects. Oneness will carefully plan the second-phase indication of FB704A based on scientific evidence.
  • The company’s original research published in Frontiers in Pharmacology in May 2019 shows that the mechanism of action of PA-F4 may be to reduce the secretion of IL-1b by inhibiting NLRP3 inflammasome activation and NF-kB activation; Is there a plan to reproduce the mechanism in human bodies and explore the correlation between the mechanism and the efficacy? If so, is the study expected to be submitted to an international scientific journal in the third quarter of the year? Thank you!
    1.The mechanisms of NLRP3 inflammasome and NF-kB are part of the ON101 mechanism of action, and they are not the key chemokine currently being studied.
    2.Oneness found in the dB/dB wound healing model of diabetic mice that ON101 can induce specific chemokine in the wound tissue of diabetic mice and boost the infiltration of immune cells. In particular, the aggregation of M2 macrophages can inhibit wound inflammation, stimulate vascular proliferation, and eventually heal the wound which is the healing mechanism for general wounds. That is to say, ON101 uses a special pharmacological mechanism to transform complex chronic diabetic wounds into normal wounds for healing, which is also the first discovery of its kind in the world.
  • Did FB825 and FB704A originate from Fully Human Antibody Library? Thank you!
    FB825 is obtained from a murine antibody through humanization engineering. FB704A is a fully human antibody, which is obtained after screening and optimizing IL6 by using the Fully Human Antibody Library.
  • Was the Fully Human Antibody Library exclusively licensed to Fountain Biopharma Inc. (now incorporated into Oneness Biotech) by Academia Sinica? Thank you!
    The Fully Human Antibody Library was completed in collaboration with Fountain Biopharma and Academia Sinica. After Fountain Biopharma was incorporated into Oneness Biotech, it became a technology platform for Oneness Biotech.
  • For the fully human antibody library originally belongs to Fountain Biopharma Inc., as long as there is a clear target (e.g. IL-6, GAD-65...), there is a chance to select candidate antibody drugs; In the future, with the progress of scientific research, it will bring more drugs with development potential for Oneness Biotech, is it right? Thank you!
    Yes, the fully human antibody library contains more than 20 billion (2×1011) antibodies. As long as the treatment target is confirmed, the fully human antibody library can be used to screen out monoclonal antibodies. Anti-IL6 (FB704A) monoclonal antibody, which has been developed by the fully human antibody library, has entered Phase II human trials in the United States this year. At present, the anti-IL33 new target monoclonal antibody candidate (FB918) has also been developed using the fully human antibody library and is still under preclinical development. Oneness Biotech will not blindly develop new antibodies because each new antibody must be funded by 1 billions dollars at a follow-up, and the target must be carefully selected before deciding whether to develop it or not.
  • Are there more researches to be done for ON101? If so, to what extent should the researches be done?
    ON101 is already in the NDA process in Taiwan. After the additional documents are submitted, it must wait for the competent authority to review and decide whether it can be launched. Unless required by the competent authority, Oneness does not need to do any more research for the drug permit license in Taiwan.
    ON101 is an international new drug. To apply for a marketing license in other markets, it is necessary to decide whether or not to conduct further research according to the requirements of the competent authorities in charge of that region.
  • Is the role of key chemokine explained by the currently known biochemical mechanism, or is it a brand new mechanism? In the future, is there a chance to directly synthesize this chemokine to make small molecule drugs? Thank you!
    As a known protein that has a brand new mechanism for healing the diabetic foot ulcers, chemokines were significantly increased in ON101 before applied to the wound for tissue repair.
  • Have you found a key chemokine for ON101? Has the paper been written so that it can be submitted to the scientific journals as soon as the unblinding is completed? Which scientific journal will the paper expected to be submitted to?
    At present, the key chemokine closely related to wound healing has been found in the chronic wound test of diabetic rats. To be specific, Oneness has launched repetitive animal experiments on a great scale. At the same time, academic human trials have also been conducted on a small scale to verify the performance of key chemokines in human wound healing.
    It is expected that in the third quarter (Q3) of 2020, the results of the mechanism of action, together with the complete clinical results of the three-phase trial, can be submitted to the internationally renowned journals for publication.
  • Are there other new drugs currently in the process of development?
    In addition to FB825 and new DFU drugs, the company has the following new drugs in the process of research and development:
    1. OB318 Antrodia Cinnamomea anticancer drug The new Antrodia Cinnamomea anti-cancer drug OB318 has acquired the first phase clinical trial license from the US FDA and the domestic TFDA. In order to reduce costs and improve market competitiveness, we have continued to improve the fermentation process for more than 3 years, increasing the mycelium output by 25 times, and completed the bridging study of the process change in 2019. It is expected to launch the Phase I clinical trials of OB318 on humans in 2020 to explore human safety and pharmacokinetics properties.
    2. SNS01 Anti-CDX Antibodies targeting cancer stem cells As a new target of cancer stem cells, the CDX is the reason why the company developed a new antibody-drug SNS01 for the treatment of tumors and metastases. At present, the manufacturing conditions for fully human antibody have been established, and a small amount of antibody production has been conducted to verify the cytotoxic effect on cancer stem cells. SNS01 is expected to complete preclinical drug research in the third quarter of 2020, go/no go evaluation, and decide whether to be included in the company’s product line and enter the preclinical development stage for the new drug.
    3. FB918 New Antibody Drug for Asthma/Chronic Obstructive Pulmonary Disease Interleukin aggravates T helper 2’s immune and inflammatory reactions, not only playing an important role in asthma, but also serving as one of the main pathological mechanisms that lead to chronic obstructive pulmonary disease. In this regard, the FB918 antibody may be used in the treatment of asthma and chronic obstructive pulmonary disease. The company has now developed a full-human antibody FB-918, completed the binding activity test after small-batch production as well as the functional testing of two different cells, where antibody optimization is currently underway. It is estimated that the preclinical research will be completed for FB-918 before the end of this year. After go/no go evaluation, it will enter the pre-clinical development stage and continued to move towards the goal of IND.
  • The company announced that it has begun to organize the patents of Antagonistic CTLA-4 aptamers and antagonist PDL1 aptamers. Is there any plan to start research and trials on cancer immunotherapy?
    The PDL1 aptamer (SNA02) developed by the company has been shown to inhibit the growth of CT-26 colon carcinoma cell by 60% in a mouse models for cancer research, which is similar to the data of PDL1 antibody.
    However, the half-life period of aptamer drugs is too short, and the aptamer drugs will be excreted by mice on average in one day. Therefore, the long-term survival rate of mice with cancer after treatment cannot compete with long-acting PDL1 antibody. The company’s research and development team is trying to use chemical modification and patented polyploid technology to extend the half-life of the drug.
    As PD1/PDL1 antibody drugs flood the market, the company’s immune-checkpoint antagonizing aptamers should not only have cost advantages but also the same efficacy and convenience as antibodies before any developmental value kicks in.
    Nucleic acid-based drugs are innovative drug types entering a fast-developing period. Compared with mature antibody drugs, although nucleic acid-based drugs are full of prospects, the uncertainty is also high. The company will continue its steady R&D with a cautious attitude.
  • Many biotechnology companies have established the platform of therapeutic antibody for protein drug research and development, such as HUMORIGIN and GLYCONEX in Taiwan, and Regeneron abroad. What are the advantages and disadvantages of Oneness's all-human antibody library screening platform?
    The advantages of Oneness's all-human antibody library screening platform includes:
    1. The antibody library screening platform has an antibody potency of up to 200 billion, with a wide range of antibodies and a high probability of successful screening.
    2. Coming from healthy people and cancer patients, the antibody genes are diverse and widely used.
    3. The screening period is short and can be applied to antibody optimization.
    With rich experience and ability in antibody research and development, the Oneness R&D team can design different drug screening modes for different pathogenic mechanisms to increase drug screening efficiency and success rate. The antibody library can screen out the antibodies that are the targets of many listed drugs. Oneness uses the new therapeutic antibody FB704A (anti-IL6) independently developed by this antibody library and is about to complete the first phase of clinical trials in the United States. In addition, there are still other all-human antibodies that have entered the stage of research and development.
  • Regarding the key role of chemokine in ON101, is there sufficient data to prove the direct relationship between this mechanism and the efficacy? Will the proof of this relationship affects the unblinding result? Will it raise the possibility to send additional documents for the application of a drug permit license?
    1. Please refer to the Investor Relations/Investor Q&A/By Category/Drug R&D of Oneness official website, link URL: By Category: https://bit.ly/3bswegd
    2. The main conditions for obtaining a drug permit license are the drug's effectiveness and safety to the human body, with the mechanism of action playing an adjunct role. This chemokine is not an indicator of a clinical trial and will neither affect the results of unblinding nor lead to the requirement of additional documents.
  • Greetings to you, does ON101 have the same effect for diabetic foot ulcers as it is for bedridden bedsores? My family had bedridden bedsores that have been unable to heal, making him suffer for a long time. If it is effective, ON101 can not only save more patients but also generate greater demands from its customers.
    Pressure ulcers, also known as bedsores, are chronic wounds like diabetic foot ulcers. Judging from the mechanism of action of ON101, this indication should have a therapeutic effect, but there is no complete clinical data to verify. In the future, venous ulcers and bedsores will be listed as targets for the development of new ON101 indications.