echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Medical World News > Ano Pharmaceutical CEO Lu Yang: "C drug" strategy - the post-PD-1 era of new exports of cancer immunotherapy.

    Ano Pharmaceutical CEO Lu Yang: "C drug" strategy - the post-PD-1 era of new exports of cancer immunotherapy.

    • Last Update: 2020-09-11
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Source / Co-writing Interview / snr . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
    more important to the industry is that this new Class 1 drug, coden named AN2025, has adopted a leading global synchronous development strategy.
    "We should be one of only a few pharmaceutical companies in China to do Global Phase III clinical work in accordance with the MNC standard," Ano Pharmaceutical CEO Lu Yang responded, "This trial includes more than a dozen mainstream drug market countries in Europe, America, Japan, China, and is being carried out simultaneously around the world."
    " previous Phase II clinical, Buparlisib also obtained the best data in the same type of scenario.
    , Buparlisib is not only the first drug to increase the medium lifetime (mOS) of second-line treatment for head and neck cancer to 10 months (the industry's best value is about 6 months), but also achieves an objective mitigation rate (ORR) of about 40 percent.
    based on this result, the FDA granted fast-track eligibility and agreed that Ano Pharma should declare the NDA in advance based on ORR's in-period analysis.
    above is just the tip of the iceberg for this potential stock.
    addition to AN2025, Ano Pharma has two new drugs in the clinic.
    , the lysosovirus AN1004 (Pelareorep) project, which can be administered intravenously, is also available on the FDA's Fast-Track;
    know that if the name change from the reform of the shareholding system, Ano Pharma was only four years old.
    this has to generate strong public interest in the Hangzhou innovative pharmaceutical company.
    Clinical pipeline, self-study platform, global talent mechanism Ano to build "China Speed" three "engines" in the Ano Pharmaceutical website pipeline introduction page, Ano Pharmaceuticals only listed three clinical stage products.
    by showing intent, visitors can see that both AN1004 and AN2025 are in phase III clinical phases.
    to understand the foothold that underpins Ano's rapid-forward project, it's clear that it needs to be dug out of the picture.
    is worth noting that AN2025's IND approval time, somewhat reveals the clinical development strategy advantages of Ano Pharmaceuticals.
    approved by the U.S. and Canadian drug regulators before the National Drug Review Center agreed to the Phase III clinical trial program submitted by Ano Pharmaceuticals.
    " Ano adopted the idea of first completing early drug estration validation in Europe and the United States, and then introducing China as one of the registered listings for development in Phase III clinical trials.
    " Lu Yang explained the large difference in clinical speed between China and the United States, said, "The reason for choosing such a development method is partly because the clinical Leading PI in Europe and the United States has a relatively rich first-phase clinical experience."
    , we are developing First In Class drugs, and at this stage, early clinical data from Europe and the United States is more recognized by the industry.
    " but Ano Pharma needs to be more flexible in developing specific combinations of strategies.
    introduced AN2025 from Novaral, the project has been using CDMO institutions in Europe and the United States for clinical sample production.
    Ano Pharma has not made CDMO changes due to the rapid launch of its products.
    and AN0025 is still in the early clinical, involving more clinical drug production, Ano Pharma chose to put it in the domestic, with the drug Mingkangde cooperation to promote.
    more important booster engine is the tumor target verification and screening platform established by Ano Pharmaceuticals.
    According to Dr. He Nanhai, head of Ano Pharmaceutical Life Sciences, this PLATFORM for Immune Therapeutic Discovery and Development immunopharmaceutical development platform can be used not only to quickly identify the function of I/O drugs on immune cells, but also to effectively assess the potential of different I/O drugs in the joint use and the corresponding toxic side effects, providing a "one-stop" solution for the early development of immunologies.
    " through the testing and analysis of a series of drugs that have different effects on the immune system on the PIT-2D platform with a 'full chain' I/O immune response system, we have developed algorithms to effectively predict the drug's dosing, co-use, and later development.
    "He Nanjin added.
    , a graduate of the University of California, Berkeley, was a very good scientist, and had been offered Anoffer, an assistant professor at several U.S. universities.
    his visit to Ano, he led the exploration of many innovative biological mechanisms, including the construction of Ano's current PIN-2D platform.
    " Lu Yang recalls, in order to impress the classmate to start a business together, he has flown to the United States several times, with He Nanhai and his family repeatedly communicate.
    attitude has also brought together a large number of excellent researchers for Ano Pharmaceuticals.
    , passion, efficiency, is Lu Yang to this 30-person management team description.
    Ano Pharmaceuticals accommodates people from many countries who embrace innovation while remaining efficient.
    company as a guideline for action to "accept scientific risks and aversion to any risks other than science."
    In order to achieve the goal, Lu Yang built an open environment for scientific discussion and decision-making: "We will not pay attention to the level of administration, more from a scientific point of view to divide the right to speak, as long as your science is correct."
    ", such a talent collaboration mechanism has allowed Ano Pharmaceuticals to move forward.
    Take the E7046 (EP4 antagonist, modern as AN0025) as an example of a large company that takes several months to evaluate the introduction of products, but at Ano Pharmaceuticals, this cycle takes only two weeks and does not degrade the quality and skip the link because of the speed.
    Cocktail Therapy for Cancer Immunotherapy (Cocktail Therapy) Ano Pharmaceutical "Drug C" Strategy: In addition to the "global new" of oncology immunotherapy in the post-PD-1 era, Ano Pharma was positioned to conquer cancer as a non-lethal and even curable disease through oncology immunotherapy.
    problem is that competition for the circuit has been fierce since two PD-1 antibody drugs were approved for sale in 2014 and cancer entered the era of immunotherapy.
    "because in the age of cancer immunotherapy 1.0, it is itself a revolutionary technology of 'intergenerational'.
    other words, oncology immunotherapy is very early, so you can be very successful if you make a little bit of innovation on that basis.
    " Lu Yang believes, "as the dividend of micro-innovation fades, the risk of failure increases, although some companies in the industry have shifted their focus to targeted therapy, but this is more of a temporary stagnation."
    Lu Yang's trend to replace functional phones with smartphones, believes that immunotherapy is still the main direction of cancer treatment.
    inflection point is to improve the effectiveness of immunotherapy.
    If the single use of CAR-T/PD-(L)1 inhibitors is regarded as the first generation of tumor immunotherapy, the combination of PD-(L)1 inhibitors and other therapies such as chemotherapy is regarded as the second generation of tumor immunotherapy, orR in solid tumor patients is about 20% and 40%, respectively.
    this clearly does not meet clinical needs and it is necessary to achieve alternatives to traditional treatments for oncology immunotherapy, provided that very high response rates, extremely long lifetimes, and very low adverse reactions (AEs) are achieved.
    is exactly where the goal of Ano Pharmaceuticals is.
    the cocktail therapy, which is the third generation of cancer immunotherapy, could eventually achieve a very high ORR.
    Ano Pharmaceuticals U.S. laboratory from the way of action, the current tumor immunotherapy generally has two pathways, one is for immune checkpoints.
    PD-1, CTLA-4 and other molecules expressed in immune cells, can inhibit immune cell function, so that the tumor escape, so it is necessary to intervene in it;
    the use of cell engineering technology to enhance and stimulate the body's anti-tumor immunity, accelerate the removal of tumor cells.
    cocktail therapy developed by Ano Pharmaceuticals combines these two ideas and introduces other immunotherapy therapies to treat the vast majority of solid tumors with maximum efficiency.
    " market has not yet emerged, and this will become Ano's 'killer' in the I/O field.
    " Lu Yang revealed that Ano Pharmaceuticals internally called the project "C drug", when it is put into clinical, is expected to change the current tumor treatment pattern.
    "We believe that future surgery will no longer be a treatment option for patients with mid- to early-stage tumors, starting with 'C-drugs', 80-90% of patients with tumors that can be controlled, and then being able to maintain long-term survival through long-term use of 'C-drugs'."
    " Lu Yang further envisaged.
    when the writing Jun asked, for three or four drugs, the clinical stage will add more work to verify a combination with advantages? Lu Yang pointed out that this is true in theory, but because Ano Pharmaceuticals products do not enter the clinic at the same time, so when the last drug for use, the previous AN1004, AN2025, AN0025 and so on may have been approved for market.
    these foundations will help with subsequent "C-drug" development and make it less difficult.
    really let Lu Yang care is after the "C drug" treatment, there is still a tumor escape of the very small number of patients.
    " For example, after 5 or 10 years, tumor cells may lose MHC (the main tissue compatible complex), T cells can not identify tumors, then what technical means to treat tumors? That's what needs to be considered next.
    " Lu Yang said, Ano Pharmaceuticals in addition to the "C drug" strategy, has begun to lay out the erred situation.
    deep-ploughed drug development, cooperation to promote commercialization and strive to add 1-2 clinical products per year "C drug" strategy is not a sourceless water, its prototype comes from the cooperative exploration of Ano Pharmaceuticals.
    January 2019, based on AN0025's good performance in preclinical studies, Ano Pharma and Mercadon reached an agreement to jointly conduct clinical trials of AN0025 joint PD-1 single-anti-Keytruda for five adaptations, including non-small cell lung cancer, colorectal cancer, trisomy breast cancer, cervical cancer, and uremic cell carcinoma.
    Ano Pharmaceuticals and Mercadon reached a strategic partnership" in the cooperative way, Mercadon provided 'Keytruda' free of charge, with Ano's EP4 antagonist AN0025 to test.
    specific clinical costs are borne by Ano, and Mercadon has the priority to cooperate after the co-use enters Phase III clinical.
    said AN0025 will also explore more combinations with other oncology immunotherapy drugs to support adaptation expansion and market development, "as soon as September this year, Ano will disclose a dear, is still in another large company's internal approval process."
    " previous public reports show that prosthyroid E2 (PGE2) and its subject EP4 can induce inhibitory tumor micro-environment, playing a key role in tumor progression.
    EP4 antagonists can reverse the tumor immunosuppression of PGE2 and enhance the body's immune function by competitively binding to the EP4 subject with prostaglandin E2 (PGE2).
    this mechanism also provides the possibility of ano-medicine tumor immunotherapy.
    PGE2 involved in tumor immunology control mechanism Lu Yang also believes that not only in the AN0025 project, the breakthrough of the whole tumor immunotherapy depends on the academic, industrial and other efforts.
    "every year the industry to do so many clinical trials, behind the need for us to have a very in-depth understanding of science, the future trend of technological development to predict."
    " Ano's achievements are from some of the existing research results, from which point of view, we are very cooperative.
    "Like 'Drug C', it's a lot of clinical trials of tumor immunotherapy in the past, so let's see this direction in the field of tumor micro-environment, and then make valuable choices," Lu Yang continued.
    " for the future of industrialization and commercialization, Ano Pharmaceuticals also has its own considerations.
    to the surprise of the writing jun, although the domestic policy environment is favorable, some park conditions are also quite superior, Ano Pharmaceuticals has not built its own production base idea.
    " some domestic pharmaceutical companies started early, MAH system is not perfect, CDMO industry competition is not clear, these background factors contributed to their own factory necessity.
    but now the environment is different, foreign head MNC is actually streamlining their factory assets, which has become another trend.
    " Lu Yang to Ano Pharmaceutical positioning has always revolved around the world's first innovative drug research and development, the core is innovation, in the existing resources, as soon as possible to bring new drugs to market is the first priority, so the company to spend money on the cutting edge.
    addition to the three new drugs entering the clinic, Ano Pharma currently has a number of preclinical research products.
    hopes that in the future, Ano Pharma can add 1-2 products a year into clinical trials, through different stages of pipeline combinations, to form their own continuous expansion of social and commercial value.
    .
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.