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With the new crown vaccine standing under the flashing lights, can mRNA reproduce the highlight moment in the field of cancer?
On October 12, local time, Merck paid $250 million to Moderna to advance research on mRNA-4157 as a personalized cancer therapy in combination with Keytruda, Moderna President Dr.
Stephen Hoge said that he was quite excited
that mRNA could become a new model of cancer treatment in the future.
Stephen Hoge, president of Moderna, said he is excited
that mRNA can become a new model for cancer treatment in the future.
The arrival of the global new crown epidemic has directly promoted the "heat" of mRNA vaccines, a relatively unpopular research field, from the cold bench to the spotlight, Moderna, BioNtech and other overseas companies rely on mRNA vaccines to earn a lot of money, and a number of mRNA companies
have also appeared in China during the same period.
It is worth noting that with the saturated production of overseas new crown original strain vaccines, the aura of wealth brought by mRNA new crown vaccines has gradually dimmed, where is the next imagination space of mRNA technology?
This is not only the answer that the industry wants to seek, but also the question
that mRNA companies in China are still struggling with the new crown vaccine need to answer.
Behind the big deal between Merck and Moderna, there is obviously a next step for the combined use of mRNA cancer vaccines and PD-1, will this provide some new ideas for the domestic mRNA industry?
01 Domestic vaccine institutions are still surrounding the new crown, and overseas mRNA companies have turned?
Domestic vaccine agencies are still surrounding the new crown, and overseas mRNA companies have turned to ? According to public information, mRNA-4157 is a personalized tumor vaccine, encoding up to 34 neoantigens
according to the specific mutations of the targeted patient.
It is currently in the phase II clinical research stage as an adjuvant therapy in combination with Merck's PD-1 antibody K drug for the treatment of high-risk melanoma patients
.
Merck and Moderna have been working together on this vaccine for nearly 6 years
since 2016.
Under the agreement, Merck pays $250 million to Moderna, and the two companies will split costs and profits
equally.
As soon as the news was announced, Moderna rose more than 12% premarket and closed up 8.
3%, the largest one-day gain in nearly two months
.
Compared with other vaccines, mRNA technology not only has the characteristics of high efficiency, safety, and short production cycle, but also its strong clinical performance and imagination in
the future.
At the 2019 ASCO Annual Meeting, Moderna preliminarily disclosed the phase I activity data of mRNA-4157 combined with K drug combination
.
Its disease control rate for malignant tumors is as high as 90%, surpassing many marketed targeted and immunotherapy drugs
.
The trial is expected to receive primary data
in the fourth quarter of 2022.
A median follow-up of 8 months showed that 11 patients in the monotherapy group remained disease-free
.
In the combination treatment group, 6 out of 20 patients had a clinical response to the combination; These included one complete response and five partial responses
.
Six patients were in stable condition and eight were deteriorating
.
.
When given to patients as monotherapy or in combination with K drugs, no vaccine-related adverse events
for PCV were reported.
In addition to Moderna, BioNtech, one of the three giants of mRNA, is also planning the combined use
of tumor vaccines.
BioNtech partners are Roche, which is currently in phase II clinical trials
in combination with PD-L1 antibodies to treat cancer.
in combination with PD-L1 antibodies to treat cancer.
Compared with overseas institutions, domestic mRNA companies are quite quiet after a short financing highlight, and the progress that has been reported one after another still revolves
around the new crown vaccine.
On October 9, the mRNA new crown vaccine developed by Abogen Biosciences and Watson Biologics was granted emergency use authorization (EUA) in Indonesia, which is also the first new crown mRNA vaccine
approved for clinical trials in China.
However, Indonesia has always been regarded by the industry as one of the easiest countries to obtain EUA, and compared with the domestic listing that investors generally expect, this EUA has lost a lot
of color.
From the beginning of 2020 to August 2021, Abogen Biosciences has completed five rounds of financing, with a total public financing of nearly RMB5.
8 billion, of which the Series C financing alone exceeded RMB5 billion (US$700 million), and more than 25 investment institutions such as Temasek, Yunfeng Fund, Lilly Asia Fund, Gao Rong Capital, and Qiming Venture Capital have flocked to it
.
As the company with the highest financing amount in China's mRNA track and the fastest industry progress, the current report card handed over by Abogen Biosciences is not a big
gap for many investors who invest and pay attention to the mRNA track.
8 billion yuan.
In addition to Watson and Abogen, in April 2022, Microbiome announced that the mRNA new crown second-generation vaccine was approved for clinical trials, CanSino Biologics said that the mRNA new crown vaccine it developed had been approved for clinical trials, Genting Sun Yao announced that it cooperated with China Resources Pharmaceutical to accelerate the development and commercialization of mRNA vaccines, and CSPC said that the mRNA new crown vaccine it developed had been approved by the State Food and Drug Administration for clinical research
.
In terms of progress, the current second only to Abogen Biologics is Emmi's mRNA new crown vaccine LVRNA009, which was approved for clinical trial
in China in March 2021.
There are many big bulls
among the founders of domestic mRNA companies.
InBev, the founder of Abogen Biosciences, once worked for Moderna, and Wu Chenyan, the founder of Minor Hengkang, was a senior chief scientist
of Pfizer.
However, compared with the technical accumulation and patent accumulation of foreign mRNA tracks, there is still a long distance
.
mRNA technology has existed for a long time, from the 60s of the 20th century was proposed, after nearly 60 years of research and development period before the product landed, BioNTech and Moderna were established in 2000 and 2010 respectively, after more than ten years of research and development accumulation, most of the domestic related enterprises were established in 2016-2019, the momentum of the latter is obvious
.
On the mRNA track that strives to keep up, where will domestic companies go next, smashing the new crown or holding a lot of cash to turn around, this cooperation between Merck and Moderna can be said to provide a new idea
.
02 PD-1+ mRNA vaccine, a new hope for combined research and development?
PD-1+ mRNA vaccine, a new hope for combined research and development? Undoubtedly, at present, most domestic pharmaceutical companies have regarded PD-1 as the basic drug of tumor immunotherapy, and have taken the combination of drugs as an important measure for
PD-1 to expand the market space.
For example, Junshi's fundraising plan disclosed in June this year showed that among the R&D projects supported by its fundraising, its PD-1 product JS001 (trepilimab injection) planned to invest more than 2.
7 billion yuan, involving 13 co-use projects
.
JS001 combination therapy programs include an international multicenter phase III clinical study in combination with standard chemotherapy for postoperative adjuvant therapy for gastric or gastroesophageal junction adenocarcinoma; International multicenter phase III clinical study in combination with lenvatinib and standard chemotherapy versus standard chemotherapy regimen for the first-line treatment of unresectable advanced intrahepatic cholangiocarcinoma; and an international multicenter phase III clinical study for the perioperative treatment of operable locally advanced head and neck squamous cell carcinoma
.
Looking at Hengrui, according to the information disclosed in its 2022 semi-annual report, Hengrui Carrelizumab has 16 new indications under development, of which only one indication for relapsed and refractory classic Hodgkin lymphoma is being developed as a single drug, and the remaining 15 new indications are all the development of combination therapies, involving chemotherapy, apatinib, fametinib, etc
。 BeiGene's tislelizumab joint R&D pipeline includes chemotherapy, HER2 bispecific antibody + chemotherapy, sulfatinib, fruquintinib, OX40 target BGB-A445, P13k target BGB-10188, HPK1 target BGB-15025, TIGIT target osperilimab, etc
.
Overall, the current joint development of PD-1 by domestic enterprises is still focused on the research and development of combined chemoradiotherapy, targeted drugs and
other immunomodulators.
Combined drugs include paclitaxel, glumetinib, ipilimab, apatinib, fruquintinib, etoposide, etc.
, while related companies continue to combine with emerging products and therapies, such as combination therapy
with PARP inhibitors, TIGIT, TGFβ/TGFR, TLRs, oncolytic viruses and cancer vaccines.
However, in terms of the combination of PD-1 and cancer vaccines, there is good news from
giant companies.
In March this year, Regeneron and BioNTech expanded their strategic R&D cooperation to jointly promote the clinical trial of BioNTech's cancer candidate BNT116 in combination with the PD-1 inhibitor Libtayo for the treatment of patients with
advanced non-small cell lung cancer.
Although the results of the phase II trial are not yet known, Merck's move can also be described as a landmark event in the research and development of PD-1 combinations, and it also gives hope to many companies exploring the combination of PD-1
.
If Chinese pharmaceutical companies develop PD-1 products, they have the foundation to compete with global pharmaceutical companies, then how should Chinese pharmaceutical companies stand out in the era of PD-1 combination? Especially under the new cycle of medicine, how should Chinese pharmaceutical companies break the involution, get out of the quagmire of homogenization, achieve further innovation and upgrading, develop internationally competitive products, and quickly complete the leap from "0" to "1" and upgrade to the FIC era of international standards?
Whether it is between biotech and big pharma, or between biotech, there is no doubt that strong cooperation will become an important magic weapon
to win the new cycle.
For local pharmaceutical companies, how to promote the optimal allocation of resources and reasonable division of labor is a problem
that must be faced and answered in the new cycle.
