Fierce Biotech's 2021 biopharmaceutical Waterloo event inventory

Compiler: Fan Dongdong

During the COVID-19 pandemic, companies such as Moderna, Pfizer, and BioNTech responded and adjusted very quickly, and introduced new vaccines and treatment methods from the laboratory to the clinic in record time
.

However, some companies are not so lucky.

01 Bojian's controversial AD drug Aduhelm

01 Bojian's controversial AD drug Aduhelm

The controversial approval of Biogen's Alzheimer's disease drug Aduhelm was undoubtedly the company's biggest problem last year
.

Although there are serious doubts about whether the drug is effective and whether it is safe enough for the general population, the company eventually managed to push it past the US FDA's approval line

In addition to the controversial Aduhelm, Bojian also experienced a series of R&D failures
.

In February of this year, a Phase II study on BIIB054 (cinpanemab) for the treatment of Parkinson's disease failed

02 Cassava suspected of trial fraud

02 Cassava suspected of trial fraud

Aduhelm's approval also stimulated the revival of Alzheimer's research by biopharmaceuticals, and Cassava is such a company that wants to ride a ride
.

Cassava is the core business simufilam, the therapy does not attempt to clear amyloid in the brain, but by stabilizing scaffold protein called Protein A filament play a role

First of all, the mechanism of the drug does not have sufficient scientific basis.
Previously, no other laboratory has confirmed the connection between filaggrin A and Alzheimer’s disease or its effect on disease models.
Cassava is also suspected of using human brain after death.
Organize experiments to test the efficacy of simufilam
.

Other issues criticized by the company involve data anomalies and human manipulation, including image tampering and so on

03 The Cel-Sci anti-cancer magic drug bubble burst

03 The Cel-Sci anti-cancer magic drug bubble burst

Beginning at the end of 2019, Cel-Sci's stock price began to rise, rising from around US$3 per share that year to a long-term high of nearly US$20 per share in 2021, and then plummeted again
.

The core of the stock price roller coaster is Multikine, a drug that claims to cure all cancers

When Cel-Sci's immunotherapy drug candidate missed its primary endpoint, the longest phase 3 clinical trial in the world finally reached a definite conclusion that Multikine failed to improve the overall survival achieved by standard care for head and neck cancer Rate
.

Cel-Sci began its third phase as early as 2010.

However, Cel-Sci CEO Geert Kersten did not face the failure head-on, but warned investors that "do not understand the agreement and statistical analysis, and have ulterior motives for Cel-Sci's stock price
.

" Through some alternative data mining, Kersten tried to think that the test results were successful

04 CytoDyn uses the epidemic to manipulate stock prices

04 CytoDyn uses the epidemic to manipulate stock prices

CytoDyn has been working on leronlimab to treat HIV and prevent graft-versus-host disease but has made no progress
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Last year the company’s hype about the 3-phase leronlimab trial missed its primary and all major secondary endpoints, but the company borrowed from COVID-19 gimmicks, and its stock price continued to rise in the process
.
After the test structure failed, the company, like Cel-Sci, continued to work hard to dig out the positive side of the data
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However, even after applying age adjustments, the study did not meet its primary endpoint and all other primary and secondary endpoints for patients in the modified intention-to-treat population
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However, CytoDyn insists on emphasizing that the primary endpoint is "closer to a statistically significant value
.
" In May of this year, the U.
S.
FDA publicly condemned CytoDyn's attempt to artificially select the so-called positive data from two completely failed studies, which was completely wrong and discordant
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The US FDA said, “It is clear that the currently available data do not support the clinical benefit of leronlimab in the treatment of COVID-19, and all analyses of this therapy have not reached statistical significance
.
” In addition, the company’s stock price abnormality has also been investigated
.
In August of this year, the U.
S.
Department of Justice and the U.
S.
Securities and Exchange Commission subpoenaed the company and its executives, specifically requesting CytoDyn to publish documents and information related to the public statement of leronlimab.
In addition, CytoDyn is also facing a class action lawsuit.
Feasibility in -19 made false and misleading statements
.

05 Zymergen science fiction technology may be reduced to a scam

05 Zymergen science fiction technology may be reduced to a scam

The emerging synthetic biology company Zymergen once had all the conveniences: a large IPO of up to 575 million US dollars, a popular synthetic biology platform, at the intersection of biology and technology, and a new "biomanufacturing" approach
.
However, all of this shattered in August.
In just a few months, Zymergen's market value has shrunk by more than two-thirds.
Zymergen announced that its market value has shrunk by nearly $2.
5 billion, and there will be no sales this year
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In addition to this tragic news, its former CEO and co-founder also announced his departure
.
Former Illumina CEO Jay Flatley is now the company's interim CEO
.
The core of the Zymergen platform is the promise of using genetically engineered microorganisms to assemble breakthrough new materials for electronics, agriculture and healthcare
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Zymergen describes itself as a "biomanufacturing company that uses biology to reimagine the world.
" The official website shows the company's core product Hyaline, which is a polyimide film that is mainly used for foldable displays and touch sensor panels
.

Zymergen launched its first product to the market in December last year.
Zymergen stated that it has established a product certification process with customers.
It is expected that it will take 6 to 18 months to obtain the so-called profit, but it is now delayed due to manufacturing problems.

.
Prior to this, Zymergen attracted investment from companies such as SoftBank and Goldman Sachs.
In 2018, it raised up to 400 million US dollars to help it target the 3 trillion US dollars worth of chemical and materials manufacturing.
At present, these financing seem to be in vain
.

06 U.
S.
FDA negligence and maladjustment

06 U.
S.
FDA negligence and maladjustment

Since the new U.
S.
President Bibi took office, the U.
S.
FDA seems to have been unable to rectify its medical expertise and objective independence.
Especially during the epidemic control period, the agency has been subjected to unprecedented political influence and has made a series of shocking decisions.

.
The spread of the intervention of Biden’s government forces to FDA regulation is the biggest problem facing the agency.
Appointment has also become a battle between all parties in the White House.
The most confusing thing is that Biden took office at the beginning of this year, 10 times after the appointment.
No new FDA commissioner has been appointed after this month
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In addition, the impartiality of the US FDA has also been widely questioned, including Aduhlem's approval process.
Bojian was accused of bribing FDA officials and other "abnormal coordination" methods to promote the drug's final regulatory approval
.
Although the FDA’s external expert advisory committee rejected Aduhlem completely last year, earlier this year, the FDA under the leadership of Woodcock ordered the approval of the drug, which directly caused some AdComm expert committees to choose to leave.
How did the drug with false evidence of its efficacy pass the rigorous FDA scrutiny
? Respect for science and precedent is the cornerstone of regulatory agencies.
However, the US FDA has completely lost its basic credibility in a series of regulatory decisions such as Aduhelm, and has been spurned by the majority of Americans
.

Reference source: Fierce Biotech's Rotten Tomatoes 2021