Inovio Pharmaceuticals
was one of the earlier companies to identify a potential vaccine
candidate against COVID-19, but the company has run into manufacturing
problems that have stymied its development plans, while other biopharma
groups have pushed ahead in their own development programs.
Inovio’s development issues for its vaccine candidate have become
mired in a conflict with the contract manufacturing organization it has
worked with on previous projects. Because of the issues with the CMO,
Korea-based VGXI, Inc., Inovio has filed a lawsuit
seeking to break the impasse and transfer an existing supply agreement
to another agency. VGXI, according to the company’s lawsuit, is unable
or unwilling to manufacture its vaccine candidate in large quantities.
Inovio has been pushing to develop its vaccine candidate, INO-4800, but
without the large-scale manufacturing necessary, the company’s efforts
have been slowed down considerably. Inovio had a goal of producing one
million doses of INO-4800 by the end of 2020 to support its clinical
trials and emergency use. VGXI could not meet that demand.
Inovio and VGXI have been partners since 2008. VGXI produces and
supplies the DNA plasmids for Inovio’s research and early clinical
trials for its product candidates. Inovio has no purchase commitments
under this supply agreement. The company said purchase agreements are
determined on an individual purchase order basis. Under the Supply
Agreement, Inovio said it agreed to treat VGXI as its most favored
supplier for DNA plasmids, and VGXI agreed to treat Inovio as its most
favored customer.
As COVID-19 took gripped the world, Inovio began to develop its vaccine candidate and in April, received permission
from the U.S. Food and Drug Administration to initiate a Phase I study.
As the company eyes a potential Phase II, VGXI informed Inovio that is
does not have the capacity to manufacture the company’s full order of
DNA plasmids on the requested timeline, nor would it be able to
manufacture plasmids for the commercial sale of INO-4800, if it achieved
regulatory approval.
On June 3, Inovio filed a complaint in the Court of Common Pleas of
Montgomery County in Pennsylvania seeking emergency relief to compel
VGXI to “facilitate the transfer of manufacturing methods, using VGXI’s
technology, under the parties’ existing supply agreement,” the company
said in a filing with the U.S. Securities and Exchange Commission. The
technology transfer is permitted under the existing supply agreement
and, if it goes through, would allow Inovio to find another manufacturer
who can meet its needs. When VGXI told the company it did not have the
capabilities to meet its demands, Inovio said it began discussions with
other third-party contract manufacturers, as permitted by the Supply
Agreement. Inovio struck a deal with Ology Bioservices Inc. and
Richter-Helm BioLogics GmbH & Co. KG to support large-scale
manufacturing of INO-4800 and sought to have VGXI turn over the
technology required. VGXI refused, which prompted the lawsuit.
In its filing,
Inovio said it believes the widespread availability of INO-4800 is
essential in quest to develop a medication against the disease that has
been linked to the deaths of more than 390,000 people across the globe,
including 108,000 in the United States.
https://www.biospace.com/article/inovio-files-complaint-to-break-ties-with-cmo-over-covid-19-vaccine-production-issues/
Friday, June 5, 2020
China in thick of race for COVID-19 vaccine
Aimed squarely at the prestige from being first in
the global race for a SARS-CoV-2 vaccine, China’s government, including
the military and several state-backed companies, has committed “hundreds of millions” of dollars and cleared regulatory barriers to accelerate R&D.
Domestic drugmakers have already been ramping up
production as Chairman Xi Jinping has committed to share a domestically
developed vaccine with the world.
Five Chinese companies are behind five of 10
vaccine candidates being testing in humans according to WHO. Two are
being developed by state-run China National Biotec Group Co.
Another group, tied to China’s military, has received the nod to run a late-stage study in Canada.
Tianjin-based CanSino Biologics, together with the
military, was the first to publish study results (Phase 1) in an
established medical journal (The Lancet).
China is a step behind with vaccine-making
technologies, however. Four of the candidates in clinical trials were
produced by an older method using inactivated viruses, the same approach
long-used for flu, hepatitis A, polio and rabies vaccines. Moderna’s
top candidate, currently in a Phase 2 trial, is an RNA vaccine.
Privately held Sinovac Biotech Ltd., along with
several government entities, is conducting Phase 1 & 2 studies on
its candidate in Jiangsu province.
Regardless of who wins the race, Chinese companies
should play a key role in vaccine manufacturing considering their
capacities. The country is already one of the top producers in the
world.
Both the China and the U.S. expect to have a vaccine available by year-end.
https://seekingalpha.com/news/3580791-china-in-thick-of-race-for-covidminus-19-vaccineRoche revenue may pick up after 2022 – CEO
In an interview with Swiss newspaper Finanz und Wirtschaft, Roche (OTCQX:RHHBY -0.4%)
CEO Severin Schwan said he “sees a chance” that revenues will ramp up
after 2022 driven by demand for new products. Additional points:
Tecentriq has “big” potential, can envision market boosting sales estimates after study results.
Company has “very early stage” program for COVID-19 antiviral but it will take “years” for clinical studies to wind up.
Expects 2020 revenue erosion of $4B related to Avastin, Mabthera and Herceptin.
https://seekingalpha.com/news/3580850-roche-revenue-may-pick-up-after-2022-ceoSorrento up on encouraging COVIDTRAP data
Sorrento Therapeutics (SRNE +14.6%) is up in early trade on the heels of its announcement of positive preclinical data on STI-4398 (COVIDTRAP).
STI-4398, an ACE2 (angiotensin-converting enzyme
2)-Fc fusion protein, binds to the SARS-CoV-2 spike protein. Results
from an in vitro assay showed that it “completely inhibited” the ability
of the coronavirus to infect VERO/E6 cells (cell culture) at a low
concentration.
The company intends to advance the candidate as both a treatment and preventative therapy for COVID-19.
Last month, it announced that
another COVID-19 candidate, STI-1499, a neutralizing antibody,
completely inhibited SARS-CoV-2 infection in an in vitro experiment at
low concentration.
Shares spiked in response to the company calling it a “cure” but retraced. Including today’s action, the stock is more than 55% below the intraday high of $10.00 on May 18.
https://seekingalpha.com/news/3580801-sorrento-up-15-on-encouraging-covidtrap-dataXpresSpa, Hyperpointe team for COVID-19 screening, testing at US airports
XpresSpa (NASDAQ:XSPA) +40% teams
up with HyperPointe to create its newly formed business unit XpresCheck
to provide COVID-19 screening and testing at U.S. airports.
XpresCheck has begun construction and intends to
start a pilot program at New York’s airport terminal 4 by the end of
June, offering testing for airline employees, contractors and workers,
airport concessionaires and their employees, TSA officers, and U.S.
Customs and Border Protection agents.
XpresCheck also plans to expand with locations in additional airports to serve travelers as well as industry personnel.
Source: Press Release
https://seekingalpha.com/news/3580755-xpresspaplus-40-teams-up-hyperpointe-for-covidminus-19-screening-and-testing-u-s-airportsLegend Biotech prices IPO, trading kicks off today
Legend Biotech (LEGN) has priced its IPO of
18,425,000 American Depositary Shares (ADSs) at $23, each representing
two ordinary shares. Gross proceeds should be ~$433.8M.
The Nanjing, China-based biopharmaceutical firm
develops cell therapies for cancer and other indications. Lead candidate
is LCAR-B38M (in China) for the potential treatment of multiple
myeloma. The asset is being developed ex-China by Johnson & Johnson
(NYSE:JNJ) unit Janssen Biotech as JNJ-4528.
2019 Financials: Revenue: $57.3M (+17%); Net Loss: ($133.0M) (-999%); Cash Flow Ops: ($83.1M) (-127%).
Trading commences today.
https://seekingalpha.com/news/3580756-legend-biotech-prices-ipo-trading-kicks-off-todayBritish Airways owner threatens legal action over Covid quarantine plans
British Airways owner IAG is
considering mounting a legal challenge to quarantine rules which are due
to come into effect on Monday.
The dramatic move marks another sign of a breakdown in relations between the airline and the UK government.IAG boss Willie Walsh told Sky News that airlines had not been consulted on the 14-day quarantine period for people arriving in the UK.
He said he expected other airlines to also mount legal challenges.
“We think it’s irrational, we think it’s disproportionate and we are giving consideration to a legal challenge to this legislation, so we’re reviewing that with the lawyers later on today,” Mr Walsh told Sky News.
“I suspect there are other airlines who are doing so, because it’s important to point out there was no consultation with the industry prior to enacting this legislation and we do believe it is an irrational piece of legislation.”
Airlines and holiday firms have been arguing against a two-week quarantine period for anyone arriving in the UK that will be enforced from 8 June. Travellers to the UK will be required to isolate for 14 days or face a £1,000 fine.
The government has said that the period is needed to “keep the transmission rate down and prevent a devastating second wave” of coronavirus.
However, industry body Airlines UK has said quarantine “would effectively kill off air travel”.
The plans have caused friction between the government and British Airways. On Thursday the airline refused to attend a meeting with Home Secretary Priti Patel to discuss the quarantine rules.
British Airways is under huge financial strain due to the pandemic, and has said it is currently burning through its cash reserves at a rate of around £1m per hour.
Mr Walsh told Sky News that the Bank of England has loaned it £300m, which is the “maximum amount” available to it.
“We have done everything that is within our power to boost the cash balance of British Airways. We’re exhausting every single opportunity we can,” he said.
BA has faced heavy criticism from some MPs over a plan to slash jobs while accessing the government’s furlough scheme.
The airline has been under fire said for plans to cut 12,000 jobs and weaken terms and conditions for its remaining staff.
It announced the redundancies just weeks after putting 30,000 workers on the job retention scheme which pays workers’ wages.
The letter said travel could be possible for people – without quarantine – between destinations “deemed safe from coronavirus”.
The so-called “air bridges” would allow visitors from countries where coronavirus infection rates are low into the UK, without having to self-isolate.
It is understood that the government is working on a list of countries it is hoping to secure air bridge agreements with, which include all major European tourist destinations such as Portugal, Spain and France as well as Australia and Singapore.
However, the government’s official position is that the idea is “under consideration”, and not established policy.
https://www.bbc.com/news/business-52938831
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