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Friday, July 17, 2020

Dosing underway in ADC Therapeutics’ LOTIS 3 combo trial in blood cancer

July 17, 2020

The first patient has been dosed in ADC Therapeutics’ (NYSE:ADCT) Phase 2 portion of LOTIS 3, a Phase 1/2 clinical trial evaluating loncastuximab tesirine (Lonca, formerly ADCT-402) in combination with ibrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL).
The trial is intended to support the submission of a supplemental BLA to the FDA. The company is on track to file a BLA for Lonca as monotherapy for the treatment of relapsed or refractory DLBCL in H2.
The 161-patient trial will enroll three cohorts: non-germinal center B-cell-like (non-GCB) DLBCL, GCB DLBCL and MCL.
Previously, as reported on June 12, ADC’s lonca showed encouraging action in blood cancer studies.

Lilly’s mirikizumab tops Novartis’ Cosentyx in psoriasis study

Eli Lilly (NYSE:LLY) announces results from a Phase 3 clinical trial, OASIS-2, comparing mirikizumab, an inhibitor of the p19 subunit of interleukin-23 (IL-23), to placebo and Novartis’ (NYSE:NVS) Cosentyx (secukinumab) in patients with moderate-to-severe plaque psoriasis.
The study met the primary and all key secondary endpoints.
At week 16, the proportions of patients achieving at least a two-point improvement in a scale called Static Physician’s Global Assessment (sPGA) at week 16 in the mirikizumab, Cosentyx (per labeling) and control arms were 79.7%, 76.3% and 6.3%, respectively. The proportions achieving PASI 90 (almost clear skin) were 74.4%, 72.8% and 6.3%, respectively. Both were the primary endpoints.
At week 52 the proportions of patients achieving the sPGA endpoint in the Cosentyx (per labeling), mirikizumab (250 mg Q4W/125 mg Q8W) and mirikizumab (250 mg Q4W/250 mg Q8W) arms were 68.5%, 83.1% and 83.3%, respectively.
At week 52, the proportions of patients in the three groups achieving PASI 90 were 69.4%, 81.4% and 82.4%, respectively.
Additional data will be reported at future medical conferences.
Lilly is also testing mirikizumab in ulcerative colitis and Crohn’s disease.

Euro panel accepts Bristol Myers Squibb CAR T application for lymphoma

The European Medicines Agency (EMA) has accepted for review Bristol-Myers Squibb’s (NYSE:BMY) marketing application seeking approval of lisocabtagene maraleucel, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two prior therapies.

Applied DNA Sciences rallies on positive COVID-19 vaccine data

July 17, 2020

Nano cap Applied DNA Sciences (NASDAQ:APDN) and development partner Takis Biotech announce that all five of their LinearDNA vaccine candidates induced seroconversion in mice. IgG antibodies against the SARS-CoV-2 spike protein were produced by day 14 with “significantly enhanced” responses by day 38.
Applied DNA CEO Dr. James Hayward says, “We look forward to supporting further studies by Takis with a goal of entering human trials in early autumn. We believe no single vaccine will provide the security we need as a global population, and that our LinearDNA vaccines will complement those already marching toward the market.”
Takis CEO Dr. Luigi Aurisicchio says, “Our results are very encouraging, and we have good reason for optimism. We must proceed with toxicology studies and move on to large animal studies as we march toward the clinic. We are now moving to engage third parties to help take us to market on the basis of these encouraging results.”
Shares up 56% premarket on average volume.

Thursday, July 16, 2020

US, UK, Canada catch Russia hacking into coronavirus vaccine projects

The UK, US and Canada have discovered hackers working on behalf of the Russian state launching attacks against coronavirus vaccine development projects.
Criminals working for the hacking group Advanced Persistent Threat 29 (APT29), also known as Cozy Bear, have been caught attacking pharmaceutical businesses and academic institutions involved in vaccine development. Officials in the three countries believe these have been attempts to steal intellectual property and information about potential vaccine candidates.
The hackers used “custom malware” that’s not been previously linked to Russia and a number of publicly known vulnerabilities in widely used software, such as VPNs. These have been accompanied with spear-phishing attempts that have looked to gather login details to “internet-accessible” parts of the organisations targeted.
They’re so confident in the attacks emanating from Russia that the UK’s National Cybersecurity Centre (NCSC), Canadian Communication Security Establishment and various US security agencies, including the NSA and Department for Homeland Security, have decided to publicly call out APT29. The public shaming is the latest in an increasingly hostile approach to hacking by groups working on behalf of Russia and comes at the same time as an admission from the UK government that Russia tried to influence the 2019 general election.
APT29 is widely believed to be linked to the Russian intelligence services and has been involved in a high number of cyberattacks in recent years, including the hacking of the Democratic National Committee ahead of the 2016 US presidential election. On the US hacks, APT29 worked alongside fellow Russian hackers Fancy Bear and APT28.
“We condemn these despicable attacks against those doing vital work to combat the coronavirus pandemic,” Paul Chichester the NCSC’s director of operations said in a statement. The NCSC also published an advisory notice detailing the efforts it had seen from APT29 in its attacks on vaccine developments. Officials have not commented on whether the attacks were successful but also have not ruled out that this is the case.
The advisory issued by the cybersecurity groups hints towards there being some success – even if this is just scoping out potential elements of organisations that are vulnerable to attack. “In recent attacks targeting Covid-19 vaccine research and development, the group conducted basic vulnerability scanning against specific external IP addresses owned by the organisations,” the NCSC guidance states. “The group then deployed public exploits against the vulnerable services identified.”
The NCSC also states that APT29 has been “successful” in using publicly known vulnerabilities to “gain initial footholds” in the universities and businesses it has been attacking. The advisory lists a number of well-known vulnerabilities that APT29 looked to take advantage of. These include flaws within Citrix networking systems and VPNs. It is believed that once details of the vulnerabilities have been publicly disclosed, the state-backed actors have been quick to attempt to exploit them in an attempt to strike before security experts can implement fixes.
“Upon gaining access to a system, the group likely drops further tooling and/or seeks to obtain legitimate credentials to the compromised systems in order to maintain persistent access,” the NCSC says in its warning notice. “The actor is likely to use anonymising services when using the stolen credentials.”
In some of the incidents seen by the NCSC and its US and Canadian counterparts, APT29 has deployed custom malware. They believe this to be the WellMess malware and a new version, called WellMail. The malware has been in use since at least 2018, the NCSC says. “WellMess is a lightweight malware designed to execute arbitrary shell commands, upload and download files. The malware supports HTTP, TLS and DNS communications methods,” the cybersecurity body says.
It’s not the first time during the pandemic that hackers have sought to gain advantage of the ongoing health crisis. There has been an increase in attacks against businesses as employees have moved to work from home, with hospitals and other medical organisations also targeted.
The APT29 attacks against vaccine groups are continuing, the NCSC says. It’s advisory concludes by saying: “APT29 is likely to continue to target organisations involved in COVID-19 vaccine research and development, as they seek to answer additional intelligence questions relating to the pandemic.”

Tracking COVID-19 in wastewater from plane and cruise ship passengers

As Australia considers how to safely welcome international visitors again, testing wastewater systems on long-haul planes and cruise ships could provide crucial information on detecting the presence of the COVID-19 virus in incoming passengers.
A new paper in the Journal of Travel Medicine reported that testing of aircraft and cruise ship upon arriving at their destination had detected genetic fragments of the COVID-19 virus, SARS-CoV-2, a step forward in using this test as an additional public health management tool.
Researchers from The University of Queensland (UQ) and Australia’s national science agency CSIRO worked with to test on-board wastewater from lavatories.
Minister for Industry, Science and Technology Karen Andrews said Australian scientists are doing outstanding work and making a difference in the fight against coronavirus.
“Our science and research communities are among our greatest assets in our efforts to not only overcome this pandemic, but also to assist in the economic recovery from COVID-19,” Minister Andrews said.
“The ability to test wastewater from planes and is another piece of the puzzle as we look to the future of travel and keeping Australians safe.”
CSIRO Chief Executive Larry Marshall said rapidly pinpointing hotspots for COVID-19 will help keep all Australians safe as we start to travel again.
“Responding to a pandemic is not just about the race for a vaccine, Australian is supporting our by delivering for partners like Qantas,” Dr. Marshall said.
“Our relationship with air travel goes back to the 60s, and today our unique coatings already protect aircraft, so it’s great to be trusted to keep Australia flying while helping to stay ahead of any potential new outbreaks.”
Paper co-author and Professor Jochen Mueller from UQ’s Queensland Alliance for Environmental Health Sciences said this tool could help as governments and transport industries develop plans to minimize transmission associated with resuming international .
“This could provide additional peace of mind to track and manage infection and play an important role in opening up long-haul flights or cruises resuming,” Professor Mueller said.
The test provides an early warning of infection, as the virus sheds in the stools of infected passengers even before they show symptoms.
Lead author and CSIRO researcher Warish Ahmed said the virus fragments in the wastewater were unviable, so not infectious.
“The study indicates that surveillance of wastewater from large transport vessels with their own sanitation systems has potential as a parallel data source to prioritize clinical testing among disembarking passengers,” Dr. Ahmed said.

Explore further

More information: Warish Ahmed et al. Detection of SARS-CoV-2 RNA in commercial passenger aircraft and cruise ship wastewater: a surveillance tool for assessing the presence of COVID-19 infected travelers, Journal of Travel Medicine (2020). DOI: 10.1093/jtm/taaa116


J&J in talks with Japan, Gates Foundation to lock in deals on COVID-19 vaccine

Johnson & Johnson (JNJ.N) is in talks with the government of Japan and the Bill and Melinda Gates Foundation about locking up allocations of its potential COVID-19 vaccine as it prepares to kick off human trials, the company’s Chief Financial Officer Joseph Wolk told Reuters in an interview.
More than a hundred vaccines are under development to try and stop the COVID-19 pandemic, and drugmakers including J&J are working to ramp up supply for their vaccines in the face of unprecedented demand.
J&J has already agreed to prioritize an allocation to the United States as part of its funding agreement with the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA), Wolk said.
The Bill and Melinda Gates Foundation would focus on allocating any vaccine it acquired to developing countries, Wolk added. Reuters previously reported that J&J is also in talks with the European Union.
“Nothing has been finalized yet. We continue to have those discussions,” Wolk told Reuters. “People from the countries and the organizations we mentioned want to lock in a certain minimum level of capacity that they would get.”
Wolk said that the “general construct” of the discussions is likely to take a form similar to AstraZeneca Plc’s (AZN.L) deal with the U.S. government, which provided $1.2 billion in drug development aid to the U.K. drugmaker in exchange for locking in a delivery of around 300 million doses for fall 2020.
AstraZeneca has also signed a contract with France, Germany, Italy and the Netherlands for up to 400 million doses of its potential vaccine. It has also partnered with non-profits to ensure distribution to developing countries.
Wolk added that these discussions will help Johnson & Johnson determine pricing for its vaccine, which the U.S. drugmaker intends to sell on a not-for-profit basis during the pandemic.
“The more demand we have the better and lower that cost would potentially be,” Wolk said.
The company aims to begin manufacturing the vaccine later this year, depending on its success in clinical trials, he added.
In its Thursday earnings call, J&J said it plans to start its first human trials of its COVID-19 vaccine on July 22 and could kick off late-stage studies as soon as September.