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Thursday, September 2, 2021
SeaGen recent sales by CEO
Sesen Bio approves restructuring plan
On August 30, 2021, Sesen Bio, Inc. (the “Company”) approved a restructuring plan to reduce operating expenses and better align its workforce with the needs of its business following receipt of the complete response letter from the US Food and Drug Administration (“FDA”) regarding the Company’s Biologics License Application for Vicineum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. Execution of the restructuring plan is expected to be substantially complete by the end of the fourth quarter of 2021.
The restructuring plan includes a reduction in the Company’s workforce by approximately 18 positions (approximately 35%) as well as additional cost-saving initiatives intended to preserve capital while the Company continues development of Vicineum. The Company expects that these reductions will decrease its annual cash costs by approximately $5.7 million. The Company currently estimates that it will incur aggregate restructuring charges in the third quarter of approximately $5.8 million, consisting primarily of one-time costs of approximately $3.0 million associated with the termination of certain contracts and severance and other employee-related costs of approximately $2.8 million.
Sesen Bio is committed to the highest standards of ethics and integrity and continues to believe in the safety and efficacy data of Vicineum. The Company intends to work closely with the FDA to understand next steps for Vicineum.
Celsion Reports T-cell , B-cell Response from In Vivo Studies of DNA Vaccine Platform
Results Indicate Induction of Adaptive Immune Response Against SARS-CoV-2
Company Plans Additional Development Work to Further Optimize its Vaccine Platform Through Vector Compositions, Delivery Route, Dosing and Dosing Frequency, and Use of Molecular Adjuvant
Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced results from preclinical in vivo studies showing production of antibodies and cytotoxic T-cell response specific to the spike antigen of SARS-CoV-2 when immunizing BALB/c mice with the Company’s next-generation PLACCINE DNA vaccine platform. Moreover, the antibodies to SARS-CoV-2 spike antigen prevented the infection of cultured cells in a viral neutralization assay. The production of antibodies predicts the ability of PLACCINE to protect against SARS-CoV-2 exposure, and the elicitation of cytotoxic T-cell response shows the vaccine’s potential to eradicate cells infected with SARS-CoV-2.
These findings demonstrate the potential immunogenicity of Celsion’s PLACCINE DNA vaccine, which is intended to provide broad-spectrum protection and resistance against variants by incorporating multiple viral antigens, to improve vaccine stability at storage temperatures of 4o C and above, and to facilitate cheaper and easier manufacturing. Celsion expects to report these data at the International Vaccines Conference to be held on October 19 – 21, 2021.
https://finance.yahoo.com/news/celsion-reports-t-cell-b-120000986.html
Innate Pharma-Astrazeneca Data Tol Be Presented at ESMO 2021 Virtual Congress
AstraZeneca to present new data on monalizumab in combination with durvalumab in a late-breaking abstract on COAST Phase 2 trial
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that two oral presentations will be highlighted at the ESMO 2021 Virtual Congress.
AstraZeneca will present a late-breaker abstract on the COAST Phase 2 trial, highlighting progression-free survival (PFS) results for novel durvalumab combinations with potential new medicines, including Innate’s monalizumab, and oleclumab, an anti-CD73 monoclonal antibody, in unresectable, Stage III non-small cell lung cancer (NSCLC). Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.
In addition, Innate will present pre-clinical data from its next-generation, proprietary, multi-specific NK cell engager platform known as ANKETTM (Antibody-based NK cell Engager Therapeutics).
“We’re pleased with the continued progress of monalizumab, particularly in a combination trial with durvalumab in unresectable, Stage III non-small cell lung cancer,” said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. “Furthermore, the pre-clinical ANKETTM data at ESMO validates the importance of NK cell science and its role in the next wave of immunotherapy, while serving as the scientific engine to further advance our clinical pipeline. We look forward to seeing both oral presentations at ESMO.”
Presentation details
Monalizumab:
Title: COAST: an open-label, randomised, phase 2 platform study of durvalumab alone or in combination with novel agents in patients with locally advanced, unresectable, Stage III NSCLC
Date and time: September 17, 2021, at 2:20 p.m. CEST
Presentation number: LBA42
https://finance.yahoo.com/news/monalizumab-anket-data-presented-esmo-060000303.html
Abbott Acquires Walk Vascular, LL
Abbott (NYSE: ABT) announced today that it has acquired Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive mechanical aspiration thrombectomy system designed to remove peripheral blood clots. Walk Vascular's peripheral thrombectomy systems will be incorporated into Abbott's existing endovascular product portfolio. Financial terms were not disclosed.
"The acquisition of Walk Vascular fits well into our leading vascular device offerings and further drives Abbott's ability to provide one-of-a-kind endovascular therapy solutions to improve patient care," said Julie Tyler, senior vice president of Abbott's vascular business. "Walk Vascular's technology provides physicians with tools to efficiently remove dangerous clots from blood vessels to improve patient care."
Walk Vascular's JETi Peripheral Thrombectomy System and next-generation JETi AIO (All In One) Peripheral Thrombectomy System are unique aspiration systems for the removal of intravascular clots, known as thrombus, that can reduce blood flow and lead to serious complications for patients. The innovative JETi systems are designed to break-up and remove clots from the peripheral vascular system while reducing the risk of dislodged clots. The systems are backed by real-world clinical experiences, and Walk is currently enrolling up to 250 patients in the United States and Europe in the JETi Registry.
Both the JETi Peripheral Thrombectomy Systems have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the aspiration and breaking up of soft emboli and thrombus from the peripheral vasculature, as well as CE Mark in Europe and approvals in other countries.
Pfizer, Merck launch large new trials of oral COVID-19 drugs
- Pfizer and Merck & Co. each launched pivotal clinical studies of new experimental oral COVID-19 drugs, building on previous work to provide outpatient alternatives for patients.
- Merck is studying whether its medicine, molnupiravir, can prevent COVID-19 in adults who live with a symptomatic patient with a confirmed coronavirus infection. The trial will include about 1,300 patients who will take molnupiravir or a placebo every 12 hours for five days.
- Pfizer said the first of about 1,140 patients has received a dose of its therapy in a trial to treat symptomatic patients who have not been hospitalized and aren’t at high risk of severe illness. The dosing of the Pfizer treatment – a combination of an older medicine and an experimental drug called PF-07321332 – is also every 12 hours for five days and measured against a placebo.
Pfizer executives told investors in July that they see a sustained market for COVID-19 therapies as virus mutations and vaccine hesitancy leave the world exposed. The company estimated that hundreds of millions of patients may be candidates for its new COVID-19 therapy.
Pfizer’s treatment is a combination of protease inhibitors, a type of medicine long used to battle HIV. The idea is to block an enzyme that the coronavirus needs to replicate, helping the body combat the intruder. The combination includes ritonavir, a 25-year-old drug sold under the brand name Norvir by AbbVie.
The company in July also began studying the combination in non-hospitalized COVID-19 patients who are at increased risk of severe disease. Pfizer told investors it’s hoping to seek emergency approval of the therapy in the fourth quarter.
Merck is working with Ridgeback Biotherapeutics on its option, which is also being studied as a treatment for patients with mild to moderate COVID-19 and at least one risk factor for a poor outcome. Data from that trial is due before the end of the year.
The new study, dubbed MOVe-AHEAD, is taking place in more than a dozen countries, including the U.S., Brazil and South Africa. Researchers will look at how many patients develop symptomatic COVID-19, how many experience an adverse event and how many drop out because of an adverse event after 14 days.
Wednesday, September 1, 2021
Rapid Antigen Tests Twice a Week May Be Enough to Catch New COVID-19 Cases
At-home direct rapid antigen tests may catch all new COVID-19 cases if used twice a week, new data suggest.
Researchers had 257 employees use the tests twice a week for six months and also undergo regular qRT-PCR tests. The home tests caught all 15 cases, 11 on day one or two, according to the report published in JAMA Network Open.
"We were faced with an issue to solve," said the study's senior author, Laura Holberger, vice president of strategic partnerships at BioInnovation Labs, LLC, a privately held network of co-working labs with locations in biotech hub cities across the country.
"Employees of biotech companies can't work from home," Holberger said. "We had to come up with a solution to help advance the research of the member companies."
"The main take home is that with this protocol we were able to detect all 15 infections and prvent all cases of community spread during the pandemic," Holberger said.
The new study included workers at three co-working laboratories in the Massachusetts cities of Cambridge and Boston. At the time, the prevalence of COVID-19 in this area ranged from less than 1% to 8%.
Participants self-collected nasal swab specimens twice weekly at home for the Direct Antigen Rapid Test (DART) from E25Bio Inc., and the findings were compared with laboratory qRT-PCR tests.
"The process of administering the antigen test involves swabbing both nostrils, suspending the sample in a small volume of buffer and using a dropper to apply the sample to the test cassette," Holberger explained. "The sample flows over the test window which reads out the result with a positive control."
Information on symptoms was collected contemporaneously. Self-reported race and ethnicity were also collected in accordance with Department of Health and Human Services and Food and Drug Administration reporting guidelines for non-laboratory-based tests.
The median participant age was 35, 120 (46.7%) were women, 161 (62.6%) were white, 49 (19.1%) were Asian, 29 (11.3%) were Hispanic, and 8 (3.1%) were Black. A total of 2,951 pairs of nasal swabs were self-collected by participants and tested by qRT-PCR and DART.
The sensitivity of DART within days 0 to 12 of symptom onset was 78.9% (60 of 76 swabs), and the specificity of DART was 97.1% (2,791 of 2,875 swabs).
The duration of SARS-CoV-2 nucleocapsid and RNA detection for individual infections ranged from one to 12 days, with peak levels observed between 2 and 6 days of symptoms (median, three days).
The sensitivity of DART was calculated for each day. DART sensitivity was 96.3% (26 of 27) within days zero to three of symptoms. Eleven participants tested positive on day one or two. One was presymptomatic the day of their initial DART positive result. One infection was detected by qRT-PCR one day before DART. For one positive participant, DART detected infection one day before qRTPCR did.
There are a number of issues with the report, said Dr. Otto Yang, a professor of medicine in the division of infectious diseases and of microbiology, immunology and molecular genetics at the David Geffen School of Medicine at the University of California, Los Angeles.
First, Dr. Yang said, "they apparently use a home-brewed RT-PCR kit, and not an FDA-approved commercial kit. Is their test as good as the commercial tests? What was their limit of detection? It's true that RT-PCR is the gold standard, but not all RT-PCR tests are equal."
Beyond that, "the overall number of patients is only 15," Dr. Yang said in an email. "By any standard, that's pretty small. They inflate the number by mentioning the number of swabs since there were multiple swabs per patient, but the bottom line is that 15 is quite few."
With so few participants, "the sensitivity and specificity numbers are hard to trust; they are doing these per swab rather than per patient," Dr. Yang said. "It would be easy to get better specificity numbers by running more samples on negatives."
Moreover, "many people are asymptomatic--especially if vaccinated--or shed virus for a couple of days before showing symptoms," Dr. Yang said. "How does the test compare to PCR in those situations? From the standpoint of public health, this is critical. Confirming a diagnosis in someone who is already symptomatic is useful, but not as useful as finding infection in people without symptoms."
The paper is in line with the current knowledge about antigen testing for COVID-19, said Dr. Heba Mostafa, an assistant professor of pathology at the JHU School of Medicine.
"Rapid antigen testing has lower sensitivity (can cause false negatives) compared to the gold standard nucleic acid amplification methods (for example, PCR), yet highly specific, Dr. Mostafa said in an email. "The sensitivity of antigen testing is largely highest when viral loads are high and within the first few days after symptoms onset."
"Even though the gold standard for diagnosis so far remains nucleic acid amplification, as the authors mentioned, the cost could be a limitation as well as turnaround time in certain locations where molecular methods are not readily available," Dr. Mostafa said. "In these situations, antigen testing could be helpful, especially if used frequently for diagnosis and quarantine. The impact of frequent antigen testing on reducing the transmission of SARS-CoV-2 has been proposed but to the best of my knowledge was not experimentally shown yet."
SOURCE: https://bit.ly/3tfCClz JAMA Network Open, online August 27, 2021.
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