Resubmission of NDA is On Track for First Half of Q2 24
Extended Cash Runway into 2025
Wednesday, March 6, 2024
'GSK's ViiV upbeat on ultra-long-acting HIV treatment study'
GSK announced on Tuesday that its specialist GIV joint venture with Pfizer and Shionogi, ViiV Healthcare, had reported encouraging results from its phase one clinical trial of an investigational formulation of cabotegravir, termed cabotegravir ultra long-acting (CAB-ULA).
The FTSE 100 pharmaceuticals giant said the study showed that CAB-ULA allowed for dosing intervals of at least four months, marking a significant advancement in the development of ultra-long-acting injectable HIV treatment and prevention medications.
It said the findings, presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2024) in Denver, Colorado, demonstrated the potential of CAB-ULA to double the current dosing interval.
Importantly, the intramuscular administration of CAB-ULA exhibited a favourable safety and pharmacokinetic profile, supporting the feasibility of extending the dose interval.
With the promising results, ViiV was proceeding with a registrational study of CAB-ULA this year, focusing on its potential for HIV prevention in adults.
Additionally, future research would explore its use in combination with other medications to form a complete, ultra-long-acting HIV treatment regimen.
“The HIV community has told us of their desire for longer-acting medicines that can help alleviate the burden of daily treatment,” said ViiV’s head of research and development Kimberly Smith.
“ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the HIV community.
“This new formulation of cabotegravir (CAB-ULA) with a higher concentration and at least double the half-life puts us on the path toward delivering dosing every four months for HIV treatment and PrEP.”
WHO Warns of Growing Resistance in Individuals to GSK, ViiV’s HIV Drug Tivicay
The World Health Organization on Tuesday flagged growing HIV drug resistance against GSK and ViiV Healthcare’s antiretroviral medication Tivicay (dolutegravir), noting that observational and survey data suggest that resistance may now be higher than levels observed in clinical trials.
Results from four surveys placed resistance rates from 3.9% to 8.6%, according to the World Health Organization (WHO). In some cases, resistance reached as high as 19.6%, particularly in treatment-experienced patients who transitioned to Tivicay antiretroviral therapy (ART) while still having high viral loads. The global health authority has yet to receive survey data from all participating countries.
A report from Haiti also pointed to worrying trends of potential resistance in ART-naïve infants. One infant, whose mother had been treated with Tivicay, also showed resistance to the drug.
Meg Doherty, director of the WHO’s Department of the Global HIV, Hepatitis and STI Programs, in a statement said that the mounting global HIV resistance to Tivicay “underscores the necessity for increased vigilance and intensified efforts to optimize the quality of HIV care delivery.”
Effective viral suppression in pregnant and breastfeeding women, along with strict surveillance of resistance in newborns, is similarly crucial to stem transmission and better direct ART treatment regimens in the future, according to the WHO announcement.
These HIV resistance data come from the WHO’s latest HIV Drug Resistance Report, which aims to spot where treatment resistance is emerging globally and provide guidance to help countries monitor and respond to related challenges.
“The resistance analysis focuses on subgroups whose virus was not suppressed and the data does not indicate that resistance was prevalent in the overall population", a GSK spokesperson told Reuters on Tuesday, adding that company agrees with the WHO “that there is a need for further surveillance.”
In a report published last week, the WHO said that most countries fell short of global standards in terms of various HIV quality of care indicators, such as ART retention, viral load testing coverage, timely switch to second-line ART and timely second viral load testing. To more effectively slow or prevent drug resistance to Tivicay, countries should conduct routine monitoring of these indicators and improve their data reporting systems, according to the global health authority.
The WHO also recommends the implementation and scale-up of pre-exposure prophylaxis (PrEP) treatments, accompanied by strict surveillance of resistance among people who test positive for HIV despite being on PrEP.
Tivicay’s active ingredient is dolutegravir, an integrase inhibitor that works by targeting the HIV’s integrase protein and blocks its active site. This mechanism of action allows Tivicay to prevent the virus from integrating its DNA into the host cell, disrupting its replication cycle.
Given its efficacy, favorable side effect profile and ease of administration, the WHO in 2018 recommended dolutegravir as the preferred first- and second-line treatment for HIV-1 across all population groups. The broad use of dolutegravir, combined with the increasing uptake of PrEP, “promises to revolutionize HIV care and prevention,” the WHO wrote in its report brief.
Waste Of The Day: NIH Awards $200,000 Grant For Transgender Voice Training
by Adam Andrzejewski via RealClear Wire,
Topline: The National Institutes of Health is paying $214,000 for three researchers to create a “transgender voice training” app, according to Fox News.
Key facts: The study aims to address “voice dysphoria,” which researchers say causes lower quality of life when a person’s voice does not match their gender identity.
Researchers will coach 40 trans women to help change the pitch and resonance of their voice to sound more feminine.
The participants will meet once a week with a speech-language pathologist. Half of them will use a generic voice training software and half will use the app specifically made for transgender people, so that results can be compared.
If tests are successful, the software will be released to the public for free.
The researchers — a professor from the University of Cincinnati and two speech scientists from New York University — have each already received taxpayer money for similar voice dysphoria studies, according to the College Fix.
Background: The study focuses on “gender-affirming voice and communication training,” a service that is already dipping into taxpayers’ wallets. As of 2022, 13 states’ Medicaid covered the training, with 18 more having no clear policy on the coverage.
The 2024 research grant comes from the National Institute on Deafness and Other Communication Disorders, an agency of the National Institutes of Health.
The NIH is part of the Department of Health and Human Services, which sent paychecks to almost 90,000 people in 2022, according to auditors at OpenTheBooks.com.
There were 2,646 employees who earned more than $214,000, the grant amount for the voice training app.
Supporting quote: "Some trans people can be negatively impacted if their voice is perceived as incongruous with their gender identity, and they may choose to work with a speech pathologist to achieve a vocal presentation that is comfortable for them," said Tara McAllister, one of the three study leaders.
"The staRt software allows learners to visualize the resonant frequencies of the vocal tract, which could make it easier to adjust them to match a target that is appropriate for their personal speech goals."
Summary: Three researchers are getting an additional $214,000 the federal government to study gender-affirming voice therapy — from an agency that’s supposed to focus on deafness and other communication disorders — on top of past funding they’ve already received.
The #WasteOfTheDay is brought to you by the forensic auditors at OpenTheBooks.com
https://www.zerohedge.com/political/waste-day-nih-awards-200000-grant-transgender-voice-training
Vincerx to Present 3 Posters at American Association for Cancer Research Apr. 8
Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced it will present three posters at the American Association for Cancer Research (AACR) Annual Meeting 2024, taking place in San Diego, CA, from April 5 – 10, 2024. Vincerx will also share clinical data for VIP236 at the conference.
“We are extremely pleased to highlight the continued development of our next-generation VersAptx™ bioconjugation platform in these three abstract/poster presentations,” said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. “In addition to the preclinical results of our VersAptx platform, our SMDC poster (#3197) will also present, for the first time, early clinical results for VIP236. To date, 20 patients with relapsed/refractory advanced or metastatic solid tumors have been treated with two different dosing schedules of VIP236. The poster will summarize preliminary safety, efficacy, and pharmacokinetic results from this first-in-human, dose-escalation study (NCT05712889).”
Virtual Investor Event:
Vincerx will host a virtual investor event featuring company management and key opinion leaders on Monday, April 8, 2024. The event will be webcast live, and details can be accessed in the Investor Calendar section of the Vincerx website on March 27, 2024. An archived replay will be available shortly after the conclusion of the live event.
Poster presentation details:
Title: Activity of VIP943 on AML patient-derived leukemic blasts and healthy donor-derived bone marrow hematopoietic stem cells
Abstract Number: 629
Session Category: Experimental and Molecular Therapeutics
Session Title: Mechanisms of Drug Action
Session Date and Time: Sunday, April 7, 2024, 1:30 PM – 5:30 PM PT
Location: Poster Section 26; Poster Board Number 6
Presented by Beatrix Stelte-Ludwig, Ph.D., Vincerx Pharma
Title: Innovations in ADC technology platform with legumain-cleavable KSP-inhibitor payloads adaptable to various aspects of cancer biology
Abstract Number: 2051
Session Category: Experimental and Molecular Therapeutics
Session Title: New Technologies
Session Date and Time: Monday, April 8, 2024, 9:00 AM – 12:30 PM PT
Location: Poster Section 28; Poster Board Number 8
Presented by Hans-Georg Lerchen, Ph.D., Vincerx Pharma
Title: Addressing drug metabolism and pharmacokinetics (DMPK) challenges of small molecule-drug conjugates (SMDCs)
Abstract Number: 3197
Session Category: Experimental and Molecular Therapeutics
Session Title: Cancer Immunotherapy and Drug Delivery
Session Date and Time: Monday, April 8, 2024, 1:30 PM – 5:00 PM PT
Location: Poster Section 23; Poster Board Number 14
Presented by Anne-Sophie Rebstock, Ph.D., Vincerx Pharma
A copy of the presentation materials can be accessed on the Investors section of the Company’s website at https://investors.vincerx.com/news-events/presentations once each presentation has concluded.
TRxADE Health Special Cash Dividend
TRxADE HEALTH Inc. (Nasdaq: MEDS) (the “Company”), announced that the Company’s board of directors has declared a special cash dividend of $8.00 per share of common stock. The special dividend is being paid using a portion of the proceeds from the closing of the recently announced sale of the Company’s web-based market platform assets. The special cash dividend is payable to stockholders of record as of March 18, 2024, with the dividend being paid on or about March 22, 2024.
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