Autoimmunity

Tiziana Life Sciences plc - Interim Results for the Six Months Ended 30 June 2021

Friday, September 24, 2021 - 5:51pm

LONDON, Sept. 24, 2021 (GLOBE NEWSWIRE) -- London, 24 September 2021 Tiziana Life Sciences plc (Tiziana, LSE: TILS, NASDAQ: TLSA), a biotechnology company a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases today announces its interim results for the six months ended 30 June 2021.

Key Points: 
  • LONDON, Sept. 24, 2021 (GLOBE NEWSWIRE) -- London, 24 September 2021 Tiziana Life Sciences plc (Tiziana, LSE: TILS, NASDAQ: TLSA), a biotechnology company a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases today announces its interim results for the six months ended 30 June 2021.
  • Furthermore these pharmacodynamic data point to a clinical dose range that Tiziana intends to test in further clinical development among MS patients.
  • For the six months to 30 June 2020 the consolidated Group made a loss of 12.59m (six months to 30 June 2020: 3.9m).
  • The Group ended the period with 38.6m cash as at 30 June 2021 (31 December 2020: 48.2m).

vTv Therapeutics Announces Results of Multiple Ascending Dose Study and Development Plan for HPP737, an Oral PDE4 Inhibitor for the Treatment of Psoriasis

Thursday, September 23, 2021 - 9:30pm

HIGH POINT, N.C., Sept. 23, 2021 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and psoriasis, today announced results of a multiple ascending dose study evaluating HPP737, an orally administered phosphodiesterase type 4 (“PDE4”) inhibitor, in healthy adults. The trial enrolled 12 subjects in each of two dose cohorts, 15mg and 20mg, randomized to receive HPP737 or placebo (3:1) orally once daily for 14 days. Dose escalation up to 20mg/day demonstrated approximate dose proportional increases in exposure, while maintaining a favorable safety and tolerability profile with no dose limiting safety or tolerability findings observed. There were no serious adverse events and no discontinuations due to treatment emergent adverse events. vTv therefore believes that the current safety profile allows it to move forward in development with a drug that may achieve anti-inflammatory and anti-psoriatic responses without the significant safety issues of other PDE4 inhibitors. Results of the two multiple ascending dose studies conducted by vTv to date will be presented at an upcoming scientific conference focused on dermatology.

Key Points: 
  • Results of the two multiple ascending dose studies conducted by vTv to date will be presented at an upcoming scientific conference focused on dermatology.
  • With these results, vTv held a successful pre-IND meeting with the U.S. Food and Drug Administration Division of Dermatology and Dentistry.
  • An oral, once-daily PDE4 inhibitor with robust efficacy, absent adverse events of gastrointestinal distress, would be a significant benefit for patients with psoriasis.
  • vTv has a pipeline of clinical drug candidates led by programs for the treatment of type 1 diabetes and psoriasis.

 Horizon Therapeutics plc Announces Agenda for Virtual R&D Day for Investors and Analysts on Sept. 29, 2021

Thursday, September 23, 2021 - 2:00pm

Horizon Therapeutics plc (Nasdaq: HZNP) today announced the agenda for its virtual R&D Day for investors and analysts on Sept. 29, 2021.

Key Points: 
  • Horizon Therapeutics plc (Nasdaq: HZNP) today announced the agenda for its virtual R&D Day for investors and analysts on Sept. 29, 2021.
  • During the event, Horizons R&D leadership, executives and key opinion leaders will discuss its expanded pipeline and participate in three Q&A sessions.
  • The virtual event will be held from 9 a.m. to 12:30 p.m. Eastern Time and may be accessed at https://horizonrdinvestorday.stagepro.io/ .
  • Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients.

Quell Therapeutics Significantly Expands Clinical Manufacturing Capacity for its Engineered Treg Cell Therapies through a Collaboration with the Cell and Gene Therapy Catapult

Thursday, September 23, 2021 - 8:00am

LONDON, Sept. 23, 2021 /PRNewswire/ -- Quell Therapeutics Ltd ("Quell"), the world leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, today announced it has entered a collaboration with the Cell and Gene Therapy Catapult (CGT Catapult). The collaboration will expand Quell's clinical manufacturing capabilities and capacity in one of the recently opened specialist large-scale manufacturing modules at CGT Catapult's manufacturing innovation centre in Stevenage, UK. This will add a second GMP facility to Quell's manufacturing operations and allow the Company to efficiently develop and scale the production of its novel multi-modular engineered Treg cell therapies for clinical trials.

Key Points: 
  • The collaboration will expand Quell's clinical manufacturing capabilities and capacity in one of the recently opened specialist large-scale manufacturing modules at CGT Catapult's manufacturing innovation centre in Stevenage, UK.
  • The LIBERATE study will be the first Treg based therapy in transplantation aiming to free patients from all systemic immune suppression.
  • The Stevenage Manufacturing Innovation Centre allows companies developing cell and gene therapies to develop their manufacturing processes at scale to Good Manufacturing Practice (GMP) standards.
  • "Quell is a ground-breaking company with leading technology which is progressing engineered Treg cell therapies into the clinic.

Better For You Wellness Announces Results from its September 17, 2021, Board of Directors Meeting

Tuesday, September 21, 2021 - 2:00pm

"I'm incredibly proud of the progress we've made and the initiatives we're working on," commented Ian James, Chief Executive Officer of Better For You Wellness.

Key Points: 
  • "I'm incredibly proud of the progress we've made and the initiatives we're working on," commented Ian James, Chief Executive Officer of Better For You Wellness.
  • David Deming serves as Partner and Chief Operating Officer of ID Fund LLC, an investor-directed firm for accredited investors.
  • Subsequent to the Special Meeting of the Board, the Company entered into the Engagement Agreement.
  • At the Special Meeting, the Board further scheduled an in-person Board of Directors meeting on October 1, 2021 in Columbus, Ohio.

Zenith Epigenetics and Newsoara Announce Initiation of a Randomized Phase 2b Metastatic Castration-Resistant Prostate Cancer (mCRPC) Study

Tuesday, September 21, 2021 - 1:00pm

The study will evaluate the efficacy of ZEN-3694 + enzalutamide vs. single agent enzalutamide as measured by its primary endpoint, radiographic free progression.

Key Points: 
  • The study will evaluate the efficacy of ZEN-3694 + enzalutamide vs. single agent enzalutamide as measured by its primary endpoint, radiographic free progression.
  • Abiraterone, also an ARSI, is frequently prescribed as a first line therapy for patients with metastatic prostate cancer.
  • Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide.
  • Ovarian cancer in combination with immune-checkpoint inhibitors, nivolumab and ipilimumab in collaboration with the National Cancer Institute.

Moderna COVID-19 Vaccine Clinical Trial for People With Organ Transplant Starts at Feinstein Institutes

Tuesday, September 21, 2021 - 4:16pm
Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20210921005840/en/
    Darla Smyth (center) an organ transplant recipient receives her third dose of Moderna COVID-19 vaccine as part of a new clinical trial at the Feinstein Institutes.
  • (Credit: Feinstein Institutes)
    People who have received an organ transplant are at a high-risk for contracting COVID-19 and becoming severely sick.
  • Now, with the support of Moderna, we hope this vaccine clinical trial will give insight into the best way to protect a high-risk population.
  • Since then, Feinstein Institutes initiated more than 17 clinical trials and programs and enrolled more than 1,800 patients.

Horizon Therapeutics plc Announces New Genetic Counselor Curated Algorithms and Next-Generation Sequencing Data as Winning Solutions of First-Ever Horizon Prize, Powered by MIT Solve, to Accelerate Rare Disease Diagnosis

Tuesday, September 21, 2021 - 1:00pm

The winners will share $150,000 in funding to continue evolving their solutions for reducing the time it takes to be diagnosed with a rare disease.

Key Points: 
  • The winners will share $150,000 in funding to continue evolving their solutions for reducing the time it takes to be diagnosed with a rare disease.
  • Congenica uses software to analyze next-generation sequencing data to provide a free-of-charge diagnostic solution for people from disadvantaged groups affected by rare conditions.
  • Congratulations on being the first-ever winners of The Horizon Prize, said Tim Walbert, chairman, president and chief executive officer, Horizon.
  • The Horizon Prize is a first-of-its-kind global innovation challenge focused on speeding diagnosis and care for people impacted by rare disease.

CorEvitas and Inovalon Leverage Advanced Analytics to Deliver A Holistic View of the Patient

Tuesday, September 21, 2021 - 3:00pm

"We are excited to collaborate with CorEvitas to accelerate these insights with an initial focus on rheumatoid arthritis and psoriasis."

Key Points: 
  • "We are excited to collaborate with CorEvitas to accelerate these insights with an initial focus on rheumatoid arthritis and psoriasis."
  • Insights made possible through these analytics can advance clinical development, inform trial design and recruitment, substantiate value narratives, and inform patient-specific intervention plans.
  • Raymond Hill, Chairman and Chief Executive Officer for CorEvitas, noted, "As an organization, we recognize the immeasurable value of understanding the whole patient.
  • By furthering our collaboration with Inovalon, we can leverage the data-driven insights that provide integrated and actionable insights for the patient.

Serimmune and Mymee Collaborate on Research Study to Better Define the Role of Antibodies in SARS-CoV-2 Symptoms

Tuesday, September 21, 2021 - 1:00pm

The partnership includes collaborating on research to understand the presence of antibodies in people with autoimmunity, including disease activity and those most at risk.

Key Points: 
  • The partnership includes collaborating on research to understand the presence of antibodies in people with autoimmunity, including disease activity and those most at risk.
  • This data will help researchers better understand how variations in antibody response may influence COVID-19 symptoms from very mild to severe.
  • Serimmune is a leader in understanding antibody repertoire and is focused on identifying and exploiting the universe of relationships between antibodies and antigens.
  • 79% Mymee members see reductions in common autoimmunity symptoms like fatigue, brain fog and pain within the first 8 weeks.