Cytokine | Jotup

Vaxxinity Announces First Subjects Dosed in Phase 1 Clinical Trial of VXX-401, Investigational Anti-PCSK9 Vaccine to Treat Hypercholesterolemia

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Monday, March 20, 2023

Heart disease remains the leading cause of death globally, claiming over 18 million lives per year, despite the existence of approved treatments that lower LDL.

Key Points:

Heart disease remains the leading cause of death globally, claiming over 18 million lives per year, despite the existence of approved treatments that lower LDL.
“PCSK9 antibody therapies are well-tolerated and effective, but huge unmet patient need remains.
The objectives of the trial are to evaluate safety, tolerability and immunogenicity (as measured by serum anti-PCSK9 antibody titers).
Pharmacodynamics of the immune response will be measured by LDL cholesterol levels, an established model of PCSK9 inhibition in hypercholesterolemia.

LEO Pharma Presents Late-Breaking Positive Phase 2a Efficacy and Safety Results of LEO 138559 in Moderate-to-Severe Atopic Dermatitis at the 2023 AAD Annual Meeting

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Saturday, March 18, 2023

LEO Pharma A/S, a global leader in medical dermatology, today announced that a Phase 2a trial evaluating the efficacy and safety of investigational agent LEO 138559 in adults with moderate-to-severe atopic dermatitis met its primary endpoint.

Key Points:

LEO Pharma A/S, a global leader in medical dermatology, today announced that a Phase 2a trial evaluating the efficacy and safety of investigational agent LEO 138559 in adults with moderate-to-severe atopic dermatitis met its primary endpoint.
Results were shared as one of two LEO Pharma late breaker oral presentations at the 2023 American Academy of Dermatology (AAD) Annual Meeting.1 LEO 138559 is an investigational agent and its efficacy and safety are subject to further larger trials.
LEO Pharma and argenx BV jointly developed LEO 138559 under an exclusive option and research agreement.
LEO Pharma obtained the license to LEO 138559 in 2022 and now assumes the responsibility to develop and commercialize LEO 138559 for inflammatory skin disorders, such as atopic dermatitis.

SeaStar Medical Holding Corporation Closes Initial $3.3 Million Tranche of $9.8 Million Private Placement

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Thursday, March 16, 2023

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DENVER, March 16, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, today announced the signing and closing of the initial $3.3 million tranche of a total anticipated $9.8 million private placement with a single institutional investor.

Key Points:

DENVER, March 16, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, today announced the signing and closing of the initial $3.3 million tranche of a total anticipated $9.8 million private placement with a single institutional investor.
The investment is in the form of a Senior Unsecured Original Issue 8.0% Discount Convertible Note (the “Note”), resulting in proceeds before expenses to SeaStar Medical of approximately $3.0 million.
Maxim Group LLC acted as the exclusive placement agent for the private placement.
SeaStar Medical is a medical technology company focusing on redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs.

Monte Rosa Therapeutics Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

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Thursday, March 16, 2023

Initiated patient dosing in October of its Phase 1/2 clinical trial evaluating MRT-2359 for the treatment of MYC-driven solid tumors, including lung cancer.

Key Points:

Initiated patient dosing in October of its Phase 1/2 clinical trial evaluating MRT-2359 for the treatment of MYC-driven solid tumors, including lung cancer.
When activated, VAV1 relays a signal cascade that results in immune cell activation and the secretion of several pro-inflammatory cytokines.
Net Loss: Net loss for the fourth quarter of 2022 was $30.8 million compared to $23.4 million for the fourth quarter of 2021, and $108.5 million for the year ended December 31, 2022, compared to $74.0 million for the year ended December 31, 2021.
Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2022, were $268.1 million, compared to $351.4 million as of December 31, 2021.

Bolt Biotherapeutics to Present Preclinical Data for BDC-3042, a Dectin-2-Targeting Agonistic Antibody, at 2023 AACR Annual Meeting

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Tuesday, March 14, 2023

Poster, Cancer, Tumor-associated macrophage, Tumor microenvironment, AACR, American Association for Cancer Research, Mouse, Publication, Tams, Chemokine, Cytokine, Orange County Convention Center, PD-1, Doctor of Philosophy, Therapy, Neoplasm, Pharmaceutical industry, Telescopic sight, Vaccine

The conference is being held at the Orange County Convention Center in Orlando, Fla. from April 14-19, 2023.

Key Points:

The conference is being held at the Orange County Convention Center in Orlando, Fla. from April 14-19, 2023.
BDC-3042 has the potential to treat many types of cancer,” said Randall Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics.
“We will be presenting new data in our AACR poster demonstrating recent progress in the development of this proprietary program.
Additionally, a copy of the poster will be available on the Publications page of the Bolt Biotherapeutics website following the conference.

Xencor to Present Preclinical Data from Novel XmAb® CD28 Bispecific Antibody Programs at the American Association for Cancer Research Annual Meeting 2023

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Tuesday, March 14, 2023

Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, today announced it will present preclinical data on novel XmAb® CD28 bispecific antibody programs at the American Association for Cancer Research (AACR) Annual Meeting, being held April 14-19, 2023 at the Orange County Convention Center in Orlando, Florida.

Key Points:

Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, today announced it will present preclinical data on novel XmAb® CD28 bispecific antibody programs at the American Association for Cancer Research (AACR) Annual Meeting, being held April 14-19, 2023 at the Orange County Convention Center in Orlando, Florida.
“T cells in the tumor microenvironment require engagement of their T cell receptor (TCR) and their co-stimulatory receptors like CD28 to achieve full activation.
This is diminished in cancer because tumor cells usually do not express CD28 ligands.
We have developed an XmAb antibody platform that allows for the rapid generation of drug candidates that co-stimulate CD28 only in the presence of tumor cells and TCR engagement,” said John Desjarlais, Ph.D., senior vice president and chief scientific officer at Xencor.

Rare Event Analysis in Flow Cytometry: Design Control and Validation Aligned with CLSI H62, Upcoming Webinar Hosted by Xtalks

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Wednesday, March 15, 2023

CD34, Research, Drug discovery, Drug development, MRD, CLSI, Design controls, Cell, CAR, PNH, Validation, Cytokine, Clinical Laboratory, Clinical trial, Flow cytometry, Doctor of Philosophy, Bone marrow, Bureau of Oceans and International Environmental and Scientific Affairs, Medical device

TORONTO, March 15, 2023 /PRNewswire-PRWeb/ -- Rare event analysis by flow cytometry is relatively common in research settings, in clinical laboratories and during drug discovery and development. For example, in research and drug discovery environments, the measurement of intracellular cytokines and intracellular signaling events (i.e., protein phosphorylation) are some of the more common rare event assays. Whereas in clinical laboratories, assays for rare events often include the measurement of CD34+ hematopoietic stem cells, paroxysmal nocturnal hemoglobinuria (PNH) and minimal residual disease (MRD) of blood cancers. During drug development and clinical trial evaluation of new therapeutic modalities, rare event methods might also include the monitoring of CAR cellular therapies and the efficacy of cell-depleting therapies.

Key Points:

In this free webinar, learn about rare event analysis in flow cytometry using design control and validation approaches aligned with CLSI H62.
Attendees will learn how the application of Design Control during assay design and development will lead to successful outcomes.
Attendees will learn impact of instrument set-up, panel design and assay optimization on the validation of the assay specificity and sensitivity.
Register today and learn about rare event analysis in flow cytometry using design control and validation approaches aligned with CLSI H62.

BIO-TECHNE ANNOUNCES COMPLETION OF CELL AND GENE THERAPY CATAPULT PROCESS ANALYTICAL TECHNOLOGY (PAT) CONSORTIUM

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Wednesday, March 15, 2023

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MINNEAPOLIS, March 15, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced it has completed its participation in the Cell and Gene Therapy Catapult Process Analytical Technology (Catapult PAT) consortium, a multi-year collaboration involving 24 partner companies, technology providers, therapy developers, and charities.

Key Points:

MINNEAPOLIS, March 15, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced it has completed its participation in the Cell and Gene Therapy Catapult Process Analytical Technology (Catapult PAT) consortium, a multi-year collaboration involving 24 partner companies, technology providers, therapy developers, and charities.
The Catapult PAT consortium is the first initiative of this scale and functional expertise with member companies and organizations collaborating to develop cell and gene therapy-specific process analytical technologies.
With its robust performance in this project, the Cell and Gene Therapy Catapult plans to incorporate Ella™ into an existing CGT Catapult facility to further support scientists in the UK.
Established by Innovate UK, the Cell and Gene Therapy Catapult fosters collaborations between academia, industry, and healthcare providers to develop new technology and drive innovation.

BIO-TECHNE TO PRESENT AT THE BARCLAYS GLOBAL HEALTHCARE CONFERENCE

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Friday, March 10, 2023

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MINNEAPOLIS, March 10, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Jim Hippel, Executive Vice President and Chief Financial Officer, will present at the Barclays Global Healthcare Conference on Tuesday, March 14, 2023, at 2:35 p.m. EDT.

Key Points:

MINNEAPOLIS, March 10, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Jim Hippel, Executive Vice President and Chief Financial Officer, will present at the Barclays Global Healthcare Conference on Tuesday, March 14, 2023, at 2:35 p.m. EDT.
A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne's Investor Relations website at https://investors.bio-techne.com/ir-calendar .
These reagent and protein analysis solutions are sold to biomedical researchers as well as clinical research laboratories and constitute the Protein Sciences Segment.
With thousands of products in its portfolio, Bio-Techne generated approximately $1.1 billion in net sales in fiscal 2022 and has approximately 3,000 employees worldwide.

Aclaris Therapeutics Announces Preliminary Topline Data from 12-Week Phase 2a Study of Oral Zunsemetinib (ATI-450) for Moderate to Severe Hidradenitis Suppurativa

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Monday, March 6, 2023

WAYNE, Pa., March 06, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced preliminary topline results from a 12-week, Phase 2a, multicenter, randomized, placebo-controlled clinical study to investigate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of zunsemetinib (ATI-450), an investigational oral MK2 inhibitor, in patients with moderate to severe hidradenitis suppurativa (HS) (ATI-450-HS-201).

Key Points:

The study did not meet its primary endpoint of change from baseline in inflammatory nodule/abscess count (AN) of zunsemetinib 50mg BID versus placebo at week 12.
The study also did not meet the secondary efficacy endpoints assessed in the topline data, including percentage of patients achieving HiSCR-50.
The placebo effect observed across all efficacy endpoints was higher than what has been observed in other published HS studies reported to date.
Thirty-seven patients discontinued study treatment (22 on zunsemetinib and 15 on placebo), with 15 patients discontinuing treatment due to AEs (11 on zunsemetinib and 4 on placebo).