SAB Biotherapeutics' Type 1 Diabetes Candidate Moves One Step Closer To Human Trials

SAB Biotherapeutics 

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 has completed an IND-enabling GLP-tox study for SAB-142, further progressing the therapeutic to prevent and/or delay onset and progression of type 1 diabetes (T1D) and potentially other T-cell mediated autoimmune diseases. 

What Happened: The study assessed the toxicity and pharmacodynamic effects of SAB-142 at 1, 5, and 10 mg/kg doses against commercially available anti-thymocyte globulin at 5 mg/kg.

The candidate was well tolerated and showed a desired dose-dependent pharmacologic effect. SAB will submit the IND filing within approximately 12 months.

The study results showed that both SAB-142 and the FDA-approved animal-derived polyclonal anti-thymocyte immunoglobulin induced transient lymphodepletion, confirming the SAB-142 mechanism. 

The depletion dynamics were more prolonged in the cohort with SAB-142 treatment.

In November, the company outlined data on SAB-185 for COVID-19 and SAB-176 for seasonal and pandemic influenza showing the candidates being effective against variants of several highly mutating viruses associated with the diseases.

Last week, SAB Biotherapeutics announced results from a project in collaboration with CSL, confirming that SAB's DiversitAb platform can generate functional fully-human anti-idiotype polyclonal antibodies that can effectively target and neutralize autoantibodies associated with autoimmune diseases.

https://www.benzinga.com/general/biotech/23/01/30346438/exclusive-sab-biotherapeutics-type-1-diabetes-candidate-moves-one-step-closer-to-enter-human-tria

Sutro Biopharma Posts Updated Data From Ovarian Cancer Candidate

 

• Sutro Biopharma Inc 
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   announced results from a Phase 1 dose-expansion study of STRO-002 (luvelta) and interim safety data from exploratory cohort C of advanced ovarian cancer treated at the higher dose of luvelta (5.2mg/kg), along with prophylactic pegfilgrastim. 
• Results demonstrated that luvelta provided substantial clinical benefit, with a 37.5% overall response rate (ORR), a median duration of response (median DOR) of 5.5 months, and median progression-free survival (median PFS) of 6.1 months, regardless of starting dose. 
• Results also demonstrated that the higher starting dose of 5.2 mg/kg provides greater patient benefit than the lower dose of 4.3mg/kg. 
• Consistent with prior luvelta data, the primary adverse event from the dose-expansion cohort was predominantly asymptomatic neutropenia, with no meaningful ocular toxicity signals or complications reported.
• In cohort C, an additional 15 patients with advanced ovarian cancer were enrolled and treated with prophylactic pegfilgrastim on Day 8 after each 5.2 mg/kg administration of luvelta. Initial data on neutropenia and dose delays were available on the first ten patients. This showed that patients in cohort C experienced substantial decreases in neutropenia and potential increases in dose intensity due to decreased dose delays.
• Sutro plans to initiate a Phase 2/3 registration-directed study called REFRaME in the second quarter of 2023.

https://www.benzinga.com/general/biotech/23/01/30351779/sutro-biopharma-posts-updated-data-from-ovarian-cancer-candidate

Why VYNE Therapeutics Is Skyrocketing

 

• VYNE Therapeutics Inc 
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   announced that the first vitiligo patient had been dosed in a Phase 1a/b trial of VYN201, a locally administered, small molecule, pan-bromodomain and extra-terminal domain (BET) inhibitor for immuno-inflammatory diseases. 
• The clinical trial is a first-in-human study designed to generate safety and pharmacokinetic data in healthy volunteers (Phase 1a) and provide early clinical proof-of-concept data in vitiligo patients (Phase 1b).
• The company expects topline data for Phase 1a and Phase 1b parts of the study in the first half of 2023.
• In the Phase 1b portion, up to 30 patients with a clinical diagnosis of non-segmental vitiligo will receive VYN201 once daily in up to three dose cohorts. 
• The primary objective of the Phase 1b portion of the study will be to evaluate the safety and pharmacokinetics of VYN201. 
• The exploratory efficacy of VYN201 in non-segmental vitiligo patients will also be evaluated, including pharmacodynamic biomarkers and photography.
• In August, VYNE Therapeutics announced results from the Phase 2a segment of a Phase 1b/2 trial of FMX114 for mild-to-moderate atopic dermatitis (AD), missing the primary endpoint of the disease severity index.

https://www.benzinga.com/general/biotech/23/01/30354940/why-penny-stock-vyne-therapeutics-is-skyrocketing-today

Illuminas stock falls 10% on more cautious outlook for 2023

 Shares of Illumina Inc. (ILMN) tumbled about 10% in premarket trading on Tuesday, the day after the company said it expects lower-than-expected earnings per share of of $1.25 to $1.50 in 2023. The FactSet consensus is $2.67. Illumina also said it expects revenue growth of 7% to 10% this year. Analysts had been expecting a 10% bump in revenue. "The company is now issuing a more cautious outlook," J.P. Morgan analysts told investors on Monday. "The significantly lowered guidance is attributed to conservatism around macro headwinds." llumina's stock is down 42.8% over the past 12 months, while the S&P 500 is down 16.8%.

https://www.morningstar.com/news/marketwatch/20230110193/illuminas-stock-falls-10-on-more-cautious-outlook-for-2023

Amarin sees revenue stabilize

 Company Delivers Fourth Consecutive Quarter of U.S. Revenue Stabilization, Positive Fourth Quarter Cash Flow and Continued Progress on European Reimbursements --

-- Amarin to Present at 41st Annual J.P. Morgan Healthcare Conference on January 10, 2023 --

https://finance.yahoo.com/news/amarin-provides-preliminary-fourth-quarter-121500031.html

Bright Health ups revenue guidance

 

• Increases 2023 Enterprise Revenue guidance to $3.4 - $3.6 billion on higher-than-expected attributed value-based consumers, greater than 30% year-over-year Revenue growth at the midpoint excluding the ACA Marketplace Insurance business

• Strong California Medicare Advantage enrollment during AEP; reaffirms guidance for 125K+ end of year 2023 consumers

• Reaffirms guidance for Adjusted EBITDA profitability in 2023

https://finance.yahoo.com/news/bright-health-group-announces-updated-120000820.html

Qualigen gets orphan drug status

 Qualigen Therapeutics, Inc. (“Qualigen” or “the Company,” Nasdaq: QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead drug candidate, QN-302, for the indication of Pancreatic Cancer. QN-302 is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells.

https://finance.yahoo.com/news/qualigen-therapeutics-receives-orphan-drug-140000385.html