Breaking News

Landec VP James Hall disclosed in a filing that he had purchased 10,000 shares of company stock at $10.62 per share on April 14, for a total transaction cost of $106,200.

Chinook Therapeutics today announced six poster presentations at the ISN World Congress of Nephrology 2021. The final 4 posters include the following information. The third poster is titled "WCN21-0398: Human Renal Mesangial Cell Activation Induced by Endothelin-1 or IgA Nephropathy Patient Immune Derived Complexes is Blocked by Selective ETA Antagonist Atrasentan." Human renal mesangial cell activation is considered the initiating intra-renal event in the pathogenesis of IgAN and occurs in response to the deposition of pathogenic galactose-deficient IgA (Gd-IgA)-containing immune complexes. This activation results in increased cellular proliferation and inflammatory cytokine secretion. Exogenous ET-1 directly stimulates mesangial cell activation, inducing proliferative, pro-inflammatory and pro-fibrotic pathways, which can be blocked by atrasentan. Atrasentan prevented HRMC hyperproliferation in response to IgAN patient-derived immune complexes. This suggests that the autocrine action of endogenously produced ET-1 on ETA receptors contributes to mesangial cell activation resulting from pathogenic IgA-containing immune complexes. These results support the therapeutic potential of atrasentan in patients with IgAN, not only via its well characterized effect of reducing proteinuria, but also by potentially reducing mesangial cell activation, a hallmark of IgA nephropathy. Poster titled "WCN21-0848: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Atrasentan in Patients with IgA Nephropathy." The ALIGN Study is a global, randomized, multicenter, double-blind, placebo-controlled phase 3 clinical trial comparing the efficacy and safety of atrasentan versus placebo in patients with IgAN at risk of progressive loss of kidney function. Approximately 320 patients with biopsy-proven IgAN will be randomized to receive 0.75 mg atrasentan or placebo as a once-daily oral pill for approximately 2.5 years. The primary efficacy endpoint of the ALIGN Study is to evaluate the effect of atrasentan versus placebo on proteinuria as measured by urine protein to creatinine ratio from baseline to 24 weeks. Secondary and exploratory objectives include evaluating the change in kidney function over time as measured by eGFR, safety and tolerability, as well as quality of life. Chinook expects to report top-line data from the 24-week primary endpoint efficacy analysis in 2023. Poster titled "WCN21-0717: Atrasentan in Patients with Proteinuric Glomerular Diseases." The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function. Four initial cohorts will consist of patients with: IgAN with UPCR of 0.5 to less than 1.0 g/g, focal segmental glomerulosclerosis, Approximately 20 patients will be enrolled in each cohort to receive 0.75 mg atrasentan for 52 weeks. Patients in all cohorts will continue receiving an optimized and stable dose of a RAS inhibitor as standard of care. The primary efficacy endpoint of the AFFINITY Study is the effect on proteinuria as measured by UPCR in patients with IgAN, FSGS and Alport syndrome and the change in albuminuria as measured by urine albumin to creatinine in patients with DKD, from baseline to 12 weeks. Chinook expects to report data from initial cohorts of patients in the AFFINITY Study during 2022. Poster titled "WCN21-0612: Discovery of CHK-336: A First-in-Class, Liver-Targeted, Small Molecule Inhibitor of Lactate Dehydrogenase for the Treatment of Hyperoxaluria." CHK-336, is a liver-targeted oral small molecule LDHA inhibitor for the treatment of PH. LDHA catalyzes the final step in the production of oxalate in the liver, and therefore LDHA inhibition has the potential to treat all forms of PH - PH1, PH2 and PH3 - as well as other disorders arising from excess oxalate. CHK-336 demonstrates tight LDHA binding and a very slow enzyme off-rate, to extend the duration of action and enable the potential of once-daily dosing in humans. CHK-336 was engineered with a liver-targeted distribution profile to effectively block hepatic oxalate synthesis while minimizing systemic exposures.

Chinook Therapeutics today announced six poster presentations at the ISN World Congress of Nephrology 2021. The first two posters include the following information. The first poster is titled "WCN21-0706: A Phase 1, Open Label, Randomized, Single Dose, Parallel Group Safety and Bioavailability Study of BION-1301 Administered by Intravenous and Subcutaneous Routes," BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 1 clinical development for IgAN. Blocking APRIL is a potential disease-modifying approach to treating IgAN by reducing circulating levels of Gd-IgA1 to prevent the formation of immune complexes that deposit in the glomeruli of the kidney, causing damage. The ongoing phase 1 multi-center trial evaluated the safety and tolerability of BION-1301 in 63 healthy volunteers in double-blinded, placebo-controlled single-ascending dose, or SAD, and multiple-ascending dose, or MAD, settings. Recently analyzed data from this study in healthy volunteers demonstrated that BION-1301 produced dose-dependent reductions in serum Gd-IgA1 levels that were greater in magnitude than previously reported for total IgA concentrations. In the MAD cohort, BION-1301 reduced Gd-IgA1 levels by 39%, 51% and 55% on Day 29 following the first two doses but prior to the third dose of BION-1301 at 50 mg, 150 mg and 450 mg, respectively, compared to a mean 6% increase in Gd-IgA1 in the placebo group. Upon further follow-up on Day 85, which was 56 days after the third and final dose of BION-1301, Gd-IgA1 reductions were sustained, with mean reductions of 24%, 48% and 70%, at 50 mg, 150 mg and 450 mg, respectively, compared to a mean 4% increase in Gd-IgA1 in the placebo group. Part 3 of the phase 1 study is ongoing to evaluate BION-1301 in adult IgAN patients in an open-label setting. Preliminary data from Part 3 will be presented at nephrology conferences in 2021. Data generated in this study will be used to enable SC administration of BION-1301 in ongoing and future clinical studies. Poster titled "WCN21-0358: Selective ETA Antagonist Atrasentan, Rapidly Reduces Albuminuria and Downregulates Intra-renal Pro-Inflammatory and Pro-Fibrotic Transcriptional Networks in the g-ddY Mouse Model of Spontaneous IgA Nephropathy." The effect of short-term treatment of selective ETA antagonist atrasentan was investigated in gddY mice, a spontaneous and accelerated model of IgAN. Four days of treatment with atrasentan reduced urinary albumin to creatinine ratio from baseline by 28%, 62% and 63% at 10 mg/kg/day, 20 mg/kg/day and 30 mg/kg/day, respectively. This effect was statistically significant at the two higher doses. Five days of treatment with atrasentan demonstrated dose-dependent effects on intra-renal gene expression profiles, assessed by RNA sequencing analysis of the kidney cortex. The dynamic transcriptional changes in the kidney, following only five days of treatment and prior to sustained long-term reductions in albuminuria and blood pressure that could mediate this benefit, are consistent with direct anti-inflammatory and antifibrotic effects of ETA blockade in IgAN. These results support the therapeutic potential of atrasentan in IgAN to reduce proteinuria and kidney inflammation and fibrosis, key drivers of IgAN progression.

Amyris announced that it has executed a binding term sheet for the acquisition of Gen Z-focused beauty brand, EcoFabulous Cosmetics. The acquisition furthers Amyris's growth and market leadership in clean beauty and complements Amyris's family of consumer brands, consisting of Biossance, Pipette, Rose Inc., JVN, Terasana, and Costa Brazil. Amyris is acquiring a 70% controlling interest in EcoFabulous and expects to grow the Gen Z consumer segment through Amyris's innovative science, sustainable ingredients, clean formulation and direct-to-consumer marketing expertise. Marissa will join Amyris to lead brand innovation and be the Chief Creative Officer for the EcoFabulous brand.

Amyris announced that it has agreed to acquire Beauty Labs, an AI technology company that provides connected consumer experiences to the beauty and wellness community. The parties expect to sign a definitive agreement and close over the next 30 days subject to the successful completion of due diligence and customary closing conditions.