K-001 / Shanghai Jiao Tong University, Hwealth Pharma - LARVOL DELTA

[VIRTUAL] PhaseI/IIa Study evaluating the safety, efficacy of K-001 in advanced pancreatic ductal adenocarcinoma. (ASCO 2020) - "K001 has promising efficacy and light side-effect profile. The activity observed demonstrates clinical benefit in pancreatic ductal adenocarcinoma, justifying the conduct of further studies. Research Funding: Beijing HuaShiTianFu Biomedical Technology Co., Ltd"

Clinical • P1/2 data • Dyspepsia • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

A phase I study of the safety and activity of K-001 in patients with advanced pancreatic ductal adenocarcinoma. (PubMed, BMC Cancer) - P1 | "K-001 manifests satisfactory safety and tolerability, as well as meaningful antitumor activity in advanced PDAC patients. Further evaluation of K-001 in phase II/III appears warranted."

Clinical • Journal • P1 data • Constipation • Dyspepsia • Gastroenterology • Gastrointestinal Disorder • Oncology • Oral Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Pivotal Dose of Pembrolizumab - A Dose Finding Strategy for Immuno-Oncology. (PubMed, Clin Pharmacol Ther) - "Despite numerous publications emphasizing the value of dose finding, drug development in oncology is dominated by the mindset that higher dose provides higher efficacy. Simulations showed that 200 mg Q3W can achieve ≥90% TE in clinically relevant scenarios resulting in the recommendation of 200 mg Q3W as RP2D. Randomized dose comparison studies (KN001 B2 and D) showing similar efficacy over 5-fold dose/exposure range confirmed RP2D as the pivotal dose."

IO biomarker • Journal • Oncology

The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - P2/3; N=600; Recruiting; Sponsor: RenJi Hospital; Trial primary completion date: Mar 2020 ➔ Mar 2021

Clinical • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Muricauda brasiliensis sp. nov., isolated from a mat-forming cyanobacterial culture. (PubMed, Braz J Microbiol) - "nov. The type strain is K001 (=CBMAI 2315 = CBAS 752)."

Journal • CAT

Cryptochrome 1 is modulated by blue light in human keratinocytes and exerts positive impact on human hair growth. (PubMed, Exp Dermatol) - "Specific silencing of CRY1 promotes catagen, while stimulation of CRY1 by KL001 prolongs anagen ex vivo by altering the expression of genes involved in apoptosis and proliferation...Previously we demonstrated positive effects of 453 nm blue light on hair growth ex vivo. Taken all together, our study suggests that CRY1 might mediate blue light dependent positive effects on hair growth."

Journal • Dermatology • CRY1

Genomic and Pathogenic Characteristics of Virulent Newcastle Disease Virus Isolated from Chicken in Live Bird Markets and Backyard Flocks in Kenya. (PubMed, Int J Microbiol) - "Histopathological findings in four-week-old SPF chicken challenged with the NDV isolates KE001, KE0811, and KE0698 showed multiple organ involvement at five days after infection with severe effects seen in lymphoid tissues and blood vessels...Phylogenetic analysis confirmed that the three isolates are closely related to NDV genotype V strains but form a distinct cluster together with NDV strains from the East African countries of Uganda and Tanzania to form the newly characterized subgenotype Vd. Our study provides the first description of the genomic and pathological characteristics of NDV of subgenotype Vd and lays a baseline in understanding the evolutionary dynamics of NDV and, in particular, Genotype V. This information will be useful in the development of specific markers for detection of viruses of genotype V and generation of genotype matched vaccines."

Journal

Amarogentin from Gentiana rigescens Franch Exhibits Antiaging and Neuroprotective Effects through Antioxidative Stress. (PubMed, Oxid Med Cell Longev) - "It significantly extended the replicative lifespan of K6001 yeast at doses of 1, 3, and 10 μM...Interestingly, amarogentin exhibited neuritogenic activity in PC12 cells. Therefore, the natural products, amarogentin from G. rigescens with antioxidant activity could be a good candidate molecule to develop drug for treating neurodegenerative diseases."

Journal • CNS Disorders • CAT

Engineering Escherichia coli to improve tryptophan production via genetic manipulation of precursor and cofactor pathways. (PubMed, Synth Syst Biotechnol) - "First, glutamine synthesis was improved by expressing heterologous glutamine synthetase from Bacillus subtilis and Bacillus megaterium in the engineered Escherichia coli strain KW001, resulting in the best candidate strain TS-1...Taken together, our results demonstrate that the combination of optimizing precursor supply and regulating cofactor metabolism is an effective approach for high-level production of tryptophan. Similar strategies could be applied to the production of other amino acids or related derivatives."

Journal

Newly added product (clinicaltrials.gov) - P3, Pancreatic Cancer, Oncology

Pipeline update