Zerviate (cetirizine ophthalmic solution) / Nicox, Ocumension Therap, Santen - LARVOL DELTA

Cuproptosis- and m6A-related lncRNA prognostic signature for breast cancer, in which Z68871.1 contributes to triple-negative breast cancer progression. (PubMed, Int J Biol Macromol) - "The results showed that Z68871.1 promoted the progression of triple-negative breast cancer (TNBC) by regulating cuproptosis, m6A modification and tumor immunity via the RBM15/YTHDC2/Z68871.1/ATP7A axis. In conclusion, the signature we constructed serves as an accurate, independent and specific prognostic model for BC patients, and Z68871.1 could be a promising therapeutic target for TNBC."

Journal • Tumor mutational burden • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ATP7A • MFF-DT • RBM15 • TMB • YTHDC2

Identification of electron transfer enzymes in Thermoanaerobacterium saccharolyticum. (PubMed, J Bacteriol) - "The phenotypes of the hfsD, hydA, and hfsD hydA double-deletion strains are consistent with their function via hydrogen cycling. The improved understanding of electron transfer pathways in T. saccharolyticum will enable future efforts to transfer the robust ethanol production pathway from this microbe to other organisms, with potential implications for industrial biofuel production."

Journal

Pairwise graph edit distance characterizes the impact of the construction method on pangenome graphs. (PubMed, Bioinformatics) - "Supplementary data are available online at https://doi.org/10.5281/zenodo.10932489. Code to replicate figures and analysis is available online at https://github.com/dubssieg/pancat_paper."

Journal

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Acepodia Biotech, Inc. | Recruiting ➔ Completed | N=36 ➔ 12

Enrollment change • IO biomarker • Metastases • Trial completion • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Transcriptome analysis of the diseased intervertebral disc tissue in patients with spinal tuberculosis. (PubMed, BMC Med Genomics) - "The DE mRNAs and LncRNAs in spinal tuberculosis are both associated with immune regulatory pathways. These pathways promote or inhibit the tuberculosis infection and development at the mechanistic level and play an important role in the process of tuberculosis transferring to bone tissue."

Journal • Infectious Disease • Inflammation • Musculoskeletal Diseases • Orthopedics • Pulmonary Disease • Respiratory Diseases • Tuberculosis • LINC01094 • TNFA

Nicox Provides Second Quarter 2024 Update (GlobeNewswire) - "Nicox SA...today provided the revenue and cash position for Nicox SA and its subsidiaries (the 'Nicox Group') for the second quarter of 2024 and provided an update on key activities...Approval and launch of ZERVIATE in China by Nicox’s partner, Ocumension Therapeutics: expected in 2024. Whistler Phase 3b clinical trial, initiated in December 2023, investigating NCX 470’s (bimatoprost grenod) dual mechanism of action (nitric oxide and prostaglandin analog) in IOP2 lowering: results are currently expected in the first quarter of 2025. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: the randomization in the Denali trial is approaching the 95% level and expected to generate topline results in H2 2025, based on current recruitment rates. Completion of recruitment of patients in the U.S. is expected in Q4 2024."

China approval • Launch non-US • P3 data • Trial status • Glaucoma • Ophthalmology

Harrow Licenses Canadian Rights to Apotex for Five Branded Ophthalmic Pharmaceutical Products (Businesswire) - "Harrow...and Apotex...jointly announced an exclusive out-licensing agreement under which Apotex will market and distribute VERKAZIA and over-the-counter (OTC) Cationorm PLUS in the Canadian market, and concurrently, pursue market approval in Canada for VEVYE, IHEEZO, and ZERVIATE....Under the terms of the agreement, Apotex licensed exclusive rights and marketing authorizations of the...products in the Canadian market from Harrow..."

Licensing / partnership • Conjunctivitis • Dry Eye Disease • Ophthalmology

Isolation and Identification Antagonistic Bacterium Paenibacillus tianmuensis YM002 against Acidovorax citrulli. (PubMed, Front Plant Sci) - "Indeed, treatment of cucumber roots with YM002 significantly enhanced plant growth parameters, such as fresh and dry weight of leaves or roots. This study suggests the potential of YM002 as an effective PGPR with biological control activity against Acidovorax citrulli in cucumber plants."

Journal

Nicox’s Partner Ocumension Therapeutics Receives Priority Review Status for ZERVIATE New Drug Application in China (GlobeNewswire) - "Accelerates the ZERVIATE® approval and launch, which are expected in China in 2024...Nicox SA...announced that the New Drug Application (NDA) for approval to commercialize ZERVIATE® (cetirizine ophthalmic solution), 0.24%, submitted in China by its exclusive Chinese partner, Ocumension Therapeutics, has been included in the priority review and approval process of National Medical Products Administration of the People’s Republic of China ('NMPA'). This will accelerate the approval process and potentially the launch of ZERVIATE in China....The ZERVIATE NDA in China is supported by the data package licensed by Nicox to Ocumension and an additional Chinese Phase 3 clinical trial of ZERVIATE run by Ocumension."

Launch non-US • Non-US regulatory • Ophthalmology

A prognostic signature of pyroptosis-related lncRNAs verified in gastric cancer samples to predict the immunotherapy and chemotherapy drug sensitivity. (PubMed, Front Genet) - " The 3 PRlncRNAs identified in this study could be utilized to predict disease outcome in GC patients. It may also be a potential therapeutic target in GC therapy, including immunotherapy and chemotherapy."

IO biomarker • Journal • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Immune Modulation • Inflammation • Oncology • Pancreatic Cancer • Solid Tumor • CD276 • CTLA4 • PVT1

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Acepodia Biotech Inc. | Trial completion date: Jul 2022 ➔ Jun 2024 | Trial primary completion date: Jan 2022 ➔ Jun 2024

Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • IFNG • IL10 • IL2 • IL6 • TNFA

Construction and Validation of an Immune-Related lncRNA Prognosis Model for Thyroid Cancer. (PubMed, Comb Chem High Throughput Screen) - "We identified and experimentally validated seven immune-related lncRNAs that can serve as potential biomarkers for THCA prognosis."

Journal • Endocrine Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Acepodia Biotech Inc.; N=24 ➔ 36

Clinical • Enrollment change • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • IFNG • IL10 • IL2 • IL6 • TNFA

A Novel off-the-Shelf Trastuzumab-Armed NK Cell Therapy (ACE1702) Using Antibody-Cell-Conjugation Technology. (PubMed, Cancers (Basel)) - "The irradiated and cryopreserved ACE-oNK-HER2, designated as ACE1702, retained superior HER2-specific in vitro and in vivo potency with no tumorigenic potential. In conclusion, this study provides the evidence to support the potential clinical application of ACE1702 as a novel off-the-shelf NK cell therapy against HER2-expressing solid tumors."

Journal • Graft versus Host Disease • Immunology • Inflammation • Oncology • Solid Tumor • IFNG

Genome-wide identification and characterization of NAC genes in Brassica juncea var. tumida. (PubMed, PeerJ) - "Together, the results of this study provide a strong foundation for future investigation of the biological function of NAC genes in B. juncea var. tumida."

Journal • Oncology

Super-enhancer-associated long noncoding RNA RP11-569A11.1 inhibited cell progression and metastasis by regulating IFIT2 in colorectal cancer. (PubMed, J Clin Lab Anal) - "RP11-569A11.1 inhibited CRC tumorigenesis by IFIT2-dependent and could serve as a promising diagnostic biomarker in CRC."

Journal • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Rx perspective - Drop for ocular itching hits U.S. market (Ophthalmology Management) - "'In my experience, Zerviate is quite comfortable on instillation,' notes Marguerite McDonald, MD...'It is non-blurring; in one blink, the patient can see clearly,' says Dr. McDonald...'Zerviate is effective and works locally - on the ocular surface - rather than systemically, thereby avoiding the potential side effects of an allergy pill. Zerviate also leaves no aftertaste."

Media quote

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Acepodia Biotech Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Let's Talk Pharma: Expert Recommendations in the COVID-19 Era (eyetube) - "...Lisa Nijm, MD, JD...I. Paul Singh, MD...discuss the pharmaceutical technology they're utilizing to reduce patient visits, increase compliance, and prevent eye-touching during COVID-19, including Zerviate (Eyevance Pharmaceuticals), Xiidra (Novartis), and Dextenza (Ocular Therapeutix)."

Video

Differential Induction of Flavonoids in Groundnut in Response to Helicoverpa armigera and Aphis craccivora Infestation. (PubMed) - Int J Insect Sci - "The common compounds observed were chlorogenic, syringic, quercetin, and ferulic acids. These results suggest that depending on the mode of feeding, flavonoids are induced differentially in groundnut plants."

Journal • Biosimilar

Allergic Conjunctivitis: Introducing ZERVIATE (eyetube) - "Dr. Sheppard will end the program with a live Q&A session with attendees. Key Takeaways: Allergic conjunctivitis: The competitive landscape; Overview of ZERVIATE; Pivotal Phase III; Studies: Efficacy; Safety and Tolerability Study."

Live event

Comprehensive analysis of long non-coding RNA and mRNA expression profile in rectal cancer. (PubMed, Chin Med J (Engl)) - "This study offers convincing evidence of differentially expressed lncRNAs and mRNAs as potential biomarkers in RC."

Journal • IL17A • PCR

ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Acepodia Biotech Inc.

Clinical • New P1 trial

Blog: Do we need another topical antihistamine? (Healio) - "We need a medicine we can actually use. Zerviate is at least as good as everything else out there, and it may actually be just a little bit better. As I noted at the outset, Zerviate is carried by Eyevance. This is the same company that found a forgotten little gem called Flarex in the back of a linen closet at Alcon and sells it for St. Elsewhere-era prices. I have no idea what they plan to do with Zerviate, but a top-of-class topical antihistamine with access that is reminiscent of the ’90s?"

Blog

Nicox Fourth Quarter 2019 Business Update and Financial Highlights (GlobeNewswire, NICOX) - "NCX 4251: Meeting with the U.S. FDA is scheduled in Q1 2020 to discuss the next steps of the development plan. ZERVIATE U.S. launch: Commercial launch of ZERVIATE (cetirizine ophthalmic solution), 0.24% in the U.S. is planned in H1 2020 by Nicox’s partner Eyevance Pharmaceuticals, LLC. The total number of prescriptions1 for VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024%, in the U.S. in the fourth quarter of 2019 increased by 12% compared to the third quarter 2019 and by 72% compared to the fourth quarter of 2018."

Clinical • Clinical data • Commercial • Launch • Regulatory