Nypozi (filgrastim-txid) / Tanvex BioPharma, Sandoz - LARVOL DELTA

Taifu-KY moves forward with both feet to expand revenue as soon as possible; no additional capital increase is required this year [Google translation] (MoneyDJ) - "Reorganizing its positioning, macromolecular drug manufacturer Taifu-KY...actively reduced unnecessary waste in the first half of the year, expanded its business opportunities in professional drug manufacturing (CDMO), and confirmed its strategy of advancing with its own product lines. CEO Chen Linzheng...said that the U.S. drug license application for TX01 is in the final stage, and he hopes to obtain the certificate and launch it as soon as possible. In addition, TX05 will also be supplemented as soon as possible, and there is no need to apply for a capital increase this year...As for its own products, Chen Linzheng said that TX01 is in the final stage of drug license review. The good news is that according to the latest response from the FDA, it is possible that injection and drip dosage forms will be marketed together again....It is estimated that the supplements will be completed before the middle of the third quarter."

Commercial • FDA event • FDA filing • Breast Cancer • Gastric Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Dimethyl sulfoxide as a gas phase charge-reducing agent for the determination of PEGylated proteins' intact mass. (PubMed, Anal Methods) - "In this work, we have explored the capabilities of post-column infusion of dimethyl sulfoxide (DMSO) following reversed-phase liquid chromatography-mass spectrometry (RP-LCMS) to determine PEG-filgrastim' intact mass, and to characterize its PEG moiety. The PDI for all Neulasta® lots was 1.0003. This study provides an insightful characterization of Neulasta® and describes a robust LC-MS methodology for the characterization of the PEGylated proteins."

Journal

'Biomedical Stocks' Taifu focuses on the listing of TX01 and TX05 to expand CDMO capacity Google translation] (stock.yahoo) - "Taifu-KY (6541) held a briefing today (1) afternoon. Chairman Chen Linzheng emphasized that the core strategy of focusing on biosimilars and deploying CDMOs remains unchanged. With its technological advantages, in the future, it will focus more on maximizing the value of TX 01 and TX 05 after they are launched, while expanding CDMO service capacity and reaching new milestones....Taifu Biotechnology is currently awaiting notification of the final review conclusion from the U.S. FDA for its TX 01 drug marketing inspection and registration review application. According to communications with the U.S. FDA, all received positive responses. The company said it hopes to share the news with everyone soon."

Commercial • FDA event • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Tanvex BioPharma Receives Complete Response Letter on Its Filgrastim Biosimilar Application (Biosimilar Review and Report) - "...Tanvex BioPharma, Inc. issued a press release announcing that the FDA has not approved its 351(k) application for TX01, a biosimilar version of filgrastim....Tanvex stated, 'Based on the [complete response letter], Tanvex will continue to update FDA with supplemental information and the Company plans to work closely with FDA to get the application approved.'"

FDA event • Neutropenia

Edwardsiella piscicida YefM-YoeB: A Type II Toxin-Antitoxin System That Is Related to Antibiotic Resistance, Biofilm Formation, Serum Survival, and Host Infection. (PubMed, Front Microbiol) - "To investigate the biological role of the TA system, two markerless yoeB and yefM-yoeB in-frame mutant strains, TX01ΔyoeB and TX01ΔyefM-yoeB, were constructed, respectively...In addition, we found that YefM-YoeB negatively autoregulated the expression of yefM-yoeB and YefM could directly bind with own promoter. This study provides first insights into the biological activity of type II TA system YefM-YoeB in aquatic pathogenic bacteria and contributes to understand the pathogenesis of E. piscicida."

Journal • Infectious Disease

An aptamer interacting with heat shock protein 70 shows therapeutic effects and prognostic ability in serous ovarian cancer. (PubMed, Mol Ther Nucleic Acids) - "Our data demonstrated that Tx-01 interacted with HSP70 and showed therapeutic and prognostic effects in serous OvCa. Tx-01 might be a potential inhibitor for use in serous OvCa treatment."

Journal • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • CTCs • NOTCH1

Taifu-KY completed the capital increase before the end of KY. The company obtained the key process patent of the two drugs [Google translation] (money.udn.com) - "...obtained key process patents for its two self-developed drugs TX05 and TX16, and the chances of success in subsequent challenges to the original patents have greatly increased....Taifu's TX05 Phase III human clinical trial has been completed on October 21st, US time. It is expected to eliminate blindness in the first quarter of next year and submit a drug certification application to the US Food and Drug Administration (FDA) in the middle of next year. It will be launched in 2022; TX16 is going to undergo Phase III clinical testing. The legal person estimates that Taifu's TX-01 and TX-05 are expected to start sales in the third quarter of next year. The two drugs are expected to contribute more than 10 million US dollars in revenue."

Biosimilar launch • BLA • Patent • Sales • Trial status • Oncology

"Biomedical Stocks" Taifu-KY biosimilar TX01 drug certificate review application materials to the US FDA [Google translation] (China Times) - "Tanvex BioPharma USA, Inc., a subsidiary of Taifu-KY (6541) , has delivered the biosimilar drug TX01 (Neupogen Biosimilar) drug certification review application materials to the US Food and Drug Administration (FDA)."

NDA • Neutropenia

The Translocation and Assembly Module (TAM) of Edwardsiella tarda Is Essential for Stress Resistance and Host Infection. (PubMed, Front Microbiol) - "Furthermore, TX01ΔtamA and TX01ΔtamB were significantly impaired in the ability to survive under low pH and oxidizing conditions, and were unable to maintain their internal pH balance and cellular structures in acidic environments, which led to increased susceptibility to lysozyme destruction. Taken together, these results indicate that TamA and TamB are essential for the virulence of E. tarda and required for E. tarda to survive under stress conditions."

Journal • Psychiatry

Tanvex BioPharma submits filgrastim biosimilar to FDA (GaBI) - "...Tanvex BioPharma (Tanvex) announced...that it had submitted its first biosimilar application to the US Food and Drug Administration (FDA). The application is for its proposed filgrastim biosimilar TX‑01."

BLA • Neutropenia

Universal stress proteins contribute Edwardsiella piscicida adversity resistance and pathogenicity and promote blocking host immune response. (PubMed, Fish Shellfish Immunol) - "To investigate the biological role of usp13, a markerless usp13 in-frame mutant strain, TX01Δusp13, was constructed...These results suggested that the deletion of usp13 attenuated the ability of bacteria to overcome the host immune response to pathogen infection. Taken together, our study indicated Usp13 of E. piscicida was not only important participant in adversity resistance, but also was essential for E. piscicida pathogenicity and contributed to block host immune response to pathogen infection."

Journal

HutZ is required for biofilm formation and contributes to the pathogenicity of Edwardsiella piscicida. (PubMed, Vet Res) - "To explore the biological role of HutZ, a markerless hutZ in-frame mutant strain, TX01ΔhutZ, was constructed...The expression of hutZ was directly regulated by the ferric uptake regulator Fur. This study is the first functional characterization of HutZ in a fish pathogen, and these findings suggested that HutZ is essential for E. piscicida biofilm formation and contributes to host infection."

Journal

Another biosimilar litigation settlement: Amgen v. Tanvex (filgrastim) (JD Supra) - "...Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar candidate. The stipulation states that the parties agree 'to the dismissal, without prejudice, of all remaining claims and counterclaims in this action with the parties to bear their own costs and attorney’s fees.'"

Corporate lawsuit

FDA rejects Tanvex's proposed filgrastim biosimilar, TX01 (Center for Biosimilars) - "The FDA has issued a complete response letter (CRL) for Tanvex Biopharma’s TX01, a proposed biosimilar filgrastim referencing Neupogen. Tanvex said in a statement that the FDA did not request additional clinical data or express concerns about the product’s safety, and the company said it plans to resubmit its Biologics License Application (BLA) to the FDA as soon as it has addressed items raised by the regulator."

BLA • FDA event

Amgen files new patent infringement suit over Neupogen biosimilar (Lexology) - "Amgen, maker of the cancer treatment drug Neupogen (filgrastim), filed patent infringement claims in the Southern District of California against Tanvex Biopharma over Tanvex’s proposed filgrastim biosimilar in the Southern District of California....Amgen asserts a patent that claims methods of refolding recombinant proteins used in the manufacture of Neupogen."

Patent

Thioredoxin H (TrxH) contributes to adversity adaptation and pathogenicity of Edwardsiella piscicida. (PubMed, Vet Res) - "...Compared to the wild type TX01, a markerless trxH in-frame mutant strain TX01∆trxH exhibited markedly compromised tolerance of the pathogen to hydrogen peroxide, acid stress, and iron deficiency...There is likely to be a complex relationship of functional complementation or expression regulation between TrxH and another two thioredoxins, TrxA and TrxC, of E. piscicida. This is the first functional report of TrxH in fish pathogens, and the findings suggest that TrxH is essential for coping with adverse circumstances and contributes to host infection of E. piscicida."

Journal

PAnTheRA: Predictive Analytics for Theranosis in RA (clinicaltrials.gov) - P=N/A; N=110; Recruiting; Sponsor: DNAlytics; Trial completion date: Jul 2018 ➔ Apr 2020; Trial primary completion date: Jan 2018 ➔ Dec 2019

Trial completion date • Trial primary completion date