Augmenta Bioworks and TFF Pharmaceuticals Announce Selection of Lead Monoclonal Antibody Candidate AUG-3387 for Clinical Development Against COVID-19
Notably, in in vitro preclinical testing, AUG-3387 effectively neutralizes SARS-CoV2 and has demonstrated activity against all variant strains tested to date, including the major COVID variants of concern, including the previously identified
“The activity of AUG-3387 against all SARS-CoV2 variants tested to date provides strong justification for the continued development of this unique monoclonal antibody therapy, especially when combined with the potential to break the cold chain requirement of other therapies and the cost-effective delivery of lower doses via inhalation, made possible through the TFF process,” stated Dr.
“By combining the novel pan-variant activity of AUG-3387 with the enhanced stability and ease of delivery provided by the TFF technology, we believe this drug could potentially make significant impact on bringing COVID-19 disease under control where vaccines with extreme cold chain requirements are not feasible,” added
About Augmenta Bioworks
Augmenta Bioworks is a venture-backed biotechnology company leveraging immune profiling technologies to enable breakthroughs in medicine. Through its patented DeepGridTM and SingleCyte® Technologies, Augmenta endeavors to profile human immunity at increased scale and speed, shrinking new drug discovery timelines. The company's platform utilizes the latest software, automation, microfluidics, high throughput DNA sequencing, and scalable computational analysis to identify immune receptors and their antigen specificity. The results are therapeutics derived from natural human immunity. The company works through partnerships in antibody discovery (infectious disease), cell therapy development (oncology), and other advanced research (auto-immunity).
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company’s TFF platform and its dry powder versions of Voriconazole and Tacrolimus, the potential development of one or more dry powder mAbs through its collaboration with Augmenta Bioworks and the Company’s plans to add to its existing pipeline of product candidates and license its technology to other third-parties. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that results obtained in dry powder formulation and in vitro testing of the Augmenta mAbs may not be indicative of results obtained in future preclinical or clinical trials; (ii) the risk that TFF Pharmaceuticals’ dry powder formulation of the Augmenta mAbs may not advance through the preclinical development and clinical trial process on a timely basis, or at all; (iii) the risk that the results of such trials will not warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (iv) the risk that TFF Pharmaceuticals and Augmenta may not be able to successfully conclude clinical testing or obtain pre-market approval of their dry powder versions of the Augmenta mAbs, (v) the fact that no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) TFF Pharmaceuticals has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (vi) those other risks disclosed in the section “Risk Factors” included in the TFF Pharmaceuticals’ 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2020. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.
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Source: TFF Pharmaceuticals, Inc.