Data Shows AUG-3387 Neutralizes SARS-CoV-2 Delta Variant in Infective Assays
Supports Earlier Data Showing AUG-3387 Binds Strongly to Delta Variant in Addition to Wild-Type Spike Protein and Other Variants of Concern
Catalent Selected as
Scale-up Manufacturing for AUG-3387 Proceeding Rapidly; Early Batches Show Promising Results
Recent data indicates that the Delta variant, which was recently declared a “Variant of Concern” by the
“We are very excited about these new data, which reinforce our view that AUG-3387 could represent an important new class of biologic-based treatment modalities that can effectively target the emerging and potentially more pathogenic variants of the SARS-CoV-2 virus,” stated Dr. Christopher Emig, Chief Executive Officer of Augmenta Bioworks. “As global health officials look for innovative solutions to help curb human-to human spread of coronaviruses, we expect the treatment landscape for COVID-19 to evolve so that scalable, biologic-based therapies can play a more prominent role in efficiently combating viral transmission, particularly with respect to new, more infectious COVID-19 variants.”
Augmenta and TFF Pharmaceuticals plan to develop AUG-3387 as an inhaled therapy for the treatment of COVID-19 disease in two types of individuals: (1) those already infected with SARS-CoV-2
The companies have selected a final formulation of AUG-3387 that will be used to complete in vivo preclinical efficacy studies in the coming weeks and will proceed with toxicology studies by the end of 2021. Ongoing formulation development studies are expected to demonstrate that a sufficient dose of AUG-3387 to achieve a neutralizing concentration in the lungs can be delivered via already approved commercial dry powder inhaler devices.
In prior in vitro preclinical testing, AUG-3387 effectively neutralized SARS-CoV-2 and demonstrated activity against other major COVID variants of concern, including the previously identified Alpha variant (B.1.1.7), Beta variant (B.1.351), Gamma variant (P.1) and Kappa variant (B.1.617.1). The additional positive neutralization data against the delta variant reflects TFF and Augmenta’s ongoing commitment to monitor activity of AUG-3387 against emerging SARS-CoV-2 variants, and to develop a therapy that is as effective as possible against currently dominant strains.
In November 2020,
About Augmenta Bioworks
Augmenta Bioworks is a venture-backed biotechnology company leveraging immune profiling technologies to enable breakthroughs in medicine. Through its DeepGridTM and SingleCyteR Technologies, Augmenta profiles human immunity at unprecedented scale and speed, shrinking new drug discovery timelines from years to days. 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).
About TFF Pharmaceuticals
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company’s TFF platform, its Joint Development and Collaboration Agreement with Augmenta Bioworks, TFF’s and Augmenta’s potential joint development of AUG-3387 to combat the SARS-CoV-2 virus and its variants and the parties’ potential joint development of two additional Augmenta mAbs for indications other than COVID-19. 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 AUG-3387 and any other 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 AUG-3387 and any other 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 AUG-3387 or any other 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, 2021. 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.