TFF Pharmaceuticals Announces Positive Preclinical Data from Bivalent Universal Influenza Vaccine Candidates Manufactured by TFF Following Intranasal Immunization
TFF Pharmaceuticals (Nasdaq: TFFP) has announced positive preclinical data for their bivalent universal influenza vaccine candidates manufactured using Thin Film Freezing (TFF) technology. The study, conducted in collaboration with Dr. Ted Ross from Cleveland Clinic, showed that TFF-dry powder HA antigen vaccine candidates induced neutralizing antibody titers in ferrets against H1 and H3 influenza strains when administered intranasally.
The research, funded by a $2.97 million NIAID grant, aims to develop a shelf-stable mucosal universal influenza vaccine that could be effective against multiple strains and self-administered. Ongoing studies will assess antibody titers against a broader panel of influenza A viruses. The company's goal is to advance a vaccine candidate to IND and early clinical trials, with potential for significant market impact if successful.
TFF Pharmaceuticals (Nasdaq: TFFP) ha annunciato dati preclinici positivi per i loro candidati a vaccini bivalenti universali contro l'influenza, prodotti utilizzando la tecnologia Thin Film Freezing (TFF). Lo studio, condotto in collaborazione con il Dr. Ted Ross della Cleveland Clinic, ha dimostrato che i candidati vaccinali a base di antigeni HA in polvere secca TFF hanno indotto titoli di anticorpi neutralizzanti nei furetti contro i ceppi H1 e H3 dell'influenza quando somministrati per via intranasale.
La ricerca, finanziata da un grant di 2,97 milioni di dollari della NIAID, mira a sviluppare un vaccino universale contro l'influenza mucosale stabile a temperatura ambiente che potrebbe essere efficace contro più ceppi e auto-somministrato. Studi in corso valuteranno i titoli di anticorpi contro un panel più ampio di virus influenzali A. L'obiettivo dell'azienda è portare un candidato vaccinale a IND e a trial clinici preliminari, con potenziali significativi impatti sul mercato se avrà successo.
TFF Pharmaceuticals (Nasdaq: TFFP) ha anunciado datos preclínicos positivos para sus candidatos a vacunas bivalentes universales contra la inflación, fabricados utilizando la tecnología Thin Film Freezing (TFF). El estudio, realizado en colaboración con el Dr. Ted Ross de Cleveland Clinic, mostró que los candidatos a vacunas de antígenos HA en polvo seco TFF indujeron títulos de anticuerpos neutralizantes en hurones contra las cepas H1 y H3 de influenza cuando se administraron por vía intranasal.
La investigación, financiada por una subvención de 2,97 millones de dólares del NIAID, tiene como objetivo desarrollar una vacuna universal mucosal estable a temperatura ambiente contra la influenza que podría ser efectiva contra múltiples cepas y autoadministrada. Los estudios en curso evaluarán los títulos de anticuerpos contra un panel más amplio de virus de influenza A. El objetivo de la empresa es avanzar un candidato a vacuna hacia IND y ensayos clínicos tempranos, con un impacto potencial significativo en el mercado si tiene éxito.
TFF Pharmaceuticals (Nasdaq: TFFP)는 Thin Film Freezing (TFF) 기술을 사용하여 제조된 이황화물 범용 인플루엔자 백신 후보에 대한 긍정적인 전임상 데이터를 발표했습니다. 클리블랜드 클리닉의 테드 로스 박사와 협력하여 수행된 이 연구는 TFF 건조 분말 HA 항원 백신 후보가 H1 및 H3 인플루엔자 변종에 대해 족제비에서 중화 항체 역치를 유도했다는 것을 보여주었습니다. 이 백신은 비강으로 투여되었습니다.
이 연구는 297만 달러의 NIAID 보조금으로 자금을 지원받아, 여러 변종에 효과적이고 자가 투여가 가능한 온도 안정성 점막 범용 인플루엔자 백신을 개발하는 것을 목표로 하고 있습니다. 진행 중인 연구는 더 광범위한 인플루엔자 A 바이러스 패널에 대해 항체 역치를 평가할 것입니다. 회사의 목표는 후보 백신을 IND와 초기 임상 시험으로 발전시키는 것이며, 성공할 경우 시장에 미치는 영향이 상당할 가능성이 있습니다.
TFF Pharmaceuticals (Nasdaq: TFFP) a annoncé des données précliniques positives pour ses candidats vaccins bivalents universels contre la grippe, fabriqués à l'aide de la technologie de congélation par film mince (TFF). L'étude, réalisée en collaboration avec le Dr Ted Ross de la Cleveland Clinic, a montré que les candidats vaccins à base d'antigène HA en poudre sèche TFF ont induit des titres d'anticorps neutralisants chez des furets contre les souches de grippe H1 et H3 lorsqu'ils étaient administrés par voie intranasale.
La recherche, financée par une subvention de 2,97 millions de dollars de la NIAID, vise à développer un vaccin mucosal universel contre la grippe, stable à température ambiante qui pourrait être efficace contre plusieurs souches et auto-administré. Les études en cours évalueront les titres d'anticorps contre un panel plus large de virus de la grippe A. L'objectif de l'entreprise est de faire progresser un candidat vaccin vers une IND et des essais cliniques précoces, avec un impact potentiel significatif sur le marché en cas de succès.
TFF Pharmaceuticals (Nasdaq: TFFP) hat positive präklinische Daten für ihre bivalenten universellen Influenza-Impfstoffkandidaten bekannt gegeben, die mit der Thin Film Freezing (TFF)-Technologie hergestellt wurden. Die Studie, die in Zusammenarbeit mit Dr. Ted Ross von der Cleveland Clinic durchgeführt wurde, zeigte, dass die TFF- getrocknete Pulver-HA-Antigenimpfstoffkandidaten bei Frettchen neutralisierende Antikörpertiter gegen die H1- und H3-Influenza-Stämme induzierten, als sie intranasal verabreicht wurden.
Die Forschung, die durch einen NIAID-Zuschuss in Höhe von 2,97 Millionen US-Dollar finanziert wird, zielt darauf ab, einen bei Raumtemperatur stabilen mukosalen universellen Influenza-Impfstoff zu entwickeln, der gegen mehrere Stämme wirksam sein und selbst verabreicht werden kann. Laufende Studien werden die Antikörpertiter gegen ein breiteres Spektrum von Influenza-A-Viren bewerten. Ziel des Unternehmens ist es, einen Impfstoffkandidaten bis zur IND und frühen klinischen Studien voranzubringen, mit dem Potenzial für signifikante Auswirkungen auf den Markt, sofern er erfolgreich ist.
- TFF-dry powder HA antigen vaccine candidates showed positive results in ferret studies
- Vaccine induced neutralizing antibody titers against H1 and H3 influenza strains
- Research funded by a $2.97 million NIAID grant
- Potential for a universal flu vaccine with billions in annual sales
- None.
Insights
The preclinical data for TFF Pharmaceuticals' universal influenza vaccine candidates show promising results. The TFF-dry powder HA antigen vaccines induced neutralizing antibody titers against H1 and H3 influenza strains in ferrets, a model closely resembling human immune responses. This is a significant step towards developing a broadly protective influenza vaccine.
The use of intranasal delivery and mucosal adjuvants is noteworthy, as it could potentially enhance both cellular and antibody immune responses. This approach may lead to more effective protection against multiple influenza strains. The ongoing studies assessing neutralizing antibody titers against a panel of 13 influenza A viruses will provide important data on the vaccine's breadth of protection.
If successful, this universal flu vaccine could revolutionize influenza prevention by offering protection against more than 75% of circulating strains, addressing the challenge of annual strain prediction and vaccine reformulation.
The positive preclinical data for TFF Pharmaceuticals' universal influenza vaccine candidates could significantly impact the company's future prospects. The global influenza vaccine market is substantial, with annual sales potential in the
The
TFF-dry powder HA antigen vaccine candidates induced neutralizing antibody titers in ferrets against H1 and H3 influenza strains
Ongoing funded work to assess additional influenza strains
FORT WORTH, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc (Nasdaq: TFFP) (the “Company” or “TFF Pharmaceuticals”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, announces positive preclinical data advancing a multivalent universal influenza vaccine manufactured by TFF to protect against seasonal and pandemic viruses. The data were produced in collaboration with Dr. Ted Ross, Global Director of Vaccine Development at Cleveland Clinic.
“These preliminary data suggest that the intranasal administration of the TFF-dry powder hemagglutinin (HA) antigen vaccine candidates is highly immunogenic and produces protective antibody titers in ferrets,” said Dr. Harlan Weisman, TFF Pharmaceuticals Chief Executive Officer. “These data support continued development of a shelf-stable mucosal universal influenza vaccine that could be effective regardless of which strain emerges in any year and that could be self-administered.”
The experiments conducted by Dr. Ross demonstrated that TFF-dry powder HA antigen vaccine candidates induce neutralizing antibody titers in ferrets against H1 and H3 influenza strains. No response was observed in animals vaccinated with mock vaccine.
The ferret model is the gold standard to study host immune responses and evaluate influenza vaccine and antiviral therapies due to similarities with humans. Pre-immune female ferrets received TFF-dry powder HA antigen vaccine for intranasal (IN) delivery with various mucosal adjuvants that can elicit both cellular and antibody immune responses. Mock vaccine (adjuvant only) was used as a control. Serum was collected to assess neutralizing antibody titers against influenza A viruses for H1N1 and H3N2 subtypes.
Ongoing studies will assess neutralizing antibody titers against a panel of 13 influenza A viruses isolated between 2006-2018 for H1N1 and 2012-2019 for H3N2 subtypes. After viral challenge, ferrets will be monitored daily for clinical signs and symptoms and antibody titers. These positive results will allow TFF to select an adjuvant for advanced development of a universal influenza vaccine candidate that will be delivered as a dry powder designed to protect against greater than
This work is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, under a previously awarded Direct to Phase II Small Business Innovation Research (SBIR) grant of approximately
The goal of this program is to advance a vaccine candidate to IND and early clinical trials. If successful, a TFF-formulated universal flu vaccine has the potential to generate several billion dollars in annual sales, presenting a highly attractive out-licensing opportunity for the company.
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY
TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by TFF can deliver as much as
ABOUT TFF PHARMACEUTICALS
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose and the skin.
SAFE HARBOR
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the potential development of a multivalent universal influenza vaccine manufactured by TFF to protect against seasonal and pandemic viruses, using its TFF technology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk that the Company’s collaboration with Cleveland Clinic may not lead to the successful development of a dry powder multivalent universal influenza vaccine, (ii) the risk that the Company may not be able to obtain additional working capital with which to continue its current operations and clinical trials as and when needed, (iii) success in early phases of pre-clinical and clinical trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company 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 Company’s Quarterly Report on Form 10-Q filed with the SEC on August 14, 2024. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company 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.
Investor Relations Contact:
Core IR
Jason Nelson
investorinfo@tffpharma.com
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