Barinthus Bio Announces Results From Ongoing Phase 2b Chronic Hepatitis B Trial, Including Achievement of Functional Cure and HBsAb Seroconversion
Barinthus Biotherapeutics announced significant results from its ongoing Phase 2b HBV003 clinical trial for chronic hepatitis B treatment. The study, involving 121 participants, evaluated VTP-300 combined with low-dose nivolumab. Key findings include: eight participants achieved complete HBsAg loss, two met functional cure criteria, and two participants who discontinued NUC therapy developed HBsAb positivity. Among 40 participants assessed for NUC discontinuation, 24 were eligible, and nine chose to discontinue. Six remained off NUC therapy, with five maintaining this status for over six months. The treatment was generally well-tolerated with no treatment-related SAEs reported.
Barinthus Biotherapeutics ha annunciato risultati significativi dal suo studio clinico in fase 2b HBV003 per il trattamento dell'epatite B cronica. Lo studio, che ha coinvolto 121 partecipanti, ha valutato VTP-300 combinato con nivolumab a basso dosaggio. Le principali scoperte includono: otto partecipanti hanno raggiunto una perdita completa di HBsAg, due hanno soddisfatto i criteri per la cura funzionale e due partecipanti che hanno interrotto la terapia con NUC hanno sviluppato positività per HBsAb. Tra i 40 partecipanti valutati per l'interruzione del NUC, 24 erano idonei e nove hanno scelto di interrompere. Sei sono rimasti senza terapia NUC, con cinque che hanno mantenuto questo stato per oltre sei mesi. Il trattamento è stato generalmente ben tollerato, senza SAE correlati al trattamento riportati.
Barinthus Biotherapeutics anunció resultados significativos de su ensayo clínico en fase 2b HBV003 para el tratamiento de la hepatitis B crónica. El estudio, que involucró a 121 participantes, evaluó VTP-300 combinado con nivolumab en dosis bajas. Los hallazgos clave incluyen: ocho participantes lograron una pérdida completa de HBsAg, dos cumplieron con los criterios de cura funcional y dos participantes que interrumpieron la terapia con NUC desarrollaron positividad para HBsAb. Entre los 40 participantes evaluados para la interrupción del NUC, 24 eran elegibles y nueve eligieron interrumpir. Seis se mantuvieron sin terapia NUC, con cinco que mantuvieron este estado durante más de seis meses. El tratamiento fue generalmente bien tolerado, sin SAE relacionados con el tratamiento reportados.
Barinthus Biotherapeutics는 만성 B형 간염 치료를 위한 진행 중인 2b상 HBV003 임상 시험에서 중요한 결과를 발표했습니다. 121명의 참가자가 참여한 이 연구는 VTP-300과 저용량의 nivolumab을 평가했습니다. 주요 발견으로는 8명의 참가자가 HBsAg를 완전히 잃었고, 2명은 기능적 치료 기준을 충족했으며, NUC 요법을 중단한 2명은 HBsAb 양성을 보였습니다. NUC 중단을 평가한 40명의 참가자 중 24명이 자격이 있었고, 9명이 중단하기로 선택했습니다. 6명은 NUC 요법 없이 지냈으며, 5명은 이 상태를 6개월 이상 유지했습니다. 치료는 일반적으로 잘 견디는 것으로 나타났으며 치료와 관련된 중대한 부작용(SAE)은 보고되지 않았습니다.
Barinthus Biotherapeutics a annoncé des résultats significatifs de son essai clinique en phase 2b HBV003 pour le traitement de l'hépatite B chronique. L'étude, impliquant 121 participants, a évalué VTP-300 associé à du nivolumab à faible dose. Les résultats clés incluent : huit participants ont obtenu une perte complète d'HBsAg, deux ont atteint les critères de guérison fonctionnelle, et deux participants ayant interrompu la thérapie NUC ont développé une positivité pour HBsAb. Parmi les 40 participants évalués pour l'interruption du NUC, 24 étaient éligibles et neuf ont choisi d'interrompre. Six sont restés sans thérapie NUC, dont cinq ont maintenu ce statut pendant plus de six mois. Le traitement a été généralement bien toléré, sans effets indésirables graves (SAE) liés au traitement signalés.
Barinthus Biotherapeutics hat bedeutende Ergebnisse aus der laufenden Phase 2b HBV003-Studie zur Behandlung von chronischer Hepatitis B bekannt gegeben. Die Studie, an der 121 Teilnehmer beteiligt waren, bewertete VTP-300 in Kombination mit niedrig dosiertem Nivolumab. Wichtige Ergebnisse sind: acht Teilnehmer erreichten einen vollständigen Verlust von HBsAg, zwei erfüllten die Kriterien für eine funktionale Heilung und zwei Teilnehmer, die die NUC-Therapie abbrachen, entwickelten eine HBsAb-Positivität. Von 40 Teilnehmern, die auf NUC-Abbruch überprüft wurden, waren 24 geeignet, und neun entschieden sich für einen Abbruch. Sechs blieben ohne NUC-Therapie, wobei fünf diesen Status über sechs Monate hinweg aufrecht erhielten. Die Behandlung wurde allgemein gut vertragen, und es wurden keine behandlungsbedingten schwerwiegenden unerwünschten Ereignisse (SAEs) berichtet.
- Eight participants achieved complete HBsAg loss
- Two participants achieved functional cure criteria
- 66% (6/9) of participants remained successfully off NUC therapy
- Two participants developed positive HBsAb antibodies
- No treatment-related serious adverse events reported
- Only 2 out of 121 participants (1.7%) achieved functional cure
- 33% (3/9) of participants who discontinued NUCs had to resume therapy
Insights
The Phase 2b trial results for VTP-300 demonstrate significant progress in treating chronic hepatitis B, with 8 participants achieving HBsAg loss and 2 reaching functional cure. The development of HBsAb antibodies in 2 participants is particularly noteworthy, as it suggests immune system control over the infection. The 66% success rate (6 out of 9) in maintaining NUC discontinuation for over 6 months indicates potential treatment durability.
The combination therapy with low-dose nivolumab (Groups 1 and 2) appears to generate stronger responses. The safety profile is favorable, with no treatment-related serious adverse events reported. For a disease affecting approximately 296 million people globally, these results could represent a significant advancement in treatment options, potentially allowing some patients to discontinue antiviral medications while maintaining disease control.
For Barinthus Bio, with a modest market cap of
The data suggests potential for reduced long-term treatment costs through NUC discontinuation, which could enhance market adoption. Investors should note that while these results are promising, the trial size is relatively small at 121 participants and further validation through larger studies will be necessary for regulatory approval and commercial success.
- Eight participants achieved HBsAg loss at any time.
- Two participants met criteria for functional cure.
- Two participants who discontinued NUC therapy seroconverted to HBsAb positivity.
OXFORD, United Kingdom, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), today announced the most significant data so far from the ongoing Phase 2b HBV003 clinical trial. The data will be presented by Dr. Chun-Jen Liu as an oral presentation on November 18, 2024, at 17:30 PT at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2024. Barinthus Bio is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease.
The HBV003 study (NCT05343481) is fully recruited with a total of 121 participants, including 69 participants who had entered the trial with HBsAg levels below 200 IU/mL. The study is evaluating different dosing regimens of VTP-300 in combination with low-dose nivolumab, an anti-PD-1 monoclonal antibody. The new data showed that as of data cut off, eight participants were reported with complete HBsAg loss (defined as HBsAg levels below the lower limit of quantitation [<LLOQ, 0.05 IU/mL]) and two participants met the criteria for functional cure.
Uniquely, two of the eight participants with HBsAg loss, became positive for anti-hepatitis B antibodies (HBsAb) that they did not have before, including one of those who met functional cure criteria. The data from this ongoing study indicate that stronger responses may happen in participants treated with the combination of VTP-300 and a low dose of the anti-PD1 antibody nivolumab (Groups 1 and 2).
“Sustained HBsAg loss has proven to be the largest hurdle in getting chronic hepatitis B patients to functional cure,” said Dr. Chun-Jen Liu, investigator on HBV003 and Director of the Hepatitis Research Center and Clinical Trial Center, National Taiwan University Hospital, Taiwan. “The data we are seeing with VTP-300 is unique because they indicate a durable loss of HBsAg in participants, including two who met the criteria for functional cure. Although the study is still ongoing, these early data may bring us a step closer to potentially allowing some patients with chronic hepatitis B to come off antiviral treatment without their chronic hepatitis B progressing.”
40 participants, with HBsAg below 200 IU/mL at screening, who had reached Day 169 were assessed for nucleos(t)ide analogue (NUC) discontinuation. The data showed the following:
- 24 were eligible for NUC discontinuation.
- Eight achieved HBsAg loss at any time, two of whom achieved it after Day 169.
- Nine participants chose to discontinue NUCs.
66% (n=6/9) remained off NUC therapy, five for more than six months.- Two of these six have met the criteria for functional cure.
- Two of these six seroconverted to HBsAb positivity.
- Follow up is continuing with the remaining participants to assess if they will meet functional cure criteria.
- Durable HBsAg declines were observed in all treatment groups, consistent with data previously presented at the European Association for the Study of the Liver (EASL) Congress, in June 2024.
- Preliminary safety data indicate that VTP-300 in combination with low-dose nivolumab was generally well tolerated with no treatment-related SAEs observed or reported as of data cut off.
"These Phase 2 data are incredibly encouraging and highlight the ability of VTP-300 to stimulate the immune response and induce sustained reductions in HBsAg to the point of meeting functional cure criteria,” said Dr. Nadege Pelletier, Chief Scientific Officer of Barinthus Bio. "Moreover, the finding that one of the participants meeting functional cure criteria had antibodies against hepatitis B is promising as HBsAb positivity is associated with long-term control of the infection by the immune system.”
Functional cure is defined by AASLD as sustained HBsAg loss and hepatitis B virus DNA <LLOQ for 6 months off-treatment. Data cut off was September 30, 2024, for lab data and October 8, 2024, for clinical data.
About the HBV003 Trial
The HBV003 trial is designed to obtain critical information on treatment dosing regimen with participants receiving VTP-300 and low-dose (LD) nivolumab. All Groups received ChAdOx at Day 1; Groups 1 & 2 received MVA with nivolumab at Day 29; Group 2 was dosed again with MVA and nivolumab at Day 85; Group 3 received only MVA at Day 29, nivolumab at Day 36, and a conditional second MVA dose at Day 85 to evaluate anti-PD-1 inhibition timing. The conditional MVA dose was administered if participants had HBsAg ≥10 IU/mL. In 2023, the study inclusion criteria was amended from people with CHB with HBsAg ≥10 and <4,000 IU/mL to ≥10 and ≤200 IU/mL, as strongest responses were observed in participants with HBsAg ≤200 IU/ml.
About VTP-300
VTP-300 is an immunotherapeutic candidate consisting of an initial dose using the ChAdOx vector and a secondary dose(s) using the MVA vector, both encoding multiple HBsAg, including full-length surface, modified polymerase, and core antigens. VTP-300 is the first antigen-specific immunotherapy that has been shown to induce sustained reductions in HBsAg. Barinthus Bio is studying VTP-300 in combination with other agents, including siRNA and low-dose anti-PD-1 antibodies in the ongoing IM-PROVE II trial, to control the infection, and counterbalance the immune suppression and T cell exhaustion in the liver caused by chronic HBV infection.
About Barinthus Bio
Barinthus Bio is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases and autoimmunity. Helping people living with serious diseases and their families is the guiding principle at the heart of Barinthus Bio. With a focused pipeline built around our proprietary platform technologies, Barinthus Bio is advancing immunotherapeutic product candidates in infectious diseases and autoimmunity, including: VTP-300, utilizing our ChAdOx/MVA platform designed as a potential component of a functional cure for chronic HBV infection and VTP-1000, utilizing our SNAP-Tolerance Immunotherapy (SNAP-TI) platform and designed to treat people with celiac disease. Barinthus Bio is also conducting a Phase 1 clinical trial for VTP-850, a second-generation immunotherapeutic candidate designed to treat recurrent prostate cancer. Barinthus Bio’s differentiated technology platforms and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with chronic infectious diseases and autoimmunity. For more information, visit www.barinthusbio.com.
Barinthus Bio's Forward Looking Statements
This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding our product development activities and clinical trials, including timing for readouts of any interim data or next steps for any of our programs, including VTP-300 and the HBV003 trial, the tolerability or potential benefits of VTP-300 or imdusiran, including in combination with nivolumab, and our ability to develop and advance our current and future product candidates and programs. Any forward-looking statements in this press release are based on our management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of our clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, our ability to execute on our strategy, regulatory developments, the risk that we may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, our ability to fund our operations and access capital, our cash runway, including the risk that our estimate of our cash runway may be incorrect, global economic uncertainty, including disruptions in the banking industry, the conflict in Ukraine, the conflict in Israel and Gaza, and other risks identified in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We expressly disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
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