VACC Vaccitech plc
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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VTP-300 (HBV002)
Hepatitis B
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Phase 1/2
Phase 1/2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
VTP-200
Human papillomavirus (HPV)
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Phase 1/2
Phase 1/2
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Phase 1/2a safety and immunogenicity data presented at the International Papillomavirus Conference November 15-19, 2021.
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AZD1222
COVID-19 vaccine
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Phase 3
Phase 3
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Phase 3 data exhibited 70% efficacy (90% and 60% across two dosing regimens) - UK and Brazil trial. Data from U.S. trial noted 76% efficacy rate - March 24, 2021.
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|
VTP-300 (HBV001)
Hepatitis B and healthy volunteers
|
Phase 1
Phase 1
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Phase 1 data reported total T cell responses to the HBV immunogen peaked at day 28 post dose in both HC and CHB patients, noted November 12, 2021.
|
|
VTP-600 and KEYTRUDA (pembrolizumab)
Non-small cell lung cancer
|
Phase 1/2
Phase 1/2
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Phase 1/2 trial to initiate dosing in 4Q 2021.
|
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AB-729 and VTP-300
Hepatitis B
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Phase 2a
Phase 2a
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Phase 2 trial to be initiated early 2022.
|
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ChAdOx1
Middle Eastern Respiratory Syndrome (MERS)
|
Phase 1
Phase 1
|
Phase 1 data reported induced robust antibody and T cell immune responses in all volunteers. Antibodies peaked at day 28 and T cell responses peaked at day 14, both of which were maintained until the end of follow-up at six months. The most common adverse event
as headache (58% of volunteers) followed by muscle pain (54%), noted November 4, 2021.
|
|
VTP-850
Prostate cancer
|
Phase 1/2
Phase 1/2
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Phase 1/2 trial to commence 1Q 2022.
|
Latest News
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OXFORD, United Kingdom, Nov. 24, 2021 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ:VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines, today announced that Bill Enright, Chief Executive Officer, and Georgy Egorov, Chief Financial Officer, are participating at the 33rd Annual Virtual Piper Sandler Healthcare Conference November 30th to December 2nd, 2021. A pre-recorded fireside chat with Bill Enright and Georgy Egorov is available at the link below.
Event: 33rd Piper Sandler Annual Healthcare Conference Fireside Chat: Virtual on-demand webcast Time/date: 10 a.m. EST, Nov. 22 and available for approximately 90 days Webcast: Events section of the Vaccitech website About Vaccitech plc
Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer. The company's proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and without the ability to replicate in humans. The combination of a ChAdOx prime treatment with subsequent MVA boost has consistently generated significantly higher magnitudes of CD8+ T cells compared with other technologies and approaches. The company has a broad pipeline of both clinical and preclinical stage therapeutic programs in solid tumors and viral infections and prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of the milestones and royalty income received by OUI from AstraZeneca.Vaccitech Media contacts:
Katja Stout, Scius Communications (EU)
Direct: +44 (0) 7789435990
Email: [email protected]
Robert Flamm, Ph.D.
212-213-0006 ext. 364
Email: [email protected]
Henry Hodge, Vaccitech
Email: [email protected]
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Interim data from two studies, HBV001 and HBV002, showed that in chronic Hepatitis B (CHB) patients the heterologous prime-boost vector combination, ChAdOx1-HBV + MVA-HBV (VTP-300), induced robust T cells against targeted hepatitis B viral antigens.
ChAdOx-1-HBV alone (HBV001) was well tolerated in healthy volunteers and CHB patients; VTP-300 (HBV002) was well-tolerated in CHB patients.
T cells from subjects in both studies were shown to be cross-reactive to two major HBV genotypes (C and D), indicating the potential for VTP-300 to form part of a functional cure regimen for CHB globally.
OXFORD, United Kingdom, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ:VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines, today announced results from ongoing Phase 1 and Phase 1b/2a clinical trials of VTP-300, an immunotherapy candidate in development for the treatment of CHB infection. Results to date showed that both the ChAdOx1-HBV (prime), in study HBV001 (healthy volunteers and CHB patients), and the combination of ChAdOx1-HBV (prime) and MVA-HBV (boost), in study HBV002 (CHB patients only), were highly immunogenic to all HBV viral targets, and were generally well tolerated. The data are available in two posters at the AASLD The Liver Meeting®.
"The interim results of these ongoing studies are promising in the field of HBV immunotherapy," said Thomas Evans, M.D., Chief Scientific Officer of Vaccitech. "They showed that our prime-boost strategy was able to establish potent T cell responses against virally-infected liver cells in immune-suppressed CHB patients, and no vaccine-associated serious adverse events were reported. We are pleased to receive this initial immunological data on VTP-300 ahead of evaluating results from patients receiving VTP-300 in combination with a low-dose checkpoint inhibitor."
Professor Eleanor Barnes, Chief Investigator on the HBV001 and HBV002 studies said, "These data are exciting, as they support our approach for providing cell-targeting immunotherapy in chronic hepatitis B patients. The high levels of T cells that targeted several major HBV genes, and their cross-reactivity towards two of the major circulating HBV viral genotypes, support further evaluation of this candidate to meet an unmet medical need for patients across the globe."
HBV001
HBV001 is an open-label, non-randomised, Phase I clinical trial (NCT042979.17) to evaluate the safety, tolerability, and immunogenicity of ChAdOx1-HBV in humans. Participants are healthy controls (HC) and patients with CHB with supressed HBV DNA on nucleos(t)ide therapy. ChAdOx1-HBV was well tolerated with no serious adverse events reported as of the date of interim analysis. Total T cell responses to the HBV immunogen peaked at day 28 post dose in both HC (mean 1,284 SFU per million PBMCs) and CHB patients (mean 184 SFU). HBV-specific T cell responses generated by ChAdOx1-HBV were induced to all immunogens in the product candidate and were reactive to both genotype C and genotype D peptides. The most common adverse event reported was injection site pain, and all cases were mild in severity.
HBV002
HBV002 is an open-label trial to determine the safety, immunogenicity and preliminary efficacy of ChAdOx1-HBV and MVA-HBV (VTP-300), with or without nivolumab, in patients with chronic HBV with supressed HBV DNA on nucleos(t)ide therapy.
As of September 2021, 30 patients had been enrolled, and no concerning safety signals or Serious Adverse Reactions have been reported. Day 35 results from the first six CHB patients in Group 1 (MVA-HBV Day 0, MVA-HBV Day 28) and Group 2 (ChAdOx1-HBV Day 0, MVA-HBV Day 28) are reported in our presentation. Total T cell responses were superior, in the high hundred SFUs per million PBMCs, following the heterologous prime-boost (VTP-300) in Group 2, compared to Group 1.
VTP-300 induced antigen specific T cell responses to all antigens, with elevated responses to core and polymerase, as compared to healthy controls dosed with ChAdOx1-HBV alone in HBV001, who exhibited a greater response to surface antigen. As in the HBV001 results, T cell responses cross-reactive to Genotype D specific peptides were measured in the majority of patients.
Additional patients receiving VTP-300 in combination with low-dose nivolumab (Groups 3 and 4) are currently enrolling in the HBV002 trial with data, including surface antigen (HBsAg) levels, anticipated during the first quarter of 2022.
Presentation details
Poster Title: Interim results of HBV001, a Phase 1 study evaluating the safety and tolerability of therapeutic vaccination with ChAdOx1-HBV in healthy volunteers and patients with chronic hepatitis B infection
Publication Number: 833
Session Title: Hepatitis B: Therapeutics: New Agents
Presenter: Tamsin Cargill, Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, UK
Abstract: HBV001
Poster: HBV001 posterPoster Title: Phase 1b/2a study of heterologous ChAdOx1-HBV/MVA-HBV therapeutic vaccination (VTP-300) combined with low-dose nivolumab in virally-suppressed CHB patients
Publication Number: 835
Session Title: Hepatitis B: Therapeutics: New Agents
Presenter: Thomas Evans, M.D., Chief Scientific Officer, Vaccitech plc
Abstract: HBV002
Poster: HBV002 posterAbout Vaccitech plc.
Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer. The company's proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and without the ability to replicate in humans. The combination of a ChAdOx prime treatment with subsequent MVA boost has consistently generated significantly higher magnitudes of CD8+ T cells compared with other technologies and approaches. The company has a broad pipeline of both clinical and preclinical stage therapeutic programs in solid tumors and viral infections and prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of the milestones and royalty income received by OUI from AstraZeneca.
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding: the clinical trials of ChAdOx1-HBV and the ChAdOx1-HBV/MVA-HBV combination (VTP-300), the continued development of VTP-300 and the potential therapeutic effects and expected patient population of VTP-300. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on 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: the success, cost and timing of the Company's product development activities and planned and ongoing clinical trials, the Company's ability to execute on its strategy, regulatory developments, the Company's ability to fund its operations and the impact that the current COVID-19 pandemic will have on the Company's clinical trials and preclinical studies and other risks identified in the Company's filings with the Securities and Exchange Commission (the "SEC"), including its Quarterly Report on Form 10-Q for the first quarter of 2021 and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims 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.Media contacts:
Katja Stout, Scius Communications (EU)
Direct: +44 (0) 7789435990
Email: [email protected]Robert Flamm, Ph.D. / Harrison Wong (US)
Burns McClellan, Inc.
212-213-0006 ext. 364 / 316
Email: [email protected] / [email protected]Henry Hodge, Vaccitech
Email: [email protected]
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OXFORD, United Kingdom, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ:VACC) today announced its financial results for the third quarter, ended September 30, 2021, and provided an overview of the Company's recent corporate developments. Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.
"We continue to advance our promising pipeline with the recent publication of data on our MERS vaccine program. We also anticipate that initial clinical data on two of our chronic infectious disease therapeutic programs will be presented at scientific conferences next week," commented Bill Enright, Vaccitech's CEO. "As we continue to expand and advance our programs, we will need additional lab and office space for our talented staff so we have planned a move mid next year into a new, state of the art facility."
Third Quarter and Recent Corporate Developments
- Signed a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate an innovative therapeutic combination for the treatment of subjects with chronic hepatitis B virus infection (CHB) who are already receiving standard-of-care nucleoside or nucleotide analog (NA) therapy. The Phase 2a clinical trial will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of Arbutus's RNAi therapeutic, AB-729, followed by the Company's immunotherapy candidate, VTP-300, in NA-suppressed subjects with CHB.
- Preclinical research demonstrated that VTP-600, a ChAdOx1/MVA prime-boost immunotherapeutic, demonstrated potential as an anti-cancer therapeutic. The research was conducted by scientists at the University of Oxford and the Ludwig Institute for Cancer Research.
- Signed a lease for 31,000 square feet within the Zeus development at Harwell Science and Innovation Campus. The site will house the Company's headquarters, state-of-the-art wet laboratory and offices. Vaccitech anticipates completing the relocation by mid-2022.
- Announced online publication in The Lancet Microbe of the results of a Phase 1 clinical trial of VTP-500, a vaccine candidate in development to prevent Middle East Respiratory Syndrome (MERS). The study, conducted by researchers at The King Abdullah International Medical Research Centre and Oxford University, showed that the vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses.
Upcoming Milestones
- At the virtual AASLD's The Liver Meeting® in November, two posters will present safety and immunogenicity data from the Phase 1 and Phase 1b/2a trials of VTP-300: HBV001, in healthy volunteers and patients with chronic hepatitis B (CHB) infection and HBV002 in patients with CHB infection. The posters become available for viewing by attendees at 8 a.m. EST on November 12.
- At the virtual 34th International Papillomavirus Conference in November, the Company expects to present safety and immunogenicity data from the lead-in portion of the Phase 1/2a clinical trial of VTP-200.
- In the fourth quarter, the Company expects to initiate dosing in a Phase 1/2a trial of VTP-600 in patients with non-small cell lung cancer in combination with a checkpoint inhibitor and chemotherapy. The trial is currently open for enrollment.
- In the first quarter of 2022, the Company intends to conduct an interim efficacy review of HBV002, the Phase 1b/2a clinical trial of VTP-300 in patients with chronic HBV infection.
- In the second quarter of 2022, the Company expects to initiate dosing in a Phase 1/2a clinical trial of VTP-800/850, in combination with a checkpoint inhibitor, in patients with prostate cancer.
- In the third quarter of 2022, the Company intends to conduct an interim efficacy review of HPV001, a Phase 1/2a clinical trial of VTP-200, a potential non-invasive treatment for persistent high-risk HPV infection.
Third Quarter 2021 Financial Highlights:
- Cash position: As of September 30, 2021, cash and cash equivalents were $233.9 million, compared to $43.3 million as of December 31, 2021. The increase was primarily due to completion of the Series B financing in the first quarter of 2021, which raised $168 million including the conversion of our previously issued convertible loan notes, and to the initial public offering in the second quarter, which raised gross proceeds of $110.5 million. The Company believes its cash and cash equivalents are sufficient to fund operations into the first half of 2024.
- Research and development (R&D) expenses: Research and development expenses were $4.4 million for the third quarter of 2021 compared to $3.7 million for the comparable period of the prior year. The increase in R&D expenses was primarily due to increased spending on progressing the development of VTP-300 and VTP-850.
- General and administrative expenses: General and administrative expenses were $1.2 million for the third quarter of 2021 compared to $1.0 million for the comparable period of the prior year. The third quarter of 2021 expense includes a $5.8 million unrealized foreign exchange gain on revaluation of Company's cash balances. Net of this gain, the increase in general and administrative expenses between the periods was attributable to higher personnel costs, reflecting an increase in the Company's headcount over the prior period and higher insurance costs associated with operating as a public company.
- Net loss: The Company generated a net loss attributable to its shareholders of $4.6 million, or ($0.13) per share on both basic and fully diluted bases, for the third quarter of 2021 compared to a net income of $0.2 million, or $0.02 per share a basic basis and $0.01 on a fully diluted basis, for the same period of the prior year.
About Vaccitech
Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer. The Company's proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and without the ability to replicate in humans. The combination of a ChAdOx prime treatment with subsequent MVA boost has consistently generated significantly higher magnitudes of CD8+ T cells compared with other technologies and approaches. The company has a broad pipeline of both clinical and preclinical stage therapeutic programs in solid tumors and viral infections and prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca plc through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of the milestones and royalty income received by OUI from AstraZeneca plc.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing and advancement of the Company's programs, including the clinical trials of VTP-200, VTP-300, VTP-600, and VTP-800/850 and the Company's cash runway The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on 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: the success, cost and timing of the Company's product development activities and planned and ongoing clinical trials, the Company's ability to execute on its strategy, regulatory developments, the Company's ability to fund its operations and the impact that the current COVID-19 pandemic will have on the Company's clinical trials and preclinical studies and other risks identified in the Company's filings with the Securities and Exchange Commission (the "SEC"), including its Quarterly Report on Form 10-Q for the first quarter of 2021 and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims 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.
VACCITECH PLC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
(UNAUDITED)September 30, December 31, 2021 2020 ASSETS Current assets: Cash and cash equivalents $ 233,871 $ 43,266 Accounts receivable 42 518 Research and development incentives receivable 5,382 2,708 Prepaid expenses and other current assets 6,684 1,409 Total current assets 245,979 47,901 Property and equipment, net 1,033 629 Right of use assets, net 8,780 2,136 Deferred tax assets 60 — Other assets 719 — Total assets $ 256,571 $ 50,666 LIABILITIES, REDEEMABLE PREFERRED SHARES AND SHAREHOLDERS' DEFICIT Current liabilities: Accounts payable $ 1,337 $ 4,667 Accrued expenses and other current liabilities 4,404 2,537 Deferred revenue 196 245 Current portion of lease liability 435 192 Total current liabilities 6,372 7,641 Convertible loan notes – non current — 44,700 Lease liability – non current 7,728 1,472 Total liabilities $ 14,100 $ 53,813 Commitments and contingencies Series A redeemable convertible preferred shares (Series A shares); £0.10 nominal value; no shares issued and outstanding; (December 31, 2020: issued and outstanding: 22,065) $ — $ 33,765 Series B redeemable convertible preferred shares (Series B shares); £0.10 nominal value; no shares issued and outstanding; (December 31, 2020: issued and outstanding: no shares issued or outstanding) $ — $ — Shareholders' equity: Ordinary shares, £0.000025 nominal value; 34,328,231 shares authorized, issued and outstanding (December 31, 2020: authorized, issued and outstanding: 7,960,458) 1 0 Deferred A shares, £1 nominal value; 63,443 shares authorized, issued and outstanding (December 31, 2020: no shares issued or outstanding) 86 — Deferred B shares, £1 nominal value; 570,987 shares authorized, issued and outstanding (December 31, 2020: no shares issued or outstanding) 8 — Deferred C shares, £0,000007 nominal value, 27,828,231 shares authorized, issued and outstanding (December 31, 2020: authorized, issued and outstanding: 7,960,458) 0 1 0 Additional paid-in capital 344,396 21,660 Accumulated deficit (93,472 ) (57,720 ) Accumulated other comprehensive loss – foreign currency translation adjustments (9,041 ) (1,243 ) Noncontrolling interest 493 391 Total shareholders' equity $ 242,471 $ (36,912 ) Total liabilities, redeemable convertible preferred shares and shareholders' equity $ 256,571 $ 50,666
1 indicates amount less than thousand
VACCITECH PLC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(IN THOUSANDS, EXCEPT NUMBER OF SHARES AND PER SHARE AMOUNTS)
(UNAUDITED)Three months ended Nine months ended September 30, 2021 September 30, 2020 September 30, 2021 September 30, 2020 License revenue $ 16 $ 2,663 $ 48 $ 2,705 Service revenue — 60 21 376 Research grants and contracts 3 528 200 1,386 Total revenue 19 3,251 269 4,467 Operating expenses Research and development 4,371 3,702 13,490 11,821 General and administrative 1,184 977 15,332 3,059 Total operating expenses 5,555 4,679 28,822 14,880 Loss from operations (5,536 ) (1,428 ) (28,553 ) (10,413 ) Other income (expense): Change in fair value of derivatives — 3 5,994 3 Unrealized exchange gain on convertible loan notes — 982 209 982 Loss on extinguishment of convertible loan notes — — (13,789 ) — Interest income — — 2 — Interest expense — (969 ) (2,650 ) (969 ) Research and development incentives 959 1,612 2,789 2,989 Other — — (3 ) — Total other (expense) income 959 1,628 (7,448 ) 3,005 Tax (expense)/benefit 7 — 60 — Net (loss)/ income (4,570 ) 200 (35,941 ) (7,408 ) Net loss/ (income) attributable to noncontrolling interest 13 (42 ) 189 157 Net (loss)/ income attributable to Vaccitech plc Shareholders (4,557 ) 158 (35,752 ) (7,251 ) Weighted-average ordinary shares outstanding, basic 34,843,154 7,937,384 22,697,462 7,886,488 Weighted-average ordinary shares outstanding, diluted 34,843,154 15,867,533 22,697,462 7,886,488 Net( loss)/ income per share attributable to ordinary shareholders, basic $ (0.13 ) $ 0.02 $ (1.58 ) $ (0.92 ) Net (loss)/ income per share attributable to ordinary shareholders, diluted $ (0.13 ) $ 0.01 $ (1.58 ) $ (0.92 ) Net (loss)/ income $ (4,570 ) $ 200 $ (35,941 ) $ (7,408 ) Other comprehensive (loss)/ income – foreign currency translation adjustments (6,473 ) 68 (7,803 ) (759 ) Comprehensive (loss)/ income (11,043 ) 268 (43,744 ) (8,167 ) Comprehensive loss/ (income) attributable to noncontrolling interest 25 (49 ) 194 169 Comprehensive (loss)/ income attributable to Vaccitech plc shareholders $ (11,018 ) $ 219 $ (43,550 ) $ (7,998 ) Investors:
Vaccitech Investor Relations
[email protected]Vaccitech Media Contacts:
Katja Stout, Scius Communications (EU)
Direct: +44 (0) 7789435990
Email: [email protected]Robert Flamm, Ph.D. (US) / Harrison Wong, Burns McClellan, Inc.
212-213-0006 ext. 364 / 316
Email: [email protected] / [email protected]Henry Hodge, Vaccitech
Email: [email protected]
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OXFORD, United Kingdom, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ:VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines, today announced that Bill Enright, Chief Executive Officer, will be presenting at the Jefferies London Healthcare Conference.
Event: Jefferies London Healthcare Conference Presentation: In person and webcast fireside chat Date: November 17 Time:
Webcast:8 a.m. GMT (3 a.m. EST)
Events section of the Vaccitech websiteAn audio webcast of each presentation can be accessed through the Events section of the Company's website at https://investors.vaccitech.co.uk/news-and-events/events. An archived replay of each webcast will also be available on the Company's website.
About Vaccitech plc
Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer. The company's proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and without the ability to replicate in humans. The combination of a ChAdOx prime treatment with subsequent MVA boost has consistently generated significantly higher magnitudes of CD8+ T cells compared with other technologies and approaches. The company has a broad pipeline of both clinical and preclinical stage therapeutic programs in solid tumors and viral infections and prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of the milestones and royalty income received by OUI from AstraZeneca.Vaccitech Media contacts:
Katja Stout, Scius Communications (EU)
Direct: +44 (0) 7789435990
Email: [email protected]Robert Flamm, Ph.D. / Harrison Wong, Burns McClellan, Inc. (US)
212-213-0006 ext. 364 / 316
Email: [email protected] / [email protected]Henry Hodge, Vaccitech
Email: [email protected]
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The Phase 1 clinical trial was conducted by The King Abdullah International Medical Research Centre (KAIMRC), in the Kingdom of Saudi Arabia (KSA), in partnership with the University of Oxford. Vaccitech retains commercial rights to this vaccine.
The ChAdOx1 MERS vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses, which continued through the six-month follow-up period.
Study published online in The Lancet Microbe (https://www.thelancet.com/journals/lanmic/article/PIIS2666-5247(21)00193-2/fulltext).
OXFORD, United Kingdom, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ:VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer, today announced the publication in The Lancet Microbe of the first Phase 1 clinical trial conducted in the Middle East evaluating the safety and tolerability of the ChAdOx1 MERS (Middle Eastern Respiratory Syndrome) vaccine candidate. The study builds on the first Phase 1 clinical trial of ChAdOx1 MERS conducted in the United Kingdom and published in Lancet ID last year.
The Phase 1 trial is part of a collaboration between the University of Oxford's Jenner Institute and the King Abdullah International Medical Research Center (KAIMRC). It is the first vaccine clinical trial to be conducted within the Kingdom of Saudi Arabia. Vaccitech retains commercial rights to the vaccine.
"The high fatality rate of diagnosed MERS-CoV makes it one of the most dangerous coronaviruses communicable between humans," says Naif Alharbi, KAIMRC, DPhil, vaccinologist and co-principal investigator on the MERS vaccine trial. "Research into robust preventative measures for a virus with pandemic potential is a global health imperative. The completion of our trial is the latest achievement for KAIMRC's world-leading MERS research and supports advancing the ChAdOx1 MERS vaccine candidate into its next phase of development. This multi-partner experience has also set the stage for more MERS vaccine clinical development in KSA, improving both research and regulatory expertise."
Dame Sarah Gilbert Ph.D., co-founder of Vaccitech said, "This was the first phase I trial of any vaccine conducted in KSA, and it is fitting that it was a trial of a vaccine against MERS. The results provide further evidence on the tolerability and immunogenicity profile of this vaccine candidate and pave the way for its further development."
Tom Evans, M.D., Chief Scientific Officer of Vaccitech added, "These important trial results, collected by scientists at the Jenner and KAIMRC, have the potential to progress us toward a much-needed vaccine for MERS. Their publication also builds on the already extensive dataset which supports our ChAdOx platform for prophylactic, pandemic preparedness, and therapeutic uses."
Twenty-four healthy adult volunteers aged 18 to 50 years received one of three single doses of ChAdOx1 MERS (at dose levels of 5 x 109 viral particles (VP), 2.5 x 1010 VP and 5 x 1010 VP). The primary objective was to assess safety and tolerability. Secondary objectives included evaluation of cellular and humoral immunogenicity from baseline through six months. The trial showed that ChAdOx1 MERS was generally well tolerated with most adverse events either mild or moderate. The most common adverse event was headache (58% of volunteers) followed by muscle pain (54%). The vaccine candidate induced robust antibody and T cell immune responses in all volunteers. Antibodies peaked at day 28 and T cell responses peaked at day 14, both of which were maintained until the end of follow-up at six months. The results of the study support advancing the vaccine candidate into Phase 2 development.
There have been more than 2,500 cases of MERS reported globally to the World Health Organization (WHO), including 886 deaths. The MERS case fatality rate is 34%, an order of magnitude greater than the rate reported for the COVID-19 coronavirus, SARS-CoV-2. The WHO lists MERS-CoV as a priority pathogen for vaccine development due to its threat to global health security.
Notes to editors:
About the trial and KAIMRC
The trial took place at King Abdullah International Medical Research Center (KAIMRC) and King Abdulaziz Medical City (KAMC). Both are part of the Ministry of National Guard Health Affairs (Saudi NGHA). KAMC in Riyadh has been recognised as a distinguished healthcare provider in Saudi Arabia and the region, with a bed capacity of 1501, and commenced its operations in May 1983. Since then, it has continued expanding, while providing services for a rapidly growing patient population in all of its catchment areas. Recently KAIMRC and KAMC have received approval for a Phase 1 clinical trial unit from the national regulator (Saudi FDA).
About MERS
First identified in 2012 in Saudi Arabia, MERS is a viral respiratory illness caused by the highly pathogenic MERS coronavirus (MERS-CoV). MERS-CoV is likely a zoonotic bat virus, with the dromedary camel implicated as the major animal host for spread to humans. Human to human transmission via droplets and contact can occur, especially in nosocomial settings, which lack robust infection control practices. MERS-CoV leads to severe disease of the lower respiratory tract, with a high symptomatic case fatality rate of ~34%. More than 2,500 cases of MERS have now been reported from 27 countries, including 12 Eastern Mediterranean countries. Globally, as of June 2021, MERS has now been responsible for 886 deaths with eight new cases of MERS reported from January 1, 2021, to May 3, 2021, in Saudi Arabia and UAE.
About Vaccitech plc
Vaccitech is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer. The company's proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, as well as the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and without the ability to replicate in humans. The combination of a ChAdOx prime treatment with subsequent MVA boost has consistently generated significantly higher magnitudes of CD8+ T cells compared with other technologies and approaches. The company has a broad pipeline of both clinical and preclinical stage therapeutic programs in solid tumors and viral infections and prophylactic viral vaccine programs. Vaccitech co-invented a COVID-19 vaccine with the University of Oxford, now approved for use in many territories and exclusively licensed worldwide to AstraZeneca through Oxford University Innovation, or OUI. Vaccitech is entitled to receive a share of the milestones and royalty income received by OUI from AstraZeneca.
Forward Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding: the Company's business plans and objectives, including the timing and advancement of the Company's programs, such as the clinical trial of ChAdOx1 MERS (VTP-500) and the continued development of ChAdOx1 MERS, the potential therapeutic effects and expected patient population of ChAdOx1 MERS and the Company's use of capital, expenses and other financial results. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on 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: the success, cost and timing of the Company's product development activities and planned and ongoing clinical trials, the Company's ability to execute on its strategy, regulatory developments, the Company's ability to fund its operations and the impact that the current COVID-19 pandemic will have on the Company's clinical trials and preclinical studies and other risks identified in the Company's filings with the Securities and Exchange Commission (the "SEC"), including its Quarterly Report on Form 10-Q for the first quarter of 2021 and subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company expressly disclaims 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.Media contacts:
Katja Stout, Scius Communications (EU)
Direct: +44 (0) 7789435990
Email: [email protected]Robert Flamm, Ph.D. / Harrison Wong (US)
Burns McClellan, Inc.
212-213-0006 ext. 364 / 316
Email: [email protected] / [email protected]Henry Hodge, Vaccitech
Email: [email protected]