A Phase 1 Study of Safety and Immunogenicity of E. Coli-Derived Recombinant Protective Antigen (rPA), a New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults

This study will provide preliminary safety and comparative immunogenicity data for the E.coli derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses will range from 5 μg to 100 μg rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel.

开始日期2003-04-01

申办/合作机构

DynPort Vaccine Co. LLC

100 项与 Plague vaccine injectable (DynPort/USAMRIID) 相关的临床结果

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100 项与 Plague vaccine injectable (DynPort/USAMRIID) 相关的转化医学

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100 项与 Plague vaccine injectable (DynPort/USAMRIID) 相关的专利（医药）

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项与 Plague vaccine injectable (DynPort/USAMRIID) 相关的文献（医药）

2024-09-25·mSphere

Delivery of Yersinia pestis antigens via Escherichia coli outer membrane vesicles offered improved protection against plague

Article

作者: Meng, Xiangze ; Guo, Xiao ; Tong, Zehui ; Wang, Tong ; Yang, Ruifu ; Wu, Gengshan ; Zhang, Yuan ; Song, Yajun ; Cao, Shiyang ; Wang, Yiqian ; Zhang, Xiangting ; Du, Zongmin

ABSTRACT:

Outer membrane vesicles (OMVs) from Gram-negative bacteria can be used as a vaccine platform to deliver heterologous antigens. Here, the major protective antigens of Yersinia pestis, F1 and LcrV, were fused either with the leader sequence or the transmembrane domain of the outer membrane protein A (OmpA), resulting in chimeric proteins OmpA-ls-F1V and OmpA 46-159 -F1V, respectively. We show that OmpA-ls-F1V and OmpA 46-159 -F1V can be successfully delivered into the lumen and membrane of the OMVs of Escherichia coli, respectively. Mutation of ompA but not tolR in E. coli enhanced the delivery efficiency of OmpA-ls-F1V into OMVs. The OmpA-ls-F1V protein comprises up to 20% of the total protein in OMVs derived from the ompA mutant (OMV dA -ALS-F1V), a proportion significantly higher than the 1% observed for OmpA 46-159 -F1V in OMVs produced by an ompA mutant that expresses OmpA46-159-F1V, referred to as OMV dA -LATM5-F1V. Intramuscular ( i.m .) immunization of mice with OMV dA -ALS-F1V induced significantly higher levels of serum anti-LcrV and anti-F1 IgG, and provided higher efficacy in protection against subcutaneous ( s.c. ) Y. pestis infection compared to OMV dA -LATM5-F1V and the purified recombinant F1V (rF1V) protein adsorbed to aluminum hydroxide. The three-dose i.m . immunization with OMV dA -ALS-F1V, administered at 14-day intervals, provides complete protection to mice against s.c. infection with 130 LD 50 of Y. pestis 201 and conferred 80% against intranasal ( i.n .) challenge with 11.4 LD 50 of Y. pestis 201. Taken together, our findings indicate that the engineered OMVs containing F1V fused with the leader sequence of OmpA provide significantly higher protection than rF1V against both s.c . and i.n . infection of Y. pestis and more balanced Th1/Th2 responses.

IMPORTANCE:

The two major protective antigens of Y. pestis , LcrV and F1, have demonstrated the ability to elicit systemic and local mucosal immune responses as subunit vaccines. However, these vaccines have failed to provide adequate protection against pneumonic plague in African green monkeys. Here, Y. pestis F1 and LcrV antigens were successfully incorporated into the lumen and the surface of the outer membrane vesicles (OMVs) of E. coli by fusion either with the leader sequence or the transmembrane domain of OmpA. We compared the humoral immune response elicited by these OMV formulations and their protective efficacy in mice against Y. pestis . Our results demonstrate that the plague OMV vaccine candidates can induce robust protective immunity against both s.c . and i.n. Y. pestis infections, surpassing the effectiveness of rF1V. In addition, immunization with OMVs generated a relatively balanced Th1/Th2 immune response compared to rF1V immunization. These findings underscore the potential of OMVs-based plague vaccines for further development.

2013-09-01·International journal of toxicology4区 · 医学

Preclinical Safety Assessment of a Recombinant Plague Vaccine (rF1V)

4区 · 医学

Article

作者: Manetz, T. Scott ; House, Robert V. ; Shearer, Jeffry D. ; Price, Jessica L.

A recombinant vaccine (rF1V) is being developed to protect adults 18 to 55 years of age from fatal pneumonic plague caused by aerosolized Yersinia pestis. A comprehensive series of studies was conducted to evaluate the general toxicity and local reactogenicity of the rF1V vaccine prior to first use in humans. Toxicity was evaluated in CD-1 mice vaccinated with control material and three dosage concentrations of rF1V with or without Alhydrogel® by intramuscular (IM) injection on Study Days 1, 29, 57 and 71 in a volume of 0.1 mL. Total immunizing protein given in each dose was 0, 20 or 60 μg/animal. Local reactogenicity was evaluated in mice at the dosages given and in New Zealand white (NZW) rabbits using the same injection volume and formulations (40, 80, 160 and 320 μg/mL total antigen and 0.3% (w/v) Alhydrogel®) intended for human use (0.5 mL). The rF1V vaccine produced no apparent systemic toxicity and only transient edema and erythema at the injection site. Together these results indicated a favorable safety profile for rF1V and supported its use in a Phase 1 clinical trial.

2012-04-01·Clinical and vaccine immunology : CVI

Establishment of a Swiss Webster Mouse Model of Pneumonic Plague To Meet Essential Data Elements under the Animal Rule

Article

作者: Robert V. House ; Jessica Price ; Bruce Gingras ; Mark Bolanowski ; Narayanan Rajendran ; Winston Lin ; Carol Detrisac ; Patricia Fellows ; Shu-Chieh Hu ; Louis Holland

ABSTRACT:

A recombinant vaccine (rF1V) is being developed for protection against pneumonic plague. This study was performed to address essential data elements to establish a well-characterized Swiss Webster mouse model for licensing the rF1V vaccine using the FDA's Animal Rule. These elements include the documentation of challenge material characteristics, aerosol exposure parameters, details of the onset and severity of clinical signs, pathophysiological response to disease, and relevance to human disease. Prior to animal exposures, an evaluation of the aerosol system was performed to determine and understand the variability of the aerosol exposure system. Standardized procedures for the preparation ofYersinia pestischallenge material also were developed. The 50% lethal dose (LD50) was estimated to be 1,966 CFU using Probit analysis. Following the LD50determination, pathology was evaluated by exposing mice to a target LD99(42,890 CFU). Mice were euthanized at 12, 24, 36, 48, 60, and 72 h postexposure. At each time point, samples were collected for clinical pathology, detection of bacteria in blood and tissues, and pathology evaluations. A general increase in incidence and severity of microscopic findings was observed in the lung, lymph nodes, spleen, and liver from 36 to 72 h postchallenge. Similarly, the incidence and severity of pneumonia increased throughout the study; however, some mice died in the absence of pneumonia, suggesting that disease progression does not require the development of pneumonia. Disease pathology in the Swiss Webster mouse is similar to that observed in humans, demonstrating the utility of this pneumonic plague model that can be used by researchers investigating plague countermeasures.

项与 Plague vaccine injectable (DynPort/USAMRIID) 相关的新闻（医药）

2023-02-23

·BioSpace

Dynavax Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Full Year 2023 Financial Guidance

2022 total revenue of $723 million, up 64% from $439 million in 2021 HEPLISAV-B® vaccine net product revenue of $126 million, representing 104% growth compared to 2021 CpG 1018® adjuvant vaccine net product revenue of $588 million 2023 HEPLISAV-B net product revenue anticipated to be between $165 million and $185 million, representing year-over-year revenue growth of approximately 30-47% Increased strength of financial position with year-end cash and investments of $624 million Conference call today at 4:30 p.m. ET/1:30 p.m. PT EMERYVILLE, Calif., Feb. 23, 2023 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today reported financial results for the fourth quarter and the full year ending December 2022. "In 2022, our team exceeded our strategic goals, achieving record HEPLISAV-B revenue, advancing our clinical pipeline and delivering orders of CpG 1018 adjuvant for the equivalent of hundreds of millions of COVID-19 vaccine doses," said Ryan Spencer, Chief Executive Officer of Dynavax. "Following a year of successful execution on our strategy, we are excited for 2023 and look forward to continuing our trend of significant and sustainable annual HEPLISAV-B revenue growth and overall advancement of our business focused on protecting patients worldwide from infectious diseases." 2023 FINANCIAL GUIDANCE Dynavax anticipates full-year 2023 revenue and operating expenses to be in the ranges below: HEPLISAV-B net product revenue between approximately $165 - $185 million Research and development expenses between approximately $55 - $70 million Selling, general and administrative expenses between approximately $135 - $155 million BUSINESS UPDATES HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S. and EU that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S. HEPLISAV-B vaccine achieved record annual net product revenue of $125.9 million for 2022, compared to $61.9 million for 2021, representing annual growth of 104%. HEPLISAV-B market share in prioritized Integrated Delivery Networks (IDNs) and Clinics increased to approximately 47%, with total market share increasing to approximately 35%, up from approximately 33% and 25%, respectively, at the end of 2021. Dynavax believes it has begun to see a positive impact on HEPLISAV-B revenue from the expanded ACIP recommendation for adult hepatitis B vaccination which has the potential to expand the market to over $800 million by 2027 with HEPLISAV-B well-positioned to achieve a majority market-share. CpG 1018® Adjuvant Supply for COVID-19 Vaccines Dynavax has established a global portfolio of CpG 1018 adjuvant commercial supply agreements (CSAs) supporting the development of COVID-19 vaccines across a variety of vaccine platforms. CpG 1018 adjuvant achieved annual net product revenue of $587.7 million for 2022, up 57% compared to $375.2 million for 2021. Due to the successful execution on the pandemic commercial supply agreements and the resulting volume of partners' overall stockpile, coupled with unknowns about the trajectory of the COVID-19 pandemic, Dynavax believes it will have minimal to as little as zero CpG 1018 adjuvant net product revenues in 2023. Clinical Pipeline Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018 adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability pro a wide range of clinical trials and real-world commercial use. Tetanus, diphtheria and pertussis (Tdap) vaccine program: In October, the Company presented adult and adolescent safety data from a Phase 1 clinical trial demonstrating the Tdap vaccine candidate was well tolerated without observed safety concerns. Immunogenicity in adults was consistent with the Company's expectations and support its plan to continue advancement of this clinical program. These clinical results were presented at ID Week 2022. Data from non-human primate challenge study is anticipated mid-2023. The Company plans to initiate a human challenge study by the end of 2023. Shingles vaccine program: In January 2023, the Company reported top line results from the Phase 1 clinical trial designed to evaluate an investigational shingles vaccine, utilizing different regimens of CpG 1018 adjuvant. The full Phase 1 data will be submitted for presentation at an upcoming medical meeting in the first half of 2023. The Company plans to initiate a Phase 1/2 study in early 2024 to evaluate various dose levels of glycoprotein E (gE). Plague vaccine candidate funded by the Defense Department (DoD): Part 1 of the Phase 2 clinical trial evaluating the immunogenicity, safety, and tolerability in adults of a plague (rF1V) vaccine candidate adjuvanted with CpG 1018 was successfully completed in January 2023. Both CpG 1018 adjuvanted arms met the Part 1 primary endpoint and demonstrated a greater than two-fold increase in antibodies over the alum adjuvanted control arm after two doses. The DoD has approved continuing to Part 2 using a bedside mix of CpG 1018 with the alum adjuvanted rF1V plague vaccine. FOURTH QUARTER AND FULL YEAR FINANCIAL HIGHLIGHTS Total Revenue. Total revenue for the fourth quarter of 2022 was $184.5 million, compared to $195.1 million for the fourth quarter of 2021. Total revenue for the full year 2022 was $722.7 million, compared to $439.4 million for the full year 2021. Product Revenue, Net. HEPLISAV-B® HEPLISAV-B vaccine product revenue, net was $34.9 million for the fourth quarter of 2022, compared to $17.2 million for the fourth quarter of 2021. HEPLISAV-B vaccine product revenue, net was $125.9 million for the full year 2022, compared to $61.9 million for the full year 2021, representing annual growth of 104%. CpG 1018® Adjuvant Supply for COVID-19 Vaccines CpG 1018 adjuvant product revenue, net was $147.2 million in the fourth quarter of 2022, compared to $177.4 million in the fourth quarter of 2021. CpG 1018 adjuvant product revenue, net was $587.7 million for the full year 2022, compared to $375.2 million for the full year 2021. Cost of Sales - Product. Cost of sales - product for the fourth quarter of 2022 increased to $77.5 million, compared to $74.0 million for the fourth quarter of 2021. Full year 2022 cost of sales - product was $262.2 million compared to $173.6 million for the full year 2021. The increase was due to higher sales volume for HEPLISAV-B and CpG 1018 adjuvant in 2022. Research and Development Expenses (R&D). R&D expenses for the fourth quarter of 2022 increased to $12.9 million, compared to $11.1 million for the fourth quarter of 2021. Full year 2022 R&D expenses were $46.6 million compared to $32.2 million for the full year 2021. The increase was primarily driven by continued investments in our product candidates utilizing CpG 1018 adjuvant through pre-clinical and clinical collaborations and additional discovery efforts. Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the fourth quarter of 2022 increased to $31.0 million, compared to $29.2 million for the fourth quarter of 2021. Full year 2022 SG&A expenses were $131.4 million compared to $100.2 million for the full year 2021. The increase was primarily driven by higher compensation and related personnel costs and an overall increase in targeted commercial and marketing efforts to increase market share and maximize the Centers for Disease Control and Prevention's Advisory Committee of Immunization Practices (ACIP) universal recommendation. Net Income. GAAP net income was $67.7 million, or $0.53 per share (basic) and $0.45 per share (diluted) in the fourth quarter of 2022, compared to GAAP net income of $99.8 million, or $0.80 per share (basic) and $0.55 per share (diluted) in the fourth quarter of 2021. GAAP net income was $293.2 million, or $2.32 per share (basic) and $1.97 per share (diluted) for the full year 2022, compared to GAAP net income was $76.7 million, or $0.62 per share (basic) and $0.57 per share (diluted) for the full year 2021. Cash and Marketable Securities. Cash and marketable securities were $624.4 million as of December 31, 2022. Conference Call and Webcast Information Dynavax will host a conference call and live audio webcast on Thursday, February 23, 2023, at 4:30 p.m. (ET)/1:30 p.m. (PT). The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at . A replay of the webcast will be available for 30 days following the live event. To dial into the call, participants will need to register for the call using the caller registration link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call. Important U.S. Product Information HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. For full U.S. Prescribing Information for HEPLISAV-B, click here. Important U.S. Safety Information (ISI) Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%). About Dynavax Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S. and the European Union for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in multiple adjuvanted COVID-19 vaccines. Dynavax is advancing CpG 1018 adjuvant as a premier vaccine adjuvant with adjuvanted vaccine clinical programs for shingles and Tdap, and through global collaborations, currently focused on adjuvanted vaccines for COVID-19, plague, seasonal influenza and universal influenza. For more information about our marketed products and development pipeline, visit and follow Dynavax on LinkedIn. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "will," "would" and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding financial guidance, the development and potential approval of vaccines containing CpG 1018 adjuvant by us or by our collaborators, potential future sales of CpG 1018 adjuvant or HEPLISAV-B vaccine, the timing of initiation and completion of clinical studies and the publication of results. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that actual demand for our products may differ from our expectations, risks related to the timing of completion and results of current clinical studies, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018 adjuvant, whether use of CpG 1018 adjuvant will prove to be beneficial in these vaccines, risks related to whether and when the quantity of CpG 1018 adjuvant actually purchased by vaccine companies will meet our expectations, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2022 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at is not incorporated by reference in our current periodic reports with the SEC. Contacts: Nicole Arndt, Investor Relations and Corporate Communications narndt@dynavax.com 510-665-7264 Derek Cole, President Investor Relations Advisory Solutions derek.cole@IRadvisory.com Company Codes: NASDAQ-SMALL:DVAX

疫苗临床结果临床1期财报临床2期

2022-09-12

·PRNewswire

Dynavax Announces First Participant Dosed in a Phase 2 Clinical Trial Evaluating an Adjuvanted Plague Vaccine

EMERYVILLE, Calif., Sept. 12, 2022 /PRNewswire/ -- Dynavax Technologies Corporation ( Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, in collaboration with the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and supported by the DOD's Chemical and Biological Defense Program, today announced that the first participant has been dosed in a Phase 2 clinical trial evaluating the immunogenicity, safety, and tolerability of the JPEO-CBRND's Recombinant Plague (rF1V) vaccine combined with Dynavax's CpG 1018®adjuvant, in adults 18 to 55 years of age. "We are proud to support the U.S. government in developing an effective adjuvanted plague vaccine that we believe will allow U.S. service members to be protected with fewer doses administered over a shorter period of time," commented Ryan Spencer, Chief Executive Officer of Dynavax. "The development of a CpG 1018 adjuvanted plague vaccine is an important example of the broad utility of our adjuvant which we are leveraging to build our pipeline of new and improved vaccines." As previously announced, Dynavax and the DOD executed an agreement which provides for approximately $22 million in funding over two and a half years to develop an improved recombinant plague vaccine adjuvanted with CpG 1018 adjuvant. Under the agreement, Dynavax will conduct a Phase 2 clinical trial combining its CpG 1018 adjuvant with the DOD's rF1V vaccine. The trial is assessing a two-dose regimen administered over one month. Previous clinical studies of the rF1V, not including CpG 1018 adjuvant, have evaluated a three-dose regimen over six months. Any future commercial supply agreements would be subject to a separate agreement between Dynavax and the U.S government. About CpG 1018 Adjuvant Dynavax developed CpG 1018 adjuvant to provide an increased vaccine immune response with an improved tolerability profile, which has been demonstrated in HEPLISAV-B vaccine for adult hepatitis B and multiple COVID-19 vaccines that have received Emergency Use Authorization outside of the U.S. CpG 1018 adjuvant provides a well-developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of novel or improved vaccines. About Dynavax Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S. and the European Union for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in multiple adjuvanted COVID-19 vaccines. Dynavax is advancing CpG 1018 adjuvant as a premier vaccine adjuvant through global research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, seasonal influenza, universal influenza, plague, shingles and Tdap. For more information about our marketed products and development pipeline, visit and follow Dynavax on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "will," "would" and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements in this document include, without limitation, statements regarding our expectations as to outcomes relating to ongoing contractual relationships, the timing and potential outcomes of trials. These forward-looking statements are subject to assumptions, risks and uncertainties that may change at any time, and readers are therefore cautioned that actual results could differ materially from those expressed in any forward-looking statements. Factors that could cause actual results to differ include, among other things: risks and uncertainties associated with actual results of our clinical trials; whether and when an improved plague vaccine candidate will be approved for use and launched; whether we can manufacture sufficient quantities of CpG 1018 to support this program; and other risks and uncertainties discussed in the Company's filings with the SEC, including the "Risk Factors" sections of the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2022. The Company undertakes no obligation to update any forward-looking statements as a result of new information, future developments or otherwise, except as expressly required by law. All forward-looking statements in this document are qualified in their entirety by this cautionary statement. Contacts: Nicole Arndt, Investor Relations and Corporate Communications [email protected] 510-665-7264 Derek Cole, President Investor Relations Advisory Solutions [email protected] SOURCE Dynavax Technologies

疫苗合作紧急使用授权

2021-10-04

·Endpoints

AstraZeneca's Enhertu gets BTD for breast cancer; Centessa nabs $300M loan

The FDA has granted breakthrough designation to AstraZeneca’s and Daiichi Sankyo’s HER2 ADC Enhertu, the companies jointly announced today . The BTD is for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens. Breakthrough therapy designation was based on data from the DESTINY-Breast03 pivotal trial at #ESMO21 just last month , which showed a 72% reduction compared to Roche’s ADC Kadcyla in the risk of disease progression or death in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. “This is an important step in bringing Enhertu as a potential new option in earlier lines of treatment for HER2 positive metastatic breast cancer, given the urgent need to improve outcomes,” said AstraZeneca EVP of oncology R&D Susan Galbraith in a statement. Previous BTDs for the drug were in late-line HER2 positive metastatic breast cancer in 2017 and HER2 mutant metastatic non-small cell lung cancer (NSCLC) and HER2 positive metastatic gastric cancer in 2020. — Paul Schloesser Centessa entered a $300 million financing agreement today with New York investment firm Oberland Capital Management. Oberland will purchase up to $300 million of 6-year, interest-only, senior secured notes, including $75 million purchased today and the next $125 million available in tranches of $75 million and $50 million within two years. This $300 million facility, combined with Centessa’s existing cash balance as of June 30, gives Centessa access to over $900 million to advance their pipeline of clinical and pre-clinical programs — which rolled out their first data for hemophilia candidate SerpinPC early last month . “This financing will allow us to further scale up our development activities and provide enhanced balance sheet flexibility for pipeline expansion,” said Centessa CFO Gregory Weinhoff. — Paul Schloesser ‘Tis the season for lawmakers to unveil their FDA-related priorities as Democrats continue to fight over what to put into and how to pay for their two major legislative packages. Just last week, 5 new FDA-related bills were introduced in Congress. Although some or all of these bills may never cross the finish line, some of the ideas contained within them may make it into law. The bills and their introducers are: Atara Biotherapeutics and Pierre Fabre agreed to an exclusive commercialization agreement for tabelecleucel, or tab-cel in Europe, Middle East, Africa, and other select markets for Epstein-Barr virus (EBV)-positive cancers, according to a statement released today . Atara will receive $45 million upfront as part of the agreement and up to approximately $320 million in additional milestones, plus royalties. They will also retain full rights to tab-cel in other markets, including North America, the Asia Pacific region, and Latin America. Atara will continue to be responsible for the pivotal ALLELE study in positive post-transplant lymphoproliferative disease, a type of lymphoma. Alera is on track to submit an application for approval to the EU next month for the drug in EBV-postive PTLD as it continues a Phase II multi-cohort study, evaluating tab-cel in six additional patient populations with the goal of expanding in EBV-driven cancers. Pierre Fabre will lead all commercialization and distribution activities in the territories, as well as medical and regulatory activities after the anticipated MAA approval in Europe. As part of the transaction, Atara will also provide manufacturing services for tab-cel to be paid by Pierre Fabre. — Paul Schloesser Sage Therapeutics and Biogen showed new data today at a European conference on their depression drug zuranolone, showing reductions in depressive symptoms with zuranolone-treated patients. That included consistent improvements in depressive mood, as well as rapid onset of significant effect by Day 3 of treatment, according to their presentations. “We believe these data represent the potential for a benefit-risk profile for zuranolone that may be differentiated from the most prescribed depression drugs on the market, and may be welcomed by patients, if approved,” said Sage CMO Steve Kanes in a statement. — Paul Schloesser California-based Dynavax and the US Department of Defense signed an agreement for $22 million over the next 2.5 years to develop a recombinant vaccine against the plague, according to a Dynavax announcement today. The DoD will develop the vaccine using the agency’s rF1V vaccine and its own adjuvant solution. Dynavax also will kick off a Phase II clinical trial next year for the vaccine candidate. “We are honored to receive this award and to support the U.S. government in developing a plague vaccine to protect the U.S. military members who put their lives at risk every day in service to the country,” said Dynavax CEO Ryan Spencer. — Paul Schloesser Seqirus announced today that BARDA selected the company to develop two Influenza A vaccine candidates for a Phase I clinical study as part of pandemic preparedness. The first candidate will use a combination of cell-based and adjuvanted technologies, while the second candidate will use self-amplifying mRNA. “We are proud to be a trusted partner in support of BARDA’s pandemic preparedness objectives,” said Seqirus executive director of pandemic response solutions Marc Lacey. — Paul Schloesser

突破性疗法疫苗抗体药物偶联物信使RNA

100 项与 Plague vaccine injectable (DynPort/USAMRIID) 相关的药物交易

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