Blindness

-- Zero shingles cases after 18.8 months follow-up in 619 patients receiving any dose of amezosvatein, a development-stage adjuvanted subunit vaccine -- Ten shingles cases would have been expected absent vaccination -- Updated data will be featured in an oral presentation at the World Vaccine Congress Barcelona, 31 October 2024, in Theatre 5 at 13:30 CEST SEATTLE, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Curevo Vaccine (Curevo), a privately-held clinical-stage biotechnology company dedicated to developing varicella zoster virus (VZV) vaccines with improved tolerability and accessibility, today announced an upcoming oral presentation at the World Vaccine Congress currently underway in Barcelona of shingles case outcomes data from an 876-patient Phase 2 trial of amezosvatein (a non-mRNA, adjuvanted subunit vaccine also known as CRV-101) head-to-head versus Shingrix® in participants aged 50 years and older. There were zero confirmed cases of herpes zoster (shingles) in the amezosvatein arm of participants, regardless of dose, after mean follow-up of 18.8 months in this post-hoc analysis of the Phase 2 trial. Based on the shingles incidence rate from the placebo arm North American cohort of ZOSTER-006, a Phase 3 trial of Shingrix, 10 of the 876 participants in the Phase 2 trial should have been diagnosed with a confirmed shingles case absent effective vaccination.1 There were also no shingles cases in the Shingrix arm of this Phase 2 trial. “With the duration of follow-up in our Phase 2 trial now sufficient for comparison, we are excited to report zero shingles cases for amezosvatein,” said Dr. Guy De La Rosa, Curevo’s Chief Medical Officer. “These data provide outcomes-based confirmation of the non-inferiority immunogenicity data we reported earlier.” “These data support our efforts to bring a new shingles vaccine to global markets,” stated George Simeon, Curevo’s Chief Executive Officer. “Though somewhat unsurprising, given amezosvatein also showed non-inferior immunogenicity to Shingrix at day 84 in this trial, these longer-term data represent additional de-risking for the program.” About the Phase 2 trialThe Phase 2 trial (NCT05304351) enrolled 876 participants to receive either amezosvatein or Shingrix on an identical two-dose, two months apart schedule. 876 participants were randomized to receive one of four different amezosvatein doses or Shingrix. The mean follow-up of the 619 participants receiving amezosvatein was 18.8 months. Mean follow-up of the 257 participants who received Shingrix was 21.5 months. The co-primary endpoint of the Phase 2 trial was anti-gE antibody humoral immune responses one month after the second vaccine dose (Day 84). The randomized, observer-blind, and active-controlled trial was conducted at multiple centers in the USA. All suspected cases of shingles were confirmed by either PCR test or, if PCR testing was inconclusive or unavailable, by a blinded panel of shingles experts – a system similar to one used in multiple prior shingles vaccine pivotal studies. As presented earlier in the month at the IDWeek scientific conference, this co-primary immunogenicity endpoint was met in the highest amezosvatein dose studied (100 μg gE plus 15 μg SLA-SE) as participants’ immune responses to amezosvatein were non-inferior to participants’ immune responses to Shingrix. High-dose amezosvatein and Shingrix generated similar serum neutralizing antibodies to the varicella zoster virus (VZV) and T-cell responses specific for the gE antigen. Vaccines are studied for both safety and reactogenicity/tolerability. Data on the reactogenicity/tolerability of amezosvatein and Shingrix were collected via a participant diary filled out for the seven days after each injection. Participants were asked to grade the tolerability of each vaccine on a scale of Grade 1 to Grade 3. Grade 1 represents what are considered normal reactions to an active vaccine that do not interfere or prevent daily activity. Grade 2 represents reactogenicity events interfering with daily activities. Grade 3 represents reactogenicity events preventing daily activities. Amezosvatein and Shingrix demonstrated comparable safety in this Phase 2 trial. However, the highest dose of amezosvatein demonstrated a clinically-meaningful and statistically-significant improvement for Grade 2 and Grade 3 reactogenicity versus Shingrix. Just 7.3% of participants in the trial receiving the highest dose of amezosvatein reported a Grade 2 (interferes with daily activity) or Grade 3 (prevents daily activity) reactogenicity event compared to 33.3% of participants receiving Shingrix. This result was statistically significant (p<0.001 in a post hoc analysis unadjusted for multiple comparisons). Reactogenicity events were broken down between local reactions (injection site pain, redness, or swelling) and systemic reactions (fever, headache, fatigue, myalgia/muscle pain, chills). Just 3.6% of high-dose amezosvatein participants had a Grade 2 or Grade 3 local reactogenicity event compared to 25.3% of Shingrix participants. For systemic reactogenicity events, 5.5% of high-dose amezosvatein participants had a Grade 2 or Grade 3 event versus 19.1% for Shingrix. Both results were statistically significant (p=0.0002 and p=0.0139, respectively, in a post hoc analysis unadjusted for multiple comparisons). No Grade 3 reactogenicity events were reported for amezosvatein. About amezosvatein‘Amezosvatein’ is the assigned non-proprietary name for CRV-101, a non-mRNA adjuvanted subunit vaccine under investigation by Curevo. Like Shingrix, amezosvatein uses a subunit protein antigen called glycoprotein ‘E’ (gE). Targeting the gE antigen is proven to elicit a long-term, protective immune response to prevent shingles. Also like Shingrix, amezosvatein uses an adjuvant targeting the TLR4 pathway to boost the immune response to the gE antigen. Amezosvatein was engineered to have a best-in-class safety profile in addition to manufacturing advantages to improve vaccine accessibility. The SLA-SE adjuvant formulation was developed at Seattle-based Access to Advanced Health Institute (AAHI) and amezosvatein was licensed from the Mogam Institute for Biomedical Research, a research institute funded by South Korea’s GC Biopharma. About shinglesAlso called ‘herpes zoster’, shingles occurs when the varicella zoster virus causing childhood chickenpox re-emerges from sensory ganglion nervous system cells where the virus lies dormant after initial exposure. Virtually all adults have been exposed to the varicella zoster virus and around 30% will develop shingles at least once in their lifetime. The blistering skin rash accompanying shingles also causes severe pain, with both pain and rash lasting up to four weeks. Between 10-18% of those who get shingles develop post-herpetic neuralgia (PHN), a condition marked by debilitating nerve pain lasting over six months and often beyond one year. There is no approved treatment for PHN. Shingles may also affect the eyes, potentially causing loss of vision. Contracting shingles has also been linked with increased risk of heart attack, stroke, and dementia/Alzheimer’s disease. About CurevoCurevo is a privately held, clinical-stage biotechnology company based near Seattle dedicated to reducing the burden of infectious disease by developing vaccines with improved tolerability and accessibility. Curevo’s lead product is amezosvatein, a non-mRNA sub-unit vaccine to prevent shingles, a serious medical condition involving a painful, blistering skin rash where 10-18% of people also develop serious, long-lasting nerve pain. The current $4+ billion shingles vaccine market is characterized by accessibility issues and vaccine hesitancy/dose avoidance related to vaccine tolerability. Curevo is also developing a non-live, non-mRNA subunit chickenpox vaccine intended to reduce or eliminate barriers to immunizing immunocompromised children. For more information visit https://curevovaccine.com/. 1. Lal, et al. New England Journal of Medicine, May 2015. Shingrix® is a registered trademark of GlaxoSmithKline, PLC.

PHOENIX, Oct. 30, 2024 (GLOBE NEWSWIRE) -- A Race Against Blindness, a nonprofit organization dedicated to funding sight-saving research for children, is pleased to announce a $1 million grant to Axovia Therapeutics to support the company’s lead program, AXV-101. This marks an important step toward developing a treatment to address blindness and obesity associated with Bardet-Biedl Syndrome 1 (BBS1), a rare genetic disorder with no current curative options. The funding from A Race Against Blindness will directly support Axovia's near-term milestones associated with the initiation of the clinical study and initial patient enrollment in the United Kingdom in mid-2025 to treat blindness caused by BBS1 mutations. Axovia Therapeutics’ future plans include initiation of a clinical trial in the United States and progression of the program to also treat obesity. BBS is a devastating genetic disorder associated with primary cilia dysfunction. One of the hallmarks is retinal degeneration commonly presenting as retinitis pigmentosa. The other hallmark is hyperphagia resulting in morbid obesity, among other complex clinical manifestations. Of the many genes known to be associated with BBS, pathogenic variants in the BBS1 gene are most commonly encountered. Axovia is developing a genetic therapy for those harboring two mutations in the BBS1 gene. There is no cure for BBS, and its prevalence ranges between one in 70,000 and one in 100,000 in Europe and North America, with up to 10 times this prevalence in the Middle East. “Our $1 million grant to Axovia is a significant step for the BBS community, and we are optimistic about Axovia’s groundbreaking clinical research. However, the path to treating RP/BBS is challenging and there is still much work to be done. A Race Against Blindness is committed to supporting the effort to raise the necessary funds to ensure the execution of the AXV-101 clinical trial and potentially bring a new therapeutic option to BBS patients like our son, Luke,” said Dr. Stephen Johnston, Co-Founder and President. “We are advancing the AXV-101 program and preparing to initiate the first clinical study in mid-2025. We are immensely grateful for this funding from A Race Against Blindness,” said Professor Phil Beales, Chief Executive Officer and Co-Founder at Axovia Therapeutics. “By utilizing gene therapy to address the loss of sight and obesity experienced by patients with BBS1, we believe our approach will have a profound and dramatic impact on the health and well-being of this community. We look forward to generating clinical data for this program.” With the goal of initiating clinical studies in mid-2025, A Race Against Blindness will continue aggressive efforts to fundraise, engage the scientific community, and raise global awareness of BBS. Media Contact:Stephen Johnston, M.D., Co-Founder and PresidentSteve@ARaceAgainstBlindness.org (520) 548 - 1807

WATERTOWN, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced the pricing of an underwritten public offering of 12,727,273 shares of its common stock at a public offering price of $11.00 per share. The aggregate gross proceeds from this offering are expected to be approximately $140.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by EyePoint. All of the shares of common stock are being sold by EyePoint. The closing of the offering is expected to occur on or about October 31, 2024, subject to the satisfaction of customary closing conditions. In addition, EyePoint has granted the underwriters an option for a period of 30 days to purchase up to an additional 1,909,090 shares of EyePoint’s common stock at the public offering price, less underwriting discounts and commissions. J.P. Morgan, Citigroup and Guggenheim Securities are acting as joint book running managers for the offering. Baird, Mizuho and Jones are acting as co-managers for the offering. EyePoint intends to use the net proceeds that it will receive from the offering to advance clinical development of DURAVYU™ for wet age related macular degeneration (wet AMD) and diabetic macular edema (DME), as well as support its earlier stage pipeline development initiatives, and for general corporate purposes. The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (No. 333-281391) previously filed with the Securities and Exchange Commission (SEC) on August 8, 2024 and declared effective by the SEC on August 16, 2024. The securities are being offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement relating to the offering was filed with the SEC on October 28, 2024 and is available on the SEC’s website at www.sec.gov. The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website at www.sec.gov. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that EyePoint has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about EyePoint and the offering. Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™ (f/k/a EYP-1901), is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. DURAVYU is presently in Phase 3 global, pivotal clinical trials as a sustained delivery treatment for wet AMD, the leading cause of vision loss among people 50 years of age and older in the United States, and in a Phase 2 clinical trial in DME. EyePoint expects full topline data from the Phase 2 clinical trial in DME in Q1 2025 and topline data from both Phase 3 pivotal trials in wet AMD in 2026. Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the timing of the closing of the offering, as well as the anticipated use of proceeds for the offering, EyePoint’s clinical development plans and the expected timing thereof; and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes satisfaction of the customary closing conditions of the offering; delays in obtaining required stock exchange or other regulatory approvals; stock price volatility and uncertainties relating to the financial markets, the medical community and the global economy; the timing, progress and results of the company’s clinical development activities; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the company’s product candidates; changes in the regulatory environment; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to the company’s Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. More detailed information on these and additional factors that could affect EyePoint’s actual results are described in EyePoint’s filings with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. All forward-looking statements in this news release speak only as of the date of this news release. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investors:Christina TartagliaPrecision AQ (formerly Stern IR)Direct: 212-698-8700christina.tartaglia@sternir.com Media ContactAmy PhillipsGreen Room CommunicationsDirect: 412-327-9499aphillips@greenroompr.com