Latest news with #JohnLeonard
Business Upturn
15-06-2025
- Business
- Business Upturn
Intellia Therapeutics Announces Positive Three-Year Data from Phase 1 Trial of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema (HAE) at the European Academy of Allergy and Clinical Immunology Congress
With up to three years of follow-up, a single dose of lonvo-z led to a 98% mean reduction in monthly HAE attack rate in all 10 patients All 10 patients were attack-free and treatment-free for a median of 23 months through the latest follow-up, demonstrating the potential of lonvo-z to become the first one-time therapy for most HAE patients Lonvo-z was well tolerated and continues to demonstrate a favorable safety profile The global Phase 3 HAELO trial of lonvo-z has concluded screening ahead of schedule with more than half screened from U.S. sites; Intellia to provide an update on enrollment in the future CAMBRIDGE, Mass., June 15, 2025 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced three-year follow-up data from the Phase 1 portion of the ongoing Phase 1/2 study in patients with HAE after receiving a single dose of lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002). Results were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held June 13-16 in Glasgow, United Kingdom. 'Today's results underscore the promising potential of Intellia's approach to gene editing therapy – a one-time treatment that was well tolerated and offered a highly differentiated, durable effect for patients suffering from a serious disease,' said Intellia President and Chief Executive Officer John Leonard, M.D. 'Seeing all 10 patients in the Phase 1 portion of this study free from both HAE attacks and chronic therapy at nearly two years of median follow-up is incredibly encouraging. These data fuel our optimism for the outcomes of our ongoing Phase 3 HAELO study, which we expect to report in the first half of 2026, and highlight the strong value we believe it will offer patients, physicians and payers.' 'People living with HAE often report a reduced quality of life because they worry about the likelihood of their next attack, either because they still experience attacks or are reminded of it by their use of chronic therapy,' said Dr. Joshua Jacobs, Medical Director, Allergy and Asthma Clinical Research, Inc. 'Based on the data, it is reasonable to expect lonvo-z could offer patients the potential to be free from both physical HAE attacks and the burden of managing chronic HAE treatment.' In the Phase 1 portion of the study, a one-time dose of 25 mg (N=3), 50 mg (N=4) or 75 mg (N=3) of lonvo-z was administered via intravenous infusion and plasma kallikrein protein levels were measured along with HAE attacks. At the time of the February 12 data cutoff, patients were attack-free and treatment-free for a median of nearly two years. With up to three years of follow-up, a single dose of lonvo-z led to a mean reduction in monthly HAE attack rate of 98% over the study period, compared to pre-treatment baseline. For all 10 patients, deep, dose-dependent and durable reductions in plasma kallikrein protein continued to be observed through the latest assessment. Safety Across all three dose levels, lonvo-z has been well tolerated and continues to demonstrate a favorable safety profile consistent with earlier data presented at EAACI in 2024. The most frequent adverse events during the study period were infusion-related reactions (IRRs). IRRs were mostly Grade 1 and resolved with all patients receiving the full dose. With up to 3 years of follow-up, no treatment-emergent serious adverse events were observed, and no treatment-related adverse events were observed during the period following 28 days after dosing. Clinical Development Plans Intellia's global Phase 3, randomized, double-blind, placebo-controlled HAELO trial is ongoing to assess the safety and efficacy of lonvo-z at the 50 mg dosage. The Company announced today the HAELO trial has successfully completed screening ahead of schedule, with over half of the patients being screened in the United States. The study is no longer recruiting and Intellia will provide an update on enrollment in the future. New and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study is planned to be presented in the second half of 2025. Intellia expects to submit a biologics license application (BLA) in 2026 to support the Company's plans for a U.S. launch in 2027. For more information on HAELO (NCT06634420), please visit About the Lonvoguran Ziclumeran (lonvo-z, also known as NTLA-2002) Clinical Program Intellia's ongoing Phase 1/2 study is evaluating the safety and efficacy of lonvo-z in adults with Type I or Type II hereditary angioedema (HAE). The Phase 1 portion of the study is an international, open-label study designed to identify the dose level of lonvo-z selected for further evaluation in the Phase 2 portion of the study. Enrollment in both portions of the Phase 1/2 study is complete. Intellia dosed the first patient in the global Phase 3, randomized, double-blind, placebo-controlled HAELO trial in January of 2025. Visit (NCT05120830) for more details. About Lonvo-z Based on Nobel Prize-winning CRISPR/Cas9 technology, lonvo-z has the potential to become the first one-time treatment for hereditary angioedema (HAE). Lonvo-z is an investigational in vivo CRISPR-based gene editing therapy designed to prevent HAE attacks by inactivating the kallikrein B1 ( KLKB1 ) gene, which encodes for prekallikrein, the kallikrein precursor protein. Interim Phase 1/2 clinical data showed dramatic reductions in attack rate, as well as consistent, deep and durable reductions in kallikrein levels. Lonvo-z has received five notable regulatory designations, including Orphan Drug and RMAT Designation by the U.S. Food and Drug Administration (FDA), the Innovation Passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Priority Medicines (PRIME) Designation by the European Medicines Agency, as well as Orphan Drug Designation (ODD) by the European Commission. About Intellia Therapeutics Intellia Therapeutics, Inc. (NASDAQ:NTLA) is a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. Since its inception, Intellia has focused on leveraging gene editing technology to develop novel, first-in-class medicines that address important unmet medical needs and advance the treatment paradigm for patients. Intellia's deep scientific, technical and clinical development experience, along with its people, is helping set the standard for a new class of medicine. To harness the full potential of gene editing, Intellia continues to expand the capabilities of its CRISPR-based platform with novel editing and delivery technologies. Learn more at and follow us @intelliatx. Forward-Looking Statements This press release contains 'forward-looking statements' of Intellia Therapeutics, Inc. ('Intellia' or the 'Company') within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia's beliefs and expectations concerning: the safety, efficacy, success and advancement of its clinical programs for lonvoguran ziclumeran or 'lonvo-z' (also known as NTLA-2002) for hereditary angioedema ('HAE'), including the ability to successfully complete its global Phase 3 HAELO study; its expectation to present additional data regarding lonvo-z, including reporting outcomes of the Phase 3 HAELO study in the first half of 2026 and presenting new and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study of lonvo-z in the second half of 2025; and its expectation to be able to support a biologics license application for lonvo-z for the treatment of HAE by 2026 for a U.S. launch in 2027. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to Intellia's ability to protect and maintain its intellectual property position; risks related to Intellia's relationship with third parties, including its contract manufacturers, licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; risks related to Intellia's ability to protect and maintain its intellectual property position; risks related to valid third party intellectual property; risks related to Intellia's relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to regulatory agencies' evaluation of regulatory filings and other information related to our product candidates, including lonvo-z; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for our product candidates, including uncertainties related to regulatory approvals to conduct clinical trials, including our ability to complete the Phase 3 HAELO study for HAE; the risk that any one or more of Intellia's product candidates, including lonvo-z, will not be successfully developed and commercialized; and the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies for the same product candidate or Intellia's other product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia's actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in Intellia's most recent annual report of Form 10-K and quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Intellia's other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law. Intellia Contacts: Investors:Brittany ChavesSenior Manager, Investor Relations [email protected]
Hamilton Spectator
11-06-2025
- General
- Hamilton Spectator
‘The right thing to do'
WE"KOQMA'Q - Pam Marston stood in the sun and watched the children excitedly zoom around both inside the community centre and outside with huge smiles on their faces. The vice-principal of We'koqma'q Mi'kmaw School in the First Nation community along highway 105 in Cape Breton was watching the joy of the activities of the 4th Annual Pride Parade for the community last week.. 'We do this every year to support the community and make sure our students and staff feel loved and included,' she said. 'Because it's the right thing to do.' The parade walk brings together members of the Pride community along with their supportive allies, to celebrate diversity and to continue to encourage respect and inclusion in their interactions with others. It is organized by the We'koqma'q Mi'kmaw School and the community. The school, a K3-12 grade school, has two-spirit and transgender students attending, but Marston stresses that every effort is made to ensure that from the smallest to the eldest student and staff, everyone is treated the same – with dignity and respect. 'In some places, often they (members of the LGTBQ2S community) don't feel welcome and have to hide, but they don't have to do that here.' The parade, that included every student in the school who chose to attend (all of them), began at the school and they walked to the nearby community centre where food, games and a fun photo booth had been set up. Marston noted how happy they all were as they ran from game table to craft table to photo booth inside the centre. She said her community has always been very accepting of different lifestyles and differences among people in general. Marston noted that the Chief and most council members were in attendance and interacting with all the students. Chief John Leonard is one of the people who actually began the event, along with former school principal Joanna Alex, who has since passed away. 'This means a lot to our community,' he said. 'And for me, it's personal because I have a family member in the (gay) community.' He said he is proud of this annual event because it is one of the things he and the director of education (Ms. Alex) began. He happily posed for a photo with several members of the band council, also in attendance. Many parents and community supporters attended the walk and BBQ wearing bright rainbow colours. They look forward to the 5th annual walk next year. We'koqma'q First Nation chief and council were on hand last week for the 4th annual Pride Parade in the small community nestled alongside the Bras d'Or Lakes in Cape Breton. Chief John Leonard said the walk is personal for him as he and a now-deceased principal at the school created it several years ago. Above, back row: Brennan Peters, Stuart Basque, Brandon Poulette, and Gordon Googoo. In front are: Jason Bernard, Chief John Leonard and Stewart Peters. ROSEMARY GODIN/CAPE BRETON POST Error! Sorry, there was an error processing your request. There was a problem with the recaptcha. Please try again. You may unsubscribe at any time. By signing up, you agree to our terms of use and privacy policy . This site is protected by reCAPTCHA and the Google privacy policy and terms of service apply. Want more of the latest from us? Sign up for more at our newsletter page .
Time of India
02-06-2025
- Sport
- Time of India
Florida Panthers set sights on Stanley Cup victory as Charlotte Checkers move toward Calder Cup Final
Florida Panthers (via Getty Images) T he Florida Panthers are pursuing their much-awaited Stanley Cup win and their AHL affiliate, the Charlotte Checkers, are making history on their own in the Calder Cup Playoffs. For the first time since coming together in 2020, both teams are within reach of championship glory—an accomplishment that could replicate an unusual feat unseen in almost 30 years in professional hockey. Charlotte Checkers overwhelm Laval Rocket to sit one win shy of Calder Cup Final undefined The Florida Panthers may not be the only team in the playoffs spotlight, as the Charlotte Checkers are within a win of heading to the Calder Cup Final with a 5-1 thumping of the Laval Rocket in Game 3 of the Eastern Conference Finals. On Sunday, the team effort was visible with Riley Bezeau scoring twice, including one during a four-goal second period, as John Leonard, Will Lockwood, and Sandis Vilmanis also scored to make the game far out of reach for the AHL affiliate Laval Rocket of the Montreal Canadiens. Goaltender Kaapo Kahkonen was again phenomenal with 22 saves, supporting Charlotte to its seventh consecutive playoff victory. The Checkers have now scored 15-4 in this best-of-seven series against Laval. 'Our guys have done it all year,'' Charlotte Checkers head coach Geordie Kinnear said. 'That's a great team,'' Bezeau said. 'They finished first in their division; they're not going to go away, and we know that. We've just got to stick to our game plan and keep going.' If Charlotte sweeps the series at home Tuesday night, and if the Florida Panthers keep their Stanley Cup Final quest alive, the two teams might duplicate a task last accomplished in 1995 when the New Jersey Devils and Albany River Rats captured the Stanley Cup and Calder Cup, respectively. Meanwhile in the Western Conference, the Abbotsford Canucks lead 2-0 against the Texas Stars and the series heads to Austin for Game 3. Also read: Brad Marchand eyes the second Stanley Cup in a career-redefining run with the Florida Panthers As the Florida Panthers eye a Stanley Cup championship, the Charlotte Checkers are forging an equally impressive argument for a Calder Cup Final appearance. If both teams win their respective titles, it would be a historic double victory for the organization, helping to make this year one of the most successful in Florida's hockey history.
Yahoo
29-05-2025
- General
- Yahoo
Charlotte Checkers lead Eastern Conference finals after win over Laval
The Charlotte Checkers are back in action Thursday night after earning a one-game lead in the Eastern Conference finals. The Checkers topped the Laval Rockets Wednesday night, 5-1. John Leonard scored his third goal of the preseason, setting an all-time franchise record. Advertisement Game two at Laval is set for 7 p.m. VIDEO: Charlotte Checkers announce new ownership
CBC
22-05-2025
- Business
- CBC
Controversy on the cul-de-sac: Residents, developer at odds over Margaret's Place plans
A developer is billing its plan to build a six-storey apartment building on Margaret's Place as part of the effort to ease the housing crisis — but a petition signed by 121 residents is asking St. John's city council to reject the project. John Leonard, an organizer of the petition, says residents aren't against development in the area — but they are against the current proposal. "Given the concerns that exist with historical problems, maintenance problems, servicing problems, fire protection and snow clearing and so on and so forth, we say 'Please listen, this is a problem,'" Leonard told CBC Radio's The St. John's Morning Show. Stonemount Enterprises Ltd. is proposing a 60-unit apartment building and eight new townhouses at the end of Margaret's Place, a long cul-de-sac between the Rabbittown and Georgestown neighbourhoods. Dozens of townhouses and two condo buildings already exist along Margaret's Place, which is behind Holy Heart High School and Brother Rice Junior High. City council has already granted permission for another housing development. Leonard believes the addition of the Stonemount development would qualify as "overdevelopment." He says the current street is already abnormally narrow and has ongoing congestion issues — especially during the winter. He believes the Stonemount development would exacerbate the problem, and potentially create issues for emergency vehicle access. Stonemount declined an interview request, but in a statement spokesperson Janine Walsh says the developers believe the proposal is well-aligned with the layout of the area, and will deliver "feasible and affordable" residential units. "Our intent has consistently been to work collaboratively with residents to achieve a mutually beneficial outcome," she said. However, Walsh says the developers were caught off-guard by the petition, which was presented to city council a few weeks ago. "We would have welcomed a more open and transparent approach to these discussions." Stonemount is also in a dispute with the McKee's Grove condo board over parking. "McKees Grove Condominium currently utilizes services and access points that are not supported by legal easements, and portions of their entrance and parking lot fall outside their property boundaries," Walsh said. Development doldrums The controversy over the Stonemount development is the latest in a series of disputes over housing proposals in existing neighbourhoods. In March, St. John's city council voted to exempt a proposal for a 10-storey apartment building on New Cove Road from the city's set-back requirement, despite pushback from area residents. Deputy Mayor Sheilagh O'Leary was one of just two council members to vote against the exemption, citing resident concerns. O'Leary also has concerns about the Stonemount development, and agreed to present the petition at a recent city council meeting. "This is not a typical cul-de-sac. This is something that we […] have really not seen in our city and as a result, it has caused a lot of conflict within the area," she said. Still, O'Leary says she isn't set on voting against the project. "I think really what needs to happen is a conversation," she said. She says the city already plans to widen Belvedere's Lane to create emergency vehicle access between Margaret's Place and Bonaventure Avenue. O'Leary says she's also concerned about the lack of open and green space for residents and students from the nearby schools. Currently, students use the future site of the Stonemount development to play sports. The Stonemount property also contains the former St. Michael's Convent, a registered historic structure. According to Heritage N.L., the building could be the second oldest in St. John's, but for years it's been falling into neglect. O'Leary said she's worried it could get worse. "We have seen this happen over and over again. This is going to be demolition by neglect. That's the bottom line," she said. In a followup email, Walsh said the Stonemount developers have heard from parties interested in purchasing the former convent. However, according to Walsh, the ongoing dispute has prevented that sale from proceeding. "As a result, despite our efforts to improve the property, we are currently unable to proceed, and the convent remains in its current state," she said. Walsh said Stonemount will follow the guidance of its legal counsel while considering next steps for the development.
