Latest news with #DanBaker
Yahoo
24-06-2025
- Business
- Yahoo
Cue Biopharma Receives FDA Feedback on Pre-IND Briefing Document Reinforcing Company's Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease
CUE-401, a first-in-class bispecific molecule designed to induce and expand Tregs in vivo through the co-activity of transforming TGF-β and a modified variant of IL-2 BOSTON, June 24, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA). The FDA reviewed the first-in-human trial design, including the Company's plan for dose escalation, proposed populations and safety monitoring plan. On the basis of the FDA feedback, the Company, intends to file an IND pending completion of final IND enabling studies. CUE-401 is the Company's lead autoimmune asset, a first-in-class bispecific fusion protein/molecule designed to induce and expand regulatory T cells (Tregs) in vivo through the co-activity of transforming growth factor beta (TGF-β) and a modified variant of interleukin 2 (IL-2). 'We are highly encouraged by the FDA's positive feedback on our proposed development plan for this important program. We believe CUE-401, with its first-in-class mechanism exploiting the combined activities of TGF-β and IL-2 is a potentially disruptive approach differentiated from other Treg-directed therapies, and has the potential to provide durable, long-lasting immune rebalance and tolerance addressing multiple, significant disease indications,' said Daniel Passeri, chief executive officer of Cue Biopharma. Dr. Dan Baker, chief development officer of Cue Biopharma commented, 'CUE-401's mechanistic design extends beyond nTreg proliferation by transforming effector/autoreactive responses to an anti-inflammatory and/or suppressive response, with the prospects of establishing tolerance. The combination of interleukin 2 (IL-2) and transforming growth factor beta (TGF-ß) is considered the 'master switch' for conversion of activated T effector cells into T cells with a regulatory phenotype.' About CUE-401CUE-401 is a preclinical, bispecific fusion protein designed to induce and expand regulatory T cells (Tregs) through the co-activity of modified variants of transforming growth factor beta (TGF-β) and interleukin 2 (IL-2) with therapeutic potential across a range of T-cell mediated autoimmune and inflammatory diseases. CUE-401 has been engineered to harness the Treg induction capacity of TGF-β combined with IL-2 signaling to provide what Cue Biopharma believes to be superior quality and stability of Tregs. The design and specifications of CUE-401 have been guided by leading scientific publications demonstrating that both IL-2 and TGF-β are required for stable and efficient production of active and durable Tregs. CUE-401 is designed to overcome multiple hurdles required to exploit the therapeutic potential of a master switch with a first-in-class, bispecific molecule integrating a masked TGF-ß, with our clinically validated, attenuated IL-2 with an antibody Fc fragment. This novel design provides for 'conditional binding' and avoids off target activity, simplifies manufacturing and has highly differentiated findings in multiple pre-clinical models. In these models, CUE-401 behaves as a master switch to convert autoreactive effector T cells (inflammatory cells) into stable, induced T-regulatory cells (iTregs). These findings suggest that CUE-401 acts by establishing a 'tolerance positive feedback loop' that not only increases nonspecific Treg populations, but critically, reduces and converts specific autoreactive T cells into transdifferentiated iTregs that are specific for the disease-causing autoantigens. About Cue BiopharmaCue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient's body. The company's proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body's intrinsic immune system without the adverse effects of broad systemic immune in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. For more information please visit and follow us on X and LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company's expectations regarding the planned IND filing for CUE-401; the Company' expectations regarding the potential characteristics and benefit of CUE-401; the company's belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective modulation of disease-relevant T cell and the applicability of the company's platform across many cancers and autoimmune diseases; and the company's business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the company's future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as 'believe,' 'expect,' 'may,' 'will,' 'should,' 'would,' 'could,' 'seek,' 'intend,' 'plan,' 'goal,' 'project,' 'estimate,' 'anticipate,' 'strategy,' 'future,' 'likely' or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company's pipeline of product candidates and platforms, and its strategies, prospects, plans and objectives are forward-looking statements. Important factors that could cause the company's actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the Company's ability to successfully advance is development plan for CUE-401; potential setbacks in the company's research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company's ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration ('FDA') or other governmental approvals for its product candidates, including FDA clearance of any future IND submission for CUE-401, and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company's trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company's reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company's ability to obtain adequate financing to fund its business operations in the near term; the company's ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company's most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor Contact Marie Campinell Senior Director, Corporate CommunicationsCue Biopharma, Media ContactJonathan PappasLifeSci Communicationsjpappas@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
1News
25-05-2025
- 1News
Airport runway lights weren't working before San Diego crash killed six
The runway lights were out, a weather alert system wasn't working and there was heavy fog at a San Diego airport when a pilot who had flown across the country made the decision to proceed with landing but came up short and crashed into a neighbourhood, likely killing all six aboard the aircraft, investigators said. Investigator Dan Baker of the National Transportation Safety Board said officials will work over the next year to determine what caused the Cessna 550 Citation to crash just before 4am Thursday (local time). The jet was carrying a music executive and five others. No one in the neighbourhood of US Navy housing died, but eight people were treated for smoke inhalation from the fiery crash and non-life-threatening injuries. The pilot acknowledged the weather conditions for landing at the small airport were not ideal and debated diverting to a different airport while discussing the visibility with an air traffic controller at a regional Federal Aviation Administration control tower, according to audio of the conversation posted by The FAA had posted an official notice for pilots that the lights were out of service, but it's not known whether the pilot had checked it. He didn't discuss the lights being out with air traffic control but was aware that the airport's weather alert system was inoperable. Ultimately, the pilot is heard saying that he'll stick with the plan to land at Montgomery-Gibbs Executive Airport. "Doesn't sound great but we'll give it a go," he told the air traffic controller. The plane crashed about 3.22km from the airport. Baker said a power surge knocked out the weather system at the airport, but the pilot was aware of the fog and an air traffic controller gave him weather information from Marine Corps Air Station Miramar, about 6.44km north. Music talent agent Dave Shapiro, and two employees of the music agency he co-founded, Sound Talent Group, were among the dead along with the former drummer for metal band The Devil Wears Prada. Shapiro, 42, had a pilot's license and was listed as the owner of the plane. The two employees who died were Kendall Fortner, 24, and Emma Huke, 25, both Southern California natives and booking associates for the agency. The crash added to a long list of aviation disasters this year while federal officials have tried to reassure travelers that flying is the safest mode of transportation, which statistics support. Shapiro's aircraft took off from Teterboro, New Jersey, near Manhattan, at about 11.15pm local time Wednesday and made a fuel stop in Wichita, Kansas, before continuing on to San Diego. He was returning to San Diego after a band he manages, Pierce The Veil, played for a sold-out audience at Madison Square Garden. That overnight schedule wouldn't be allowed for an airliner under federal crew rest rules, but those regulations don't apply to private planes. Assistant San Diego Fire Department Chief Dan Eddy said the fog was so thick in the morning that "you could barely see in front of you". Former NTSB and FAA crash investigator Jeff Guzzetti said he thinks dense fog and fatigue after the pilot flew all night long were likely factors in the crash. "This accident has all the earmarks of a classic attempt to approach an airport in really bad weather and poor visibility," Guzzetti said. "And there were other airports that the crew could have gone to." He said pilots are required to check FAA posts called Notices to Airmen that alert pilots to any issues such as runway lights being out. "It's fairly easy for the pilot to get that information and they are required to get that information before any flight they take," Guzzetti said. The pilot also would have likely noticed the lights weren't working as he descended. Without lights, procedure dictated that he should have climbed and diverted to another airport, Guzzetti said. Fragments of the plane were found under power lines that are about a half block from the homes. It went on to lose a wing on the road directly behind the homes. Guzzetti said even if the plane had missed the power lines it may have still crashed because it was coming in too low in the fog. The crash site shows more damage on the front side of homes, including a smashed stone landscaping wall and an incinerated truck that was parked across the street and shoved into the living room of its owner's home before catching fire. Ben McCarty and his wife, who live in the home that was hit, said they felt heat all around them after being woken up by an explosion. "All I could see was fire. The roof of the house was still on fire. You could see the night sky from our living room," McCarty, who has served in the Navy for 13 years, told local ABC affiliate KGTV. Flames blocked many of the exits so they grabbed their children and dogs and ran out the back but the burning debris blocked the gate so neighbours helped them climb over the fence to escape. "We got the kids over the fence and then I jumped over the fence. They brought a ladder and we got the dogs," McCarty said. Meanwhile, fiery jet fuel rolled down the block igniting everything in its path from trees to plastic trash containers to car after car. McCarty's home was the only one destroyed, though another 10 residences suffered damage, authorities said. McCarty said his family used to enjoy living under the flight path so they could watch the planes pass overhead. "Us and our kids would sit on our front porch and we'd look up and my sons would always be excited saying 'plane plane' watching the planes go by and ironically right where we were sitting is where that plane hit," McCarty said. Now, he wants to move. "I'm not going to live over that flight line again — it's going to be hard to sleep at night," McCarty said. Guzzetti said in his experience there often aren't deaths on the ground when a plane crashes in a residential area unless people are right where the plane hits such as in Philadelphia in January. At least 100 residents in the San Diego neighborhood were evacuated and officials said it was unclear when it would be safe for people to return. Thursday's crash comes only weeks after a small plane crashed into a neighborhood in Simi Valley northwest of Los Angeles, killing both people and a dog aboard the aircraft but leaving no one on the ground injured. In October 2021 a twin-engine plane plowed into a San Diego suburb, killing the pilot and a UPS delivery driver on the ground and burning homes.
Epoch Times
24-05-2025
- General
- Epoch Times
Runway Lights Weren't Working as Pilot Tried to Land at Foggy San Diego Airport Before Fatal Crash
SAN DIEGO—The runway lights were out, a weather alert system wasn't working and there was heavy fog at a San Diego airport when a pilot who had flown across the country made the decision to proceed with landing but came up short and crashed into a neighborhood, likely killing all six aboard the aircraft, investigators said Friday. Investigator Dan Baker of the National Transportation Safety Board (NTSB) said officials will work over the next year to determine what caused the Cessna 550 Citation to crash just before 4 a.m. Thursday. The jet was carrying a music executive and five others. No one in the neighborhood of U.S. Navy housing died, but eight people were treated for smoke inhalation from the fiery crash and non-life-threatening injuries. The pilot acknowledged the weather conditions for landing at the small airport were not ideal and debated diverting to a different airport while discussing the visibility with an air traffic controller at a regional Federal Aviation Administration (FAA) control tower, according to audio of the conversation posted by The FAA had posted an official notice for pilots that the lights were out of service, but it's not known whether the pilot had checked it. He didn't discuss the lights being out with air traffic control, but was aware that the airport's weather alert system was inoperable. Ultimately, the pilot is heard saying that he'll stick with the plan to land at Montgomery-Gibbs Executive Airport. 'Doesn't sound great but we'll give it a go,' he told the air traffic controller. The plane crashed about 2 miles from the airport. Related Stories 5/23/2025 5/23/2025 Baker said a power surge knocked out the weather system at the airport but the pilot was aware of the fog and an air traffic controller gave him weather information from Marine Corps Air Station Miramar, about 4 miles north. Music talent agent Dave Shapiro, and two employees of the music agency he co-founded, Sound Talent Group, were among the dead along with the former drummer for metal band The Devil Wears Prada. Shapiro, 42, had a pilot's license and was listed as the owner of the plane. The two employees who died were Kendall Fortner, 24, and Emma Huke, 25, both Southern California natives and booking associates for the agency. The crash added to a long list of aviation disasters this year while federal officials have tried to reassure travelers that flying is the safest mode of transportation, which statistics support. Shapiro's aircraft took off from Teterboro, New Jersey, near Manhattan, at about 11:15 p.m. local time Wednesday and made a fuel stop in Wichita, Kansas, before continuing on to San Diego. He was returning to San Diego after a band he manages, Pierce The Veil, played for a sold-out audience at Madison Square Garden. That overnight schedule wouldn't be allowed for an airliner under federal crew rest rules, but those regulations don't apply to private planes. Assistant San Diego Fire Department Chief Dan Eddy said the fog was so thick in the morning that 'you could barely see in front of you.' Former NTSB and FAA crash investigator Jeff Guzzetti said he thinks dense fog and fatigue after the pilot flew all night long were likely factors in the crash. 'This accident has all the earmarks of a classic attempt to approach an airport in really bad weather and poor visibility,' Guzzetti said. 'And there were other airports that the crew could have gone to.' He said pilots are required to check FAA posts called Notices to Airmen that alert pilots to any issues such as runway lights being out. 'It's fairly easy for the pilot to get that information and they are required to get that information before any flight they take,' Guzzetti said. The pilot also would have likely noticed the lights weren't working as he descended. Without lights, procedure dictated that he should have climbed and diverted to another airport, Guzzetti said. Fragments of the plane were found under power lines that are about a half block from the homes. It went on to lose a wing on the road directly behind the homes. Guzzetti said even if the plane had missed the power lines it may have still crashed because it was coming in too low in the fog. A Terrifying Wakeup The crash site shows more damage on the front side of homes, including a smashed stone landscaping wall and an incinerated truck that was parked across the street and shoved into the living room of its owner's home before catching fire. Ben McCarty and his wife, who live in the home that was hit, said they felt heat all around them after being woken up by an explosion. 'All I could see was fire. The roof of the house was still on fire. You could see the night sky from our living room,' McCarty, who has served in the Navy for 13 years, told local ABC affiliate KGTV. Flames blocked many of the exits so they grabbed their children and dogs and ran out the back but the burning debris blocked the gate so neighbors helped them climb over the fence to escape. 'We got the kids over the fence and then I jumped over the fence. They brought a ladder and we got the dogs,' McCarty said. Meanwhile, fiery jet fuel rolled down the block igniting everything in its path from trees to plastic trash containers to car after car. McCarty's home was the only one destroyed, though another 10 residences suffered damage, authorities said. McCarty said his family used to enjoy living under the flight path so they could watch the planes pass overhead. 'Us and our kids would sit on our front porch and we'd look up and my sons would always be excited saying 'plane plane' watching the planes go by and ironically right where we were sitting is where that plane hit,' McCarty said. Now, he wants to move. 'I'm not going to live over that flight line again—it's going to be hard to sleep at night,' McCarty said. It Could Have Been Much Worse Guzzetti said in his experience there often aren't deaths on the ground when a plane crashes in a residential area unless people are right where the plane hits such as in Philadelphia in January. At least 100 residents in the San Diego neighborhood were evacuated and officials said it was unclear when it would be safe for people to return. Thursday's crash comes only weeks after a small plane crashed into a neighborhood in Simi Valley northwest of Los Angeles, killing both people and a dog aboard the aircraft but leaving no one on the ground injured. In October 2021 a twin-engine plane plowed into a San Diego suburb, killing the pilot and a UPS delivery driver on the ground and burning homes. By Julie Watson and Josh Funk
Al Etihad
24-05-2025
- Al Etihad
Pilot and passengers killed in San Diego plane crash
24 May 2025 15:28 SAN DIEGO (AFP)The six people onboard a small plane that crashlanded Thursday on a California neighborhood amid dense fog were all killed, according to investigating Cessna 550 Citation, which federal records show belonged to music agent Dave Shapiro, plummeted into a residential area of San Diego at 3:47 am (1047 GMT) on Thursday, according to the National Transportation Safety Board (NTSB).It was not immediately clear what caused the Cessna to come plunging into the Murphy Canyon neighborhood, about two miles (3.2 kilometres) from the Montgomery-Gibbs Executive Airport where the aircraft was an audio recording posted to air traffic website the pilot can be heard asking about weather conditions prior to descent, while indicating that visibility was down to a minimum."Doesn't sound great, but we'll give it a go," the pilot the plane came down, it clipped a power line and the impact of the crash set several nearby houses and vehicles alight, jolting families awake before dawn."The pilot and passengers were fatally injured," NTSB investigator Dan Baker told a press conference on Friday. He added that no one on the ground had been seriously Baker did not specify the number of fatalities, the US Federal Aviation Administration previously said the private plane had six people least 10 homes in San Diego's Murphy Canyon neighborhood were hit by debris, while the street was littered with charred remnants, scattered fiberglass and jet people were treated for minor injuries, according to responding police and firefighters. The plane was not equipped with a flight data recorder.
Time of India
24-05-2025
- General
- Time of India
Runway lights weren't working as pilot tried to land at foggy San Diego airport before fatal crash
Representative Image SAN DIEGO: The runway lights were out, a weather alert system wasn't working and there was heavy fog at a San Diego airport when a pilot who had flown across the country made the decision to proceed with landing but came up short and crashed into a neighborhood, likely killing all six aboard the aircraft, investigators said Friday. Investigator Dan Baker of the National Transportation Safety Board said officials will work over the next year to determine what caused the Cessna 550 Citation to crash just before 4 a.m. Thursday. The jet was carrying a music executive and five others. No one in the neighborhood of U.S. Navy housing died, but eight people were treated for smoke inhalation from the fiery crash and non-life-threatening injuries. The pilot acknowledged the weather conditions for landing at the small airport were not ideal and debated diverting to a different airport while discussing the visibility with an air traffic controller at a regional Federal Aviation Administration control tower, according to audio of the conversation posted by The FAA had posted an official notice for pilots that the lights were out of service, but it's not known whether the pilot had checked it. He didn't discuss the lights being out with air traffic control, but was aware that the airport's weather alert system was inoperable. Ultimately, the pilot is heard saying that he'll stick with the plan to land at Montgomery-Gibbs Executive Airport. "Doesn't sound great but we'll give it a go," he told the air traffic controller. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Giao dịch vàng với sàn môi giới tin cậy IC Markets Đăng ký Undo The plane crashed about 2 miles (3.22 kilometers) from the airport. Baker said a power surge knocked out the weather system at the airport but the pilot was aware of the fog and an air traffic controller gave him weather information from Marine Corps Air Station Miramar, about 4 miles (6.44 kilometers) north. Music talent agent Dave Shapiro, and two employees of the music agency he co-founded, Sound Talent Group, were among the dead along with the former drummer for metal band The Devil Wears Prada. Shapiro, 42, had a pilot's license and was listed as the owner of the plane. The two employees who died were Kendall Fortner, 24, and Emma Huke, 25, both Southern California natives and booking associates for the agency. The crash added to a long list of aviation disasters this year while federal officials have tried to reassure travelers that flying is the safest mode of transportation, which statistics support. Shapiro's aircraft took off from Teterboro, New Jersey, near Manhattan, at about 11:15 p.m. local time Wednesday and made a fuel stop in Wichita, Kansas, before continuing on to San Diego. He was returning to San Diego after a band he manages, Pierce The Veil, played for a sold-out audience at Madison Square Garden. That overnight schedule wouldn't be allowed for an airliner under federal crew rest rules, but those regulations don't apply to private planes. Assistant San Diego Fire Department Chief Dan Eddy said the fog was so thick in the morning that "you could barely see in front of you." Former NTSB and FAA crash investigator Jeff Guzzetti said he thinks dense fog and fatigue after the pilot flew all night long were likely factors in the crash. "This accident has all the earmarks of a classic attempt to approach an airport in really bad weather and poor visibility," Guzzetti said. "And there were other airports that the crew could have gone to." He said pilots are required to check FAA posts called Notices to Airmen that alert pilots to any issues such as runway lights being out. "It's fairly easy for the pilot to get that information and they are required to get that information before any flight they take," Guzzetti said. The pilot also would have likely noticed the lights weren't working as he descended. Without lights, procedure dictated that he should have climbed and diverted to another airport, Guzzetti said. Fragments of the plane were found under power lines that are about a half block from the homes. It went on to lose a wing on the road directly behind the homes. Guzzetti said even if the plane had missed the power lines it may have still crashed because it was coming in too low in the fog. A terrifying wakeup The crash site shows more damage on the front side of homes, including a smashed stone landscaping wall and an incinerated truck that was parked across the street and shoved into the living room of its owner's home before catching fire. Ben McCarty and his wife, who live in the home that was hit, said they felt heat all around them after being woken up by an explosion. "All I could see was fire. The roof of the house was still on fire. You could see the night sky from our living room," McCarty, who has served in the Navy for 13 years, told local ABC affiliate KGTV. Flames blocked many of the exits so they grabbed their children and dogs and ran out the back but the burning debris blocked the gate so neighbors helped them climb over the fence to escape. "We got the kids over the fence and then I jumped over the fence. They brought a ladder and we got the dogs," McCarty said. Meanwhile, fiery jet fuel rolled down the block igniting everything in its path from trees to plastic trash containers to car after car. McCarty's home was the only one destroyed, though another 10 residences suffered damage, authorities said. McCarty said his family used to enjoy living under the flight path so they could watch the planes pass overhead. "Us and our kids would sit on our front porch and we'd look up and my sons would always be excited saying 'plane plane' watching the planes go by and ironically right where we were sitting is where that plane hit," McCarty said. Now, he wants to move. "I'm not going to live over that flight line again - it's going to be hard to sleep at night," McCarty said. It could have been much worse Guzzetti said in his experience there often aren't deaths on the ground when a plane crashes in a residential area unless people are right where the plane hits such as in Philadelphia in January. At least 100 residents in the San Diego neighborhood were evacuated and officials said it was unclear when it would be safe for people to return. Thursday's crash comes only weeks after a small plane crashed into a neighborhood in Simi Valley northwest of Los Angeles, killing both people and a dog aboard the aircraft but leaving no one on the ground injured. In October 2021 a twin-engine plane plowed into a San Diego suburb, killing the pilot and a UPS delivery driver on the ground and burning homes.
