– Announced positive topline efficacy and safety data from the Phase 2 DAVIO 2 trial of EYP-1901 in wet AMD achieving all primary and secondary endpoints; initiation of the first Phase 3 clinical trial expected in 2H 2024 –
– Dosed first patient in Phase 2 VERONA clinical trial of EYP-1901 in DME; topline data expected in 1Q 2025 –
– Phase 2 PAVIA clinical trial topline data of EYP-1901 in moderately severe-to-severe NPDR anticipated in 2Q 2024 –
– Announced appointment of Ramiro Ribeiro, M.D., Ph.D. as Chief Medical Officer –
– $331M of cash and investments on December 31, 2023, with cash runway through topline data of Phase 3 trials for EYP-1901 for wet AMD in 2026 –
– Management to host a conference call and webcast today at 8:30 a.m. ET –
EyePoint will host a conference call today at 8:30 a.m. ET to discuss the results for the fourth quarter and year ended December 31, 2023 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BI91be5d0e320646e887cf4047c70fe73c. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.
Dose escalation in FHD-286 combination study in AML continues to progress; clinical data anticipated in the second half of 2024
• FHD-909, a first-in-class BRM selective inhibitor, selected for clinical development by partner Lilly; preclinical data to be presented at AACR with IND planned for the second quarter, primary target patient population in non-small cell lung cancer
• Selective CBP and EP300 degrader preclinical data to be presented at AACR; IND-enabling studies for CBP degrader program planned to begin by end of 2024
• Foghorn anticipates at least six new INDs targeting significant oncology patient populations over the next four years, reflecting the continued productivity of its precision medicine platform
• Cash, cash equivalents, and marketable securities of $234.1 million, as of December 31, 2023, provide cash runway into the first half of 2026
Boundless Bio on Wednesday launched its bid to go public, seeking additional funds to develop novel therapies targeting extrachromosomal DNA for various cancer indications.
The Bayer- and RA Capital-backed biotech has yet to disclose how much it expects to make from its initial public offering (IPO), nor has it given a specific timeline for going public, only that it expects to close the offering within the year. Once closed, Boundless proposes to trade on the Nasdaq Global Market under the ticker symbol BOLD.
Boundless is planning to use its IPO proceeds to support the development of its three therapeutic candidates that target extrachromosomal DNA (ecDNA), which play a central role in the amplification of cancer-causing genes in approximately 14% of malignancies, according to the company’s SEC filing on Wednesday.
With its proprietary Spyglass platform, Boundless is now working on three cancer programs that work by blocking specific ecDNA targets, stopping them from amplifying oncogenes and preventing tumor cells from adapting and building resistance to existing therapies. The biotech’s candidates specifically target cancer cells with ecDNA without affecting healthy cells.
Two of its programs are currently in Phase I studies. Its lead program, dubbed BBI-355, is a selective blocker of checkpoint kinase 1, which is key to the replication and transcription of ecDNA in cancer cells. BBI-355 is being evaluated in the Phase I/II POTENTIATE study, with early data expected in the second half of 2024.
Boundless’ second program is BBI-825, an oral inhibitor of ribonucleotide reductase, which helps assemble and repair ecDNA in cancer cells. The biotech is running the Phase I/II STARMAP trial and expects early proof-of-concept data in the latter half of 2025.
The biotech’s third ecDNA candidate is still in the discovery phase. Boundless is planning to submit an Investigational New Drug application for this program as early as the first half of 2026, according to its SEC filing.
In addition to supporting its clinical pipeline, Boundless will also use the IPO’s proceeds to fund the development of an ecDNA diagnostic test—preliminarily dubbed ECHO—which will use genomic data from routine screening assays to detect ecDNA in patients’ tumor samples.
Boundless’ IPO will add to the more than $252 million that the biotech has raised since its inception. This sum includes an oversubscribed $105 million Series B round in April 2021, which was backed primarily by RA Capital Management and Nextech Invest. Boundless closed another fundraising round in May 2023, securing $100 million in an oversubscribed Series C led by RA and Bayer.
Wednesday’s IPO filing also continues the industry’s rally in 2024, which was started by CG Oncology in January and includes ArriVent Biopharma, Kyverna Therapeutics and pre-clinical biotech Metagenomi, as well as Alto Neuroscience and Fractyl Health.
https://www.biospace.com/article/boundless-bio-to-go-public-as-2024-ipo-rally-continues-/
Novo Nordisk during the company’s Capital Markets Day event on Thursday unveiled positive Phase I data for its next-generation obesity therapy amycretin, demonstrating an overall favorable safety profile and strong weight-loss signals.
At 12 weeks, study participants who were given the investigational drug saw a 13.1% weight loss, the Danish pharma reported in its R&D presentation at the investor event. The placebo group, on the other hand, saw only a 1.1% reduction in body weight over the same time span.
Amycretin was also safe and well-tolerated overall and its adverse effects were in line with Novo’s prior studies of GLP-1 receptor agonists, the company said. The pharmacokinetic findings in the Phase I study also encourage further assessment of amycretin.
Designed to be orally available, amycretin is a co-agonist of both the GLP-1 and amylin receptors—both of which are involved in regulating appetite and controlling blood glucose levels, though their effects are mediated through complementary pathways. Amylin receptors are located on β-cells in the pancreas, while GLP-1 receptors are concentrated in L-cells in the intestine.
According to Novo’s presentation, amycretin is a unimolecular candidate, meaning that it combines two mechanisms of action in a single molecule and yields additive effects.
Novo is developing amycretin as part of its pipeline in diabetes and obesity, which seeks to maximize its current GLP-1 franchise and leverage other innovative approaches including those that target amylin and GIP receptors. For future projects, Novo will focus on regulating appetite and energy expenditure, maintaining weight, preserving lean mass and evaluating sustained-release modes of delivery.
The pharma is looking to start another amylin program in the coming months, with a Phase I trial slated for 2024. Novo is also gearing up for another Phase I study in the next 12 months for a new tri-agonist candidate, which the company contends has the potential for greater weight loss and other obesity-related comorbidities.
Aside from amycretin and the upcoming Phase I programs, Novo is already targeting the amylin pathway through its late-stage weight-loss combo therapy CagriSema, which combines the top-selling semaglutide—marketed as Ozempic for type 2 diabetes and Wegovy for chronic weight management—with an amylin analog dubbed cagrilintide.
In August 2022, the drugmaker released Phase II data for CagriSema, demonstrating a 15.6% drop in body weight in type 2 diabetes patients who were overweight. This effect was numerically better when compared with cagrilintide or Wegovy alone. In September 2023, Novo launched a Phase III head-to-head trial pitting CagriSema against Eli Lilly’s Zepbound (tirzepatide).
Novo is also seeking to expand its expertise beyond obesity and diabetes, targeting cardiometabolic diseases more broadly.
On Tuesday, the pharma reported that Ozempic induced a 24% reduction in the risk of kidney disease progression, major adverse cardiovascular events and kidney death versus placebo in patients with type 2 diabetes and chronic kidney disease. Novo is eyeing a label expansion for Ozempic, with filings planned for later this year.
https://www.biospace.com/article/novo-touts-phase-i-data-for-next-generation-obesity-candidate-/
The latest round to reach a Gaza ceasefire deal in Cairo has failed. The Hamas delegation has departed the Egyptian capital, with no progress made, and it is accusing Israel of thwarting truce attempts while also blocking humanitarian aid operations to the Strip.
Israel for its part didn't even send a delegation to Cairo and has only been engaged through intermediaries, after Prime Minister Netanyahu called Hamas' conditions "delusional" - particularly the request for Israel's military to withdraw all forces from Gaza.
A Hamas official was cited in Al Jazeera as charging that Israel has "thwarted" all attempts by mediators to reach an agreement. The situation is growing more desperate by the hour, with local reporters saying that in some instances children are fainting on the streets due to hunger.
According to an Al Jazeera update of some of the latest key developments in the Israel-Hamas war:
Israel has “consistently and groundlessly” blocked aid operations for Gaza even as the enclave falls deeper into famine, according to a new report based on interviews with government officials, humanitarian workers, and NGO staff.
South Africa requests additional action, immediate ceasefire order from International Court of Justice to prevent “full-scale famine” in Gaza.
Houthi-claimed strike on cargo ship causes first deaths since group began attacks on Red Sea shipping in response to Israel’s war on Gaza.
At least 30,800 Palestinians have been killed and 72,198 wounded in Israeli attacks on Gaza since October 7. The death toll in Israel from the October 7 Hamas attacks stands at 1,139.
Negotiators who have left Cairo say that talks have ended with 'no substantial answer or solution'.
The Times of Israel has reported, "An official Egyptian source told the country’s Al-Qahera News state-affiliated TV channel that negotiations over a ceasefire in Gaza have reached an impasse over Hamas’s demand for a phased process culminating in an end to the war, but said talks will resume next week."
The Biden administration has meanwhile expressed that it hopes to see a legitimate deal reached by the Muslim fasting month of Ramadan, which starts March 10.
But each major battlefield incident or atrocity puts greater distance between the warring sides, and also increases pressure on each to gain the military upper hand, as mutual condemnations also abound.
https://www.zerohedge.com/geopolitical/delegations-leave-cairo-no-gaza-ceasefire-progress-made
by Tom Ozimek via The Epoch Times (emphasis ours),
A controversial bill that would let illegal immigrants receive the same kind of homebuyer assistance as U.S. citizens has advanced in the California state legislature, drawing criticism from those who object to granting perks to people who break the law by entering the country illegally.
The measure, Assembly Bill 1840, was first introduced in mid-January, and after several amendments, it advanced last week to the Committee on Housing and Community Development, where it awaits further action.
Assembly Bill 1840 would change existing law to allow illegal immigrants to be eligible for the California Dream for All Fund, which provides interest-free loans for a down payment on a home for first-time buyers.
The bill was introduced by California Assemblyman Joaquin Arambula, a Democrat, who last month told GV Wire, a Fresno-based news outlet, that he “wanted to ensure that qualified first-time homebuyers include undocumented applicants.”
Last week, as the bill advanced to committee after amendments, Mr. Arambula told the Los Angeles Times that, historically, homeownership has been the main way people accumulate generational wealth in the United States.
“The social and economic benefits of homeownership should be available to everyone,” he said, arguing that it’s wrong to exclude people from the benefits of the California Dream for All Fund program just because they’re illegal immigrants.
Some lawmakers expressed opposition to the measure as it moves closer to becoming law.
“Assembly Bill 1840 is an insult to California citizens who are being left behind and priced out of homeownership. I’m all for helping first-time homebuyers, but give priority to those who are here in our state legally,” California Sen. Brian Dahle, a Republican, said in a post on X, formerly Twitter.
The California Dream for All Fund program, administered by the state’s Housing Finance Agency, provides loans for 20 percent of a home’s value but no greater than $150,000.
Qualifying homebuyers repay the loans when selling or transferring the property plus 20 percent of any appreciation in its value. Applicants who earn less than their county’s area median income get a slight break, having to pay 15 percent of the appreciation. If a home doesn’t appreciate in value, only the principal will be paid back, meaning the loan is technically interest-free.
The proposed bill seeks to amend Section 51523 of the California Health and Safety Code to include a subsection that reads: “An applicant under the program shall not be disqualified solely based on the applicant’s immigration status.”
Mr. Arambula has defended the program, arguing in the interview with GV Wire last month that it won’t affect the state budget because the loans are supposed to be paid back with an appreciation fee.
Even though the net impact of the program on the state budget is technically neutral-to-positive, some critics argue that it sends the wrong message and effectively rewards illegal immigration.
“We have a huge housing crisis in California and anything we can do to get people into housing we should do. However, we should help our own first. This next generation of people growing up can’t afford a house. I’ve got two kids in their early 30s and most of their friends do not own houses,” San Diego County Supervisor Jim Desmond, a Republican, told NBC 7 San Diego.
Mr. Desmond has been a vocal critic of policies that he says create incentives for people to enter the country illegally.
“You incentivize illegal immigration by providing free healthcare, free unemployment benefits and tons of other freebies,” he wrote in a recent post on X, reacting to a post by California Gov. Gavin Newsom, a Democrat, who called on Congressional Republicans to back President Joe Biden’s border deal.
“It’s no wonder we are getting thousands of people by the day. This is on you as much as the Federal Government,” Mr. Desmond added.
Mr. Desmond said on March 3 that over 5,000 illegal immigrants had been released in San Diego County over the past 10 days.
“What’s striking about the people being dropped here by the Border Patrol is about 70 percent of them are single males,” he told Fox News.
While many of the new arrivals are being taken to the airport by local nongovernmental organizations to fly out to someplace else in the country, Mr. Desmond lamented that “in the meantime, our airport is now the new migrant shelter.”
His remarks come as the United States remains in the throes of an illegal immigration crisis of historic proportions, with some border patrol officials and others warning of a national security risk.
The head of the Border Patrol union recently warned about the sharp rise in the number of military-aged Chinese men crossing the U.S.–Mexico border illegally.
National Border Patrol Council President Brandon Judd said in a recent interview on “Just the News, No Noise” TV program that he believes some of them may be spies working on behalf of China’s communist regime to infiltrate the United States.
“At best, they’re here for a better life,” Mr. Judd said. “At worst, they’re here to be part of the Chinese government to infiltrate our own country.”
His remarks came as U.S. Customs and Border Protection (CBP) released its latest data for January encounters with illegal immigrants who crossed the border into the United States.
Aside from showing that Border Patrol agents encountered a record number of illegal immigrants (242,587) in January 2024 compared to any previous January, the CPB numbers show an alarming trend in the number of military-aged Chinese nationals entering the country illegally.
Border Patrol agents encountered 5,717 single Chinese adults in January, more than twice the number of any other January on record, CBP data shows. In December 2023, that figure rose to a record of 7,581, while the total since January 2023 stands at 64,979.
Some analysts say that deteriorating economic conditions in China, along with human rights abuses and policies such as strict COVID-19 lockdowns, are likely driving the increase.
The San Diego Sector has seen a more than 500 percent jump in the number of Chinese nationals entering the country illegally, according to Jason Owens, the chief of the U.S. Border Patrol.
Rudy Blalock contributed to this report.
