Biden Promises Israel 'Ironclad' Support Against Iran, Walks Back Call For Unilateral Ceasefire

 President Joe Biden has promised "ironclad" support for Israel at a moment US intelligence believes that Iranian reprisals for the April 1st Damascus embassy attack are imminent. The only question that remains is whether it will be a direct attack launched from Iranian soil, or via proxies like Hezbollah.

"As I told Prime Minister Netanyahu, our commitment to Israel’s security against these threats from Iran and its proxies is ironclad," Biden said Wednesday. "Let me say it again — ironclad. We’re going to do all we can to protect Israel’s security." He explained this is in response to Tehran "threatening to launch a significant attack on Israel."

Israeli Foreign Minister Israel Katz has vowed swift and strong retaliation: "If Iran attacks from its territory, Israel will respond and attack Iran," he said in a statement on X, echoing prior similar words of Prime Minister Netanyahu.

The US administration has also said it is not ruling out launching joint retaliatory strikes with Israel in a scenario it is attacked by Iran or its proxies, we detailed previously.

Also, Biden appeared to walk back a call for Israel to declare a six-to-eight-week ceasefire in Gaza. In an interview given to Univision which aired Tuesday, Biden had said, "So what I’m calling for is for the Israelis to just call for a ceasefire, allow for the next six, eight weeks, total access to all food and medicine going into the country."

But on Wednesday Biden said it is "up to Hamas" to be willing to release the hostages as a condition for achieving ceasefire, contradicting the prior unilateral ceasefire remarks.

According to the new statement: "It’s now up to Hamas. They need to move on the proposal that has been made [so we can] get these hostages home where they belong," Biden said during a press conference on Wednesday. "It also brings back a six-week ceasefire that we need now."

Israel on Thursday once again blamed Hamas for "walking away" in ceasefire talks. Hamas has this week told negotiators that it cannot immediate locate 40 of the hostages, as they appear to be scattered at different locations across the strip - held in some cases by various militants and families.

Meanwhile former US president Donald Trump has claimed Biden "totally abandoned Israel" and that "Any Jewish person that votes for a Democrat or votes for Biden should have their head examined."

PM Benjamin Netanyahu has reiterated Thursday regarding the Iran threat, "We set a simple principle: Anyone who hits us, we hit them."

Biden is not just feeling the pressure from the GOP frontrunner for president, but also from within his own base, as Progressives continue to express outrage at his Gaza policy and the soaring death toll. Hundreds of thousands of Democrat voters, some in key swing states, have declared they will not vote for Biden this time around.

https://www.zerohedge.com/geopolitical/biden-promises-israel-ironclad-support-against-iran-walks-back-call-israelis

Enlivex Topline Results of Phase II Septic Shock Trial Mixed

 

• Analysis of eligible1 patients from the sepsis Phase II study (NCT# NCT04612413)
• In accordance with the study protocol, the safety and efficacy topline analysis includes sequential organ failure assessment (SOFA) scores and mortality for the 28-day period post treatment.
• Efficacy:
  • Stand-alone analysis of the Allocetra™-treated patients, of which 78% had septic shock and 65% had invasive ventilation at screening, demonstrated substantial reductions in SOFA scores and 65% reduction in overall mortality rate as compared with expected mortality2.  By day 28, the analysis showed 90% reductions of SOFA scores for sepsis patients whose infection source was urinary tract, 68% for patients whose infection source was community-acquired pneumonia, and 36% for patients whose infection source was internal abdominal infection.
  • Relative analysis demonstrates a potential indication of effect of Allocetra™ as compared with placebo in high-risk, severe sepsis patient population (organ failure scores >=7), originating from urinary tract infections (“High Risk UTI”). Enlivex intends to consider a potential follow-on, randomized, controlled study of a solely High Risk UTI sepsis population. Up to 31% of sepsis cases start as urinary tract infections, representing up to 9.8 million cases in the United States and Europe, leading to as many as 1.6 million deaths3, and represents a substantial potential market opportunity for Allocetra™.
  • The study was designed for patients to be randomized with equal degree of SOFA scores across treatment and placebo groups.  The randomization resulted in the Allocetra™-treated cohorts having 20% higher frequency of septic shock and 35% higher frequency of invasive ventilation prior to treatment, as compared with the control group. Both of these patient attributes are associated with a significantly higher degree of difficulty of treatment and higher mortality rates. These imbalances made it challenging to deduce the relative effect in other patient subgroups.
• Safety: Stand-alone and placebo-compared analysis across all sepsis patient subgroups and risk categories demonstrated acceptable safety and tolerability profile of Allocetra™ IV infusions.

https://www.globenewswire.com/news-release/2024/04/11/2861472/0/en/Enlivex-Announces-Topline-Results-of-Its-Phase-II-Trial-Evaluating-Allocetra-In-Patients-With-Sepsis.html

Enliven Positive Proof of Concept Data from Phase 1 Trial of ELVN-001 in Chronic Myeloid Leukemia

 Achieved initial cumulative MMR rate of 44% (7/16) by 12 weeks in response-evaluable patients, which compares favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs

Achieved initial cumulative MMR rate of 44% (4/9) by 12 weeks in response-evaluable patients who were previously treated with asciminib

ELVN-001 was well tolerated with no ≥ Grade 3 treatment-related non-hematologic toxicities reported 

Company to host virtual event with Key Opinion Leaders at 8:00 AM ET Today

Enliven is hosting a company event with KOLs today at 8:00 AM ET. The event will feature leading CML investigators and hematology care experts, Michael Mauro, M.D., from Memorial Sloan Kettering Cancer Center, and Fabian Lang, M.D., from Goethe University Hospital, along with the management of Enliven Therapeutics. The discussion will cover details of ELVN-001’s Phase 1 initial proof of concept data, the evolving treatment paradigm in CML, and how ELVN-001 could fit into the CML landscape.

The event will be webcast live and can be accessed by visiting the investor relations section of the Company’s website at https://ir.enliventherapeutics.com. To participate in the live event, please register using this link. An archived webcast will be available following the event.

https://www.globenewswire.com/news-release/2024/04/11/2861409/0/en/Enliven-Therapeutics-Announces-Positive-Proof-of-Concept-Data-from-Phase-1-Clinical-Trial-of-ELVN-001-in-Chronic-Myeloid-Leukemia.html

Candel Orphan Drug Designation for CAN-2409 for Treatment of Pancreatic Cancer

 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, for the treatment of pancreatic cancer.

https://www.globenewswire.com/news-release/2024/04/11/2861549/0/en/Candel-Therapeutics-Receives-FDA-Orphan-Drug-Designation-for-CAN-2409-for-the-Treatment-of-Pancreatic-Cancer.html

Eliem to Acquire Tenet Medicines and Concurrent $120 Million Private Placement

 Transaction to add clinical-stage program directed towards treating unmet needs in autoantibody-mediated diseases

Combined company expected to have approximately $210 million of cash and cash equivalents, including $120 million from a concurrent private placement of common stock from leading life sciences investors

Combined company to focus on clinical development of lead product candidate, TNT119, in upcoming Phase 2 clinical trials in systemic lupus erythematosus and immune thrombocytopenia

Companies to host webcast today, April 11, 2024 at 8:30 a.m. EDT

Eliem will host a webcast today, April 11, 2024 at 8:30 a.m. EDT, to discuss the acquisition of Tenet. The webcast can be accessed in the Investors section of Eliem’s website at www.eliemtx.com. An archived replay of the webcast will be available for approximately 90 days following the presentation.

https://www.globenewswire.com/news-release/2024/04/11/2861368/0/en/Eliem-Therapeutics-Announces-Agreement-to-Acquire-Tenet-Medicines-and-Concurrent-120-Million-Private-Placement.html

FDA puts breakthrough tag on Roche, Lilly Alzheimer’s test

 A blood test being developed by Roche and Eli Lilly that could help diagnose patients with Alzheimer’s disease more quickly has been awarded breakthrough status by the FDA, which could help it to reach the market more quickly.

The pTau217 plasma biomarker test, which runs on Roche’s widely-used Elecsys analysers, is intended to look for the presence or absence of amyloid pathology in individuals with suspected Alzheimer’s.

pTau217 is a phosphorylated fragment of the protein tau that in research studies has been shown to distinguish Alzheimer’s from other neurodegenerative disorders, and potentially to detect elevated risk of the disease years before symptoms develop.

The test could potentially help identify patients eligible for treatment with new amyloid-busting drugs like Eisai and Biogen’s Leqembi (lecanemab), which is already approved for marketing in the US, China, and Japan, as well as Eli Lilly’s donanemab, which has been submitted for approval and is heading for an FDA advisory committee meeting.

In addition, Roche and Lilly hope it could be deployed to accelerate the recruitment of patients into clinical trials of new treatments for Alzheimer’s and help researchers make faster progress in understanding the complex disease.

At the moment, AD is typically diagnosed with the help of time-consuming and expensive PET brain scans or invasive cerebrospinal fluid (CSF) analysis carried out by lumbar puncture, coupled with cognitive testing, and it can take years after symptom onset to get a verdict.

“The incidence of dementia is growing worldwide, with 75% of cases remaining undiagnosed,” commented Matt Sause, chief executive of Roche Diagnostics. “Consequently, there is a critical role for diagnostics to play in addressing this global health challenge [and] we believe pTau217 is going to be crucial in the diagnosis of Alzheimer’s.”

Earlier this year, a rival pTau217 test developed by California biotech ALZpath was shown to be 96% accurate in identifying elevated levels of amyloid and up to 97% accurate in correctly identifying high levels of tau, when compared with CSF testing, in a study published in the journal JAMA Neurology.

The researchers behind the work said the test could help to reduce the demand for follow-up testing by around 80%, saving health systems money.

Roche and Lilly are also working on another Elecsys test that measures pTau181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma and has also been given breakthrough status by the FDA.

Meanwhile, a pair of independent clinical trials are getting underway in the UK that will look at a range of blood tests to investigate their potential to deliver real-world benefits to the NHS.

One study is focusing on pTau217 to see if it can be used to predict Alzheimer’s in patients with early signs of dementia and mild, progressive memory loss, while the other will look at tests for different types of dementia to see whether they can help detect the diseases at various stages.

https://pharmaphorum.com/news/fda-puts-breakthrough-tag-roche-lilly-alzheimers-test

Rallybio, J&J to Advance Treatment for Risk of Fetal and Neonatal Alloimmune Thrombocytopenia

 Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced a collaboration with Johnson & Johnson1 to support the development of complementary therapeutic approaches aimed at reducing the risk of fetal and neonatal alloimmune thrombocytopenia (FNAIT). In addition, Rallybio received an equity investment of $6.6 million from Johnson & Johnson Innovation – JJDC, Inc.

Rallybio is developing RLYB212, a novel human monoclonal anti-HPA-1a antibody designed to prevent pregnant individuals from alloimmunizing2, thereby eliminating the risk of FNAIT and its potentially devastating consequences in their fetuses and newborns. Rallybio is on track to initiate a Phase 2 dose confirmation study for RLYB212 in pregnant individuals at higher risk of alloimmunization and FNAIT in the second half of 2024.

Under this collaboration, Johnson & Johnson will provide funding for Rallybio to raise awareness of Johnson & Johnson’s FNAIT clinical program in connection with Rallybio’s ongoing FNAIT natural history study. Rallybio is also eligible to receive additional payments under the collaboration.

RLYB212 is the only investigational therapy currently reported to be in clinical development to address the needs of pregnant individuals at risk of FNAIT who have not alloimmunized2. Johnson & Johnson is conducting a Phase 3 study of nipocalimab, an investigational monoclonal antibody targeting FcRn, in pregnant individuals who are already alloimmunized. As these individuals have the alloantibodies that can cause FNAIT, preventative treatment with RLYB212 would not be appropriate.

https://www.businesswire.com/news/home/20240408380440/en