Latest news with #ARDS
India Today
22-06-2025
- Health
- India Today
From headache to hospitalization: How seasonal flu has changed post-COVID
In the past, the seasonal flu was considered a bothersome condition that resembled the common cold or "fun flu" and was characterized by minor headaches, a mild fever, some body pains, and exhaustion. Since then, the flu's clinical manifestation and/or intensity have evolved. On the other side of COVID, more people show up in hospitals with what appear to be routine flu-like symptoms that rapidly worsen because of serious respiratory issues. Dr. Pratibha Walde, Consultant - Internal Medicine, Manipal Hospital, Kharadi, Pune explains what has changedOur bodies have changed: The body's reaction to influenza viruses, co-infections, and, of course, the long-term consequences of COVID-19 has been altered by post-pandemic immunological sensitivity. A previously healthy people may develop myocarditis (inflammation of the heart tissue), pneumonia, acute respiratory distress syndrome (ARDS), and in certain situations, multi-organ hospitalisations are on the rise: The most at risk will always be elderly people, children, and those with a history of heart problems, diabetes, or asthma. However, the number of hospitalizations for severe flu-related diseases is increasing, especially among younger people without comorbidities. What usually begins as a sore throat or moderate headache can frequently worsen into a high-grade fever, dyspnea, and chest pain, necessitating oxygen therapy or an admission to the intensive care is also requiring more complex intervetions: The rise in instances requiring the procedure or pleural tapping is one of the most alarming trends we have observed. This entails removing contaminated fluid from the pleural space that envelops the lungs. These situations usually occur when the flu causes substantial pleural effusions or an empyema, which is pus in the pleural space. Large pleural effusions and empyema can cause lung collapse, sepsis, or impairment of lung function if left untreated. The probability of needing mechanical ventilation is further impacted by bruised lungs and postponed treatment, particularly if the infection triggered acute respiratory distress syndrome. With a guarded prognosis, recovery from multi-system failures like ARDS can be Early medical attention is crucial: It is necessary to seek medical attention as soon as possible. It has been shown that antiviral drugs such as oseltamivir (Tamiflu) work best when taken during the first 48 hours of symptoms. While rest, hydration, supportive care, and symptom monitoring are important, it's imperative to get medical help if symptoms initial line of defense is still vaccination: The annual flu shot has a new significance in a world where COVID-19 has changed everything. It is for the public as well as those at risk and the elderly. Vaccination can reduce the need for invasive operations and hospital stays when combined with early detection and medical treatment. Seasonal flu is more than just "the flu" these days. The clinical course is more severe and less predictable. Early symptom detection and timely medical evaluation could make the difference between a full recovery and an extended hospital to India Today Magazine
Yahoo
17-06-2025
- Health
- Yahoo
BioAegis Therapeutics Receives FDA Fast Track Designation for Lead Product, Recombinant Human Gelsolin, for the Treatment of Acute Respiratory Distress Syndrome (ARDS)
NORTH BRUNSWICK, N.J., June 17, 2025 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate, recombinant human plasma gelsolin (rhu-pGSN) for the treatment of acute respiratory distress syndrome (ARDS). The company's portfolio is built around gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function. What Fast Track Designation Means to BioAegis and PatientsThe FDA Fast Track program is designed to facilitate the development of new therapies for serious conditions with high unmet medical needs. Fast Track status enables more frequent interactions with the FDA, including rolling review of the marketing application, and eligibility for priority review, which can significantly accelerate time to market. For BioAegis, this designation highlights the therapeutic promise of rhu-pGSN and provides a clear regulatory pathway to expedite its development as a treatment for ARDS. ARDS is a life-threatening condition marked by severe pulmonary inflammation and fluid accumulation in the lungs. Even with aggressive medical management, 40% of ARDS patients do not survive, and those who do may suffer from long-term complications, including impaired lung function and reduced quality of life. In the U.S. alone, ARDS affects over 500,000 patients per year, or roughly 10% of all ICU admissions. With no effective pharmacological therapies currently available for ARDS and its high mortality rate driven by excessive inflammation, there is an urgent need for innovative treatments in this field. BioAegis is currently enrolling patients in a 600-patient global Phase 2b trial to evaluate the efficacy and safety of rhu-pGSN in moderate to severe ARDS (NCT05947955). As part of the Fast Track designation, rhu-pGSN may also be made available to patients through the FDA's Expanded Access or Compassionate Use program, offering a potential treatment option for those who are not eligible for clinical trials and have no alternative therapies. 'Receiving FDA Fast Track designation is a critical milestone for BioAegis and further validates the potential of gelsolin to address the urgent and unmet needs of ARDS patients. Despite the high mortality of ARDS and its major strain on our healthcare system, no approved treatments currently exist. Fast Track status brings us closer to delivering an effective therapy for this devastating condition,' states Susan Levinson, PhD., CEO of BioAegis Therapeutics. Gelsolin: A Multitasking Protein for Complex Inflammatory Conditions Gelsolin holds immense promise as a therapeutic intervention for serious acute and chronic conditions due to its multifaceted mechanism of action. In critical illness, gelsolin levels collapse, causing adverse outcomes. Supplementing gelsolin addresses this deficit directly—restoring immune balance while preserving host defense—and has been shown in both animals and humans to: Modulate the activation of the NLRP3 inflammasome. Enhance uptake and killing of microbial pathogens by innate immune cells. Bind to and remove harmful inflammatory mediators and toxic actin released from damaged cells. Regulate macrophage phenotype to modulate inflammation. Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated many inflammatory diseases without suppressing immune function. About BioAegisBioAegis Therapeutics Inc. is a NJ-based clinical-stage, private company whose mission is to capitalize on a key regulatory component of the body's immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation. BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women's Hospital. It holds over 40 patents issued for coverage of inflammatory disease, infection, renal failure, neurologic disease, and frailty. BioAegis will also have U.S. biologics exclusivity and has recently filed new IP in areas of unmet need. BioAegis' lead product, rhu-pGSN, is currently being studied in a 600-patient global Phase 2 trial for patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS). This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00067. Investor Inquiries:Steven Cordovano203-952-6373scordovano@ Media Inquiries:Christine Laganaclagana@ This press release contains express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management's plans, objectives, and strategies. These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are Sie sich an, um Ihr Portfolio aufzurufen.
Daily Mirror
04-06-2025
- General
- Daily Mirror
Woman who 'died' walked through 'hell' and 'met God in heaven'
Kathy McDaniel 'had no idea she was dead' during the whole ordeal A woman claimed that she journeyed through hell to meet God in heaven after being put into a three-week coma. Kathy McDaniel, speaking on the DEAD Talks Podcast, said that she still recalls everything that happened so clearly that it cannot have been down to her imagination. The mother was put into a medically induced coma after facing lung failure caused by an aggressive strain of flu back in 1999, which saw her fighting for her life. Upon recovery, she alleges to have found herself in a place she could only describe as hell. Even decades later, she vividly remembers the experience and shares her story to validate others who have had near-death experiences. Speaking on the podcast, she insisted her memory of the ordeal was still "as crisp as could be", adding: "To me, it proves it happened not in my brain but in my soul - and you can't turn the soul off." Raised Catholic, Kathy spent her childhood attending Catholic schools and Sunday church services. However, life struggles and traumas, including divorce and the loss of a baby, led her to question her faith in God. She asked: "I'm a nice person, why does this stuff keep happening to me?" She caught a severe strain of flu after caring for a friend who was ill in Seattle, reports the Express US. With alarming symptoms, she said: "I was coughing up blood... I could feel my life force draining out through my feet." A doctor diagnosed Kathy with ARDS - known fully as acute respiratory distress syndrome - a life-threatening illness that occurs when your lungs are severely compromised. Kathy, who was in her fifties at the time, was put into a drug-induced coma and given a mere 38% chance of survival. She had an experience that she says 'haunts her to this day' that started by 'waking up' in a "totally dark place". She described witnessing an eerie "reddish glow" which she initially mistook for a sunrise. However, she claimed this soon developed into a "pretty but weird" swirling fog that started getting "a little too warm" and began to give off a "really bad" smell. She said: "Then this voice just boomed out, scared me half to death and it said 'do you know where you are'. I'm thinking, and the only thing I can come up with is hell. The voice did this maniacal laugh and I just ran into the darkness. I didn't care if I hit a wall, fell in a ditch, that thing was going to get me so I kept running." Things then took a bizarre turn as Kathy found herself being transported to various strange places. She says these included a ruined city with collapsing buildings and a warzone before encountering what she describes as "a demon". She said the 'demon' offered her a "way out" if she completed a simple gardening task. Kathy claimed she "had no better offers" when she was handed "children's scissors" and was told to cut down seven-foot-tall blackberry bushes that would keep growing back. She then spent a considerable amount of time walking along a dirt road, with nothing around but the occasional pile of rocks. All the while, Kathy claimed she had "no idea [she] was dead" and mentioned in the podcast that she came across some of her living relatives during the journey she took. Kathy told the podcast host that she never experienced a flatline, indicating no physical death occurred. However, she said: "It's very common, and is accepted now in the groups that I belong to, that if you're in a coma, your consciousness can wander off." She said: "I started off in hell but ended up in the presence of God". During her experience, Kathy claims to have found "an architect's book" with a plan. She continued: "It was halfway open and I thought they were telling me something. I remember saying, 'that's going to be too hard' and then I saw my friend who had died the month before." She claimed that he had reversed in age from 53 to 35 and looked nothing like he did on his deathbed. Kathy said: "If he's dead, and I'm standing next to him, I must be dead too." Her friend informed her she had "too much left to do" and it wasn't long afterwards that she was "welcomed back to Earth". Kathy said that people who hear her story often deny it, believing that they "don't want it to happen to them". An astounding 5 to 10% of the general population are estimated to have memories of a near-death experience, claims Scientific American. Lots do report having interactions with God and getting a glimpse of the afterlife.
Yahoo
19-05-2025
- Health
- Yahoo
University of Bath develops wearable device for continuous heart monitoring
Researchers at the University of Bath in the UK have developed a wearable belt-like device that can continuously scan the lungs and heart, providing an alternative to traditional computed tomography (CT) scans. Worn around the chest, the device utilises ultrasound and functions similarly to a CT scanner. It was developed at the university in partnership with Netrix, a Polish technology company. According to the university, this device provides multiple images of the lungs, heart, and other organs over time, unlike a CT scan that captures a single image. This continuous monitoring can give doctors an understanding of a person's condition without needing repeated radiology visits or exposure to ionising radiation. The wearable employs ultrasound computed tomography (USCT) to produce real-time images via a skin-conforming sensor array positioned on the chest of a patient. It has been designed for patient comfort, featuring soft materials that are suitable for prolonged usage and wireless data transmission for integration with hospital systems. The device's usage extends beyond the hospital, with applications in remote monitoring for home care, especially for the elderly or those with chronic cardiopulmonary diseases. It could also help minimise healthcare expenses by eliminating needless hospital admissions through early detection. University of Bath's electronic and electrical engineering professor Manuch Soleimani said: 'This could fundamentally change how we monitor patients in critical care or post-surgical settings. 'The imaging quality of the device can be on par with an X-ray or CT scan, but instead of a single snapshot, we can monitor how the lungs and heart behave over time, which is far more informative when managing dynamic conditions." Clinical trials are in the planning stages to further refine the solution for regulatory clearance. Initial tests on healthy male volunteers have been concluded, with plans to include female participants with conditions such as acute respiratory distress syndrome (ARDS) in future studies. According to the research team, future enhancements may involve adding more ultrasound channels to improve image resolution and adapting the design for brain imaging in emergency settings such as stroke monitoring in ambulances. "University of Bath develops wearable device for continuous heart monitoring" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error 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
Yahoo
16-05-2025
- Business
- Yahoo
Q1 2025 Mink Therapeutics Inc Earnings Call
Jennifer Buell; Independent Director; Mink Therapeutics Inc Christine Klaskin; Independent Director; Mink Therapeutics Inc Operator Thank you for standing by. My name is Rosell, and I will be your conference operator today. At this time, I would like to welcome everyone to the MiNK Therapeutics first quarter 2025 financial results. After the speaker remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press start, followed by the number one on your telephone keypad. If you would like to withdraw your question, press start one again. I will now turn the conference call to Jack Jennifer Ball, head of investor relations, please go ahead. Thank you, operator, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including those related to our clinical development, regulatory and commercial plans, timelines for data release and partnership opportunities. These statements are subject to risks and uncertainties. Please refer to our SEC filings available on our website for a detailed description of these risks. Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer, and Christine Klaskin, principal Financial and Accounting Officer. Now, I'd like to turn the call over to Doctor Bell to highlight our progress from this quarter. Jennifer Buell Thanks very much, Jack. I appreciate it and thank you all for joining us today. This quarter we've made meaningful progress towards our mission, and that's delivering scalable, durable, off the shelf iNKT cell therapies to patients with solid tumors and other immune-related diseases. In the Q1 of 2025 we executed across three critical areas, and those include clinical progress. We presented new data in solid tumors, specifically in second line gastric cancer, at the inaugural AACR IO conference, and we showed immune activation and very early clinical activity and responses in patients who were otherwise refractory to checkpoint modulating the capital side, we continue to reduce our operating cash burn and operate extremely efficiently with a further reduction of about 47% year on year, preserving our ability to invest in our core programs. We've been able to continue to advance our clinical trials through external financing, and those include the advancement of our second line gastric cancer and also the development of two programs, one in ARDS and the other in GvHD, which I'll talk about in just a moment. We are advancing confidential discussions for proposals, each of which could extend our runway and accelerate our impact, and I'm going to go into those in some detail, just a as is core to our strategy, and it has been. It's essential to unlocking the full potential of our technology, our iNKT platform in oncology, in immunology, inflammatory diseases, and of course our next generation engineered cell therapy. Our platform is really broad and deep. It allows us to take full advantage of what these cells can do, and we remain at the forefront of advancing iNKT cell biology off the shelf in patients with immune-related today I'm pleased to share that we have 3 distinct proposals, each aligned with one of our key therapeutic areas in oncology and cancer. We're focusing on advancing 797 and solid tumor cancers, building on the momentum from our gastric and testicular cancer programs. I'll highlight a little bit more about some upcoming data in testicular cancer, but in the meantime, we did just recently present data at ACR that I'll share with you in a few on immunology and inflammatory conditions. This supports our development of iNKT cells in acute inflammation such as respiratory distress, as well as inflammatory conditions such as graft versus host disease, an area of great interest to our team. And a proposal on our next generation pipeline. This encompasses our car iNKT therapy, our TCR iNKT therapy, and our proprietary neo antigen discovery platforms with the aim of creating highly targeted off the shelf immune therapies. These transactions and proposals are not exclusive, in fact, given their distinct focus areas and complementary capabilities of these proposed partners. These proposals may be mutually reinforced reinforcing, each bringing differentiated capital, infrastructure, and scientific expertise to accelerate progress within their respective together, these proposals reflect strong external conviction in the value of our iNKT platform and represent a rare opportunity to diversify capital, reduce pollution, and accelerate development in multiple high impact areas for MiNK. We're engaging with focus and urgency and expect to advance one or more of these in the very near term. We'll continue to keep you abreast, and we plan to host a more formal presentation regrouping with our key stakeholders to be able to announce these in due I'm going to turn and highlight a couple of key elements of our programs and our progress to date. In solid tumors, we're particularly encouraged by the continued momentum in our solid tumor program, and as I mentioned at the ASCO GI and AACR IO inaugural meetings, we presented new data from our phase 2 investigator sponsored trial that's being housed at Memorial Sloan Kettering under the leadership of Dr. Yelena Janjigian, the chief of gastrointestinal study is evaluating HLA NKTs or agenT-797, in combination with two differentiated checkpoint modulating antibodies, botensilimab and balstilimab. On top of standard of care chemotherapy in patients with second line advanced gastric cancer. This is a population with no effective therapies in the second line setting. The data demonstrate that iNKT cells when delivered systemically, they rapidly traffic to the tumor microenvironment where they engage both innate and adaptive immune pathways. This is different than what you see with conventional T cells and NK cell activity, what we've observed is that we were looking at tumors that effectively were in immune desert. No CD8 T cells, therefore no ability to immunologically manage the cancer. And what we observed is upon systemic infusion of 797, we can transform a cold tumor into an immunologically active or hot tumor, promoting these very important CD8 T cells infiltration, activating dendritic cells and reversing immune exhaustion, and these are in cancers that are resistant to PD1 blockade. These findings support our core thesis. iNKT cells act as immunologic first responders, initiating multi-layered anti-tumor responses through direct tumor killing or cytotoxicity and immune orchestration. We anticipate sharing additional updated clinical updates later this year in the beginning of next parallel, we expect a peer reviewed publication describing a complete response in a patient with metastatic testicular cancer. This patient was treated on our phase 1 trial with 797, and they were treated with 797, or alloy iNKTs alone in this setting. The patient had progressed through platinum-based chemotherapy, autologous stem cell transplantation, radiation, and checkpoint and idget-based regimens prior to enrolling in the trial. Following a single infusion of agenT-797, the patient achieved a durable, complete clinical, radiological and biochemical remission. Treatment was delivered without lymph depletion or HLA matching and showed no evidence of cytokine relief syndrome or post treatment analysis reveals elevated interferon gamma. We're observing some robust tumor activity by immune effector cells, and we're also observing peripheral persistence. Our cells still continue to persist beyond 6 months, which give us a large therapeutic window to continue to dose these patients. This case exemplifies the unique biology of iNKT cells, their ability to rapidly ho to tumors, dismantle immunosuppressive barriers, and activate both NK and CD8 T cells. Even in tumors previously unresponsive to immune our gastric cancer findings, this finding reinforces iNKT cells as a novel, off the shelf immune therapy platform with the potential to deliver durable benefit and hard to treat solid tumors. Beyond oncology, we're continuing to advance 797 in immune-related diseases such as respiratory distress, acute respiratory distress syndrome, and graft versus host disease. Our INKP platform showed early on and continues to show compelling promise in immune-mediated diseases where inflammation, immune dysregulation, and poor treatment options converge to create really devastating clinical realities for ARDS, a life-threatening condition with no FDA approved therapies, AgenT-797 is shown the potential to change the treatment paradigm. As we published in Nature Communications and presented at the American Thoracic Society, our data demonstrated improved survival and meaningful inflammatory control and critically ill ventilated patients, many of whom would otherwise face mortality rates exceeding 70%. We, on the other hand, observed survival rates exceeding 70%, truly signals observed in a high-risk ICU population is a powerful indication of iNKT's steroid resistant anti-inflammatory activity and their ability to reduce secondary infections and their impact on pulmonary function and immune tonology. Consistent with the new leadership and priorities at the FDA, we are working urgently to make our therapies accessible through well-designed clinical trials, compassionate use programs, and accelerated development pathways that reflect the seriousness and unmet nature of these conditions. The agency's increased receptivity to novel immune-based approaches, especially in indications like ARDS, give us further confidence in our regulatory path graft versus host disease, we're prepared to initiate a phase 1 trial, a 797 of patients undergoing allergenic bone marrow transplant. We've spoken to you about this before, and as advancing this program has been in part contingent upon securing financing to be able to advance this really responsibly and efficiently. TBHC remains one of the most severe and unpredictable complications of transplants. Often leading to often leading to multi-organ damage, prolonged hospitalization, poor quality of life, and disease progression. Our iNKT approach, which requires no lymph depletion, no genetic matching, and poses minimal to no risk of GvHD itself, is uniquely suited for this setting. The trial will be supported primarily through external partnerships, allowing us to advance this high impact program with minimal capital reinforcing the momentum, we were recently selected for probable funding by the National Institute of Allergy and Infectious Diseases. We expect the formal award. We were recently notified just a couple of weeks ago that we expect the formal award by June. This would provide critical, non-dilutive funding and a strong endorsement from one of the world's most respected federal research agencies and with this award, MIC will launch a collaboration of pre-clinical and clinical research with our colleagues and scientific advisors at the University of ARDS and TVVHC represent a large underserved market where MP platform can deliver outsized impact. We remain committed to advancing these programs rapidly, guided by scientific conviction and a growing mandate to bring transformative immune-based therapies to patients in need. And on the operational efficiency side, we have been continuing to expand our work in the field by reducing and reducing operating burn. We have continued to retain our top scientific leaders. We continue to internalize operational execution of our programs, including data management and clinical research activities which has allowed us to operate far more efficiency in a far less capital-intensive actions further reflect our commitment to financial discipline and operational focus. With that, I'll turn the call over to Christine for a review of the financials. Christine Klaskin Thank you, Jen. We ended the quarter with a cash balance of USD3.2 million cash used in operations for the three months ended March 31, 2025, was USD1.3 million. This is reduced from USD2.5 million for the same period in 2024. Our net loss for the first quarter of 2025 was USD2.8 million or USD0.70 per share. This compares to USD3.8 million or USD1.10 per share for the first quarter of 2024. Thank you. And operator, we are now ready to take questions. Operator At this time, I would like to remind everyone in order to ask a question, press star, then the number one in your telephone keypad. We will pause for just a moment to compile the roster. Your first question comes from the line of Emily Bodnar with HC Wainwright. Please go ahead. Hi, good morning. Thanks for taking my questions. This first one on the testicular patient. Congrats on the CR there. Are you able to say how long after treatment was initiated that the CR was observed and if you can comment on, I guess your overall plan in testicular cancer going forward and if there's any other indication that you're still looking at. Jennifer Buell Emily, thanks for the question, and this is this publication is expecting out somewhat imminently, and that information will be in the publication, but I can share with you this is a unique case and it exemplifies the value of immune therapy. It's not surprising that in the 12 month follow up period, the patient actually had disease stabilization, and we were monitoring the patient and not less than a year after that, so 24 months, the patients came back in to see the PI of the study with a complete remission and no other treatment. So this patient had been treated by the investigator, continued his clinical treatment with the investigator clinical observations, with no additional treatment put into the patient after the single infusion. And the complete response was formally designated at month 24 after the initial treatment of in addition, the patient had multiple lesions. The disease was really quite widespread, and you'll see this outlined in the paper and what was really quite intriguing was disease reduction really in all of the lesions, including the liver, and that's a very important biomarker for us. We are seeing activity by NKTs in active disease in the liver. We've observed this in our phase one study, we've also observed it in our gastric cancer trial, and now we've observed it with this testicular cancer patient has a lung mat that appears to be indolent at this point, that he does not want to undergo a biopsy, but the disease appears to the nodule appears to have nothing but dead tissue. Based on all of the scanning that has been completed. So we're really quite enthusiastic about this, and it has encouraged us to continue to do another survival sweep and clinical interrogation of other patients on the trial. What we found to be most intriguing when we presented the data, we presented essentially with a median of 12 months of follow up and we had some responses in the trial, but predominantly we saw long-term disease stabilization and this includes in patients with pancreatic cancer, non-small cell lung cancer appendiceal and gastric. But in those observations when we stopped the, we concluded the follow up period of the trial, we may be underestimating the ultimate clinical benefit of iNKT cells. So, we'll be getting a further clinical sweep of these patients and updating the field on the findings. Okay, great. And on the phase two gastric trial, are you still kind of on track for initial efficacy data in the second half of this year? Jennifer Buell That's what we're on target to do. They're continuing to enroll, and we'll be in touch with Dr. Janjigian about the soonest presentation. So we are, we have been looking at some GI specific conferences as well as some of the major oncology conferences for an update and a clinical presentation. It's ultimately within her discretion, so it will be no later than early next year. That would be the latest, but we're still on track. We're still targeting to get something out by the end of this year. Okay, great. Lastly, I'm just curious in terms of the funding that you mentioned from the NAYA if you've kind of heard of any changes or delays in government funding just with all this new news lately. Jennifer Buell Well, I'm with you. We, so we had heard of a delay. We expected this at the beginning of the year. So, the 6-month delay is, the delays that we have seen globally have impacted us. However, we're, we were reassured to get a formal notification from NAYA that we can expect to hear that we had probable funding and can expect to hear conclusively in June. NAYA has not been as heavily impacted as some of the other agencies, and so this for us is a high priority for the government and for the agency graft versus host disease, and our technology presents a really novel way of addressing this problem with engraftment success and reduction in GvHD and better clinical outcomes. So, we're optimistic and the most recent correspondence from the government continues to boost our optimism. Okay great. Thanks for taking the questions. Thank you. Operator Again, if you would like to ask a question, press star one in your telephone cable. Your next question comes from the line of Max with William Blair. Please go ahead. And, one, thanks for the update, wondering if, maybe just go over some of the details of the GVAC trial. Are you still planning on booking acute patients and maybe any thoughts on kind of prior treatments or what type of patients you'll be looking to enroll. Jennifer Buell Yeah. Thanks so much, Matt. So, there are two places where we will ultimately be setting into GvHD, and the first with this financing support and with the priority at University of Wisconsin to bring this forward, and this is under the leadership of Jenny Gumpers, who's a scientific advisor and wrote the seminal paper on the mechanism of iNKTs and GvHD. The opportunity for us in steroid refractory acute GvHD represents a very fast path forward. That's what we have identified and developed a phase one program for that. We have also developed a phase one program for prophylaxis, and that's engraftment success and a reduction in GvHD. And in that disease setting, we have a pathway that may be even faster. Both of these will be going to the regulators for a discussion with them imminently. And then we will choose the priority program to advance, but both opportunities for us, I'm going to have Tiago Favano, who's been working with the investigators in the clinical development of this speak just a little bit more to the enrichment that we're planning at this time. Hi, thanks for your question. So, for the phase one, we're going to explore not only the GvHD but also a few other complications of transplants that still represent an unmet need even though we do have available treatment. And drugs for prevention, but the other effects, they still represent unmet needs. So based on prior robot literature and some of our own studies, we expect the Ng not only to prevent or combat GvHD, but also to prevent infections, contribute to a better engraftment, faster and better engraftment. And and also prevent maintaining leukemia effects to prevent disease relapse. So we all know that on the treatment of GvHD patients get immunosuppressed and that makes it easier for them to have relapse or infections, which is a major we in this phase one, we are going to observe all these other effects on top of preventing the GvHD. Which paved the way for phase 2 that Jen explained, we will explore in treatment of steroid refractor GvHD and then another opportunity in prevention which represents an even faster way for approval. Jennifer Buell Thanks. And then, I'm going to add something to this. The, there are two things happening in parallel. One is the funding opportunity and if the award is as we anticipate it will be, which is the full committed funding, then we will have an opportunity to in our own hands, interrogate both prophylaxis, as well as mitigation in steroid refractory patients. And so that's why we've developed two programs to be able to do that. In the case that we can fund independently with the grant funding one program, there's a strategic collaborator who's at the table right now and has shared a proposal with us to advance the other, which is the prophylactic study. Okay, thanks for your please, Jen. Jennifer Buell Thank you, Matt. Operator That ends the session. I will now turn the call back over to Jennifer Buell for closing remark. Please go ahead. Jennifer Buell Thank you, operator. Thank you all for joining us today. We look forward to interacting with you in the upcoming days. Operator Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect. 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