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NoneNew reliever Jordan Romano ready to go ‘electric’ for Phillies
OWINGS MILLS, Md. (AP) — Fresh off one of its best showings of the season, the Baltimore defense now has another problem to worry about. Roquan Smith missed practice again Friday because of a hamstring injury. Although the Ravens didn't officially rule him or anyone else out — they don't play until Monday night — the All-Pro linebacker's status seems dicey. “Definitely it will be a challenge if Roquan can’t go,” defensive coordinator Zach Orr said. “We’re holding out hope and everything like that. I think it’ll just be by committee. Not one person is going to replace Roquan. Roquan’s an every-down linebacker.” Although the Ravens lost 18-16 last weekend, Baltimore didn't allow a touchdown. That was an encouraging sign for a team that ranks 26th in the league in total defense. Baltimore is on the road Monday against the Los Angeles Chargers. The Ravens appear to have dodged one potential nightmare. Star safety Kyle Hamilton injured an ankle against Cincinnati on Nov. 7, but he was able to play almost every defensive snap the following week against Pittsburgh. But Smith was injured in that game and didn't practice Thursday or Friday. Linebacker Malik Harrison had a season high in tackles last weekend and figures to have a significant role if Smith can't go. “We tell these guys, ‘You’re one play away to going in there — you never know, so you got to stay ready.’ Malik — he was ready,” Orr said. “I thought he went in there and did a good job, especially after the first series, he settled down. That’s what we expect from him.” It's hard to tell whether last week can be a significant turning point for Baltimore's defense. The Ravens allowed only 10 points in a dominant win over Buffalo in Week 4, then yielded 38 against Cincinnati the following game. After allowing 10 against Denver, the Ravens were picked apart by the Bengals again a few days later. So they still haven't shown they can play a good game defensively and then build on it. “I think it’s easier said than done. It’s something that we kind of got caught up saying against Buffalo and then coming up the next week and not doing," Hamilton said. "We’re aware of it now and know that we played a good game, but I think we can get a lot better, and I think that’s kind of the mindset everybody on defense has right now.” Hamilton's ability to make a difference all over the field is part of what makes him valuable, but positioning him deep is one way the Ravens can try to guard against big passing plays. Pittsburgh's Russell Wilson threw for only 205 yards against Baltimore. That's after Joe Burrow passed for 428 and four touchdowns in the Ravens' previous game. “I’ve always seen myself as a safety. A versatile one, but at the end of the day, I think I play safety,” Hamilton said. “If I’m asked to go play safety, I feel like that’s not an issue for me to play safety if I’m a safety.” NOTES: In addition to Smith, WR Rashod Bateman (knee), DT Travis Jones (ankle), S Sanoussi Kane (ankle) C Tyler Linderbaum (back) and CB Arthur Maulet (calf) missed practice Friday. WR Nelson Agholor (illness) returned to full participation after missing Thursday's practice. AP NFL: https://apnews.com/hub/NFLKarl-Anthony Towns' stellar performance against the Rockets leaves Jordyn Woods in awe, latter shows support online while slaying at Hollywood movie premiere
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New reliever Jordan Romano ready to go ‘electric’ for Phillies
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NoneThe Phase 1b study will evaluate LV UNO in unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic solid tumor cancer patients that have progressed or have prolonged stable disease on single agent PD-1 inhibitors The primary objective of the Phase 1b study is to assess preliminary efficacy by objective response rate (ORR) and duration of response (DOR) per RECIST version 1.1 and secondarily immune-related response via iRECIST The study will recruit patients from four sites across Israel HAMILTON, Bermuda, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Beyond Cancer, Ltd., a clinical-stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, today announced that the Israeli Ministry of Health (IMOH) has approved the use of Low Volume UNO (LV UNO) in a Phase 1b clinical trial of LV UNO in combination with anti-PD-1 therapy. The trial will be conducted at four sites in Israel and patient screening will begin in the first quarter of 2025. The Phase 1b trial (NCT05351502) is a clinical proof-of-concept trial that will assess the intratumoral administration of LV UNO in patients with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions, who have shown disease progression or prolonged stable disease (≥ 12 weeks) after receiving a single agent anti-PD-1 containing treatment. The trial, which is expected to enroll up to 20 subjects, is designed to assess the preliminary efficacy of LV UNO by objective response rate (ORR) and duration of response (DOR) per RECIST v1.1 and secondarily immune-related response via iRECIST. Safety and tolerability of LV UNO in combination with anti-PD-1 therapy, as well as its potential to enhance the type, density, and distribution of immune cells within the tumor microenvironment will also be observed. Topline data from the Phase 1b portion of the study are anticipated in the second half of 2025. “We are excited to initiate the Phase 1b trial of LV UNO, a potentially groundbreaking solid tumor treatment approach, in combination with PD-1 inhibitors,” said Dr. Jedidiah Monson, Chief Medical Officer of Beyond Cancer. “In preclinical studies, a single dose of UNO has been shown to increase PD-L1 expression and improve overall survival in animal models compared to anti-PD-1 alone. Further, Phase 1a human data that demonstrated immune system activation were presented at ASCO’s Key Opinion Leader Event held in June 2024. We look forward to the Phase 1b trial results to establish the basis of further investigation of UNO in combination with PD-1 inhibitors.” “The initiation of the Phase 1b trial represents a major step forward in our vision for personalized cancer treatment. We see UNO as a complementary therapy for future cancer treatment paradigms, particularly for patients with anti-PD-1 refractory or resistant disease, potentially offering more patients access to effective treatment,” stated Dr. Selena Chaisson, Chief Executive Officer, and Director of Beyond Cancer. About Nitric Oxide Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens. About UNO Therapy for Solid Tumors Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease. In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models. Beyond Cancer, Ltd. believes that UNO has the potential to prevent relapse or metastatic disease with as little as a single 5-minute treatment and with limited toxicity or off-target effects. About Beyond Cancer, Ltd. Beyond Cancer, Ltd. is a development-stage biopharmaceutical and medical device company utilizing ultra-high concentration nitric oxide (UNO) via a proprietary delivery platform to treat primary tumors and prevent metastatic disease. Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer. A first-in-human study is underway in patients with solid tumors. Beyond Cancer is also conducting preclinical studies of UNO in multiple solid tumor models to inform additional treatment protocols. For more information, visit www.beyondcancer.com . Forward Looking Statements This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks forward,” “projects,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials concerning the ultra-high concentration nitric oxide product candidate; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for the ultra-high concentration nitric oxide product candidate; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; obtaining, maintaining and protecting intellectual property utilized by products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air, Inc.’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air, Inc.’s website. Beyond Cancer and Beyond Air undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law. CONTACTS: Corey Davis, PhD LifeSci Advisors, LLC Cdavis@lifesciadvisors.com (212) 915-2577 Matt Johnson, Head of Corporate Development & Strategy Beyond Cancer, Ltd. Mjohnson@beyondcancer.com