Digital Asset DirectContext Therapeutics
Contact Details Proactive Investors USA Proactive Investors USA +1 347-449-0879 na-editorial@proactiveinvestors.com
December 06, 2022 03:40 AM Pacific Standard Time
Video
News ReleaseUnited Network for Organ Sharing
On Monday, Interim CEO of United Network for Organ Sharing (UNOS), Maureen McBride, Ph.D., addressed the Organ Procurement and Transplantation Network (OPTN) Board of Directors and called for the donation and transplant community to address public concerns by expanding ongoing efforts to improve the U.S. organ donation and transplant system. “Our national donation and transplant system saves thousands of people’s lives every year. But as long as there are patients on the waiting list, there is more we need to do,” said Dr. McBride. “Our critics agree – they have been vocal. Our supporters, too, have offered constructive feedback. … Here is where we all agree: We can do better. We must do better. We will do better.” Dr. McBride outlined several areas for improvement, including organ utilization and transportation, equity in access to the waitlist, oversight and coordination with the government, technology and patient engagement. “It’s clear that each year, too many donated kidneys never find a recipient, and that number is growing,” said Dr. McBride. “This is unacceptable.” Acknowledging previous board work to improve organ utilization – including implementing recommendations from the National Kidney Foundation’s Consensus Conference to Decrease Kidney Discards – Dr. McBride stated that the OPTN must seek additional opportunities to address the issue. Suggested actions included examining methods to increase usage of older and more complex donor organs as well as prioritizing discussions and potential solutions for safe and efficient organ transportation. “Practical, logistical, and regulatory obstacles to the safe and efficient delivery of donor organs should be identified, remedied, and monitored,” said Dr. McBride. Dr. McBride went on to address issues of inequitable patient access to the organ transplant waitlist. While the OPTN has the data and resources to maintain equitable services for waitlisted patients, there remains a challenge in helping pre-waitlisted patients, whose needs and data currently fall outside of the OPTN’s purview. “I am committed to seeking HRSA’s continued support for access to the data,” said Dr. McBride. “In my view, it is time for us to take bigger, bolder steps to increase equity across the entire donation and transplant landscape, not just one part.” Dr. McBride also acknowledged system improvement efforts by lawmakers and members of Congress, including the U.S. Senate Committee on Finance, expressing her belief that oversight should include all members of the donation and transplant system. “In August, the Senate Finance Committee stated that ‘Everybody wants this system to work with as few errors as possible.’ We completely agree,” said Dr. McBride. “My vision for the OPTN is one in which we work alongside, closely and collaboratively, with members of Congress, HHS, HRSA, CMS and others in the federal government to do the hard work of driving change and instituting substantive reforms.” Noting OPTN technology as another focus of congressional attention, Dr. McBride spoke of the need to match public expectations and continuously evolve IT and other technologies that the system relies upon. “We stand ready to alleviate those concerns, serve as a resource and engage in one-on-one conversations to provide assurances – to HHS and Congress, patients, and the general public – that our systems remain secure and effective.” Lastly, Dr. McBride addressed the importance of patient engagement, referencing feedback from patient representatives that their input might have limited impact on board decisions and that non-volunteer patients require more comprehensive information to help them or their loved ones. “We will commit to ensure you have the support you need to make a meaningful contribution and that you feel you are heard and valued,” said Dr. McBride. “For patients not yet involved in the OPTN policy process, I’ve heard that they want an easy-to-access source of information – content and resources that will help them on their transplant journey … Work already is underway to offer more educational resources to meet those needs.” Stressing that each topic of concern aligns with ongoing initiatives to better serve the donation and transplant community, Dr. McBride urged the OPTN Board of Directors to join her in seeking these improvements. “I am calling on everyone in this room … to work with me to make these changes,” said Dr. McBride. “All of us have worked very hard to drive significant progress to date and we all are committed to doing even more. This is our profound responsibility – one we can never take lightly.” Dr. McBride was appointed Interim Executive Director of the OPTN in October. She has been with UNOS since 1995, most recently serving as the organization’s Chief Operating Officer until she accepted the role of Interim CEO. A copy of Dr. McBride’s remarks can be found here. About UNOS United Network for Organ Sharing (UNOS) is a non-profit, charitable organization that serves as the Organ Procurement and Transplantation Network (OPTN) under contract with the federal government. The OPTN helps create and define organ allocation and distribution policies that make the best use of donated organs. This process involves continuously evaluating new advances and discoveries so policies can be adapted to best serve patients waiting for transplants. All transplant programs and organ procurement organizations throughout the country are OPTN members and are obligated to follow the policies the OPTN creates for allocating organs. Contact Details Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org
December 05, 2022 01:03 PM Eastern Standard Time
Digital Asset DirectOxford Cannabinoid Technologies Holdings PLC
Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
December 05, 2022 09:38 AM Eastern Standard Time
Video
News ReleaseBruush Oral Care Inc.
Read The Latest Report About Brüush. Brüush Oral Care Inc. (NASDAQ: BRSH) is back - after a strong Thanksgiving weekend, the leading electric toothbrush company announced record revenue, with over $500,000 of revenues for the month of November, representing year-over-year growth of over 50%. The long, post-Thanksgiving weekend stretching from Black Friday to Cyber Monday is a frenetic time for shops and shoppers alike. Spending totaled $188 billion in 2020, and with things back to normal this year, consumer activity is returning to pre-pandemic levels. In response to modern consumer needs, much Black Friday sales activity has moved online - with a record-breaking $9.12 billion spent online this year - and Brüush is riding this digital market wave. The Vancouver-based toothbrush company, boasting a cutting-edge product and strong online presence, saw one of its strongest weekends of sales in company history this Thanksgiving. Brüush sells top-of-the-line electric toothbrushes and is looking to become a leader in an oral care market worth $33.7 billion. The company, which already has a big smile over its partnership with comedian Kevin Hart, is delighted with this significant weekend of sales and record numbers of Brüush subscriptions and individual purchases. Brüushing Ahead This Black Friday Brüush can be proud of a strong weekend with record revenue from sales that provide significant growth for the company. The company believes that it is poised to become a leading provider of oral hygiene products going forward. As well as its strong individual kit sales, the company saw a boom in its subscription service, with 35,000 subscribers versus 28,000 before its IPO in August. The company’s individual toothbrush kits come with an electric brush and 3 replaceable heads, while its highly affordable subscription service provides 3 replacement heads every 6 months for only $21.60. Brüush’s mid-range pricing - with kits starting at only $80 - makes its brushes an attractive option compared with competitors. These include electric brushes from Oral B, owned by Procter and Gamble (NYSE: PG) and Koninklijke Philips ’ (NYSE: PHG) product, Sonicare. Along with its affordable price tag, Brüush offers a premium product that it claims gives the best teeth cleaning in the market. The Brüush brushes at 42,000 strokes per minute - compared with the average electric brush that brushes just 30,000 times - and removes over 20% more plaque than a manual brush. Its batteries last an industry-leading 4 weeks on a single charge, and the brushes have a 2-year warranty, though the company is confident it won’t be needed. The mid-range prices that provide top-quality oral hygiene results - along with savvy digital marketing - make Brüush popular among millennials, with 18-45-year-olds forming the largest segment of the company's customer base. Building on its resounding Thanksgiving successes, Brüush reports it will be launching a range of oral hygiene products in 2023 to complement its toothbrushes, including a line of toothpaste, floss, mouthwash, and more. Want to read more about Brüush? Visit its website. About Bruush Oral Care Inc. Bruush Oral Care Inc. is on a mission to inspire confidence through brighter smiles and better oral health. Founded in 2018, Brüush is an oral care company that is disrupting the space by reducing the barriers between consumers and access to premium oral care products. The Company is an e-commerce business with a product portfolio that currently consists of a sonic-powered electric toothbrush kit and brush head refills. Brüush has developed a product to make upgrading to an electric brush appealing with three core priorities in mind: (i) a high-quality electric toothbrush at a more affordable price than a comparable electric toothbrush from the competition; (ii) a sleek, countertop-friendly design; and (iii) a convenient brush head refill subscription program that eliminates the frustrating experience of purchasing replacement brush heads at the grocery/drug store. The Company is rooted in building a brand that creates relevant experiences and content, with the goal of becoming the go-to oral care brand for millennials and Generation Z.For more information on Bruush Oral Care Inc visit https://bruush.com. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details TraDigital IR - Colette Eymontt colette@tradigitalir.com Company Website http://www.tradigitalir.com
December 02, 2022 11:15 AM Eastern Standard Time
News ReleaseBriaCell Therapeutics Corp.
The world of biotech is having what some are calling a golden age. Many companies are presenting new and innovative drugs to the FDA for approval and later the public for consumption. Smart Beta EFTs like SPDR S&P Biotech (NYSEARCA: XBI) (“XBI”) and iShares Biotechnology (NASDAQ: IBB) (“IBB”) are bringing a lot of awareness and attention to the field for investors to get excited about. BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”) presented positive initial efficacy data in its 2021-2022 cohort of 12 advanced breast cancer patients for its clinical study of Bria-IMT™ immunotherapy treatment during the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting. Breast cancer is still one of the deadliest cancers globally. Each year in the U.S. there are about 264,000 new diagnoses and about 42,000 women and 500 men die each year from breast cancer. The average risk that a woman will develop breast cancer sometime in her lifetime is around 13%. For certain populations that risk is higher; breast cancer is the number one cause of cancer death for Hispanic women. BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. BriaCell’s lead candidate Bria-IMT is marketed as an off-the-shelf personalized cellular approach to immunotherapy for the treatment of advanced solid tumors. The targeted patients are advanced breast cancer patients or terminal breast cancer patients. The Bria-IMT™ study showed disease control, tumor shrinkage, and potential survival benefits among 12 patients in Phase I/IIa when in combination with Incyte’s retifanlimab. 70% of patients showed either disease control or progression-free survival benefits compared with their previous therapy attempts. Prior to the BriaCell study, the 12 patients had each failed at least 2 previous attempts at therapy regimens like chemotherapy or “targeted” therapy. The Bria-IMT clinical success is arguably even more impressive with this in mind. “We are very pleased to report that our combination therapy with Incyte’s retifanlimab produced clear evidence of tumor shrinkage and showed potential survival benefit in heavily pre-treated advanced breast cancer patients,” stated Dr. William V. Williams, BriaCell’s President & CEO. “We interpret these results to offer a potential opportunity for treatment in otherwise terminal patients. It’s very important to emphasize that these responses and clinical benefit occurred in women with advanced-stage breast cancer who have exhausted other treatment options.” What Else Does BriaCell Have In The Pipeline? BriaCell also reports it is currently developing next-generation off-the-shelf personalized immunotherapies targeting patients with advanced breast cancer and advanced prostate cancer. Bria-OTS+™, for advanced breast cancer, and Bria-PROS™, for advanced prostate cancer, are designed to activate naïve T cells and produce a strong immune response in patients. The company is impressed with the current data showing the ability of Bria-OTS+™ and Bria-PROS™ to boost the immune system response and produce strong anti-tumor responses in patients with advanced cancers. BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details CORE IR investors@briacell.com Company Website https://briacell.com/
December 02, 2022 10:00 AM Eastern Standard Time
News ReleasePatient Safety Authority
A finger amputation while opening a wheelchair prompted the Patient Safety Authority (PSA) to issue a Safety Alert about wheelchair-related finger injuries. The alert warns the public and healthcare facilities to be vigilant when unfolding or sitting in the device. Hundreds of wheelchair-related injuries have been reported nationwide into the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) reporting system. Improperly opening a folded wheelchair can cause finger injuries, including amputation, bone fractures, nail loss, cuts, crushing, and pinching. Some reported injuries occurred when users placed their hand on the seat to open the chair. Others happened when the user tried to sit in the chair to unfold it. Wheelchairs are one of the most common assistive devices used in healthcare facilities, as well as malls, airports, arenas, courthouses, houses of worship, and other public buildings. They are often opened by volunteers, untrained staff, the users themselves, or their family members. Anyone who operates a wheelchair should read and understand the manufacturer's instructions before use. Wheelchairs are deceptively simple “The big challenge is that wheelchairs seem so simple to use. Yet, there are so many different types of chairs that there isn’t a one-size-fits-all way to open them properly,” notes PSA Patient Safely Liaison Molly Quesenberry, whose research led to the Safety Alert. "You really need the manufacturer’s instructions.” “Despite being an RN, I was never personally trained on how to unfold a wheelchair properly. I never realized the danger of losing a finger by improperly unfolding a wheelchair.” She recommends that facilities consider replacing folding wheelchairs with rigid frame ones or using an anti-fold device to keep them open, if available. PSA has also created a warning tag to urge the public to ask for assistance with a folded wheelchair and disseminated it to all Pennsylvania healthcare facilities. https://patientsafetyj.com/index.php/patientsaf/article/view/wheelchair-risks/wheelchair-tags Four additional wheelchair safety tips Check that the brakes are locked before sitting down in a wheelchair Use proper hand hygiene before and after use to decrease your risk of infection and illness Use extreme caution when considering buying used equipment Ensure seats are fully engaged before allowing someone to sit in the wheelchair “Wheelchairs are readily available from second-party vendors, such as Facebook Marketplace and EBay, but the safest choice is to purchase from a medical equipment company,” advises Quesenberry. “Get proof that it has been inspected and maintained and that the original manufacturer instructions are included.” Pennsylvania is the only state that requires healthcare facilities to report harmful events, as well as those that do not result in patient harm (i.e., near misses) but may be a harbinger of a potentially serious problem. The reports are collected in the Pennsylvania Patient Safety Reporting System (PA-PSRS), the largest repository of its kind in the United States. The PSA analyzes those events, facilitates widescale performance improvement projects, and shares the information globally. The PSA is an independent state agency that collects and analyzes patient safety data to improve safety outcomes and help prevent patient harm. http://patientsafety.pa.gov/ About PSA Established under the Medical Care Availability and Reduction of Error (MCARE) Act of 2002, the PSA, an independent state agency, collects and analyzes patient safety data to improve safety outcomes and help prevent patient harm. http://patientsafety.pa.gov/ Contact Details Bev Volpe +1 609-230-4696 bev@madisongall.com Company Website http://patientsafety.pa.gov/
December 02, 2022 09:45 AM Eastern Standard Time
Image
News ReleaseEnlivex Therapeutics, Ltd.
On November 13, Enlivex (NASDAQ: ENLV) announced that the first patient has been dosed in its Phase I/II clinical trial of Allocetra. The novel off-the-shelf cell therapy is designed to help break through the immune-suppressing tumor microenvironment – a key roadblock rendering potent immunotherapies less effective against solid cancers – to render those tough-to-treat cancers more responsive to these treatments. After a growing body of preclinical data demonstrated Allocetra’s potential to prolong survival duration and increase survival probability in mice, the Phase I/II studies are an important next step in evaluating their efficacy in humans. Immunotherapies Tap the Body’s Own Cancer-Fighting Capabilities – But Solid Cancers Remain Resistant As the field of immunotherapy makes strides, solid tumors continue to elude these novel treatments largely due to their complex and ever-adapting “tumor microenvironments.” These microenvironments leverage a range of immune-suppressing mechanisms that counteract the potent effects immunotherapies have had on skin and blood cancers. Chimeric Antigen Receptor (CAR)-T therapies, for example, have demonstrated a success rate as high as 90% for refractory B lymphocytic leukemia but as low as 17% for solid cancers. Novartis AG ’s (NYSE: NVS) Kymriah, the first CAR-T therapy to receive approval from the Food and Drug Administration, has since shown a durable remission and long-term survival rate, with as many as 55% of treated patients still alive more than five years later compared to the standard disease prognosis of 10% to 25%. The reason for this difference is largely due to the range of mechanisms tumors use to resist or evade the immune system including disguising themselves as healthy cells, releasing immune suppressing signals, and blocking immune cells from getting into the core of the tumor. The more the tumor grows, the stronger these immunosuppressive mechanisms get – making it harder for the immune system to detect it. This makes tumors some of the least responsive cells to immunotherapies of all kinds as that microenvironment counteracts the effects of the treatment. Even in cases where tumors do initially respond to the drug, they adapt to resist it and the once-helpful immunotherapy is rendered ineffective. Allocetra TM Uses Cell Reprogramming to Simultaneously Weaken Tumor Microenvironments and Strengthen the Immune Response Enlivex’s lead drug candidate, Allocetra TM, was developed as an off-the-shelf cell therapy that reprograms macrophages, the immune cells responsible for killing infected or harmful cells in the body. In cancer patients, macrophages often become reprogrammed out of their homeostatic state of relatively stable equilibrium so that they not only stop recognizing tumors as harmful but become weaponized by cancer to fend off other immune cells trying to attack the tumor. This reprogramming is a key mechanism of the resistance that cancer develops against immunotherapies. So the goal with Allocetra is to introduce healthy donor cells that have been modified with an “eat me” signal on their surface to trigger the non-homeostatic macrophages to engulf them. Once eaten, the donor cells are able to bring those macrophages back to a homeostatic state. Early preclinical results show that this process, on a stand-alone basis, is enough to increase survival duration and overall survival in mice with solid cancers similarly to current FDA-approved immune checkpoint inhibitors (anti-PD1 like Merck & Co Inc. ’s (NYSE: MRK) Keytruda, BMS’s Opdivo and Yervoy). But even more impressive was the synergistic effect of administering Allocetra in combination with these immune checkpoint inhibitors, which led to up to 100% complete remission of the cancer in the mice. The Start of Human Trials Marks a Key Milestone in Allocetra’s Development The next step for this new cell therapy is to test whether these promising preclinical results will translate to human studies. This month, Enlivex initiated a Phase I/II trial to do just that. After receiving approval from the Israeli Ministry of Health in October, Enlivex began dosing the first patients in the trial in November. The trial will enroll up to 48 patients with advanced solid tumors to evaluate the safety and tolerability of Allocetra as well as its preliminary efficacy, as measured by overall response rate and survival. Patients will be divided into two groups – stage one and stage two – with stage one patients receiving escalating doses of Allocetra as a standalone treatment while stage two patients will receive three injections of Allocetra combined with an anti-PD1 checkpoint inhibitor. As Enlivex enrolls more patients into the trial in 2023, it hopes to have top-line Phase I/II data by the second half of the year. As part of a new generation of companies representing the future of cell therapy – off-the-shelf, highly scalable and low COGS “beyond CAR-T” cell therapies – Enlivex is focused on a highly differentiated novel immunotherapeutic mechanism – macrophage homeostasis. Macrophage homeostasis is severely disrupted by certain diseases states, and such imbalance is critical to the progression of the diseases. Allocetra has the potential to introduce highly-effective, low-cost allogeneic cell therapies for life-threatening clinical indications that are defined as "unmet medical needs", including sepsis – one of the leading causes of mortality, and oncology, through restoration of macrophage homeostasis. Enlivex is led by a seasoned management team who founded PROLOR Biotech and led it to a successful $560 financial exit and a partnership with Pfizer. PROLOR’s lead product, now named NGenla® by Pfizer, recently received marketing approval in Australia, Canada, Japan and the EU. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA TM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA TM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. Contact Details Shachar Shlosberger shachar@enlivexpharm.com Company Website https://enlivex.com
December 02, 2022 08:00 AM Eastern Standard Time
News Release500NewsWire
CHARLOTTE, N.C. December 1, 2022 ( 500NewsWire )– Firebirds Wood Fired Grill is making the holidays easy this year with its complete Holiday Feast available for pre-order through Saturday, Dec. 17. Meals will be scheduled for pick up on Friday, Dec. 23 or Saturday, Dec. 24. Firebirds will be closed on Christmas Day, December 25. The award-winning contemporary polished restaurant is offering a Prime Rib Holiday Feast at participating restaurants and while supplies last. The Holiday Feast is generously portioned and serves up to six people. “While Firebirds is closed on Christmas Day so our staff can enjoy the holiday, we have prepared a ToGo prime rib feast with sides, dessert and other selections that will make your holiday meal a memorable one,” said Chef Steve Sturm, senior vice president food and beverage at Firebirds Wood Fired Grill. Orders can be easily made at firebirdsrestaurants.com or taken over the phone. Firebirds makes curbside pick-up quick and convenient on Friday, Dec. 23 from 11 a.m. - 9 p.m., and on Saturday, Dec. 24 from 9 a.m. - 4 p.m. at Firebirds Wood Fired Grill locations. Delivery is unavailable for this limited time offering. Additional specialty side items are available with the purchase of a Holiday Feast, and cooking instructions are included with each order. In addition, Firebirds is offering a holiday gift card promotion. For every $100 in gift cards purchased in-store or online, guests will receive $20 in “bonus cards.” For more information visit firebirdsrestaurants.com/gift-cards/. This special offer is available now through December 31 st and “bonus cards” are valid for redemption from January 1 – February 9, 2023. Firebirds’ Holiday Feast serves up to six people, priced at $199.95, and includes the following (while supplies last): Holiday Feast · Prime Rib with au jus & horseradish sauce · Parmesan Mashed Potatoes · Salad (choice of Mixed Greens, BLT or Caesar) · Asparagus with Roasted Garlic Thyme Butter · Bread and whipped Butter · Pineapple Brown Sugar Cake Add On Side Items (for an additional charge, with the purchase of a Holiday Feast) · Family Size Killer Mac and Cheese · Family Size Lobster Mac and Cheese · Chicken Tenders Tray · Pineapple Brown Sugar Cake · Baked French Toast with Fresh Berries About Firebirds Wood Fired Grill Firebirds Wood Fired Grill, a polished casual American restaurant, is an energetic twist on the traditional grill featuring a boldly flavored menu in a stylish, fire-centric atmosphere. Signature menu items include hand-cut steaks and fresh seafood filleted in-house and seared over locally sourced hickory, oak, or pecan wood on Firebirds’ exposed wood-fired grill. Complementing its inviting dining room, a patio with seasonal comforts and the award-winning FIREBAR ® are additional gathering spaces inside the restaurant. Firebirds has been named one of ten ‘Breakout Brands’ by Nation’s Restaurant News, and the 2022 Diners’ Choice Winner awarded by OpenTable. Firebirds supports sustainability efforts and partners with Alex’s Lemonade Stand Foundation, and surpassed $3 million raised for childhood cancer research through the sale of fresh-squeezed lemonade. To become a member of Firebirds Inner Circle, order ToGo online or to make a reservation visit firebirdsrestaurants.com. Contact: Lesley Gamwell 404-309-6915 lgamwell@rountreegroup.com Contact Details Dominic Jonas +1 618-328-3245 media@500newswire.com Company Website https://firebirdsrestaurants.com/
December 01, 2022 02:14 PM Eastern Standard Time
News ReleaseEnlivex Therapeutics, Ltd.
The Israeli Ministry of Health (MOH) approved a Phase I/II trial of Enlivex Therapeutics Ltd. ’s (NASDAQ: ENLV) proprietary immunotherapy drug-candidate Allocetra TM. Allocetra TM is a cell therapy that uses healthy donor cells to reprogram and strengthen the patient’s immune response against cancer. If approved, the drug candidate would be a universal, off-the-shelf immunotherapy that could be combined with other leading immunotherapies and cancer treatments to improve a patient’s odds of beating this hard-to-treat disease. Here’s how the Israel-based biotech’s macrophage reprogramming drug works and what the latest clinical trial measures. Allocetra TM Reprograms Macrophages To Weaken Cancer Cells The first responders of the body’s immune systems, macrophages, patrol the bloodstream looking for signs of infection. Once spotted, they engulf the pathogen, rip it apart and alert other immune cells like T cells that it’s time to take action. When cancer cells grow in the body, the disease evades detection by tricking macrophages into believing the cancerous cell is a normal, healthy cell. Then, it can turn that macrophage into a pro-tumor ally that will suppress any immune response trying to kill the cancer. With Allocetra, healthy donor cells are sent in to reprogram the patient’s own macrophages so they not only stop helping the tumor but also start working with the immune system to fight those cancer cells again. To do that, Enlivex developed a proprietary process to program those donor macrophages to send out an “eat me” signal once injected. That signal tells the patient’s macrophages to eat the donor cells. Once engulfed, they set to work restoring it to its homeostatic state. Restoring Macrophage Homeostasis Could Help Overcome Checkpoint Inhibitor Resistance While reprogramming macrophages may already help boost the body’s cancer-fighting ability on its own, one of the most exciting potentials of this novel treatment is its ability to combat the resistance that cancers often develop against other immunotherapies. Because cancer can trick macrophages into defending tumors instead of attacking them, other immunotherapies, including checkpoint inhibitors like Merck & Co. Inc. ’s (NYSE: MRK) Keytruda or Bristol-Myers Squibb Co. ’s (NYSE: BMY) YERVOY, struggle to bypass the cancer’s new defenders. This challenge has resulted in response rates as low as 13% to these novel treatments. That figure is disappointing because, in theory, checkpoint inhibitors are extremely promising. Checkpoints like PD-1 and CTLA-4, the ones blocked by Keytruda and YERVOY, respectively, are “off switches” that help the immune system recognize and avoid attacking the body’s own cells. Just as cancer can trick macrophages into coming to its defense, it can use those checkpoints to trick the immune system into believing the cancer cell is a normal cell. By blocking those checkpoints, the cancer is no longer able to escape detection in this way. However, even when those checkpoints are blocked and the immune system kicks into action to fight the cancer cells it can now recognize, dysregulated macrophages form a kind of protective layer on top of a tumor that prevents the immune system from effectively attacking it. It’s that last layer of defense that researchers think may play a role in the low response rate of checkpoint inhibitors. Enlivex hopes that Allocetra TM ’s potential to reprogram those macrophages will help remove that protective barrier so that when the checkpoint inhibitor gets rid of the cancer’s “off switch,” the patient’s immune system won’t have any obstacles in its way to attacking that tumor. The Phase I/II Clinical Trial Will Study Allocetra TM Alone and in Combination with a Checkpoint Inhibitor The recent MOH approval paves the way for Enlivex to enroll up to 48 patients with advanced solid tumors in a multicenter, open-label trial that will include two stages. In stage one, patients will receive escalating doses of Allocetra TM by itself. The intravenous injections will be administered once a week for three weeks. In stage two, patients will receive three injections of Allocetra TM in combination with an anti-PD1 checkpoint inhibitor. In preclinical studies, this combination resulted in 50% survival probability for mice with ovarian cancer, compared to 15% or less for anti-PD1 checkpoint inhibitors on their own. While the primary objective of the study is to evaluate the safety and tolerability of Allocetra TM alone and in combination, researchers will also be measuring efficacy, including overall response rate, survival and progression-free survival. Enlivex says the new trial is slated to begin in the third quarter of this year. As part of a new generation of companies representing the future of cell therapy – off-the-shelf, highly scalable and low COGS “beyond CAR-T” cell therapies – Enlivex is focused on a highly differentiated novel immunotherapeutic mechanism – macrophage homeostasis. Macrophage homeostasis is severely disrupted by certain diseases states, and such imbalance is critical to the progression of the diseases. Allocetra has the potential to introduce highly-effective, low-cost allogeneic cell therapies for life-threatening clinical indications that are defined as "unmet medical needs", including sepsis – one of the leading causes of mortality, and oncology, through restoration of macrophage homeostasis. Enlivex is led by a seasoned management team who founded PROLOR Biotech and led it to a successful $560 financial exit and a partnership with Pfizer. PROLOR’s lead product, now named NGenla® by Pfizer, recently received marketing approval in Australia, Canada, Japan and the EU. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA TM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA TM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. Contact Details Shachar Shlosberger shachar@enlivexpharm.com Company Website https://enlivex.com
December 01, 2022 02:00 PM Eastern Standard Time
Contact Us
Pricing
About us
Features
News Hub
Terms of Use
Privacy Policy