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Immunic Therapeutics shares IMU-856 mode of action and target for gastrointestinal diseases

Immunic Inc

Immunic Therapeutics Chief Scientific Officer Hella Kohlhof joins Natalie Stoberman from the Proactive newsroom to share the recently released mode of action, molecular target, preclinical data for its IMU-856 asset that targets restoration of intestinal barrier function and bowel wall architecture. Immunic is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), currently in phase 3 clinical trials for the treatment of multiple sclerosis, has shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and moderate-to-severe ulcerative colitis. IMU-856 is targeted to restore intestinal barrier function and regenerate bowel epithelium, which would be applicable in numerous gastrointestinal diseases, such as celiac disease, where it is currently in preparations for a phase 2 clinical trial. Contact Details Proactive United States +1 347-449-0879 action@proactiveinvestors.com

June 26, 2023 03:44 PM Eastern Daylight Time

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American Businesses Want Secure Borders and a Modernized Immigration System to Help Address Worker Shortages

YourUpdateTV

A video accompanying this announcement is available at: https://youtu.be/cyDh_POE9fg There might as well be a giant “Help Wanted!” sign over the United States. The economy has bounced back from the pandemic lows, but companies have been struggling to meet their workforce needs to keep up with the surge in demand for everything from household products to cars. At the same time, the crisis level situation on our southern border is not abating, as the U.S. Border Patrol has seen 133,000 more border crossings through April of this fiscal year than during the same period of time in last year’s record-shattering totals. The U.S. currently has approximately 10.1 million job openings, while there are 6 million people unemployed and looking for work. The worker shortfall has also emerged as a key factor driving persistent inflation and higher interest rates. Securing our borders and modernizing our immigration system can help us confront these challenges. Many people wonder given the seriousness of these issues and the polarization in Congress if any real progress can be achieved on border security and immigration reform? The U.S. Chamber of Commerce believes not only that it can be done, but that it must be done. The immigration challenges we face today didn’t arrive at our doorstep overnight; they’ve been around for decades and have only grown in size and severity due to many years of congressional inaction. The U.S. Chamber of Commerce is leading the LIBERTY Campaign (Legal Immigration and Border Enforcement Reform This Year) with over 430 national, state, and local business associations. The campaign launched with a letter calling upon Congress to address the crisis at our border and the critical workforce shortage before the year’s end. Many experts believe that expanding legal immigration to the U.S. would help spawn economic output by driving much needed labor force growth at a time when America’s population growth is stagnating. A nationwide media tour was conducted on June 20 th featuring Neil Bradley from the U.S. Chamber of Commerce, discussing why Congress cannot afford to wait any longer to secure our borders and modernize our broken immigration system. Topics that Neil Bradley from the U.S. Chamber of Commerce discussed included: How serious our border and legal immigration problems are. What the consequences will be if Congress foregoes fixing the problems on our borders and within our legal immigration system. How a modern, pro-growth immigration system will help address the chronic workforce issues plaguing many American employers today and other economic problems we’re suffering from. Why the Chamber launched the LIBERTY Campaign with over 430 other associations. Contact Details YourUpdateTV +1 212-736-2727 yourupdatetv@gmail.com

June 26, 2023 03:00 PM Eastern Daylight Time

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Sevita Appoints Philip Kaufman as new CEO

Sevita

Sevita, a leading national provider of community-based health care and support services, has announced Philip Kaufman as its new Chief Executive Officer. Kaufman is an established executive whose leadership career has spanned two decades with UnitedHealth Group, most recently as Chief Growth Officer and CEO of UnitedHealthCare Individual and Family Plans. While there, he led initiatives focused on targeted and personalized programs to improve care coordination, decrease disparities in care, and reduce medical costs – all part of UnitedHealth’s mission to help people live healthier lives and to make the health system work better for everyone. “On behalf of everyone at Sevita, I’m thrilled to welcome Philip to our organization,” said Alan Wheatley, executive chair of Sevita’s Board of Directors. “Philip is mission-oriented and cares deeply about improving quality of life for people of all backgrounds. As a leader, he values strong relationships and a collaborative spirit, which is foundational to the person-centered work we do. I’m confident he will steward Sevita toward an even brighter future.” Sevita serves 55,000 individuals in 41 states, providing adults, children, and their families innovative, quality services and supports that lead to growth and independence, regardless of the physical, intellectual, or behavioral challenges they face. This includes residential care and periodic care services for individuals with intellectual and developmental disabilities; rehabilitation services for neurological injuries, illnesses, and other complex health needs; therapeutic and medically complex foster care; behavioral health supports; and clinically supported adult day health programs. “I’m excited to join this impactful organization and support the incredible work being done to help people with intellectual and developmental disabilities and other complex health needs to live more independently in their homes and communities,” Kaufman said. “Sevita has been a leader in this industry for nearly 50 years and has both the vision and expertise to provide solutions that expand access to the quality supports and services that millions of Americans need. I look forward to being part of its next chapter and driving progress for our business, our industry, and most importantly, our communities.” About Sevita Sevita is a leading provider of community-based specialized health care, inspired by our core values of respect, integrity, inclusion and growth. We provide people with quality services and individualized supports that lead to growth and independence, despite the physical, intellectual, or behavioral challenges they face. We’ve made this our mission for more than 50 years. Today our team members continue to innovate and enhance care for the 55,000 individuals we serve. sevitahealth.com Contact Details Melissa Patricio media@sevitahealth.com Company Website https://sevitahealth.com/

June 26, 2023 10:00 AM Eastern Daylight Time

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Pancreatic Cancer Trials & New Treatments Receiving Increased Funding as Incidences of Cancer Grows

STORM Partners

FinancialNewsMedia.com News Commentary - Pancreatic cancer is one of the leading causes of cancer death globally. The increasing incidence of this cancer across the U.S. and other parts of the world is one of the factors driving the need for the drugs used in the treatment. The increase in the geriatric population is one factor driving the pancreatic cancer treatment market growth. The incidence is significantly higher in the geriatric population above 65 years of age compared to other types of cancers. The increase in the number of patients suffering from the condition has increased the demand for the drugs used in treatment. A report from Fortune Business Insights said that this factor will be driving the growth for the next several years. The report projected that the global pancreatic cancer treatment market size was valued at USD 2.48 billion in 2022 and will grow to USD 6.85 billion by 2029, exhibiting a CAGR of 15.7% during the forecast period. The report continued: “Companies engaged in manufacturing cancer drugs have increased their focus on R&D activities to develop new drugs for pancreatic cancer treatment. Additionally, the companies operating in the market have received approval from several regulatory bodies, such as the U.S. Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA) (U.K.), among others, thereby propelling the growth of the market. Moreover, new testing technologies are being adopted by hospitals and diagnostic centers to diagnose cancer. The increase in the diagnosis rates is driving the demand for drugs, thereby providing opportunities for the players.” Active biotech and pharma companies in the markets this week include Oncolytics Biotech ® Inc. (ONCY – ONC.TSX), Sotera Health Company (NASDAQ: SHC), Centessa Pharmaceuticals plc (NASDAQ: CNTA), Bristol Myers Squibb (NYSE: BMY), Gilead Company (NASDAQ: GILD). Fortune Business Insights continued: “Shifting the focus of key players in extensive R&D activities to develop new drugs and an increase in funding for cancer research led to the development of new drugs for treatment. Additionally, several pharmaceutical companies are involved in clinical trials to develop new drugs and explore the potential of the molecule to treat the disease. It concluded: “Thus, with the increased funding for R&D activities, companies are focused on developing new drugs, thereby contributing to the overall rise in demand for drugs for pancreatic type of cancer treatment through 2029.” Oncolytics Biotech ® Inc. (ONCY - ONC) BREAKING NEWS: Oncolytics Biotech’s® Pelareorep Selected for Inclusion in Precision PromiseSM Pivotal Phase 3 Platform Trial – Adaptive clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce cost of a Phase 3 study for pelareorep by ~50% compared to a traditional trial If successful, new clinical study expected to support approval of pelareorep in combination with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic cancer Data presented at SITC 2022 showed a near tripling of overall response rate for pelareorep + gemcitabine + nab-paclitaxel + a PD-L1 inhibitor compared to historical control trials Oncolytics Biotech ® (trading on the NASDAQ under the Symbol ONCY and the TSX exchange under ONC) today announced pelareorep has been selected for inclusion as a new investigational treatment in Precision PromiseSM, an innovative adaptive Phase 3 clinical trial. The Precision Promise study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel. If successful, the clinical study is expected to support approval of the studied combination as a treatment for first-line metastatic pancreatic ductal adenocarcinoma (PDAC). Precision Promise has a primary endpoint of overall survival and can include multiple investigational treatments as well as control arms evaluating: (1) gemcitabine plus nab-paclitaxel or (2) mFOLFIRINOX. Each investigational therapy is subject to pre-specified interim analyses prior to proceeding to the registrational portion of the trial. This design, which was developed with guidance from the U.S. Food and Drug Administration, minimizes the number of participants needed to generate licensure-enabling data, thereby accelerating late-stage development by up to two years and reducing costs compared to non-platform trials. “We are delighted at being selected by the Precision Promise panel of experts,” said Dr. Matt Coffey, President, and Chief Executive Officer of Oncolytics Biotech. “Our next step is to engage with stakeholders to finalize the protocol for Precision Promise’s pelareorep-containing investigational treatment so that we can enter into this study. We are thrilled to have the opportunity to leverage Precision Promise, which we expect will allow us to reduce the time and costs needed to reach a potential approval.” Julie Fleshman, JD, MBA, President and CEO of PanCAN commented, “With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options. This urgent unmet need was the driving inspiration behind the Precision Promise platform trial, which was designed specifically to identify, accelerate, and de-risk the development of promising pancreatic cancer treatments. We are thrilled to be bringing pelareorep into Precision Promise as a new investigational therapy to study against the current standard of care.” Dr. Thomas Heineman, Chief Medical Officer of Oncolytics Biotech, commented, “Prior trials in pancreatic cancer show pelareorep-based combinations outperforming historical controls on key metrics such as one and two-year survival and objective response rate. In addition, mechanistic data from these studies highlight how pelareorep’s immunologic mechanism of action allows it to synergize with chemotherapy and checkpoint inhibition in this indication. I look forward to working with the Precision Promise team of investigators to seek to confirm the therapeutic value of pelareorep in a randomized setting so that we can potentially provide pancreatic cancer patients with a new treatment option.” CONTINUED …Read this full press release and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/ Other recent breast cancer developments in the biotech industry of note include: Sotera Health Company (NASDAQ: SHC) recently announced that the opt-in process for the January 2023 settlements of ethylene oxide claims against Sterigenics in the Circuit Court of Cook County, Illinois is complete and Sterigenics has elected to proceed with the settlements. 879 of the 882 claimants eligible to participate in the settlement program have opted in. The settling claimants and Sterigenics will now request that the Circuit Court enter an order confirming that these are good-faith settlements under the Illinois Contribution Among Joint Tortfeasors Act. The settlement funds will be released from escrow for disbursement to the settling claimants ten days after the Court enters the anticipated good-faith determination and their claims against Sterigenics will subsequently be dismissed with prejudice. The lawsuits of the three claimants who opted out of the settlement will proceed to pretrial discovery pursuant to a schedule to be set by the Circuit Court. Centessa Pharmaceuticals plc (NASDAQ: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, recently announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or without inhibitors. "We are pleased with the FDA’s decision to grant Fast Track designation for SerpinPC as we continue to advance the PRESent registrational studies for SerpinPC in hemophilia B,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “This designation is important recognition of SerpinPC’s novel mechanism of action and underscores the critical need for new treatment options for persons with hemophilia B. We believe SerpinPC has the potential to be a first-in-class subcutaneously administered therapy with a differentiated safety profile for persons with hemophilia B, subject to review and approval.” Bristol Myers Squibb (NYSE: BMY) announced the first disclosure of primary analysis results from two pivotal studies, TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory follicular lymphoma (FL) and the relapsed or refractory mantle cell lymphoma (MCL) cohort of TRANSCEND NHL 001, an open-label, multicenter, Phase 1, single-arm, seamless-design study evaluating Breyanzi. These data were presented in late-breaking oral presentations at the 2023 International Conference on Malignant Lymphoma (ICML) on Saturday, June 17. "With Breyanzi, we’re dedicated to delivering a CAR T cell therapy with a differentiated profile to transform outcomes for some of the most difficult-to-treat lymphomas," said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. "Based on results from TRANSCEND FL and TRANSCEND NHL 001, Breyanzi continues to demonstrate the ability to elicit significant deep and durable responses alongside a manageable safety profile, potentially addressing areas of high unmet need and reinforcing our commitment to advancing innovative solutions for the broadest array of hematologic malignancies of any CD19-directed CAR T cell therapy." Kite Pharma, Inc., a Gilead Company (NASDAQ: GILD) announced that the Marketing Authorization in Japan for Yescarta® (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, has been transferred from Daiichi Sankyo Co., Ltd. to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc. This follows the announcement made by Daiichi Sankyo and Kite Pharma, Inc. in December 2022 about changes to their initial 2017 partnership whereby Daiichi Sankyo obtained the Marketing Authorization for Yescarta®. With this completion of the Marketing Authorization transfer, the sales and promotion activities of Yescarta® in Japan now will be managed by the Kite Cell Therapy Business Unit of Gilead Sciences K.K. DISCLAIMER: FN Media Group LLC (FNM), which owns and operates FinancialNewsMedia.com and MarketNewsUpdates.com, is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with any company mentioned herein. FNM and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNM's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. FNM is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed FNM was compensated forty nine hundred dollars for news coverage of the current press releases issued by Oncolytics Biotech ® Inc. by a non-affiliated third party. FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE. This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements. SOURCE Financialnewsmedia.com Contact Details Financial News Media Media Contact +1 561-325-8757 editor@financialnewsmedia.com

June 23, 2023 01:09 PM Eastern Daylight Time

TalkMarkets Announces Company Spotlight Featuring Evogene

TalkMarkets on EVGN

TalkMarkets.com announces a company spotlight series featuring Evogene (NASDAQ: EVGN ), an agri-tech (agricultural technology) and bio-tech company with a computational predictive biological platform technology that it leverages to five relatively early-stage subsidiaries: three of which have reached the commercialization phase. Today's article is titled, “ Evogene - A Company With Valuable Assets Trading At Zero Enterprise Value.” Key Highlights include: Trading at cash: The company's market cap is around $30 million, trading at around cash levels since mid-2022, following a very sharp 90%+ fall from its peak of around $9.50 in February 2021. The subsidiaries have real value, as evidenced by external investments from professional VC funds: investment into subsidiaries, suggest that Evogene's subsidiaries, Biomica and Lavie Bio, are each worth well more, than the market valuation of Evogene itself. Casterra, a subsidiary focused on genetically advanced castor seeds for oil production, has the highest potential for significant value creation in the short-term and just announced a large $9 million initial purchase order from a major oil company for seeds for growing biofuel. Evogene's technology platform, the Computational Predictive Biology platform (CPB), has significant value due to the company's extensive investment in research and development over two decades, and partnerships with leading ag-companies. The conservative valuation of Evogene and its subsidiaries, along with its technology, suggests a value well above $224 million, or over $5 per share, indicating a potential upside of over 6X. Recent positive developments, such as sales of Casterra seeds and investments in subsidiaries, indicate increasing cash flow for Evogene, reducing the risk of capital depletion. Read the fuill article here. Previous artricles in the series include: Looking To Invest In Artificial Intelligence? Consider Evogene And Its Five Subsidiaries Evogene Offers An Excellent Risk/Reward Ratio More By This Newswire: TalkMarkets Announces Company Spotlight Featuring Adamas One Biomica Announces Closing of $20 Million Financing Round led by Shanghai Healthcare Capital RenovoRx Announces Positive New Data from Phase III Clinical Trial Interim Analysis: 60% Survival Benefit and Fewer Side Effects than Systemic Chemotherapy Originallay published at TalkMakets. TalkMarkets is a financial site that customizes, optimizes, and socializes content to ensure a personalized experience. For more information, please visit www.TalkMarkets.com Contact Details TalkMarkets ir@talkmarkets.com

June 22, 2023 05:50 PM Eastern Daylight Time

News Release

Xeris Biopharma reaches Phase 2 milestone by dosing first participant in hypothyroidism study

Xeris Biopharma Holdings

Xeris Biopharma Chairman & CEO Paul Edick joins Natalie Stoberman from the Proactive newsroom to share the latest milestone of having its first participant being dosed in a multi-center, open label, Phase 2 study of XP-8121 for the treatment of adults with hypothyroidism. Edick says this milestone is crucial considering initiating such studies is challenging and time-consuming. He adds that Xeris Biopharma aims to compare its stable therapy with existing treatments in the market, which are often poorly tolerated or improperly absorbed. Xeris' innovative liquid stable formulation offers a once-weekly subcutaneous injection, bypassing the gastrointestinal tract and providing consistent blood levels. The ongoing clinical study will need to dose around 40 to 50 patients before moving on to Phase 3 of the program. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

June 22, 2023 01:50 PM Eastern Daylight Time

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News Release

Endexx CEO reveals major distribution agreement for Hyla vapes in the Middle East

ENDEXX Corp.

Endexx CEO Todd Davis joins Natalie Stoberman from the Proactive studios to share the company's latest distribution contract for Hyla "No-Nicotine" vape products with Sahara Trading UAE. Davis says the agreement covers an eight-country territory that is targeting a minimum 100,000 units per month as the expansion roles out. Endexx develops and distributes all natural, plant-derived wellness products and topical skincare products. Its products vary from balms, creams, lotions, butters, masks, scrubs, and oils, all with the shared purpose of healthy skin and grooming wellness. Contact Details Proactive Investors +1 347-449-0879 na-editorial@proactiveinvestors.com

June 22, 2023 01:45 PM Eastern Daylight Time

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Sona Nanotech "building a mountain of data" to support use of proprietary gold nanorods

Sona Nanotech Inc

Sona Nanotech Inc. (CSE: SONA, OTCQB: SNANF) CEO David Regan speaks to Thomas Warner from Proactive about his ambitious plans for the Canadian company's proprietary gold nanorods. He says that Sona Nanotech is currently "building a mountain of data" to support the potential use of its technology in innovative cancer treatments, having recently announced that it had received the third set of results of an independent assessment of its nanorods from the U.S. National Cancer Institute’s Nanotechnology Characterization Laboratory (“NCL”). Contact Details Proactive United States Proactive United States +1 347-449-0879 action@proactiveinvestors.com

June 22, 2023 09:34 AM Eastern Daylight Time

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Poolbeg Pharma sees "significant commercial opportunity" in oral vaccines

Poolbeg Pharma PLC

Poolbeg Pharma PLC (AIM:POLB, OTCQB:POLBF) CEO Jeremy Skillington speaks to Thomas Warner from Proactive after announcing that work on the company's Oral Vaccine Programme collaboration is now set to move into a new phase. Taking place over three years, the EncOVac Consortium is funded to develop a Phase I clinical trial ready oral vaccine candidate. Skillington says "as technologies develop, we move away from injectables so we see great significant commercial opportunities in having an oral alternative." The focus of the next phase is to commence the validation of the encapsulation process. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

June 22, 2023 04:50 AM Eastern Daylight Time

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