News Release
Immunic reports successful 2023 and prepares for key 2025 milestones
Immunic Inc
Immunic Inc CEO Dr Daniel Vitt joined Proactive's Stephen Gunnion following what he described as a successful 2023. Outlining the company's achievements, Dr Vitt noted the company strengthened its balance sheet by raising up to $240 million. The first tranche of the three tranche private placement is expected to extend the company's cash runway into the third quarter of 2025, beyond important clinical readouts for its Phase 2 study in progressive multiple sclerosis (MS), known as the CALLIPER study, with results anticipated in April 2025. Clinically, Immunic achieved positive results across its portfolio, including its Vidofludimus calcium and IMU-856. Dr Vitt said vidofludimus calcium showed promising phase 2 interim results in 2023, including a significant reduction in NfL biomarkers in patients with progressive MS, indicating its potential as a unique treatment option. IMU-856, targeting gastrointestinal disorders, demonstrated effectiveness in improving gut function in celiac disease patients, with results published in spring 2023. Looking ahead to 2024, he said the focus is on preparing for the CALLIPER study readout in April 2025 and exploring further studies for IMU-856 in additional indications. The company continues discussions with potential pharmaceutical partners for its programs. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com
February 22, 2024 10:59 AM Eastern Standard Time
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Oncotelic Therapeutics Shares Groundbreaking Discovery In Pediatric Brainstem Tumors Demonstrating Potential For New Cancer Immunotherapy Treatments
Benzinga
Oncotelic Therapeutics (OTCQB: OTLC), a therapeutics company with a focus on cancer and viral infection treatments, recently published a foundational discovery in pediatric brainstem tumors. The study showed that levels of two specific molecules – Transforming Growth Factor Beta 2 (TGF-B2) and Interferon Gamma Receptor 2 (IFNGR2) – in the tumor environment of children with diffuse midline gliomas (DMG) can significantly impact their overall survival. IFNGR2 is an important part of the body's immune system and helps fight against cancer. High expression of TGF-B2 in patients with low IFNGR2 reduced median survival from 13 months to only 7 months. Therefore, suppressing TGF-B2 with a drug called OT-101 could enhance the immune system's ability to fight tumor growth and improve survival. This finding could have implications for new cancer immunotherapy treatments. "In light of our foundational discovery that elevated levels of TGF-B2 worsen mortality in various cancers, including Diffuse Midline Glioma (DMG), we have further elucidated the underlying mechanisms, particularly focusing on the impact of TGF-B2 on interferon signaling. We hope that sharing these findings from our research team will contribute to the eradication of cancer," shared Dr. Vuong Trieu, CEO and Chairman of Oncotelic. Oncotelic has been involved in developing many cancer and viral infection treatments, including for COVID-19. The company currently has five drug candidates in its pipeline and recently unveiled a state-of-the-art GMP Manufacturing Plant through its joint venture- Sapu Biosciences LLC. The facility is situated in San Diego’s biotechnology hub. This plant will help with the expansion of the drug OT-101, among others. OT-101, also known as Trabedersen, is being developed for the treatment of various types of cancer, including brain cancer in adults and a specific type of childhood brain cancer called diffuse intrinsic pontine glioma (DIPG). OT-101 is an antisense oligodeoxynucleotide that targets TGF-B2, which is commonly found in cancer cells. As Oncotelic’s study found, cancer cells often overexpress TGF-B2, which dampens the body's immune response to the cancer. The company has received pediatric designation from the FDA specifically for the treatment of DIPG in children. This drug has shown promising results in early clinical trials for pancreatic cancer, melanoma and glioblastoma, demonstrating both efficacy and safety. Oncotelic’s partnership with Sapu Biosciences has a common goal of being a global leader in the research, development and commercialization of innovative therapies focusing on conditions with extreme unmet medical needs, especially age-related diseases. This is evident in the drug pipeline with its focus on cancers like DIPG, which is highly aggressive and difficult to treat. Approximately 300 children in the U.S. are diagnosed with DIPG each year. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com
February 21, 2024 08:20 AM Eastern Standard Time
News Release
Elutia's CanGarooRM: Pioneering Drug-Eluting Biologic for Secure Medical Implants
Elutia Inc.
Elutia CEO Randy Mills joined Steve Darling from Proactive to discuss the company's groundbreaking product, CanGarooRM, a drug-eluting biologic designed to safeguard implanted medical devices such as pacemakers. Founded by Mills and Kevin Rakin, both esteemed veterans in the biotech industry, Elutia aims to revolutionize healthcare by combining regenerative medicine with localized drug delivery. Mills shed light on CanGarooRM's unique formulation, which includes antibiotics to prevent infections and device migration, ultimately enhancing patient safety. With the FDA accepting their filing in December, Elutia is optimistic about receiving favorable results in the second quarter of this year. If approved, CanGarooRM has the potential to capture a significant share of the market, estimated to exceed $500 million. Mills further elaborated that Elutia has completed product development and is poised to commence commercial production by the late second quarter. A soft launch is planned for the third quarter, followed by full-scale deployment by the fourth quarter of this year. This strategic timeline positions Elutia for substantial growth pending regulatory approval, with CanGarooRM poised to address critical needs in the healthcare industry and improve patient outcomes. In summary, the interview underscored Elutia's promising trajectory and the transformative potential of CanGarooRM in enhancing medical device safety. With a strong foundation in regenerative medicine and localized drug delivery, Elutia is poised to make a significant impact in healthcare innovation, driving positive change and improving patient care globally. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com
February 20, 2024 10:37 AM Eastern Standard Time
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Simply Solventless Concentrates announces new VP as company plans 2024 products launch
Simply Solventless Concentrates
Simply Solventless Concentrates CEO Jeff Swainson joins Steve Darling from Proactive to share exciting updates regarding the company's upcoming activities. Simply Solventless Concentrates anticipates a busy month ahead, with approximately $1.25 million in purchase orders lined up from Alberta and Ontario. Additionally, the company is set to launch six third-party branded products in Alberta and one in Ontario, further expanding its market presence. Swainson underscored the importance of strategic leadership in supporting the company's growth trajectory. To this end, Simply Solventless Concentrates announced the appointment of Jeff Lawrence to the position of Vice President, Marketing & Sales. Lawrence brings over 30 years of experience in industrial and consumer packaged goods, including five years in the cannabis industry. With a proven track record of driving sales growth and propelling startups through strategic development, team building, and effective leadership, Lawrence is poised to make a significant impact on the company's sales and marketing initiatives. Swainson highlighted Lawrence's previous role as National Director of Sales at Dycar Pharmaceuticals, where he played a key role in overseeing the launch of four brands and scaling store listings from 70 to over 2,200 across five provinces. Lawrence's extensive experience and leadership acumen make him a valuable addition to the Simply Solventless Concentrates team, positioning the company for continued success and expansion in the competitive cannabis market. With a robust pipeline of purchase orders and new product launches on the horizon, Simply Solventless Concentrates is primed for growth under Lawrence's leadership. Stay tuned for further updates as the company continues to execute its strategic initiatives and capitalize on emerging opportunities in the cannabis industry. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com
February 20, 2024 10:29 AM Eastern Standard Time
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CervoMed appoints drug development veteran Dr. Joshua Boger as Chairman of the Board
CervoMed
CervoMed Inc CEO John Alam joined Steve Darling from Proactive to announce a significant addition to the company's leadership team. CervoMed has appointed Joshua Boger to its Board of Directors as Chair, leveraging his wealth of experience in drug development and biopharmaceutical leadership to drive the company's strategic initiatives forward. Dr. Boger is a seasoned industry veteran with over 40 years of experience, renowned for his innovative approach to science and proven track record as a business executive. Currently serving as Executive Chairman of Alkeus Pharmaceuticals, Dr. Boger brings invaluable insights and expertise to CervoMed. Alam elaborated on the significance of Dr. Boger's appointment and the pivotal phase the company is entering, with topline data from the RewinD-LB Phase 2b clinical trial evaluating neflamapimod in dementia with Lewy bodies (DLB) expected in the second half of 2024. Neflamapimod, an investigational orally administered small molecule brain penetrant that inhibits p38MAP kinase alpha, holds immense promise in addressing synaptic dysfunction, particularly in the basal forebrain cholinergic system, which is most impacted in DLB. Drawing from preclinical studies and clinical trials involving over 300 participants, Alam highlighted neflamapimod's favorable safety profile and its significant impact on dementia severity as demonstrated in the AscenD-LB Phase 2a clinical study. These promising results underscore the potential of neflamapimod to address the unmet medical needs in DLB and pave the way for transformative treatment options. The appointment of Dr. Boger and the advancements in CervoMed's clinical trials signify a significant milestone in the company's mission to develop innovative therapies for neurodegenerative diseases. With a visionary leadership team and a promising pipeline of treatments, CervoMed is poised to make a meaningful impact on the lives of patients and caregivers affected by DLB and related conditions. Stay tuned for further updates as CervoMed continues its journey towards advancing neurological healthcare. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com
February 20, 2024 10:22 AM Eastern Standard Time
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Cloud DX secures key partnership with Sanrai International for worldwide distribution
Cloud DX
Cloud DX CEO Robert Kaul joined Steve Darling from Proactive to announce a new Partnership Agreement with New York-based Sanrai International. Sanrai International, a leading medical device distribution company with a global presence, will now market and resell the Cloud DX Connected Health platform across more than 65 countries. Kaul highlighted the significance of this partnership, emphasizing Sanrai's extensive customer and sub-distributor network, which spans Latin America, Africa, the Middle East, Asia, and beyond. The focus of this collaboration will be on addressing chronic disease management and post-surgical recovery, leveraging Cloud DX's innovative Connected Health products and services. With the partnership in place, both Cloud DX and Sanrai aim to equalize access to innovative medical devices, particularly in the areas of chronic illness and post-surgical recovery. Kaul also mentioned that Cloud DX has already announced over $2.5 million CAD in new business in 2024, reflecting the company's continued growth and market expansion efforts. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com
February 20, 2024 10:06 AM Eastern Standard Time
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Filament Health announces FDA opening of IND application for substance abuse disorder
Filament Health Corp
Filament Health CEO Ben Lightburn joined Steve Darling from Proactive to share the groundbreaking news that the U.S. Food and Drug Administration (FDA) has given its approval for the Investigational New Drug application for PEX010, Filament Health's botanical psilocybin drug candidate designed for the treatment of Substance Use Disorders. This development paves the way for Filament Health to commence research activities in the United States, focusing on the potential use of their botanical psilocybin drug candidate in addressing substance use disorders, including those involving opioids. Lightburn went on to explain that the IND-opening protocol had previously been submitted to Health Canada and had received the department's no-objection status, underlining the company's commitment to adhering to rigorous regulatory standards on both sides of the border. Moreover, Lightburn highlighted the extensive scope of research and collaboration surrounding PEX010. Currently, a network of 24 research institutions and licensing partners across Canada, the USA, Europe, and Israel is actively studying PEX010 for various conditions. These include but are not limited to alcohol use disorder, depression, and coma, showcasing the versatile potential of this botanical psilocybin drug candidate in addressing a wide range of medical conditions. The acceptance of the IND application by the FDA marks a pivotal moment in Filament Health's journey, offering a pathway for innovative and potentially transformative treatments for substance use disorders. It also underscores the company's global reach and collaborative efforts in advancing the field of psychedelic medicine. This milestone is a testament to the commitment of Filament Health to research and develop solutions that hold promise for individuals struggling with these challenging conditions. Contact Details Proactive North America Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com
February 20, 2024 09:40 AM Eastern Standard Time
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Hemogenyx Pharmaceuticals achieves breakthrough with HEMO-CAR-T program, CBR platform
HemoGenyx Pharmaceuticals
Hemogenyx Pharmaceuticals PLC CEO Dr Vladislav Sandler and non-executive director Peter Redmond joined Proactive's Stephen Gunnion after the company pioneering breakthrough treatments for life-threatening diseases, including blood and solid cancers, achieved a number of significant milestones. Sandler highlighted the company's significant progress with its HEMO-CAR-T program after it received the green light from the US Food and Drug Administration (FDA) to enter Phase 1 clinical trials for acute myeloid leukaemia, marking its transition to a clinical-stage biopharmaceutical company. This development symbolises a pivotal milestone, offering potential life-changing treatments for patients with limited options. Additionally, Hemogenyx is advancing its proprietary Chimeric Bait Receptor (CBR) platform, announcing that it has demonstrated in vivo that the CBR can be delivered intranasally in the form of messenger RNA (mRNA) for the potential treatment of airborne viral infections. As 2024 unfolds, Hemogenyx anticipates starting clinical trials and advancing its CBR platform towards IND-enabling studies, signaling a landmark year with promising outcomes for investors and patients alike. Contact Details Proactive UK Ltd Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
February 20, 2024 08:09 AM Eastern Standard Time
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hVIVO chairman Cathal Friel says he remains committed to hVIVO following share sale
hVIVO PLC
hVIVO chairman Cathal Friel joined Proactive's Stephen Gunnion to discuss the sale of shares in hVIVO PLC by directors, including himself. Friel explained his decision to sell a portion of his shares in hVIVO was to accommodate the high demand from major institutions while emphasising his commitment to remain a long-term, supportive shareholder despite this sale. Friel, who co-founded hVIVO (formerly known as Open Orphan) in 2017, highlighted the company's significant growth and his active involvement in its operations and strategic direction. He mentioned his 25-year experience in mergers and acquisitions (M&A) and his confidence in the company's ability to surpass its medium-term revenue target of £100 million, partly through strategic M&A activities. Additionally, Friel talked about his new role as Executive Chairman at Poolbeg, a company associated with hVIVO, assuring that this would not diminish his involvement with hVIVO. He shared his enthusiasm for the future of both companies, underscoring his role in identifying market opportunities and assembling high-performing teams to capitalize on them. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
February 20, 2024 04:55 AM Eastern Standard Time
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