Deucravacitinib

JERUSALEM, Nov. 27, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai" or the "Company"), a biopharmaceutical company focused on developing inflammation and immunology (I&I) biological products and providing CDMO services through its Scinai Bioservices business unit, announced today that Dr. Jonathan Sadeh has been appointed as a member of the Company's Scientific Advisory Board (SAB). In this capacity, Dr Sadeh will play a significant role in advancing the clinical development of Scinai's lead IL-17 program along with other promising assets in their unique VHH antibody pipeline. Dr. Sadeh is an accomplished physician-scientist with over 20 years of experience in drug development and clinical research. He spent the last five years at Bristol-Myers Squibb (BMS), where he held multiple senior leadership positions, including Senior Vice President and Global Programs Head for Immunology, Cardiovascular, and Neuroscience; Immunology Therapeutic Area Head; and China R&D Head. Throughout his career, he has been responsible for multiple drug approvals across various fields, including pulmonary, rheumatology, dermatology, gastroenterology, and neurology. His most recent achievement is the approval of Sotyktu, a first-in-class TYK2 inhibitor for the treatment of psoriasis. Prior to BMS, Dr. Sadeh held senior leadership positions at Sanofi, AstraZeneca, and Schering-Plough. Dr. Sadeh earned his MD in Medicine from the Mount Sinai School of Medicine and an M.Sc. degree in Clinical Research from Harvard Medical School. He completed his fellowship in pulmonary and critical care at Harvard Medical School. He began his medical career as an academic researcher at Brigham and Women's Hospital. Dr. Jonathan Sadeh commented: "As a physician, scientist, and drug developer, I am deeply committed to advancing innovative therapies for patients with significant unmet medical needs. Scinai's use of VHH antibodies as a bio-better approach leverages the unique attributes of VHH antibodies to overcome the shortcomings of other approved biologics. This presents a unique way to provide patients with treatments that truly address their conditions in a meaningful way. The opportunity to collaborate with esteemed institutions like Max Planck and UMG further strengthens my belief in Scinai's potential. I look forward to contributing to Scinai's mission and helping establish it as a globally recognized leader in scientifically driven drug development". Amir Reichman, CEO of Scinai, commented: "We are thrilled to welcome Dr. Jonathan Sadeh to our Scientific Advisory Board. His extensive experience and proven track record in drug development and clinical research will be invaluable as we continue to advance our pipeline of innovative I&I biological products. We look forward to his contributions and insights as we strive to bring transformative therapies to patients in need." About Scinai Immunotherapeutics Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (nanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development projects. Company website: . Company Contacts Investor Relations | +972 8 930 2529 | [email protected] Business Development | +972 8 930 2529 | [email protected] Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. Examples of such statements include, but are not limited to, the development of meaningful drugs and the potential of Scinai's NanoAb program. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to; the risk that the Company will otherwise be unable to remain compliant with the continued listing requirements of Nasdaq; a delay in the commencement and results of pre-clinical and clinical studies, including the Phase 1/2a study for psoriasis; the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; inability to develop meaningful drugs; lower than anticipated revenues of Scinai's CDMO business in 2024 and thereafter; failure to sign agreements with other potential clients of the CDMO business; the risk that Scinai will not be successful in expanding its CDMO business or in-license other NanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of NanoAbs will not be met or that Scinai will not be successful in bringing the NanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 15, 2024, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason. Logo - SOURCE Scinai Immunotherapeutics Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The phase 3 ICONIC-LEAD study showed ​ that icotrokinra, a peptide drug that blocks the interleukin (IL)-23 receptor, was able to induce significant clearance of psoriatic plaques. The drug is being developed in conjunction with Johnson & Johnson and Protagonist will earn $115 million as a milestone payment from the big pharma for successful completing a phase 3 study. Protagonist has already earned $35 million due to acceptance of an NDA in psoriasis and $15 million for starting a phase 3 study in a second indication bringing its total milestone payments up to $165 million. The IGA scale is used to measure severity of psoriasis and ranges from 0 to 4, where 0 is clear skin and 4 indicates severe disease. The results from the trial show 65% of patients were able to achieve clear skin (an IGA score of 0 or 1) at week 16 versus only 8% of the placebo group. The PASI score relates to the amount of surface area on each part of the body that is covered by psoriasis plaques and also grades severity of the plaques. A score of 90 or more means that this has improved by 90% from the start of the study, which 50% of icotrokinra patients achieved versus only 4% of the placebo group. The effects of the drug improved with time and by week 24, 74% of patients had achieved clear skin and 65% achieved PASI90. Around 49% of people in the treatment and placebo group had some form of adverse event, showing no increase with icotrokinra treatment. "These positive phase 3 results confirm the compelling efficacy and safety trends that were observed with the previous Phase 2b FRONTIER-1 and -2 studies, highlighting icotrokinra's potential as a best-in-class oral agent providing an ideal combination of significant skin clearance with demonstrated tolerability in a once-daily pill for treating plaque psoriasis," said Dinesh Patel, President and CEO of Protagonist. googletag.cmd.push(function () { googletag.display('text-ad1'); }); "These results also continue to validate Protagonist's innovative peptide technology platform and its effectiveness in creating highly differentiated new chemical entities to address unmet needs in various disease areas." New options for a common skin disorder ​ Psoriasis impacts around 2-3% of the world’s population. It is an autoimmune skin condition where the body produces too many skin cells following a triggering event that causes the immune system to start this overproduction. In people with psoriasis, immune cells secrete inflammatory biomarkers that cause the skin to overproduce keratinocytes and create plaques on the skin that are characteristic of plaque psoriasis, which accounts for 85-90% of people with the skin condition. There is no cure for psoriasis, but many treatments are available ranging from topical to systemic. The most effective of the systemic drugs tend to be injectable, such as the monoclonal antibody therapies infliximab or ustekinumab. Icotrokinra is aiming to be as effective as the injectable therapies but taking the oral route to reduce invasiveness and make the treatment easier for patients. Bristol Myers Squibb has a popular oral psoriasis medication Sotyktu (deucravacitinib), a tyrosine kinase 2 (TYK2) inhibitor, which was approved in 2022. Protagonist and J&J are hoping to compete for some of this market and phase 3 trials testing the two drugs head-to-head are in progress.