- Acquisition expands GSK’s respiratory pipeline adding AIO-001, a phase II-ready, long-acting antibody targeting the clinically validated TSLP pathway
- AIO-001 could redefine the standard-of-care with dosing every six months
- AIO-001 has potential to expand GSK’s respiratory biologics portfolio to reach a broader portion of asthma patients
SAN FRANCISCO & LONDON–(BUSINESS WIRE)–GSK plc (LSE/NYSE: GSK) and Aiolos Bio, Inc. (Aiolos) today announced that they have entered into an agreement under which GSK will acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing the unmet treatment needs of patients with certain respiratory and inflammatory conditions, for a $1 billion upfront payment and up to $400 million in certain success-based regulatory milestone payments.
The acquisition provides GSK with access to Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter phase II clinical development for the treatment of adult patients with asthma, with potential for additional indications including chronic rhinosinusitis with nasal polyps. AIO-001 was exclusively licensed to Aiolos outside of Greater China by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui).
Tony Wood, Chief Scientific Officer, GSK, said: “We have a proud heritage and deep development expertise in respiratory medicines, especially addressing diseases driven by IL-5 with high levels of eosinophils or high T2 inflammation. Adding AIO-001, a potentially best-in-class medicine targeting the TSLP pathway, could expand the reach of our current respiratory biologics portfolio, including to the 40% of severe asthma patients with low T2 inflammation where treatment options are still needed.”1
KeifeRx is currently advancing programs investigating KFRX03, KFRX04, KFXR05 and KFX06 in neurodegenerative, neuroinflammatory, and mast cell-associated diseases
WASHINGTON, Jan. 8, 2024 /PRNewswire/ — KeifeRx, an emerging clinical-stage biopharmaceutical company specializing in the discovery and development of new treatment options for neurodegenerative and immune diseases, announced today entry into an amended exclusive licensing agreement with Georgetown University to advance the development of novel tyrosine kinase inhibitor (TKI) chemical entities (NCE) for the treatment of multiple disease indications. The amendment provides an extension of the exclusively licensed rights to these four novel chemical entities for the treatment of new disease conditions including inflammatory, mast-cell associated diseases, and oncology, in addition to existing rights in neurodegenerative diseases. KeifeRx is currently conducting optimizing and IND-enabling studies involving four separate formulations of the TKI (renamed KFRX03, KFRX04, KFRX05, and KFRX06) with patent life through 2037.
ROCKVILLE, Md., Jan. 8, 2024 /PRNewswire/ — Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”) today announced they have received the ‘Safe to Proceed’ letter from the U.S. Food and Drug Administration (FDA) for the Company’s investigational new drug (IND) application for its Phase II study of Ropidoxuridine (IPdR) as a radiation sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter. Receipt of the letter allows Shuttle to commence the Phase II study.
Shuttle Pharma is currently finalizing site enrollment with ‘first patient, first dose’ expected in the coming months. Ropidoxuridine is Shuttle Pharma’s lead radiation sensitizer candidate for use in combination with radiation therapy (RT) to treat glioblastoma, a deadly malignancy of the brain with no known cure.
- New Business Unit Veridix AI Launched to Embed Technology and AI in Day-to-Day Clinical Operations
- Dr. Rama Kondru to Join the Emmes Group as CEO, Veridix AI
- Industry Leader Matthew Holt to Join Board of Directors
SAN FRANCISCO, Jan. 9, 2024 /PRNewswire/ — Emmes today announced the creation of the Emmes Group, with Sastry Chilukuri serving as its executive chairman and chief executive officer. The company also announced a new board member, Matthew Holt.
The Emmes Group will have two business units: Emmes, its Clinical Research Organization (CRO) led by Peter Ronco, and Veridix AI, the newly launched technology and artificial intelligence (AI) group, led by recently appointed executive Dr. Rama Kondru.
The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward ARPA-H mission needs and Small Business Innovation Research (SBIR) program objectives.
SOLICITATION 75N91024R00006 is anticipated to be made available on or about January 23, 2024 through SAM.gov. This solicitation is anticipated to have a closing date of February 22, 2024 for receipt of proposals.
The purposes of the SBIR program are to: (a) stimulate technological innovation; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and (d) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth.
Are you prepared to discover a transformative shift in orthopedic innovation? Join us in this episode of BioTalk with Rich Bendis as step into the world of Nanochon with CEO Ben Holmes.
Nanochon is leading the charge in the field of medical technology, reimagining the landscape of joint injury treatment. Their inventive implant not only restores damaged cartilage but also fosters fresh tissue growth. Utilizing cutting-edge 3-D printing technology and groundbreaking material, Nanochon’s implant serves as both a resilient orthopedic load-bearing device and a scaffold for tissue regeneration. This advancement is poised to redefine patient recoveries, trim healthcare costs, and establish new benchmarks in cartilage rehabilitation.
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The overall deal flow in biopharma tapered off in 2023 but the big companies sure know what they want (what they really, really want), according to a new report from J.P. Morgan.
And that’s antibody-drug conjugates, which drove a fourth-quarter spike in licensing deal proceeds and provided a glimmer of hope to an industry battered by outside forces and grim financing prospects.
2023 was tough, but clinical biotechs still had a lot of opportunities to wheel and deal, according to J.P. Morgan. While licensing deals, venture investments, M&A and IPOs were down overall in the fourth quarter, deal values stayed fairly high thanks to a flurry of late-stage tie ups.
- NeuMoDx CT/NG Assay designed to improve accessibility, affordability and timeliness in sexually transmitted infection (STI) testing in the U.S.
- U.S. regulatory clearance of new assay for use on both NeuMoDx 96 and 288 versions of integrated PCR-based clinical molecular testing system
- Global presence anchored by 16 EU-certified in-vitro diagnostics (CE-IVD) tests, positioning NeuMoDx as having one of the broadest test menus available to customers
Germantown, Maryland, and Venlo, the Netherlands, Jan. 08, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.
This assay is designed for direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis (CT) and / or Neisseria gonorrhoeae (NG) – the most common type of bacterial infection among sexually transmitted infections (STIs), according to the U.S. National Institutes of Health. The majority of these infections are asymptomatic and generally curable with existing single-dose regimens of antibiotics. However, the time it takes for results to be received is often long, impeding follow-up care.
Thomas (Tommy) Luginbill has accepted the position of executive director of the Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC). PIC MC is part of Montgomery College’s efforts to grow a hub of education, business, and entrepreneurship, where industry partners co-locate and actively interact with faculty and students to achieve both educational and economic success. In this capacity, Luginbill will continue to advance the development of this innovative science and technology hub in collaboration with academic, corporate and government partners.
“I am honored to follow in the footsteps of those who have paved the way before me at PIC MC. Their dedication and hard work have laid the foundation for our mission,” Luginbill said. “We are committed to building upon this legacy, creating a vibrant hub for education, business, and innovation that will continue to thrive and benefit the Montgomery County community. Together with our partners, we are ready to embrace this challenge and honor the past while shaping the future.”
Board appointees represent expertise of Maryland’s academic research institutions
COLUMBIA, Md., Jan. 4, 2024 /PRNewswire/ — TEDCO, Maryland’s economic engine for technology companies, announced the recent appointment of Christina DeMur, director of technology development at Johns Hopkins Technology Ventures, to the Maryland Innovation Initiative Board of Directors.
The Maryland Innovation Initiative (MII) was created as a collaboration between the State of Maryland and five Maryland academic research institutions: Johns Hopkins University (JHU); Morgan State University (MSU); University of Maryland, College Park (UMCP); University of Maryland, Baltimore (UMB); University of Maryland, Baltimore County (UMBC).
Recently this collaboration has expanded to include two more comprehensive universities – Frostburg State University and Bowie State University. This expansion will allow MII to further its reach and help bring more innovative research to the market.