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Gilead, Xilio Therapeutics Ink Exclusive Licensing Agreement to Develop Early Phase Tumor-Activated IL-12

Don Tracy, Associate Editor Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies. Gilead Sciences and Xilio Therapeutics announced that they have agreed to terms on a licensing agreement regarding XTX301, Xilio’s Phase I tumor-activated IL-12. According to Gilead, the partnership aims to expand the company’s focus in immuno-oncology, leveraging Xilio’s novel tumor-activation platform to improve its therapeutic nature and build a consistent pipeline of tumor-activated molecules. As per the deal, Xilio will receive an upfront payment of $43.5 million, with $30 million in cash and an equity investment of $13.5 million provided by Gilead in common stock. Overall, Xilio will have the opportunity to earn up to $604 million based on specified development, regulatory, and sales-based milestones.1 “Xilio’s novel tumor-activation platform naturally complements Gilead’s clinical development program in difficult-to-treat cancers and expands our focus in immuno-oncology,” said Bill Grossman, MD, PhD, SVP, ...
- Source: drugdu
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- April 3, 2024
Upgraded Syndromic Testing Analyzer Enables Remote Test Results Access

QIAGEN (Venlo, the Netherlands) has released the QIAstat-Dx Analyzer 2.0, including the Software 1.6 upgrade. This represents a significant advancement from the initial QIAstat-Dx Analyzer 1.0, offering enhanced capabilities for the accurate, rapid, and cost-effective identification of complex syndromes. The system, which is designed for laboratory settings, incorporates economical, disposable cartridges that integrate sample preparation with all necessary reagents on board. Leveraging multiplex real-time PCR technology, it can identify and distinguish between various pathogens, delivering results within approximately one hour. Additionally, the system enables the display of cycle threshold (Ct) values and amplification curves, providing deeper analytical insights beyond those achievable with endpoint PCR or alternative methodologies. A key feature of this upgraded system is the introduction of the QIAstat-Dx Operational Module PRO, which is equipped with a 64-bit processor and 4GB of RAM. This enables the Remote Results Application, a pioneering tool in syndromic testing that allows for the ...
- Source: drugdu
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- April 3, 2024
Single Genetic Test to Accelerate Diagnoses for Rare Developmental Disorders

Alterations in human DNA range from minor single nucleotide variations to substantial alterations involving the deletion or duplication of extensive DNA segments, known as copy number variations (CNVs). While CNVs contribute significantly to human genetic diversity and are often harmless, they can also lead to various neurodevelopmental disorders like Angelman syndrome, DiGeorge syndrome, and Williams-Beuren syndrome. Children suspected of having genetic conditions due to these significant DNA deletions or duplications typically undergo a lengthy diagnostic process that begins with microarray testing and may advance to more comprehensive genome-wide sequencing tests, such as exome or genome sequencing. Detecting CNVs in sequencing data and interpreting them can be challenging for clinical teams, which is why microarrays are commonly employed. Scientists have now created a single approach to identify these structural alterations using data from genome-wide exome sequencing assays. The findings of the study by researchers from the Wellcome Sanger Institute (Cambridgeshire, UK) ...
- Source: drugdu
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- April 3, 2024
A step towards global harmonisation of GMP inspection protocols

In a letter dated March 21, the US FDA India office country director Sarah McMullen said that four states (Gujarat, Telangana, Goa and Karnataka) had been ‘sensitised to FDA’s inspection process and, as such, are eligible for inclusion as observers for relevant inspection in their respective states.’ The letter goes on to mention, ‘We would appreciate relevant opportunities being made available to state inspectors to attend as observers as practical.’ US FDA’s ‘Observed Inspection Program‘ involves interaction between the USFDA India office and State Drug Control Authorities, with the former inviting the latter as observers during inspections. As the letter indicates, ‘FDA has shared best practices and inspectional protocols in regulatory forums with several states.’ It is logical that the US FDA would now turn to replicate these efforts in other states, especially those with many FDA-registered facilities, like Maharashtra, for instance, and explore the possibility of adding to this ...
- Source: drugdu
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- April 3, 2024
GlobalData

In the dynamic landscape of the pharma industry, collaboration often serves as the key to innovation and expanding market presence. In recent years, the Asia-Pacific (APAC) market has emerged as a hub for pharmaceutical development and investment, attracting attention from both local and global players. While cooperation between APAC-based pharmaceutical companies and their global counterparts has been on the rise, active cooperation among pharma companies within the APAC region is gaining traction, observes GlobalData. According to GlobalData’s Pharmaceutical Intelligence Center, from 2019 to 2023, 673 deals (strategic alliances) occurred among companies that are purely based in APAC, with 360 deals* of them being for unique therapy areas. It is interesting to note that 44 per cent of these deals* are for oncology, followed by infectious diseases (20 per cent), central nervous system disorders (12 per cent), cardiovascular disorders (4 per cent), and ophthalmology (4 per cent). The infectious disease space ...
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- April 3, 2024
WHO publishes new guidelines on hepatitis B

WHO has released new Guidelines on prevention, diagnosis and treatment of chronic hepatitis B (HBV) infection at the 2024 Asian Pacific Conference for the Study of Liver Disease (APASL) in Kyoto, Japan. These guidelines provide a substantial simplification and expansion of eligibility for treatment to overcome barriers in access to HBV testing and treatment. More than 250 million people live with chronic hepatitis B infection, leading to increasing deaths each year. Most of the global burden of chronic hepatitis B (CHB) is due to mother-to-child transmission at or shortly after birth. WHO’s Global health sector strategy sets actions and targets to eliminate viral hepatitis by 2030 by driving new infections and deaths down to half a million each globally – a reduction of 90% and 65%, respectively. Considerable progress has been made towards eliminating mother-to-child transmission of HBV through universal infant HBV immunization, including the timely hepatitis B birth dose. ...
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- April 3, 2024
Promoting a risk-based approach for the regulatory oversight of vaccines used in pandemics

Global guidelines on regulatory preparedness for pandemic influenza vaccines have been revised to strengthen the regulating of vaccines risk-based approaches to vaccine regulation in the event of a pandemic. During the 2009 H1N1 influenza pandemic, the deployment of pandemic influenza vaccines in importing countries was delayed or disrupted due to the lack of regulatory preparedness. This resulted in WHO developing guidelines for non-vaccine producing countries on the appropriate regulatory approaches to the marketing authorization and lot release of pandemic influenza vaccines in public health emergency conditions. These guidelines were developed in the context of the Pandemic Influenza Preparedness (PIP) Framework’s Partnership Contribution High Level Implementation Plan, covering regulatory capacity-building and strengthening of pandemic preparedness and response. However, subsequent public health emergencies such as the Ebola epidemic and COVID-19 pandemic further exposed gaps in regulatory preparedness for other types of pandemic vaccines. The role of national regulatory authorities was not acknowledged ...
- Source: drugdu
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- April 3, 2024
Alebund’s Innovative Investigational Drug AP303 Receives FDA Orphan Drug Designation (ODD) for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

SHANGHAI, March 29, 2024 /PRNewswire/ — Alebund Pharmaceuticals (“Alebund” or the “Company”), an integrated biopharmaceutical company focusing on developing innovative therapies for the treatment of renal diseases and related chronic conditions, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AP303 for the treatment of autosomal dominant polycystic kidney disease (ADPKD). “We are very excited that AP303 has been granted Orphan Drug Designation by the FDA”, Dr. Gavin Xia, Co-founder, Chairman, and CEO of Alebund commented. “It is an important milestone for Alebund as well as our efforts to address the significant unmet medical needs with ADPKD. We look forward to advancing AP303 to improve future treatment options for patients in need.” AP303, a novel drug candidate developed in-house by Alebund, has demonstrated a meaningful improvement of renal survival in an ADPKD mice model. AP303 has completed its first-in-human study in healthy ...
- Source: drugdu
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- April 3, 2024
IASO Bio Announces NMPA’s IND Approval for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma

SHANGHAI and NANJING, China and SAN JOSE, Calif., March 29, 2024 /PRNewswire/ — IASO Bio, a biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, today announced that China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for Equecabtagene Autoleucel (IASO Bio R&D code: CT103A), a self-developed fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma (R/RMM) patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide. The New Drug Application (NDA) for FUCASO ® (Equecabtagene Autoleucel) was approved by NMPA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent on June 30, 2023. The NDA approval was based on the ...
- Source: drugdu
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- April 3, 2024
Labcorp’s $237M Tuck-In Deal Brings Lab Testing Assets From BioReference Health

Labcorp is buying the clinical diagnostics and reproductive women’s health businesses of BioReference Health, excluding those assets in New York and New Jersey. Labcorp has returned to being fully focused on lab testing after last year’s spinoff of Fortrea, its former clinical trial services business. By FRANK VINLUANLabcorp’s testing capabilities are getting a little broader with the $237.5 million acquisition of certain laboratory assets from BioReference Health, a subsidiary of Opko Health. The BioReference assets going to Labcorp span clinical diagnostics and reproductive women’s health across the U.S. and account for about $100 million in annual revenue. The deal announced Thursday excludes those assets in New York and New Jersey, where BioReference will continue to maintain its full operations. BioReference will also continue to offer oncology and urology diagnostic services nationwide. Burlington, North Carolina-based Labcorp was founded as a laboratory testing company in 1969. In 2015, it entered drug development ...
- Source: drugdu
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- April 2, 2024

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