Top 5 Target	Count

KRAS G12C(GTPase KRas G12C)	2
EGFR(Epidermal growth factor receptor erbB1)	2
TLR9(Toll like receptor 9)	1
VCP(Transitional endoplasmic reticulum ATPase)	1
PI3Ks(Phosphatidylinositol 3-kinase family)	1

Drugs associated with Leidos Biomedical Research, Inc.

Cetuximab Sarotalocan Sodium (Genetical Recombination)

Target

EGFR

Mechanism

EGFR antagonists

Active Org.

Rakuten Medical, Inc. [+2]

Originator Org.

Rakuten Medical, Inc.

Active Indication

Head and Neck Neoplasms [+10]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

Japan

First Approval Date25 Sep 2020

BBO-8520

Target

KRAS G12C

Mechanism

KRAS G12C inhibitors

Active Org.

BridgeBio Pharma, Inc. [+2]

Originator Org.

BridgeBio Pharma, Inc.

Active Indication

KRAS G12C mutant Non-small Cell Lung Cancer [+2]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

UPCDC-30766

Target

VCP

Mechanism

VCP inhibitors

Active Org.

Leidos Biomedical Research, Inc.

Originator Org.

Leidos Biomedical Research, Inc.

Active Indication

Neoplasms

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Leidos Biomedical Research, Inc.

NCT06274853

/ WithdrawnPhase 1IIT

A Phase 1, Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose, Multiple Ascending Dose, and Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-441524 in Healthy Subjects

The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of GS-441524 in healthy subjects. The main questions to answer are: 1) What dosage of GS-441524 is required for adequate therapeutic plasma levels? 2) Does fed or fasted state produce variability in plasma levels? 3) How is GS-441524 eliminated from the body.
Participants will receive varying levels of GS-441524 or placebo to evaluate AEs and plasma levels.

Start Date15 Jun 2024

Sponsor / Collaborator

National Center for Advancing Translational Sciences

[+2]

NCT06136117

/ RecruitingNot ApplicableIIT

Mpox, Biology, Outcome, Transmission and Epidemiology - Prospective Follow-up of High-risk Contacts

With the MBOTE-CONTACT study, a detailed follow-up study of high-risk contacts of mpox patients will be done. The MBOTE-CONTACT study will be nested in the NIH-Funded PALM-007 clinical trial (NCT05559099) and the MBOTE project on mpox transmission. The study will take place in Maniema Province, Democratic Republic of Congo (DRC). Participants will be recruited among high-risk contacts of mpox patients included in the PALM-007 trial. Consenting contacts will be either followed daily at the central study site or visited weekly by an outreach team in the community. They will be examined daily for signs and symptoms and asked to provide daily saliva and weekly blood samples for polymerase chain reaction (PCR) and/or serology. If participants develop mpox, they are offered treatment and enrollment in the PALM-007 trial.

Start Date22 May 2023

Sponsor / Collaborator

University of California, Los Angeles

[+4]

NCT04301154

/ Active, not recruitingPhase 1IIT

Phase I, Proof of Concept, Open-Label, Randomized Clinical Trial to Evaluate the Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens With or Without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth

Phase I, Proof of Concept, Open-Label, Randomized Clinical Trial to Evaluate the Safety and Effects of Using Prime-boost HIVIS DNA and MVA-CMDR Vaccine Regimens with or without Toll-like Receptor 4 Agonist on HIV Reservoirs in Perinatally HIV Infected Children and Youth

Start Date18 Feb 2022

Sponsor / Collaborator

The Henry M. Jackson Foundation

[+11]

100 Clinical Results associated with Leidos Biomedical Research, Inc.

0 Patents (Medical) associated with Leidos Biomedical Research, Inc.

234

Literatures (Medical) associated with Leidos Biomedical Research, Inc.

25 Apr 2025·Journal of Human Immunity

DOCK8 Deficiency: Extended Clinical Phenotypes and the Impact of Somatic Reversions

Author: Wang, Chen ; Pai, Sung-Yun ; Rosen, Lindsey ; Jing, Huie ; Harris, Annalie ; Su, Helen ; Gonalez, Corina ; Bianca Chan, Su-Wan ; Shah, Nirali ; Holland, Steven ; Kong, Heidi ; Uzel, Gulbu ; Hickstein, Dennis ; Oram, Layne ; Lisco, Andrea ; Rajasekaran, Sanathanasabapathy ; Freeman, Alexandra ; Kayaoglu, Basak ; Suh, Grace ; Urban, Amanda

IntroductionDOCK8 deficiency is a rare combined immunodeficiency characterized by atopy, recurrent oto-sinopulmonary infections, viral skin infections, and malignancy. Mortality is approximately 50% by age 20 without curative hematopoietic cell transplantation (HCT). We clinically phenotyped our cohort and assessed whether somatic reversions in lymphocytes impacted clinical severity.MethodsWe reviewed the clinical characteristics, laboratory studies, and outcomes of 59 patients with DOCK8 deficiency evaluated at the NIH Clinical Center. Twenty-one anti-cytokine autoantibodies were screened using a multiplex particle-based assay. Somatic reversions restoring DOCK8 protein expression in lymphocytes were assessed by flow cytometry in 49 patients.ResultsThe median age at initial evaluation was 10 years (range 0.5-42), with 54% female. The most common clinical findings were sinopulmonary infections (96.6%), recurrent or chronic viral skin infections (96.6%), and eczema (93.2%). End-organ damage included bronchiectasis (44.1%), liver disease (primarily Cryptosporidium-related) (28.1%), and vasculopathy (17.9%). Malignancies (27.1%) included squamous cell carcinoma (13.6%) and lymphoma (23.7%). Laboratory findings showed elevated serum IgE (87.9%), low serum IgM (62.1%), and lymphopenia-affecting CD4 (64.9%), CD8 (43.9%), and NK cells (52.6%). The overall survival was 64% (age of death 7-45 years; median 18). Forty-five patients (76.3%) underwent HCT with a survival rate of 75.6%; 14 (23.7%) did not undergo HCT with a survival rate of 21.4%. Neutralizing autoantibodies against type I/II interferons were not detected in 57 patients. Forty-nine patients were assessed for lymphocyte somatic reversions; 23 had reversions in lymphocytes, while 26 either did not have reversions or had mutations (e.g., large homozygous deletions) that could not be reverted. Patients with reversions had milder eczema, an increased incidence of warts, older age at HCT, and less CD8 lymphopenia; other clinical features, including malignancy and mortality did not differ from those without reversions.ConclusionsDOCK8 deficiency is associated with a high incidence of morbidity and mortality by early adulthood without curative HCT. Neutralizing autoantibodies against type I/II interferon were not present despite a high burden of viral infections. Somatic reversions were common but did not preclude life-threatening complications, including malignancy.

25 Apr 2025·Journal of Human Immunity

Clinical Features of Adults Aged 50 and Older with STAT3DN Hyper IgE Syndrome

Author: Lafeer, Christine ; Urban, Amanda ; Freeman, Alexandra ; Roy, Susan ; Patel, Meera ; Ulrick, Jean

Backgrounds and AimsHyper IgE syndrome (HIES) resulting from dominant negative STAT3 (STAT3DN) mutations is a multisystem disease where pulmonary infections and complications are recognized as a cause of disability and mortality. Comorbidities for patients with STAT3 DN HIES include hypertension, chronic pain, and depression, which can lead to disruption of daily activities and contribute to decreased quality of life. The aim of this project is to describe the clinical features and disease burden of older patients with STAT3 DN HIES.MethodsWe retrospectively reviewed patients with STAT3 DN HIES, identifying 18 patients aged 50 years or older (9 male, 11 living, median age 56 years).Fifteen patients (83%) had parenchymal lung abnormalities with 6 (33%) requiring oxygen.Thirteen patients (72%) had decreased 6-minute walk distances, which was compounded by chronic pain, which was seen in 10 patients (55%). Three patients had joint replacement and seven had other orthopedic surgeries. 14 (78%) had osteoporosis/osteopenia.Other comorbid conditions include significant gastrointestinal bleeding (5), reflux (12), history of cancer—lymphoma (2), lung (1), thyroid (1), and skin cancer (2). Hearing loss is documented in 9 patients. Eleven patients (61%) take medication for anxiety, depression, or sleep disturbance.Causes of death include pneumonia, respiratory failure, sepsis, lung cancer, and suicide.ConclusionsWith earlier age of diagnosis, aggressive treatment for pulmonary infections, and availability of antifungal agents, people with STAT3 DN HIES may live longer with fewer complications of pulmonary disease. However, this population is medically complicated and has risk factors for cardiovascular disease, bleeding, fractures, and malignancy. There is significant musculoskeletal disease that often leads to chronic pain and decreased mobility. Further study of the vascular and musculoskeletal complications of this disease is needed to improve survival and quality of life.Funded by the NCI Contract No. 75N91019D00024.

25 Apr 2025·Cancer Research

Abstract LB263: A transcriptomic signature predicts mortality risk and immune checkpoint inhibitor response beyond molecular and morphological features in lung adenocarcinoma from never smokers

Author: Baine, Marina K. ; Yang, Soo-Ryum ; Lee, Olivia ; Alexandrov, Ludmil B. ; Hartman, Caleb ; Khandekar, Azhar ; Rosenbaum, Jennifer ; Pesatori, Angela ; Yang, Lixing ; Consonni, Dario ; Sharma, Sunandini ; Colón-Matos, Frank J. ; McElderry, John P. ; Anyaso-Samuel, Samuel ; Sholl, Lynette M. ; Leduc, Charles ; Zhao, Wei ; Zhong, Xiaoming ; Zhang, Tongwu ; Lawrence, Scott ; Shi, Jianxin ; Landi, Maria Teresa ; Hutchinson, Amy ; Saha, Monjoy ; Joubert, Philippe ; Hicks, Belynda ; Jones, Kristine ; Sang, Jian ; Lan, Qing ; Hoang, Phuc H. ; Mutreja, Karun ; Chanock, Stephen J. ; Homer, Robert ; Rothman, Nathaniel ; Wang, Defei ; Yang, Yang ; Miraftab, Mona ; Travis, William D. ; Hua, Xing

AbstractLung adenocarcinoma in never smokers (NS-LUAD) has a high mortality rate. Compared to LUAD from patients with smoking history, NS-LUAD are less sensitive to immune checkpoint blockade (ICB) potentially due to differences in tumor mutational burden and immune microenvironment. Knowledge of NS-LUAD phenotypic plasticity and cell composition can provide guidance for prognosis and treatment. However, previous studies of LUAD gene expression landscape were predominantly conducted in smokers and full transcriptomic sequencing (RNA-seq) was only examined in a few dozens of NS-LUAD. By investigating cell dynamics through RNA-seq data from 684 NS-LUAD, we identified three gene expression-based subtypes that encapsulate tumors’ clinical, morphological, and genomic features. The ‘steady’ subtype features low proliferation markers and high fraction of alveolar cells, while it is depleted of TP53 mutations and ALK fusions. With its moderate-to-well differentiated morphological features, this subtype is associated with prolonged overall survival and predicted favorable response to immune checkpoint inhibitors, independent of the PD1/PD-L1 expression levels. The ‘proliferative’ subtype features increased proliferation, and enrichment of TP53 mutations and ALK and other gene fusions. The ‘chaotic’ subtype is characterized by elevated levels of mesenchymal cell state, increased proportions of cancer associated fibroblasts and histologic features of mixed-lineage, and is associated with worst overall survival, even within stage I tumors. We derived a signature of 60 genes’ expression sufficient to recapitulate the transcriptomic classification and validated it in an independent NS-LUAD dataset. This 60-gene signature strongly predicted survival even within subgroups based on tumor stage and beyond known molecular or morphological features, confirming its importance for NS-LUAD prognostication in clinical settings.Citation Format:Wei Zhao, Tongwu Zhang, Xing Hua, Phuc H. Hoang, Mona Miraftab, Monjoy Saha, John P. McElderry, Jian Sang, Olivia Lee, Caleb Hartman, Azhar Khandekar, Sunandini Sharma, Frank J. Colón-Matos, Samuel Anyaso-Samuel, Defei Wang, Kristine Jones, Amy Hutchinson, Belynda Hicks, Jennifer Rosenbaum, Xiaoming Zhong, Yang Yang, Angela Pesatori, Dario Consonni, Karun Mutreja, Scott Lawrence, Nathaniel Rothman, Ludmil B. Alexandrov, Charles Leduc, Marina K. Baine, Philippe Joubert, Lynette M. Sholl, William D. Travis, Robert Homer, Qing Lan, Stephen J. Chanock, Lixing Yang, Soo-Ryum Yang, Jianxin Shi, Maria Teresa Landi. A transcriptomic signature predicts mortality risk and immune checkpoint inhibitor response beyond molecular and morphological features in lung adenocarcinoma from never smokers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr LB263.

News (Medical) associated with Leidos Biomedical Research, Inc.

18 Feb 2025

·www.prnewswire.com

The Inner Circle acknowledges, Elizabeth Roulette Baseler as a 2025 Pinnacle Professional Member

UNION BRIDGE, Md., Feb. 18, 2025 /PRNewswire/ -- Prominently featured in The Inner Circle, Elizabeth Roulette Baseler is acknowledged as a 2025 Pinnacle Professional Member Inner Circle of Excellence for her contributions in Healthcare and Research. Continue Reading Elizabeth Roulette Elizabeth Roulette Baseler, a distinguished leader in healthcare and clinical research with over 46 years of experience, currently serves as a Senior Clinical Project Manager at Manpower, a position she has held since 2023. Ms. Baseler's illustrious career includes a notable tenure with Leidos Biomedical Research Inc., where she advanced from 1978 to 2022 to become the Director of Clinical Monitoring for the Research Program Directorate at the Frederick National Laboratory for Cancer Research. In her role, she has been instrumental in establishing clinical infrastructure and ensuring regulatory compliance for clinical trials conducted by the National Institutes of Health, both in the United States and internationally. Ms. Baseler has traveled to over 29 countries, setting up clinical trials and managing teams in diverse and challenging environments. Her work includes significant contributions to the Ebola outbreak response in West Africa (2014-2016). A graduate of McDaniel College with a Bachelor's degree in Biology and Hood College with a Master of Science in Administration and Management, Ms. Baseler is affiliated with several professional organizations, including the Society of Clinical Research Associates and the Regulatory Affairs Professionals Society. She is also an active volunteer mentor at Woman to Woman Mentoring and contributes to Blessings in a Backpack and the Ocean City Reef Foundation. Her career has been marked by prestigious recognitions, including the Directors Award from the NIH and accolades from the National Institute of Allergy and Infectious Diseases. As she looks to the future, Ms. Baseler aims to continue her growth in clinical research, expand her involvement in mentoring and women's leadership, and share her experiences through writing. Ms. Baseler values the support of her family and mentors, remains passionate about biology and clinical research, and believes in the importance of networking, seeking advice, and effective public speaking. Contact: Katherine Green, 516-825-5634, [email protected] SOURCE The Inner Circle WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Executive Change

04 Sep 2024

·www.globenewswire.com

Nanocarry Therapeutics' Brain Penetrating Nanoplatform Selected by the NCI Nanotechnology Characterization Laboratory for its Preclinical Characterization Program

Program Will Facilitate Filing an IND Application Toward Human Clinical TrialsNESS ZIONA, Israel, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Nanocarry Therapeutics, a pioneering biopharmaceutical company focused on advancing treatments for brain diseases through its innovative AxS nanoparticle platform, announced the selection of its lead product, AxS007, by the U.S. National Cancer Institute’s (NCI’s) Nanotechnology Characterization Laboratory (NCL) for comprehensive preclinical characterization. The NCL is located at the Frederick National Laboratory for Cancer Research, operated for NCI by Leidos Biomedical Research, Inc. Over 400 million people globally suffer from brain diseases that remain insufficiently treated due to the Blood-Brain Barrier (BBB) blocking most therapeutics. Nanocarry's AxS technology utilizes an insulin-based nanoplatform to cross the BBB, enabling the delivery of multiple copies and combinations of antibodies, small molecules, and other therapeutics to the brain, thus targeting various central nervous system disorders. AxS007 specifically targets brain metastases of HER2+ breast cancer, which affects 50% of metastatic breast cancer patients and represents a significant unmet need. The NCL was established to advance the use of nanotechnology in cancer research and accelerate the development of promising nanomedicine-based therapeutics. The NCI partners with the National Institute of Standards and Technology (NIST) and the FDA, offering preclinical testing and services on a competitive acceptance basis, to expedite the transition of nanomedicines from early-stage development to clinical applications. Through this collaboration, the NCL will conduct detailed preclinical evaluations of AxS007. These studies will support the advancement of AxS007 towards filing an Investigational New Drug (IND) application with the FDA and facilitate future clinical development. This partnership will also strengthen collaborations focused on utilizing AxS technology with diverse therapeutic agents to treat various brain diseases. "We are very pleased and honored that AxS007 has been selected for the NCL program, marking a pivotal moment for Nanocarry Therapeutics," said Revital Mandil-Levin, Co- founder and CEO of Nanocarry Therapeutics. "The detailed characterization by the NCL will significantly accelerate the development of AxS007 towards clinical trials. Our lead product addresses breast cancer brain metastases, a severe complication of HER2+ metastatic breast cancer in which current treatments often fail due to the BBB, drastically reducing survival rates. Our mission is to replicate the prominent success of HER2+ therapeutic antibodies and extend it to the brain, aiming to improve outcomes for the 1 in 8 women who will develop breast cancer in their lifetime.” About Nanocarry Therapeutics Nanocarry Therapeutics is a biopharmaceutical company dedicated to transforming brain disease treatment through an advanced insulin-based nano delivery system that crosses the blood-brain barrier. Founded in 2021 and rooted in the nano-bioengineering lab at Bar Ilan University, the company's lead product targets HER2+ breast cancer brain metastases and is now entering IND-enabling studies. The early pipeline also includes neurodegenerative diseases. Nanocarry Therapeutics aims to improve patient outcomes by delivering innovative therapies to previously unreachable areas of the brain. For more information about Nanocarry Therapeutics, visit www.nanocarry.com. Nanocarry contact:Michal Roytman Chief Business Officer Tel: +972-50-8460424michal@nanocarry.com

02 May 2024

·www.biospace.com

BridgeBio Spins Out Oncology Company with $200M in Financing

Pictured: 3D image of a KRAS oncogene iStock/Gilnature BridgeBio announced Thursday that it has secured $200 million in financing to spinout a former subsidiary to develop a KRAS-focused oncology portfolio. Called BridgeBio Oncology Therapeutics (BBOT), the company was initially formed as a subsidiary of BridgeBio known as TheRas. According to an SEC filing, the subsidiary has existed since 2016 and formed a research and development agreement with Leidos Biomedical Research in 2017. BBOT’s mission now is to generate a pipeline of small molecule therapeutics targeting RAS and PI3K malignancies. The company aims to advance three programs, including BBO-8520, a direct inhibitor of KRAS that seeks to bind to the protein’s “on” and “off” states. The spinout is enrolling patients with mutant non-small cell lung cancer in a Phase Ia/Ib trial. A second asset that BBOT will be advancing is BBO-10203, a PI3Kα:RAS breaker that blocks the interaction between RAS and PI3Ka to inhibit the PI3Kα/AKT effector signaling in tumors. The company plans to IND application sometime in the second quarter of 2024 and enroll patients later this year. The other asset is BBO-11818, a pan-KRAS inhibitor that is going after the “on” and “off” states of KRASG12X, and BBOT plans to IND sometime in early 2025. The company is also pursuing a discovery-stage research program focused on developing assets that target additional oncogenic drivers within the RAS and PI3K pathways. “We believe the launch of BBOT better aligns investors with an opportunity that was being hidden in our pipeline, and our partnership with these new investors enables us to prosecute these oncology programs more quickly and with higher fidelity,” BridgeBio CEO Neil Kumar said in a statement. The spinout secured its $200 million financing in an oversubscribed round led by Cormorant Asset Management and co-led by Omega Funds. There was also participation from GV (Google Ventures), Deerfield Management, EcoR1 Capital, Wellington Management, Enavate Sciences, Surveyor Capital, Casdin Captial, Aisling Capital, and Longwood Fund. BBOT will headed by Eli Wallace, BridgeBio’s CEO of oncology R&D. Wallace joined BridgeBio in 2019 after serving as the chief scientific officer at Peloton Therapeutics. Kumar will also serve as a director of BBOT. “In conjunction with BridgeBio and an amazing suite of investors, we look forward to seeing all three of our programs progress into the clinic over the next 12 months,” Wallace said in a statement. BridgeBio has gone down the spinout path before, launching QED Therapeutics in 2018. The company secured $65 million and aimed to develop infigratinib, a cancer asset that Novartis abandoned. Infigratinib was given accelerated approval by the FDA in 2021. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Executive Change

100 Deals associated with Leidos Biomedical Research, Inc.

100 Translational Medicine associated with Leidos Biomedical Research, Inc.

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Pipeline

Pipeline Snapshot as of 12 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Preclinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Cetuximab Sarotalocan Sodium (Genetical Recombination) ( EGFR )	EGFR positive Neoplasms More	Preclinical
Panitumumab-IR700 ( EGFR )	EGFR positive Neoplasms More	Preclinical
KRAS G12C inhibitors (Leidos Biomedical Research) ( KRAS G12C )	Neoplasms More	Preclinical
BBO-8520 ( KRAS G12C )	KRAS G12C mutation Solid Tumors More	Preclinical
UPCDC-30766 ( VCP )	Neoplasms More	Preclinical

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