This phase Ib trial tests the safety, side effects, and best dose of the combination of vismodegib and atezolizumab in treating patients with non-small cell lung cancer (NSCLC) that has come back after a period of improvement (recurrent) or has spread from where it first started (primary site) to other places in the body (metastatic). Vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving a combination of vismodegib and atezolizumab may be safe, tolerable and/or effective than either drug alone in treating patients with recurrent or metastatic NSCLC.

Start Date01 Dec 2024

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

[+1]

NCT06344052 / RecruitingPhase 2

A Phase 2 Study to Assess the Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma

The goal of this clinical trial is to evaluate the efficacy of using SP-002 in participants with locally advanced Basal cell carcinoma. The main question it aims to answer is what the objective response rate for a basal cell carcinoma tumor is following 1 or 3 cycles of SP-002 treatment given as an add-on to hedgehog pathway inhibitor therapy.
Researchers will compare the objective response rate for treated Basal cell carcinoma tumors between 3 treatment Arms.
* Arm 1 participants will receive daily hedgehog pathway inhibitor, and 3 cycles of SP-002 treatment.
* Arm 2 participants will receive daily hedgehog pathway inhibitor, and 1 cycle of SP-002 treatment.
* Arm 3 participants will receive daily hedgehog pathway inhibitor only.

Start Date09 Apr 2024

Sponsor / Collaborator

Stamford Pharmaceuticals, Inc.

NCT05561634 / Not yet recruitingPhase 2IIT

Evaluation of Radiotherapy After Complete Response to Sonic Hedgehog Pathway Inhibitors in Patients With Locally Advanced Basal Cell Carcinoma: a Prospective Multicenter Study

Locally advanced basal cell carcinoma (BCC) are large BCCs or BCCs located in areas subject to functional and aesthetic risk following surgery or radiotherapy. In these particular situations, surgery and radiotherapy are sometimes not appropriate, and Sonic Hedgehog inhibitors (SHHi) (Vismodegib and Sonidegib) can be proposed. SHHi are effective treatments in laBCC but most CR patients discontinue treatment because of tolerability. Approximately 65% of the population experience a relapse after discontinuation. A few cases of patients treated concomitantly by radiotherapy and vismodegib have been reported in the literature, suggesting that combining vismodegib and concomitant radiotherapy results in an improved overall response compared to a single modality treatment. There is no study evaluating a "consolidation radiotherapy" after complete response to SHHi. We carry out a prospective multicenter study in order to evaluate consolidation radiotherapy in patients with laBCC after achieving complete response with SHHi, with the hypothesis of reducing recurrence after discontinuation of SHHi.

Start Date01 Jul 2023

Sponsor / Collaborator

Centre Hospitalier Universitaire de Lille

[+1]

100 Clinical Results associated with Vismodegib

100 Translational Medicine associated with Vismodegib

100 Patents (Medical) associated with Vismodegib

962

Literatures (Medical) associated with Vismodegib

01 Jan 2025·BIOMATERIALS

Bioactive nanocomposite hydrogel enhances postoperative immunotherapy and bone reconstruction for osteosarcoma treatment

Article

Author: Fu, Hao ; Mi, Bobin ; Yan, Chenchen ; Bian, Liming ; Zeng, Ruiyin ; Chu, Xiangyu ; Wang, Ruinan ; Liu, Guohui ; Lin, Jiali ; Liu, Tuozhou ; Xiong, Yuan ; Hu, Liangcong ; Zhang, Kunyu

Osteosarcoma, a malignant bone tumor often characterized by high hedgehog signaling activity, residual tumor cells, and substantial bone defects, poses significant challenges to both treatment response and postsurgical recovery. Here, we developed a nanocomposite hydrogel for the sustained co-delivery of bioactive magnesium ions, anti-PD-L1 antibody (αPD-L1), and hedgehog pathway antagonist vismodegib, to eradicate residual tumor cells while promoting bone regeneration post-surgery. In a mouse model of tibia osteosarcoma, this hydrogel-mediated combination therapy led to remarkable tumor growth inhibition and hence increased animal survival by enhancing the activity of tumor-suppressed CD8⁺ T cells. Meanwhile, the implanted hydrogel improved the microenvironment of osteogenesis through long-term sustained release of Mg²⁺, facilitating bone defect repair by upregulating the expression of osteogenic genes. After 21 days, the expression levels of ALP, COL1, RUNX2, and BGLAP in the Vis-αPD-L1-Gel group were approximately 4.1, 5.1, 5.5, and 3.4 times higher than those of the control, respectively. We believe that this hydrogel-based combination therapy offers a potentially valuable strategy for treating osteosarcoma and addressing the tumor-related complex bone diseases.

01 Oct 2024·TALANTA

Development of a molecularly imprinted polymer-based electrochemical sensor with metal-organic frameworks for monitoring the antineoplastic drug vismodegib

Article

Author: Kaya, S Irem ; Bellur Atici, Esen ; Ozkan, Sibel A ; Çetinkaya, Ahmet ; Hosseinzadeh, Batoul

A novel and robust electrochemical sensing tool for the determination of vismodegib (VIS), an anticancer drug, has been developed by integrating the selective recognition capabilities of molecularly imprinted polymer (MIP) and the sensitivity enhancement capability of metal-organic framework (MOF). Prior to this step, the electrochemical behavior of VIS was investigated using a bare glassy carbon electrode (GCE). It was observed that in 0.5 M H₂SO₄ solution as electrolyte, VIS has an oxidation peak around 1.3 V and the oxidation mechanism is diffusion controlled. The determination of VIS in a standard solution using a bare GCE showed a linear response in the concentration range from 2.5 μM to 100 μM, with a limit of detection (LOD) of 0.75 μM. Since sufficient sensitivity and selectivity could not be achieved with bare GCE, a MIP sensor was developed in the next step of the study. For this purpose, the GCE surface was first modified by drop casting with as-synthesized Co-MOF. Subsequently, a MIP network was synthesized via a thermal polymerization approach using 2-acrylamido-2-methylpropanesulfonic acid (AMPS) as monomer and VIS as template. MOFs are ideal electrode materials due to their controllable and diverse morphologies and modifiable surface properties. These characteristics enable the development of MIPs with more homogeneous binding sites and high affinity for target molecules. Integrating MOFs could help the performance of sensors with the desired stability and reproducibility. Electrochemical analysis revealed an observable enhancement of the output signal by the incorporation of MOF molecules, which is consistent with the sensitivity-enhancing role of MOF by providing more anchoring sites for the attachment of the polymer texture to the electrode surface. This MOF-MIP sensor exhibited impressive linear dynamic ranges ranging from 0.1 to 1.0 pM for VIS, with detection limits in the low picomolar range. In addition, the MOF-MIP sensor offers high accuracy, selectivity and precision for the determination of VIS, with no interference observed from complex media of serum samples. Additionally, in this study, Analytical GREEnness metric (AGREE), Analytical GREEnness preparation (AGREEprep) and Blue Applicability Grade Index (BAGI) were used to calculate the green profile score.

21 Sep 2024·BRITISH JOURNAL OF CANCER

Reasons for non-feasibility of therapeutic drug monitoring of oral targeted therapies in oncology – an analysis of the closed cohorts of a multicentre prospective study

Article

Author: Koolen, Stijn L W ; Steeghs, Neeltje ; van Erp, Nielka P ; van der Kleij, Maud B A ; Huitema, Alwin D R ; Gelderblom, Hans ; Desar, Ingrid M E ; Imholz, Alex L T ; Mathijssen, Ron H J ; Reyners, An K L ; Guchelaar, Niels A D ; Bleckman, Roos F ; Giraud, Eline L ; Moes, Dirk-Jan A R ; van Eerden, Ruben A G ; Groenland, Stefanie L ; Meertens, Marinda ; Fiebrich-Westra, Helle-Brit ; Otten, Hans-Martin ; Touw, Daan J ; Westerdijk, Kim ; Lubberman, Floor J E ; Vulink, Annelie J E

Abstract:

Background:

Therapeutic drug monitoring (TDM) – performing dose adjustments based on measured drug levels and established pharmacokinetic (PK) targets – could optimise treatment with drugs that show large interpatient variability in exposure. We evaluated the feasibility of TDM for multiple oral targeted therapies. Here we report on drugs for which routine TDM is not feasible.

Methods:

We evaluated drug cohorts from the Dutch Pharmacology Oncology Group – TDM study. Based on PK levels taken at pre-specified time points, PK-guided interventions were performed. Feasibility of TDM was evaluated, and based on the success and practicability of TDM, cohorts could be closed.

Results:

For 10 out of 24 cohorts TDM was not feasible and inclusion was closed. A high incidence of adverse events resulted in closing the cabozantinib, dabrafenib/trametinib, everolimus, regorafenib and vismodegib cohort. The enzalutamide and erlotinib cohorts were closed because almost all PK levels were above target. Other, non-pharmacological reasons led to closing the palbociclib, olaparib and tamoxifen cohort.

Conclusions:

Although TDM could help personalising treatment for many drugs, the above-mentioned reasons can influence its feasibility, usefulness and clinical applicability. Therefore, routine TDM is not advised for cabozantinib, dabrafenib/trametinib, enzalutamide, erlotinib, everolimus, regorafenib and vismodegib. Nonetheless, TDM remains valuable for individual clinical decisions.

News (Medical) associated with Vismodegib

23 Sep 2024

·www.prnewswire.com

Curis Announces the 3rd Annual Symposium on IRAK4 in Cancer

Symposium hosted by Eric S. Winer, MD, and Grzegorz S. Nowakowski, MD Updated data for 10 evaluable patients in Curis's PCNSL study Experts will present at the virtual meeting, free and open to the public, on September 26, 2024 LEXINGTON, Mass., Sept. 23, 2024 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced the 3rd Annual Symposium on IRAK4 in Cancer taking place virtually on September 26, 9:00 AM-1:00 PM E.T. Hosted by Dr. Eric S. Winer (Dana-Farber Cancer Institute) and Dr. Grzegorz S. Nowakowski (Mayo Clinic Comprehensive Cancer Center), this symposium will focus on IRAK4, an emerging target in the treatment of hematologic malignancies and solid tumors. Experts will discuss the promise of IRAK4 inhibition in cancer, including current clinical studies of emavusertib and opportunities for future development. Symposium presentations will include updated data for 10 evaluable R/R PCNSL patients as of the July 10, 2024 cutoff date. The Company continues to enroll patients in the PCNSL study and is on track to enroll 15-20 patients by year-end. "As the leader in IRAK4 inhibition in oncology with emavusertib, we are honored to provide a forum for discussing the biology of the IRAK4 pathway and IRAK4 inhibition in the research and development of therapies to benefit patients living with cancer," said James Dentzer, President, and Chief Executive Officer of Curis. Symposium co-chairs: Eric Winer, MD, Clinical Director and Adult Leukemia Institute Physician, Dana-Farber Cancer Institute; Assistant Professor of Medicine, Harvard Medical School Grzegorz Nowakowski, MD, Professor of Oncology and Medicine, Division of Hematology, Deputy Director of Mayo Clinic Comprehensive Cancer Center for Clinical Research and Vice-Chair of Division of Hematology Joining our hosts will be the following speakers and participants: Bently Doonan, MD, Assistant Professor, Division of Hematology and Oncology, University of Florida College of Medicine Andrés Ferreri, MD, Contract Professor of Oncology, University Vita-Salute San Raffaele; Head of the Lymphoma Unit, I.R.C.C.S. Ospedale San Raffaele Klaus Metzeler, MD, Professional of Translational Hematology, University of Leipzig Guillermo Garcia-Manero, MD, Professor, Chief of Section of Myelodysplastic Syndromes, Deputy Chair of Translational Research and Fellowship Program Director Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center Marina Konopleva, MD, PhD, Professor of the Department of Oncology, Professor of the Department of Molecular Pharmacology, and Miriam Mandel Faculty Scholar in Cancer Research, Albert Einstein College of Medicine Kian Lim, MD, PhD, Associate Professor, Department of Medicine, Division of Oncology, Washington University School of Medicine in St. Louis Lakshmi Nayak, MD, Director of the Center for CNS Lymphoma Dana‑Farber Cancer Institute; Associate Professor of Neurology, Harvard Medical School Han Tun, MD, Hematologist, Internist, Oncologist, Departments of Hematology and Mayo Clinic Comprehensive Cancer Center To learn more about this free-to-attend symposium and register, please visit About Curis, Inc. Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor. Emavusertib is currently undergoing testing in the Phase 1/2 TakeAim Lymphoma study (CA-4948-101) in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) in combination with the BTK inhibitor ibrutinib, as a monotherapy in the Phase 1/2 TakeAim Leukemia study (CA-4948-102) in patients with relapsed/refractory acute myeloid leukemia (AML) and relapsed/refractory high risk myelodysplastic syndrome (hrMDS) with either a FLT3 mutation or a splicing factor mutation (U2AF1 or SF3B2), and as a frontline combination therapy with azacitidine and venetoclax in patents with AML (CA-4948-104). Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML and MDS and from the European Commission for the treatment of PCNSL. Curis, through its 2015 collaboration with Aurigene, has the exclusive license to emavusertib (CA-4948). Curis licensed its rights to Erivedge® to Genentech, a member of the Roche Group, under which they are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis's website at . SOURCE Curis, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inOrphan DrugASH

16 Sep 2024

·www.prnewswire.com

Kyverna Therapeutics Announces Leadership Update

– Warner Biddle Appointed as Chief Executive Officer and to Board of Directors, Bringing Over 30 Years of Commercial, Product Planning and Franchise Leadership Experience, Including Successful Launches for CAR T Pioneer in Hematology – Christi Shaw, Life Sciences Leader at Multiple Major Pharmaceutical and Biotech Companies and Across Therapeutic Areas, Appointed to Board of Directors – Together Strengthen Leadership as Trailblazers of Cell Therapy with Extensive Experience Leading Through Clinical Development, Manufacturing, Commercial Launch and Expansion EMERYVILLE, Calif., Sept. 16, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced the appointment of Warner Biddle as the Company's Chief Executive Officer (CEO) and a member of its Board of Directors. Mr. Biddle succeeds Peter Maag, Ph.D., who has resigned from his role as CEO and a member of the Board, effective immediately. In addition, Kyverna announced the appointment of Christi Shaw to its Board of Directors. Ms. Shaw succeeds Brian Kotzin, M.D., who has decided to step down from the Board of Directors. "Since its inception in 2018, Kyverna has made tremendous progress in pursuit of a paradigm shift for patients with autoimmune disease. Kyverna today sits on the precipice of its next chapter, as KYV-101 is progressing rapidly into later stages of development and embarking on a path to market. This introduces new and exciting opportunities, which Peter and the Board recognized the company must evolve to meet," said Ian Clark, Chairman of the Board of Directors at Kyverna. "I am delighted to welcome Warner Biddle, who brings a broad set of experiences which are the right fit to guide Kyverna into the future. He joins with over 30 years of global experience leading product planning and commercialization, most recently for pioneering CAR T therapies at Kite, and a track record for building successful teams and delivering results. We are also excited to welcome Christi Shaw, whose decades spent in executive roles with portfolio leadership and vast operational scope make her a tremendous addition to our Board of Directors. Together, we believe their rich experience advancing and commercializing cell therapies in hematology will extend Kyverna's leading position for CAR T in autoimmune disease." Mr. Biddle is a seasoned pharmaceutical executive, with over 30 years of global experience in senior commercial and franchise leadership roles across various products, disease areas and geographies. Most recently, he served as Senior Vice President, Global Head of Commercial at Kite Pharma (a Gilead Company). In this role, Mr. Biddle led multiple product launches and market-building initiatives, driving unprecedented growth for Yescarta® and Tecartus® that established Kite as a leader in the cell therapy market. In addition, in 2023, Mr. Biddle was selected by the Gilead Chairman and CEO to act as interim Head of Kite (CEO), during which time he led Kite's research, development, medical affairs, technical operations, corporate development and G&A functions. Prior to joining Kite in 2020, Mr. Biddle spent a decade at Genentech, where he successfully led the Breast/Gynecology, Skin Cancer and Ophthalmology franchises through multiple launches and line extensions for both large and smaller products including Kadcyla®, Tecentriq®, Erivedge® and Lucentis®. Earlier, Mr. Biddle held senior commercial and franchise leadership roles at Novartis and GlaxoSmithKline (GSK) working in Canada, the United Kingdom and Switzerland. Mr. Biddle holds an Honors Degree in Commerce from the University of Saskatchewan, with a specialization in Marketing and Statistics. "CAR T therapeutics represent an entirely new therapeutic category in the treatment of autoimmune disease and Kyverna is a leader in this pursuit, with promising clinical programs in development and next-generation innovations on the horizon to further improve administration and accessibility. KYV-101 has already demonstrated encouraging efficacy and safety from an initial dataset across 15 indications, with commercial prospects accelerating for stiff person syndrome and myasthenia gravis, and still much broader potential to serve more than 8 million patients with B cell-driven diseases," said Mr. Biddle. "I am excited to join the company at this pivotal stage in its growth and to build on the strong foundation already in place at Kyverna. I have seen firsthand the transformative impact of CAR T therapeutics on patients' lives and am eager to work alongside this team to extend the reach of CAR T therapies to many more patients and bring them the innovations they are waiting for." Ms. Shaw has spent more than 30 years in executive leadership roles across the industry's largest pharmaceutical companies and a broad range of therapeutic areas. Most recently, Ms. Shaw served as the Chief Executive Officer of Kite. Earlier, Ms. Shaw served as Senior Vice President of Eli Lilly Company and President of Lilly Bio-Medicines, the business within Eli Lilly Company that comprises neuroscience and immunology. Previously, Ms. Shaw was an executive at Novartis Pharmaceutical Corporation, including as U.S. country head and President of Novartis Pharmaceutical Corporation and as North American region head of Novartis Oncology, and earlier held leadership roles of increasing responsibility at Johnson & Johnson, Inc. Ms. Shaw currently serves on the board of directors of Avantor, Beam Therapeutics and ReAlta Lifesciences, and is an advisor to Cellares and the Iowa State Ivy College of Business. In addition, she is the co-founder of the More Moments More Memories Foundation to assist people with cancer and their caregivers. Ms. Shaw holds an M.B.A. from the University of Wisconsin and a B.B.A. in Marketing from Iowa State University. Mr. Clark added, "On behalf of the Board, I also want to extend our thanks to Peter for his leadership of Kyverna. Over the past two years, Peter laid a strong foundation for the company, translating exploratory science into a robust clinical program across several indications, and establishing strong financial footing with a successful initial public offering earlier this year. We appreciate his contributions and wish him the best in his future endeavors." Inducement Grant In connection with the appointment of Mr. Biddle as Kyverna's Chief Executive Officer and a member of its Board of Directors, on September 16, 2024, Kyverna granted Mr. Biddle an option to purchase 2,579,259 shares of its common stock (Option). The Option was granted pursuant to the Kyverna Therapeutics, Inc. 2024 Inducement Equity Incentive Plan, as approved by the compensation committee of Kyverna's Board of Directors on September 14, 2024, and was granted as an inducement material to Mr. Biddle's employment with Kyverna in accordance with Nasdaq Listing Rule 5635(c)(4). The exercise price of the Option will be the closing price of Kyvenra's common stock on September 16, 2024, the date of grant. The Option will vest over four years, with 25% of the total number of shares subject to the Option vesting on the one-year anniversary of Mr. Biddle's appointment and 1/48th of the total number of shares subject to the Option vesting monthly thereafter, subject in each case to Mr. Biddle's continued service to Kyverna on each vesting date. Kyverna is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4). About Kyverna Therapeutics Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for stiff-person syndrome, multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with lupus nephritis. Kyverna's pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: leadership transition matters; KYV-101's safety, efficacy and commercial prospects; Kyverna's ongoing clinical trials; Kyverna's pipeline and the potential for Kyverna's CAR T-cell therapies to be well suited for use in B cell-driven autoimmune diseases. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, and other factors discussed in the "Risk Factors" section of Kyverna's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna's management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. For more information, please visit . Contact: Precision AQ on behalf of Kyverna Therapeutics Investors: [email protected] Media: [email protected] SOURCE Kyverna Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Executive ChangeCell TherapyPhase 2

10 Sep 2024

·www.prnewswire.com

Adcentrx Therapeutics Announces Formation of Scientific Advisory Board

Company appoints Mike Varney, Ph.D. and Kerry Blanchard, M.D., Ph.D. as founding SAB members SAN DIEGO and SHANGHAI, Sept. 10, 2024 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company focused on accelerating breakthroughs in developing protein conjugate therapeutics for cancer and other life-threatening diseases, today announces the formation of its Scientific Advisory Board (SAB) to support the advancement of its innovative Antibody-Drug Conjugate (ADC) technology platform and pipeline, including ADRX-0706, a Nectin-4 targeting ADC therapeutic currently being evaluated in a Phase 1a/b clinical trial. Continue Reading The inaugural SAB will work closely with Adcentrx's executive team to provide strategic guidance and expert insights to advance its mission of creating the best therapies to treat serious and life-threatening diseases. Formation of SAB with founding members Dr. Varney and Dr. Blanchard represents significant advancement for Adcentrx. Post this "The establishment of our SAB represents a significant advancement for Adcentrx as we progress our ADC portfolio," said Hui Li, Ph.D., President and CEO of Adcentrx. "We are privileged to welcome these exceptional scientific leaders to the Adcentrx team, and their combined expertise and guidance will be instrumental in shaping our future research and clinical development." The Founding Members of the Adcentrx SAB are: Mike Varney, Ph.D. Dr. Varney brings extensive experience in drug discovery and development, having served as Executive Vice President, Head of Genentech Research and Early Development, where he was responsible for all research activities. During his tenure at Genentech, he oversaw the discovery and development of multiple innovative therapies, including the approved cancer treatments Erivedge® and Cotellic®. Earlier in his career, Dr. Varney pioneered the use of protein-structure based drug design at Agouron Pharmaceuticals. This innovative approach led to the discovery and market approval of HIV protease inhibitor, Viracept®. After Agouron's acquisition by Warner Lambert and subsequently by Pfizer, he served as Vice President of Drug Discovery at Pfizer Global Research & Development, leading research initiatives across oncology, virology, diabetes, and ophthalmology at the La Jolla site. Dr. Varney holds a Ph.D. in Organic Synthesis from the California Institute of Technology and a B.S. in Chemistry from the University of California, Los Angeles, and was an American Cancer Society Postdoctoral Research Fellow at Columbia University. Kerry Blanchard, M.D., Ph.D. Dr. Blanchard has been a drug hunter and entrepreneur for more than four decades in the US and Asia. He is currently cofounder, Chairman, and CEO of Perpetual Medicines, a peptide therapeutics/computational AI platform company. Previously, he was the CEO of Everest Medicines, Chief Science Officer at Innovent Biologics, Senior Vice President of Lilly China Drug Development and External Innovation, and a senior executive at Eli Lilly and Company. He was a member of the board for Lilly China and Zymeworks Inc., and was the co-chairman of the Lilly Asia Ventures Investment Committee. Prior to joining Lilly in 2000, he was a tenured Professor of Medicine and Biochemistry & Molecular Biology at Louisiana State University Health Sciences Center in Shreveport, LA. Dr. Blanchard has brought four medicines to the market from his own research including Verzenio®, a CDK 4/6 inhibitor, and, his development teams in China have had more than 30 approved medicines in Asia including Trodelvy®, Trulicity®, Byetta®, Forteo®, and Tyvyt®. At Innovent and Everest, Dr. Blanchard successfully raised over $2 billion to support and expand their pipelines. His track record in accelerating clinical development and navigating regulatory landscapes will significantly enhance Adcentrx's strategic initiatives and global expansion. Dr. Blanchard received his M.D. and Ph.D. in Biochemistry from Indiana University and completed his residency and fellowships at Brigham and Women's Hospital, Dana Farber Cancer Institute, and Harvard Medical School. About Adcentrx Therapeutics Adcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of i-Conjugation™, an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. In addition to ADRX-0706, Adcentrx is developing a robust pipeline of ADCs with first-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit . Contact Information: Investor Relations [email protected] SOURCE Adcentrx Therapeutics

Executive ChangeAcquisitionADC

100 Deals associated with Vismodegib

External Link

KEGG	Wiki	ATC	Drug Bank
D09992	Vismodegib	L01XX43	DB08828

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Metastatic basal cell carcinoma	EU	Roche Registration GmbH	12 Jul 2013
Metastatic basal cell carcinoma	IS	Roche Registration GmbH	12 Jul 2013
Metastatic basal cell carcinoma	LI	Roche Registration GmbH	12 Jul 2013
Metastatic basal cell carcinoma	NO	Roche Registration GmbH	12 Jul 2013
Basal Cell Carcinoma	US	Genentech, Inc.	30 Jan 2012

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Platinum-Resistant Fallopian Tube Carcinoma	Phase 2	US	Genentech, Inc.	15 May 2023
Platinum-Resistant Primary Peritoneal Carcinoma	Phase 2	US	Genentech, Inc.	15 May 2023
Odontogenic Tumors	Phase 2	US	Genentech, Inc.	27 Oct 2015
Chronic graft-versus-host disease	Phase 2	US	Genentech, Inc.	08 Sep 2015
Steroid Refractory Graft Versus Host Disease	Phase 2	US	Genentech, Inc.	08 Sep 2015
Idiopathic Pulmonary Fibrosis	Phase 2	-	Hoffmann-La Roche, Inc.	01 Oct 2014
Advanced Malignant Solid Neoplasm	Phase 2	US	Genentech, Inc.	14 Apr 2014
Biliary Tract Neoplasms	Phase 2	US	Genentech, Inc.	14 Apr 2014
Bladder Cancer	Phase 2	US	Genentech, Inc.	14 Apr 2014
Salivary Gland Neoplasms	Phase 2	US	Genentech, Inc.	14 Apr 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02091141 (MyPathway, CTgov)	Phase 2	Advanced Malignant Solid Neoplasm \| Bladder Cancer \| Biliary Tract Neoplasms ... View more	673	Trastuzumab+Pertuzumab (Trastuzumab Plus Pertuzumab)	enpbdmchbk(dcibrhocou) = fqboyqiyuu zqmsyflpbx (kqnjdpcxce, kdxvnhojoj - bvoogndbvp) View more	-	23 Jul 2024
NCT02091141 (MyPathway, CTgov)	Phase 2		673	atezolizumab (Atezolizumab)	enpbdmchbk(dcibrhocou) = ohkbtilmro zqmsyflpbx (kqnjdpcxce, qhodzhfupm - gotvplycyl) View more	-	23 Jul 2024
NCT01835626 (Phase II, Single-Arm Trial of Induction and Concurrent Vismodegib With Curative-Intent Radiation Therapy for Locally Advanced, Unresectable Basal Cell Carcinoma, Pubmed)	Phase 2	Locally Advanced Unresectable Breast Carcinoma	-	Vismodegib	epfybbktyv(fzfmxspyxt) = gmdodsnxkh vtltnxwaxs (etydxqdmes, 68 - 98) View more	Positive	17 Apr 2024
WCD2023	Not Applicable	Xeroderma Pigmentosum	-	Vismodegib 150 mg/day	rslghptnsl(rlktabqtwo) = yzzortwfry ajeensluzi (azdxrdcknx )	-	03 Jul 2023
NCT02465060 (EAY131, ASCO2022) Manual	Phase 2	Neoplasms PTCH1 Mutation \| SMO Mutation	31	vismodegib 150 mg (all analyzable pts)	bimuiviicn(upeigrgcbu) = jozowwakho jsosrqntpn (reqcjyklko ) View more	Negative	02 Jun 2022
NCT02465060 (EAY131, ASCO2022) Manual	Phase 2	Neoplasms PTCH1 Mutation \| SMO Mutation	31	vismodegib 150 mg (MATCH-confirmed)	bimuiviicn(upeigrgcbu) = tjbgbhfdrq jsosrqntpn (reqcjyklko ) View more	Negative	02 Jun 2022
NCT02436408 (VISORB \| VISORB trial, CTgov)	Phase 4	Basal Cell Carcinoma	35	Vismodegib	cztnldwuij(zmefwobmat) = aolqwsemuv smvrywnvnc (sdvbywbczo, bktqchchdc - byaqmrthtg) View more	-	28 Oct 2021
ASN2021	Not Applicable	-	-	Vismodegib	iuvrcxjqus(fghvyuoblc) = ohtpnvxstf euakbkpiux (fhartlcuba )	Positive	27 Oct 2021
NCT02337517 (CTgov)	Phase 2	Steroid Refractory Graft Versus Host Disease \| Chronic graft-versus-host disease	6	Laboratory Biomarker Analysis+Vismodegib	thiugikiaq(yvvukfrpyg) = odvasmnvnd wqavlkanim (ctirdpdcps, zbpbluaaov - crbjgyduuz) View more	-	16 Jun 2021
NCT02667574 (VISMONEO, Pubmed) Manual	Phase 2	Basal Cell Carcinoma Neoadjuvant	55	Vismodegib	qnylyuoswd(niafpdoyfk) = knvmwkewxa zlahbmrkvb (zulcjsilcr, 67 - 90) View more	Positive	26 Apr 2021
NCT00957229 (GDC-0449, CTgov)	Phase 2	Gorlin syndrome	41	GDC-0449 (Sugar Pill)	fiaydllnrp(bzrqgqnnrt) = oyvvgtduag ynolevkvrp (vywrfqxvaf, dzkwsusqhn - qiqylfqomy) View more	-	11 Jan 2021
NCT00957229 (GDC-0449, CTgov)	Phase 2	Gorlin syndrome	41	GDC-0449 (GDC-0449)	fiaydllnrp(bzrqgqnnrt) = mcloqaeauu ynolevkvrp (vywrfqxvaf, vtowhyfriw - vrhdwmmdgs) View more	-	11 Jan 2021
ESMO_ASIA_VIRTUAL2020	Not Applicable	Metastatic basal cell carcinoma	29	Vismodegib	gfvggpqugy(ofpiuhsrmw) = 13.8% roysnsgdlw (ymueebihuh ) View more	Positive	22 Nov 2020

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