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

971

Literatures (Medical) associated with Vismodegib

01 Jan 2025·Biomaterials

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

Article

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

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 Dec 2024·Reproductive Toxicology

Efcab7 deletion sensitizes mice to the teratogenic effects of gastrulation-stage alcohol exposure

Article

Author: Parnell, Scott E ; Parnell, Scott E. ; Fish, Eric W ; Boschen, Karen E ; Boschen, Karen E. ; Fish, Eric W.

Alcohol exposure during the gastrulation stage of development can disrupt Sonic hedgehog (Shh) signaling and cause eye, craniofacial, and brain defects. One of the genes that regulates Shh signaling is Efcab7, which encodes a protein that facilitates the actions of Smoothened (Smo), a critical component of the Shh pathway. Previous work from our lab has demonstrated that Efcab7 is differentially expressed between two sub-strains of C57BL/6 mice that differ in their sensitivity to gastrulation-stage alcohol exposure. The more alcohol-sensitive C57BL/6 J mice express lower levels of Efcab7 during gastrulation than do the less alcohol-sensitive C57BL/6NHsd mice. The current study examined whether partial or full Efcab7 deletions render mice more sensitive to gastrulation-stage alcohol exposure and affect the sensitivity to other modulators of Shh signaling that cause craniofacial malformations. Efcab7^+/- dams were mated with Efcab7^+/- sires to produce Efcab7^+/+, Efcab7^+/-, and Efcab7^-/- fetuses. On gestational day 7 (GD 7), they received either alcohol (two doses of 2.9 g/kg, i.p., given 4 hours apart), the Smo antagonist vismodegib (40 mg/kg, or vehicle, p.o.), the Smo agonist SAG (20 mg/kg) or the appropriate vehicles. GD 17 fetuses were collected and examined for ocular and craniofacial dysmorphology. As compared to Efcab7^+/+ fetuses, Efcab7^-/- fetuses exposed to alcohol or vismodegib treatment had more severe ocular and craniofacial malformations. In contrast, Efcab7^-/- fetuses had less severe malformations induced by SAG. These results confirm that Efcab7 can modify responses to Shh agonists and antagonists and further identify Efcab7 as a gene important for the sensitivity to gastrulation-stage alcohol exposure.

01 Nov 2024·Ophthalmology

Oral Hedgehog Inhibitor, Vismodegib, for Locally Advanced Periorbital and Orbital Basal Cell Carcinoma

Review

Author: Foster, Jill A ; Kim, Stephen J ; Freitag, Suzanne K ; Vagefi, M Reza ; Wladis, Edward J ; Aakalu, Vinay K ; Tao, Jeremiah P ; McCulley, Timothy J

PURPOSETo review the efficacy and safety of oral vismodegib (Erivedge; Genentech) in the management of locally advanced orbital and periorbital basal cell carcinoma (BCC).METHODSA literature search was conducted last in September 2023 in the PubMed database for English language original research that evaluated the effect of oral vismodegib on orbital and periorbital BCC. Sixty articles were identified and 16 met the inclusion criteria.RESULTSMost studies demonstrated high response rates, with up to 100% of patients responding to the medication in individual studies and initial complete regression occurring in up to 88% of patients. Vismodegib treatment resulted in significant reductions in tumor volume, resulting in globe preservation for most patients. However, in 12% of patients, the response was partial. Recurrences also occurred with substantial frequency, even after an initial complete response. As such, up to 79.4% of patients required surgical intervention, and up to 23% of patients still required exenteration. Use of these agents resulted in reductions in tumor volume that may delay or prevent the need for exenteration in some, but not all, patients. Importantly, molecular analysis of tissue excised after vismodegib therapy revealed persistent tumor in all patients, with frequent accumulation of mutations that may confer resistance to further hedgehog inhibitor therapy. Although most adverse events were rated as level I or II, side effects were common, with up to 100% of patients in studies experiencing at least 1 event. Muscle cramps, alopecia, weight loss, fatigue, and dysgeusia were the most common adverse events, and several patients discontinued therapy because of them. Furthermore, 1 patient died of sepsis that may have resulted from the therapy.CONCLUSIONSAlthough level I and II evidence are lacking, most studies indicate a benefit from the use of oral vismodegib to treat orbital and periorbital BCC tumor volume. However, patients should be cautioned about the adverse side effects of treatment and the persistence of tumor cells with mutations that may cause long-term resistance. Use of vismodegib as short-term neoadjuvant therapy may be effective in shrinking tumor volume to reduce surgical morbidity while reducing the frequency and severity of side effects.FINANCIAL DISCLOSURE(S)The author(s) have no proprietary or commercial interest in any materials discussed in this article.

News (Medical) associated with Vismodegib

29 Oct 2024

·www.prnewswire.com

Curis Announces $12.1 Million Registered Direct and Concurrent Private Placement

LEXINGTON, Mass., Oct. 29, 2024 /PRNewswire/ -- Curis, Inc. ("Curis") (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced that it has entered into a definitive agreement with a combination of existing and new investors for the purchase of 2,398,414 shares of its common stock in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, Curis also agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to an aggregate of 2,398,414 shares of common stock. The unregistered warrants to be issued in the concurrent private placement will have an exercise price of $4.92 per share of common stock, will be exercisable immediately and will expire five years following the issuance date. The combined purchase price for one share of common stock and the associated unregistered warrant is $5.045. Gross proceeds to Curis from the offering are expected to be approximately $12.1 million, before deducting the placement agents' fees and other offering expenses payable by Curis. Curis intends to use the net proceeds from the offering on research, development, working capital, and other general corporate purposes. The registered direct offering and concurrent private placement are each expected to close on or about October 30, 2024, subject to the satisfaction of customary closing conditions. Truist Securities and Laidlaw & Company (U.K.) Ltd. are acting as placement agents for the registered direct offering and the concurrent private placement. The shares of common stock offered in the registered direct offering (but excluding the unregistered warrants to be issued in the concurrent private placement and shares of common stock underlying the unregistered warrants) are being offered by Curis pursuant to a shelf registration statement on Form S-3 (File No. 333-276950) that was filed with the U.S. Securities and Exchange Commission ("SEC") on February 8, 2024 and declared effective by the SEC on April 12, 2024. A prospectus supplement relating to and describing the terms of the registered direct offering will be filed with the SEC and will be available on the SEC's website at . The registered direct offering is being made only by means of a prospectus and related prospectus supplement. When available, electronic copies of the prospectus supplement and the accompanying prospectus may also be obtained from Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, Georgia 30326, by telephone at (800) 685-4786, or by email at [email protected]; and Laidlaw & Company (U.K.) Ltd., Attention: [email protected]. The unregistered warrants are being offered in the concurrent private placement pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), provided in Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Curis has agreed to file a resale registration statement with the SEC covering the resale of the shares of common stock underlying the unregistered warrants. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. 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. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including, without limitation, any statements with respect to Curis's registered direct offering and concurrent private placement, anticipated use of proceeds, prospects for Curis and the expected closing of the registered direct offering and the concurrent private placement. Forward-looking statements may contain the words "believes," "expects," "anticipates," "plans," "intends," "seeks," "estimates," "assumes," "predicts," "projects," "targets," "will," "may," "would," "could," "should," "continue," "potential," "focus," "strategy," "mission" or similar expressions. Actual results may differ materially from those indicated by such forward-looking statements. Factors that may cause such a difference include, without limitation, risks and uncertainties related to market and other conditions, the satisfaction of customary closing conditions related to the registered direct offering and the concurrent private placement and the impact of general economic, industry or political conditions in the United States or internationally. There can be no assurance that Curis will be able to complete the registered direct offering and the concurrent private placement on the anticipated terms, or at all. You should not place undue reliance on these forward-looking statements. Additional risks and uncertainties relating to the registered direct offering, Curis and its business can be found under the caption "Risk Factors" included in Curis's Annual Report on Form 10-K for the year ended December 31, 2023, Curis's prospectus supplement to be filed with the SEC, and in other filings that Curis periodically makes with the SEC. In addition, any forward-looking statements included in this press release represent the view of Curis only as of today and should not be relied upon as representing Curis's views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by law. 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

Orphan DrugLicense out/inClinical Study

25 Oct 2024

·www.prnewswire.com

Sun Pharma Announces Multiple Data Presentations Highlighting its Dermatology Portfolio to be Featured at the 2024 Fall Clinical Dermatology Conference

Data from a wide range of the Sun Pharma dermatology portfolio, including data on alopecia areata, psoriasis, acne and actinic keratosis products, will be highlighted during the meeting. MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma") today announced it will present more than a dozen posters at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada. The presentations will include data from across the Sun Pharma dermatology portfolio, including study results for LEQSELVI™ (deuruxolitinib), WINLEVI® (clascoterone), ILUMYA® (tildrakizumab-asmn), ODOMZO® (sonidegib) and LEVULAN® KERASTICK® (aminolevulinic acid HCl) + BLU-U® (blue light photodynamic therapy). "As an organization dedicated to supporting the dermatology community, the Fall Clinical Dermatology Conference offers a vitally important forum to present new data and highlight how Sun's innovative dermatology portfolio can support those living with alopecia areata, psoriasis, acne and other skin-related diseases," said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma. "We look forward to sharing data from across our portfolio with the dermatology research community and our esteemed industry colleagues." Six abstracts, accepted for poster presentations, will highlight clinical efficacy and safety data of LEQSELVI™ (deuruxolitinib). Approved earlier this year by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata, LEQSELVI™ is an oral JAK inhibitor that interrupts the pathways thought to contribute to hair loss in severe AA and delivered statistically significant efficacy at 24 weeks across two Phase 3 clinical trials. LEQSELVI™ data being presented at Fall Clinical showcase pooled long-term results for ongoing clinically meaningful improvements in scalp hair regrowth in adults with alopecia areata. Additionally, two posters will present patient and clinician preferences for the treatment of alopecia areata. The WINLEVI® poster presentations will include new data showing significant reductions in casual facial sebum levels from baseline, stability in the presence of other commonly prescribed acne medications, and efficacy and safety from a pilot study in patients with skin of color. The conference will also feature data from three additional WINLEVI® studies. Sun Pharma will present the following posters at the 2024 Fall Clinical Dermatology Conference: LEQSELVI™ Presentations: Deuruxolitinib results in ongoing clinically meaningful improvements in scalp hair regrowth in adults with alopecia areata: Pooled long-term efficacy and safety data from the open-label extension studies Patient Preferences for the Treatment of Alopecia Areata A Discrete Choice Experiment to Assess Clinician Preferences for the Treatment of Alopecia Optimization of deuruxolitinib dosing in adult patients with alopecia area: Results from a randomized, parallel-group, multicenter Phase 2 trial Change in patient-reported hair satisfaction during deuruxolitinib treatment of severe alopecia areata: Pooled data from the Phase 3 THRIVE-AA1 and THRIVE-AA2 trials Improvement in anxiety and depression in adult patients with severe alopecia areata treated with deuruxolitinib: Pooled data from the THRIVE-AA1 and THRIVE-AA2 Phase 3 trials WINLEVI® Presentations: Clinical evaluation of the sebum reduction induced by clascoterone cream 1%: Week 12 interim analysis Assessment of clascoterone cream 1% levels when layered with other topical acne medications Efficacy and safety of clascoterone cream 1% in patients with acne with skin of color: 16-week interim analysis The efficacy and safety of clascoterone cream 1% for the treatment of acne vulgaris are not dependent on patient age and sex: Results of a post hoc analysis Improvement in skin moisturization and lack of barrier damage with clascoterone cream 1% treatment: Results of a randomized, single-blind, split-face study in acne-prone individuals Comparison of the efficacy of clascoterone vs trifarotene and tazarotene for the treatment of acne vulgaris at Week 12: A systematic review and meta-analysis ILUMYA® Presentation: A systematic literature review and meta-analysis of the real-world effectiveness, quality of life, and safety of tildrakizumab for moderate-to-severe plaque psoriasis ODOMZO® Presentation: Lower rate of discontinuation of sonidegib compared to vismodegib in a real-world analysis of patients with basal cell carcinoma LEVULAN® KERASTICK® + BLU-U® Presentation: Evaluating the safety and efficacy of aminolevulinic acid 20% topical solution activated by blue light in the treatment of facial cutaneous squamous cell carcinoma in situ About Sun Pharmaceutical Industries Limited. (CIN – L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing Sun Pharma's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. Sun Pharma does not undertake any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultPhase 2

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

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
Metastatic basal cell carcinoma	Phase 2	BR	Hoffmann-La Roche Ltd.	01 Jul 2011
Metastatic basal cell carcinoma	Phase 2	IL	Hoffmann-La Roche Ltd.	01 Jul 2011
Metastatic basal cell carcinoma	Phase 2	CH	Hoffmann-La Roche Ltd.	01 Jul 2011
Metastatic basal cell carcinoma	Phase 2	AU	Hoffmann-La Roche Ltd.	01 Jul 2011
Secondary malignant neoplasm of pancreas	Phase 2	US	Genentech, Inc.	17 Sep 2010
Basal Cell Nevus Syndrome	Phase 2	US	Genentech, Inc.	01 Aug 2009
Pancreatic Ductal Adenocarcinoma	Phase 1	GB	Roche Pharma AG	01 Feb 2011
Pancreatic Ductal Adenocarcinoma	Phase 1	GB	Genentech, Inc.	01 Feb 2011
Ovarian Cancer	Phase 1	-	Genentech, Inc.	01 Dec 2008
Metastatic Colorectal Carcinoma	Phase 1	-	Genentech, Inc.	01 May 2008

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 \| Salivary Gland Neoplasms	673	Trastuzumab+Pertuzumab (Trastuzumab Plus Pertuzumab)	aobvainsbg(fxdnhsuztm) = kqdjivjztu gehfwurwrn (pcftglkkgx, wppcbqeptk - mtxztesduk) View more	-	23 Jul 2024
NCT02091141 (MyPathway, CTgov)	Phase 2		673	atezolizumab (Atezolizumab)	aobvainsbg(fxdnhsuztm) = fedmtlrfax gehfwurwrn (pcftglkkgx, ikwztrirmp - erewixnlro) View more	-	23 Jul 2024
ENV-101 (EADV2023)	Phase 2	Basal Cell Carcinoma PTCH1 Loss of Function mutations	44	Taladegib 200 mg	bbholdgkli(mjaogksblg) = Patient reported alopecia during the study cnvkzlxtqu (xbrrlhrvuq ) View more	Positive	11 Oct 2023
ENV-101 (EADV2023)	Phase 2	Basal Cell Carcinoma PTCH1 Loss of Function mutations	44	Vismodegib		Positive	11 Oct 2023
WCD2023	Not Applicable	Xeroderma Pigmentosum	-	Vismodegib 150 mg/day	(wnrsucnqro) = fsvrtwnxeo xmlvfhknjl (tgrjchfwct )	-	03 Jul 2023
NCT02465060 (EAY131, ASCO2022) Manual	Phase 2	Neoplasms PTCH1 Mutation \| SMO Mutation	31	vismodegib 150 mg (all analyzable pts)	(dzbvceevra) = agrllfrktc wccnbibinm (xopdqdpryz ) View more	Negative	02 Jun 2022
NCT02465060 (EAY131, ASCO2022) Manual	Phase 2	Neoplasms PTCH1 Mutation \| SMO Mutation	31	vismodegib 150 mg (MATCH-confirmed)	(dzbvceevra) = eaoskfuaoq wccnbibinm (xopdqdpryz ) View more	Negative	02 Jun 2022
NCT02436408 (VISORB \| VISORB trial, CTgov)	Phase 4	Basal Cell Carcinoma	35	Vismodegib	qhcadqedqw(yijujvpchj) = qpdzbhuxbg xnetmfzfsd (mgbgllrqyk, clpvgjvkcb - skkgxsncze) View more	-	28 Oct 2021
ASN2021	Not Applicable	-	-	Vismodegib	dnxekuyqsn(glxtewfpaj) = ejxlaoclzs tswcdepspv (jfewyeulqi )	Positive	27 Oct 2021
NCT02337517 (CTgov)	Phase 2	Steroid Refractory Graft Versus Host Disease \| Chronic graft-versus-host disease	6	Laboratory Biomarker Analysis+Vismodegib	vrkshyryfz(cqmzripgyt) = lqcbyzeasa vbzajfxybv (xhbfcvmutt, pqwnqtblru - gxvkbvyxvx) View more	-	16 Jun 2021
NCT02667574 (VISMONEO, Pubmed) Manual	Phase 2	Basal Cell Carcinoma Neoadjuvant	55	Vismodegib	(bgghcwxxip) = wydifoqepu otoqgccdre (wuvflftcql, 67 - 90) View more	Positive	26 Apr 2021
NCT00957229 (GDC-0449, CTgov)	Phase 2	Basal Cell Nevus Syndrome	41	GDC-0449 (Sugar Pill)	vacwjtsljp(iquefeobqk) = hfcsqtrvom vhxfyejcwa (suvqhrsngj, xuqsdzgxxb - azjcorljck) View more	-	11 Jan 2021
NCT00957229 (GDC-0449, CTgov)	Phase 2	Basal Cell Nevus Syndrome	41	GDC-0449 (GDC-0449)	vacwjtsljp(iquefeobqk) = lttkowwbcn vhxfyejcwa (suvqhrsngj, mrcenwlohn - klsmezmxoo) View more	-	11 Jan 2021
ESMO_ASIA_VIRTUAL2020	Not Applicable	Metastatic basal cell carcinoma	29	Vismodegib	zfhavbcswn(vjezgwdgst) = 13.8% shtbeehyoq (aoealyophl ) View more	Positive	22 Nov 2020

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