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.

ACTRN12619001298101 / Not yet recruitingPhase 2

A Phase IIa Study to assess the Efficacy and Safety of ASN-002 alone and in combination with chemotherapy in adult participants with Low-Risk Basal Cell Carcinomas

Start Date07 Oct 2019

Sponsor / Collaborator

Ascend Biopharmaceuticals Ltd.

[+1]

NCT03208296 / SuspendedPhase 1/2

A Phase 1b/2a Study of ASN-002 to Treat Basal Cell Carcinomas (BCCs) in Individuals With Basal Cell Nevus Syndrome (BCNS)

The primary objective is to confirm the safety of treating multiple BCCs once weekly x 3 weeks in individuals with Basal Cell Nevus Syndrome (BCNS).
The secondary objectives of the study are to obtain preliminary data on the effectiveness of ASN-002 in the treatment of BCCs in individuals with Basal Cell Nevus Syndrome (BCNS) by
evaluating the histological clearance of BCCs in patients with BCNS, and
assessing the clinical changes of BCCs after treatment with ASN-002, and
assessing the systemic effect of ASN-002 by determining response in non-injected lesions
assess the safety and clinical changes after a second cycle of ASN-002 injections

Start Date01 Dec 2017

Sponsor / Collaborator

Ascend Biopharmaceuticals Ltd.

100 Clinical Results associated with Adenovirus interferon gamma(Transgene)

100 Translational Medicine associated with Adenovirus interferon gamma(Transgene)

100 Patents (Medical) associated with Adenovirus interferon gamma(Transgene)

Literatures (Medical) associated with Adenovirus interferon gamma(Transgene)

01 Nov 2016·Annals of surgical oncologyQ2 · MEDICINE

Phase 1b Trial to Evaluate Tissue Response to a Second Dose of Intravesical Recombinant Adenoviral Interferon α2b Formulated in Syn3 for Failures of Bacillus Calmette–Guerin (BCG) Therapy in Nonmuscle Invasive Bladder Cancer

Q2 · MEDICINE

Article

Author: Zhang, Guangcheng ; Shah, Jay B ; Navai, Neema ; Ainslie, Nancy ; Abraham, Alice ; Benedict, William F ; Kamat, Ashish M ; Grossman, H Barton ; Dinney, Colin P N

BACKGROUND:

A phase 1b trial was conducted to evaluate the duration of interferon-alpha (IFNα) production after intravesical administration of recombinant adenovirus-mediated interferon α2b (Ad-IFN) formulated with the excipient Syn3. The primary aim was to determine whether a second instillation 3 days after initial treatment produced prolonged urinary IFN production.

METHODS:

The study enrolled seven patients who experienced recurrent non-muscle invasive bladder cancer after bacillus Calmette-Guerin therapy. Each treatment consisted of intravesical instillation of SCH721015 (Syn3) and Ad-IFN at a concentration of 3 × 10¹¹ particles/mL to a total volume of 75 mL given on days 1 and 4. The patients were followed for 12 weeks, during which the magnitude and duration of gene transfer were determined by urine INFα levels. Drug efficacy was determined by cystoscopy and biopsy, and patients who had no recurrence at 12 weeks were eligible for a second course of treatment.

RESULTS:

Seven patients were treated with an initial course (instillation on days 1 and 4). Two of the patients had a complete response at 12 weeks and received a second course of treatment. One patient remained without evidence of recurrence after a second course (total 24 weeks). One patient experienced a non-treatment-associated adverse event. Despite a transient rise in IFNα levels, sustained production was not demonstrated.

CONCLUSION:

Previously, Ad-IFNα intravesical therapy has shown promising drug efficacy. A prior phase 1 trial with a single instillation compared similarly with the current study, suggesting that a second instillation is not necessary to achieve sufficient urinary IFNα levels.

01 Jul 2015·Cancer immunology, immunotherapy : CIIQ2 · MEDICINE

Adoptive T cell therapy combined with intralesional administrations of TG1042 (adenovirus expressing interferon-γ) in metastatic melanoma patients

Q2 · MEDICINE

Article

Author: Melanie Saint-Jean ; Marie-Christine Pandolfino ; Soraya Saiagh ; Jean-Michel Nguyen ; Anabelle Brocard ; Gaelle Quereux ; Anne-Chantal Knol ; Brigitte Dreno ; Jean-Marc Limacher ; Vincent Bataille ; Lucie Peuvrel ; Amir Khammari

Tumor immune escape has recently been shown to be related to the development of an immune tolerance state of the microenvironment. Cytokines activating the immune system such as IFN-γ can be used to reverse the immune escape and thus to potentiate the efficacy of immunotherapy. A clinical study was conducted in 18 stage IIIc/IV melanoma patients treated with tumor-infiltrating lymphocytes (TILs) in combination with intratumoral TG1042 injection (adenovirus expressing IFN-γ). The primary objective was to investigate the safety of treatment. Secondary objectives were to study the clinical response and translational research. The treatment was well tolerated. Among the 13 patients evaluable for tumor response, 38.5% had an overall objective response (OOR = CR + PR) and disease control rate (DCR = CR + PR + S) of 46%. The clinical response of the 37 targeted lesions led to an OOR of 51% and a DCR of 75%. Translational research on predictive markers did not significantly differ between responder and non-responder patients. However, specifically regarding injected lesions, the clinical response correlated with CD3-/CD56+ NK cells which could be activated by TG1042. Further larger studies of this combined immunotherapy are needed to confirm our findings. Intralesional TG1042 combined with antigen-selected TILs should be discussed.

01 Nov 2014·Sheng wu gong cheng xue bao = Chinese journal of biotechnology

[Producing Ad-IFN gamma by suspension culture of HEK293 cells in a disposable bioreactor].

Article

Author: Quande Wu ; Wenlin Huang

Adenovirus vectors are promising delivery systems for gene therapy. We established a new process for clinic trial of recombinant adenovirus vectors using a novel disposable bioreactor. The suspension HEK293 cells were inoculated into a 5 L disposable bioreactor with parameters control of pH, DO, agitation and temperature. After 6 days of a fed-batch culture, the final cell density reached 2.0 x 10(6) cells/mL. The culture was infected with Ad-IFNγ at an MOI of 30. The harvest was performed at approximately 48 h post-infection and crude viral lysate was obtained after 3 freeze/thaw cycles and centrifugation. The maximum titers of crude viral lysate was 1.49 x 10(13) Infectious units (IFU) and the bulk product specific was 3,800 IFU/cell. Purified Ad-IFNγ by anion-exchange chromatography and the final recovery of infectious unit reached 35.9%. The result demonstrates that an efficient and stable process of producing Ad-IFNγ using a disposable fed-batch bioreactor is established.

News (Medical) associated with Adenovirus interferon gamma(Transgene)

11 Apr 2024

·www.biospace.com

Stamford Pharmaceuticals Inc Announces the First Patient to Be Treated with SP-002 in Combination with Erivedge® in a Phase 2 Study in Locally Advanced BCC Subjects

AUSTIN, Texas, April 11, 2024 /PRNewswire/ -- Stamford Pharmaceuticals Inc, a clinical-stage biotechnology company developing science-driven immune therapies, today announced initiation of its locally advanced basal cell carcinoma (laBCC) trial (NCT06344052). The study will evaluate SP-002, an adenoviral-based immunotherapy, in combination with Roche's vismodegib (Erivedge®), a Hedgehog Pathway inhibitor (HHPI), approved for the treatment of adult patients presenting with locally advanced and metastatic basal cell carcinoma. The phase 2 clinical study is funded with proceeds from a Series A led by Tenmile Ventures, Prevail Partners and other syndicate parties completed in October 2023. SP-002 is a biologic therapeutic based on an adenovirus (a type of cold-virus) that has been engineered to produce the immunostimulatory anti-cancer protein, Interferon-g. Stamford has an exclusive worldwide license to develop SP-002 (formerly TG1042) from the French biopharmaceutical company Transgene SA. Clinical studies with SP-002 alone have already been completed in cutaneous lymphomas, melanomas and BCC. These studies demonstrated that SP-002 was safe, well tolerated and showed favorable clinical activity. "We are excited to progress SP-002 in combination with HHPI into this subset of locally advanced BCC patients. This study was motivated by encouraging results observed in clinical studies evaluating SP-002 as a monotherapy or in combination with HHPI in other BCC settings. We believe there is an opportunity to further improve patient benefit in locally advanced BCC patients based on the current standard of care," said Clement Leong, PhD., CEO of Stamford Pharmaceuticals. SP-002-004 is a multi-center randomized, phase 2 study that will enroll patients with locally advanced BCC patients. Patients will be randomized to receive oral vismodegib in combination with intratumoral injection of SP-002 or vismodegib alone. The primary objective is to determine overall response rate (ORR) for a target tumor following 1 or 3 cycles of SP-002 given as an add-on to HHPI in patients with laBCC. While the secondary objective is to determine the clinical benefit for a target tumor following 1 or 3 cycles of SP-002 given as an add-on to HHPI in patients with laBCC. About locally advanced basal cell carcinoma Basal cell carcinomas (BCCs) account for 80% of non-melanoma skin cancers. Their incidence is increasing worldwide with a lifetime risk of 20–30%. Basal cell carcinomas are usually located in sun-damaged areas of skin. Risk factors therefore include chronic ultraviolet light exposure, blistering sunburns, tanning bed use, ionizing radiations, fair skin, age >70 years, immunosuppression and chronic inflammation3. Approximately 3 million patients in the United States (US) are affected by BCC annually and the incidence is estimated to be increasing worldwide between 7-10% annually. About 2% of these patients progress to advanced disease and it is estimated that there are ~60,000 advanced cases annually in the US. Locally advanced basal cell carcinomas (laBCCs) can be large, aggressive, or recurrent tumors that have the potential to become invasive and require extensive surgery4 and reconstruction. laBCCs continue to pose a challenge as existing options have modest complete response (CR) rates and durability and significant morbidity and complications. Surgical resection is generally considered first-line treatment. However, this is not always feasible if the laBCC has invaded into surrounding tissues, requiring extensive surgery. Radiation therapy may be offered as a definitive treatment for patients who are not surgical candidates, however it has modest efficacy and durability. Systemic therapy with hedgehog pathway inhibitors (HHPIs) is generally considered when surgery and radiation are no longer an option, followed by Programmed death 1 (PD-1) inhibitors for patients that have progressed on HHPI. The use of HHPI and PD-1 are associated with many adverse events (AEs). It is estimated that only ~10-15% of patients with laBCC use HHPIs. This is primarily due to modest complete and durable response rates and the persistence of residual cancer cells even with continued HHPI treatment. These residual cancer initiating cells can cause recurrences when patients discontinue treatment which occurs often due to intolerability. Additionally, it has been widely reported that 20-30% of advanced BCCs harbor primary or develop secondary resistance to HHPIs further reducing the efficacy of this treatment option. Details on the trial: For more information, please contact: Clement Leong Stamford Pharmaceuticals Inc T: +1 512 694 4241 E: 375968@email4pr.com About Stamford Pharmaceuticals Stamford's a clinical-stage company developing innovative cancer treatments. The company focuses on identifying disease settings where targeting the disease microenvironment or important cell types can bring about meaningful improvements in clinical outcomes. For more information, please visit About Tenmile Tenmile is a dedicated health technology investment business owned by Tattarang, one of Australia's largest private investment groups. With an initial capital allocation of $250 million, we act fast and with confidence, investing without some of the constraints of other venture capital funds. Focused on supporting and building early-stage companies, we have the know-how, networks, and evergreen capital to partner through all stages of growth. With team members in Perth, Sydney, and San Franscisco, we seek to address unmet needs in human health and support the development of a globally significant health science and technology sector in Australia. For more information, please visit About Transgene Transgene is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene's programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells. The Company's clinical-stage programs consist of a portfolio of therapeutic vaccines and oncolytic viruses: TG4050, the first individualized therapeutic vaccine based on the myvac® platform, TG4001 for the treatment of HPV-positive cancers, as well as BT-001 and TG6050, two oncolytic viruses based on the Invir.IO® viral backbone. With Transgene's myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC. With its proprietary platform Invir.IO®, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses. Additional information about Transgene is available at: Follow us on social media: X (formerly Twitter): @TransgeneSA – LinkedIn: @Transgene

Phase 2ImmunotherapyLicense out/inVaccine

13 Apr 2023

·www.prnewswire.com

Simcere Zaiming will Present 8 Research Abstracts at the 2023 AACR Annual Meeting

Just four months after Simcere Zaiming's founding, the organization is sharing details on targets and technologies, including two oral presentations BOSTON, April 13, 2023 /PRNewswire/ -- Simcere Zaiming (Company), a pharmaceutical company focused on developing drugs to address unmet clinical needs for cancer patients around the globe, and subsidiary of Simcere Pharmaceutical Group Limited (2096.HK) (Simcere), a global pharmaceutical company, today announced two oral and six poster presentations will be presented on the Company's preclinical programs at the 2023 American Association for Cancer Research (AACR) Annual Meeting, taking place April 14-19, 2023, in Orlando, FL. The AACR annual meeting is one of the most influential oncology conferences of the year and attracts tens of thousands of scientists and clinical experts to share and discuss the latest progress in basic research, translational research, clinical research and prevention research in the field of oncology. Today's announcement marks a significant milestone for the company as it will be the first time Simcere Zaiming will participate in an international academic conference as an independent oncology entity with multiple studies, including on-site oral presentations. The eight studies cover several targets including SMARCA2, CBL-b, Polθ, SOS1, MUC17, USP1, SIRPα, GPRC5D, and involve multiple novel technologies such as targeted protein degradation, mutant fusion proteins, bispecific T engager and others. Oral Presentations: Title: Identification of a high selective SMARCA2 degrader which effectively suppresses the SMARCA4-deficient tumors M vitro and in Wvo Session Type: Minisymposium Session Category: Experimental and Molecular Therapeutics Session Title: Innovative Therapeutic Approaches Session Date/Time: Sunday Apr 16, 2023 3:00 PM - 5:00 PM Location: Room W331 Abstract Presentation Number: 1137 Presenter: Dr. Zhengtao Li, Vice President, Simcere Zaiming Targeting the "synthetic lethal" partner proteins SMARCA2/4 (human chromatin SWI/SNF- Related, Matrix-Associated, actin-dependent regulatory factor subfamily A member 2 and 4), SCR-9140 selectively degrades SMARCA2 to precisely kill SMARCA4-deficient tumors in preclinical studies while preventing damage to normal cells, thus exhibiting strong antitumor efficacy and favorable safety profile. Title: Identification of the selective CBL-b inhibitors which effectively prevent T cells from exhaustion and demonstrate synergistic anti-tumor activity in combination with an anti-PD1 antibody Session Title: Immune Checkpoints at Tumor Beds Session Date/Time: Monday Apr 17, 2023 2:30 PM - 4:30 PM Abstract Presentation Number: 3474 Presenter: Dr. Tamas Oravecz, Senior Vice President, Chief Scientific Officer, Simcere Zaiming The E3 ubiquitin ligase CBL-b (Casitas B-cell lymphoma protein b) negatively regulates immune function and is considered a potential novel intracellular immune checkpoint. In preclinical studies, a group of Cbl-b inhibitor candidate drugs developed by Simcere Zaiming have demonstrated strong immune activation capabilities and synergistic effects with PD-1 inhibitors, suggesting strong potential for clinical application. Poster Presentations: Title: Identification of SS008871, a novel Polθ inhibitor that effectively inhibits tumors with homologous recombination deficiency in vitro and in vivo Session Title: Experimental and Molecular Therapeutics, Novel Antitumor Agents 2 Session Date and Time: Sunday Apr 16, 1:30 PM – 5:00 PM Location: Poster Section 18 Poster Board Number: 12 Abstract Number: 512 DNA polymerase θ (Polθ) is a key enzyme for DNA double-strand break repair and cell survival in homologous recombination-deficient tumors, and it is also a potential synthetic lethal new therapeutic target. The small molecule inhibitor of Pol θ, SS008871, has shown significant anti-tumor effect and good safety in various preclinical models. Title: SCR-8388, a potent and selective SOS1::KRAS inhibitor, is effective in KRAS-addicted cancers Session Title: Oncogenes and Tumor Suppressor, Genes as Targets for Therapy 2 Session Date and Time: Monday, Apr 17, 9 AM – 12:30 PM Location: Poster Section 20 Poster Board Number: 21 Abstract Number: 1724 The most common oncogene, KRAS, was once regarded as the most difficult drug target, and there was a large unmet clinical need. SCR-8388 is a selective SOS 1 protein inhibitor that acts on the upstream pathway of KRAS and prevents KRAS activation. Preclinical studies have shown that SCR-8388 can significantly inhibit the growth of KRAS mutant tumors in both in vitro and in vivo models, and has a synergistic effect with EGFR antagonists. Title: SCR-9171, a MUC17-targeted bispecific T cell engager molecule for gastrointestinal cancer Session Title: Immunology, Therapeutic Antibodies 1 Session Date and Time: Monday Apr 17, 9:00 AM - 12:30 PM Location: Poster Section 25 Poster Board Number: 21 Abstract Number: 1882 MUC17 is a transmembrane mucin that is often overexpressed in gastric cancer tissues and is also a potential target for gastric cancer therapy. SCR-9171 is a MUC17/CD3 bispecific T cell engager that precisely inhibits MUC17 expressing tumors with optimal CD3 affinity. In preclinical studies, SCR-9171 induces T cell activation, thereby potently killing MUC17-positive tumors, while releasing low level of cytokines that can lead to better treatment tolerability. Title: A novel T cell engager targeting BCMA and GPRC5D showed promising preclinical activity with low toxic risk for multiple myeloma treatment Session Title: Immunology, Therapeutic Antibodies 1 Session Date and Time: Monday Apr 17, 9:00 AM - 12:30 PM Location: Poster Section 25 Poster Board Number: 22 Abstract Number: 1883 SCR-8572, a T-cell engager developed against two specific targets in multiple myeloma, BCMA and GPRC5D, demonstrated potent tumor-killing effects in preclinical in vitro and in vivo models, with preliminary good safety results. It is expected to become a candidate drug for clinical development. Title: Identification of SP-002, a highly selective USP1 inhibitor effectively inhibits HRD tumor growth and displays low hematotoxicity risk Session Title: Experimental and Molecular Therapeutics, DNA Repair / Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes / Others Session Date and Time: Wednesday Apr 19, 9:00 AM - 12:30 PM Location: Poster Section 18 Poster Board Number: 3 Abstract Number: 6201 USP1 (ubiquitin-specific peptidase 1) is a synthetic lethal protein of HRD (homologous recombination deficient) tumors. As a highly selective USP1 inhibitor, SP-002 has significant anticancer activity against HRD tumors as a single drug or in combination with PARP inhibitors in preclinical in vitro studies. Furthermore, no significant hematological toxicity was observed. Title: Generation of a mutant SIRPa fusion protein with highly-improved affinity and favorable safety profile Session Title: Immunology, Immune Checkpoints Session Date and Time: Wednesday Apr 19, 9:00 AM - 12:30 PM Location: Poster Section 23 Poster Board Number: 1 Abstract Number: 6357 Interaction of the transmembrane glycoprotein CD47 with signal regulatory protein alpha (SIRPα) triggers "don't eat me" signaling to the macrophage, thereby serving as a key immune checkpoint in a variety of hematological malignancies. SCR9168 is a SIRPα mutant protein fused with Fc, which has significantly improved CD47 affinity, and has good safety in various animal models including cynomolgus monkeys and has best-in-class potential of SIRPα mutant protein in the treatment of hematological tumors. About Simcere Zaiming Simcere Zaiming is a pharmaceutical company specializing in oncology, and a subsidiary of Simcere Pharmaceutical Group Limited, that focuses on the R&D, production and commercialization of innovative cancer therapeutics. The company was formed in 2023 and is committed to solving unmet clinical needs for cancer patients in China and around the world by developing breakthrough treatments. Simcere Zaiming has an innovative R&D pipeline with differentiated clinical value, among which 15 assets are currently in clinical trials. In addition to the company's R&D portfolio, Simcere Zaiming is marketing three innovative drugs, COSELA®, Endostar®, and Envafolimab®. By collaborating with partners globally, Simcere Zaiming strives to bring potentially new innovative therapeutics to cancer patients worldwide. Media Contact: [email protected] About Simcere Pharmaceutical Group Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The Company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future, aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D and commercial stage collaborations have made it a strategic alliance partner with world-leading innovative companies and research institutes. For more information, please visit: Media Contact: [email protected] Tyler Gagnon Simcere Pharmaceutical Group Limited Director, Corporate Communications & Public Affairs [email protected] SOURCE Simcere Zaiming

AACRImmunotherapy

100 Deals associated with Adenovirus interferon gamma(Transgene)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Skin Neoplasms	Phase 2	AU	Ascend Biopharmaceuticals Ltd.	01 Sep 2015
Basal Cell Nevus Syndrome	Phase 2	AU	Ascend Biopharmaceuticals Ltd.	01 Sep 2015
Primary cutaneous diffuse large cell B-cell lymphoma	Phase 2	US	Transgene SA	01 Nov 2006
Primary cutaneous diffuse large cell B-cell lymphoma	Phase 2	FR	Transgene SA	01 Nov 2006
Primary cutaneous diffuse large cell B-cell lymphoma	Phase 2	CH	Transgene SA	01 Nov 2006
Cutaneous T-Cell Lymphoma	Phase 2	FR	Transgene SA	-
Cutaneous T-Cell Lymphoma	Phase 2	DE	Transgene SA	-
Cutaneous T-Cell Lymphoma	Phase 2	CH	Transgene SA	-
Melanoma	Phase 2	FR	Nantes University Hospital	-
Squamous Cell Carcinoma	Phase 2	US	Stamford Pharmaceuticals, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2012 Manual	Phase 1/2	Metastatic melanoma	12	TG1042+TIL+IL2	kdijhvdrvz(kljbrgftlh) = htjkgborwm cfgeatvlce (kkeozanvbd ) View more	Positive	20 May 2012

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