Shanghai Simnova Biotechnology Co., Ltd. is a clinical-stage biotechnology company specializing in the development of first-class cancer cell therapies. Supported by Simcere Pharmaceutical, Simnova Biotech was established in Boston, USA, in 2019, initiating early-stage drug research and layout for cell therapy. In 2021, Simnova Biotech spun off from Simcere Pharmaceutical to operate independently. By 2020, its GMP facility was constructed in Shanghai.

Tags

Neoplasms

Hemic and Lymphatic Diseases

Immune System Diseases

CAR-NK

CAR-T

Fusion protein

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	9
Hemic and Lymphatic Diseases	4
Immune System Diseases	4
Nervous System Diseases	1

Top 5 Drug Type	Count

CAR-NK	4
CAR-T	2
Fusion protein	1
Immune cell therapy	1
mRNA vaccine	1

Top 5 Target	Count

BCMA(B-cell maturation protein)	2
BCMA x GPRC5D	1
CD70 x DLL3	1
Cbl-b(E3 ubiquitin-protein ligase CBL-B)	1
EGFR x EGFRvIII x HER2 x IL-13Rα2	1

Drugs associated with Shanghai Simnova Biotechnology Co.,Ltd.

CAR-NK-CD19 Cells(Simnova)

Target

CD19

Mechanism

CD19 inhibitors

Active Org.

Shanghai Simnova Biotechnology Co.,Ltd.

Originator Org.

Shanghai Simnova Biotechnology Co.,Ltd.

Active Indication

Systemic Lupus Erythematosus [+5]

Inactive Indication

CD19 Expressing Malignancies [+1]

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

SNC-115

Target-

Mechanism-

Active Org.

Shanghai Simnova Biotechnology Co.,Ltd.

Originator Org.

Shanghai Simnova Biotechnology Co.,Ltd.

Active Indication

Large cell neuroendocrine carcinoma of lung [+2]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

SNC-109

Target

EGFR x EGFRvIII x HER2 x IL-13Rα2

Mechanism

EGFR antagonists [+5]

Active Org.

Shanghai Simnova Biotechnology Co.,Ltd.

Originator Org.

Shanghai Simnova Biotechnology Co.,Ltd.

Active Indication

Glioblastoma Multiforme [+1]

Inactive Indication-

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Shanghai Simnova Biotechnology Co.,Ltd.

NCT06468683 / Not yet recruitingPhase 1

A Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of F01 in Patients With Moderate-to-severe Refractory Systemic Lupus Erythematosus

This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus.

Start Date15 Jun 2024

Sponsor / Collaborator

Shanghai Simnova Biotechnology Co.,Ltd.

NCT06384482 / RecruitingPhase 1

To Evaluate the Safety and Pharmacokinetic of SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Crcinoma: an Open-label, Single-arm, Dose Escalation Exploratory Study

This study is a FIH dose escalation clinical study, with single arm, open label and design, in order to observe the preliminary safety and Pharmacokinetic of SNC115 Injection in participants with Recurrent/refractory small cell lung cancer and Lung large cell neuroendocrine carcinoma.

Start Date30 Apr 2024

Sponsor / Collaborator

Shanghai Simnova Biotechnology Co.,Ltd.

[+1]

NCT06206902 / RecruitingPhase 1

A Multicenter, Open Phase I Study to Evaluate the Safety and Pharmacokinetic Profile of F01 in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma

This is a multicenter, open, Phase I clinical study to evaluate the safety and tolerability of F01 in subjects with relapsed/refractory non-Hodgkin lymphoma, and to determine MTD and/or RD.

Start Date01 Apr 2024

Sponsor / Collaborator

Shanghai Simnova Biotechnology Co.,Ltd.

[+1]

100 Clinical Results associated with Shanghai Simnova Biotechnology Co.,Ltd.

0 Patents (Medical) associated with Shanghai Simnova Biotechnology Co.,Ltd.

Literatures (Medical) associated with Shanghai Simnova Biotechnology Co.,Ltd.

02 Nov 2023·Blood

Phase I Clinical Study of Humanized BCMA-Single-Domain Antibodies-Targeting CAR T (BCMA-CART) in Patients with Relapsed/Refractory Multiple Myeloma

Author: Ye, Gang ; Zheng, Gaofeng ; Cai, Zhen ; Cao, Zhuoxiao ; Mei, Heng ; Zhou, Ling ; Wen, Cheng

Background:The CAR structure adopted by CART-BCMA is composed of a single-domain antibody targeting BCMA, CD8 hinge region, transmembrane region, 4-1BB co-stimulatory domain, and CD3-ζ T cell activation domain. In the phase I clinical study (NCT05346198) carried out in China, the safety and efficacy of CART-BCMA were initially evaluated through the dose escalation + dose expansion design, and the recommended dose (RD dose) for follow-up studies was determined as well.Method:Enrolled patients with relapsed and/or refractory multiple myeloma (RRMM) had previously received at least 3 lines of therapy including at least one proteasome inhibitor and one immune modulator. After lymphatic preconditioning chemotherapy (program: fludarabine 30mg/m 2/d and cyclophosphamide 300mg/m 2/d, -5, -4, -3, for 3 consecutive days), all patients received a single dose of CART-BCMA at 2.5×10 6, 5×10 6 and 7.5×10 6 CAR-positive T cells/kg (subject body weight), according to the dose level in which they were enrolled.R esults :Up to June 26, 2023, a total of 15 cases of RRMM received 2.5×10 6 CAR-positive T cells/kg (n=3), 5×10 6 CAR-positive T cells/kg (n=11) or 7.5×10 6 CAR-positive T cells/kg (n=1) dose level of CART-BCMA cell infusion therapy on the basis of the dose level in which they were enrolled. The median follow-up time was 14.42 months (range: 10.2-26.6 months). The median age of the subjects was 63.0 years old (range: 36-73 years old) (Table 1), 73.3% of the subjects (n=11) had previously received ≥4 lines of multiple myeloma therapy, and the median line of treatment was 5 lines (range: 3-9 lines), among which, 2 subjects (13.3%) had previously received autologous hematopoietic stem cell transplantation, and 4 subjects (26.7%) had relapsed/refractory diseases after previous treatment with proteasome inhibitors, immune modulators and CD38 monoclonal antibodies (three-drug relapsed/refractory). Nine subjects (60.0%) had high-risk cytogenetic abnormalities according to sMART 3.0 criteria, and 6 subjects (40.0%) had extramedullary plasmacytoma.The most common grade ≥3 adverse events were hematological toxicity, including decreased neutrophil count (n=13, 86.7%), decreased white blood cell count (n=12, 80.0%), decreased lymphocyte count (n=10, 66.7%), anemia (n=8, 53.3%), decreased platelet count (n=4, 26.7%). The first patient in the 7.5×10 6 CAR-positive T cells/kg dose group had a dose-limiting toxicity (DLT) event of grade 4 platelet count decrease, and no DLT event occurred in the other low-dose groups (2.5 and 5×10 6 CAR-positive T cells/kg). All 15 patients (100.0%) developed grade 1-2 cytokine release syndrome (CRS), no grade ≥3 CRS occurred, and the median time to CRS was 2.0 days (range: 1-13 days) , with a median duration of 7.0 days (range: 2 to 17 days). After the occurrence of CRS, all patients recovered without sequelae after supportive treatment, and 6 patients (40%) received tocilizumab (3 subjects received 2 doses, 3 subjects received 1 dose), 4 patients (26.7%) used glucocorticoids. There was no event of immune effector cell-associated neurotoxicity syndrome (ICANS), and no death event occurred.The median time to the first response (TTR) of the patients was 0.953 months (range: 0.92 to 2.23 months). All 15 patients who received CART-BCMA infusion achieved remission, and the overall remission rate (ORR) ( At least achieve PR or better efficacy) was 100% (95%CI, 78.20%-100.00%), as shown in Figure 1, among which, the best response of 9 patients (60%) was strict complete remission ( sCR), 5 patients (33.3%) achieved very good partial response (VGPR), and 1 patient (6.7%) achieved PR. All sCR patients achieved MRD negativity. The ORR of 6 patients with extramedullary plasmacytoma was 100%, of which 2 achieved sCR and 4 achieved VGPR. Notably, gradual deepening of remission was observed in 12 patients (80%), of which 10 patients (66.7%) further deepened the depth of remission on days 60-90 after infusion, and 2 patients (13.3%) were assessed sCR at day 360.Conclusion:Data from this phase 1 clinical study showed that CART-BCMA is well tolerated and highly efficacious in patients with RRMM. Patients with extramedullary plasmacytoma had the comparable response to those without extramedullary diseases. Notably, 12 patients (80%) patients elicted deeper response after 3 months of CART-BCMA infusion

04 Apr 2023·Cancer Research

Abstract 4087: Co-expression of membrane bound IL-15 enhanced anti-tumor response of CAR-T

Author: Liu, Tingting ; Yang, Cuiqing ; Jiang, Fuwei ; Wang, Yifang ; Wang, Qin ; Wang, Qingyang ; Wang, Chao ; Tang, Renhong ; Cao, Zhuoxiao ; Ye, Gang

AbstractIntroduction: Chimeric antigen receptors (CARs) T cells have been used successfully to treat patients with hematologic malignancies, but showed less effective in solid tumors. We investigated multiple approaches to engineer and enhance CAR-T activity in solid tumors. It has been previously reported that improvement in the quality of CAR-T cells, through CAR design or manufacturing optimization, could enhance the therapeutic potential of CAR-T cells. One parameter influencing the effectiveness of CAR-T cell therapy is the differentiation status of the final product: CAR-T cells that are less-differentiated and less exhausted are more therapeutically potent. It is well known that IL-2 is the main cytokine used to culture cells for adoptive cell therapy, as it plays an important role in the proliferation and functional effect of T cells. However, it has been noted T cells cultured with IL-2 are phenotypically heterogeneous, being predominantly composed of effector memory cells. In comparison with IL2, IL-15 can induce a memory stem-like T cell phenotype, which is less differentiated and with a superior capacity for cell expansion and survival. Several groups reported that compared with cells cultured with IL-2, CAR-T cells expanded with IL-15 preserve a less-differentiated stem cell memory (Tscm) phenotype and exhibited reduced expression of exhaustion markers, higher antiapoptotic properties, increased proliferative capacity upon antigen challenge, and promoted superior anti-tumor responses in vivo.Method: To provide localized IL-15 mediated signaling to T cells, we constructed a version of IL-15 as a membrane-bound molecule (mIL-15) designed to stimulate T cells in cis and in trans, and mIL-15 is tethered to the cell surface and functions locally to enhance the functionality of the CAR-T cell without systemic delivery of IL-15.Result: Expression of mbIL-15 is shown to enhance T cell expansion, preserve a less-differentiated Tscm phenotype and prevent CAR-T cell exhaustion, leading to longer persistence and an enduring anti-tumor response over the conventional CAR-T cells.Conclusion: We demonstrate that CAR-T activity and persistence can be enhanced by simultaneous expression of mIL-15, which preserves the CAR-T cell Tscm phenotype and improves their metabolic fitness, resulting in superior antitumor activity. These preclinical data support the notion that CAR-T cells are designed and optimized to persist in the hostile tumor microenvironment and potentially improve efficacy against solid tumors.Citation Format: Cuiqing Yang, Fuwei Jiang, Yifang Wang, Tingting Liu, Chao Wang, Qingyang Wang, Qin Wang, Gang Ye, Renhong Tang, Zhuoxiao Cao. Co-expression of membrane bound IL-15 enhanced anti-tumor response of CAR-T. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 4087.

04 Apr 2023·Cancer Research

Abstract 2900: To develop a next generation NK therapy with deep and durable response by engineered CD16 enhancing NK cytotoxicity

Author: Wang, Qingyang ; Tang, Renhong ; Ye, Gang ; Liu, Tingting ; Yang, Cuiqing ; Jiang, Fuwei ; Cao, Zhuoxiao ; Wang, Yifang ; Wang, Qin

AbstractIntroduction: Allogeneic NK cell-based therapies have been demonstrated to elicit clinical efficacy against hematopoietic malignancies. Unlike T-cell therapies, allogeneic NK cells do not cause toxicities such as serious cytokine release syndrome, neurotoxicity, or graft-vs-host-disease, and are less expensive. We believe NK cell-based therapies provide an important platform for “off-shelf” allogeneic cell therapies, so we designed a panel of arming strategies to enhance NK cytotoxicity and elicit deep and durable response. CD16a is a transmembrane protein that co-localizes with CD3ζ and FcεRIγ on NK cells and binds to the Fc portion of IgG antibodies. Upon ligation, it induces a potent series of signals resulting in cytokine production and cytotoxic effector activity via ADCC. Here we use the term CD16 to refer to CD16a on NK cells. CD16 is a potent activating receptor and is necessary for NK cell cytotoxic effector, so engineered CD16 is the cornerstone of NK enhancing strategy. CD16 displays a functional allelic dimorphism generating allotypes with either a phenylalanine (F) or a valine (V) residue at amino acid position 158. CD16VV is associated with higher ADCC activity and clinical response than CD16VF and CD16FF. However, only 15% of the population is CD16VV that maximizes ADCC. Several studies reported that tumor microenvironment may cause the shedding of CD16 which suppresses ADCC though ADAM17-mediated proteolytic cleavage upon NK cell activation. Therefore, selective inhibition of ADAM17 can reduce the shedding of CD16 in NK cells.Method: We designed a library of CD16 point mutations in the cleavage region of ADAM17 to screen for ADAM17-resistant CD16 mutations to prevent CD16 shedding and improve the efficacy of NK therapy. NK92 cells lacking expression of endogenous CD16 were transduced to express wild type CD16 or CD16 mutations, then activated with PMA. The surface expression of CD16 on these cells was then examined using flow cytometry.Result: We found 3 mutations effectively blocked CD16 cleavage in cell-based assays, while wild-type CD16 and other CD16 mutations underwent a marked down-regulation of expression. We also demonstrated these 3 mutations were resistant to cleavage when expressed in the human primary NK cells and did not disrupt IgG binding.Conclusion: We developed a non-cleavable CD16 with high affinity to Fc receptor, which can be expressed in engineered NK cells to develop a next generation NK therapy to elicit more potent and durable cytotoxic response.Citation Format: Cuiqing Yang, Fuwei Jiang, Yifang Wang, Tingting Liu, Qingyang Wang, Qin Wang, Gang Ye, Renhong Tang, Zhuoxiao Cao. To develop a next generation NK therapy with deep and durable response by engineered CD16 enhancing NK cytotoxicity [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 2900.

News (Medical) associated with Shanghai Simnova Biotechnology Co.,Ltd.

05 Jan 2023

·www.prnewswire.com

Simnova and Orna Therapeutics Collaborate to Advance Orna's Next Generation Circular RNA Technology in China

Orna Therapeutics (PRNewsfoto/Orna Therapeutics) Simnova Biotherapeutics Simnova to lead clinical development, regulatory submissions, and commercialization across all oncology indications in Greater China SHANGHAI, China and CAMBRIDGE, Mass., January 5, 2023 /PRNewswire/ -- Shanghai Xianbo Biotech Co., Ltd., also known as Simnova outside of China, an affiliate of Simcere Investment Group and a clinical-stage biotechnology company developing proprietary off-the-shelf CAR-NK and BiTE-armed CAR-T cell therapies, and Orna Therapeutics, a biotechnology company pioneering a new investigational class of engineered circular RNA (oRNA) therapies, today announced a collaboration agreement to discover, develop, and commercialize multiple potential therapeutics in the area of oncology. Under the terms of the agreement, Simnova will gain access in greater China to certain programs built on Orna's breakthrough isCAR technology, including Orna's lead anti-CD19 in situ CAR (isCAR) program, ORN-101. In addition, Orna will gain access to investigator-initiated clinical trials in China to accelerate the validation of select programs in patients. Orna will receive an upfront payment from Simnova and be eligible for development, regulatory, and sales milestones as well as royalties on any approved products derived from the collaboration. Orna's proprietary isCAR technology comprises two components: elegantly engineered circular RNAs (oRNAs) expressing chimeric antigen receptors, and custom-built lipid nanoparticles (LNPs) designed to deliver the oRNAs to cells of the immune system. oRNAs have greater stability in immune cells and are engineered to produce more proteins inside the body, than linear mRNAs. More broadly, Orna's oRNA-LNP platform has potential across a range of indications including oncology, genetic and infectious disease, and more. "This strategic collaboration broadens Orna's capability to develop circular RNA therapeutics in China through Simnova's development capabilities," said Dr. Zhouxiao Cao, Simnova's Chief Executive Officer. "We look forward to closely working with the innovative scientific and technical teams at Orna." "This collaboration again recognizes the value of our oRNA-LNP platform and will allow us together to diversify the number of programs using isCAR technology while bringing the value of isCAR to patients more efficiently," said Tom Barnes Ph.D., Orna's Chief Executive Officer. "This marks another important step in our overall business strategy where we look to thoughtfully engage partners to deliver on the promise of circular RNA therapies." About ORN-101: ORN-101, Orna's lead program, is an in situ CAR therapy designed to modify a patient's immune cells inside their body. Comprising an oRNA molecule packaged inside a proprietary LNP, this easily redosable format could avoid patient lymphodepletion and allow for reliable dose control, overcoming barriers of existing ex vivo CAR-T therapies without sacrificing efficacy. Preclinical data presented at a scientific conference demonstrated tumor suppression and eradication in an animal model, suggesting the possibility that oRNA-LNP based cancer therapies could eventually overtake cell therapies. About Orna Therapeutics: Orna Therapeutics was founded on groundbreaking research by Alex Wesselhoeft, Ph.D., and Daniel G. Anderson, Ph.D. from MIT and built by MPM Capital and its affiliate BioImpact Capital. Orna's proprietary circular RNA (oRNA) is engineered as linear RNA that self-circularizes. oRNA exhibits numerous advantages over traditional linear mRNA therapies such as simplified production, increased protein expression, and a superior immunogenicity profile. With proprietary lipid nanoparticles (LNPs), our technologies expand the possibilities of what RNA therapeutics can achieve. To learn more visit: and follow Orna Therapeutics on Twitter and LinkedIn. About Simnova: Shanghai Xianbo Biotech Co., Ltd., also known as Simnova Biotherapeutics outside of China, is dedicated to creating life changing cell therapies for cancer patients with either hematologic malignancies or solid tumors. Simnova has a rich R&D pipeline including both clinical and pre-clinical programs and is developing proprietary off-the-shelf CAR-NK and BiTE armed CAR-T cell therapies. Simnova operates in Boston and Shanghai and is a sister company of Simcere Pharmaceutical Group Limited (2096.HK). To learn more, please visit and follow Simnova on LinkedIn. SOURCE Orna Therapeutics

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100 Deals associated with Shanghai Simnova Biotechnology Co.,Ltd.

100 Translational Medicine associated with Shanghai Simnova Biotechnology Co.,Ltd.

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Pipeline

Pipeline Snapshot as of 23 Nov 2024

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

Discovery

Preclinical

Phase 1 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Anti-BCMA CAR T Cell Therapy (Shanghai Simnova Biotechnology) ( BCMA )	Relapse multiple myeloma More	Phase 1
CAR-NK-CD19 Cells(Simnova) ( CD19 )	refractory acute lymphoid leukemia in relapse More	Phase 1
SNC-115	Large cell neuroendocrine carcinoma of lung More	Phase 1
SNC-109 ( EGFR x EGFRvIII x HER2 x IL-13Rα2 )	Glioblastoma Multiforme More	Phase 1
CD70 armored DLL3 CAR-T(Simnova) ( CD70 x DLL3 )	Small Cell Lung Cancer More	Preclinical

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