Phase Ib Study Evaluating the Safety and Efficacy of Intratumoral Agonistic Anti-CD40 (Selicrelumab) in Combination With Anti-PDL1 (Atezolizumab) in Patients With Refractory or Relapsed B Cell Lymphoma

This is a multicenter, open, dose escalation phase Ib trial of intratumoral agonistic anti-CD40 Ab (Selicrelumab intratumoral every 3 weeks for 3 cycles) in combination with anti-PDL1 Ab (Atezolizumab 1200mg intravenous every 3 weeks) in patients with refractory or relapsed B cell lymphoma

Start Date04 Jul 2019

Sponsor / Collaborator

Le LYSARC

[+1]

NCT03555149

/ TerminatedPhase 1/2

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)

A phase Ib/II, open-label, multicenter, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with metastatic colorectal cancer (mCRC) that became refractory to first- and second-line standard therapies. Eligible patients will be assigned to one of several treatment arms.

Start Date27 Sep 2018

Sponsor / Collaborator-

NCT03424005

/ RecruitingPhase 1/2

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Treatment Combinations In Patients With Metastatic Breast Cancer (Morpheus-panBC)

This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.
The study will be performed in two stages. During Stage 1, four cohorts will be enrolled in parallel in this study:
Cohort 1 will consist of Programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line [1L] PD-L1+ cohort).
Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line [2L] CIT-naive cohort).
Cohort 3 will consist of participants with locally-advanced or metastatic HR+, HER2-negative disease with PIK3CA mutation who may or may not have had disease progression during or following previous lines of treatment for metastatic disease (HR+cohort).
Cohort 4 will consist of participants with locally-advanced or metastatic HER2+ /HER2-low disease with PIK3CA mutation who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort).
In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). In addition, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination (Stage 2), provided Stage 2 is open for enrollment.

Start Date30 Mar 2018

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

[+1]

100 Clinical Results associated with Selicrelumab

100 Translational Medicine associated with Selicrelumab

100 Patents (Medical) associated with Selicrelumab

Literatures (Medical) associated with Selicrelumab

29 May 2024·Journal of leukocyte biology

Systemic immune response to a CD40 agonist antibody in nonhuman primates

Article

Author: Schubert, Christine ; Caudell, David L ; Passioukov, Alexandre ; Cline, J Mark ; Stern, Martin ; Wasserman, Ken ; Braendli-Baiocco, Annamaria ; Babitzki, Galina ; Acona, Gonzalo ; Dugan, Gregory O ; Charo, Jehad

Abstract:

The cell surface molecule CD40 is a member of the tumor necrosis factor receptor superfamily and is broadly expressed by immune cells including B cells, dendritic cells, and monocytes, as well as other normal cells and some malignant cells. CD40 is constitutively expressed on antigen-presenting cells, and ligation promotes functional maturation, leading to an increase in antigen presentation and cytokine production, and a subsequent increase in the activation of antigen-specific T cells. It is postulated that CD40 agonists can mediate both T cell–dependent and T cell–independent immune mechanisms of tumor regression in mice and patients. In addition, it is believed that CD40 activation also promotes apoptotic death of tumor cells and that the presence of the molecule on the surface of cancer cells is an important factor in the generation of tumor-specific T cell responses that contribute to tumor cell elimination. Notably, CD40 agonistic therapies were evaluated in patients with solid tumors and hematologic malignancies with reported success as a single agent. Preclinical studies have shown that subcutaneous administration of CD40 agonistic antibodies reduces systemic toxicity and elicits a stronger and localized pharmacodynamic response. Two independent studies in cynomolgus macaque (Macaca fascicularis) were performed to further evaluate potentially immunotoxicological effects associated with drug-induced adverse events seen in human subjects. Studies conducted in monkeys showed that when selicrelumab is administered at doses currently used in clinical trial patients, via subcutaneous injection, it is safe and effective at stimulating a systemic immune response.

01 Feb 2024·Cytokine & growth factor reviews

Harnessing the potential of CD40 agonism in cancer therapy

Review

Author: Richmond, Ann ; Yan, Chi ; Zhou, Yang

CD40 is a member of the tumor necrosis factor (TNF) receptor superfamily of receptors expressed on a variety of cell types. The CD40-CD40L interaction gives rise to many immune events, including the licensing of dendritic cells to activate CD8⁺ effector T cells, as well as the facilitation of B cell activation, proliferation, and differentiation. In malignant cells, the expression of CD40 varies among cancer types, mediating cellular proliferation, apoptosis, survival and the secretion of cytokines and chemokines. Agonistic human anti-CD40 antibodies are emerging as an option for cancer treatment, and early-phase clinical trials explored its monotherapy or combination with radiotherapy, chemotherapy, immune checkpoint blockade, and other immunomodulatory approaches. In this review, we present the current understanding of the mechanism of action for CD40, along with results from the clinical development of agonistic human CD40 antibodies in cancer treatment (selicrelumab, CDX-1140, APX005M, mitazalimab, 2141-V11, SEA-CD40, LVGN7409, and bispecific antibodies). This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them.

15 Aug 2021·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

Neoadjuvant Selicrelumab, an Agonist CD40 Antibody, Induces Changes in the Tumor Microenvironment in Patients with Resectable Pancreatic Cancer

Q1 · MEDICINE

Article

Author: Mick, Rosemarie ; Väyrynen, Sara A. ; Sivagnanam, Shamilene ; Vonderheide, Robert H. ; O'Hara, Mark H. ; Wherry, E. John ; Ohtani, Takuya ; Huffman, Austin P. ; Laheru, Daniel A. ; Furth, Emma E. ; Wolpin, Brian M. ; Nowak, Jonathan A. ; Ferreira, Ana P. ; Bajor, David L. ; Liudahl, Shannon M. ; Alanio, Cécile ; Newcomb, Craig ; Chiorean, E. Gabriela ; Byrne, Katelyn T. ; Coussens, Lisa M. ; Lacroix, Andreanne M. ; Dias Costa, Andressa ; Park, Byung S. ; Kaiser, Judith C. ; Redlinger, Colleen ; Jaffee, Elizabeth M. ; Cheever, Martin A. ; Betts, Courtney B. ; Stern, Martin

Abstract:

Purpose::

CD40 activation is a novel clinical opportunity for cancer immunotherapy. Despite numerous active clinical trials with agonistic CD40 monoclonal antibodies (mAb), biological effects and treatment-related modulation of the tumor microenvironment (TME) remain poorly understood.

Patients and Methods::

Here, we performed a neoadjuvant clinical trial of agonistic CD40 mAb (selicrelumab) administered intravenously with or without chemotherapy to 16 patients with resectable pancreatic ductal adenocarcinoma (PDAC) before surgery followed by adjuvant chemotherapy and CD40 mAb.

Results::

The toxicity profile was acceptable, and overall survival was 23.4 months (95% confidence interval, 18.0–28.8 months). Based on a novel multiplexed immunohistochemistry platform, we report evidence that neoadjuvant selicrelumab leads to major differences in the TME compared with resection specimens from treatment-naïve PDAC patients or patients given neoadjuvant chemotherapy/chemoradiotherapy only. For selicrelumab-treated tumors, 82% were T-cell enriched, compared with 37% of untreated tumors (P = 0.004) and 23% of chemotherapy/chemoradiation-treated tumors (P = 0.012). T cells in both the TME and circulation were more active and proliferative after selicrelumab. Tumor fibrosis was reduced, M2-like tumor-associated macrophages were fewer, and intratumoral dendritic cells were more mature. Inflammatory cytokines/sec CXCL10 and CCL22 increased systemically after selicrelumab.

Conclusions::

This unparalleled examination of CD40 mAb therapeutic mechanisms in patients provides insights for design of subsequent clinical trials targeting CD40 in cancer.

News (Medical) associated with Selicrelumab

21 Mar 2024

·www.biospace.com

Biosion to Present Three Posters at the 2024 AACR Meeting

NEWARK, Del. and NANJING, China, March 21, 2024 /PRNewswire/ -- Biosion, a global, clinical-stage biotechnology company, today announced upcoming presentations of pre-clinical data for its oncology pipeline assets, including BSI-111, an anti-CD16a monoclonal antibody, BSI-730, a HER2/PD-L1 bispecific antibody and BSI-093, an anti-BTN3A monoclonal antibody at the American Association for Cancer Research (AACR) Annual Meeting to be held from April 5 to 10, 2024. "We are thrilled to present three posters at the AACR annual meeting. BSI-093, BSI-111 and BSI-730 demonstrate favorable biophysical and functional characteristics, supporting the initiation of development activities including manufacturing and IND-enabling studies" said Mingjiu Chen, Ph.D., Founder and Chief Executive Officer of Biosion, Inc. "We look forward to sharing the key data of these important therapeutic assets with the oncology research community at AACR." 01. BSI-111, a highly selective anti-CD16a monoclonal antibody with potent agonist activity for building a NK cell engager platform BSI-111 is a fully human monoclonal antibody discovered through Biosion's proprietary H³ Antibody Discovery Platform. BSI-111 binds specifically to CD16a without recognizing CD16b and binds the two allelic variants of CD16A - 158F and 158V with similar high affinity. BSI-111 demonstrates superior biophysical properties and functional characteristics, supporting the development of anti-CD16a-based NK cell engagers for the potential benefit of cancer patients. Time：April 8, 2024, 9:00 AM - 12:30 PM Location: Poster Section 2 Poster Board Number: 26 Published Abstract Number: 1343 02. BSI-730, a bispecific antibody targeting HER2 and PD-L1 for the development of a first-in-class bispecific ADC BSI-730 is a novel bispecific antibody for the development of a first-in-class bispecific ADC，identified through Biosion's proprietary SynTracer® High Throughput Endocytosis Platform. BSI-730 showed comparable binding affinity to HER2 as compared to trastuzumab, as well as comparable bioactivity to the parental anti-PD-L1 antibody regarding PD-L1 binding and PD-1/PD-L1 blocking. Time：April 8, 2024, 1:30 PM - 5:00 PM Location: Poster Section 21 Poster Board Number: 16 Published Abstract Number: 3135 03. BSI-093, a best-in-class anti-BTN3A monoclonal antibody for the treatment of cancer through the activation of Vγ9Vδ2 T cells BSI-093 is a highly differentiated, humanized anti-BTN3A agonistic monoclonal antibody with strong Vγ9Vδ2 T cell activation activity. The BTN3A family including BTN3A1, BTN3A2 and BTN3A3 are members of the Ig superfamily receptors, and is essential for the activation of Vγ9Vδ2 T cell-mediated anti-tumor immune responses. BTN3A's expression is significantly higher in tumor samples of cholangiocarcinoma, esophageal carcinoma, head and neck squamous cell carcinoma, compared to their counterpart normal tissue controls. Time：April 9, 2024, 1:30 PM - 5:00 PM Location: Poster Section 3 Poster Board Number: 7 Published Abstract Number: 5298 Additionally, Biosion's partner, CTTQ Pharma, OBI Pharma and Pyxis Oncology, will also be presenting posters at the AACR meeting. Partner：CTTQ A first-in-human phase 1 study of TQB2916, a novel CD40 agonist antibody for advanced malignancies TQB2916（BSI-038） is an anti-CD40 humanized agonist monoclonal antibody with 7-fold higher binding affinity and 4-fold higher cellular bioactivity compared to selicrelumab. By binding to CD40 receptor, it triggers the cellular proliferation and activation of antigen-presenting cells. In 2019, Biosion licensed Greater China rights of BSI-038 to CTTQ and retains all rights for development and commercialization in the rest of the world. Time：April 9, 2024, 9:00 AM - 12:30 PM Location: Poster Section 48 Poster Board Number: 20 Published Abstract Number: CT192 Partner：OBI Pharma 1. OBI-992, a novel TROP2 targeting antibody-drug conjugate, displayed excellent antitumor efficacy in various animal models Time：April 8, 2024, 9:00 AM - 12:30 PM Location: Poster Section 23 Poster Board Number:4 Published Abstract Number:1893 2. In vitro characterization of a novel TROP2-targeting antibody-drug conjugate OBI-992 Time：April 8, 2024, 1:30 PM - 5:00 PM Location: Poster Section 21 Poster Board Number: 11 Published Abstract Number:3130 3. OBI-992, a novel TROP2 targeting antibody drug conjugate demonstrates superior in vivo PK/PD properties and a favorable safety pro > Time：April 10, 2024, 9:00 AM - 12:30 PM Location: Poster Section 24 Poster Board Number: 20 Published Abstract Number: 7179 OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, and gastric cancer, rendering it an ideal target for cancer therapy.OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. OBI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety pro animal models. OBI-992 received US IND clearance in December 2023 and Phase 1/2 efficacy and safety human studies are planned to commence early Q2,2024. The TROP2 targeting antibody was in-licensed from Biosion, Inc. , in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992. Partner：Pyxis Oncology Gene expression correlation of immune checkpoint molecules Siglec-15 and PD-L1 varies widely by cancer indication TIME：April 8, 2024, 9:00 AM - 12:30 PM Location: Poster Section 3 Poster Board Number: 24 Published Abstract Number: 1373 PYX-106 (BSI-060T) is a humanized anti-Siglec-15 monoclonal antibody being developed for solid tumors, including for patients that are not candidates for anti-PD-(L)1 treatment approaches. In this research, analysis of Siglec-15 mRNA expression was performed across single cells, cell lines, and bulk tumor samples to evaluate Siglec-15 target expression across a range of cancer types, including non-small cell lung cancer (NSCLC), cholangiocarcinoma, breast, thyroid, head and neck, colon, rectal, bladder, kidney, and endometrial cancers. These results demonstrate that Siglec-15 and PD-L1 are rarely found co-expressed on the same cell, provide detailed data on Siglec-15 and PD-L1 expression patterns by cancer type, and are expected to help inform potential future PYX-106 (BSI-060T) therapeutic strategies. In Mar 2022, Biosion licensed ex-Greater China rights of BSI-060T to Pyxis Oncology and retains all rights for development and commercialization in Greater China. Pyxis Oncology is conducting a Phase 1 clinical study of PYX-106 (BSI-060T) in solid tumors in the US and Europe. About Biosion Biosion is a global, clinical-stage biotechnology company committed to developing breakthrough antibody-based therapies to improve patient outcomes for the treatment of immune and oncologic diseases. Established in 2017, Biosion has built a pipeline of innovative biologics through its internally derived proprietary technologies including the H³ antibody discovery platform, SynTracer® HT endocytosis platform, and Flexibody® bispecific platform. Biosion's lead asset, Bosakitug (BSI-045B/TQC2731), an anti-TSLP mAb, is currently in phase II for severe asthma, atopic dermatitis, and chronic rhinosinusitis with nasal polyps (CRSwNP), with another 6 partnered assets in phase I/II. Biosion has operations in the US, China and Australia. For more information, please visit . Contact: Mason Xu mason.xu@biosion.com

Phase 1AACRPhase 2IND

08 May 2023

·www.biospace.com

Biosion Presents Discovery and Development Data at PEGS for its Anti-CD40 Agonistic Antibody

NEWARK, Del. and NANJING, China, May 8, 2023 /PRNewswire/ -- Biosion USA, Inc. (Biosion), a global R&D biotechnology company, today announced the upcoming presentation of discovery and development data for BSI-038, an anti-CD40 agonistic antibody at the PEGS Boston conference to be held from May 15 to 19, 2023. BSI-038 is an anti-CD40 agonistic monoclonal antibody, discovered through Biosion's H³ antibody discovery platform. BSI-038 exhibits enhanced binding affinity and bioactivity when compared to Selicrelumab analog. It exhibited potent and dose-dependent anti-tumor activity in animal models. It was well tolerated in pre-clinical studies with the highest non-severely toxic dose (HNSTD) established at 150 mg/kg in non-human primates. Biosion has a licensing agreement with Chia Tai Tianqing Pharmaceutical Group (CTTQ) in which CTTQ has an exclusive license to develop and commercialize BSI-038 (also referred to as TQB2916 by CTTQ) in Greater China. CTTQ is currently conducting a Phase 1 clinical study of BSI-038 in advanced tumors in China. Learn more about clinical trials of CD40，please visit About PEGS Boston Conference & Expo PEGS Boston is the world's largest gathering of protein engineering and biotherapeutics experts. PEGS is the leading biologics event with comprehensive programming covering all aspects of biologic drug development with in-depth presentations on protein and antibody engineering, immunotherapy, oncology, expression, analytics, immunogenicity, and more. Please visit for more information. About Biosion Biosion is a clinical-stage biotechnology company committed to developing breakthrough antibody-based therapies to improve patient outcomes for the treatment of immune and oncologic diseases. Established in 2017, Biosion has built a pipeline of innovative biologics through its internally derived proprietary technologies including the H³ antibody discovery platform, SynTracer® high-throughput endocytosis platform, and Flexibody bispecific platform. Biosion's lead asset, BSI-045B (anti-TSLP mAb), is currently in phase-II for severe asthma and atopic dermatitis, with 4 other assets in the clinic with our partners. Biosion has operations in the US, Australia and China. For more information, please visit .

License out/inPhase 1Immunotherapy

22 Jul 2021

·www.biospace.com

In Wake of Biogen Aduhelm Approval, Roche in Talks with FDA Over Own Alzheimer’s Drug

Jonathan Weiss/Shutterstock The antibody is still being evaluated in clinical studies, with a large-scale Phase III trial expected to wrap in the second half of 2022. Jonathan Weiss/Shutterstock Switzerland-based Roche is in talks with the U.S. Food and Drug Administration (FDA) over its own Alzheimer’s drug candidate, gantenerumab. The antibody is still being evaluated in clinical studies, with a large-scale Phase III trial expected to wrap in the second half of 2022. The FDA set a precedent in its unexpected and controversial approva l of Biogen’s Aduhelm for Alzheimer’s disease. It was approved not based on clinical efficacy but instead on a surrogate endpoint that it cleared amyloid plaques. This is particularly controversial because many experts, and quite a few previous clinical studies, say that clearing amyloid does not necessarily improve the disease. Yet now, several biopharma companies with drugs in the pipeline or that previously were abandoned for clearing amyloid but not showing cognitive and memory improvement are being reevaluated. “There is a continued dialogue with the FDA. I wouldn’t be able to speculate what the outcome of this dialogue will be,” Roche’s Chief Executive Officer Severin Schwan told reporters. He added, “Our trial is a well-designed, very comprehensive trial so, whatever the outcome of this trial will be, we will have a definitive answer of what we can do for patients with this terrible disease so let’s keep fingers crossed.” In late June, a few weeks after the FDA’s June 7 approval of Aduhelm, Eli Lilly and Co . announced it planned to request accelerated approval from the FDA for its Alzheimer’s candidate, donanemab. The company indicated plans to application based on results from a Phase II study that in January 2021 demonstrated it slowed the rate of decline in cognition and function. Schwan’s comments were part of Roche’s second-quarter report . The company reported half-year group sales up 8%, Pharmaceutical Division sales dropped 3%, although they rose 4% in the second quarter after a first-quarter drop of 9%. New drugs increased sales by 30%. The company’s Diagnostics Division grew 51%, mainly on the backs of COVID-19 tests. The company also noted it was dropping some compounds from its pipeline. These include selicrelumab combinations in solid tumors, which was in Phase I. Selicrelumab is a CD40-targeting drug. They also dropped two gene therapies it was partnered on with 4D Molecular Therapeutics in Phase I. The programs included 4D-110 for choroideremia and 4D-125 for X-linked retinitis pigmentosa. Other programs on the chopping block included BCMAxCD16a bispecific RG6206 in multiple myeloma, which it partnered with Affimed, and EOS789 that it was partnered on with Chugai for hyperphosphatemia. Schwan stated , “We have achieved good results in the first half, primarily thanks to the demand for our new medicines and COVID-19 tests. The Pharma Division began to grow again in the second quarter. The base diagnostics business shows strong momentum.” He went on to say, “As expected the demand for COVID-19 tests peaked in the second quarter and is likely to decrease in the second half of the year even though this of course depends on how the pandemic will develop and significant uncertainties remain. This virus will stay with us, it will continue to mutate, and as such there will be a continued need for vaccines, for new vaccines and boosters, as well as tests and medicines.”

Phase 3Phase 2Phase 1Clinical Result

100 Deals associated with Selicrelumab

External Link

KEGG	Wiki	ATC	Drug Bank
D11491	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Colorectal Carcinoma	Phase 2	United States	-	27 Sep 2018
Metastatic Colorectal Carcinoma	Phase 2	Australia	-	27 Sep 2018
Metastatic Colorectal Carcinoma	Phase 2	France	-	27 Sep 2018
Metastatic Colorectal Carcinoma	Phase 2	Switzerland	-	27 Sep 2018
Locally advanced breast cancer	Phase 2	United States	Hoffmann-La Roche, Inc.	30 Mar 2018
Locally advanced breast cancer	Phase 2	Australia	Hoffmann-La Roche, Inc.	30 Mar 2018
Locally advanced breast cancer	Phase 2	France	Hoffmann-La Roche, Inc.	30 Mar 2018
Locally advanced breast cancer	Phase 2	Germany	Hoffmann-La Roche, Inc.	30 Mar 2018
Locally advanced breast cancer	Phase 2	Israel	Hoffmann-La Roche, Inc.	30 Mar 2018
Locally advanced breast cancer	Phase 2	Spain	Hoffmann-La Roche, Inc.	30 Mar 2018

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03555149 (MORPHEUS-CRC \| MORPHEUS, CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	96	Regorafenib (Regorafenib (Control))	ijjvrrrnod = bysigelxjn nyyzxuxcxv (lbwcolqxjx, sxpxsiahse - hwoknzeuel) View more	-	07 Nov 2023
				Imprime PGG+Atezolizumab+Bevacizumab (Atezolizumab + Imprime PGG + Bevacizumab)	ijjvrrrnod = hksaledhmx nyyzxuxcxv (lbwcolqxjx, nejobpvgrb - jdttsvuwfj) View more
NCT02304393 (Phase Ib study of selicrelumab, SITC2020)	Phase 1	Advanced Malignant Solid Neoplasm	140	Selicrelumab	hkhsnkdrdc(wltfjspfjq) = 92% qnsnglalvw (ywrqbswubs ) View more	Negative	09 Nov 2020
				Atezolizumab

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