On June 7, 2021 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported in an oral presentation at the 57th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, updated results from a Phase II study of the MDM2-p53 inhibitor alrizomadlin (APG-115) in combination with pembrolizumab in patients with unresectable or metastatic melanoma or advanced solid tumors that have progressed on prior immuno-oncologic (IO) drugs (Press release, Ascentage Pharma, JUN 7, 2021, View Source;ascentage-pharma-presents-updated-results-of-mdm2-p53-inhibitor-alrizomadlin-apg-115-demonstrating-an-orr-of-24-1-including-complete-response-in-combination-with-pembrolizumab-in-patients-with-advanced-mel-301307261.html [SID1234583679]).

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As a leading Chinese biotechnology company with progressive visibility at international scientific congresses in recent years, Ascentage Pharma’s clinical study results have been selected for presentations at the ASCO (Free ASCO Whitepaper) Annual Meeting for the fourth year. This year, results from four of its studies clinical studies were selected for presentations at the meeting, including two oral presentations. The clinical study data from the on-going Phase II study of alrizomadlin have demonstrated a manageable safety profile and meaningful clinical antitumor activity, including one patient with a complete response (CR), an objective response rate (ORR) of 24.1% and a disease control rate (DCR) of 55.2% in the PD-1/PD-L1 inhibitor-resistant melanoma cohort. In addition, partial responses (PRs) were reported in enrolled patients with other tumor types.

"The clinical data of alrizomadlin presented in our oral presentation are encouraging, as they suggest clinical activity in hard-to-treat tumor types across multiple indications, including several without currently available standard of care, such as relapsed or refractory melanoma subtypes," said Dr. Anthony W. Tolcher, Founder and CEO of NEXT Oncology, Director of Clinical Research at Texas Oncology, and the Global Principal Investigator of the study. "Our data provide a clinical validation of the recently published paper in Nature Immunology demonstrating that alrizomadlin synergizes with immunotherapy by sustaining STAT5 stability and controlling T-cell-mediated antitumor immunity via the novel pathway of MDM2 inhibition. This seminal publication elucidates why patients who previously failed to respond to IO therapy may derive clinical benefit from the addition of alrizomadlin to the IO agent pembrolizumab."

"This study of alrizomadlin in combination with pembrolizumab offers a clinical validation of the therapeutic synergy between MDM2-p53 inhibitors and existing immuno-oncologic drugs and shows the potential as a new treatment option that could bring renewed hope for patients with solid tumors," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "At this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, we have announced results from multiple studies, including that of Alrizomadlin, in two oral presentations and two poster presentations. I am very proud of these advances, which attest to Ascentage Pharma’s robust capabilities in global innovation. Moving forward, we will remain committed to our mission of addressing unmet clinical needs in China and around the world, and strive to accelerate our clinical programs in the hope of soon benefitting patients."

An overview of the four abstracts presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting:

Drug Candidate

Abstract Title

Abstract #

Format

Lisaftoclax

(APG-2575)

First-in-human study of lisaftoclax (APG-2575), a novel Bcl-2 inhibitor (Bcl-2i), in patients (pts) with relapsed/refractory (R/R) CLL and other hematologic malignancies (HMs)

7502

Oral

Presentation

Alrizomadlin

(APG-115)

Preliminary results of a phase II study of alrizomadlin (APG-115), a novel, small-molecule MDM2 inhibitor, in combination with pembrolizumab in patients (pts) with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic (I-O) drugs

2506

Oral

Presentation

Trial in progress: A phase I/II trial of novel MDM2 inhibitor alrizomadlin (APG-115), with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma

TPS6094

Poster

Presentation

Pelcitoclax

(APG-1252)

Trial in progress: A multicenter phase Ib/II study of pelcitoclax (APG-1252) in combination with paclitaxel in patients with relapsed/refractory small-cell lung cancer (R/R SCLC)

TPS8589

Poster

Presentation

Highlights of the oral presentation on alrizomadlin at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting:

Preliminary results of a phase II study of alrizomadlin (APG-115), a novel, small-molecule MDM2 inhibitor, in combination with pembrolizumab in patients (pts) with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic (I-O) drugs

Abstract: #2506

This open-label, multicenter Phase II study in the US assessed the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of alrizomadlin in combination with pembrolizumab in patients with advanced solid tumors.
As of April 15, 2021, 102 patients had been enrolled in the Phase II part of the study and treated with alrizomadlin at the recommended Phase II dose (RP2D) of 150 mg every other day, in combination with pembrolizumab. This study has 6 cohorts, including patients with: PD-1/PD-L1 inhibitor-resistant melanoma, non-small cell lung cancer (NSCLC), and urothelial carcinoma; or malignant peripheral nerve sheath tumor (MPNST), liposarcoma, and ATM mutant solid tumors.
Antitumor Effects:
In the PD-1/PD-L1 inhibitor-resistant melanoma cohort (n=29), there was 1 confirmed partial response (PR) out of 7 patients with uveal (ocular) melanoma; 2 PRs (1 confirmed + 1 unconfirmed) out of 5 patients with mucosal melanoma; and 1 complete response (CR, confirmed) and 3 PRs (2 confirmed + 1 unconfirmed) out of 15 patients with cutaneous melanoma. The ORR and DCR in the melanoma cohort were 24.1% (7/29) and 55.2% (16/29), respectively.
In the MPNST cohort (n=6), 1 PR (unconfirmed).
In the liposarcoma cohort (n=16), 1 PR (unconfirmed) and 12 stable diseases (SDs), at a DCR of 81.2% (13/16).
In the PD-1/PD-L1 inhibitor-resistant NSCLC (n=15) and urothelial carcinoma (n=8 evaluable) cohorts, 1 patient in each cohort achieved confirmed PR.
Common treatment-related adverse events (TRAEs) observed in more than 10% of patients were nausea, thrombocytopenia, vomiting, fatigue, decreased appetite, diarrhea, neutropenia, and anemia.
In conclusion, alrizomadlin combined with pembrolizumab is well tolerated, and did not exhibit any overlapping toxicity. These preliminary results have established proof of concept clinically that the combination regimen has antitumor activity in patients with IO relapsed/refractory metastatic melanoma, (including uveal melanoma, mucosal melanoma, or cutaneous melanoma). In addition, this combination therapy also showed promising antitumor activity in patients with MPNST or liposarcoma for which pembrolizumab has no approved indications.

On June 7, 2021 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported updated results from the first-in-human study of the Bcl-2 inhibitor lisaftoclax (APG-2575) in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) and other hematologic malignancies (Press release, Ascentage Pharma, JUN 7, 2021, View Source;ascentage-pharma-delivers-oral-presentation-featuring-updated-data-demonstrating-promising-efficacy-and-safety-of-bcl-2-inhibitor-lisaftoclax-apg-2575-in-patients-with-relapsed-or-refractory-cllsll-301307266.html [SID1234583678]). The findings were reported in an oral presentation at the 57th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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As one of the Chinese biotechnology companies that have been increasingly visible at international scientific congresses in recent years, Ascentage Pharma has entered the fourth year in which its clinical advances have been selected for presentations at the ASCO (Free ASCO Whitepaper) Annual Meeting. This year, results from four of the company’s clinical trials were selected for presentations at the meeting, and of these data, the two oral presentations have received widespread and avid interest from research and medical communities. Updated data on lisaftoclax have demonstrated favorable preliminary safety and efficacy, including an objective response rate (ORR) of 80% and a favorable tolerability profile, with manageable adverse events (AEs) in patients with R/R CLL/SLL. Moreover, no dose-limiting toxicity (DLT) was observed at the maximum tested dose of 1,200 mg. The maximum tolerated dose (MTD) has not been reached, and no laboratory or clinical tumor lysis syndrome (TLS) has been reported.

Dr. Asher Chanan-Khan, MD, of Mayo Clinic, and the Global Principal Investigator of this study, commented: "Lisaftoclax is a potent, selective Bcl-2 inhibitor which can both induce apoptosis and inhibit tumor cell growth. In this first-in-human study in the US and Australia, lisaftoclax showed a favorable safety profile and promising antitumor activity in patients with R/R CLL/SLL, and potential disease control in several other hematologic malignancies. In view of the preliminary safety and clinical activity observed in this Phase I study, we look forward to further evaluating the antitumor activity of lisaftoclax in individual hematologic malignancies and solid tumors."

"The initial objective response rate of 80%, together with a favorable safety profile and no TLS despite a daily dose ramp-up, demonstrated by lisaftoclax in patients with R/R CLL/SLL are particularly encouraging and once again support the best-in-class potential of lisaftoclax," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "At this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, we have announced results from multiple studies, including that of lisaftoclax, in two oral presentations and two poster presentations. I am very proud of these advances, which attest to Ascentage Pharma’s robust capabilities in global innovation. Moving forward, we will remain committed to our mission of addressing unmet clinical needs in China and around the world, and strive to accelerate our clinical programs in the hope of soon benefitting patients."

An overview of the four abstracts presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting:

Drug Candidate

Abstract Title

Abstract #

Format

Lisaftoclax

(APG-2575)

First-in-human study of lisaftoclax (APG-2575), a novel Bcl-2 inhibitor (Bcl-2i), in patients (pts) with relapsed/refractory (R/R) CLL and other hematologic malignancies (HMs)

7502

Oral

Presentation

Alrizomadlin

(APG-115)

Preliminary results of a phase II study of alrizomadlin (APG-115), a novel, small-molecule MDM2 inhibitor, in combination with pembrolizumab in patients (pts) with unresectable or metastatic melanoma or advanced solid tumors that have failed immuno-oncologic (I-O) drugs

2506

Oral

Presentation

Trial in progress: A phase I/II trial of novel MDM2 inhibitor alrizomadlin (APG-115), with or without platinum chemotherapy, in patients with p53 wild-type salivary gland carcinoma

TPS6094

Poster

Presentation

Pelcitoclax

(APG-1252)

Trial in progress: A multicenter phase Ib/II study of pelcitoclax (APG-1252) in combination with paclitaxel in patients with relapsed/refractory small-cell lung cancer (R/R SCLC)

TPS8589

Poster

Presentation

Highlights of the oral presentation on lisaftoclax at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting:

First-in-human study of lisaftoclax (APG-2575), a novel Bcl-2 inhibitor (Bcl-2i), in patients (pts) with relapsed/refractory (R/R) CLL and other hematologic malignancies (HMs)

Abstract: #7502

This first-in-human global Phase I study assessed the safety, pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and MTD/recommended Phase II dose (RP2D) of lisaftoclax in patients with R/R CLL and other HMs. Lisaftoclax was orally administered once daily in a 28-day cycle. Patients with CLL or intermediate-high TLS risk were initiated on a daily ramp-up schedule until the dose assigned before the study cycles.
As of April 15, 2021, 36 patients had been enrolled and treated with lisaftoclax at doses ranging from 20 to 1,200 mg, with a median of 2 (range: 1-13) prior lines of treatment. These patients had been diagnosed with R/R CLL/SLL (n=15), multiple myeloma (MM, n=6), follicular lymphoma (FL, n=5), Waldenström macroglobulinemia (WM, n=5); and either acute myeloid leukemia (AML), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), myelodysplastic syndromes (MDS), or hairy cell leukemia (HCL; n=1 each). These patients received a median of 6 cycles (range: 1-24) of treatment with lisaftoclax.
Lisaftoclax was well tolerated, with manageable AEs. No DLT was observed even at the maximum dose of 1,200 mg. The MTD has not been reached, and no laboratory or clinical TLS has been reported. Hematologic treatment-related adverse events (TRAEs) of any grade in more than 10% patients included neutropenia and anemia, while nonhematologic TRAEs included fatigue, diarrhea, constipation, and nausea.
In the 15 evaluable patients with R/R CLL/SLL, 7 (46.7%) each were assessed as Rai stage III-IV or intermediate-high per International Prognostic Index (IPI). Patients in this cohort received a median of 9 (range: 5-24) cycles of treatment, and 12 patients achieved partial responses (PRs), for an ORR of 80% and a median time to response of 2 (range: 2-8) treatment cycles.
Among 21 patients with R/R non CLL/SLL, who received a median of 3 (range: 1-13) prior lines of treatment, 20 were evaluable. Of these individuals, 1 with t (11;14)-mutant MM achieved minor response (MR) after 2 treatment cycles. A total of 10 (50%) patients in this cohort achieved stable disease (SD) or deeper responses.
The preliminary PK profile showed that exposures increased with lisaftoclax at doses ranging from 20 to 1,200 mg (average half-life: 4-5 hours). On BH3 profiling, lisaftoclax rapidly triggered changes in Bcl-2 complex in CLL/SLL patient samples, which were consistent with rapid clinical reductions in absolute lymphocyte counts (ALCs).
In conclusion, efficacy and safety data showed that the Bcl-2 inhibitor lisaftoclax offers a potential alternative treatment for patients with R/R CLL/SLL and other HMs, with a daily ramp-up schedule that may be more patient-friendly and a favorable preliminary safety profile.

On June 7, 2021 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, together with IASO Biotherapeutics (IASO Bio), reported to deliver an oral presentation on updated data from the Phase I study of IBI326 in patients with relapsed/refractory multiple myeloma (R/R MM) at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, June 9-17, 2021 (Press release, Innovent Biologics, JUN 7, 2021, View Source [SID1234583677]). The presentation will further demonstrate the safety, efficacy, and increased persistence of IBI326.

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IBI326 is a fully-human B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell therapy co-developed by IASO Bio and Innovent (Innovent: IBI326, IASO Bio: CT103A), and it is currently under the pivotal Phase II clinical trial. In February 2021, IBI326 was granted the Breakthrough Therapy Designation (BTD) by China regulatory authority, National Medical Production Administration (NMPA) for the treatment of relapsed/refractory multiple myeloma.

In the oral presentation, Professor Chunrui Li with Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (HUST) in China will report the clinical data on 35 patients with R/R MM, who received 1.0, 3.0, or 6.0 × 106/kg IBI326 treatment respectively in the dose-escalation phase and dose-expansion cohort. The 1.0 × 106/kg dose was determined as Recommended Phase II Dose (RP2D). The median age of the 35 patients was 54 (27, 72). Among them, eight patients had extramedullary multiple myeloma (EMM) and one patient had complication with plasma cell leukemia. The median number of prior treatment regimens was four (3, 12). Ten patients previously received autologous hematopoietic stem cell transplantation (AHSCT), and 10 patients received murine BCMA CAR-T treatment. As of May 1, 2021, the median follow-up of the 35 patients was 291 days (21, 954).

IBI326 has a rapid onset of action and long-lasting efficacy. The overall response rate (ORR) was 97.1% in the 35 patients, among whom 29 patients (82.9%) achieved ≥ VGPR and 20 patients (57.1%) achieved complete response/stringent complete response (CR/sCR). And 34 patients evaluable for MRD achieved minimal residual disease (MRD) negativity, with the median time to MRD negativity 1.3 (0.7, 4.1) months.
All patients previously treated with murine BCMA CAR-T or patients with extramedullary multiple myeloma (EMM) benefited from IBI326. Among all 35 patients, eight were with EMM, among whom eight (75%) achieved ≥VGPR, two (25%) achieved PR, eight patients achieved ≥PR. Among all 35 patients, 10 patients were treated with a prior murine BCMA CAR-T treatment, among whom eight (80%) achieved ≥VGPR, one (10%) achieved PR, one（10%）achieved stable disease (SD).
IBI326 has a good safety profile. Five of the 35 patients had cytokine release syndromes (CRS) of Grade 3 or above. The median time to onset of CRS was 4 (1, 9) days, and all CRS could be efficiently controlled by tocilizumab and/or steroids. ICANS was observed in only one patient whose symptom was drowsiness; the patient later spontaneously relieved without any treatment.
IBI326 was persistent in the patients. The median time to reach the peak of IBI326 expansion in the patients was 12 (7, 17) days. As of the cut-off date, three patients had IBI326 persistence for over two years, and the first patient of them achieved persistent sCR.
IBI326 has lower immunogenicity. Only two patients (5.7%) were detected positive for anti-drug antibody (ADA), and the immunogenicity was significantly lower than that of the prior murine BCMA CAR-T treatment.
The clinical data of the study in patients with R/R MM presented at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in 2019 highlighted the impressive safety profile, efficacy, and durability of response of IBI326. The study also included four patients who had relapsed after prior murine BCMA CAR T-cell treatment. The overall response of these four patients demonstrated that IBI326 can also be an effective treatment option for patients who have relapsed from a prior CAR-T therapy.

In June 2021, the results were published in Blood, a peer-reviewed journal specializing in hematology, in an article titled "A phase 1 Study of a Novel Fully Human BCMA-targeting CAR (IBI326) in Patients with Relapsed/Refractory Multiple Myeloma." The editors of Blood were impressed by the unique persistence of IBI326 and the authors’ exposition on the re-treatment prospects of the disease during the study. Therefore, they invited experts from University College London Cancer Institute to write a review titled "BCMA CARs in multiple myeloma: room for more?" (DOI 10.1182/blood.2021010833).

Dr. Hui Zhou, Senior Vice President of Medical Development, Innovent Biologics, said, "We are glad to see that the excellent clinical data of IBI326 (IASO: CT103aA) has been highly recognized by the EHA (Free EHA Whitepaper) congress. In particular, it still shows good clinical benefits to the patients who received prior murine BACM CAR-T treatment, and provides better treatment options for patients with relapsed/refractory multiple myeloma. We look forward to the launch of this cell therapy to benefit patients in the future. "

Maxwell Wang, Chief Executive Officer of IASO Bio, said, "We are very glad that our high-quality clinical data are presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress, one of the top global academic conferences. It’s also the only oral presentation on a China-developed BCMA CAR-T treatment at this year’s EHA (Free EHA Whitepaper) Congress. The updated data reinforce the advantages and uniqueness of CT103A in the treatment of patients with relapsed/refractory multiple myeloma. Particularly, we enrolled 8 patients with extramedullary multiple myeloma and 10 patients receiving prior murine BCMA CAR-T treatment. All patients have obtained clinical benefits. IASO Biotherapeutics will continue to leverage its innovative clinical development strategy to further prove the advantages of CT103A. We also look forward to the oral presentation by Professor Chunrui Li with Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology (HUST) at the EHA (Free EHA Whitepaper) Congress."

Presentation details:

Abstract: S194 AN UPDATED PHASE 1 STUDY OF A NOVEL FULLY HUMAN BCMA-TARGETING CAR-T CELLS (CT103A) IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

Type: Oral Presentation

Session title: T cell re-directing therapies in relapsed/refractory multiple myeloma

About Multiple Myeloma

Multiple Myeloma is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For multiple myeloma patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there’s currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma.

About IBI326 (BCMA CAR-T)

IBI326 is an innovative therapy co-developed by Innovent and IASO Bio. Previous studies indicate subjects with relapsed/refractory multiple myeloma (R/R MM) who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells will not be effective. To solve this dilemma, IBI326 has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3ζ activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the BCMA CAR-T is potent and persistent. In February 2021, IBI326 was granted breakthrough therapy designation by the NMPA for the treatment of relapsed/refractory multiple myeloma.

On June 7, 2021 NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that it will host a virtual KOL event for analysts, investors, and the scientific community on Friday, June 11, 2021 at 8AM ET / 2PM CET (Press release, Nanobiotix, JUN 7, 2021, View Source [SID1234583676]). The event will feature several key opinion leaders, including current study investigators.

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The Nanobiotix KOL event will provide an in-depth review of the immunotherapy data presented at the 2021 Annual Meeting of American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) along with clinical perspectives on the implications of potential first-in-class radioenhancer NBTXR3 across the oncology landscape.

Registration for the event is now open on the events section of the Company’s website. A live webcast of the discussion and an archived recording will be available on the events section as well.

Nanobiotix Virtual KOL Event Program

Can NBTXR3 Turn Anti-PD-1 Non-responders into Responders and Deepen Response in Naïve Patients?

Agenda:

Opening Remarks (8:00AM ET / 2:00PM CET)
Presented by Jeffrey Bockman, PhD, EVP and Oncology Practice Head, Cello Health BioConsulting
NBTXR3 Mode of Action (8:05AM ET / 2:05PM CET)
Presented by Laurent Levy, PhD, co-founder and CEO, Nanobiotix
Overview of the Treatment Landscape: Promise and Limitations of Immunotherapy, and Rationale for Combination-based Approaches (8:10AM ET / 2:10PM CET)
Presented by Jared Weiss, MD, Associate Professor of Medicine, Division of Oncology, University of North Carolina Lineberger Comprehensive Cancer Center
Nanobiotix Study 1100 Safety and Efficacy Data Update (8:20AM ET / 2:20PM CET)
Presented by Tanguy Seiwert, MD, Assistant Professor of Oncology, Director, Head and Neck Cancer Oncology Disease Group, Johns Hopkins Medicine and Colette Shen, MD, PhD, Assistant Professor, Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center
NBTXR3 as a Potential Combination-agnostic Product, Rationale, and Future Opportunity (8:40AM ET / 2:20PM CET)
Presented by James Welsh, MD, Associate Professor, Department of Radiation Oncology, University of Texas MD Anderson Cancer Center
Discussion and Q&A, Implications of Study 1100 in Head and Neck Cancer and Beyond (8:50AM ET / 2:50PM CET)
Panel Discussion Moderated by Jeffrey Bockman
Summary Close (9:10AM ET / 3:10PM CET)
Presented by Jeffrey Bockman

On June 7, 2021 Osel Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, reported that City of Hope, a world-renowned independent cancer and diabetes research and treatment center, presented data from a Phase 1b trial showing that an LBP, CBM588 (Clostridium butyricum MIYAIRI 588 strain), plus nivolumab/ipilimumab improved overall response rate (ORR) and progression-free survival (PFS) compared to nivolumab/ipilimumab alone in patients with metastatic renal cell carcinoma (RCC) (Press release, Osel, JUN 7, 2021, View Source [SID1234583675]).

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Osel licensed the rights for the pharmaceutical use of CBM588 in the United States, Canada and Europe from Miyarisan Pharmaceutical Co., Ltd., and has a clinical trial agreement for the CBM588 study with City of Hope.

The data were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting by City of Hope’s Luis Meza, a postdoctoral fellow, and Sumanta K. Pal, M.D., clinical professor, Department of Medical Oncology & Therapeutics Research. The presentation titled First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM588 in patients with metastatic renal cell carcinoma (Abstract #4513) is part of the session titled Genitourinary Cancer – Kidney and Bladder.

"We are very pleased with results generated from this clinical study," said Thomas Parks, Ph.D., Head of Development at Osel. "There is considerable interest in microbiome modulation to enhance immune checkpoint inhibitor efficacy that is more consistent and scalable than fecal transplants. These data are an encouraging indicator of potential patient benefit in an initial indication of metastatic RCC."

CBM588 is a spore forming anaerobe that produces short chain fatty acids, mainly butyric acid, which is a well-known energy source of intestinal epithelium. The bacterial strain exerts several beneficial effects through multiple modes of action, including inhibition of pathogenic microorganisms, immunomodulatory activities and restorative effects on intestinal dysbiosis.

"Adjunctive treatment with CBM588 is associated with improvements in response rate and PFS in patients treated in combination with standard of care versus standard of care alone – there is also a compelling trend favoring overall survival early on," Pal said. "These results warrant further investigation in a larger multi-center trial."

CBM588 is manufactured and marketed in Japan by Miyarisan Pharmaceutical as a prescription product known as Clostridium butyricum MIYAIRI 588 strain for the treatment of gastrointestinal (GI) indications. It has an excellent safety profile in all age groups and immunocompromised patients, as confirmed by post-marketing surveillance.

"Microbiome analysis showed a statistically significant increase in Bifidobacteria in CBM588 treated clinical responders compared to CBM588 treated non-clinical responders or standard of care patients," said Motomichi Takahashi, Ph.D., Executive Senior Director, Miyarisan Pharmaceutical. "These preliminary data support the GI microbiome being successfully modulated as a mechanism of clinical efficacy."