On June 1, 2022 Harbour BioMed (the "Company", HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics, reported the progress of its dual MOA of CTLA-4 inhibition and Treg depletion, next-generation fully human heavy-chain antibody (HBM4003) with studies of monotherapy and combination therapy with anti-PD-1 antibody (Press release, Harbour BioMed, JUN 1, 2022, View Source [SID1234615385]). The two abstracts have been published on the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website and will be presented at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting.

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Abstract One:

Study title: A Phase I Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HBM4003 in Subjects with Advanced Solid Tumors

Abstract number: 2641

Poster number: 296

This is an open-label, multi-center study on subjects with solid tumors to receive HBM4003 at dose levels (DLs) of 0.3mg/kg QW (28-day cycle), 0.45mg/kg Q3W (21-day cycle), and 0.6mg/kg Q3W (21-day cycle). In the dose-expansion part, patients with advanced hepatocellular carcinoma (HCC), melanoma, and renal cell carcinoma (RCC) received 0.45 mg/kg Q3W (21-day cycle).
24 patients with advanced solid tumors in the dose-escalation part and 36 patients in the dose-expansion part, from 12 sites in mainland China, 5 sites in Australia, and 1 site in Hong Kong, China; including 19 HCC patients and 19 RCC patients. 46 patients (77%) received ≥ 2 lines of previous systemic therapies and 37 patients (62%) received previous PD-1/PD-L1 treatment.
In the HCC cohort, all 19 patients received previous PD-1/PD-L1 therapy, and 12 patients were evaluable for efficacy. 2 patients had stable disease (SD) and 2 patients had partial response (PR) as the best response. The objective response rate (ORR) was 16.7% and the disease control rate (DCR) was 33.3%.
Among the 19 RCC patients, 18 patients were evaluable for efficacy. 8 patients had SD as the best response; the DCR was 44.4%.
Overall, the most common treatment-related adverse event (TRAE) of all grades was rash (16 [26.7%] patients). At the 0.45 mg/kg Q3W DL, Grade≥3 TRAEs occurred in 4 (9.3%) patients, 1 patient reported Grade 4 TRAE, and no Grade 5 TRAE was reported.
The recommended phase II dose was selected as 0.45mg/kg Q3W.
Sustained Treg depletion was observed in tumor tissue on day 21 post dosing.
Abstract Two

Study title: A Phase I Open-label Study to Evaluate the Safety, Tolerability, PK/PD and Anti-tumor Activity of HBM4003 in Subjects with Advanced Melanoma and Other Solid Tumors

Abstract number: e14586

This is a phase I study to evaluate the safety, anti-tumor activity, PK/PD, and recommended phase II dose of HBM4003 in combination with toripalimab. In dose-escalation part, patients were enrolled to receive HBM4003 at 3 dose levels (DLs) (0.03 mg/kg Q3W, 0.1 mg/kg Q3W, and 0.3 mg/kg Q3W) combined with toripalimab 240 mg. In dose-expansion part, patients with advanced melanoma will be treated at recommended phase II dose.
As of 30 November 2021, in total 11 patients have been treated at one site in China, including 9 with melanoma, 1 with renal cell carcinoma, and 1 with urothelial carcinoma. 4 patients received ≥ 2 lines of previous systemic therapies and 8 received previous PD-1/PD-L1 treatment.
The most common TRAE of all grades was leukopenia (4 [36.4%] patients), followed by lymphopenia (3 [27.3%] patients). No > Grade 3 TRAE reported.
At the 0.3mg/kg Q3W DL, 6 patients were evaluable for efficacy: 2 patients had SD as the best response, whereas 1 patient had PR as the best response (mucosal melanoma, 2 lines of previous treatment including toripalimab), with tumor shrinkage of 32.6% (Week 12).
HBM4003 0.3mg/kg Q3W in combination with toripalimab showed promising antitumor activity and a tolerable safety profile in advanced melanoma and other solid tumors. Hence, 0.3mg/kg Q3W was selected as the recommended dose for dose-expansion in advanced melanoma.
Particularly in the study of HBM4003 in combination with toripalimab, another PR from a urothelial carcinoma patient (3 lines of previous treatments including toripalimab) was observed at the end of 2021. As of the date of issue, the patient recruitment of the dose-expansion part in this study has been completed.

Commenting on the studies’ results, Dr. Humphrey Gardner, CMO of Harbour BioMed, said, "we are excited to observe the promising efficacy and excellent safety profile of HBM4003 and its potential to lead the development of next-generation therapy of immuno-oncology for multiple solid tumors. The Treg depleting activity of HBM4003 offers a potential for clinical efficacy in indications hitherto unaddressed by first generation CTLA4 inhibitors. The clinical results obtained so far have given us the confidence for further global development of HBM4003, and further relevant study results will be published in the upcoming academic conferences."

As the Company further implements its global innovation and development strategy, it will continue to fully commit to advancing the global clinical development project of HBM4003, as part of its broad and innovative immuno-oncology pipeline to address the significant unmet medical needs in multiple solid tumor indications.

About HBM4003

HBM4003 is a fully human anti-CTLA-4 monoclonal heavy chain only antibody (HCAb) generated from Harbour Mice. It is the first fully human heavy-chain-only monoclonal antibody entered into clinical stage globally. By enhancing antibody-dependent cell cytotoxicity (ADCC) killing activity, HBM4003 has demonstrated significantly improved depletion specific to high CTLA-4 expressing Treg cells in tumor tissues. The potent anti-tumor efficacy and differentiated pharmacokinetics with durable pharmacodynamic effect presents a favorable product profile. This novel and differentiated mechanism of action has the potential to improve efficacy while significantly reducing the toxicity of the drug in monotherapy and combination therapy.

On June 1, 2022 SOPHiA GENETICS (Nasdaq: SOPH), a leader in data-driven medicine, reported three abstracts accepted for poster presentation and one for online publication at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7 in Chicago (Press release, Sophia Genetics, JUN 1, 2022, View Source [SID1234615383]). SOPHiA GENETICS and GE Healthcare will also be hosting an Innovation Symposium on Monday, June 6th from 6:30 – 8:00 pm to present how the companies are working together to deliver on the promise of integrated cancer medicine by bringing global insights across multiple diagnostic modalities to clinical and biopharma customers.

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"These high-impact ASCO (Free ASCO Whitepaper) contributions from SOPHiA GENETICS and collaborators demonstrate how our multimodal technology and solutions help drive novel insights and enhance oncology discoveries," said Dr. Philippe Menu, Chief Medical Officer at SOPHiA GENETICS. "By utilizing our data-driven medicine approach and by applying our AI and machine learning algorithms to real-world multimodal data sets, SOPHiA GENETICS has the potential to help inform treatment decisions at the individual patient level for cancer patients globally. I am really excited to attend ASCO (Free ASCO Whitepaper) to share how our mission to democratize data-driven medicine is helping transform cancer care."

An overview of the four accepted SOPHiA GENETICS abstracts at ASCO (Free ASCO Whitepaper) 2022 are included below. The full abstracts will be published in the Meeting Proceedings, an online supplement of the Journal of Clinical Oncology.

Individualized prediction of post-surgical pathologic T3a (pT3a) upstaging risk in localized renal tumors undergoing nephrectomy (UroCCR 15 study) (Abstract # 4547, Poster # 38)
Overview: UroCCR is a French national network of 37 multidisciplinary teams for kidney cancer management that collects longitudinal data on the routine clinical care of its patients. For the study, a retrospective cohort of 4,395 cases of clinical T1-T2 kidney tumors was analyzed. The study suggests that machine learning applied to pre-surgical multimodal data can predict the risk of pT3a upstaging of a localized kidney tumor and inform long-term outcomes at the individual patient level. The results have been validated on an external cohort of 1,759 patients with data from the clinical routine.
This abstract has been accepted for poster presentation in the "Genitourinary Cancer-Kidney and Bladder" session on June 4, 2022, 13:15-16:15 CDT.
Multimodal machine learning model prediction of complete pathological response to neoadjuvant chemotherapy in triple-negative breast cancer (Abstract # 601, Poster # 372)
Overview: Triple negative breast cancer (TNBC) is a biologically and clinically heterogenous disease, associated with poorer outcomes when compared with other subtypes of breast cancer. A retrospective cohort of 57 patients with early-stage TNBC treated with neoadjuvant chemotherapy was analyzed. The study suggests that machine learning applied to baseline multi-modal data can help predict pCR status after neoadjuvant chemotherapy for TNBC at the individual patient level, as well as stratify patients to inform long-term outcomes. Patients that would be predicted as non-pCR could benefit from concomitant treatment with immunotherapy, or dose intensification.
This abstract has been accepted for poster presentation in the "Breast Cancer-Local/Regional/Adjuvant" session on June 6, 2022, 08:00-11:00 CDT.
Multimodal prediction of response to neoadjuvant nivolumab and chemotherapy for surgically resectable stage IIIA non-small cell lung cancer (Abstract # 8542, Poster # 169)
Overview: The NADIM trial (NCT03081689), led by the Spanish Lung Cancer Group, assessed the antitumor activity and safety of neoadjuvant chemoimmunotherapy for resectable stage IIIA NSCLC. This study is, to our knowledge, the first to offer a multimodal analysis of the response to neoadjuvant treatment for surgically resectable stage IIIANSCLC and is a proof of concept that a machine learning algorithm can be used to predict the pCR in this context. These preliminary results are being confirmed in the ongoing NADIM II trial (NCT03838159).
This abstract has been accepted for poster presentation in the "Lung Cancer-Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers" session on June 6, 2022, 08:00-11:00 CDT.
Multimodal machine learning model prediction of "individual" response to immunotherapy in 1L stage IV NSCLC (Abstract # e21151)
Overview: Immunotherapy (IO) is the standard of care in 1L stage IV non-small cell lung cancer (NSCLC) cases that are not eligible for targeted therapies. A retrospective 1-year cohort of 63 patients with advanced NSCLC, PD-L1 expression > 50%, and treated with 1L pembrolizumab monotherapy was analyzed. This proof-of-concept study suggests that machine learning applied to baseline multi-modal data can help predict response to IO at the individual patient level, as well as stratify patients to inform long-term outcomes. This algorithm is being improved and validated through a large real-world multicentric international observational study including more than 4000 patients (DEEP-Lung-IV study, NCT04994795).
This abstract has been accepted for online publication

On June 1, 2022 EpicentRx, Inc, a privately-held clinical-stage biotechnology company at the forefront of developing oncolytic viruses and small molecules for the treatment of cancer and other inflammatory-driven diseases, reported that data from a Phase 2 randomized clinical trial with RRx-001 in first line head and neck cancer has been selected for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3-7, 2022, in Chicago, Illinois (Press release, EpicentRx, JUN 1, 2022, View Source [SID1234615382]). Positive results from the completed Phase 2 study called PREVLAR that was carried out in collaboration with Dr. Stephen Sonis, Distinguished Faculty member at the Dana-Farber Cancer Institute and CMO of Primary Endpoint Solutions and a leading expert in cancer-related oral mucositis, will be presented, highlighting the anti-inflammatory and antioxidant properties of RRx-001 as well as plans to initiate a follow-on trial called KEVLAR.

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Details on the company’s poster presentation are below:

Abstract Title: Phase 2 pilot trial of RRx-001 as an anti-mucositis agent in head and neck cancer patients treated with chemoradiation (PREVLAR)

Session Title: Head and Neck Cancer

Abstract Number for Publication: 6078

Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT

About RRx-001
RRx-001 leads EpicentRx’s CyNRGY platform as a first-in-class investigational treatment sourced from an exclusively licensed portfolio of aerospace-derived small molecules. RRx-001 is a multifaceted treatment with a dual-functioning mechanism that starts under "normal" conditions, or healthy tissues that are reasonably well-oxygenated, and the activity changes in poorly oxygenated (hypoxic) tissues, which is a distinguishing characteristic of cancerous tumors.

On June 1, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, reported the activation of the initial clinical sites to screen and enroll patients in the company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA-201, a readily available cell therapy candidate for the treatment of follicular and diffuse large B cell lymphomas (NCT05296525) (Press release, Gamida Cell, JUN 1, 2022, View Source [SID1234615381]). On April 26, 2022, Gamida had announced that the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application and removed the clinical hold for a cryopreserved formulation of GDA-201.

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"We are excited to be screening patients for enrollment in our company-sponsored Phase 1/2 clinical study of our novel, cryopreserved formulation of GDA-201, which has the potential to address the significant unmet need that exists for patients with follicular and diffuse large B cell lymphomas having relapsed or refractory disease," said Ronit Simantov, M.D., chief medical and scientific officer of Gamida Cell. "As described in previously announced clinical data, an investigator-sponsored (IS) study evaluating the fresh formulation of GDA-201 demonstrated encouraging results in heavily pretreated patients with lymphoma. With the initiation of enrollment, we look forward to dosing the first patient in our clinical study of the novel cryopreserved formulation of GDA-201."

GDA-201 leverages Gamida Cell’s proprietary NAM technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity. Of the 19 patients with non-Hodgkin lymphoma (NHL), 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%. The most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. At the December 2021 Annual Meeting of American Society of Hematology (ASH) (Free ASH Whitepaper), two-year follow-up data were reported on outcomes and cytokine biomarkers associated with survival. The data demonstrated a median duration of response of 16 months (range 5-36 months) and an overall survival at two years of 78% (95% CI, 51%–91%). In the IS study, GDA-201 was well-tolerated and no dose-limiting toxicities were observed in 19 patients with NHL and 16 patients with multiple myeloma.

The study of the cryopreserved formulation of GDA-201 is currently open to enrollment at Henry Ford Health (Detroit, MI) and the Masonic Cancer Center at the University of Minnesota; additional sites will be added in the coming months and updated in Clinicaltrials.gov (NCT05296525). The Phase 1 portion of the study is designed to evaluate the safety of GDA-201 in patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL), marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in two patient cohorts, FL and DLBCL/HGBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T or stem cell transplant.

About NAM Technology

Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU, which is the patient population that will be studied in the GDA-201 Phase 1/2 clinical trial.

For more information about GDA-201, please visit View Source For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On June 1, 2022 Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, reported the presentation of preclinical data supporting further investigation of a rationally designed microbial consortium candidate (DE486) to prevent or treat gastrointestinal (GI) mucositis – a common and often painful complication of radiation and chemotherapy involving the breakdown of the rapidly-dividing epithelial cells lining the GI tract (Press release, Seres Therapeutics, JUN 1, 2022, businesswire.com/news/home/20220601005127/en/Seres-Therapeutics-Presents-Microbiome-Therapeutic-Research-at-the-2022-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting [SID1234615380]). These results are available online as part of the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"Microbiome-based therapeutics may offer a potentially novel approach to mitigate debilitating side-effects that can lead to delays or dose reductions of life-saving cancer treatments," said Matthew Henn, Ph.D., Chief Scientific Officer at Seres. "This microbial consortium builds on our scientific and clinical data, and we are encouraged by these preclinical results that suggest potential areas of investigation and future development opportunities for this new area of medicine."

In laboratory experiments, chemotherapy caused mice to develop mucositis of the small intestine and rapidly lose weight. Treatment with a defined consortium of microbes from Seres’ proprietary strain library was shown to reduce inflammation and restore the mice to their normal weight after about a week. In contrast, treating mice with a different microbial cocktail that was intentionally selected to include pro-inflammatory bacteria that may be found in cancer patients with a disrupted microbiome was observed to have the opposite effect, resulting in continued weight loss.

These data support the potential of specifically designed combinations of microbes to minimize damage done to the lining of the GI tract by cancer treatment as a strategy to prevent or manage GI mucositis.

Seres will also present a poster on June 4 at 8:00-11:00 AM CDT detailing the design of an early Phase 1b trial evaluating the efficacy, safety and pharmacokinetics of SER-155 in adults undergoing allogeneic hematopoietic stem cell transplantation (HSCT). SER-155 is a cultivated investigational microbiome therapeutic rationally designed to improve clinical outcomes in patients undergoing HSCT by restoring colonization resistance to pathobionts, promoting epithelial barrier integrity, and reducing colonic inflammation. In addition to SER-109, SER-155 represents Seres’ second active development program in its Infection Protection franchise.

Another poster presentation on June 4 at 1:15-4:15 PM CDT will reprise Phase III trial results of SER-109, an investigational microbiome therapeutic for recurrent C. difficile infection (rCDI). The data showed SER-109 was associated with lower recurrence rate vs. placebo regardless of baseline comorbidity score category. This suggests SER-109 has a side effect profile comparable to placebo and may significantly reduce rCDI rates, which disproportionately affect cancer patients.

Phase 1b Study of SER-155 in Stem Cell Transplant

Hematopoietic stem cell transplant (HSCT) is frequently used to treat lymphoma, leukemia and multiple myeloma or for people who received high doses of chemotherapy or radiation that damaged their bone marrow. While it can be curative, stem cell transplant also carries the risk of life-threatening complications.

A Phase 1b clinical trial (NCT04995653) is now enrolling adults undergoing allogeneic HSCT to test whether the investigational microbiome therapeutic SER-155 is safe and effective at preventing graft-versus-host disease, blood infections and other serious complications.

The trial is designed to enroll 10 participants in an initial open-label cohort to gauge safety. Then, an additional 60 adults will be enrolled into a double-blind, randomized, placebo-controlled arm to assess efficacy. Participants in the second cohort will receive either vancomycin followed by SER-155 or placebo. Adverse events and microbiome samples will be logged for the first year following stem cell transplantation.

Phase 3 ECOSPOR III Study of SER-109 Data Encore

Cancer patients are at greater risk of developing rCDI and tend to have worse outcomes, due to their weakened immune system and frequent antibiotics exposure.i

Encore data from the completed double-blind, randomized, placebo-controlled Phase 3 ECOSPOR III trial (NCT03183128) show that the investigational microbiome therapeutic SER-109 significantly reduced rCDI rates. SER-109 was also observed to be well tolerated, with a safety profile comparable to placebo and no serious drug-related adverse events observed. From 4 weeks post-treatment through 24 weeks, adults with a history of rCDI had fewer recurrences after taking SER-109 compared with those who received placebo.

Seres expects to finalize a Biologics License Application (BLA) submission for SER-109 with the U.S. Food and Drug Administration (FDA) in mid-2022, with an anticipated launch in the first half of 2023, if approved. SER-109 has obtained FDA Breakthrough Therapy and Orphan Drug Designations, supporting the expectation of an expedited review timeline.

About SER-155
SER-155, an oral consortium of cultivated bacteria, is a microbiome therapeutic candidate in clinical development. SER-155 is designed using microbiome biomarker data from human clinical data, human cell-based assays, and in vivo disease models, with the aim to decrease infection and translocation of antibiotic-resistant bacteria in the gastrointestinal tract and modulate host immune responses to decrease GvHD. The rationale for this program is based in part on published clinical evidence from Seres’ collaborators at Memorial Sloan Kettering Cancer Center showing that allogeneic HSCT patients with decreased diversity of commensal microbes are significantly more likely to die due to infection and/or lethal GvHD. SER-155 was developed using Seres’ reverse translational discovery platform to potentially reduce incidences of gastrointestinal infections, bloodstream infections and GvHD in immunocompromised patients, including in patients receiving allogeneic HSCT or solid organ transplants.

About SER-109
SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores, which normally live in a healthy microbiome. SER-109 is designed to prevent the recurrence of CDI by restructuring the microbiome to a state that resists C. difficile colonization and growth. The SER-109 manufacturing purification process is designed to remove unwanted microbes, thereby reducing the risk of pathogen transmission beyond donor screening alone. The FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the prevention of rCDI.