On May 26, 2022 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported the presentation of a trial in progress poster from the Phase II clinical trial of MRx0518 in combination with BAVENCIO (avelumab), a PD-L1 blocking antibody, as a first-line maintenance therapy for patients with unresectable locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy, at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (Press release, 4d Pharma, MAY 26, 2022, View Source [SID1234615128]).

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"We are continuing to build a strong body of evidence to support MRx0518 as a novel immunotherapy with broad potential to address significant unmet need across multiple oncology indications," said Dr Alex Stevenson, Chief Scientific Officer at 4D pharma. "MRx0518 has previously demonstrated single agent immuno-modulation of the tumor microenvironment, and this data supports the potential of this combination to significantly enhance and improve outcomes for patients beyond treatment with BAVENCIO alone. Not only are we able to evaluate MRx0518 with a leading immune checkpoint inhibitor, we are also able to assess its potential in earlier treatment settings. We are pleased to be sharing further details on the design of our first-line maintenance study with BAVENCIO for the treatment of locally advanced or metastatic urothelial carcinoma with the oncology medical community at ASCO (Free ASCO Whitepaper)."

Poster Presentation Details:
Poster Title: Trial in progress: A phase II switch maintenance study of live biotherapeutic MRx0518 and avelumab in patients with unresectable locally advanced or metastatic urothelial carcinoma (UC) who did not progress on first-line platinum-containing chemotherapy
Presenting Author: Amishi Y. Shah MD, The University of Texas MD Anderson Cancer Center, Houston, TX
Session Title: Genitourinary Cancer – Kidney and Bladder
Abstract Number: TPS4610
Poster Number: 95a
Date and Time: Saturday, June 4, 2022 at 13:15 CDT

Highlights from the trial in progress poster include:

The multi-center study (NCT05107427) will enroll 30 patients with unresectable locally advanced or metastatic urothelial carcinoma. Patients must have measurable disease after a partial response (PR) or stable disease (SD) on 4-6 cycles of platinum-containing induction chemotherapy.
Patients will receive intravenous BAVENCIO (avelumab) every two weeks, in combination with one oral capsule of MRx0518 twice daily, until disease progression, patient withdrawal, or unacceptable toxicity.
In addition to assessing the safety of the combination of MRx0518 with BAVENCIO, the study will assess the effect of the combination on progression-free survival (PFS) at 6 months.
Secondary objectives are to assess other efficacy measures including objective response rate (ORR), time to response, duration of response (DOR), disease control rate (DCR), PFS, and overall survival (OS).
Immunological changes of the microbiome and metabolome will be assessed through biopsies, longitudinal blood sampling and stool and urine samples.
The study is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc.
Study sites are open for patient enrolment.
The poster will be available on the "Posters & Publications" section of the 4D pharma website at www.4dpharmaplc.com.

About MRx0518

MRx0518 is single strain Live Biotherapeutic Product (LBP) in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumors. It is currently being evaluated in four clinical trials in patients with solid tumors. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumors and is being conducted at Imperial College (London, UK). MRx0518-I-002 is in combination with KEYTRUDA (pembrolizumab) in patients with acquired resistance to prior anti-PD-1/PD-L1 immune checkpoint therapies. The Coordinating Investigator of the study is at The University of Texas MD Anderson Cancer Center, Houston, USA, with multiple additional sites in the US. The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 is in combination with preoperative radiotherapy in resectable pancreatic cancer. MRx0518-004 (AVENU) is a Phase II clinical trial of MRx0518 in combination with BAVENCIO (avelumab) in the first-line maintenance setting for urothelial carcinoma, conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc.

On May 26, 2022 I-Mab (the "Company") (Nasdaq" IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported preliminary data of its ongoing Phase 2 clinical trial (NCT04322006) with uliledlimab (also known as TJD5, or TJ004309), a differentiated CD73 antibody, and its global clinical development plan (Press release, I-Mab Biopharma, MAY 26, 2022, View Source [SID1234615144]).

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At the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, preliminary results through December 2021 from an ongoing Phase 2 clinical study of uliledlimab in combination with toripalimab (TUOYI) in patients with non-small cell lung cancer (NSCLC) were released.[1] These results were largely consistent with those observed in Phase 1 clinical trial in relation to favorable drug safety and pharmacokinetics (PK) and pharmacodynamic (PD) profile of ulilelimab. Uliledlimab appears safe and well-tolerated up to the highest doses tested at 30 mg/kg Q3W, as a monotherapy and a combination therapy with toripalimab with no dose limiting toxicity (DLT). Uliledlimab exhibited a linear PK profile at doses ≥5mg/kg and a dose-dependent receptor occupancy with no "hook effect", where the antibody loses its effectiveness at high concentrations.

The most updated Phase 2 data are summarized as follows with the new data cutoff of March 29, 2022. Among three NSCLC patient cohorts who were under different treatment settings, clinical response varied. The highest response rates were observed in the patient cohort with advanced NSCLC (mostly stage 4 disease) who were previously ineligible for standard of care, while the other two cohorts with advanced NSCLC who were heavily treated showed a lower clinical response. Among 19 efficacy evaluable patients from this cohort, 5 partial responses (5 PR, overall response rate [ORR]=26%) and 9 stable disease (9 SD, disease control rate [DCR] =73.7%) were observed. Approximately 80% patients in this cohort showed low PD-L1 expression in baseline tumor samples (tumor proportion score [TPS] 1-49% or TPS<1%) who were considered less responsive to a checkpoint inhibitor therapy as demonstrated in KEYNOTE-042 (ORR=16.9% for patient with PD-L1 TPS 1-49%)[2]. Noticeably, the clinical response observed in this patient cohort displayed a correlation with CD73 expression in tumors. High CD73 expression (≥35% expression level in tumor cells or immune cells) was found in 4/5 PRs with a mean value of 53.4%, 4/9 SDs with a mean value of 30.5% and none in the 5 remaining patients with a mean value of 19.2% who progressed on the treatment. The clinical data continue to mature.

"The data represent a step forward for advanced non-small-cell lung cancer patients. To date, uliledlimab has shown a favorable safety profile and positive anti-tumor activity in lung cancer patients, particularly in those patients with a higher baseline CD73 expression," said Professor Yi-Long Wu, Principal Investigator of the study and Professor of Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences and Guangdong Lung Cancer Institute. "While the study is ongoing and we are analyzing the data as they mature, we are extremely encouraged by these results and the clinical benefits that uliledlimab may offer to cancer patients."

This Phase 2 clinical trial is still ongoing with patients on-study for continued treatment and follow-up evaluation. The Company plans to expand the study with the aim to focus on the selected NSCLC patient cohort for further evaluation of treatment efficacy as well as the role of CD73 as a potential predictive biomarker. The future clinical development plan of uliledlimab includes a Phase 3 registrational clinical trial in patients with NSCLC to be expected next year if approved by the China National Medical Products Administration and another clinical trial in the United States in other selected cancer types and beyond combination with PD-1/PD-L1 therapy in the next 12 months.

"The latest data readout, although preliminary, gives hope to those lung cancer patients who often do not benefit from the currently available treatments," said Dr. Andrew Zhu, President of I-Mab. "We are excited by uliledlimab’s potential as a best-in-class CD73 antibody and the clinical results obtained so far have given us the confidence for further clinical development towards registration. We look forward to accelerating our clinical development plan in China and the U.S. with the goal to initiate a registrational clinical study soon."

Uliledlimab is a differentiated CD73 antibody that is designed to avoid a "hook effect" seen in other clinical stage CD73 antibodies. This differentiated property is enabled through uliledlimab’s novel C-terminus epitope and its associated intra-dimer binding mode, leading to a favorable PK and PD relationship as confirmed in both Phase 1 and the ongoing Phase 2 clinical trials.

In a Phase 1 clinical trial of uliledlimab in combination with atezolizumab (Tecentriq), uliledlimab was well tolerated with encouraging efficacy signals in heavily treated cancer patients (ORR=23%, DCR=46%) as presented at ASCO (Free ASCO Whitepaper) 2021[3]. Recommended Phase 2 dose (RP2D) was determined at 20 mg/kg, Q3W and there was a potential correlation between high tumoral expression of CD73 and the observed clinical response.

The Company will host an investor conference call to provide an in-depth clinical data analysis at 8 a.m. Eastern Time on May 27, 2022. Details for the conference call are as follows:

About Uliledlimab (TJD5)

Uliledlimab (TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine in turn binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in tumor microenvironment. Uliledlimab is expected to offer clinical benefit by suppressing tumor growth in concert with checkpoint therapies such as PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties as evident in preclinical studies.

On May 26, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported initial clinical data from the Phase 1/2 study evaluating nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, in combination with BLENREP (belantamab mafodotin-blmf), GSK plc’s (LSE/NYSE: GSK) antibody drug conjugate targeting B-cell maturation agent (BCMA), in patients with relapsed or refractory multiple myeloma (RRMM) (Press release, SpringWorks Therapeutics, MAY 26, 2022, View Source [SID1234615161]). In addition, SpringWorks also highlighted long-term follow-up data from a Phase 2 study sponsored by the National Cancer Institute (NCI) evaluating nirogacestat in patients with progressing desmoid tumors, which included follow-up on progression-free survival and long-term safety data.2 These data sets will be shared in poster sessions at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 3-7, 2022 in Chicago.

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"We are encouraged by the emerging clinical profile of nirogacestat with low-dose BLENREP given the promising efficacy and safety profile that we have seen to date, and we look forward to the maturation of the Phase 2 portion of the study in parallel with the initiation of new sub-studies to evaluate this combination with standard of care treatments in multiple myeloma," said Saqib Islam, Chief Executive Officer of SpringWorks. "I would also like to thank the NCI for their commitment to evaluating nirogacestat in patients with progressing desmoid tumors. We were very pleased to recently report positive topline data from our Phase 3 DeFi trial and these follow-up data from the NCI-sponsored Phase 2 study provide valuable information on the long-term safety and efficacy profile of nirogacestat in desmoid tumor patients."

Synergistic Effects of Low-Dose Belantamab Mafodotin in Combination with a Gamma-Secretase Inhibitor (Nirogacestat) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): DREAMM-5 Study (Poster # 443)

The objective of this sub-study of GSK’s DREAMM-5 platform trial (NCT04126200) is to determine if low-dose BLENREP in combination with nirogacestat results in similar efficacy with an improved ocular toxicity profile compared to single-agent BLENREP at its approved dose and schedule. The study opened with a dose-exploration (DE) arm evaluating 0.95 mg/kg BLENREP Q3W combined with 100 mg BID nirogacestat dosed continuously, and subsequently moved into a cohort expansion (CE) arm. The target enrollment for the CE arm of the study is 70 patients randomized either to BLENREP 2.5mg/kg Q3W monotherapy (control arm) or low-dose BLENREP plus nirogacestat combination using the same dose as the DE arm cohort.

The following results of the pre-planned interim analysis will be presented at ASCO (Free ASCO Whitepaper):

The study enrolled patients with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy (median: 4.5), including an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody. The poster being presented at ASCO (Free ASCO Whitepaper) includes data from a total of 24 patients treated with low-dose BLENREP + nirogacestat across the DE and CE cohorts (N=10 and N=14, respectively) and 14 patients treated with monotherapy BLENREP in the CE cohort.
At the time of the March 4, 2022 data cut-off, the median (range) of follow-up in the low-dose BLENREP plus nirogacestat DE cohort was 34.5 weeks (5-88 weeks), with durations of response exceeding one year in some patients. Data from the CE cohorts are not yet mature with a median duration of follow-up of 12 weeks available at the time of data cut-off.
The CE cohorts utilized the KVA ocular toxicity grading scale; Grade 3 ocular adverse events occurred in 1/14 (7%) patients in the low-dose BLENREP plus nirogacestat combination compared to 7/14 patients (50%) in the BLENREP monotherapy arm. The DE cohort utilized the CTCAE-5 ocular toxicity grading scale; the low-dose BLENREP plus nirogacestat combination demonstrated Grade 3 ocular adverse events in 2/10 (20%) patients.
At the time of data cut-off, the objective response rate (ORR) of low-dose BLENREP plus nirogacestat across the DE and CE cohorts was 38%, with 17% of patients achieving a VGPR or better (N=24). The ORR of the BLENREP monotherapy control arm was 50%, with no patients achieving a VGPR or better (N=14).
These data will be presented in a poster discussion session at ASCO (Free ASCO Whitepaper) on June 4, 2022 from 5:30 – 7:00 p.m. EDT by Sagar Lonial, MD, FACP, Professor and Chair Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University.

Extended Progression-Free Survival and Long-Term Safety of Nirogacestat in Patients with Desmoid Tumors (Poster #449)

The primary objective of this open-label, NCI-sponsored Phase 2 study (NCT01981551) was to assess the RECIST 1.1-determined objective response rate of nirogacestat in patients with progressing desmoid tumors. Seventeen adult patients received 150 mg BID of nirogacestat dosed continuously.

The following results will be presented at ASCO (Free ASCO Whitepaper):

Of the 16 evaluable patients, no disease progression has been observed for any patient while on study.
The median time on treatment for all evaluable patients was 4.4 years (range 0.17-7.99 years) with 4/16 patients remaining on treatment over 7 years. At the time of the Kummar, et. al publication,3 the median time on treatment was >25 months (range: 3-30 months), with 10/16 patients remaining on treatment as of the publication.
The adverse event profile was generally consistent with what was previously reported by Kummar, et. al. Long-term follow-up data reported one new Grade 3 adverse event of diarrhea and one new Grade 3 adverse event of fatigue.
These data will be presented in a poster session on June 5, 2022 from 9:00a.m.-12:00p.m. EDT by Geraldine Helen O’Sullivan Coyne, MD, PhD, Developmental Therapeutics Clinic/Early Clinical Trials Development Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute.

About Multiple Myeloma

Multiple myeloma is the second most common blood cancer in the U.S. and is generally considered treatable, but not curable.4,5 It originates in the bone marrow and is characterized by abnormalities in plasma cells that reproduce uncontrollably in the bone marrow and other disease sites. In the U.S., more than 34,000 people are estimated to be diagnosed with multiple myeloma this year and nearly 13,000 people will die from the disease.6 New therapies are needed as multiple myeloma commonly becomes refractory to available treatments.7

About Desmoid Tumors

Desmoid tumors are rare, aggressive, locally invasive, potentially morbid tumors of the soft tissues.8,9 While they do not metastasize, desmoid tumors are associated with a high rate of recurrence.9,10,11 Sometimes referred to as aggressive fibromatosis, or desmoid fibromatosis, these soft tissue tumors can be serious, debilitating, and in rare cases when vital organs are impacted, they can be life-threatening.9,12

Desmoid tumors are most commonly diagnosed in patients between the ages of 20 to 44 years, with a two-to-three times higher prevalence in females.11,13,14 It is estimated that there are 1,000-1,650 new cases diagnosed per year in the United States.14,15

Historically, desmoid tumors were treated with surgical resection, but this approach has become less favored due to a high recurrence rate after surgery.8,11,16 There are currently no FDA-approved therapies for the treatment of desmoid tumors.

About Nirogacestat

Nirogacestat is an investigational, oral, selective, small molecule gamma-secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has eight collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies, four bispecific antibodies and a monoclonal antibody. SpringWorks has also formed research collaborations with Fred Hutchinson Cancer Research Center and Dana-Farber Cancer Institute to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA-directed therapies using a variety of preclinical multiple myeloma models.

Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma. The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

On May 26, 2022 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported updated interim safety and efficacy data from its Phase 1/1b AURELIO-03 dose escalation study of the IL-2/IL-15 receptor βγ superagonist, SOT101, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors (Press release, SOTIO, MAY 26, 2022, View Source [SID1234626226]). Data from the study show that SOT101 has a favorable safety profile. The recommended Phase 2 dose was defined at 12 µg/kg SOT101.

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The AURELIO-03 study is an open label, single arm Phase 1/1b dose escalation study to determine the recommended Phase 2 dose and to evaluate the preliminary efficacy of SOT101 in patients with advanced solid tumors either as a monotherapy or in combination with pembrolizumab. SOT101 is administered subcutaneously on days 1, 2, 8, and 9 of every three-week cycle. 30 patients were treated on monotherapy dose levels 0.25 to 15 μg/kg and twenty-one patients on combination therapy dose levels 1.5 to 12 μg/kg.

Interim results of SOT101 as a monotherapy demonstrated four patients pretreated with checkpoint inhibitor (CPI) with confirmed stable disease. A partial response was confirmed in one patient with skin squamous cell carcinoma whose tumor was CPI-refractory. The preliminary efficacy is currently being further evaluated in an ongoing monotherapy extension in skin squamous cell carcinoma, melanoma, and renal cell cancer.

In 19 patients with at least one post-baseline tumor assessment across all dose levels who were treated with SOT101 in combination with pembrolizumab, one complete response in a patient with mesothelioma, four partial responses and 10 confirmed stable diseases have been reported.

The adverse event profile of SOT101 in combination with pembrolizumab was in line with the adverse event profile of either compound as monotherapy. No additive toxicity was seen when combining SOT101 with pembrolizumab. For both monotherapy and combination treatment, the recommended Phase 2 dose of SOT101 was established at 12 μg/kg.

This data will be presented by principal investigator Dr. Elena Garralda from the Vall D’Hebron Institute of Oncology, Barcelona, Spain at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois on Saturday, June 4, 2022.

"Despite decades of progress in clinical oncology, the difficulty of treating solid tumors has remained a significant challenge for physicians," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. "Given the promising results from our first-in-human study of SOT101, we are greatly encouraged to have observed excellent preliminary safety and efficacy data both as a monotherapy and in combination with pembrolizumab. We look forward to initiating a basket study of SOT101 in combination with KEYTRUDA to evaluate efficacy and safety in patients with selected advanced or refractory solid tumors. This large Phase 2 AURELIO-04 trial in collaboration with MSD will be initiated in the coming weeks."

Dr. Garralda added: "The patients in this study are some of the hardest to treat, some with up to nine prior lines of therapy, so the clinical benefit observed in the AURELIO-03 study is especially encouraging. These data highlight the potential impact of SOT101 on the treatment landscape for solid tumors."

The presentation from ASCO (Free ASCO Whitepaper) is available below:

ASCO 2022 – AURELIO-03 results.pdf

About SOT101:
SOT101 (SO-C101) is a subcutaneously administered IL-15Rβγ superagonist that is fused to the sushi+ domain of the IL-15 receptor α chain. SOT101 has demonstrated strong preclinical in vivo efficacy in various tumor models showing increased long-term survival and tumor regression, as well as a favorable toxicology profile. SOT101 has been shown in pre-clinical models to synergize with checkpoint inhibitors and antibody therapies exerting ADCC.

On May 26, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that members of its management team will participate in two upcoming investor conferences (Press release, Syndax, MAY 26, 2022, View Source [SID1234615064]):

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A virtual fireside chat at Cowen’s 3rd Annual Oncology Innovation Summit at 12:30 p.m. ET on Thursday, June 2, 2022.
A fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference at 6:20 p.m. ET/ 3:20 p.m. PT on Tuesday, June 14, 2022 in Rancho Palos Verdes, CA.
A live webcast of the fireside chats can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the events will also be available for a limited time.