On May 26, 2022 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported the publication of abstract #9037 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022, in Chicago (Press release, Candel Therapeutics, MAY 26, 2022, View Source [SID1234615170]). The abstract summarizes initial data as of January 10, 2022, from Candel’s open-label phase 2 clinical trial evaluating CAN-2409 in combination with anti-PD-1 or PD-L1 agents in patients with stage III/IV non-small cell lung cancer (NSCLC) who have had an inadequate response to immune checkpoint inhibitor treatment. The data presented in the poster will include additional data not included in the abstract from a total of 20 patients as of April 20, 2022, including 16 patients from cohort 2.

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"The achievement of an 87.5 percent disease control rate in patients whose cancer was progressing on anti-PD-1 treatment at enrollment bolsters the evidence of CAN-2409’s potential to induce immunization against cancer neoantigens in both injected tumors and uninjected metastases so that resistance to checkpoint blockade can be overcome," said Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel. "The occurrence of abscopal effects and clinically meaningful and durable activity, supported by significant biomarker responses and prior monotherapy activity data, strengthens our belief that this investigational agent has the potential to improve outcomes for patients with NSCLC who are progressing on anti-PD-1 agents."

Experimental treatment with CAN-2409 plus valacyclovir in combination with anti-PD-1 agents appeared to be well tolerated. The most common treatment-related adverse events were transient flu-like symptoms, such as chills, fever and fatigue, with no grade 4 and two grade 3 events reported.

Additional data highlights include:

Most patients experienced a reduction in tumor burden.
There were three objective responses in cohorts 1 and 2 (patients with stable disease or progressive disease upon entry, respectively). A fourth patient with PR initially reported in the abstract became ineligible for RECIST assessment due to an irradiated lesion; the patient still showed an absence of disease progression for more than 6 months.
Two of the three patients with a PR had PD-L1 expression below 1 percent, the third being unknown; 19 of 20 patients in the trial had negative or low PD-L1 expression.
CAN-2409 treatment induced 1) increased tumor infiltration by cytotoxic T cells, 2) a systemic increase in actively proliferating, granzyme B positive T cells, 3) an increase in interferon gamma producing effector cells in both CD4+ and CD8+ compartments, and 4) increased levels of soluble granzymes A, B and H, all consistent with the hypothesized mechanism of action of CAN-2409.
"As a physician who cares for patients with NSCLC, I am frequently confronted with the problem faced by the majority of patients with lung cancer who ultimately progress on immune checkpoint therapy," said Daniel Sterman, M.D., Professor at NYU Langone Heath, and a principal investigator for the phase 2 clinical trial. "The data from this clinical trial are incredibly exciting, suggesting that the addition of CAN-2409 to pembrolizumab or nivolumab containing treatment regimens in patients experiencing progression may offer a new therapeutic option where few good alternatives exist. Importantly, CAN-2409 was administered only two times in this setting, with intratumoral administration providing a simple and straightforward approach."

Details on the abstract are below:

Abstract Title: First report of safety/tolerability and preliminary antitumor activity of CAN-2409 in inadequate responders to immune checkpoint inhibitors for stage III/IV NSCLC

Presenter: Charu Aggarwal, MD, MPH, Associate Professor of Lung Cancer Excellence, Perelman School of Medicine, University of Pennsylvania
Session Date and Time: June 6, 2022, from 8:00 – 11:00 am CDT
Session Title: Lung Cancer – Non-Small Cell Metastatic
Location: McCormick Convention Center, Hall A
Abstract Number: 9037
Candel also announced that an in-person and webcast investor event will be held on Saturday, June 4, 2022, from 6:30 – 7:45 am CDT.

Key speakers will be:

Dr. Roy Herbst, Professor of Medical Oncology and Chief of Medical Oncology at the Yale Cancer Center, and member of Candel’s Research Advisory Board
Dr. Daniel S. Sterman, Professor of Pulmonary and Critical Care Medicine, at the New York University, Director of the Multidisciplinary Pulmonary Oncology Program at NYU Langone Health, and a principal investigator on the phase 2 clinical trial
Dr. Paul Peter Tak, President and CEO of Candel Therapeutics
The webcast and slides will be accessible live under "Events and Presentations" on the Investors page of the company’s website at View Source or by clicking here. A replay will be available on the website for approximately 90 days after the event.

Dr. Charu Aggarwal is serving as the co-principal investigator of this phase 2 clinical trial. For more information on the clinical trial please visit: View Source

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a specific CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity. Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in non-small cell lung cancer, high-grade glioma, pancreatic cancer, and localized, non-metastatic prostate cancer in ongoing clinical trials.

On May 26, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported the presentation of research across various types of cancer from its oncology portfolio during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (#ASCO22), which is taking place virtually and in-person in Chicago from June 3 to 7 (Press release, Eisai, MAY 26, 2022, View Source [SID1234615166]). Notable presentations include a poster discussion of safety and efficacy data (NCT03386942(New Window); Abstract: #5513) from the platinum-resistant ovarian cancer cohort expansion of a Phase 1 study evaluating the antibody drug conjugate (ADC) co-developed by Eisai and Bristol Myers Squibb (Headquarters: the United States), farletuzumab ecteribulin (MORAb-202), as well as a poster presentation featuring dose optimization findings for farletuzumab ecteribulin (NCT03386942(New Window); Abstract: #3090).

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"Safety and efficacy analyses in platinum-resistant ovarian cancer for farletuzumab ecteribulin suggest antibody drug conjugates may represent a promising therapeutic strategy for these patients with limited treatment options," said Dr. Takashi Owa, President, Oncology Business Group at Eisai. "Eisai’s first antibody drug conjugate combines our in-house developed anti-folate receptor alpha antibody and our anticancer agent eribulin using an enzyme cleavable linker, illustrating our dedication to building on our medicines to improve cancer care for more patients."

New research from the LEAP (LEnvatinib And Pembrolizumab) clinical program evaluating lenvatinib (LENVIMA) plus pembrolizumab (KEYTRUDA), the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, includes subgroup analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma (RCC) and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanced endometrial carcinoma (EC). A poster discussion will evaluate the impact of subsequent therapies in patients with advanced RCC receiving the combination (NCT02811861(New Window); Abstract: #4514); while a poster presentation will discuss the efficacy of next line therapy after treatment with lenvatinib plus pembrolizumab in advanced EC (NCT03517449(New Window); Abstract: #5587).

"The combination of lenvatinib plus pembrolizumab has helped to expand physicians’ arsenal of treatment options for patients living with advanced renal cell carcinoma and advanced endometrial carcinoma around the world," said Richard C. Woodman, MD, Chief Clinical Officer, Oncology Business Group at Eisai. "Our data at ASCO (Free ASCO Whitepaper) 2022 demonstrate our commitment to continuing to investigate the combination through post-hoc analyses with the goal of providing healthcare professionals with tools to support them in making better-informed treatment decisions for their patients."

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with pembrolizumab. To date, more than 20 trials have been initiated under the LEAP clinical program, which is evaluating the combination across more than 10 different tumor types.

In June 2021, Eisai and Bristol Myers Squibb entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of farletuzumab ecteribulin, a folate receptor alpha (FRα)-targeting ADC. Eisai and Bristol Myers Squibb are currently investigating farletuzumab ecteribulin in FRα-positive solid tumors (inclusive of endometrial, ovarian, lung and breast cancers) in two studies: a Phase 1 clinical study in Japan and a Phase 1/2 clinical study in the United States.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

The full list of Eisai presentations is included below. The majority of abstracts have been made available on Thursday, May 26, 2022, at 5:00 PM EDT and will be available on demand via ASCO (Free ASCO Whitepaper)’s website.

　

Cancer Type Study/Compound Abstract Title Abstract Type & Details
Pipeline
Gynecologic Cancer Farletuzumab Ecteribulin Safety and Efficacy of MORAb-202 in Patients (pts) With Platinum-Resistant Ovarian Cancer (PROC): Results From the Expansion Part of a Phase 1 Trial.
Poster Discussion
Abstract #5513
June 4, 2022
5:30 PM EDT

Shin Nishio, MD, PhD
Kurume University School of Medicine

Farletuzumab Ecteribulin Dose Optimization for MORAb-202, an Antibody-Drug Conjugate (ADC) Highly Selective for Folate Receptor-Alpha (FRα), Using Population Pharmacokinetic (PPK) and Exposure-Response (E-R) Efficacy and Safety Analyses.
Poster Presentation
Abstract #3090
June 5, 2022
9:00 AM EDT

Seiichi Hayato
Eisai
Lenvatinib Combinations

(Plus Pembrolizumab, Pembrolizumab and Chemotherapy or Pembrolizumab and Belzutifan)

Genitourinary Cancer CLEAR (Study 307)/ KEYNOTE-581 Impact of subsequent therapies in patients (pts) with advanced renal cell carcinoma (aRCC) receiving lenvatinib plus pembrolizumab (LEN + PEMBRO) or sunitinib (SUN) in the CLEAR study
Poster Discussion
Abstract #4514
June 4, 2022
5:42 PM EDT

Martin H. Voss, MD
Memorial Sloan Kettering Cancer Center
Gynecologic Cancer Study 309/ KEYNOTE-775 Efficacy of next line of therapy after treatment with lenvatinib (LEN) in combination with pembrolizumab (pembro) versus treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): exploratory analysis of Study 309/KEYNOTE-775
Poster Presentation
Abstract #5587
June 4, 2022
2:15 PM EDT

Vicky Makker, MD
Memorial Sloan Kettering Cancer Center
Gastrointestinal Cancers LEAP-014 First-line lenvatinib plus pembrolizumab plus chemotherapy in esophageal squamous cell carcinoma: LEAP-014 trial in progress
Poster Presentation
Abstract #TPS4167
June 4, 2022
9:00 AM EDT

Jong-Mu Sun, MD
Samsung Medical Center, Sungkyunkwan University School of Medicine
MK-6482-016 Phase 2 Open-label Study of Pembrolizumab Plus Lenvatinib and Belzutifan in Patients With Advanced Solid Tumors
Poster Presentation
Abstract #TPS4173
June 4, 2022
9:00 AM EDT

Robin K. Kelley, MD
University of California San Francisco
Lenvatinib
Gastrointestinal Cancer REFLECT Characterization of tumor responses in patients (pts) with unresectable hepatocellular carcinoma (uHCC) treated with lenvatinib in REFLECT
Poster Presentation
Abstract #4078
June 4, 2022
9:00 AM EDT

Masatoshi Kudo, MD
Kindai University Faculty of Medicine
Additional Research
Gynecologic Cancer ECHO EU Treatment Pattern Treatment patterns and outcomes among patients with recurrent or advanced endometrial cancer in Europe: Endometrial Cancer Health Outcomes Europe (ECHO EU) Study
Online Publication
Abstract #e17627
May 26, 2022
5:00 PM EDT

Vimalanand S Prabhu, PhD
Merck & Co., Inc., Rahway, NJ, USA
Genitourinary Cancer Translational Research Exploratory analysis on crosstalk between intra-tumor immunity and FGF/FGFR pathway in clear cell renal cell carcinoma
Online Publication
Abstract #e16525
May 26, 2022
5:00 PM EDT

Takafumi Narisawa, MD
Yamagata University Faculty of Medicine

On May 26, 2022 Race Oncology Limited ("Race") reported the dose escalation Phase 1b stage of the relapsed or refractory Acute Myeloid Leukaemia (R/R AML) trial running at the Chaim Sheba Medical Centre, Israel has successfully completed after the treatment of the first six patients (Press release, Race Oncology, MAY 26, 2022, View Source [SID1234615165]).

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The six patients were heavily pre-treated and had received a median of four prior lines of AML treatment (range 2-8).

By design, the primary endpoint of the initial phase of this 2-stage clinical trial is establishing the recommended dose to be used in the subsequent Phase 2 expansion (efficacy) stage. This first stage requires identifying the treatment dose level that achieves two or fewer dose-limiting toxicities (DLTs) from six consecutively treated patients. In the initial six patients treated, two DLTs were reported (one Grade 3 elevated liver enzymes and one Grade 5 infection). Both DLTs occurred in the most heavily pre-treated patients who had received five and eight prior lines of treatment, respectively.

"The positive results from the first stage of this trial in such a heavily pre-treated relapsed or refractory Acute Myeloid Leukaemia population is encouraging, especially with three of the patients being subsequently bridged to transplant. We look forward to the next stage of this study which, together with data from the EMD AML Trial (RAC-006) which is soon to commence recruitment in Australia, is extending our understanding of Zantrene in a modern AML setting."

Race CMO Dr David Fuller
Efficacy results in this refractory patient population were very encouraging, with one patient showing a complete response (CR) based on morphology, two patients having a partial response (PR) including one with extramedullary disease, two showing no response (NR), and one patient not assessable (NA) due to death from infection. Infection is a known side effect of all intensive chemotherapeutic regimens and is one of the leading causes of death in AML patients.

"The encouraging results of our Phase I study with Zantrene monotherapy and moreover the current Phase II study altogether with Zantrene in combination in extremely heavily treated advanced high risk AML patients are encouraging and may indicate a role for Zantrene in modern AML treatment paradigm to the benefit of our patients."

Study Lead Prof Arnon Nagler
Three patients (1 CR and 2 PR) were bridged to an allogeneic stem cell transplant. Bridging a patient to transplant is an important positive outcome in AML treatment as it offers the patient the potential of long-term remission. Of note, these three patients had all received less than five prior lines of treatment. Poor or no response to known efficacious treatments is common and expected in heavily pre-treated cancer patients.

"We are very excited about the positive data from the first stage of this trial in such a heavily pre-treated R/R AML population, and we now look forward to the next phase, where we expect to see more patients respond favourably and with a consistently tolerable side effect profile. It appears that bridging to transplantation with long-term disease control can be achieved with confidence, given we can since perceive that the side effects reverse within a few weeks of the course being completed."

Race Clinical Advisory Board Chair Prof Borje Andersson
The trial will now progress to the Phase 2 efficacy (expansion) stage using a 4-day schedule of Zantrene (bisantrene dihydrochloride) in combination with fludarabine and clofarabine.

On May 26, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported it will present new data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrating BMF-219’s activity in ex vivo preclinical models of CLL (Press release, Biomea Fusion, MAY 26, 2022, View Source [SID1234615164]). In addition, the company will present a Trial In Progress (TIP) poster presentation detailing the design of COVALENT-101. Once released at the ASCO (Free ASCO Whitepaper) Annual Meeting, the preclinical and TIP presentations can be viewed on Biomea’s website at View Source

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"Given our leadership team’s involvement with the discovery and development of ibrutinib and, thus, its demonstrated efficacy in CLL, we were highly encouraged to see BMF-219 demonstrate greater activity than ibrutinib ex vivo, especially in patient samples with TP53 alterations and NOTCH1 mutations," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. "BMF-219’s powerful cell-killing activity across ex vivo CLL models as a single agent, at similar concentrations as our prior experiments of BMF-219 in ex vivo models of other cancer types, is a very important finding. We are eager and very excited to fully explore the clinical potential of a covalent menin inhibitor across multiple liquid and solid tumor types."

BMF-219 demonstrated potency across ex vivo CLL tumor models with varying cytogenetic risk profiles and Rai stages, indicating broad activity with over 98% cell lethality in all of these models. Additionally, BMF-219 showed consistently strong activity compared to venetoclax (used as a positive control) and significantly greater activity than a clinical non-covalent (reversible) menin inhibitor. Additionally, BMF-219 exhibited robust growth inhibition in patient samples that were less responsive to bendamustine and ibrutinib.

Poster Presentation Details:

Preclinical activity of irreversible Menin inhibitor, BMF-219, in chronic lymphocytic leukemia. (Abstract #7541)
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Session Date and Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
Full Text:
Background: Menin is a scaffold protein that drives oncogenic function through transcriptional modulation directed by its various cofactors. A previous report demonstrated that menin regulates a distinct set of gene targets independent of its function with the MLL proteins in hematopoiesis and is essential for B-cell maturation (Li et al.Blood.2013;122(12):2039-46.). Chronic Lymphocytic Leukemia (CLL) is a disease of malignant B lymphocytes, for which standard-of-care agents are generally well tolerated; however, CLL patients with certain genetic backgrounds demonstrate inferior outcomes to these regimens. A major driving feature of CLL is overexpression of the anti-apoptotic marker, BCL2. We previously reported the ability of BMF-219, a selective, irreversible menin inhibitor, to downregulate the expression of BCL2 in acute leukemia cells. Additionally, we have reported the synergy of BCL2-targeted agent, venetoclax, with BMF-219 in potent cell killing of diffuse large B-cell lymphoma (DLBCL) preclinical models, prompting our exploration of BMF-219 activity in CLL. Here, we provide the first preclinical evidence for menin as a therapeutic target in CLL, by demonstrating high potency of BMF-219 against a diverse collection of CLL patient specimens.

Methods: A comprehensive panel of CLL samples isolated from patients with Rai Stages 1 to 3 disease, including relapsed or refractory disease, were cultured ex vivo in the presence of BMF-219 or clinical reversible menin inhibitors to assess the antileukemic activity of the compounds. Samples were analyzed for differential gene expression of select targets in response to treatment.

Results: BMF-219 demonstrated high potency, achieving >98% cell lethality at 1 μM exposure in all patient samples tested, with IC50 values in the range of 0.1 to 0.38 μM. Specimens isolated from patients with clinical profiles of high-risk genetic backgrounds associated with inferior outcomes to standard therapy, such as mutations in TP53 and NOTCH1, and chromosomal aberrations such as del(13q), trisomy 12 and complex karyotype, exhibited high sensitivity to BMF-219 treatment. BMF-219 was also highly effective against patient samples with clinical profiles of resistance to bendamustine, ibrutinib and venetoclax therapy. In comparison, clinical reversible menin inhibitors demonstrated no significant activity across all patient samples tested, with incalculable IC50 values and <15% reduction in cell viability at 1 μM exposure. Expression of select target genes in treated CLL cell lines was explored and will be reported.

Conclusions: Collectively, our data demonstrate the potent preclinical activity of BMF-219 against CLL patient specimens harboring various mutational and cytogenetic backgrounds, including categories of high-risk. These data highlight the unique potential of irreversible menin inhibition as a novel therapeutic option for patients with CLL.

COVALENT-101: A phase 1 study of BMF-219, a novel oral irreversible menin inhibitor, in patients with relapsed/refractory (R/R) acute leukemia (AL), diffuse large B-cell lymphoma (DLBCL), and multiple myeloma (MM). (Abstract #TPS7064)
Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session Date and Time: Saturday, June 4, 2022, 8:00 AM-11:00 AM CDT
Full Text:
Background: Menin, a protein involved in transcriptional regulation, impacting cell cycle control, apoptosis, and DNA damage repair, plays a direct role in oncogenic signaling in multiple cancers. Inhibition of menin is therefore a novel approach to cancer treatment. Preclinical data of BMF-219, a highly selective, orally bioavailable, small-molecule irreversible inhibitor of menin, show sustained potent abrogation of menin-dependent oncogenic signaling in vitro and in vivo. BMF-219 exhibited a strong anti-proliferative effect on various menin-dependent acute myeloid leukemia (AML) cell lines, DLBCL lines representing Double/Triple Hit Lymphoma (DHL/THL) and Double Expressor Lymphoma (DEL), and MM cell lines with diverse mutational backgrounds. BMF-219 also showed high potency ex vivo in patient samples from MLL-rearranged and NPM1-mutant AML, THL and MYC-amplified DLBCL, and bone marrow mononuclear cells from treatment-naive and R/R MM.

Methods: COVALENT-101 (NCT05153330) is an open-label, multi-cohort, non-randomized, multicenter Phase I study evaluating the safety, tolerability, and clinical activity of escalating doses of once daily oral BMF-219 in patients with R/R AL, DLBCL and MM who have received standard therapy. Utilizing an accelerated titration design, doses of BMF-219 will be escalated in single-subject cohorts independently for each indication until 1 subject experiences either a ≥ Grade 2 related-adverse event or dose limiting toxicity (DLT). At that point, the cohort will switch to a classical "3 +3" design. Treatment will continue in 28-day cycles until progression or intolerability. Expansion cohorts for each indication will enroll patients to obtain further safety and efficacy data. Patients with R/R AL, R/R DLBCL ≥ 2 but ≤ 5 therapies, and R/R MM who received ≥ 3 therapies and failed or are ineligible for any standard therapies are eligible. Patients must have ECOG PS ≤ 2, and adequate organ function. Key exclusion criteria include known CNS disease involvement, prior menin inhibitor therapy, and clinically significant cardiovascular disease.

The primary objective is to determine independently for each cohort/indication the optimal biological dose (OBD)/ recommended Phase 2 dose (RP2D) of BMF-219 oral monotherapy. Key secondary objectives include further evaluation of safety and tolerability, characterization of the pharmacodynamics and pharmacokinetics of BMF-219, and assessment of its antitumor activity based on best overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and time to progression (TTP) per disease-specific response criteria as assessed by the investigator. Food-effect studies will be performed in DLBCL and MM patients at certain dose levels. The enrollment commenced in January 2022. Clinical trial information: NCT05153330.

About Chronic Lymphocytic Leukemia (CLL)

CLL is a chronic leukemia that progresses relatively slowly and typically impacts older adults. In the United States, approximately 20,000 patients are diagnosed with CLL each year. While the existing treatments options produce 5-year survival outcomes greater than 87%, there is an unmet need for patients that have high- or medium-risk cytogenetic profiles and those that are relapsed or refractory to existing treatments.

On May 26, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune, and infectious diseases reported it will deliver an oral presentation and two poster presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held from June 3 – 7, 2022 (Press release, Immunocore, MAY 26, 2022, View Source [SID1234615163]).

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CLINICAL SCIENCE SYMPOSIUM

Title: Updated overall survival (OS) data from the phase 1b study of tebentafusp (tebe) as monotherapy or combination therapy with durvalumab (durva) and/or tremelimumab (treme) in metastatic cutaneous melanoma (mCM)

Presenter: Mark Middleton
Date and Time: June 5, 2022; 9:45 a.m. CDT
Session: Clinical Science Symposium: Bispecifics: Are two better than one?
Abstract ID: 104
POSTER PRESENTATIONS & ABSTRACTS

Title: Treatment with tebentafusp beyond radiographic progressive disease (PD) in metastatic uveal melanoma (mUM)

Presenter: Ryan Sullivan
Date and Time: June 6, 2022; 1:15 – 4:15 p.m. CDT
Session: Melanoma / Skin Cancers
Abstract ID: 9585
Title: Analysis of the effect of systemic corticosteroids on survival from tebentafusp in a phase 3 trial of metastatic uveal melanoma

Presenter: Alexandra Ikeguchi
Date and Time: June 6, 2022; 1:15 – 4:15 p.m. CDT
Session: Melanoma / Skin Cancers
Abstract ID: 9584
Title: Overall survival (OS) in metastatic uveal melanoma: A summary of recent prospective trials

Author: Josep M. Piulats
Publication only
Presentations and posters will be available for registered attendees on the ASCO (Free ASCO Whitepaper) website from June 3-7, 2022.

About Uveal Melanoma
Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.

About KIMMTRAK
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma.

About Phase 3 IMCgp100-202 Trial
The IMCgp100-202 (NCT03070392) is a randomized pivotal trial that evaluated overall survival (OS) of KIMMTRAK (tebentafusp-tebn) compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in HLA-A*02:01-positive adult patients with previously untreated mUM. KIMMTRAK demonstrated an unprecedented OS benefit with a Hazard Ratio (HR) in the intent-to-treat population favoring KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).

About ImmTAC Molecules
Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.