On June 4, 2021 Ichnos Sciences Inc., a global biotechnology company developing innovative biologics in oncology and autoimmune diseases, reported preclinical data that support the potential of ISB 1342, a first-in-class bispecific T-cell engager targeting CD38 expressed on the surface of multiple myeloma (MM) cells (Press release, Ichnos Sciences, JUN 4, 2021, View Source [SID1234583536]). ISB 1342 is currently in Phase 1 (NCT03309111) for the treatment of patients with MM that have relapsed or do not respond to available therapies. Ichnos shared the data via a prerecorded video presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Ichnos’ data demonstrate the ability of ISB 1342 to redirect T lymphocytes against tumor cells expressing varying levels of CD38 in preclinical in vitro and in vivo potency models. ISB 1342 engages a different epitope than do approved CD38-targeted biologics, and these models suggest that it may be effective in patients who have progressed despite treatment with such therapies.

"The data confirm the potential for ISB 1342 in patients with relapsed/refractory multiple myeloma," said M. Lamine Mbow, Ph.D., Head of the New Biologics Entity unit at Ichnos. "ISB 1342 demonstrates strong in vitro killing potency against tumor cell lines with different expression levels of CD38; the in vivo data show strong tumor-killing potential in a therapeutic model of disease."

ISB 1342 is based on Ichnos’ proprietary BEAT technology platform, which is the Bispecific Engagement by Antibodies based on the T-cell receptor. Using this platform, Ichnos is exploring the full design space for treating cancer and engineering bi-/tri-specific antibodies capable of simultaneously engaging tumor and immune cells.

The video presentation is available to registered attendees of ASCO (Free ASCO Whitepaper) starting today. Additional details are below:

Poster 8044
ISB 1342: A first-in-class CD38 T-cell engager for the treatment of relapsed/refractory multiple myeloma
Marie-Agnès Doucey, Ph.D., et al.abstract)

On June 4, 2021 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Company presented data from a phase I pharmacokinetic study of oral docetaxel plus encequidar ("oral docetaxel") and updated data from the phase III study of oral paclitaxel plus encequidar ("oral paclitaxel") illustrating tumor responses by molecular subtype (Press release, Athenex, JUN 4, 2021, View Source [SID1234583535]). The data are being presented in two posters at the American Society for Clinical Oncology 2021 (ASCO2021) Virtual Scientific Program, being held from June 4th to June 8th, 2021.

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An open label, pharmacokinetic study to determine the bioavailability, safety and tolerability of single dose oral docetaxel (Oradoxel) in metastatic prostate cancer mPC patients treated with IV docetaxel
Abstract 5050; Poster session: Genitourinary Cancer – Prostate, Testicular, and Penile

Data were presented from the open-label, two-way crossover phase I pharmacokinetic study of oral docetaxel vs IV docetaxel, which demonstrated the drug was well tolerated with no dose limiting toxicities, or drug-related serious adverse events. The mean absolute bioavailability was 15.9% (range 8% to 25%) with PK exposure becoming non-linear at 300 mg/m2. Based on these results and the results of other related studies, oral docetaxel 300 mg/m2 as divided doses is being further evaluated.

Confirmed Tumor Response by Molecular Subtype in Patients with Metastatic Breast Cancer (MBC): Sub analysis From a Phase 3 Clinical Study Comparing Oral Paclitaxel and Encequidar to IV Paclitaxel
Abstract 1073; Poster session: Breast Cancer – Metastatic

Updated data were presented from the phase III trial of oral paclitaxel, specifically tumor response rates by receptor subtype. Athenex presented the results of a post-hoc subgroup efficacy analysis based on additional tumor subtype data. Overall response rate in the intent-to-treat (ITT) population demonstrated that oral paclitaxel was superior to IV paclitaxel with confirmed response rates of 35.8% versus 23.4%, respectively (p=0.0107). Response based on tumor subtypes is listed in the table below.

On June 4, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, reported that updated data from the Company’s Phase 1 study of TJ004309 and Tecentriq (atezolizumab) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) virtual annual meeting (Press release, Tracon Pharmaceuticals, JUN 4, 2021, View Source [SID1234583534]).

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In poster presentation 2511 entitled, "The safety, pharmacokinetics (PK), pharmacodynamics (PD) and clinical efficacy of uliledlimab (TJ004309), a differentiated CD73 antibody, in combination with atezolizumab in patients with advanced cancer," data were presented from 20 refractory cancer patients with advanced or metastatic solid tumors treated with the combination of uliledlimab and atezolizumab.

Key results included:

Uliledlimab was safe and well-tolerated up to 20 mg/kg every three weeks (Q3W) and 15 mg/kg once weekly (QW) as a monotherapy and in combination therapy with atezolizumab 1200 mg Q3W. No dose limiting toxicity was observed and the maximum tolerated dose was not reached.
Full saturation of circulating and cell-bound CD73 was achieved at doses ≥ 10 mg/kg.
Linear PK profile was observed at the doses ≥10 mg/kg following a single dose and the PK profile of uliledlimab supports Q3W dosing.
There was evidence of clinical activity (one complete response, two partial responses and three cases of stable disease) in both PD-(L)1 treatment naïve and refractory cancer patients, following treatment with uliledlimab and atezolizumab.
Higher tumor CD73 and PD-L1 co-expression were found in responders compared to non-responders.
"Uliledlimab was safe and refractory solid tumor patients benefitted following treatment with uliledlimab and atezolizumab," said Francisco Robert M.D., lead author and Professor of Medicine at the University of Alabama, Birmingham. "Further evaluation of uliledlimab in combination with checkpoint inhibitors in lung and ovarian cancers is warranted."

The poster is available on TRACON’s website at www.traconpharma.com.

About TJ004309

TJ004309 is a novel, humanized antibody discovered by I-Mab, against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TRACON is developing TJ004309 in collaboration with I-Mab Biopharma through one of our two strategic agreements with them, whereby we are responsible for the regulatory and clinical development of TJ004309 in the U.S. and Europe for this study. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On June 4, 2021 Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported that Dr. Roger B. Cohen, MD, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, presented an overview of the latest HS-110 data at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting which is being held from June 4-8, 2021 (Press release, Heat Biologics, JUN 4, 2021, View Source [SID1234583533]). This poster presentation can be viewed on Heat Biologics’ website at: View Source The ASCO (Free ASCO Whitepaper) Annual Meeting is the world’s largest oncology conference showcasing the latest advancements in cancer research.

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HS-110, in combination with a checkpoint inhibitor (CPI), is a potentially transformational agent to improve survival benefit for patients with non-small cell lung cancer (NSCLC). This is a first-in-class, allogeneic, off-the shelf cell-based therapy developed by Heat leveraging its proprietary gp96 platform. At this year’s ASCO (Free ASCO Whitepaper) meeting, the Company is pleased to report the latest data of HS-110 in combination with OPDIVO (nivolumab) in two distinct treatment settings in a total of 115 previously treated patients with NSCLC:

Median overall survival (mOS) of 24.6 months was observed in previously treated, CPI naïve patients with advanced NSCLC (Cohort A, n=47). This data compares favorably with published data of Checkmate 057, which reported a mOS of 12.2 months in patients who received nivolumab as single agent in a similar treatment setting.
mOS of 11.9 months was reported in NSCLC patients who were previously treated with CPI and whose disease had subsequently progressed (Cohort B, n=68). Published data from other studies stated median OS of 6.8 to 9.0 months for NSCLC patients treated with chemotherapies after CPI progression.
Multiple subset analyses including injection-site reaction (ISR) and tumor PD-L1 expression were performed.
Significantly longer mOS was observed in patients with ISR compared with those without such a reaction for both Cohorts A and B.
Extended survival benefit was observed in PD-L1 positive patients in Cohort A.
A trend of improved overall survival was observed in patients with low blood tumor mutation burden in Cohort B.
Dr. Roger B. Cohen, Professor of Medicine at the University of Pennsylvania Perelman School of Medicine, commented, "HS-110 is a promising agent for treatment of incurable NSCLC. The latest data presented support further clinical evaluation in combination with first line regimens that include a CPI as well as addressing high unmet medical needs for CPI progressors."

Jeff Wolf, Chief Executive Officer of Heat, commented, "This data further reinforces the potential utility of HS-110 in combination with a CPI for multiple treatment settings of NSCLC. The growing body of clinical data demonstrates that HS-110 in combination with a CPI is well tolerated and has the potential to enhance survival benefit when given with a CPI. Our latest results, consistent with previously reported data, provide a strong foundation for the Company to discuss possible Phase 3 registration trial designs with the FDA and potential partners."

About HS-110
HS-110 is a first-in-class, off-the-shelf, allogeneic cell therapy designed to utilize gp96 for immune activation against multiple tumor testis antigens. Phase 2 trial of HS-110 in combination with Bristol Myers Squibb’s OPDIVO (nivolumab) has completed enrollment in patients with incurable or metastatic NSCLC. OPDIVO is a programmed death-1 immune checkpoint inhibitor. HS-110 has broad potential for providing multiple treatment options to NSCLC patients in combination with a PD-1 inhibitor. Positive interim survival data has been demonstrated in two distinct treatment settings in previously treated NSCLC patients who have not been treated with CPI as well as patients who have progressed during or after previous treatment with a CPI. Combination of HS-110 and PD-(L)1 therapies may confer additional survival benefit.

On June 4, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported data from TG-1701, the Company’s investigational once-daily, oral BTK inhibitor, as a monotherapy and as a triple therapy in combination with ublituximab, the Company’s novel glycoengineered anti-CD20 monoclonal antibody, and UKONIQ (umbralisib), the Company’s once-daily, inhibitor of PI3K-delta and CK1-epsilon in patients with front line or relapsed/refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (Press release, TG Therapeutics, JUN 4, 2021, View Source [SID1234583532]). Data from this trial were made available on demand this morning during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Presentation highlights are included below.

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are pleased to see that with additional patients and longer follow-up, TG-1701, our BTK inhibitor, continues to show encouraging clinical activity paired with what appears to be a tolerable safety profile, especially in the triple combination with U2. It is also exciting to see some early complete responses in patients treated with the triple therapy. We look forward to continuing to enroll on this trial and presenting additional data."

PRESENTATION HIGHLIGHTS:

Poster Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Chronic Lymphocytic Leukemia (CLL) and Lymphoma

A total of 125 patients with R/R CLL or B-cell lymphoma have been treated with TG-1701, with patients receiving monotherapy in the dose-escalation cohort (n=25), 200 mg in a dose-expansion cohort (n=61), 300 mg in a CLL dose-expansion cohort (n=20), or TG-1701 in combination with U2 in the dose escalation cohort (n=19).
TG-1701 monotherapy was well tolerated and the maximum tolerated dose was not reached up to 400 mg QD.
Adverse Events (AEs) of special interest in patients treated with 200 mg and 300 mg QD of TG-1701 (n=81), included Grade 3 hypertension (4.9%), atrial fibrillation (1.2%), and no instances of major bleeding observed. Grade 3 AEs occurring in ≥10% of patients treated with U2+1701 included diarrhea (11%), neutropenia (11%), ALT increase (16%), and AST increase (16%), and Grade 4 AEs occurring in ≥10% of patients treated with U2+1701 included neutropenia (11%).
At a median follow up of 12.2 months in the 200 mg QD monotherapy expansion cohorts, overall response rates (ORR) were: 95% (19/20) in CLL, 65% (13/20) in mantle cell lymphoma (MCL), and 95% (19/20) in Waldenstrom macroglobulinemia (WM).
100% ORR observed at a median follow up of 8.6 months in the 300 mg CLL monotherapy cohort (n=19).
At a median follow up of 15.6 months, the 1701+U2 dose escalation (using doses of 100mg to 300 mg QD of TG-1701) resulted in 79% ORR, with 21% CR rate across patients with WM, CLL, marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) (n=19).
Data presented at ASCO (Free ASCO Whitepaper) 2021 is available on the Publications page of the Company’s website at View Source