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Selecta Biosciences to Participate in Cantor Virtual Global Healthcare Conference

On September 21, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Company’s Management will participate in a fireside chat and one-on-one investor meetings at the Cantor Virtual Global Healthcare Conference to be held September 27-30, 2021 (Press release, Selecta Biosciences, SEP 21, 2021, View Source [SID1234588087]).

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Details on the conference be found below.

Cantor Virtual Global Healthcare Conference
Format: Fireside chat and one-on-one investor meetings
Date: Monday September 27, 2021
Presentation Time: 3:20 p.m. EST
Webcast: Click Here

An archived webcast will also be accessible in the Investors & Media section of the company’s website at www.selectabio.com.

OSE Immunotherapeutics Presented Positive Final Results of Tedopi® Phase 3 Clinical Trial

On September 20, 2021 OSE Immunotherapeutics reported that the positive final results of its Phase 3 trial of neoepitope-based cancer vaccine Tedopi, called Atalante 1, in HLA-A2 positive patients with advanced non-small cell lung cancer (NSCLC) after immune checkpoint inhibitor (PD-1/PD-L1) failure, were presented in a late-breaking oral presentation(1) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress being held on September 16 – 21, 2021 (Press release, OSE Immunotherapeutics, SEP 20, 2021, View Source [SID1234646971]).

Pr. Benjamin Besse, Director of Clinical Research at Gustave Roussy (Villejuif, France), and Principal Investigator of the Atalante 1 study, commented: "There was a lot learned during this trial about Tedopi and its potential clinical benefit that will help inform future studies in the immunotherapy field. Applying the 2020 SITC (Free SITC Whitepaper)(2) guidelines defining resistance categories for PD-1/PD-L1 checkpoint inhibitors to our trial, developed while this trial was ongoing, suggest there is great potential for Tedopi in patients with secondary resistance(3) . Therefore, we are very pleased to share such very promising results demonstrating the substantial benefits of Tedopi for NSCLC patients with secondary resistance to anti-PD-1 treatments, a hard to treat patient population with high medical need."

The Atalante 1 clinical trial evaluated the benefit of Tedopi in an HLA-A2 positive patient population with NSCLC at invasive stage IIIB or metastatic stage IV, in 2nd or 3rd line treatment following checkpoint inhibitor failure. The Tedopi treatment was compared to docetaxel or pemetrexed chemotherapy (CT) treatments in this patient population, with overall survival as the primary endpoint of the trial.

A total of 219 patients were enrolled in Atalante 1. 183 (84%) of these patients received sequential CTimmunotherapy (IO), of which 118 patients (54%) met the definition of PoI, with otherwise similar other baseline characteristics to the overall Atalante 1 population.

Tedopi demonstrated a favorable benefit/risk ratio versus standard of care (SoC) docetaxel or pemetrexed in advanced HLA-A2+ NSCLC patients with secondary resistance to immune checkpoint inhibitors.

The main results were:
Improved efficacy
1. Overall survival (primary endpoint) was statistically significantly improved for Tedopi: HR=0.59 (95% CI: 0.38, 0.91) in favor of the Tedopi arm. A clinically meaningful gain in median overall survival of 3.6 months in favor of the Tedopi arm with Tedopi OS at 11.1 months versus 7.5 months for SoC (p=0.017).

2. The objective response rate and progression free survival (PFS) were lower in the Tedopi arm, as
expected for a therapeutic vaccine versus a cytotoxic drug while at 6 months, the disease control
rate (DCR) was similar (25 % Tedopi versus 24 % SoC).

3. Post progression survival was also significantly longer in the Tedopi arm (7.7 months versus 4.6 months; p=0.004).

Improved safety profile
1. A good ECOG performance status(5), with time to ECOG deterioration significantly longer in the Tedopi arm (8.6 months versus 3.3 months; p=0.0005).

2. A maintained quality of life was observed with Tedopi (p= 0.04).

3. A good tolerance profile of Tedopi with fewer Severe Adverse Events (Tedopi 38% vs SoC 68%, p<0.001). No Treatment Emergent Adverse Effects of concern in the Tedopi arm.

New results with Yondelis® (trabectedin) in sarcoma will be presented at ESMO 2021

On September 20, 2021 PharmaMar (MSE:PHM) reported that new data on Yondelis (trabectedin) in patients with metastatic or inoperable leiomyosarcoma will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress, which is being held virtually from 16th to 21st September (Press release, PharmaMar, SEP 20, 2021, View Source [SID1234596669]).

Under the title "LMS-04 study: a randomised, multicenter phase-III study comparing doxorubicin alone versus doxorubicin with trabectedin followed by trabectedin in nonprogressive patients as first-line therapy, in patients with metastatic or unresectable leiomyosarcoma. A French Sarcoma Group study," the French Sarcoma Group will present data from a phase III study comparing first-line treatment with trabectedin in combination with doxorubicin versus standard-o-care single-agent doxorubicin for the first-line treatment of patients with metastatic or unresectable leiomyosarcoma.

The study achieved its primary endpoint of Progression Free Survival (PFS), progression RECIST (Response Evaluation Criteria In Solid Tumors)1 , supplemented by central review. In the combination arm of trabectedin with doxorubicin, median PFS reached 12.2 months, compared to 6.2 months with single-agent doxorubicin (HR = 0.41; 95% CI 0.29-0.58; P<0.0001).

In addition, the Overall Response Rate (ORR) was 38% using the combination, compared to 13% in the comparator arm. Overall Survival (OS) was 30.5 months in patients who received trabectedin in combination with doxorubicin, compared to 24.1 months in patients who received doxorubicin alone.

Patricia Pautier, M.D., oncologist, head of the multidisciplinary committee of gynecologic oncology at Gustave-Roussy and lead author of the study, said: "Leiomyosarcoma has been classically reported as the most frequent soft tissue sarcoma subtype together with liposarcoma, a third of them have a uterine location. Patients have a poor prognosis when leiomyosarcomas are metastatic. In prospective clinical trials, a median PFS of about 6 months and overall survival of around 12–15 months are usually reported for patients treated with any first-line chemotherapy, representing a true unmet medical need. In general, Doxorubicin and Ifosfamide are the backbone of sarcoma treatment, but nor other association nor new therapies are superior to doxorubicin in terms of overall survival." She added: "Trabectedin is known to be active in second line treatment for leiomyosarcomas.

The previous phase II of the trabectedin-doxorubicin combination in metastatic or advanced LMS in first line therapy (LMS02) share very encouraging results in terms of ORR, PFS and OS. The results of the LMS04 study have confirmed that this combination is superior in terms of PFS to doxorubicin alone with a 6 months statistical benefit; the impact on PFS2 also is in favor of the use of the association in combination rather than in a sequential way. There is a clinical impact on overall survival and a longer follow-up will let us know if this therapy will impact overall survival and will be the new standard of treatment in this indication.

Aprea Therapeutics Presents Data From Phase 1/2 Trial of Eprenetapopt (APR-246) in Advanced Solid Tumors at ESMO Congress 2021

On September 20, 2021 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, reported that data at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 from its Phase I/II clinical trial in advanced solid tumors (Press release, Aprea, SEP 20, 2021, View Source [SID1234594086]). The trial is evaluating the safety and efficacy of eprenetapopt in combination with pembrolizumab.

As of the July 31, 2021 data cutoff, 33 patients were enrolled on study and 31 had initiated treatment. The Phase I safety lead-in part was a dose de-escalation design and no dose-limiting toxicities were reported in the 6 enrolled patients. A Phase II expansion part was initiated and, as of the data cutoff, has enrolled 3 patients in the gastric/GEJ cancer, 3 in the bladder/urothelial cancer and 19 in the non-small cell lung cancer (NSCLC) cohorts. Patients in the NSCLC Phase II cohort were required to have prior exposure to a PD-1 or PD-L1 inhibitor. Across all patients, 25 (76%) had a mutation in the TP53 gene. The trial continues to enroll and treat patients and exploratory studies involving analyses of patient-derived immune cell populations are ongoing.

In the bladder/urothelial cohort, 1 patient with locally advanced TP53 mutant high-grade transitional cell bladder cancer had achieved complete remission (CR) by RECIST criteria at the first response assessment at 9 weeks. In the NSCLC cohort, 2 patients with TP53 mutant squamous NSCLC had reductions in target lesions of 26.7% and 8.2%, respectively, from baseline by RECIST criteria at the first response assessment at 9 weeks. Adverse events, regardless of causality, were mostly grade 1/2. Grade ≥3 events occurring in more than 1 patient included anemia (3), dyspnea (3), dizziness (2), pain (2) and malnutrition (2). Dizziness (2 patients) was the only grade ≥3 adverse event assessed by an investigator as eprenetapopt-related and occurring in more than 1 patient. One patient experienced a fatal adverse event of disease progression which was assessed by an investigator as not related to study treatment, and one patient experienced adverse events of fatigue, dyspnea and maculo-papular rash leading to discontinuation of eprenetapopt.

"The emerging data for the combination of eprenetapopt and pembrolizumab in these difficult-to-treat patients is very encouraging," said Dr. Haeseong Park of Washington University in St. Louis. "Particularly promising are tumor reductions in lung cancer patients who previously received I/O therapy, and the complete remission in a bladder cancer patient with prior chemotherapy exposure, which is rare. In addition, the clinical experience to-date suggests the combination is well-tolerated with adverse events readily managed with standard of care measures. The other investigators and I look forward to maturation of the data from this clinical trial as we seek to enroll and treat additional patients with this novel combination."

Aligos Therapeutics to Present at the Cantor Virtual Global Healthcare Conference

On September 20, 2021 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported that Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos, will present at the Cantor Virtual Global Healthcare Conference being held September 27-30, 2021 (Press release, Aligos Therapeutics, SEP 20, 2021, View Source [SID1234591818]).

Cantor Virtual Global Healthcare Conference
Date: Monday, September 27rd, 2021
Time: 1:20 pm to 1:50 pm Eastern Time
Presenter: Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos
Webcast: View Source
* a replay will be available following the presentation for 90 days
Please contact your Cantor Fitzgerald representative to schedule virtual one-on-one meetings with Aligos during the conference.

For more information about the Cantor Virtual Global Healthcare Conference, please refer to the Cantor Fitzgerald conference website.