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]).

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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.

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.

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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."

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]).

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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.

On September 20, 2021 NovelStem International Corp. (OTC Pink: NSTM), a biotechnology company focused on the stem cell-based technology platform developed by 30%-owned Israel-based, NewStem, Ltd., reported that NewStem, along with six other genomic companies, was selected by Illumina for its global Illumina Accelerator (Press release, NewStem, SEP 20, 2021, View Source [SID1234590975]). Illumina Accelerator is a company creation engine that focuses on partnering with and building companies with unique genomic technologies. Illumina Accelerator provides selected companies with access to seed investment, access to Illumina sequencing systems and reagents, as well as business guidance, genomics expertise, and fully operational lab space. Under the Illumina Accelerator – NewStem agreement, NewStem is entitled to a match funding for new capital of up to $5.5 million within 18 months.

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NewStem has developed a novel stem-cell-based technology platform for the development of therapeutics and diagnostics. Using this technology, NewStem has identified and completed the analysis of resistance to the most frequently prescribed standard-of-care cancer treatments. NewStem is a spinoff of Yissum, The Hebrew University of Jerusalem’s technology-transfer company. NewStem holds intellectual property rights related to stem cells, including genome-wide screening methodologies and its main patents were granted in United States, Europe, Japan and Israel and are in national phase in additional countries.

NewStem’s diagnostic technology is based on the research of specialized stem cells that carry just one set of chromosomes (haploid cells) by Professor Nissim Benvenisty, Director of the Azrieli Center for Stem Cells and Genetic Research at the Hebrew University. NewStem’s most advanced solution is a diagnostic and database that enables NewStem to predict patients’ resistance to certain anti-cancer therapies, allowing for better, targeted personal-oncology treatments with the potential to reduce incidents of anti-cancer drug resistance, which occur in nearly 50% of all cancer cases.

NewStem CEO, Ayelet Dilion-Mashiah, commented, "We are very excited to be selected by Illumina, the global leader in DNA sequencing and array-based technologies, for this program. In addition to potential capital and professional support, we believe selection to the Illumina Accelerator further validates the significant potential of NewStem’s therapeutic and diagnostic development technology and will assist us in bringing our first products to market and potentially advancing additional commercial solutions."

Amanda Cashin, PhD, co-Founder and Global Head of Illumina For Startups said, "The global reach of Illumina Accelerator is demonstrated by our investment in these seven diverse startups from six countries. This diversity is testament to the strength and breadth of the talented entrepreneurs around the world focused on unlocking the power of the genome to improve human health and beyond."

On September 20, 2021 Immunocore Holdings Plc (Nasdaq: IMCR), a late-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, infectious and autoimmune disease, reported that new data from the Company’s lead program, tebentafusp (IMCgp100), at an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Press release, Immunocore, SEP 20, 2021, View Source [SID1234590903]).

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The findings presented by Alexander N. Shoushtari MD, medical oncologist at Memorial Sloan Kettering Cancer Center, demonstrated that reduction by Week 9 in circulating tumor DNA (ctDNA) while on tebentafusp is strongly associated with overall survival (OS). A majority (70%) of evaluable patients had any ctDNA reduction while 5% of patients had radiographic response per the RECISTv1.1 criteria. In addition, 14% of patients had complete ctDNA clearance and long OS; this included some patients with best response of stable or progressive disease. The analysis was based on the phase 2 trial of tebentafusp in HLA-A*02:01 positive, previously treated patients with metastatic uveal melanoma (mUM) (IMCgp100-102).

"Uveal melanoma is characterized by a defined set of unique mutations that can be measured in the blood as free circulating tumor DNA," said David Berman, Immunocore’s Head of Research and Development, "We found that the degree of ctDNA reduction from tebentafusp was strikingly correlated with overall survival. This association was observed even in patients whose tumor lesions appeared radiographically stable or progressing and suggests that clinical benefit from tebentafusp may occur even in patients who did not have a RECIST response."

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) have each accepted applications seeking the approval of tebentafusp for the treatment of HLA-A*02:01-positive ad