On May 26, 2023 Aurealis Therapeutics, a synthetic biology company developing ground-breaking cell and gene therapies for unmet medical needs, reported its expansion in Oncology with its first-in-class four-in-one Bacterial Cell and Gene Therapy AUP-55 (Press release, Aurealis Therapeutics, MAY 26, 2023, View Source [SID1234632136]). The company’s first abstract, Effect of multi-targeting bacterial gene therapy on tumor regression and survival in mouse models of ovarian and intraperitoneal cancer, has been accepted and published on the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website.

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This moment marks a pivotal turning point for Aurealis Therapeutics, as the company expands from its acclaimed focus on chronic wounds into the field of oncology and creates therapeutic solutions such as AUP-55 for ovarian, intraperitoneal or bladder cancer. The Aurealis Therapeutics Team is proud for the publication of its first abstract as it prepares for its participation in the ASCO (Free ASCO Whitepaper) Annual Meeting which will take place from 2-6 June in Chicago, IL.

On May 26, 2023 Amgen (NASDAQ: AMGN) reported that it will present at the TD Cowen 4th Annual Oncology Innovation Summit at 11:00 a.m. ET on Wednesday, May 31, 2023. David M. Reese, M.D., executive vice president of Research and Development at Amgen will present at the conference (Press release, Amgen, MAY 26, 2023, View Source [SID1234632134]). The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

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The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On May 26, 2023 PharmaMar (MSE:PHM) has reported that it will present, together with its partners, seven new abstracts from various clinical studies with Zepzelca (lurbinectedin) and Yondelis (trabectedin) at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (ASCO, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)), which will be held from June 2 to 6, 2023 virtually and in person in Chicago, United States (Press release, PharmaMar, MAY 26, 2023, View Source [SID1234632088]).

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Among the studies that will be presented during the congress, two oral presentations with two PharmaMar compounds stand out. With the abstract titled: " Efficacy of combination lurbinectedin (LURBI) + doxorubicin (DOX) from the phase 1B soft-tissue sarcoma (STS) lead-in to a randomized phase 2 trial in leiomyosarcoma (LMS)", Dr. Gregory Cote , a medical oncologist at Massachusetts General Hospital, will present updated efficacy and tolerability data of the combination of lurbinectedin with doxorubicin, from the phase 1B introduction of soft tissue sarcoma to a phase II randomized trial in leiomyosarcoma (LMS).

For his part, Dr. Peter Reichardt, Chief Medical Officer of the HELIOS Klinikum Berlin-Buch Interdisciplinary Oncology Clinic, will present the abstract entitled: "Efficacy and safety of nivolumab and trabectedin in pretreated patients with advanced soft tissue sarcomas (STS): Results of a phase II trial of the German Interdisciplinary Sarcoma Group (GISG-15, NitraSarc)", in which he will present data on the efficacy and safety of trabectedin plus nivolumab as second-line treatment of patients with metastatic or inoperable soft tissue sarcoma previously treated with anthracyclines. The study confirms the activity of trabectedin plus nivolumab, particularly in patients with lipo or leiomyosarcomas, suggesting a synergistic activity. Furthermore, the safety of trabectedin and nivolumab was consistent with the safety profiles of each drug separately, with no new findings relevant to the combination.

All ASCO (Free ASCO Whitepaper) abstracts are available upon request to registered participants for 180 days from May 26, 2023: View Source

Studies featured at ASCO (Free ASCO Whitepaper) 2023

PRODUCT TITLE PRIMARY AUTHOR ABSTRACT
Zepzelca (lurbinectedina) Efficacy of combination lurbinectedin (LURBI) + doxorubicin (DOX) from the phase 1B soft-tissue sarcoma (STS) lead-in to a randomized phase 2 trial in leiomyosarcoma (LMS) Gregory Cote ABSTRACT: 11507 SESSION TYPE: Oral Abstract Session S100a DATE: June 5, 2023 11:30 – 14:30 GMT-5
Zepzelca (lurbinectedina) Efficacy and safety of lurbinectedin in elderly patients with relapsed SCLC Sophie Cousin ABSTRACT: 8591 SESSION TYPE: Poster Session POSTER: 218 DATE: June 4, 2023 8:00 – 11:00 GMT-5
Zepzelca (lurbinectedina) A phase III study of lurbinectedin alone or in combination with irinotecan vs investigator’s choice (topotecan or irinotecan) in patients with relapsed small cell lung cancer (SCLC; LAGOON trial) Benjamin Besse ABSTRACT: TPS8613 SESSION TYPE: Poster Session POSTER: 233a DATE: June 4, 2023 8:00 – 11:00 GMT-5
Zepzelca (lurbinectedina) IFCT-2105 lurbiclin real-world effectiveness and treatment sequences in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) who received lurbinectedin as part of the French Early Access Program (EAP-ATU) Nicolas Girard ABSTRACT: 8584 SESSION TYPE: Poster Session POSTER: 211 DATE: June 4, 2023 8:00 – 11:00 GMT-5
Yondelis (trabectedin) Efficacy and safety of nivolumab and trabectedin in pretreated patients with advanced soft tissue sarcomas (STS): Results of a phase II trial of the German Interdisciplinary Sarcoma Group (GISG-15, NitraSarc) Peter Reichardt ABSTRACT: 11500 SESSION TYPE: Oral Abstract Session S100a DATE: June 5, 2023 11:30 – 14:30 GMT-5
Yondelis (trabectedin) SARC037: Results of phase I study of trabectedin given as a 1-hour (h) infusion in combination with low dose irinotecan in relapsed/refractory Ewing sarcoma (ES) Patrick Grohar ABSTRACT: 11519 SESSION TYPE: Poster Discussion Session POSTER: 453 DATE: June 3, 2023 16:30 – 18:00 GMT-5
Yondelis (trabectedin) Trabectedin (T) versus adriamycin plus dacarbazine (A-DA) in advanced solitary fibrous tumor (SFT): Results from a phase II randomised clinical study (STRADA) Silvia Stacchiotti ABSTRACT: 11571 SESSION TYPE: Poster Session POSTER: 505 DATE: June, 2023 13:15 – 16:15 GMT-5

On May 26, 2023 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on May 25, 2023, for FoundationOneLiquid CDx Cancer Genomic Profile to be used as a companion diagnostic for an anti-cancer agent/MET inhibitor, Tabrecta (generic name: capmatinib hydrochloride hydrate) of Novartis Pharma K.K. (Novartis), which is approved for the treatment of MET exon 14 skipping mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC) (Press release, Chugai, MAY 26, 2023, View Source;category= [SID1234632087]). With this approval, patients with advanced NSCLC who may be eligible for treatment with capmatinib can be identified through both tissue-based and liquid-based comprehensive genomic profiling (CGP) tests.

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"We are pleased that FoundationOne Liquid CDx Cancer Genomic Profile was approved as a companion diagnostic for capmatinib for advanced and/or recurrent unresectable NCSLC, in addition to the currently approved tissue-based FoundationOne CDx Cancer Genomic Profile," said Chugai’s President and CEO, Dr. Osamu Okuda. "Obtaining tissue samples can be a challenge for patients with NSCLC. Therefore, blood-based testing is an important option when considering treatment options for patient care. We are committed to advancing personalized healthcare by continuing to collaborate with many biopharma partners."

With this approval FoundationOne Liquid CDx Cancer Genomic Profile can be used as a companion diagnostic for capmatinib in advanced and/or recurrent unresectable NSCLC. It identifies patients eligible for the treatment by detecting MET exon 14 skipping gene alterations. The efficacy and safety of capmatinib in patients with advanced and/or metastatic NSCLC patients with MET exon 14 skipping alterations were investigated in the Phase II GEOMETRY mono-1 study conducted by Novartis. Novartis received approval from the MHLW in June 2020 for commercialization.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized healthcare in oncology and contributing to patients through the expansion of CGP.

Approval information The underlined part has been newly added.
Intended uses or indications

The Product is used for comprehensive genomic profiling of blood samples in patients with solid tumors.
The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.
Alterations Cancer type Relevant drugs
Activated EGFR alterations
Non-small cell lung cancer (NSCLC) afatinib dimaleate, erlotinib hydrochloride, gefitinib, osimertinib mesilate
EGFR exon 20 T790M alterations osimertinib mesilate
ALK fusion genes alectinib hydrochloride, crizotinib, ceritinib
ROS1 fusion genes entrectinib
MET exon 14 skipping alterations capmatinib hydrochloride hydrate
NTRK1/2/3 fusion gene Solid tumors entrectinib
BRCA1/2 alterations Prostate cancer olaparib
About FoundationOne Liquid CDx Cancer Genomic Profile

Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a next-generation sequencing-based in vitro diagnostic device using blood samples for advanced cancer patients with solid tumors. It is intended to identify genomic alterations in 324 cancer-related genes through the detection of circulating tumor DNA (ctDNA) in blood. The test is approved by the MHLW for use in cancer genome profiling to report alterations (substitutions, insertion/deletion and select gene rearrangements) for short variants in 324 genes. It is also indicated for use as a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in the Table above of Intended uses or indications). For the latest information about the product, including companion diagnostic indications, please refer to the approval information.

Trademarks used or mentioned in this release are protected by laws.

On May 25, 2023 Oxford BioTherapeutics Ltd. (OBT), a clinical stage oncology company with a pipeline of immuno-oncology and antibody-drug conjugate (ADC)-based therapies, reported that it has extended its second multi-year collaboration with Boehringer Ingelheim for an additional two years (Press release, Oxford BioTherapeutics, MAY 25, 2023, View Source [SID1234656436]). With this extension further programs will be added into the existing collaboration, with the goal to enable the development of novel cancer immunotherapies in areas of high unmet patient need.

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The two partnerships between OBT and Boehringer Ingelheim were initiated in April 2013 and October 2020. They are both focused on the discovery of novel tumor targets enabled by OBT’s proprietary OGAP discovery platform for Boehringer Ingelheim’s unique immuno-oncology and ADC platforms, contributing to the company’s aspiration of transforming the lives of people living with cancer with the ultimate goal of curing a range of cancers.

Christian Rohlff, PhD, Chief Executive Officer of Oxford BioTherapeutics, said: "Last month marked the 10-year anniversary of our partnership with Boehringer Ingelheim and it is fitting to mark this anniversary by extending our collaboration both in time and in value. Over the past decade, we have built a successful relationship with Boehringer Ingelheim’s cancer research, now in its third phase, through high-quality outputs enabled by our proprietary OGAP discovery platform. Since 2013, the company has selected three targets discovered using OGAP, of which two programs have led to therapeutic assets in Phase 1 clinical development. We look forward to the next phase of our highly successful partnership and to continuing to work together to develop innovative first-in-class treatments for patients with difficult to treat cancers."

A major differentiator between OBT’s discovery platform and other approaches is the retention of the link between individual patient samples through to the design of therapeutic antibodies and diagnostic patient selection tools, which increases the overall success rate of these novel compounds transitioning into clinical development.

Under the terms of the extended agreement, Boehringer Ingelheim is responsible for the development and commercialization of treatment candidates that interact with the novel targets identified by OGAP. OBT will receive research funding as well as success-based development and regulatory milestone payments and royalties on potential future product sales.