On November 24, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported 18-month follow-up data from the randomized phase I/II trial of ONCOS-102 in combination with standard-of-care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM) (Press release, Targovax, NOV 24, 2020, View Source [SID1234571637]).

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The study is an open-label, exploratory phase I/II trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first- and second- (and later) line treatment of MPM to assess safety, immune activation and efficacy versus SoC only. In total, 31 patients have been included in the trial, with 20 patients in the experimental group receiving the ONCOS-102 and SoC combination (8 randomized in first-line), and 11 patients in the control group receiving SoC only (6 in first-line).

At the 18-month follow-up, more than half of the patients in the first-line ONCOS-102-treated group were still alive, and the mOS was not yet reached. Based on current survival data the mOS will be 18.2 months or longer. For the first-line SoC-only control group, less than half of the patients were alive, and mOS will be 14.2 months or less, which is similar to outcomes from previously reported trials where patients received the same chemotherapy treatment1. An analysis of all the first-line patients, including 3 experimental safety lead-in patients, shows similar results as the randomized first-line patients. The next survival analysis is planned in first half of 2021.

In June, it was reported that ONCOS-102 treatment induces broad and powerful immune activation in MPM, far beyond what is achieved with SoC alone. Importantly, this immune activation is associated with better survival outcomes at the 18-month analysis, indicating that the immunological activity of ONCOS-102 drives the observed clinical benefit.

The powerful immune activation generated by ONCOS-102 builds a strong rationale for combining ONCOS-102 with a checkpoint inhibitor in MPM. This combination could provide further clinical benefits in this indication. Targovax and Merck (known as MSD outside of the USA) are currently reviewing next steps for combining ONCOS-102 and pembrolizumab (Keytruda) in MPM. Recently, the U.S. Food and Drug Administration (FDA) approved the combination of ipilimumab and nivolumab (Yervoy and Opdivo) for the first-line treatment of MPM based on mOS of 18.1 months (Baas 2020), and this is expected to serve as a benchmark for further approvals.

Magnus Jäderberg, Chief Medical Officer of Targovax, said: "We are very pleased that overall survival in first-line patients, is tracking well in the ONCOS-102 treated group. We have already established in the current study that ONCOS-102 drives favorable remodeling of the tumor microenvironment, and we are now starting to see this immune activation translating into the encouraging improved survival outcomes in these 18-month results. This is exactly what we had hoped to see and prepares the way for combining ONCOS-102 with checkpoint inhibition. The immune data suggest to us that survival outcomes in combination with Keytruda may be further improved from the results reported today."

The first results from the trial were announced in January 2020 (see press release here), while immunological data and 12-month survival rate were reported in June 2020 (see press release here) and presented at the SITC (Free SITC Whitepaper) annual meeting in November 2020 (see poster here).

On November 24, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), reported that Dan Menichella, Chief Executive Officer, will participate in a fireside chat at the virtual Piper Sandler 32nd Annual Healthcare Conference taking place November 30-December 3, 2020 (Press release, Kaleido Biosciences, NOV 24, 2020, View Source [SID1234571663]).

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The presentation will be available for registered attendees via the Piper Sandler conference site during the conference until December 3, 2020, and will also be available November 30, 2020, on the Investors & Media section of the Kaleido website at View Source An archived replay will be accessible for 90 days following the event.

On November 24, 2020 Phoenix Molecular Designs (PhoenixMD), an industry leader in the development of precise cancer therapeutics focusing on first-in-class RSK kinase inhibitors, reported that the first patient has been dosed in their Phase 1b clinical trial of PMD-026 (Press release, PhoenixMD, NOV 24, 2020, View Source [SID1234571687]). This RSK targeting trial is a first of its kind in the battle to combat the most aggressive subtype of breast cancer, known as Triple Negative Breast Cancer (TNBC), which claims the lives of thousands of patients each year. This patented small molecule, PMD-026, positions PhoenixMD in the lead to fill an unmet medical need as an effective treatment for this serious medical condition.

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This new trial comes at a critical time as, to date, durable treatment options for TNBC have been extremely limited. PhoenixMD’s lead asset, PMD-026, is the first purpose-built investigational drug specifically designed for TNBC. The company’s goal is to develop a therapy to treat TNBC that offers advantages over current approaches by taking aim at RSK, which is an entirely new drug target. PMD-026 is different from other therapies in that it is an oral capsule that can be taken at home rather than requiring an in-clinic or in-hospital administration. In addition, based on the data obtained in their Phase 1 clinical trial, PMD-026 was well-tolerated without hair loss or peripheral neuropathy, which are side effects of a number of other chemotherapy drugs. This data from their Phase 1 clinical trial of PMD-026 in metastatic cancer will be presented at the San Antonio Breast Cancer Conference Dec 8-12, 2020.

"Our mission is to improve the outcome for TNBC patients. This is a pivotal time for PhoenixMD; our extensive research to finding a path forward has reached the next important clinical milestone. PhoenixMD continues to aggressively pursue the clinical development of PMD-026 in an accelerated timeline while always ensuring that patient care is first and foremost in every decision that we make. As we begin our Phase 1b clinical trial, I am excited about the opportunity to bring this therapy, that uniquely targets the RSK pathway, to women with TNBC who participate in our clinical trial and who so desperately need help not provided by existing treatment options," said Sandra Dunn, Ph.D., Chief Executive Officer, PhoenixMD."

Initially, 20 TNBC patients will be enrolled in this Phase 1b expansion trial. As with the Phase 1 trial, this new trial will be conducted at leading medical centers across the United States.

"As a TNBC survivor, who was diagnosed at 34 years old, and patient advocate in the breast cancer community, I cannot emphasize enough how important this trial could be in the lives of so many. For a long time, there has been an utter lack of treatment options for this vulnerable breast cancer population," said Tara Coleman, Licensed Occupational Therapist, and Lymphedema Therapist. "Trials like this are urgently needed, and it is my hope that this trial proves to be a game-changer for the TNBC community. It has been my honor to work with Sandra and her team; the strides they have made coupled with their enthusiasm and commitment to patient advocate involvement and patient care has been truly incredible."

"Today’s announcement builds on PhoenixMD’s success with our Phase 1 clinical trial in metastatic cancer patients, which PhoenixMD completed in September of 2020," said F. Andrew Dorr, M.D., Chief Medical Officer, PhoenixMD. "At this pivotal time, I would like to recognize the PhoenixMD and SciQuus Oncology teams who have worked so diligently throughout the COVID-19 pandemic and the Phase 1 clinical trial. We are ready to meet the challenges and successes ahead in this next phase. I firmly believe that every step we take is a step closer towards finding a successful treatment for TNBC."

For more information about the Company’s Phase 1b clinical trial of PMD-026 in metastatic triple negative breast cancer, please visit www.clinicaltrials.gov (identifier NCT04115306).

On November 24, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in a fireside chat at the 2020 Piper Sandler Healthcare Conference, which is scheduled to take place from December 1 – 3, 2020 (Press release, Bicycle Therapeutics, NOV 24, 2020, View Source [SID1234571645]). The conference will be held in a virtual meeting format.

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A recording of the fireside chat will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.coma at 9:00 a.m. ET on Tuesday, December 1. An archived replay of the webcast will be available for 90 days following the fireside chat date.

On November 24, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it will be hosting a virtual investor event to provide a review of the Company’s oral, potent and selective menin inhibitor, KO-539, following the oral presentation of preliminary clinical data at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Kura Oncology, NOV 24, 2020, View Source [SID1234571664]). The event will feature members of the Kura management team along with two of the investigators from KOMET-001, an ongoing Phase 1/2A clinical trial of KO-539. The virtual event will take place at 2:00 p.m. ET / 11:00 a.m. PT on Saturday, December 5, 2020.

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A live video webcast of the event will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available shortly after the conclusion of the event.