On September 25, 2019 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported the appointment of Mr. Jan Skvarka as President and Chief Executive Officer effective today (Press release, Trillium Therapeutics, SEP 25, 2019, View Source [SID1234539769]). Mr. Skvarka has also been appointed to the Board of Directors of the company.

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"We are delighted to welcome Mr. Skvarka to Trillium," said Robert L. Kirkman, M.D., Executive Chair of Trillium. "We are looking forward to his leadership as we continue to advance the clinical development of TTI-621, our novel CD47 immune checkpoint inhibitor. We believe his long experience in healthcare and finance will be invaluable as we position Trillium for the future."

Added Mr. Skvarka, "I am thrilled at the opportunity to join Trillium, which has positioned itself as a leading CD47-focused immuno-oncology company. TTI-621 is a unique and differentiated molecule that has shown promising results as a monotherapy in early-stage studies in both T- and B-cell lymphomas. I look forward to working with the Trillium team and Board of Directors to take this promising investigational therapy to the next stage of clinical development, and, ultimately, to patients."

Before joining Trillium, Mr. Skvarka was President and Chief Executive Officer of Tal Medical, a clinical-stage neuroscience company in Boston, Massachusetts, from 2014 until 2018. Prior to that he had a long career from 1999 to 2013 as a healthcare consultant at Bain & Company, Boston. He was a partner in the Bain Healthcare practice from 2007 until 2013, with a focus on pharmaceutical, biotechnology and medical technology companies. Earlier in his career he worked in the corporate finance arm of Price Waterhouse in London, UK and Vienna, Austria. Mr. Skvarka holds an MBA degree from Harvard Business School.

Inducement Grant under Nasdaq Listing Rule 5635(c)(4)

Effective September 25, 2019, the Board of Directors adopted the Trillium Therapeutics Inc. 2019 Inducement Stock Option Plan, or the 2019 Inducement Plan, under which Trillium may grant inducement equity awards outside of Trillium’s current stockholder-approved stock option and incentive plans.

The 2019 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Trillium (or following a bona fide period of non-employment) as an inducement material to such individual’s entering into employment with Trillium in accordance with Nasdaq Listing Rule 5635(c)(4).

In connection with the appointment of Mr. Skvarka as Chief Executive Officer, the Board of Directors has granted to Mr. Skvarka an option to purchase 1,800,000 common shares under the 2019 Inducement Plan at an exercise price equal to the closing market price of Trillium’s common shares on September 24, 2019. One quarter of the stock options vest 12 months after the date of grant and 1/48th of the remaining options vest each month for the following three years, subject to his continued service with Trillium on such vesting dates. Other terms of the stock option grant are as determined by the Board of Directors and set forth in the 2019 Inducement Plan and applicable award agreement covering such grant. The award is intended to qualify as an "employment inducement award" within the meaning of Nasdaq Listing Rule 5635(c)(4).

On September 25, 2019 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that Amit D. Munshi, President and Chief Executive Officer of Arena, will present a corporate update at the Cantor Global Healthcare Conference on Wednesday, October 2, at 3:00 PM EDT (Press release, Arena Pharmaceuticals, SEP 25, 2019, View Source [SID1234539788]). The conference will take place October 2-4, 2019, in New York City.

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A live audio webcast of the presentation will be available under the investor relations section of Arena’s website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event.

On September 25, 2019 AnHeart Therapeutics (Hangzhou) Co., Ltd. reported that preclinical results of AB-106 (original R&D code: DS-6051b), an innovative anti-cancer drug made available exclusively from Daiichi Sankyo Company Limited, were published online by the peer-reviewed academic journal Nature Communications on August 9.[1] (Press release, AnHeart Therapeutics, SEP 25, 2019, View Source [SID1234555759])

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The research results reveal that (1) AB-106 can inhibit ROS1 tyrosine kinase and NTRK tyrosine kinase (NTRK1, NTRK2, and NTRK3) at low concentrations; (2) AB-106 has demonstrated tumor-reducing effects in the model cell lines harbouring ROS1 and NTRK fusion genes, patient-derived cancer cell lines, and tumor-bearing mice models with transplantation of these genes; (3) AB-106 also has inhibitory activity against the highly crizotinib-resistant ROS1-G2032R mutation and NTRK inhibitor-resistant variations.

ROS1 fusion gene is a potent oncogene found in approximately 1-2% of non-small cell lung cancer (NSCLC), and the first generation ROS1 inhibitor crizotinib has been approved for clinical use. However, in most cases, crizotinib-resistant tumors develop and the condition deteriorates again. The mechanism of resistance is often caused by a G2032R mutation in ROS1. However, no effective drugs against this resistance mutation have been developed. The emergence of AB-106 is expected to provide such patients with new treatment options.

AB-106, an oral and efficient ROS1/NTRK dual-target small molecule inhibitor, is a leading asset in AnHeart’s R&D pipeline. Two clinical trials of phase 1 on AB-106 have been conducted in Japan and the United States. The results showed that AB-106 was effective not only in patients with ROS1 positive lung cancer who had not been treated with ROS1 inhibitor but also in patients with ROS1 fusion gene-positive lung cancer who failed to be cured with ROS1 inhibitors such as clozotinib. At the same time, AB-106 has also demonstrated tumor-reducing effects on NTRK fusion gene-positive patients.

Dr. Wang Junyuan, co-founder and CEO of AnHeart, said "AB-106 is ready to start phase II clinical trials in China and the United States in the first quarter of 2020, as we pursue our goal of providing patients with effective, easy-to-take, low-cost and safer therapeutic drugs as soon as possible."

Dr. Yan Bing, co-founder and Chief Medical Officer at AnHeart, said: "our team has a wealth of clinical development experience, including successful drug approval experience in Asia, Europe and the United States, and maintains a good long-term cooperative relationship with a number of top external partners and opinion leaders in the industry. In the future, we will continue to explore innovative ways to maximize the potential of compounds in our tumor pipelines and provide sufficient resources to implement a rapid approval development strategy that achieves our mission of transforming scientific research results into value for cancer patients and bringing new treatments like this ROS1/NTRK inhibitor to patients as soon as possible."

Since its establishment in 2018, AnHeart has attracted professionals with many years of working experience in both multinational and innovative domestic pharmaceutical companies to create a senior management team with rich clinical development experience. AnHeartsecured round A financing of USD 15 million upon inception. At present, AnHeart aims to collaborate with large and medium-sized biopharma companies to strengthen its clinical product pipeline by obtaining and developing clinical assets that have shown good potential in animal experiments, before they enter clinical trials.

[1]Link to the original text:

The new-generation selective ROS1/NTRK inhibitor DS-6051b overcomes crizotinib resistant ROS1-G2032R mutation in preclinical models

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On September 25, 2019 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., will present at the following upcoming investor conferences in October (Press release, Selecta Biosciences, SEP 25, 2019, View Source [SID1234539770]).

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Event: 2019 Cantor Global Healthcare Conference
Date: Wednesday, October 2, 2019
Presentation Time: 10:40 a.m. Eastern Time
Location: New York City

Event: Chardan’s 3rd Annual Genetic Medicines Conference
Date: Tuesday, October 8, 2019
Presentation Time: 10:30 a.m. Eastern Time
Location: New York City

To access copies and the live webcasts of Selecta’s presentations, please visit the Investors & Media section of the Selecta website at www.selectabio.com. Replays of the webcasts will be available on the Selecta website for 90 days following the events.

On September 25, 2019 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage immuno-oncology company developing first-in-class Superkines and Empowered Cytokines, reported that updated clinical results from its Phase 2b clinical trial of MDNA55, an IL4-guided toxin, in patients with recurrent glioblastoma (rGBM), the most common and uniformly fatal form of brain cancer, at the Inaugural Targeting Innate Immunity Congress held from September 23-25, 2019 in Cambridge, MA (Press release, Medicenna Therapeutics, SEP 25, 2019, View Source [SID1234539789]).

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The presentation by Dr. Fahar Merchant, President & CEO of Medicenna, focused on updated efficacy results from the Phase 2b clinical trial MDNA55-05 in rGBM patients using the interleukin 4 receptor (IL4R) as an immunotherapy target, as it is overexpressed in glioblastoma as well as in cells that make up the brain tumor microenvironment (TME).

"The data continues to show very promising results for MDNA55 when compared to approved therapies for rGBM. These new findings are consistent with previous results showing that patients suffering from rGBM, particularly those with the IL4R biomarker an indicator of a more aggressive form of rGBM, are surviving substantially longer with just one treatment," states Dr. Fahar Merchant. "This is very exciting for both Medicenna and the broader health community, as this not only offers considerable benefit to patients with this devastating disease, but also offers hope for patients with at least 20 other cancer indications where the tumor and associated tumor microenvironment over-expresses the IL4R."

These data imply that targeting the TME, particularly in GBM, is critical where almost half of the tumor mass consists of non-cancerous cells that make up the TME – a cancer swamp that hides the tumor from the immune system. The TME is emerging as one of the key reasons why glioblastoma is extremely aggressive, and continues to be one of the most difficult cancers to treat. Since MDNA55 can simultaneously purge both the tumor and the TME by targeting the IL4R, the results to date continue to show that MDNA55 is likely to emerge as a new treatment modality for this deadly disease.

"We’re beginning to truly understand and appreciate the TME and the many layers of immunosuppression that evolve to protect and prevent an immune attack on the tumor," adds Dr. Merchant. "This means it is necessary to find a sustained way to break down the tumor’s protective walls, as well as attack the tumor itself. The multi-pronged approach utilized by MDNA55 allows us to do just that."

Highlights from the presentation are summarized below:

Irrespective of IL4R status, median overall survival (mOS) in subjects treated at low doses of MDNA55 (n=21) is 11.8 months; this is sustained when high dose subjects with mature survival data are added (n=33 total; mOS 11.9 months). However in the first 12 of 25 patients receiving the high dose, mOS is 16.7 months. This substantially exceeds landmark mOS reported for approved drugs for rGBM (mOS is 8-9 months for Avastin and Lomustine).1-3

Following treatment with MDNA55 at low doses (median 63µg; n=21), mOS of subjects with high IL4 receptor expression (IL4RHigh; n=12), a biomarker for aggressive disease, is 13.7 months compared to 8.1 months in subjects expressing no/low IL4R (IL4RLow; n=8).

When updated to include survival data from subjects treated at higher doses (median 180µg; n=12), MDNA55 continues to show promising survival outcomes in subjects with high IL4R expression: mOS in the IL4RHigh group (n=19) is 15.2 months as compared to 8.5 months in the IL4RLow group (n=11).

In the 33 subjects, irrespective of IL4R expression, subjects showing tumor shrinkage or stabilization from nadir (tumor control rate of 81%; 25 of 31 evaluable subjects) were seen to live longer than those with progressive disease (mOS of 16.1 months versus 8.3 months, respectively). These results are consistent with earlier reports suggesting that occurrence of immunogenic cell death following treatment with MDNA55 is associated with improved clinical prognosis and survival.4

Furthermore, safety data in the 12 additional subjects treated at higher doses of MDNA55 (median total dose 180µg) show a similar safety profile to previous MDNA55 trials with no systemic toxicities or drug related deaths.
Results for the majority of remaining patients participating in the Phase 2b clinical trial MDNA55-05 will be released before the end of 2019 followed by an End of Phase 2 meeting with the US FDA in Q1 2020.

About the MDNA55-05 Clinical Trial

MDNA55-05 is a Phase 2b study of the safety and efficacy of MDNA55, an IL4R-directed toxin, in patients with de novo GBM at first or second relapse where the tumor is not amenable to surgical resection. In the study, investigators administer MDNA55 once directly into the brain tumor using a technique known as Convection Enhanced Delivery (CED). CED allows precision delivery of MDNA55 into the tumor and the surrounding healthy brain containing infiltrative tumor cells, while avoiding systemic exposure.

The primary endpoint of the study is median Overall Survival (mOS) comparing a null survival rate of 8.0 months (based on historical control) with an alternative pursue rate of 11.5 months (1-sided alpha = 0.10 and 80% power for 46 ITT subjects). The secondary endpoint is objective response rate (ORR) assessed by the modified Response Assessment in Neuro-Oncology (mRANO)-based criteria incorporating advanced imaging modalities according to a null response rate of 6% with alternative pursue rate of 18% (1-sided alpha = 0.10 and 80% power for at least 35 subjects evaluable for response).