1stOncology™: Cancer Intelligence Service – Page 13148 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Alkermes Announces Clinical Collaboration With Fred Hutchinson Cancer Research Center for Novel Immuno-Oncology Drug Candidate ALKS 4230

On October 21, 2019 Alkermes plc (Nasdaq: ALKS) reported that it has entered into a clinical research collaboration with Fred Hutchinson Cancer Research Center (Fred Hutch) for ALKS 4230, Alkermes’ immuno-oncology drug candidate (Press release, Alkermes, OCT 21, 2019, View Source [SID1234542385]). ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The planned phase 2 multi-site trial, ION-01, is designed to estimate the response rate to ALKS 4230 in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced or recurrent head and neck squamous cell cancer who did not achieve complete remission with an anti-PD-(L)1 antibody treatment. Secondary objectives include evaluation of the duration of response, progression-free survival, time to progression and overall survival of patients with advanced or recurrent head and neck squamous cell cancer receiving treatment with ALKS 4230 in combination with pembrolizumab. As an exploratory objective, the ION-01 study will assess the tumor microenvironment using paired tumor biopsies to evaluate potential predictive biomarkers for response to the addition of ALKS 4230. This multi-site study is designed to leverage the scientific, clinical and management resources of the Immune Oncology Network (ION), a network of foremost academic immunologists at top North American universities and cancer centers. The study is expected to initiate in the fourth quarter of 2019.

"We are honored to collaborate with Fred Hutch, given its commitment to improving outcomes and advancing care for people living with cancer," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "We’re encouraged by the profile emerging from the preclinical and initial clinical data for ALKS 4230 and are eager to explore whether this novel investigational drug may improve the therapeutic benefit of checkpoint inhibition with pembrolizumab, in patients with head and neck cancers. The ION-01 study, along with our ongoing ARTISTRY clinical development program, offers the opportunity to strengthen and advance our scientific and clinical understanding of ALKS 4230 and its potential role in treating cancer patients with high unmet needs."

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, a recently-initiated monotherapy expansion stage and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with select advanced solid tumors. ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.

IDERA PHARMACEUTICALS ANNOUNCES NEW U.S. PATENT FOR TILSOTOLIMOD THROUGH SEPTEMBER 2037

On October 21, 2019 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), or the Company, reported that the U.S. Patent and Trademark Office will issue on November 5, 2019 U.S. Patent No. 10,10,463,686 entitled "Immune Modulation With TLR9 Agonists For Cancer Treatment," which includes the Company’s investigational therapy tilsotolimod (IMO-2125) (Press release, Idera Pharmaceuticals, OCT 21, 2019, View Source [SID1234542384]).

The patent includes 24 claims directed to methods of treating melanoma with intratumoral administration of tilsotolimod in combination with certain immune checkpoint inhibitor therapies including CTLA-4, PD-1 or PD-L1 proteins. The patent provides exclusivity through September 2037.

"We are pleased with the continued development of tilsotolimod, including the breadth and duration of our patent portfolio," said Vincent Milano, Idera’s Chief Executive Officer. "This new patent provides additional intellectual property coverage and demonstrates our ongoing commitment to tilsotolimod, patients living with melanoma and innovation."

About Tilsotolimod (IMO-2125)
Tilsotolimod is a TLR 9 agonist that received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of anti-PD-1 refractory melanoma, in combination with ipilimumab as well as orphan drug designation from the FDA for the treatment of melanoma Stages IIb to IV. It signals the immune system to create and activate cancer-fighting cells (T-cells) to target solid tumors. Currently approved immuno-oncology treatments, specifically check-point inhibitors, provide benefit for some patients, but these therapies are limited in patients whose immune responses are missing or weak. Intratumoral injections with tilsotolimod are designed to selectively enable the tumor-specific T-cells to recognize and attack cancers that remained elusive and unrecognized by the immune system exposed to checkpoint inhibitors alone, while limiting toxicity or impact on healthy cells in the body.

4SC AG: Poster presentation at 1st International Symposium on Merkel Cell Carcinoma

On October 21, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported that a poster entitled: The preclinical rationale and clinical design for the combination of domatinostat with avelumab in Merkel Cell Carcinoma patients: the MERKLIN 1 and MERKLIN 2 studies by Dr. René Bartz will be presented at the 1st International Symposium on Merkel Cell Carcinoma 21-22 October 2019, Tampa, Florida, USA (Press release, 4SC, OCT 21, 2019, View Source [SID1234542383]). The poster will be available on 4SC’s website after the presentation.

Veracyte Announces Clinical Data Demonstrating Clinical Validity and Utility of Percepta Classifier in Lung Cancer Diagnosis When Bronchoscopy Results Are Inconclusive

On October 21, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported data demonstrating the clinical validity of its next-generation Percepta Genomic Sequencing Classifier (GSC) and the clinical utility of its first-generation test in a real-world setting in improving lung cancer diagnosis when bronchoscopy results are inconclusive (Press release, Veracyte, OCT 21, 2019, View Source [SID1234542382]). The findings will be presented on Thursday, October 23, at the annual meeting of the American College of Chest Physicians (CHEST) in New Orleans.

"These data confirm the performance of our Percepta classifier and its ability to guide care for lung nodule patients when bronchoscopy findings are inconclusive," said Bonnie H. Anderson, Veracyte’s chairman and chief executive officer. "We have been especially pleased by physicians’ positive response to our next-generation Percepta GSC, which we introduced in June of this year and which provides expanded information to physicians."

For the first study, researchers prospectively validated the Percepta GSC on a blinded, independent set of 412 samples from patients with lung nodules that were referred for bronchoscopy evaluation. Among a subset of patients with low or intermediate pre-test risk for whom malignancy was confirmed, the Percepta GSC significantly improved sensitivity for lung cancer detection in combination with bronchoscopy (95.5 percent), compared to bronchoscopy alone (40.9 percent). The genomic classifier demonstrated improved sensitivity compared to bronchoscopy regardless of nodule size or location or cancer subtype.

Among a subset of 188 patients with an intermediate pre-test risk of cancer, which account for the majority of lung nodules, the Percepta GSC demonstrated high accuracy when it down-classified patients to "low risk" for cancer (negative predictive value of 91 percent). The test also had a positive predictive value of 65 percent when it up-classified patients to "high risk" for cancer. The American College of Chest Physicians recommends that patients with a low risk of cancer undergo monitoring with CT imaging and that patients with a cancer risk of 65 percent or greater undergo surgical treatment.

"Bronchoscopy is often used to evaluate potentially cancerous lung nodules because it offers a nonsurgical way to detect lung cancer. However, bronchoscopy results are often inconclusive, which leaves physicians with a dilemma of whether to direct the patient for more invasive procedures or just monitor them with imaging at the risk of missing a cancer," said Giulia C. Kennedy, Ph.D., chief scientific officer and chief medical offer for Veracyte, who was a researcher in the study. "Our findings suggest that use of the Percepta GSC can improve the performance of bronchoscopy, making it a potentially more useful diagnostic tool that can help lung nodule patients at low risk for cancer avoid unnecessary invasive procedures or those at high risk get more timely treatment."

The next-generation Percepta GSC was developed on Veracyte’s RNA whole-transcriptome sequencing and machine learning platform and is based on novel "field of injury" science – which identifies genomic changes associated with lung cancer in current or former smokers using a simple brushing of the person’s airway. The test is performed on a sample from the patient’s main lung airway, which is collected during a bronchoscopy. Veracyte estimates that approximately 360,000 bronchoscopies are currently performed each year to evaluate suspicious lung nodules for cancer and that up to 60 percent of these produce inconclusive results.

A second, independent study is being presented at the CHEST meeting by researchers from LAC+USC Medical Center, a county hospital in Los Angeles, on their experience using the original Percepta classifier.

Lung cancer is the leading cause of cancer deaths worldwide. In the United States, lung cancer causes more than 154,000 deaths each year – more than the next three most prevalent cancers combined. Because lung cancer is difficult to diagnose before it has metastasized, only 16 percent of cases are detected at an early stage, when the disease is more treatable. Lung cancer’s five-year survival rate is only 18 percent, much lower than that of other common cancers. Approximately 80 percent of lung cancer deaths are caused by smoking.

Invitation to MorphoSys Q3 2019 Conference Call on October 30, 2019

On October 21, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; Nasdaq: MOR) reported that it will publish its first nine months’ 2019 results on October 29, 2019 at 10:00pm CET (9:00pm GMT; 5:00pm EDT) (Press release, MorphoSys, OCT 21, 2019, View Source [SID1234542381]).

The Management team of MorphoSys AG will host a conference call and webcast on October 30, 2019 at 2:00pm CET (1:00pm GMT; 9:00am EDT) to present MorphoSys’s third quarter results 2019 and provide further details on the Company’s latest developments.

Date of the conference call: Wednesday, October 30, 2019
Time: 2:00pm CET (1:00pm GMT, 9:00am EDT)
Dial-in numbers:
Germany: +49 69 201 744 220
United Kingdom: +44 203 009 2470
USA: +1 877 423 0830
Participant PIN: 97683318#

Participants are kindly requested to dial in up to 10 minutes before the call to ensure a secure line and a prompt start.

The presentation slides and webcast link will be available at the Company’s website at View Source

A replay of the conference will also be available at the corporate website following the live event.