On October 11, 2018 Context Therapeutics reported Phase 1 data for its investigational new drug, Apristor (Onapristone extended release), an oral progesterone receptor antagonist that is being developed for progesterone receptor-positive (PR+) cancers (Press release, Context Therapeutics, OCT 11, 2018, View Source [SID1234529858]). Data from the study showed that Apristor, a novel extended release formulation of onapristone, was well tolerated and provided a clinical benefit in patients with previously treated recurrent or metastatic progesterone receptor-driven breast, ovarian and endometrial cancers. These findings were published in the medical journal PLOS One and can be accessed here.

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!

"I’m encouraged by the early data seen in this Phase 1 study of Apristor. Apristor appears to be well tolerated, with responses seen across a broad range of PR+ cancers," commented Paul Cottu, M.D., Ph.D., Deputy Head, Department of Oncology, Institute Curie, and lead investigator for the trial. "Many hormonally-driven malignancies are difficult to treat, and new agents are clearly needed. Targeted therapies, including Apristor, have the potential not only to add therapeutic options for our patients but also to reduce or delay the need for chemotherapy, possibly changing the way many of these malignancies are treated."

"Context is pleased with the Phase 1 Apristor study results demonstrating clinical efficacy across PR+ cancers in heavily pretreated patients who are typically unresponsive to currently approved hormonal treatments," stated Martin Lehr, CEO of Context Therapeutics. "We believe Apristor has the potential to be the first anti-progestin approved to treat cancer and we are rapidly advancing Apristor into multiple Phase 2 trials with a goal of addressing significant medical needs."

Apristor Phase 1 Data in Patients with PR+ Breast, Ovarian, or Endometrial Cancer

Design

52 patients were randomized to five cohorts of Apristor (onapristone extended release tablets 10, 20, 30, 40 or 50 mg BID; n=46), or immediate release onapristone 100 mg QD (n=6) until progressive disease or intolerability. Primary endpoint was to identify the recommended phase 2 dose. Secondary endpoints included safety, clinical benefit and pharmacokinetics.

Results

Tumor diagnosis includes: endometrial carcinoma 12; breast cancer 20; ovarian cancer 13; and other 7. Median age was 64 (36-84). No dose limiting toxicity was observed with reported liver function test elevation related only to liver metastases. The recommended Phase 2 dose (RP2D) was 50mg BID. For patients on Apristor (n=46), dose responsive activity was noted, and 20% (9 of 46) patients had clinical benefit ≥24 weeks. The most common side effects were asthenia and low-grade, transient gamma-glutamyl transferase elevations.

Clinical Activity

Tumor assessments strongly suggested anti-cancer efficacy, even in heavily pretreated patients. In Apristor treated patients, 20 of 46 patients experienced stable disease as best response and 9 of 46 patients had durable disease stabilization.

Conclusions

The new extended release formulation of Onapristone (Apristor) was well tolerated and resulted in clinical benefit in heavily pretreated patients with ovarian, breast and uterine endometrial cancers. The recommended Phase 2 dose for Apristor is 50mg BID. There were no grade 3-4 LFT elevations in the absence of progressive liver metastases, no new safety signals were observed, and dose limiting toxicity was not observed. The data support the development of Apristor in PR+ cancers.

About Apristor

Apristor, an investigational new drug, is an oral progesterone receptor (PR) antagonist. PR is an oncogene that is enriched in up to 70% of all breast, ovarian, and endometrial cancers. Apristor is being developed to treat metastatic breast, ovarian and endometrial cancers.

On October 11, 2018 Forbius (Formation Biologics) reported that it was nominated in the "Best New Drug Developer" category at the 5thAnnual World ADC Awards (Press release, Forbius, OCT 11, 2018, View Source [SID1234531671]). This competitive nomination process involved over 2,545 casted votes to recognize leaders and innovators in the antibody-drug conjugate (ADC) research field.

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!

Forbius’ lead program, AVID100, is an ADC targeting EGFR. AVID100 is undergoing Phase 2 clinical trials in patients with confirmed EGFR overexpression in squamous cell carcinoma of the head and neck, squamous non-small cell lung cancer, and triple negative breast cancer. Phase 2a development of AVID100 is supported by the recently announced $18.75M peer-reviewed grant from the Cancer Prevention Research Institute of Texas (CPRIT).

On October 11, 2018 Incyte Corporation (Nasdaq:INCY) reported that it has scheduled its third quarter 2018 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, October 30, 2018 (Press release, Incyte, OCT 11, 2018, View Source [SID1234530094]).

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 schedule for the press release and conference call/webcast is as follows:

•

Q3 2018 Press Release:

October 30, 2018 at 7:00 a.m. ET
•

Q3 2018 Conference Call:

October 30, 2018 at 8:00 a.m. ET
•

Domestic Dial-In Number:

877-407-3042
•

International Dial-In Number:

201-389-0864
•

Conference ID Number:

13683637

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13683637.

The live webcast with slides can be accessed at www.incyte.com under For Investors, Events and Presentations and will be available for replay for 30 days.

On October 11, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported publication of an abstract on pelareorep (formerly known as REOLYSIN) for the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place October 19-23 in Munich (Press release, Oncolytics Biotech, OCT 11, 2018, View Source [SID1234530639]).

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 abstract, authored by Sanjay Goel, Department of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, et al., "Dose finding and safety study of Reovirus (Reo) with irinotecan/ fluorouracil/ leucovorin/ bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer (mCRC): Final results", outlines positive clinical trial results for pelareorep in the treatment of patients with KRAS mutant metastatic colorectal cancer. Thirty-six patients received treatment with FOLFIRI/B and pelareorep, and the results demonstrated that the combination is not only safe and well tolerated, but that progression free survival (PFS) and overall survival (OS) are significantly superior to historical data.

The patients receiving the recommended phase 2 dose had a 50 percent response rate (3 of 6 patients) and the median PFS and OS were 65.6 weeks and greater than 98.3 weeks (as of May 9, 2018), respectively.

"The noted improvement in both PFS and OS compared to historical results are meaningful for Oncolytics and for the patients," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "The favorable results reported from this clinical trial demonstrate the potential of pelareorep to be a compelling treatment choice for a patient population that otherwise has limited therapeutic options after they have progressed on current standard-of-care chemotherapy."

The complete Abstract can be found online at View Source Full details from the poster presentation will be announced after it is presented.

Presentation Number:
565P
Date:
October 21, 2018
Lecture Time:
1:05 pm CEST
Location:
Hall A3 – Poster Area Networking Hub, ICM München, Munich, Germany
Speakers:
Sanjay Goel
Session Name:
Basic science, Endocrine tumours, Gastrointestinal tumours – colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The

compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

On October 11, 2018 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported a clinical collaboration to evaluate the safety and efficacy of MEI’s ME-401, an investigational PI3K delta inhibitor, in combination with BeiGene’s zanubrutinib, an investigational BTK inhibitor, for the treatment of patients with B-cell malignancies (Press release, MEI Pharma, OCT 11, 2018, View Source;p=irol-newsArticle&ID=2371323 [SID1234529862]).

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!

"We are excited to be working with BeiGene to explore the potential of ME-401 in combination with zanubrutinib," said Robert Mass, M.D., chief medical officer of MEI Pharma. "Combinatorial approaches to fighting difficult to treat cancers historically have proven to be important in the delivery of better treatments to patients, and we believe that the data observed to date for ME-401, with its unique pharmaceutical properties, and for zanubrutinib support the evaluation of the combination for the treatment of patients with various B-cell malignancies."

"Zanubrutinib is a potentially differentiated BTK inhibitor that is being globally developed in a number of B-cell malignancies both as a monotherapy and in combination. We look forward to exploring this interesting combination in patients with B-cell malignancies," commented Jane Huang, M.D., chief medical officer, hematology, at BeiGene.

Under the terms of the clinical collaboration agreement, MEI will amend its ongoing Phase 1b trial to include evaluation of ME-401 in combination with zanubrutinib in patients with B-cell malignancies.

Study costs will be shared equally by the parties, and MEI will supply ME-401 and BeiGene will supply zanubrutinib. MEI will retain full commercial rights for ME-401 and BeiGene will retain full commercial rights for zanubrutinib.

About ME-401
ME-401 is an investigational oral phosphatidylinositol 3-kinase ("PI3K") delta inhibitor; PI3K delta is often overexpressed in cancer cells and plays a key role in the proliferation and survival of hematologic cancer cells. ME-401 displays high selectivity for the PI3K delta isoform and has distinct pharmaceutical properties from other PI3K delta inhibitors. It is being clinically evaluated in patients with various B-cell malignancies. MEI is initiating a Phase 2 study to evaluate the efficacy, safety, and tolerability of ME-401as a single agent in patients with follicular lymphoma after failure of at least two prior systemic therapies including chemotherapy and an anti-CD20 antibody. The Phase 2 study is intended to support an accelerated approval marketing application with the U.S Food and Drug Administration.

About Zanubrutinib
Zanubrutinib (BGB-3111) is an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated in a broad pivotal clinical program globally and in China as a monotherapy and in combination with other therapies to treat various B cell malignancies.