On May 16, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a biotechnology company specializing in the development of innovative drugs in oncology, notably against rare or resistant forms of cancer, reported its consolidated revenues and cash position at March 31, 2018 (Press release, Onxeo, MAY 16, 2018, View Source [SID1234526713]).

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Judith Greciet, Chief Executive Officer of Onxeo, said: "The first quarter of 2018 was highlighted by strong momentum in the development of AsiDNA, our lead product candidate. Following the significant efforts of our R&D team over the previous months, we recently initiated the DRIIV phase I clinical trial in order to evaluate the potential of AsiDNA, our first-in-class DNA repair inhibitor, administered intravenously, in patients with advanced solid tumors. We expect interim data from this study to be available in the second half of 2018. If these results confirm both the safety profile of AsiDNA and its activity, we will have achieved a key milestone in our AsiDNA development program. Importantly, we continue to advance our core R&D programs according to plan while maintaining strict cost control. As such, we expect that our current cash position of €9.2 million will support our currently planned activities until mid-2019, including through multiple potentially value-creating inflection points for our company.

On May 16, 2018 bluebird bio, Inc. (Nasdaq: BLUE) reported that updated interim data from CRB-401, its Phase 1 study of bb2121, an anti-BCMA CAR T cell therapy being developed by the company and Celgene, will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, bluebird bio, MAY 16, 2018, View Source [SID1234526698]).

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"Since we first presented data for bb2121 in heavily pretreated patients with multiple myeloma, we have been hopeful about its potential to markedly improve the outcomes and expectations for this incurable disease," said David Davidson, M.D., chief medical officer, bluebird bio. "One of the most striking changes has been to see patients testing negative for minimal residual disease (MRD), which was previously unexpected in this population with advanced disease. As the data from the Phase 1 study continue to advance our understanding of the bb2121 dose response and safety profiles, we and Celgene are applying these lessons to optimize outcomes in KarMMA, the ongoing registration-enabling study of bb2121 in patients with relapsed/refractory multiple myeloma."

Oral Presentation
bb2121 anti-BCMA CAR T-cell therapy in patients with relapsed/refractory multiple myeloma: Updated results from a multicenter phase I study. (Abstract 8007)

Presenter: Noopur S. Raje, M.D., Massachusetts General Hospital, Boston, Massachusetts
Date & Time:Friday, June 1, 2018, 2:45-5:45 p.m. CT (3:45-6:45 p.m. ET)
Location: E450
Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

Poster Presentation
Early MRD negativity to predict deepening myeloma response in relapsed/refractory multiple myeloma (RRMM) patients treated with bb2121 anti-BCMA CAR T cells. (Abstract 8024)

Presenter: Nikhil C. Munshi, M.D., Dana-Farber Cancer Institute, Boston, Massachusetts
Poster Session Date & Time:Monday, June 4, 2018, 8:00 – 11:30 a.m. CT (9:00 a.m. – 12:30 p.m. ET)
Location: Poster Area Hall A
Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia

Conference Call & Webcast Information

bluebird bio will host a conference call and live webcast at 6:30 p.m. CT (7:30 p.m. ET) on Friday, June 1, 2018. To access the live webcast, please visit the "Events & Presentations" page within the Investors and Media section of the bluebird bio website at View Source Alternatively, investors may listen to the call by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 1489304. A replay of the webcast will be available on the bluebird bio website for 90 days following the call.

On May 16, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that the cells it will encapsulate and then use in its planned clinical trial in patients with locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) have successfully passed all 29 tests required by the U.S. Food and Drug Administration (FDA) (Press release, PharmaCyte Biotech, MAY 16, 2018, View Source [SID1234526714]). Most of the tests were conducted by PharmaCyte’s contractor, Eurofins Lancaster Laboratories, Inc. (Eurofins). The rest of the tests were conducted by third party laboratories subcontracted by Eurofins.

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "We are pleased that the cells being used in our LAPC trial have now successfully passed all of the rigorous and extensive testing done on them by Eurofins and its subcontractors. The nature of the various tests was quite varied and some of the tests were more complex than others, so we’re excited that the cells, which are at the heart of our pancreatic cancer therapy, could endure such a wide range of testing and pass each and every one. Now that testing is complete and all results are positive, we have been advised by Eurofins that we will have a final Certificate of Analysis next week. With this document in hand, the cell encapsulation process can begin."

Before any tests could be started, cells from the Master Cell Bank had to be thawed from frozen storage and then cultured to obtain enough cells for all of the planned tests. This was completed on January 24, 2018. In all, the cells underwent 29 different tests. Because of processes involved at Eurofins pertaining to the tests, not all tests could begin at the same time.

Once each test was completed, the test results had to be analysed and a report written by Eurofins. Then the conduct and results of each test had to examined and approved by Eurofins’ Quality Assurance/Quality Control department. Now that all the tests have been successfully completed, Eurofins is preparing the necessary Certificate of Analysis to be sent to Austrianova in Thailand where encapsulation will be performed using PharmaCyte’s signature live-cell encapsulation technology. Having the Certificate of Analysis is a cGMP requirement before encapsulation can begin.

On May 16, 2018 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported that there will be two poster presentations on tesetaxel at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 1 – 5, 2018 in Chicago, Illinois (Press release, Odonate Therapeutics, MAY 16, 2018, View Source [SID1234526730]). Abstracts for these presentations were made publicly available today and can be found on the ASCO (Free ASCO Whitepaper) website at View Source and by clicking the titles below.

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Presentation Details:

Abstract 1042 (Poster Board #123): Activity of Tesetaxel, an Oral Taxane, Given as a Single-agent in Patients (Pts) with HER2-, Hormone Receptor + (HR+) Locally Advanced or Metastatic Breast Cancer (MBC) in a Phase 2 Study
Presenter:Andrew Seidman, M.D.
Poster Session: Breast Cancer – Metastatic
Date/Time:Saturday, June 2, 2018 / 8:00AM – 11:30AM (CT)
Location: Hall A

Abstract TPS1106 (Poster Board #184a): CONTESSA: A Multinational, Multicenter, Randomized, Phase 3 Registration Study of Tesetaxel in Patients (Pts) with HER2-, Hormone Receptor + (HR+) Locally Advanced or Metastatic Breast Cancer (MBC)
Presenter:Joyce O’Shaughnessy, M.D.
Poster Session: Breast Cancer – Metastatic
Date/Time:Saturday, June 2, 2018 / 8:00AM – 11:30AM (CT)
Location: Hall A

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several potential therapeutic advantages over currently available taxanes, including: oral administration with a low pill burden and a patient-friendly dosing regimen; no history of hypersensitivity (allergic) reactions; and robust activity against chemotherapy-resistant tumors. More than 500 patients have been treated with tesetaxel across 22 clinical studies. In patients with locally advanced or metastatic breast cancer (MBC), tesetaxel was shown to have robust single-agent antitumor activity in two, multicenter, Phase 2 studies.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (MBC). CONTESSA will compare tesetaxel dosed orally at 27 mg/m2 on the first day of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival, objective response rate (ORR) assessed by IRC, disease control rate assessed by IRC and patient-reported outcomes. To learn more, please visit www.contessastudy.com.

On May 16, 2018 Peloton Therapeutics, Inc., reported that it will present first-in-human Phase 1 clinical data for its lead investigational oncology agent and hypoxia-inducible factor-2α (HIF-2α) inhibitor, PT2977, at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place June 1-5, 2018 in Chicago (Press release, Peloton Therapeutics, MAY 16, 2018, View Source [SID1234526831]). PT2977 is a selective, orally available HIF-2α antagonist with improved potency and a superior pharmacokinetics profile relative to Peloton’s first-generation agent PT2385, which had demonstrated clinical activity in patients with clear cell renal cell carcinoma (ccRCC) as reported in a study published in the Journal of Clinical Oncology (JCO).

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The ASCO (Free ASCO Whitepaper) abstract (#2508) titled "A First-in-Human Phase 1 Dose-Escalation Trial of the Oral HIF-2α Inhibitor PT2977 in Patients with Advanced Solid Tumors," was accepted for an oral presentation to be delivered on Friday, June 1, 2018 at 5:09 p.m., Eastern time. In this Phase 1 dose-escalation trial, patients with locally advanced or metastatic solid tumors, who had received at least one prior systemic therapy, were treated with PT2977 once daily. The primary objective of the study was to determine the recommended Phase 2 dose and evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of PT2977. PT2977 had a favorable safety profile and demonstrated early evidence of clinical activity.

"HIF-2α is a transcription factor that has been implicated in cancer initiation, progression, and metastasis especially in renal cell carcinoma. We are excited about the availability of a once-daily oral, potent, and selective inhibitor of HIF-2α," said Kyriakos P. Papadopoulos Co-Director of Clinical Research, START Center for Cancer Care (San Antonio, TX) and presenter of the Phase 1 data at ASCO (Free ASCO Whitepaper). "PT2977 had a favorable safety, pharmacokinetics, and pharmacodynamics profile."

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Patients were treated with PT2977 in doses ranging from 20 to 160 milligrams (mg). Exposure increased with dose along with dose-dependent reductions in erythropoietin levels (a PD marker). No treatment-related, dose-limiting toxicities were observed. Anemia (13 percent) was the most common Grade 3 adverse event. Early evidence of clinical antitumor activity including radiographic response and durable disease control were observed.

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"We are encouraged by the results from this Phase 1 dose-escalation study of our superior HIF-2α antagonist PT2977, which support further clinical development and evaluation of this novel agent," said John A. Josey, Ph.D., Peloton’s Chief Executive Officer. "Based on the favorable PK and PD findings from this study, a dose of 120 mg has been selected for further clinical development and we have recently recruited 50 patients into an expansion arm to evaluate PT2977 in patients with advanced renal cell carcinoma, a malignancy with poor prognosis where effective tolerable therapies continue to be in desperate need."

Further information on the clinical trial of PT2977 can be found on clinicaltrials.gov (Study identifier: NCT02974738).

About PT2977

Peloton has succeeded in creating a series of orally-available small molecules that bind to HIF-2α and inhibit its transcription of disease-promoting genes. PT2977 is a once-daily, orally-active agent that blocks hypoxia-inducible factor-2α (HIF-2α). It is a structurally-related compound designed to be more potent with less pharmacokinetics variability compared to PT2385. PT2977 has demonstrated anti-tumor activity with a favorable safety profile in an early-stage clinical study in patients with solid tumors. Given its superior pharmacokinetics profile, PT2977 is the lead agent being developed in oncology by Peloton. Peloton is currently evaluating PT2977 in an international Phase 2 trial in von Hippel-Lindau (VHL) disease-associated RCC and a Phase 1 clinical trial for the treatment of RCC.