1stOncology™: Cancer Intelligence Service – Page 11484 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Athenex Announces Data on Oral Paclitaxel and Encequidar to be Presented at the 2020 San Antonio Breast Cancer Symposium (SABCS)

On November 17, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported that oral paclitaxel and encequidar ("oral paclitaxel") data will be presented in four separate poster presentations at the 2020 San Antonio Breast Cancer Symposium (SABCS) to be held virtually December 8-11 (Press release, Athenex, NOV 17, 2020, View Source [SID1234573869]). Presentations will include, from the pivotal Phase 3 clinical trial of oral paclitaxel in metastatic breast cancer (MBC), a spotlight poster on progression-free survival (PFS) and overall survival (OS), and posters on neuropathy (CIPN), and management of gastrointestinal (GI) side effects. An additional poster explores oral paclitaxel in the treatment of cutaneous angiosarcoma of the breast.

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 symposium will also feature an immersive Athenex Oncology virtual exhibit experience with distinct hubs for CIPN, Medical Affairs, and the Facing MBC Together program.

Details of the oral paclitaxel presentations are as follows:

Spotlight Poster Presentation

Abstract Title: Oral Paclitaxel and Encequidar (oPac+E) versus IV Paclitaxel (IVPac) in the treatment of metastatic breast cancer (mBC) patients (Study: KX-ORAX-001)

Session: Spotlight Poster Discussion 1

Program Number: PD1-08

Date and Time: Wednesday, December 9, 2020, at 4:00 PM to 5:15 PM Central Time (CT)

For more information, please visit: View Source

Abstracts selected for spotlight poster presentation will only have titles posted to the SABCS website until the embargo lifts on December 9, 2020, when the complete abstract will post online.

Additional Poster Presentations

Abstract Title: A phase 2 study of Oral Paclitaxel and Encequidar (oPac+E) in the treatment of cutaneous angiosarcoma: the breast angiosarcoma group

Program Number: PS13-05

Session: Poster Session 13

Date and Time: Wednesday, December 9, 2020, at 8:00 AM CT

For more information, please visit: View Source

Abstract Title: Lower rates of neuropathy with Oral Paclitaxel and Encequidar (oPac+E) compared to IV Paclitaxel (IVPac) in treatment of metastatic breast cancer (mBC): Study KX-ORAX-001

Program Number: PS13-06

Session: Poster Session 13

Date and Time: Wednesday, December 9, 2020, at 8:00 AM CT

For more information, please visit: View Source

Abstract Title: Oral Paclitaxel and Encequidar (oPac+E) in the treatment of metastatic breast cancer (mBC): Management of gastrointestinal adverse events (GI AE). Study KX-ORAX-001

Program Number: PS13-11

Session: Poster Session 13

Date and Time: Wednesday, December 9, 2020, at 8:00 AM CT

For more information, please visit: View Source

Athenex Exhibit Booth

Athenex Oncology will have an immersive virtual exhibit experience at SABCS. This unique booth will feature three separate hubs: 1) Chemotherapy-Induced Peripheral Neuropathy (CIPN) augmented reality simulation, designed to deepen a visitor’s understanding and virtually experience what it feels like to have CIPN; 2) Facing MBC Together, a public education and patient support program that addresses the issue of isolation for people living with metastatic breast cancer; and 3) Medical Affairs, where visitors can learn about how inhibition of P-gp facilitates absorption of orally administered chemotherapies. The booth will be accessible to meeting registrants throughout SABCS during exhibit hall hours, which are from 10am-7pm on Tuesday, December 8; 8am-7:45pm on Wednesday, December 9; and 10am-5pm on Thursday and Friday, December 10 and 11 (all Central Time).

FDA Delay for BMS’ Liso-cel Likely Kills $9 Celgene CVR Hopes for Investors

On November 17, 2020 Bristol Myers Squibb reported cold water on Celgene shareholders who have been hoping to see a payout related to the merger of the two companies (Press release, BioSpace, NOV 17, 2020, View Source [SID1234571461]). This morning, the pharma giant signaled it will fail to meet a deadline related to $9 per share Contingent Value Rights (CVR) tickets, essentially killing that payment.

When BMS and Celgene merged, CVR payouts hinged on the approval of three drugs. The first of the three CVR medicines, Celgene’s multiple sclerosis drug Zeposia (ozanimod), was approved in March. The other drugs related to the CVR are cancer treatments, ide-cel and liso-cel (lisocabtagene maraleucel). Under terms of the deal, ide-cel, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, must be approved by the U.S. Food and Drug Administration by March 31, 2021. The FDA accepted the Biologics License Application for ide-cel under priority review in September.

Liso-cel, though, is another matter. The deadline to meet the CVR milestone for this cancer drug is Dec. 31. BMS had a Prescription Drug User Fee Act (PDUFA) action date of Nov. 16, but COVID-19 threw a spanner into the works, pushing back the timeline for its review.

Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy designed to target CD19, which is a surface glycoprotein expressed during normal B-cell development and maintained following malignant transformation of B cells. BMS is seeking approval of the drug as a treatment for adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.

The BLA is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma. TRANSCEND NHL 001 is the largest study of CD19-directed CAR T cells to support a BLA to date.

In its announcement this morning, BMS said the delay is due to COVID-19-related travel restrictions at the FDA. The travel restrictions prevented the FDA from conducting an inspection of a third-party manufacturing facility in Texas before the PDUFA date. Because the regulatory agency could not ensure that the manufacturing facility meets its standards, it has deferred potential approval of liso-cel until the inspection can be completed. The FDA has not provided a new anticipated date for approval, BMS said.

Samit Hirawat, chief medical officer of Global Drug Development at BMS, said the company will continue to work with the FDA to support the ongoing review of the liso-cel BLA. Hirawat said the company is "committed to bringing liso-cel to patients with relapsed or refractory large B-cell lymphoma who still have significant unmet need."

This isn’t the first delay for liso-cel that jeopardized potential approval. Earlier this year, the FDA delayed review of the BLA for liso-cel by three months, which gave it the Nov. 16 PDUFA date.

BeiGene Plans to Raise up to $2.5 Billion in Shanghai Star IPO

On November 17, 2020 BeiGene (NSDQ: BGNE; HK: 06160) reported an IPO on the Shanghai Star Exchange that could raise up to $2.5 billion (Press release, BeiGene, NOV 17, 2020, View Source [SID1234571400]). The Beijing company is already listed in Hong Kong and the US, and it raised $2.1 billion in a secondary offering on the Hong Exchange in July of this year. Now ten years old, BeiGene is spending big to conduct clinical trials for drug approvals and additional indications for its products. At the end of Q3, the company has $4.7 billion of cash in hand, but it lost $560 million in the first nine months of 2020 on revenues totaling $371 million.

Oncternal Therapeutics Announces $20.0 Million Bought Deal Offering

On November 17, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 6,451,613 shares of common stock of the Company, at a price to the public of $3.10 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, NOV 17, 2020, View Source [SID1234571347]). The closing of the offering is expected to occur on or about November 20, 2020, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 967,741 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $20.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

OncoSynergy Launches Phase I rial for Patients With Recurrent Glioblastoma

On November 17, 2020 OncoSynergy, a patient-focused biotech startup founded by physicians trained in neurosurgery reported that it has opened enrollment in their phase 1 trial which will study OS2966, a novel therapeutic antibody, for treatment of glioblastoma (Press release, OncoSynergy, NOV 17, 2020, View Source [SID1234571311]). The trial will take place at Moffitt Cancer Center in Tampa, Florida under the leadership of Michael Vogelbaum, MD, PhD.

OS2966 inhibits Beta1 integrin (CD29), a critical receptor responsible for integrating cancer promoting signals and driving cancer growth and spread. Studies have demonstrated that resistance to anti-angiogenic therapy (i.e., bevacizumab) is associated with increased expression of Beta1 integrin. OncoSynergy studied OS2966 in animal models implanted with patient tumor samples that had become resistant to treatment with bevacizumab. These studies revealed that OS2966 prevented the ability of bevacizumab-resistant tumor cells to invade the surrounding brain and resulted in significant tumor cell death (Carbonell et al, 2013).

Despite advancement of several new promising cancer treatments, successful treatment of glioblastoma has been limited by the presence of the brain’s protective blood brain barrier and the invasive nature of glioblastoma. To combat these obstacles, a technique called convection-enhanced delivery (CED) will be utilized to deliver OS2966 directly to the brain tumor and surrounding tumor-infiltrated brain.

The primary goal of this phase 1 study is to determine the safety and tolerability of OS2966 when delivered directly to the brain. That said, given pre-clinical data demonstrating OS2966’s ability to address therapy resistant tumors and a delivery technique designed to overcome obstacles specific to glioblastoma, the ultimate hope is to improve outcomes for patients suffering from this formidable disease.