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Spectrum Pharmaceuticals Presents Same Day Dosing Data for ROLONTIS® (eflapegrastim) at AACR Virtual Annual Meeting II

On June 22, 2020 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported preclinical data evaluating the administration of ROLONTIS (eflapegrastim) on the same day as chemotherapy (Press release, Spectrum Pharmaceuticals, JUN 22, 2020, View Source [SID1234561283]). The duration of neutropenia in a rat model of chemotherapy induced neutropenia (CIN) was observed to be significantly shorter with eflapegrastim versus pegfilgrastim, regardless of the timing of administration: concomitantly or on the same day post-chemotherapy at 2, 5 or 24 hours post-chemotherapy.

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The poster titled "Chemotherapy induced neutropenia in rats following administration of eflapegrastim or pegfilgrastim on the same day at three different time points and at 24 hours post-chemotherapy" was part of today’s Special Populations, Survivorship, Outcomes, and Supportive Care session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II. ROLONTIS is an investigational drug not approved by the U.S. Food and Drug Administration (FDA) and the BLA (Biologics License Application) is currently under active review by the agency for the treatment of chemotherapy induced neutropenia with a PDUFA date of October 24, 2020.

"These data in rats suggest that eflapegrastim administered at the time of chemotherapy, rather than waiting 24 hours, may be able to provide prophylaxis against chemotherapy induced neutropenia," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "Based on these preclinical results, we recently initiated a Phase 1 clinical trial to compare the effect of same day dosing of eflapegrastim on the duration of neutropenia in patients with early-stage breast cancer when administered on the same day, at varying intervals following docetaxel and cyclophosphamide chemotherapy."

TG Therapeutics Announces Preclinical Data Presentation at the 2020 American Association for Cancer Research Annual Meeting

On June 22, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported preclinical data presentation for TG-1701, the Company’s highly selective, BTK inhibitor, at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, being held virtually (Press release, TG Therapeutics, JUN 22, 2020, View Source [SID1234561282]).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are encouraged by the preclinical data presented today which showed TG-1701 to be just as active and more selective for BTK than ibrutinib, a currently approved BTK inhibitor. Importantly, we are pleased to see the additive anti-tumor inhibition seen when TG-1701 was combined with umbralisib plus ublituximab (U2), supporting our combinatorial approach to development. The proprietary triple combination regimen of U2 + TG-1701 has shown strong responses clinically in an ongoing Phase 1 study, and we look forward to continuing this research and presenting updated data on TG-1701 as a monotherapy and as a triple regimen with U2."

Highlights from the data presentation are included below.

Title: TG-1701, a novel irreversible Bruton’s kinase (BTK) inhibitor, does not inhibit anti-CD20-driven ADCC and ADCP in vitro, and cooperates with the glycoengineered anti-CD20 mAb, ublituximab, in in vivo mantle cell lymphoma models

In vitro and in vivo studies were undertaken to evaluate the activity of TG-1701 alone and in combination with ublituximab and umbralisib in models of lymphoma
TG-1701 showed greater selectivity for BTK than, and similar activity to, ibrutinib in mantel cell lymphoma (MCL) models
TG-1701, in contrast to ibrutinib, did not block ublituximab-driven antibody-dependent cellular cytotoxicity (ADCC) or antibody-dependent cell phagocytosis (ADCP) in vitro
In vivo xenograft studies suggested that TG-1701 synergized with the U2 combination, resulting in greater anti-tumor activity than either TG-1701 or U2 alone

Dynavax to Present at the H.C. Wainwright Virtual Fireside Chat Series

On June 22, 2020 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported that Ryan Spencer, Chief Executive Officer, will participate in a virtual fireside chat at the H.C. Wainwright Virtual Fireside Chat Series on Thursday, June 25, at 10:50 a.m. E.T (Press release, Dynavax Technologies, JUN 22, 2020, View Source [SID1234561281]).

The presentation will be webcast and may be accessed through the "Events & Presentations" page on the "investors" section of the Company’s website at View Source

Forbius to Participate at SVB Leerink’s Biopharma Private Company Connect

On June 22, 2020 Forbius, a clinical-stage protein engineering company that develops biotherapeutics to treat cancer and fibrosis, reported that it will participate at SVB Leerink’s inaugural Biopharma Private Company Connect July 7th-9th, 2020 (Press release, Forbius, JUN 22, 2020, View Source [SID1234561276]).

Agenus and Betta Pharmaceuticals Enter Into a License Agreement for Balstilimab and Zalifrelimab in Greater China

On June 22, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with an extensive pipeline of agents designed to activate immune response to cancers, reported that it has entered into an agreement with Betta Pharmaceuticals (SZ300558), a top Chinese pharmaceutical company focusing on the development of innovative oncology therapies, for an exclusive collaboration and license agreement for the development and commercialization of balstilimab and zalifrelimab in Greater China, including Mainland China, Hong Kong, Macau and Taiwan (Press release, Agenus, JUN 22, 2020, View Source [SID1234561275]).

Under the terms of the agreement, Agenus will receive $35 million, which includes $15 million in upfront cash and a $20 million equity investment. The agreement also includes $100 million in potential milestones plus royalties on net sales. Betta receives exclusive rights for the development and commercialization of balstilimab and zalifrelimab to either as monotherapies or combination therapies, excluding intravesical delivery in greater China.

Agenus’ balstilimab (anti-PD-1) is advancing in trials planned for BLA filing this year as a monotherapy and in combination with zalifrelimab (anti-CTLA-4) for the treatment of refractory or metastatic cervical cancer. Agenus has recently reported positive results suggesting robust and durable responses of balstilimab and zalifrelimab in patients with relapsed or refractory metastatic cervical cancer. The US FDA recently granted Fast Track designation for balstilimab alone and in combination with zalifrelimab in this indication.

"Betta has a strong track record of advancing innovative products in China and a growing portfolio of complementary oncology therapies," said Garo Armen, Chairman and Chief Executive Officer of Agenus. "Betta is an ideal partner to enable us to address significant patient needs in China while also advancing global development of balstilimab and zalifrelimab."

"We are delighted to enter this collaboration with Agenus, a leader in the immuno-oncology field, as the first step in a long-term strategic partnership," said Lieming Ding, Chairman and Chief Executive Officer of Betta Pharmaceuticals. " Based on the compelling clinical data reported to date, we believe Agenus’ balstilimab and zalifrelimab hold great promise for Chinese patients with cervical cancer, with the potential to further expand in additional tumor types through synergistic combinations with Betta’s existing pipeline programs."

The equity purchase component of the transaction is subject to China regulatory approval and other customary closing conditions.