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]).

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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]).

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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]).

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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]).

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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.

Tetraphase Announces Receipt of Proposal from La Jolla Pharmaceutical Company, Determination of Superior Offer and Notice to Melinta

On June 22, 2020 Tetraphase Pharmaceuticals, Inc. (Nasdaq:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVATM (eravacycline for injection) to treat serious and life-threatening infections, reported that on June 19, 2020, its Board of Directors received an unsolicited proposal from La Jolla Pharmaceutical Company ("La Jolla") to acquire Tetraphase for $43.0 million in cash, plus an additional aggregate amount of $16.0 million in cash potentially payable under contingent value rights ("CVRs") to be issued in the transaction (the "La Jolla Proposal"), and that on June 21, 2020 the Board determined that the La Jolla Proposal is a "Superior Offer" under the terms of the Agreement and Plan of Merger, dated June 4, 2020, to which the Company is a party with Melinta Therapeutics, Inc. ("Melinta") and Toronto Transaction Corp., a wholly-owned subsidiary of Melinta (the "Melinta Merger Agreement") (Press release, Tetraphase, JUN 22, 2020, View Source [SID1234561274]). In connection with this determination and in accordance with the terms of the Melinta Merger Agreement, the Company has given notice to Melinta of such determination and of its intention to consider changing its recommendation of the tender offer under the Melinta Merger Agreement or terminating the Melinta Merger Agreement unless Melinta proposes revisions to the terms of the Melinta Merger Agreement or makes another proposal on or prior to Friday, June 26, 2020 that, if accepted, would result in the La Jolla Proposal ceasing to be a Superior Offer.

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Under the Melinta Merger Agreement, Melinta would acquire Tetraphase through a cash tender offer by its subsidiary for all of Tetraphase’s outstanding shares of common stock, for an aggregate of $39.0 million in cash (representing consideration of $1.79 per share of Tetraphase common stock), plus CVRs representing the right to receive cash consideration based on the achievement of certain net sales milestones, in an aggregate amount of up to $16.0 million.

Under the La Jolla Proposal, La Jolla would acquire Tetraphase through a cash tender offer for all of Tetraphase’s outstanding shares of common stock. The upfront cash consideration under the La Jolla Proposal would be as follows: (i) $2.00 per share of Tetraphase common stock (including common stock underlying restricted stock units, performance-based stock units and pre-funded warrants), (ii) $2.68 per share of Tetraphase common stock underlying the common stock warrants issued by the Company in November 2019, and (iii) $2.69 per share of Tetraphase common stock underlying the common stock warrants issued by the Company in January 2020. The total upfront consideration to be received by Tetraphase equityholders under the La Jolla Proposal at closing is approximately $43.0 million, with approximately $21.4 million of this amount allocated to the Company’s outstanding common stock warrants. The La Jolla Proposal is not subject to any financing contingencies. The definitive terms and conditions of a merger agreement detailing the La Jolla Proposal have been fully negotiated. If the La Jolla Proposal continues to constitute a Superior Offer through Friday, June 26, 2020, the Tetraphase Board will consider terminating the Melinta Merger Agreement and entering into the merger agreement with La Jolla.

At this time, the Tetraphase Board (1) continues to recommend the offer under the Melinta Merger Agreement, (2) is not modifying or withdrawing its recommendation with respect to the offer under the Melinta Merger Agreement, or proposing to do so, and (3) is not making any recommendation with respect to the La Jolla Proposal or the offer under the proposed merger agreement with La Jolla.

Janney Montgomery Scott LLC is acting as financial advisor to Tetraphase and Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal advisor.