Sutro & Celgene to Refocus 2014 Immuno-Oncology Collaboration on Four Programs

On August 10, 2017 Sutro Biopharma reported it is refocusing its 2014 immuno-oncology collaboration with Celgene on four programs that are advancing through preclinical development, including an antibody drug conjugate (ADC) program targeting B-Cell maturation antigen (BCMA) previously disclosed by Celgene (Press release, Sutro Biopharma, AUG 10, 2017, View Source [SID1234538058]). Sutro may also produce both GLP and cGMP material as the BCMA ADC program progresses.

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These programs are additive to Sutro’s proprietary pipeline which includes two 2018 investigational new drug (IND) candidates: STRO-001, an ADC targeting CD74, a cell surface protein associated with B-cell malignancies, including non-Hodgkin lymphoma and multiple myeloma; and STR0-002, an ADC which targets folate receptor alpha which is overexpressed in platinum-resistant ovarian cancer and other solid tumors. Sutro is also advancing six ADC programs under the 2014 collaboration with Merck KGaA.

In the 2014 agreement, Celgene had worldwide rights to the first collaboration program to reach IND status. Under the newly modified agreement, Celgene can acquire worldwide rights to a second collaboration program to reach IND status. Sutro will retain U.S. development and commercialization rights, and Celgene will retain ex-U.S. rights, to the next two programs to reach IND status from the four programs. Under the revised agreement, Sutro receives an undisclosed amount upon signing of the revised agreement and continues to be entitled to development and regulatory milestone payments and royalties.

To acquire worldwide rights to the second program to reach IND status, Celgene must make payments to Sutro in undisclosed amounts.

In addition, Sutro grants Celgene the right to purchase shares of Sutro stock in a future private financing and a right to purchase shares in a private placement contemporaneous with an initial public offering by Sutro. In conjunction with this revision, the option to acquire Sutro has been terminated along with restrictions from Sutro entering into additional collaborations or accessing the public financial markets.

"Our goal is to continue to build momentum for promising antibody drug conjugates and bispecific antibodies for immuno-oncology therapeutics developed with Sutro’s cell-free protein synthesis platform," Sutro CEO Bill Newell said. "With this revised agreement, Celgene continues to support Sutro’s development, while we can move rapidly into development of multiple product candidates and evaluate new opportunities for partnerships and funding."

10-Q – Quarterly report [Sections 13 or 15(d)]

AnaptysBio has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, AnaptysBio, 2018, AUG 10, 2017, View Source [SID1234527557]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Aileron Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Aileron Therapeutics, 2017, AUG 10, 2017, View Source [SID1234522297]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Sophiris Bio has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Sophiris Bio, AUG 10, 2017, View Source [SID1234520159]).

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TG Therapeutics, Inc. Announces Successful Outcome from the First Pre-Planned Interim Analysis by Independent DSMB of the DLBCL Cohort in the UNITY-NHL Phase 2b Trial

On August 10, 2017 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that the independent Data Safety Monitoring Board (DSMB) of the UNITY-NHL Phase 2b registration directed trial has successfully completed the first pre-specified interim analysis to evaluate the Overall Response Rate (ORR) in the cohort enrolling patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) that are not eligible for high-dose chemotherapy or transplant (Press release, TG Therapeutics, AUG 10, 2017, View Source [SID1234520157]). Upon review of the available ORR data, based on pre-specified efficacy thresholds of ORR, the DSMB recommended the Company cease enrollment into the single agent TGR-1202 arm, while continuing enrollment into the TG-1101 + TGR-1202 arm which has demonstrated an acceptable level of efficacy to warrant continued evaluation. Per the UNITY-NHL protocol, the single agent TGR-1202 arm will be replaced by an arm evaluating the triple combination arm of TG-1101, TGR-1202, and bendamustine.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "The DLBCL cohort in our UNITY-NHL trial was designed to evaluate the contribution of TGR-1202 in our combination ‘U2’ regimen. We are extremely pleased that the DSMB has recommended continued enrollment in the U2 arm, while allowing us to proceed with replacing the single agent TGR-1202 arm with the triple combination of TG-1101, TGR-1202, and bendamustine (also referred to as U2 + Benda) as planned. As recently presented, the triplet combination of U2 + Benda was highly active, with a 50% ORR in patients with refractory DLBCL and a 100% ORR in relapsed DLBCL patients. We have long believed that patients with aggressive DLBCL in particular are best treated with combination therapy rather than single agents and are pleased to see our UNITY-NHL study advancing to the next level."

ABOUT UNITY-NHL PHASE 2b TRIAL

UNITY-NHL is a global Phase 2bclinical trial evaluating TG-1101 and TGR-1202, ("U2"), in patients with various types of B-cell lymphoma. The trial consists of three independent cohorts enrolling patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Small Lymphocytic Lymphoma (SLL), and Marginal Zone Lymphoma (MZL). The study is evaluating the U2 combination and the combination of U2 + bendamustine in patients with DLBCL; TGR-1202 monotherapy and in the U2 combination in patients with FL and SLL; and TGR-1202 monotherapy in patients with MZL.

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