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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Takeda and Shattuck Labs Announce Research Collaboration to Explore Agonist Redirected Checkpoint Fusion Proteins in Immuno-Oncology

On August 10, 2017 Takeda Pharmaceutical Company Limited (TSE: 4502) and Shattuck Labs, Inc. reported that they have entered into a research collaboration to explore and develop checkpoint fusion proteins that have the potential to become highly differentiated, next-generation immunotherapies (Press release, Shattuck Labs, AUG 10, 2017, View Source [SID1234520210]). Under the terms of the collaboration agreement, Takeda will hold options for exclusive global development and commercialization rights for up to four molecules resulting from the collaboration.

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Shattuck Lab’s Agonist Redirected Checkpoint (ARC) platform combines two binding domains to create fusion proteins that potentially restore and enhance immune system function in a single construct. The ARC molecules block checkpoint molecules while simultaneously stimulating TNF superfamily co-stimulatory receptors on T-cells and innate cells, which are targets controlling the immune system and often dysregulated in cancers, thereby enabling combination immunotherapy with a single product.

"Shattuck Labs has pioneered the unique ARC platform, and we are excited about the opportunity this collaboration presents to develop groundbreaking, next-generation immuno-oncology treatments," said Christopher Arendt, Ph.D., Head, Oncology DDU & Immunology Unit, Takeda. "Research partnerships are a key aspect of our continued dedication to oncology innovation, and this collaboration will bring us closer to our goal of discovering, developing and delivering breakthrough oncology therapies."

The collaboration will include two pre-clinical and four discovery stage programs. Takeda will provide funding for pre-clinical and clinical development and will have the option to take an exclusive license to further develop and commercialize up to four ARC molecules resulting from the collaboration. Additional terms of the collaboration are not disclosed.

"Takeda shares our passion and mission to develop and advance novel therapies in oncology, with the goal of achieving better clinical outcomes in patients," said Josiah Hornblower, Chairman and CEO of Shattuck Labs. "We are very excited to work with Takeda, a proven leader in oncology, to continue to validate the ARC technology."

Takeda signed the collaboration agreement through its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc.

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in Emerging Markets, are currently fueling the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. For more information, visit www.takeda.com/news.

About Shattuck Labs

Headquartered in Austin, Texas, Shattuck Labs, Inc. is a biopharmaceutical company committed to developing biologic medicines for oncology and inflammatory disease. Shattuck Labs developed the Agonist Redirected Checkpoint (ARC) platform to enable immuno-oncology therapeutics capable of simultaneously blocking immune checkpoints and stimulating TNF superfamily receptors. Shattuck Lab’s state-of-the-art research and development organization is currently advancing multiple lead products toward clinical trials.