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Compass Therapeutics Announces Issuance of Composition of Matter and Method Patents Covering Its Lead Immuno-oncology Candidate, CTX-471

On June 17, 2019 Compass Therapeutics, a clinical-stage biotechnology company targeting the human immune synapse with a new generation of monoclonal and multispecific antibody therapeutics, reported that the U.S. Patent and Trademark Office issued three U.S. patents covering certain anti-CD137 antibodies, including its lead therapeutic candidate, CTX-471 (Press release, Compass Therapeutics, JUN 17, 2019, View Source [SID1234537113]).

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CTX-471 is a fully human antibody that binds and activates a unique epitope of the co-stimulatory receptor CD137 (4-1BB) expressed on T- and NK-cells. In preclinical studies, CTX-471 demonstrates potent monotherapy activity in multiple syngeneic tumor models, including curative efficacy against very large, established tumors where other validated IO antibodies, such as antibodies targeting PD-1, PD-L1, CTLA-4 and OX40 have no or minimal effect. CTX-471 efficacy is associated with a comprehensive reprogramming of the tumor microenvironment, increasing CD8+ T-cell infiltration and penetration while reducing T-cell exhaustion. Unlike other clinical and preclinical CD137 antibodies, CTX-471 shows no evidence of hepatic toxicity in both mice and non-human primates, supporting the potential for a wide therapeutic window in patients.

The CTX-471 Phase 1 study is now open. For more information: View Source

"We’re truly excited about the promise CTX-471 holds for patients with cancer and we’re delighted to secure these patents, which affirm the novelty of our approach," said Thomas Schuetz, MD, PhD, the scientific founder and chief executive officer of Compass. "The intellectual property portfolio we have generated at Compass provides an excellent foundation for us to build on as we continue to advance our pipeline of innovative therapeutic candidates in oncology and autoimmunity."

The newly issued patents are: U.S. Patent No. 10,279,038, which covers the composition of CTX-471; and U.S. Patent Nos. 10,279,039 and 10,279,040, which cover the use of CTX-471 in methods for treating cancer and inducing or enhancing an anti-tumor immune response, respectively. The base term for each patent extends until July of 2038. Additional patent filings by Compass related to CTX-471 are under review.

Molecular Templates Announces FDA Acceptance of IND Application for TAK-169, An Engineered Toxin Body Targeting CD38

On June 17, 2019 Molecular Templates, Inc., (Nasdaq: MTEM, "Molecular," "Molecular Templates" or "MTEM") a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, reported that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for TAK-169, an ETB targeting CD38 (Press release, Molecular Templates, JUN 17, 2019, View Source [SID1234537112]).

MTEM and partner Takeda Pharmaceutical Company Limited (Takeda) are co-developing TAK-169 and plan to conduct an open label Phase I dose escalation and expansion study in relapsed/refractory multiple myeloma patients.

"We are excited to continue our collaboration with Takeda advancing the development of TAK-169 for the treatment of multiple myeloma patients," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "It represents a novel CD38 targeted therapy which could provide benefit in patients with multiple myeloma and overcome mechanisms of resistance to existing CD38 targeted therapies."

About TAK-169
TAK-169 is an ETB consisting of a single chain variable fragment (scFv) with affinity for CD38, fused to the enzymatically active de-immunized Shiga-like toxin-A subunit (SLTA). TAK-169 specifically binds and kills CD38 expressing cells in a manner consistent with SLTA mediated cellular cytotoxicity. TAK-169 has been specifically designed to avoid competition with and to overcome the primary mechanisms of tumor resistance to daratumumab and other monoclonal antibodies targeting CD38. TAK-169 has been shown to be active in the presence of daratumumab. As such, TAK-169 may have the potential to be combined with approved CD38 targeted therapies. TAK-169 mediated ribosomal inhibition and cell death take place intracellularly so changes in the tumor microenvironment, such as CD55/59 upregulation, which inhibit immune-mediated mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC) or complement dependent cytotoxicity (CDC) are not expected to inhibit TAK-169 activity.

About the CD38 Co-Development Partnership with Takeda
On September 19, 2018, MTEM announced an agreement with Takeda for the joint development of CD38-targeted ETBs for the treatment of multiple myeloma. TAK-169, the lead development candidate, is a CD38-targeted ETB that resulted from a previous discovery collaboration between the two companies. Under the terms of the agreement, Takeda has made an upfront payment of $30 million and Molecular Templates is eligible to receive development, regulatory and commercial milestone payments of up to $632.5 million if Molecular Templates exercises its co-development option or $337.5 million if Molecular Templates does not exercise or opts out of its co-development option. Takeda has also agreed to pay royalties on sales of the commercial product developed through the collaboration. Molecular Templates and Takeda will share equally in the development costs. MTEM has been awarded a $15.2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to fund development and manufacturing of CD38-targeted ETBs including TAK-169.

CymaBay Therapeutics to Participate in the Raymond James Life Sciences and MedTech Conference

On June 17, 2019 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, reported that Sujal Shah, President and Chief Executive Officer, will participate in a fireside chat at Raymond James Life Sciences and MedTech Conference on Wednesday, June 19, 2019 at 8:00 a.m. ET (5:00 a.m. PT) at the Lotte New York Palace in New York City (Press release, CymaBay Therapeutics, JUN 17, 2019, View Source [SID1234537111]).

A live audio webcast of the presentation can be accessed through the Investors section of the CymaBay Therapeutics corporate website at View Source The webcast will be archived on the corporate website for 90 days

About Seladelpar
Seladelpar is a potent, selective, orally active PPARδ agonist that is in development for the treatment of the liver diseases PBC and NASH. For PBC, seladelpar has received an orphan designation from the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA). Seladelpar also received Breakthrough Therapy Designation from the FDA and PRIority MEdicine status from the EMA for PBC.

TG Therapeutics Presents Preclinical Data for TG-1801, a First-in-Class Anti-CD47/CD19 Bispecific Antibody, at the 24th European Hematology Association Annual Congress

On June 17, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the presentation of preclinical data for TG-1801, the Company’s first-in-class anti-CD47/CD19 bispecific antibody, highlighting the synergistic effect of TG-1801 in combination with ublituximab, the Company’s anti-CD20 monoclonal antibody and umbralisib, the Company’s PI3K-delta inhibitor (Press release, TG Therapeutics, JUN 17, 2019, View Source [SID1234537110]). These data were presented over the weekend at the 24thEuropean Hematology Association (EHA) (Free EHA Whitepaper) annual congress held in Amsterdam, The Netherlands.

Highlights from this poster presentation include:

Title: The novel bispecific CD47-CD19 antibody TG-1801 potentiates the activity of ublituximab-umbralisib (U2) drug combination in preclinical models of B-NHL

TG-1801 is a first-in-class anti-CD47-CD19 bispecific antibody that selectively targets CD47 on CD19+ B-cells, sparing red blood cells and platelets, and blocking the CD47-SIRPα macrophage checkpoint on mature B cells
Ublituximab exerts stronger ADCP and ADCC activity in B-NHL cells when compared to rituximab, and TG-1801 increased the ADCC and ADCP activities initiated by both ublituximab and the U2 combination
The triple combination of TG-1801 + U2 was found to regulate genes related to cell architecture
TG-1801 triggers synergistic tumor growth inhibition and results in prolonged remission when added to U2 in an in vivo Raji lymphoma model, which appears to be mediated by increased infiltration of immune effector cells
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "TG-1801 is a first-in-class anti-CD47/CD19 bispecific antibody targeting the ‘don’t eat me’ self-defense signal that protects cancer cells from the immune system. This agent is designed to target CD19 expressing cells to avoid off-target CD47 toxicity, representing a novel immunological therapeutic strategy with potential for synergistic or complimentary activity with our current pipeline." Mr. Weiss continued, "We are excited by the preclinical data presented today for TG-1801. The synergistic effects of TG-1801 in combination with U2 are encouraging and we look forward to evaluating TG-1801 as a single agent in our on-going TG-1801 Phase 1 clinical study and as soon as possible in combination with U2 and our other pipeline drug candidates. TG is committed to improving the outcome of patients with B-cell malignancies through combination therapy and we believe TG-1801 may play an important role in that effort."

PRESENTATION DETAILS:

The above referenced presentation is available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

BioNTech and Genmab Initiate First-In-Human Phase I/IIa Trial of Bispecific Antibody DuoBody®-PD-L1x4-1BB in Solid Tumors

On June 17, 2019 BioNTech SE, a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases, reported that the first-in-human Phase I/IIa study with DuoBody-PD-L1x4-1BB has been initiated (Press release, BioNTech, JUN 17, 2019, View Source [SID1234537109]). DuoBody PD-L1x4-1BB is a bispecific antibody in joint development with Genmab A/S, which is being studied in patients with metastatic or unresectable malignant solid tumors, who are not candidates for standard therapy. DuoBody-PD-L1x4-1BB is the first product candidate from the companies’ worldwide 50% cost-sharing 50% profit-sharing collaboration to enter the clinic. The objective of the collaboration, signed in 2015 and expanded in 2016 to include additional targets and technologies, is to develop and commercialize multiple novel bispecific antibodies with superior in vivo efficacy that specifically activate the immune system against cancer cells.

"The achievement of starting a Phase I/IIa clinical trial with a product candidate developed in only four years is a validation of our highly productive partnership with Genmab," said Prof. Ugur Sahin, CEO of BioNTech. "DuoBody-PD-L1x4-1BB’s pan-cancer, dual-immuno-stimulatory mode of action contributes an additional layer of treatment options to our overall cancer pipeline. It also serves BioNTech’s strategy of exploiting novel targets and mechanisms to harness the full potential of the immune system for cancer immunotherapy."

DuoBody-PD-L1x4-1BB is a novel bispecific antibody that combines checkpoint blockade of the inhibitory PD-1:PD-L1 signaling axis with conditional stimulation of T cells by activation of the 4-1BB receptor, thereby enhancing the proliferation of activated T cells to efficiently target cancer cells. The original idea and concept for this approach to combine immune-brake removing (PD-L1) and acceleration properties (4-1BB) to combat cancer are based on research conducted at BioNTech. The open-label safety trial of DuoBody-PD-L1x4-1BB (ClinicalTrials.gov Identifier NCT03917381) consists of two parts: a dose escalation part (Phase I, first-in-human) and an expansion part (Phase IIa). As primary endpoint, the multi-center trial will foremost assess safety including dose limiting toxicity and adverse events.