Biogen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Biogen, 2018, JUL 24, 2018, View Source [SID1234527837]).

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On July 24, 2018 Minomic International Ltd (Minomic) is an immuno-oncology company specializing in therapeutics and diagnostics for solid tumors, including prostate, bladder and pancreas (Press release, Minomic, JUL 24, 2018, View Source [SID1234528622]). The Company reported that it has completed enrolment and dosing of all 12 patients in its pioneering clinical trial of Miltuximab, a chimeric version of Minomic’s MIL-38 anti-Glypican 1 antibody conjugated to the radioactive isotope 67Gallium.

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The Miltuximab Trial is a first-in-human study to evaluate the safety and tumor targeting of Miltuximab, in patients with metastatic prostate, bladder, and pancreatic cancer. The primary endpoint of the MILGa trial is safety and tolerability of Miltuximab. Secondary endpoints include tumor targeting, pharmacokinetics and dosimetry to determine relative accumulation of Miltuximab, in different organs.
All patients have now been dosed and we are pleased to report Miltuximab was well tolerated with patients reporting no drug related adverse events. Secondary endpoints will be reported when data analysis is completed – to date these are progressing well.

Minomic’s CEO, Dr Brad Walsh, said, "These results will inform the future development of the drug and most importantly the next step, progression to a Phase 1 trial in Australia. Each phase in this process enhances the attractiveness of the company to potential partners. "

We are grateful to the principal investigator Prof. Howard Gurney and his team at Macquarie University Hospital for their dedication to bringing new therapies to cancer patients.

On July 24, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patient was dosed in a global Phase 3 clinical trial of pamiparib, an investigational PARP inhibitor, as maintenance therapy in patients with inoperable locally advanced or metastatic gastric cancer who responded to platinum-based first-line chemotherapy (Press release, BeiGene, JUL 24, 2018, View Source;p=RssLanding&cat=news&id=2359579 [SID1234527826]).

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"We are pleased to announce the initiation of the first global Phase 3 trial of pamiparib, an important compound in our clinical pipeline. With our recently announced Phase 3 clinical trial of pamiparib in China for patients with platinum-sensitive recurrent ovarian cancer and now with this global Phase 3 trial in gastric cancer, we are striving to maximize opportunities for patients with a broad range of cancer diagnoses to be treated with and potentially benefit from pamiparib," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"Our focus at BeiGene is on developing treatments for patients who often have limited options. We are excited about this opportunity to evaluate our PARP inhibitor as maintenance therapy for patients with platinum-sensitive gastric cancer, especially considering more than 50 percent of these patients worldwide live in Eastern Asia, mainly China1," commented Amy Peterson, M.D., Chief Medical Officer for Immuno-Oncology at BeiGene.

The global Phase 3, randomized, double-blind, placebo-controlled trial in China, the U.S., Europe, Japan, Australia, and Singapore, is designed to compare the efficacy and safety of pamiparib to placebo as maintenance therapy in approximately 540 patients with advanced gastric cancer who have responded to first-line platinum-based chemotherapy. The primary endpoint of the trial is progression-free survival (PFS) by blinded independent review committee assessment. Overall survival (OS) is a key secondary endpoint as are progression after the next line of therapy (PFS2) and safety and tolerability.

"Inoperable, locally advanced and metastatic gastric cancer has limited treatment options. While first-line platinum-based therapy can result in initial responses, platinum-based chemotherapies are associated with significant toxicities. We are currently studying pamiparib, a PARP inhibitor, as a maintenance therapy to understand if a response to chemotherapy can be maintained without the associated toxicities," said Johanna Bendell, M.D., Chief Development Officer at Sarah Cannon, Nashville, Tenn., and co-chair of the steering committee for this trial.

About Pamiparib
Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Pamiparib is currently in global clinical development as a monotherapy and in combination with other agents for a variety of solid tumor malignancies

On July 24, 2018 Sutro Biopharma, Inc., reported that it has signed a collaboration and licensing agreement with Merck, known as MSD outside the United States and Canada, to discover and develop novel immune-modulating therapies for cancer and autoimmune disorders (Press release, Sutro Biopharma, JUL 24, 2018, View Source [SID1234529410]).

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The research and development activities will leverage Sutro’s proprietary cell-free protein synthesis andsite-specific conjugation platforms, which facilitate precision design and rapid empirical optimization of protein conjugates, to discover and develop best-in-class immune-modulating cytokine derivativesfor both oncology and autoimmune indications.

Under the agreement, Sutro will be primarily responsible for preclinical research and Merck will gain exclusive worldwide rights to therapeutic candidates derived from the collaboration.

Sutro will receive an upfront payment of $60 million and is eligible for milestone payments totaling up to $1.6 billion associated with the development and sale of all therapeutic candidates and all possible indicationsidentified under the collaboration, as well as tiered royalties on the sale of products.

"There’s an urgent need for novel, targeted and well-tolerated therapies with improved therapeutic profiles for cancer and autoimmune disease," Sutro CEO Bill Newell said. Dr. Joe Miletich, Senior Vice President, Discovery, Preclinical and Early Development, Merck Research Laboratories, said: "Sutro has an impressive suite of technologies that make possible the discovery, characterization and manufacture of novel therapeutic proteins in a timely manner. We look forward to collaborating with Sutro to further expand our pipeline of promising candidates targeting oncology and autoimmune diseases."

On July 24, 2018 BioXcel Therapeutics, Inc. ("BTI") (Nasdaq: BTAI), is a clinical stage biopharmaceutical development company utilizing proprietary artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology, reported that dipeptidyl peptidase (DPP) 8/9 inhibition, the primary mechanism of action of its lead immuno-oncology candidate, BXCL701, was highlighted in an article in the July 2018 edition of the peer-reviewed journal Nature Medicine (Press release, BioXcel Therapeutics, JUL 24, 2018, View Source [SID1234527859]).

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BXCL701 is a potential first-in-class, highly potent oral small molecule immuno-modulator that has demonstrated single agent activity in melanoma, with an established safety profile from 700 healthy subjects and cancer patients. It is designed to stimulate both the innate and acquired immune systems by inhibiting DPP8/9 and blocking immune evasion by inhibiting Fibroblast Activation Protein (FAP).

The paper titled "DPP8/DPP9 inhibitor-induced pyroptosis for treatment of acute myeloid leukemia" by Darren C. Johnson, et al., concluded that activation of caspase recruitment domain-containing protein 8 (CARD8) acts as an inflammasome sensor to activate caspase-1 and mediates DPP8/9 inhibitor-induced cell death in myeloid cells(1). This therapeutic strategy serves as a potential pathway for direct cytotoxicity of acute myeloid leukemia (AML) cells and indirect response to solid tumors. Multiple prior studies have established DPP8/9 as a novel immune checkpoint that controls the activation of the innate immune system(2),(3)

"BXCL701 is novel in its ability to stimulate both the innate and acquired immune systems by inhibiting DPP8/9 and blocking immune evasion by inhibiting FAP," said Vimal Mehta, PhD, Chief Executive Officer of BTI. "This publication highlights one component of BXCL701’s dual mechanism of action, providing valuable insights on the effects of DPP8/9 inhibition. BXCL701 differentiates itself by activating the innate immune system and stimulating neutrophils, natural killer cells and effector T cells. The paper provides further mechanistic understanding of DPP8/9 inhibition and validates its importance as a promising therapeutic approach, not only for solid tumors but for hematologic malignancies as well."

BTI expects to initiate Phase 2 proof of concept studies evaluating BXCL701 in pancreatic cancer and tNEPC later this year. BTI is also evaluating BXCL701’s potential in additional indications, both as a monotherapy and in combination with other immuno-oncology agents and partnering strategies.

Vincent J. O’Neill, MD, Chief Medical Officer of BTI added, "BXCL701 has generated compelling preclinical data in pancreatic cancer and a variety of other tumor models. Particularly exciting is its ability to block immune evasion and aid in the formation of memory T-cells, which may support long-term immunity in certain types of cancer as presented by BTI at ASCO (Free ASCO Whitepaper) 2018(4)."

This study in AML led by Dr. Bachovchin’s team at the Memorial Sloan Kettering Cancer Center and the Weil Cornell Graduate School of Medical Sciences, demonstrates that the therapeutic potential of a DPP8/9 inhibitor such as BXCL701 can extend beyond solid tumors into hematologic malignancies.

Dr O’Neill concluded, "We look forward to further evaluating BXCL701 in our lead indications, and potentially expanding its application to other cancer types."

(1) Johnson, DC, et al. DPP8/DPP9 inhibitor-induced pyroptosis for treatment of acute myeloid leukemia." Nat Med (2018), PMID: 29967349; DOI:10.1038/s41591-018-0082-y

(2) Okondo, Marian C., et al. "DPP8 and DPP9 inhibition induces pro-caspase-1-dependent monocyte and macrophage pyroptosis." Nat Chem Biol 13.1 (2017): 46-53. PMID: 27820798; DOI:10.1038/nchembio.2229

(3) Okondo, Marian C., et al. "Inhibition of Dpp8/9 activates the Nlrp1b inflammasome." Cell Chem Biol 25.3 (2018): 262-267. PMID: 29396289; DOI:10.1016/j.chembiol.2017.12.013

(4) Rastelli et al., Presented at ASCO (Free ASCO Whitepaper) 2018, Illinois, Abstract #3085