On October 16, 2019 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company addressing key mechanisms of tumor drug resistance, reported that data from four of the Company’s pipeline programs will be presented in poster sessions at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) to be held October 26-30, 2019 in Boston, MA (Press release, Deciphera Pharmaceuticals, OCT 16, 2019, View Source [SID1234542304]).

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A copy of each abstract will be available via the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) website.

Details of the four poster sessions are as follows.

Poster Title: Phase 1b/2 study of rebastinib (DCC-2036) in combination with paclitaxel: preliminary safety, efficacy, pharmacokinetics and pharmacodynamics in patients with advanced or metastatic solid tumors
Session Title: Immune Modulators
Author: Filip Janku, MD, University of Texas MD Anderson Cancer Center
Session Date and Time: Monday, October 28, 12:30-4:00 PM ET
Location: Hall D, Hynes Convention Center
Abstract Number: B055

Poster Title: Preclinical studies with DCC-3116, an ULK kinase inhibitor designed to inhibit autophagy as a potential strategy to address mutant RAS cancers
Session Title: New Molecular Targets
Author: Bryan D. Smith, PhD, Deciphera Pharmaceuticals
Session Date and Time: Monday, October 28, 12:30-4:00 PM ET
Location: Hall D, Hynes Convention Center
Abstract Number: B129

Poster Title: Updated results of phase 1 study of ripretinib (DCC-2618), a broad-spectrum KIT and PDGFRA inhibitor, in patients with gastrointestinal stromal tumor (GIST) by line of therapy (NCT02571036)
Session Title: Therapeutic Agents: Small Molecule Kinase Inhibitors
Author: Ping Chi, MD, PhD, Memorial Sloan Kettering Cancer Center
Session Date and Time: Tuesday, October 29, 12:30-4:00 PM ET
Location: Hall D, Hynes Convention Center
Abstract Number: C077

Poster Title: Phase 1 study of DCC-3014, an oral inhibitor of CSF1R, to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced solid tumors, including diffuse-type tenosynovial giant cell tumor
Session Title: Therapeutic Agents: Small Molecule Kinase Inhibitors
Author: Matthew H. Taylor, MD, Oregon Health & Science University
Session Date and Time: Tuesday, October 29, 12:30-4:00 PM ET
Location: Hall D, Hynes Convention Center
Abstract Number: C087

About Ripretinib

Ripretinib is an investigational tyrosine kinase switch control inhibitor that was engineered to broadly inhibit KIT and PDGFRα mutated kinases by using a unique dual mechanism of action that regulates the kinase switch pocket and activation loop. Ripretinib is currently in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including gastrointestinal stromal tumors, or GIST, systemic mastocytosis, or SM, and other cancers. Ripretinib inhibits initiating and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST, as well as the primary D816V exon 17 mutation involved in SM. Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14 and 18, including the exon 18 D842V mutation, involved in a subset of GIST. In June 2019, the U.S. FDA granted Fast Track Designation to ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib.

Deciphera Pharmaceuticals has an exclusive license agreement with Zai Lab (Shanghai) Co., Ltd. for the development and commercialization of ripretinib in Greater China (MainlandChina, Hong Kong, Macau and Taiwan). Deciphera Pharmaceuticals retains development and commercial rights for ripretinib in the rest of the world.

About Rebastinib

Rebastinib is an investigational, orally administered, potent and selective inhibitor of the TIE2 kinase, the receptor for angiopoietins, an important family of vascular growth factors in the tumor microenvironment that also activate pro-tumoral TIE2 expressing macrophages. In a Phase 1 clinical study, biomarker data have demonstrated rebastinib-induced increases in the TIE2 ligand angiopoietin 2, secondary to TIE2 inhibition. Rebastinib is currently being evaluated in a Phase 1b/2 clinical study in combination with paclitaxel (NCT03601897), in a Phase 1b/2 clinical study in combination with carboplatin (NCT03717415), and in an investigator sponsored Phase 1b trial in patients with metastatic breast cancer in combination with paclitaxel or eribulin (NCT02824575).

About DCC-3014

DCC-3014 is an investigational, orally administered, potent and highly selective inhibitor of CSF1R. DCC-3014 was designed using the Company’s proprietary switch control kinase inhibitor platform to selectively bind to the CSF1R switch pocket. DCC-3014 has greater than 100-fold selectivity for CSF1R over other closely related kinases and has an even greater selectivity for CSF1R over approximately 300 other human kinases. CSF1R controls the differentiation and function of macrophages including Tumor Associated Macrophages (TAMs) whose density within certain tumors including cancers of the breast, cervix, pancreas, bladder and brain correlates with poor prognosis. Tumors induce TAMs to suppress a natural immune response mediated by cytotoxic T-cells, a type of lymphocyte that would otherwise eradicate the tumor; a process known as macrophage checkpoints. Through inhibition of CSF1R, DCC-3014 has in preclinical studies demonstrated potent macrophage checkpoint inhibition as both a single agent and in combination with PD1 inhibitors and other T-cell checkpoint inhibitors. DCC-3014 is currently being evaluated in a Phase 1 clinical study. For more information about the clinical trial design please visit www.clinicaltrials.gov (NCT03069469).

About DCC-3116

DCC-3116 is a potential first-in-class small molecule designed to inhibit cancer autophagy, a key tumor survival mechanism, by inhibiting the ULK kinase. Subject to favorable investigational new drug (IND)-enabling studies and filing and activation of an IND, expected in mid-2020, Deciphera intends to develop DCC-3116 for the potential treatment of mutant RAS cancers in combination with inhibitors of downstream RAS effector targets including RAF, MEK, or ERK inhibitors as well as with direct inhibitors of mutant RAS.

On October 16, 2019 Navire Pharma, Inc., a BridgeBio Pharma, Inc. subsidiary developing small molecule inhibitors of the protein tyrosine phosphatase SHP2 (Src homology 2 domain-containing phosphatase), reported preclinical data demonstrating the potential for the Company’s SHP2 inhibitor to lung cancer tumor cells that have acquired resistance to EGFR inhibitors, which are common targeted cancer medicines (Press release, Navire Pharma, OCT 16, 2019, View Source [SID1234542303]). The data will be presented at AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on October 29, 2019.

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"Our work with MD Anderson’s Institute for Applied Cancer Science (IACS) adds to the growing body of evidence that SHP2 is an important node in MAPK signaling and supports combining a SHP2 inhibitor with an RTK inhibitor in RTK-driven cancers," said Shafique Virani, CEO of Navire Pharma. "The aim of BridgeBio’s BBP-398 program is to rapidly translate this exciting science into the clinic to evaluate the program’s potential to manage treatment-resistant cancers. We are preparing the program to be ready for clinical testing in 2020."

In a poster entitled "Discovery of IACS-13909, an allosteric SHP2 inhibitor that overcomes multiple mechanisms underlying osimertinib resistance," Yuting Sun, Ph.D., a member of the Institute for Applied Cancer Science at MD Anderson Cancer Center, from which Navire licensed its SHP2 inhibitors, will present preclinical data demonstrating that the allosteric SHP2 inhibitors were able to reduce growth of EGFR-driven non-small cell lung cancer (NSCLC) in vitro and in vivo. Importantly, IACS-13909 enhanced the anti-tumor activity of osimertinib, a front-line therapy for EGFR mutated NSCLC, when used in combination with osimertinib in preclinical models.

SHP2, a conserved protein tyrosine phosphatase, is a critical node in growth factor, cytokine and integrin signaling, all of which are important in the progression of cancer. SHP2 regulates multiple downstream signaling pathways including RTK/MAPK and the adaptive immune response through checkpoint inhibition. Alterations in RTK/MAPK and checkpoint inhibition pathways are common in cancer. Thus, targeting SHP2 may offer a potential new approach to treat this disease.

On October 16, 2019 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that an abstract related to the Company’s Phase 2 clinical trial of tipifarnib in HRAS mutant head and neck squamous cell carcinomas (HNSCC) has been accepted for presentation at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), which will be held from October 26-30, 2019 in Boston (Press release, Kura Oncology, OCT 16, 2019, View Source [SID1234542302]). Details are as follows:

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Title: Preliminary results from a phase 2 trial of tipifarnib in squamous cell carcinomas (SCCs) with HRAS mutations
Session Title: Clinical Trials
Session Date: Sunday, October 27
Session Start Time: 12:30
Session End Time: 16:00
Location: Hall D, Hynes Convention Center
Abstract Number: A087

The abstract has been selected as a newsworthy candidate for the meeting’s official press program and will be embargoed until 11:00 a.m. ET on Friday, October 25, 2019. A copy of the poster will be available at www.kuraoncology.com following presentation at the meeting.

On October 16, 2019 PharmaCyte Biotech (OTCQB: PMCB) reported that it has now moved one step closer to submitting an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to request a clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) in the United States (Press release, PharmaCyte Biotech, OCT 16, 2019, View Source [SID1234542301]). The company has successfully completed the first of two manufacturing runs to produce the clinical trial product (Cell-in-a-Box capsules) it needs for its upcoming Phase 2b clinical trial in LAPC.

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Kenneth L. Waggoner, PharmaCyte’s Chief Executive Officer, said that the completion of the first manufacturing run "is a major milestone" towards the completion of the IND.

A few other key events will play themselves out in the weeks to come—all leading to the submission of the IND. The first of which has already begun. PharmaCyte stated this week that the second of two staggered and back-to-back manufacturing runs is already underway, and that the cells from the company’s Master Cell Bank (MCB) are growing well in this second run and will be encapsulated within the next week or two.

A successful second run should be regarded as an even greater milestone and extremely good news for the company and its shareholders as it will represent the conclusion of all necessary manufacturing runs on the way to submitting an IND. cGMP Validation is the company that will take responsibility for PharmaCyte’s clinical trial product coming into the United States and being used in human patients, so two successful manufacturing runs undoubtedly gives cGMP Validation the comfort level it needs to take on this responsibility.

Waggoner said of the second manufacturing run, "Our cGMP expert has recommended that a second manufacturing run be done because, by doing so, we can firmly validate to the FDA that our manufacturing process is both reproducible and robust. Also, additional information on duplicate manufacturing runs may be beneficial to our cGMP expert, who will also serve as our ‘Release Agent’ so that our clinical trial product can be used in human patients in the U.S. in a clinical trial."

Validating that the company’s manufacturing process is both "reproducible and robust" to the FDA is significant today and well into the future for PharmaCyte, according to the company’s CEO.

"Although we have been advised that the IND for a Phase 2 clinical trial doesn’t require information related to successful duplicate manufacturing runs, it’s important for us to take the extra time to complete the second manufacturing run because the manufactured product is not only the ‘centerpiece’ of our planned clinical trial in LAPC, but it will also likely play a similar role in the treatment of other forms of cancer."

The most important event left to complete outside of the final manufacturing run is "release testing" of the clinical trial product. PharmaCyte said that a representative sample of frozen syringes from the first successful manufacturing run, which are filled with 300 Cell-in-a-Box capsules each, are in the process of being shipped to external testing labs for the release testing that is required by the FDA.

The data that those tests will produce are all that remains for the company to complete the IND and then submit it to the FDA.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, watch the company’s documentary video complete with medical animations at: View Source

On October 16, 2019 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized chimeric antigen receptor T cell ("CAR T") platform technology engineered to target patient-specific tumor neoantigens, reported that Jeffrey Eisenberg, Chief Executive Officer of Xenetic, will present at BIO Investor Forum on Wednesday, October 23, 2019 at 2:45 PM PT in San Francisco, CA (Press release, Xenetic Biosciences, OCT 16, 2019, View Source [SID1234542300]).

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As part of his presentation, Mr. Eisenberg will provide a Company overview and discuss the Company’s novel CAR T platform technology, called "XCART," a proximity-based screening platform capable of identifying CAR constructs that can target patient-specific tumor neoantigens, with a demonstrated proof of mechanism in B-cell Non-Hodgkin lymphomas. Xenetic is currently advancing the development program for XCART to confirm the positive preclinical results shown to date and to demonstrate a more attractive safety profile than existing therapies.

In addition to the presentation, management will also be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

A live audio webcast of the presentation will be available on the IR Calendar in the Investors section of Xenetic’s website (www.xeneticbio.com) or by accessing the conference website here. Within three days of the event, a webcast replay will be made available on the Company’s website.

About BIO Investor Forum

Now in its 17th year, the BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables, therapeutic workshops, company presentations, and BIO One-on-One Partnering meetings. For more information, please visit the conference website here.