On May 16, 2018 Genosco, a clinical-stage biotechnology company focused in immunology and oncology, reported that the abstract from a Phase 1/2 study evaluating YH25448 (GNS-1480) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) is now available on the website of the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. YH25448 (GNS-1480), Genosco’s 3rd-generation EGFR-TKI candidate partnered for clinical development and commercialization with Yuhan Corporation, is an oral, potent, irreversible EGFR-TKI that is highly selective for activating (EGFRm) and T790M resistance mutations.

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"We are encouraged by the safety and efficacy results shown in these data and look forward to the presentation of the full data set which will inform the future clinical trials," said Jong Sung (John) Koh, Ph.D., Genosco CEO.

Results from an open-label, multi-center Phase 1/2 study of YH25448 (GNS-1480) for patients with advanced NSCLC with or without CNS metastases will be presented in a poster session (Abstract 9033) by Byoung Chul Cho, M.D., Ph.D., Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea, at ASCO (Free ASCO Whitepaper) in Chicago. The poster (#356) is titled YH25448, a 3rd-generation EGFR-TKI, in patients with EGFR-TKI-resistant NSCLC: Phase I/II study results and will be presented in the Lung Cancer—Non-Small Cell Metastatic session on Sunday, June 3, 2018, 8:00 AM – 11:30 AM CT.

A total of 105 patients with EGFRm advanced NSCLC with acquired resistance to EGFR-TKIs with or without brain metastasis were enrolled in a Phase 1/2 study with dose-escalation and expansion cohorts.

Updated data will be presented at ASCO (Free ASCO Whitepaper).

About YH25448
YH25448 (GNS-1480) is an oral, potent, highly mutant-selective and irreversible, investigational 3rd-generation EGFR-TKI that penetrates the blood-brain barrier (BBB). It targets the activating EGFR mutations Del19 and L858R, as well as the T790M mutation, while sparing wild type. EGFR mutations are present in approximately 10-15% of NSCLCs. YH25448 (GNS-1480) is being evaluated in advanced NSCLC as both first- and second-line treatments.

On May 16, 2018 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported publication of an abstract on pelareorep for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting (Press release, Oncolytics Biotech, MAY 16, 2018, View Source [SID1234527101]). The meeting will take place from June 1 – 5, 2018 at McCormick Place, Chicago, IL.

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The abstract, authored by Wilkinson et al., "Pelareorep to promote the expression of a IFN-gamma-related gene signature that predicts response to checkpoint blockade therapy", outlines results of a study assessing whether pelareorep promotes a predictive inflamed tumor phenotype that correlates with a response to immunotherapy in breast cancer (BC), colorectal cancer (CRC), hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC). The results suggest that all cell lines are susceptible to pelareorep’s induced cytopathic effect. In particular, BC and HCC cells lines had a significantly inflamed phenotype and also upregulated key chemokines known to promote response to immunotherapy.

"These results clearly demonstrate that viral priming in both BC and HCC tumors can activate interferon gamma-related gene expression which both upregulates checkpoint ligands on tumor cells and promotes activation and infiltration of lymphocytes into the tumor," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "They also support the hypothesis that the virus is engaging a dramatic immune response against the tumor in our recent mBC trial but also suggests that the virus may very well act as a backbone for checkpoint blockage by promoting an inflamed phenotype in the tumor microenvironment."

The complete Abstract can be found online at View Source Full details from the poster presentation will be announced when it is being presented on Monday, June 4 from 8:00 – 11:30 in Hall A, poster board #303.

About REOLYSIN/Pelareorep

REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

On May 16, 2018 CytomX Therapeutics, Inc. (Nasdaq:CTMX) a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported that preliminary clinical results from PROCLAIM-072, an ongoing Phase 1/2 trial evaluating CX-072, a Probody therapeutic targeting PD-L1, will be presented at the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, CytomX Therapeutics, MAY 16, 2018, View Source [SID1234527068]). The conference will take place from June 1-5 in Chicago, Illinois.

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Two posters will detail initial results from two ongoing dose escalation arms of the PROCLAIM-CX-072 trial as monotherapy and in combination with Yervoy (ipilimumab) in patients with advanced unresectable solid tumors.

"Our goal at CytomX is to reinvent therapeutic antibodies for the treatment of cancer and these first-in-human data represent a key milestone for the Probody platform," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "We look forward to expounding on our initial findings, published today in abstract form, at ASCO (Free ASCO Whitepaper). The preliminary data in these abstracts are encouraging as we are observing initial signs of antitumor activity for both CX-072 monotherapy and the ipilimumab combination, in this difficult-to-treat, late-stage patient population for whom approved PD-agents are not available. Furthermore, these data suggest that CX-072 is well tolerated and shows an encouraging, emerging safety profile as a monotherapy and in combination with ipilimumab. Taken together, our preliminary findings are consistent with the Probody hypothesis and align with our vision of transforming lives with safer, more effective therapies."

CytomX’s ASCO (Free ASCO Whitepaper) poster presentations will include longer follow-up periods in both the monotherapy and combination arms, as well as data from additional patients treated in combination with ipilimumab and will reflect a data cutoff approximately five months after the abstract data cutoff. Additional data from the PROCLAIM-072 trial is expected during the second half of 2018 and in 2019.

Abstract 3071/Poster #285 – Preliminary Results of the First-In-Human, Dose-Finding PROCLAIM-072 Trial of the PD-L1 Probody Therapeutic CX-072 as Monotherapy in Patients with Advanced Solid Tumors

Presenter: Karen A. Autio, M.D., MSc., Memorial Sloan Kettering Cancer Center
Session: Developmental Therapeutics—Immunotherapy
Date/Time: Monday, June 4, 8:00 – 11:30 a.m.
Location: Hall A

Abstract 3072/Poster #286 – Preliminary Interim Results of the First-In-Human, Dose-Finding PROCLAIM-072 Trial of the PD-L1 Probody Therapeutic CX-072 in Combination with Ipilimumab in Patients with Advanced Solid Tumors

Presenter: Rachel E. Sanborn, M.D., Earle A. Chiles Research Institute, Providence Cancer Center
Session: Developmental Therapeutics—Immunotherapy
Date/Time: Monday, June 4, 8:00 – 11:30 a.m.
Location: Hall A

Abstract Book – Preliminary Single-Dose Clinical Pharmacokinetics of an Anti–PD-L1 Probody Therapeutic (Pb-Tx) in Cancer Patients

Pharmacokinetic data published in the conference abstract book suggests that CX-072 is behaving as designed in circulation and that CX-072 circulates predominately in the intact, masked form with low or no binding to the target in the periphery.

CytomX’s posters will be available online under the Events and Presentations section of the CytomX website at the time of presentation at www.CytomX.com.

CytomX will be hosting a conference call and webcast on Monday, June 4, 2018 to discuss the ASCO (Free ASCO Whitepaper) poster presentations with specific event details to be announced closer to the start of the conference.

About PROCLAIM

PROCLAIM (Probody Clinical Assessment In Man) is an international umbrella program designed to evaluate CytomX Probody therapeutics. The first module is the PROCLAIM-072 clinical program, an open-label, dose-finding Phase 1/2 trial evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib) in patients with metastatic or locally advanced unresectable solid tumors or lymphomas. CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Tolerability: Demonstrate that CX-072 is well tolerated in patients, and potentially improves safety, particularly in the combination setting.

Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.

Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical models.

On May 16, 2018 NanOlogy LLC, a clinical-stage pharmaceutical development company, reported it will present data from preclinical studies of inhaled NanoPac (submicron particle paclitaxel) showing prolonged retention of drug in lung tissue and significant tumor regression without adverse drug-related observations in an orthotopic animal model of non-small cell lung cancer (NSCLC) (Press release, NanOlogy, MAY 16, 2018, View Source [SID1234526907]).

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The data will be presented in an abstract entitled "NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model" during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Sunday, June 3rd, from 8:00 AM to 11:30 AM in Hall A of McCormick Place in Chicago.

An initial preclinical pharmacokinetic (PK) study examined the retention of NanoPac in rat lung tissue following a single inhalation via a nose-only exposure chamber. Data showed measurable amounts of drug in the lung at the end of the 14-day study with examined tissue being microscopically indistinguishable from normal lung tissue.

A preclinical study followed to examine the therapeutic effect of inhaled NanoPac using an orthotopic model of NSCLC. Histologic analysis revealed NanoPac achieved a significant decrease in primitive tumor cell population as well as significant tumor regression.

Gere diZerega, MD, VP of Medical Affairs, said, "In our initial PK study, inhaled NanoPac resulted in longer lung retention of drug at a higher concentration compared to systemically administered paclitaxel. The evidence seen in our preclinical PK and efficacy studies has given us the confidence to move forward with IND-enabling studies in preparation for clinical trials."

Lung cancer is by far the leading cause of cancer death according to the American Cancer Society with more than 154,000 deaths expected this year. More people die of lung cancer every year than breast, prostate, and colon cancers combined.

The preclinical lung cancer studies are in addition to an extensive clinical development program underway by NanOlogy. Local administration of NanoPac is also being evaluated in Phase 2 clinical trials for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. A clinical trial of NanoDoce (submicron particle docetaxel sterile suspension) is planned to begin in September for bladder cancer.

NanOlogy is also progressing a clinical trial of a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides NME-like advantages without the risk and timeline associated with new molecular entity drug development.

On May 16, 2018 Peloton Therapeutics, Inc., reported that it will present first-in-human Phase 1 clinical data for its lead investigational oncology agent and hypoxia-inducible factor-2α (HIF-2α) inhibitor, PT2977, at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place June 1-5, 2018 in Chicago (Press release, Peloton Therapeutics, MAY 16, 2018, View Source [SID1234526831]). PT2977 is a selective, orally available HIF-2α antagonist with improved potency and a superior pharmacokinetics profile relative to Peloton’s first-generation agent PT2385, which had demonstrated clinical activity in patients with clear cell renal cell carcinoma (ccRCC) as reported in a study published in the Journal of Clinical Oncology (JCO).

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The ASCO (Free ASCO Whitepaper) abstract (#2508) titled "A First-in-Human Phase 1 Dose-Escalation Trial of the Oral HIF-2α Inhibitor PT2977 in Patients with Advanced Solid Tumors," was accepted for an oral presentation to be delivered on Friday, June 1, 2018 at 5:09 p.m., Eastern time. In this Phase 1 dose-escalation trial, patients with locally advanced or metastatic solid tumors, who had received at least one prior systemic therapy, were treated with PT2977 once daily. The primary objective of the study was to determine the recommended Phase 2 dose and evaluate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of PT2977. PT2977 had a favorable safety profile and demonstrated early evidence of clinical activity.

"HIF-2α is a transcription factor that has been implicated in cancer initiation, progression, and metastasis especially in renal cell carcinoma. We are excited about the availability of a once-daily oral, potent, and selective inhibitor of HIF-2α," said Kyriakos P. Papadopoulos Co-Director of Clinical Research, START Center for Cancer Care (San Antonio, TX) and presenter of the Phase 1 data at ASCO (Free ASCO Whitepaper). "PT2977 had a favorable safety, pharmacokinetics, and pharmacodynamics profile."

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Patients were treated with PT2977 in doses ranging from 20 to 160 milligrams (mg). Exposure increased with dose along with dose-dependent reductions in erythropoietin levels (a PD marker). No treatment-related, dose-limiting toxicities were observed. Anemia (13 percent) was the most common Grade 3 adverse event. Early evidence of clinical antitumor activity including radiographic response and durable disease control were observed.

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"We are encouraged by the results from this Phase 1 dose-escalation study of our superior HIF-2α antagonist PT2977, which support further clinical development and evaluation of this novel agent," said John A. Josey, Ph.D., Peloton’s Chief Executive Officer. "Based on the favorable PK and PD findings from this study, a dose of 120 mg has been selected for further clinical development and we have recently recruited 50 patients into an expansion arm to evaluate PT2977 in patients with advanced renal cell carcinoma, a malignancy with poor prognosis where effective tolerable therapies continue to be in desperate need."

Further information on the clinical trial of PT2977 can be found on clinicaltrials.gov (Study identifier: NCT02974738).

About PT2977

Peloton has succeeded in creating a series of orally-available small molecules that bind to HIF-2α and inhibit its transcription of disease-promoting genes. PT2977 is a once-daily, orally-active agent that blocks hypoxia-inducible factor-2α (HIF-2α). It is a structurally-related compound designed to be more potent with less pharmacokinetics variability compared to PT2385. PT2977 has demonstrated anti-tumor activity with a favorable safety profile in an early-stage clinical study in patients with solid tumors. Given its superior pharmacokinetics profile, PT2977 is the lead agent being developed in oncology by Peloton. Peloton is currently evaluating PT2977 in an international Phase 2 trial in von Hippel-Lindau (VHL) disease-associated RCC and a Phase 1 clinical trial for the treatment of RCC.