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 BioLineRx Ltd. (NASDAQ: BLRX)(TASE: BLRX)(BLRX) , a clinical-stage biopharmaceutical company focused on oncology and immunology, reported it will release its unaudited financial results for the quarter ended March 31, 2018 on Tuesday, May 22, 2018, before the US markets open (Press release, BioLineRx, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349376 [SID1234526682]).

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The Company will host a conference call on Tuesday, May 22, 2018 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until May 25, 2018; please dial +1-877-456-0009 from the U.S. or +972-3-925-5942 internationally.

On May 16, 2018 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that two abstracts will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 1-5, 2018 in Chicago (Press release, Celldex Therapeutics, MAY 16, 2018, View Source [SID1234526701]).

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The schedule for the presentations is as follows:

Abstract TPS6091: "A phase 2, multicenter, open-label study to evaluate the efficacy and safety of CDX-3379 in combination with cetuximab in patients with advanced head and neck squamous cell carcinoma (HNSCC)" (Bauman, et al)

Poster Session: Head and Neck Cancer
Date and Time: Saturday, June 2, 2018, 1:15 – 4:15 p.m. CDT
Location: Hall A
Abstract 3001: "Anti-CD27 agonist antibody varlilumab with nivolumab for colorectal and ovarian cancer: Phase 1/2 clinical trial results" (Sanborn, et al)

Oral Abstract Session: Developmental Therapeutics—Immunotherapy
Date and Time: Saturday, June 2, 2018, 3:12 – 3:24 p.m. CDT
Location: Hall B1

On May 16, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported detailed results from ADVANCE, a Phase 3 trial of ROLONTIS, demonstrating that it was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia (DSN) in all four cycles of the study (Press release, Spectrum Pharmaceuticals, MAY 16, 2018, View Source [SID1234526717]). ROLONTIS is a novel long-acting granulocyte colony-stimulating factor (G-CSF) being studied as a treatment for neutropenia in patients undergoing myelosuppressive cytotoxic chemotherapy. The data released online today in an abstract as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting, also showed similar safety profiles between the treatment groups. The abstract can be find online at View Source

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"These data expand our understanding of the clinical profile of eflapegrastim and help establish it as a possible supportive care treatment option for the multitude of patients undergoing chemotherapy," said Lee Schwartzberg, M.D., FACP, lead investigator, professor of medicine and division chief, hematology oncology, University of Tennessee Health Science Center, and executive director, UT/West Cancer Center. "The study demonstrated strong non-inferiority of ROLONTIS to pegfilgrastim, including a 95 percent confidence interval of the difference in the DSN below zero in the first cycle of treatment, helping further define the clinical profile of this novel treatment."

In the ROLONTIS Phase 3 ADVANCE study (n=406), mean DSN±SD was 0.19±0.478 days for ROLONTIS and 0.34±0.668 days for pegfilgrastim, demonstrating non-inferiority with 95 percent confidence interval (CI) of ∆DSN: [-0.260, -0.035]; p<0.0001) in Cycle 1. The non-inferiority of ROLONTIS for DSN was maintained across all four treatment cycles. There were no statistically significant differences in all secondary endpoints including time to absolute neutrophil count (ANC) recovery, depth of ANC nadir and incidence of febrile neutropenia in Cycle 1. The most common adverse events, which were observed in less than 10 percent of patients, were similar across both treatment groups and were mainly hematologic, including neutropenia, lymphopenia, anemia and leukopenia.

"The ADVANCE study is a cornerstone in the ROLONTIS clinical program, which includes two Phase 3 clinical studies involving approximately 800 patients," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "We are pleased that ROLONTIS has shown strong non-inferiority data and comparable safety profile to the current standard of care. ROLONTIS has the potential to be the first novel drug in this multibillion dollar market in more than 15 years."

Spectrum is currently conducting a second Phase 3 ROLONTIS trial, RECOVER, a multi-center study being conducted in the USA, Europe and Asia. The study is fully enrolled and expected to complete later this year. The company plans to conduct a pre-BLA meeting with the FDA in preparation for a planned BLA filing in the fourth quarter of 2018.

About ADVANCE

The ADVANCE study is a Phase 3 multicenter, randomized, active-controlled trial that enrolled 406 early-stage breast cancer patients, who received docetaxel and cyclophosphamide chemotherapy every 21 days for four cycles. Patients were randomized 1:1 to treatment with ROLONTIS or pegfilgrastim (eflapegrastim n=196; pegfilgrastim n=210). The primary study endpoint was the DSN (absolute neutrophil counts [ANC] <0.5×109/L) in Cycle 1 of chemotherapy, based on central laboratory assessment of ANC over the 21 day cycle. Secondary endpoints included, the DSN in Cycles 2, 3, and 4, time to ANC recovery, depth of ANC nadir and incidence of febrile neutropenia at Cycle 1. Patients with stage I to stage IIIA breast cancer were treated on Day 1 of each of the four cycles with adjuvant/neo-adjuvant docetaxel and cyclophosphamide. On Day 2 of each cycle, patients received a single subcutaneous dose of either eflapegrastim 13.2 mg/0.6 mL (equivalent to 3.6 mg G-CSF) or pegfilgrastim (6 mg) in a 1:1 ratio.

On May 16, 2018 BioLineRx Ltd. (NASDAQ: BLRX)(TASE: BLRX)(BLRX) , a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that the European Patent Office (EPO) has issued a Decision to Grant a patent claiming the use of BL-8040 with cytarabine, a chemotherapeutic agent, for the treatment of acute myeloid leukemia (AML) (Press release, BioLineRx, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349350 [SID1234526683]).

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This patent will be valid through March 2034, with the option of up to five years’ patent term extension. Member patents were also granted in Japan and Hong Kong. Additional corresponding patent applications are pending in China (a Notice of Acceptance was received), Israel (a Notice of Acceptance was received), the United States, India, Korea, Mexico, Brazil, Canada and Australia.

"The long-term patent exclusivity we have received from the European Patent Office for BL-8040 in combination with cytarabine provides us with significant additional patent protection in AML, one of BL-8040’s key indications," said Philip A. Serlin, Chief Executive Officer of BioLineRx. "In this regard, we are moving forward in full force with two ongoing trials in the AML space – a Phase 2b in consolidation AML and a Phase 1b/2 in maintenance AML, in addition to the continued follow-up on encouraging overall survival results shown in our recently completed relapsed/refractory AML study."

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.