On May 31, 2019 Vigeo Therapeutics, a clinical-stage biopharmaceutical company developing novel therapeutics to reprogram the tumor immune microenvironment (TIME), reported that preliminary data from its Phase 1 open label trial of VT1021 in patients with advanced solid tumors, will be presented tomorrow, June 1st from 8:00 am to 11:00 am CT at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting being held May 31 – June 4, 2019 in Chicago (Press release, Vigeo Therapeutics, MAY 31, 2019, View Source [SID1234536775]).

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Vigeo is developing therapies that target the TIME via the induction of thrombospondin-1(Tsp-1) by replicating the biological activity of prosaposin (Psap). Tsp-1 is a naturally occurring potent anti-tumorigenic protein that has been shown to reprogram the TIME and block tumor growth and progression.

"We believe that by reprogramming the TIME, we can significantly improve the outcomes of cancer treatments," said Jing Watnick, Ph.D., M.B.A., chief executive officer of Vigeo. "Emerging clinical data continue to suggest that Vigeo’s VT1021, targeting the tumor microenvironment, is safe and well tolerated and has significant potential in hard-to-treat cancers," she added.

VT1021 in Patients with Advanced Solid Tumors
Dose escalation phase of first in human study with VT1021 is ongoing. Through the first six dose levels tested, VT1021 has been shown to be safe and well tolerated with no serious drug related adverse events. Enrollment for expansion cohorts in specific tumor types is expected to be initiated in the third quarter of 2019.

"The mechanism of action of VT1021 is quite unique," said Gregory Berk MD, chief medical officer of Vigeo. "The molecule has demonstrated an excellent safety profile and PK/PD properties, and is well positioned to be an effective single agent therapy, as well as an ideal partner for standard of care therapies in various oncology indications."

Presentation

Title: A Phase 1 Study Evaluating the Safety, Pharmacology, and Preliminary Activity of VT1021 in Patients with Advanced Solid Tumors

Date & Time: Saturday June 1, 2019 from 8:00 am – 11:00 am CT

Abstract Session: Developmental Therapeutics and Tumor Biology

Abstract: TPS3158

Location: Board #144a

Presenter: Michael Cieslewicz, PhD, Vice President for Project Management and Operations, Vigeo

About VT1021
Vigeo’s lead molecule, VT1021, is a small peptide agent derived from Psap, that triggers Tsp-1 production, which reprograms the tumor microenvironment and makes it inhospitable for tumor growth to occur. Pre-clinical results have demonstrated that VT1021, when administered systemically, can cause tumor regression in animal models at both the primary and metastatic sites. VT1021 is currently being evaluated in a Phase 1, open label, multicenter trial that assesses the drug’s safety, tolerability, and preliminary anti-tumor efficacy. The trial’s dose escalation phase was launched in late 2017, and the expansion phase will initiate in 3rd quarter of 2019. An interim readout is expected in the second half of 2020.

On May 31, 2019 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 myeloid checkpoint mechanism, reported that Jaume Pons, Ph.D., President and Chief Executive Officer, will present a company overview at the Jefferies 2019 Healthcare Conference on Wednesday, June 5, 2019 at 4:00 p.m. ET at the Grand Hyatt in New York, NY (Press release, ALX Oncology, MAY 31, 2019, View Source [SID1234536774]).

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On May 31, 2019 Interim results from the EORTC 1333/PEACE phase III trial were reported at ASCO (Free ASCO Whitepaper) 2019 annual meeting in Chicago, USA (Press release, EORTC, MAY 31, 2019, View Source [SID1234536753]). This phase III study evaluates the benefit of combine Radium-233 (Ra-233) to enzalutamide in early asymptomatic or mildly symptomatic. The trial was amended, following the publications of the ERA223, to impose the co-administration bone protecting agents such as zoledronic acid or denosumab. The safety analysis of 146 patients with or without the addition of these agents was shown.

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Ra-223, enzalutamide, and abiraterone are the cornerstone modern treatment of mCRPC. They are usually used sequentially, enzalutamide and abiraterone being used usually in asymptomatic or mildly-symptomatic patients and Ra-223 being prescribed when the patients become more symptomatic from bone metastases. There is a strong rationale for combined RA-223 earlier with abiraterone or enzalutamide. Two trials were thus conducted: the ERA223 trial1 comparing the combination of RA-223 and abiraterone to abiraterone only and the EORTC-GUCG-1333(PEACE 3) trial comparing the combination of enzalutamide and RA-233 to enzalutamide alone. The ERA 223 was unfortunately unblinded in December 2017 following the demonstration of a significant increase of the risk of fracture and death in the RA-223/abiraterone combination arm.

It was recommended not to use this combination. Following these results, the ESMO (Free ESMO Whitepaper) clinical guidelines were adapted to include that mCRPC patients treated with Ra233 must also be given bone-protecting agents. In the EORTC 1333/PEACE phase III trial, it was seen that this guideline was not followed; therefore when the ERA trial was unblinded an amendment was made to enforce the use of bone protecting agents.

Overall, so far, 45% of the patients were treated without bone protecting agents and their median follow-up is 20 months, and 55% were treated with bone protection. The median follow-up of this group is only 13 months. At one year, the there was a 12.4% cumulative risk of fracture with enzalutamide that increased to 37.4% when Ra223 is added to enzalutamide. However, with mandatory continuous administration of bone protecting agents starting at least 6 weeks before the first injection of Ra223, the cumulative risk at one year was almost abolished with 0 fractures on enzalutamide alone and 2.2% with the combination.

"This safety analysis confirms the importance of complying to international recommendations when treating mCRPC patients, and especially about the importance of preventing skeletal complications in patients with bone metastases," says Professor Bertrand Tombal, leading investigator and urologist from Cliniques Universitaires Saint-Luc in Brussels, Belgium.

"These early results strongly suggest that the risk of fractures is very well controlled in both arms when patients receive bone-protecting agents. The study is closely monitored as recruitment and follow-up continues," says Laurence Collette, leading study statistician and Head of the Statistics Department, EORTC Headquarters, Brussels, Belgium

Abstract number: #5007: Decreased fracture rate by mandating bone protecting agents in the EORTC 1333/PEACE III trial comparing enzalutamide and Ra223 versus enzalutamide alone; an interim safety analysis.

Bertrand F. Tombal, Yohann Loriot, Fred Saad, Raymond S. McDermott, Tony Elliott, Alejo Rodriguez Vida, Franco Nole, Beatrice Fournier, Laurence Collette, Silke Gillessen

1Smith, M. et al. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol; 20: 408–19 (2019).

On May 31, 2019 BerGenBio ASA (OSE:BGBIO), reported that it will share its latest updates and data on an investor call on 4 June 2019, during the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting (Press release, BerGenBio, MAY 31, 2019, View Source [SID1234536747]). BerGenBio’s senior management team will be hosting the call at 15:30 CET.

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Dial-in details are:

Standard International Dial-In: +44 (0) 2071 928000
United States Dial-In: 16315107495
Participant Code: 4352428
The call will focus on two peer reviewed abstracts on Phase II clinical data with bemcentinib in the treatment of Non-Small Cell Lung Cancer and Acute Myeloid Leukemia.

On May 31, 2019 Iovance Biotherapeutics, a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it has expanded its relationship with WuXi AppTec’s Advanced Therapies Business Unit (WuXi ATU) (Press release, Iovance Biotherapeutics, MAY 31, 2019, View Source [SID1234536741]). WuXi will increase capacity for Iovance’s innovaTIL-01 and innovaTIL-04 studies, which offer lifileucel and LN-145 for treatment of metastatic melanoma and recurrent, metastatic, or persistent cervical cancer, respectively.

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"We are excited to continue our partnership with WuXi," said Maria Fardis, Ph.D., MBA, President and Chief Executive Officer of Iovance. "Being able to expand our relationship in order to broaden patient access to our treatments is very important to us. WuXi has been a strong partner in developing the Iovance TIL product and we look forward to further expansion of our ongoing relationship."

Felix Hsu, SVP and Global Head of WuXi Advanced Therapies, said, "We are pleased to expand our relationship and manufacturing partnership with Iovance, and look forward to helping to accelerate and expand their clinical trials where possible, so more patients get access to their treatments and the benefits they provide." WuXi manufactures TIL products for Iovance at its Commerce Center 3 facility, a 55,000-square-foot late phase and commercial manufacturing facility for cell therapies. It is one of three facilities in the Philadelphia Navy Yard supporting the development, manufacturing and quality control testing of cell and gene therapies.