On May 31, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the company plans to participate in the following conferences in June (Press release, Iovance Biotherapeutics, MAY 31, 2019, View Source;p=RssLanding&cat=news&id=2400226 [SID1234536726]):

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Showcasing Greater Philadelphia’s Life Sciences & Innovation Assets at BIO 2019 in Philadelphia, June 3, 2019
Location: Comcast Technology Center
Date/Time: Monday, June 3, 2019, from 3:30 p.m. – 6:30 p.m. EDT
Jefferies 2019 Healthcare Conference in New York, June 4-7, 2019
Corporate overview
Location: Grand Hyatt New York
Date/Time: Wednesday, June 5, at 11:30 a.m. EDT
A live and archived webcast of the presentation will be available by visiting the Investors section of the Iovance Biotherapeutics website at View Source

Session: Best of ASCO (Free ASCO Whitepaper) Panel
Location: Grand Hyatt New York
Date/Time: Thursday, June 6, from 12:15 p.m. – 1:15 p.m. EDT
24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Amsterdam, June 13-16, 2019
Poster: Iovance Peripheral Blood Lymphocytes (PBL): A Potential Cell Therapy Strategy For The Treatment Of Chronic Lymphocytic Leukemia
Authors: Lavakumar Karyampudi et al.
Session: Gene therapy, cellular immunotherapy and vaccination – Biology & Translational Research
Abstract Number: PF447
Location: RAI Amsterdam
Date/Time: Friday, June 14, from 5:30 p.m. – 7:00 p.m. CEST

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 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported updated data from studies of TIL therapy LN-145 in patients with advanced cervical cancer and TIL therapy lifileucel in advanced melanoma (Press release, Iovance Biotherapeutics, MAY 31, 2019, View Source;p=RssLanding&cat=news&id=2400232 [SID1234536727]). At 7.4-month median follow-up in the ongoing study of LN-145 in advanced cervical cancer, an 11 percent complete response rate (CR) was seen. Furthermore, the median duration of response (DOR) had not been reached. At 8.8-month median follow-up in the ongoing study of lifileucel in advanced melanoma, median duration of response had not been reached. Updated data from the ongoing innovaTIL-04 and innovaTIL-01 studies will be presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

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"As we continue to observe the effects of Iovance TIL therapy, we have not yet reached a median DOR for our TIL product in either our melanoma or cervical trial," commented Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "We are also extremely encouraged to see CRs in our cervical cancer study as the study continues over time, demonstrating the potential for deep responses after one treatment. The same phenomenon was noted in our melanoma trial as well with two CRs now being reported at ASCO (Free ASCO Whitepaper) in a heavily pre-treated melanoma patient population."

"The duration of response of current second line treatments for advanced cervical cancer are in the range of three to five months and options are limited," commented Emese Zsiros, M.D., Ph.D., faculty researcher at the Department of Gynecologic Oncology of the Roswell Park Comprehensive Cancer Center and Iovance LN-145 study investigator. "The observation in the study of LN-145 that median DOR has not yet been reached at a median of 7.4 months following treatment provides evidence that this therapy could provide a clinically meaningful improvement over currently available options for patients with advanced cervical cancer."

As of May 14, 2019, data from the innovaTIL-04 study in 27 patients with recurrent, metastatic or persistent cervical cancer demonstrated an objective response rate of 44 percent (3 complete responses and 9 partial responses) and a disease control rate of 85 percent. At 7.4-month median follow-up, 10 patients maintained a response and the median DOR had not been reached (range 2.6+ to 9.2+ months). The mean patient age was 45 years and study participants had experienced a mean of 2.4 prior lines of therapy. Study data will be presented on Saturday, June 1 (Abstract #2538, Poster 182).

As of May 8, 2019, results from Cohort 2 in the ongoing innovaTIL-01 study demonstrated an ORR of 38 percent (2 complete responses and 23 partial responses) in 66 consecutively dosed post-PD-1 patients with Stage IIIC/IV unresectable melanoma. In this study, patients had experienced a mean of 3.3 lines of prior therapy including anti-PD1 blocking antibody, and the patients had a high baseline tumor burden. The disease control rate was 80 percent. At 8.8-month median follow-up, median DOR had not been reached (range 1.4+ to 19.8+ months). Study data will be presented on Saturday, June 1 (Abstract #2518, Poster 162).

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 the cancer vaccine company Ultimovacs ASA reported that it has raised NOK 370 million in an oversubscribed share issue, and will be listed on the Oslo Stock Exchange on Monday, June 3, 2019 (Press release, Ultimovacs, MAY 31, 2019, View Source [SID1234536989]).

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Investors showed great interest in Ultimovac’s listing on the Oslo Stock Exchange and the issue was oversubscribed. Large Norwegian and international institutional investors have entered the company as new shareholders. Among the new, large shareholders are also specialized health funds. Ultimovacs experienced a broad interest in subscription of shares and the company will have about 1,500 shareholders on listing.

"It is very gratifying for Norwegian health care and for Ultimovacs that national and international investors show the company this confidence. In today’s uncertain market, it is extra pleasant with such great interest, both from international investors and small savers. I look forward to following the company further, "says Jonas Einarsson, chairman of Ultimovacs and CEO of Radforsk.

The funds Ultimovacs collect at the IPO will finance the company’s development plan for the universal cancer vaccine UV1. The main project is a major clinical study to document the treatment effect of the vaccine. In this study, UV1 will be combined with other immunotherapy in patients with melanoma at about 30 hospitals in Norway, Europe, the United States and possibly Australia.

Ultimovacs has already conducted three minor clinical trials of the vaccine at the Radium Hospital in patients with lung cancer, prostate cancer and mole cancer.

«The cancer vaccine has shown promising clinical signals in the studies we have conducted at Radiumhospitalet. Based on this, we have developed a development plan to document that our vaccine has an effect on cancer patients. I am very pleased that we have now completed a successful stock exchange listing. This means that the practical conditions are now in place to implement our development plan, "says Øyvind Kongstun Arnesen, CEO of Ultimovacs.