On June 2, 2020 Northwest Biotherapeutics (OTCQB: NWBO)("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported progress toward data lock for the Phase 3 trial of DCVax-L for Glioblastoma brain cancer (Press release, Northwest Biotherapeutics, JUN 2, 2020, View Source [SID1234560771]).

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The Company reported that the final data collection process has been progressing steadily despite ongoing difficulties due to coronavirus-related limitations on operations and restrictions at trial sites. The coronavirus-related difficulties have impacted most aspects of the process, including review processes at sites and even logistical matters such as the shipping of tissue slides.

The completion process includes final data collection, identification and resolution of queries, data checking and confirmation, and site sign-offs. All of these functions are performed by independent service firms (not by the Company), with oversight by the Company. The service firms have completed the final monitoring visits to the trial sites (including a number of them virtually). The service firms are in the process of resolving the queries from those final monitoring visits (each monitoring visit can generate new queries), and the firms have completed most of the data confirmations. After the query resolution and data confirmation are finished for a trial site, the site’s investigator needs to sign off on the data before it can be locked.

In light of the current status of the completion process, and the experience over recent months, the Company currently anticipates that the process may be completed by about mid-June or shortly thereafter – i.e., within a couple of weeks after the Company’s anticipated schedule at the time of the Annual Meeting in April.

If some of the information that currently remains outstanding cannot be obtained by mid-June, the Company may consider proceeding with a "soft lock" of the data at that time, if arrangements can be made for the rest of the data to be included when it is obtained later. The Company plans to obtain advice from its regulatory counsel, its Scientific Advisory Board and the Steering Committee of the trial in regard to such possibilities.

It is too early to determine what effect this update of the anticipated timing of data lock may have on the anticipated timing of the public announcement of data. There may be a similar update to the timing of the announcement of the data as to the timing of the data lock.

The steps that will take place after data lock remain the same as were outlined at the Company’s Annual Meeting. Initially following data lock, only the statisticians will be unblinded (i.e., will be given access to the database containing all of the raw data from the trial). The statisticians will need several weeks to carry out all the relevant analyses and calculations. Then the statisticians will deliver the results to the Company, and that is when the Company will become unblinded. The Company will then discuss the data with key advisors, such as its Scientific Advisory Board and the Steering Committee of the trial, and will address any comments or questions from its advisors as part of preparing the data for public announcement.

The timing of such processes cannot be predicted with precision even in normal times, and especially not in the current unprecedented circumstances. However, the Company and the independent service firms that are carrying out these processes are committed to proceeding quickly. If the anticipated timing becomes significantly different than currently anticipated, the Company plans to provide additional update bulletins.

On June 2, 2020 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported the preliminary results of a Phase 1 clinical study (NCT03545971) of the recombinant fully human anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody (IBI310) in the form of online publication at the 56th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Innovent Biologics, JUN 2, 2020, View Source [SID1234560770]). (Online publication, Abstract # 302489)

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The NCT03545971 study is an open-label study and was consisted of two parts, namely Phase 1a study and Phase 1b study, which were designed to evaluate the tolerability, safety and anti-tumor activity of IBI310 and its combination with TYVYT (sintilimab injection) in the treatment of subjects with advanced malignant tumors, respectively. In the Phase 1a study, subjects with advanced solid tumors who have progressed from standard treatment were dosed with IBI310; while in the Phase 1b study, subjects with advanced melanoma were treated with IBI310 in combination with TYVYT (sintilimab injection). The main clinical data includes:

As of November 12, 2019, a total of 10 subjects were enrolled in Phase 1a study and 17 subjects were enrolled in Phase 1b study. There were no dose limiting toxicities (DLTs) in both phases, and the dose expansion in Phase 1b is currently ongoing. The most common treatment related adverse event (TRAE) was pruritus in both Phase 1a and Phase 1b studies, and no Grade 3 or higher adverse events occurred in Phase 1a and only one subject in Phase 1b experienced a grade 3 or higher TRAE (AST increased). There were no TEAE caused death.
In Phase 1b study, three subjects in the 3mg combination dose group had at least one tumor assessment and one of these subjects had objective response.
Professor Jun Guo, Vice President of Peking University Cancer Hospital and Director of the Department of Melanoma Medicine of Renal Cancer, said: "In recent years, several breakthroughs achieved in melanoma have brought more treatment methods for patients with melanoma. The 1-year survival rate of patients with advanced melanoma has been prolonged from 25% ~ 35% in the 1990s to 75% by today, and immunotherapy is one of the most critical breakthroughs for this improvement. The results of Checkmate-067 study showed that double immunotherapy for first-line treatment of advanced melanoma can significantly improve the prognosis compared to single immunotherapy. The preliminary results of NCT03545971 study show that IBI310 have acceptable safety profile and preliminary efficacy. We hope to see more positive data in the next studies."

Dr. Hui Zhou, Vice President of Medical Science and Strategic Oncology of Innovent, said: "CTLA-4 is an important immunosuppressive receptor, and there are a number of CTLA-4 related clinical studies on-going both in domestic and abroad, while currently only one has been approved. IBI310 is the CTLA-4 monoclonal antibody of fastest progress in China. The preliminary clinical results of IBI310 in combination with sintilimab show acceptable safety and anti-tumor activity, suggesting a synergistic enhancement effect. Currently, Phase 2/3 clinical studies of IBI310 in combination with sintilimab are on-going in multi tumors. We hope to evaluate the clinical results of IBI310 in combination with sintilimab and bring this therapy to more patients in need as soon as possible. "

About IBI310 (Anti-CTLA-4 Monoclonal Antibody)

IBI310 is a fully human monoclonal antibody blocking Cytotoxic T Lymphocyte-associated Antigen-4 (CTLA-4). CTLA-4 inhibits the immune escape of tumor cells and improves the body’s own immune response against tumor cells by up-regulating the anti-tumor immune response mediated by human effector T cells and weakening the immunosuppressive activity mediated by regulatory T cells, so as to achieve the purpose of treating a variety of tumors.

On June 2, 2020 Pliant Therapeutics, Inc., a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis, reported the pricing of its initial public offering of 9,000,000 shares of its common stock at a public offering price of $16.00 per share (Press release, Pliant Therapeutics, JUN 2, 2020, View Source [SID1234560769]). All of the shares of common stock are being offered by Pliant. In addition, Pliant has granted the underwriters a 30-day option to purchase up to an additional 1,350,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Select Market on June 3, 2020 under the ticker symbol "PLRX." The gross proceeds to Pliant from the initial public offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $144.0 million. The initial public offering is expected to close on June 5, 2020, subject to satisfaction of customary closing conditions.

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Citigroup, Cowen and Piper Sandler are acting as joint book-running managers for the initial public offering. Needham & Company is acting as lead manager.

In addition to the shares being sold in the initial public offering, Pliant also announced today that it has agreed to sell an additional 625,000 shares of its common stock in a concurrent private placement at $16.00 per share to one of its existing investors, Novartis Institutes for BioMedical Research, Inc. The sale of these shares of common stock will not be registered under the Securities Act of 1933, as amended, and will be subject to a 180-day lock-up agreement. The concurrent private placement is also scheduled to close on June 5, 2020, subject to the satisfaction of customary closing conditions. The closing of Pliant’s initial public offering is not conditioned upon the closing of the concurrent private placement, but the closing of the concurrent private placement is conditioned upon the closing of the initial public offering.

A registration statement on Form S-1 relating to shares of common stock sold in the initial public offering has been filed with the Securities and Exchange Commission and became effective on June 2, 2020. The initial public offering is made only by means of a prospectus, copies of which may be obtained, when available, from: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; and Piper Sandler & Co., by mail at 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attn: Prospectus Department, by telephone at (800) 747-3924, or by e-mail at [email protected].

On June 2, 2020 Nordic Nanovector ASA (OSE: NANO) reported that members of its management team will present at Jefferies Virtual Healthcare Conference, taking place 2-4 June 2020 (Press release, Nordic Nanovector, JUN 2, 2020, View Source [SID1234560768]).

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Nordic Nanovector will also present at ABG Sundal Collier Virtual Oncology Seminar 10 June 2020.

Presentations details are as follows:

Jefferies Virtual Healthcare Conference
Date: Tuesday, 2 June 2020
Time: 16:30 CET

ABG Sundal Collier Virtual Oncology Seminar
Date: Wednesday, 10 June 2020
Time: 10:25 CET

The company presentation will be available on Nordic Nanovector’s Investors and Media page at the same time.

On June 2, 2020 Memgen, a private biotechnology company developing novel treatments for cancer and COVID-19, reported an abstract and upcoming poster presentation at the 2020 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II on June 22-24, 2020 (Press release, Memgen, JUN 2, 2020, View Source [SID1234560767]).

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The presentation summarizes preclinical research of Memgen’s cancer immunotherapy MEM-288, as both a single agent and combined with immune checkpoint inhibitors, in multiple tumor models. This research showed that a combination of MEM-288 with checkpoint inhibitors could reverse tumor resistance to checkpoint inhibitors alone, resulting in systemic tumor regression and 100% survival of animals. The research also showed tumor-selective lysis plus generation of systemic antitumor immunity leading to anti-metastatic activity for both MEM-288 as a single agent and combined with checkpoint inhibitors. This work was led by Amer Beg, PhD and his team at Moffitt Cancer Center. Beg has worked with Scott Antonia, MD, PhD, Director of Duke Cancer Institute Center for Cancer Immunotherapy and Mark Cantwell, PhD, Chief Scientific Officer of Memgen, to discover and develop MEM-288. Based on this and other supporting research, Memgen plans a Phase 1 clinical study of MEM-288 to treat patients with advanced lung cancer and other cancers later this year.

Details of the abstract and poster presentation are as follows:

Title: Development of MEM-288, a dual-transgene armed and conditionally replication-enhanced oncolytic adenovirus with potent systemic antitumor immunity (Abstract #4578)
Session Category: Immunology
Session Title: Vaccines
Date and Time: June 22, 2020 (9:00 a.m. – 6:00 p.m. EDT)
Abstract: View Source!/9045/presentation/7619