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

On June 2, 2020 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel therapeutics for highly aggressive cancers, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate its third therapeutic candidate, CFI-402411, an oral, first-in-class inhibitor of hematopoietic progenitor kinase 1 (HPK1) in patients with solid tumors as a monotherapy or in combination with PD1 pathway blockade (Press release, Treadwell Therapeutics, JUN 2, 2020, View Source [SID1234560766]). In addition, Treadwell also announced the receipt of a No Objection Letter (NOL) to a Clinical Trial Application (CTA) for CFI-402411 in solid tumors from Health Canada.

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"HPK1 represents a novel, orally targettable node of therapeutic intervention in the immune-oncology space. As a pleiotropic negative regulator of immune cell activation, inhibiting HPK1 may result in more potent anti-tumor responses in the treatment of cancer, simultaneously acting on multiple immune cell subsets to prevent tumor evasion. Therefore, we are excited to have received the FDA’s IND clearance to begin clinical trials for our first-in-class, highly-potent, oral HPK1 inhibitor," said Dr. Shane Burgess, Treadwell Co-Chief Executive Officer. "Our inhibitor program is the culmination of over two decades of pioneering work by Treadwell Founders and collaborators in HPK1 biology and immune regulation. Preclinical studies have demonstrated CFI-402411’s promise as a potential monotherapy and in combination with existing checkpoint inhibitors across both solid and hematological cancers, and we look forward to our Phase 1/2 trial later this year," added Dr. Mark Bray, Treadwell Chief Scientific Officer and Co-Founder.

Under this IND, Treadwell intends to initiate a Phase 1/2 clinical trial of CFI-402411, an oral immunomodulatory kinase inhibitor with activity toward HPK1, in the third quarter of 2020. This clinical trial is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CFI-402411, as well as to determine optimal dosing as a monotherapy and in combination with PD1 pathway inhibitors. Start-up activities are currently underway including clinical study site preparation and subject screening.

CFI-402411 is a highly potent inhibitor of HPK1, which in preclinical studies has been shown to have an immune-activing effect including the alleviation of inhibition of T cell receptors (TCR), disruption of abnormal cytokine expression, alteration of the tumor immunosuppressive environment through effector cells (i.e. Regulatory T cells or Treg), and cytotoxic effects on specific subtypes of AML mouse models.