On November 6, 2019 Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, reported that it is commencing an underwritten public offering of $90.0 million of shares of its common stock (Press release, Arvinas, NOV 6, 2019, View Source [SID1234550439]). In addition, Arvinas intends to grant the underwriters an option for a period of 30 days to purchase up to an additional $13.5 million of shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares are to be offered by Arvinas.

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Goldman Sachs & Co. LLC, Citigroup and Piper Jaffray & Co. are acting as joint book-running managers for the offering.

A shelf registration statement on Form S-3 (File No. 333-234035) relating to the shares of common stock to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") and was declared effective on October 10, 2019. The offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the offering is being filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained, when available, by contacting: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-906-9316 or by emailing [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 800-831-9146; or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at 800-747-3924 or by email at [email protected].

This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 6, 2019 ArQule, Inc. (Nasdaq: ARQL) reported the publication of the abstract highlighting data, as of July 19, 2019, from the phase 1 trial of ARQ 531, the company’s potent and reversible dual inhibitor of both wild type and C481-mutant Bruton’s tyrosine kinase (BTK), in patients with relapsed or refractory B-cell malignancies on the American Society of Hematology (ASH) (Free ASH Whitepaper) website (link here) (Press release, ArQule, NOV 6, 2019, View Source [SID1234550438]). A poster containing the final data set from the phase 1 portion of this study will be presented at the ASH (Free ASH Whitepaper) annual meeting in Orlando, FL on December 9,2019 and will detail additional data with respect to ARQ 531’s safety profile, clinical activity and durability across multiple refractory B-Cell malignancies, including C481-mutant chronic lymphocytic leukemia (CLL).

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Dr. Brian Schwartz, Chief Medical Officer of ArQule, commented, "ARQ 531 continues to demonstrate profound effects at well-tolerated doses in a highly refractory patient population. Data on clinical activity, in CLL in particular, has improved further since our last presentation at EHA (Free EHA Whitepaper) in June, and I’m looking forward to presenting important durability data for these patients at ASH (Free ASH Whitepaper). In addition, the unique kinase inhibition profile and favorable molecular properties of ARQ 531 are proving to be valuable in other, hard-to-treat B-cell malignancies, such as Richter’s Transformation."

The reported data are from the ongoing phase 1, open label, single arm dose escalation 3+3 study and include data from the first eight cohorts (n=40) at dose levels of 5, 10, 15, 20, 30, 45, 65 and 75 mg once a day in patients with relapsed or refractory (R/R) CLL, small lymphocytic leukemia (SLL), Richter’s Transformation and other B-cell Non-Hodgkin lymphomas.

Key findings of the abstract include:

ARQ 531 continues to be well-tolerated through 65 mg QD and has a manageable safety profile in multiple B-cell malignancies
Pharmacokinetic (PK) data show that patients receiving 65 mg QD of ARQ 531 exhibited steady-state mean Cmin of above 1 µM, with complete pBTK inhibition
Robust, dose-dependent, anti-tumor activity was observed, including 10 PRs, especially at the higher doses
Of the 6 evaluable patients recruited in cohort 7 with R/R CLL/SLL and dosed initially at 65 mg QD, 5 experienced a PR as of July 19, 2019
Two additional R/R CLL patients experienced a PR: 1 patient dose escalated from 45 to 65 mg QD and another de-escalated from 75 to 65 mg QD
Three additional PRs were observed outside of CLL including 1 patient with Follicular Lymphoma, 1 with Richter’s Transformation and 1 with Diffuse Large B-Cell Lymphoma
Presentation Details
Title: Final Results of Phase 1, Dose Escalation Study Evaluating ARQ 531 in Patients with Relapsed or Refractory B-Cell Lymphoid Malignancies
Abstract #: 4298
Session Name: CLL: Therapy, excluding Transplantation: Poster III
Date: Monday, December 9, 2019
Presentation Time: 6:00 PM – 8:00 PM ET
Location: Orange County Convention Center, Hall B

About BTK and ARQ 531
Bruton’s tyrosine kinase, BTK, is a therapeutic target that has been clinically proven to inhibit B-cell receptor signaling in blood cancers. ARQ 531 is an orally bioavailable, potent and reversible dual inhibitor of both wild type and C481S-mutant BTK. The C481S-mutation is a known resistance mechanism for first generation irreversible BTK inhibitors. ARQ 531 has demonstrated a manageable safety profile, predictable PK, profound pharmacodynamic effects and emerging signs of dose-proportional clinical activity in phase 1 clinical testing.

On November 6, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported three presentations at the the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held from December 7-10, 2019 in Orlando, FL (Press release, argenx, NOV 6, 2019, View Source [SID1234550437]). The presentations will include preclinical translational data highlighting the multiple modes of action of cusatuzumab to target leukemic stem cells, potential synergies of cusatuzumab in combination with a BCL-2 antagonist, and previously announced data from the Company’s completed Phase 2 trial of efgartigimod for primary immune thrombocytopenia (ITP).

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Details for the oral presentations are as follows:

Title: Targeting CD70 with Cusatuzumab Eliminates Acute Myeloid Leukemia Stem Cells in Humans

Oral Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Novel Targets and Combinations

Date and Time: Saturday, December 7, 3:15 p.m. ET

Location: Orange County Convention Center, Chapin Theater, W320

Presenter: Dr. Adrian Ochsenbein, M.D., University of Bern

Title: Phase 2 Study of Efgartigimod, a Novel FcRn Antagonist, in Adult Patients with Primary Immune Thrombocytopenia

Oral Session: 311. Disorders of Platelet Number or Function: Advances in ITP Therapy

Date and Time: Monday, December 9, 6:15 p.m. ET

Location: Orange County Convention Center, W307

Presenter: Dr. Adrian Newland, M.D., The Royal London Hospital

Details for the poster presentation are as follows:

Title: The Combination of the BCL-2 Antagonist Venetoclax with the CD70-Targeting Antibody Cusatuzumab Synergistically Eliminates Primary Human Leukemia Stem Cells

Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Date & Time: Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. ET

Location: Orange County Convention Center, Hall B

Presenter: Dr. Carsten Riether, Ph.D., University of Bern

On November 6, 2019 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported an abstract has been accepted for an oral presentation highlighting the company’s lead autoimmune/inflammatory program ALPN-101 at the 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held December 7-10, 2019 in Orlando, FL (Press release, Alpine Immune Sciences, NOV 6, 2019, View Source [SID1234550436]).

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The Company will present on its upcoming Phase 1/2 BALANCE study of ALPN-101 in steroid-resistant or steroid-refractory acute Graft-versus-Host Disease (GvHD). ALPN-101 is a first-in-class, dual inhibitor of the CD28 and ICOS costimulatory pathways with strong preclinical and translational rationale in GvHD.

Last year, preclinical data on ALPN-101 was included in an oral presentation at the 60th ASH (Free ASH Whitepaper) Annual Meeting, highlighting the novel role ICOS ligand (ICOS-L) plays in acute GvHD and extending what is currently understood about the CD28/B7 protein family in disease pathogenesis. Since then, Alpine has been conducting a first-in-human, randomized, placebo-controlled single- and multiple-ascending dose Phase I study in adult healthy volunteers. "This year’s presentation will discuss the translational and therapeutic potential of ALPN-101 based on our learnings to date," indicated Stanford Peng, M.D. Ph.D., President and Head of Research and Development at Alpine.

61st ASH (Free ASH Whitepaper) Annual Meeting Oral Presentation

Title: An Open Label Study of ALPN-101, a First-in-Class Dual CD28/ICOS Antagonist, in Subjects with Steroid-Resistant or Steroid-Refractory Acute Graft Versus Host Disease (aGvHD)
Presenter: Dr. Jan Hillson, Senior Vice President, Clinical Development, Alpine
Session Name: 802. Chemical Biology and Experimental Therapeutics: Novel Compounds and Mechanisms of Action (9:30 – 11:15 AM ET)
Oral Presentation Date and Time: Sunday, December 8, 2019: 11:00 AM ET
Location: OCCC, W414AB
About Graft Versus Host Disease (GvHD)

Graft versus host disease (GvHD) is the most common life-threatening complication of a hematopoietic cell transplant. It occurs when donor cells see recipient cells as different and attack them. Acute GvHD typically occurs within the early weeks and months after transplant, usually involving the skin, liver and gastrointestinal tract. Despite extensive studies of many different therapies in GvHD, corticosteroids remain its primary treatment.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely related costimulatory molecules with partially overlapping roles in T cell activation likely connected to multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease and multiple sclerosis, ALPN-101 demonstrates efficacy superior to blockade of the CD28 and/or ICOS pathways alone.

On November 6, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that the company will present new preclinical data showing that their drug candidate ATOR-1017 can induce a long-lasting immunological memory which is of great importance in a potential future patient setting (Press release, Alligator Bioscience, NOV 6, 2019, View Source [SID1234550435]). The results will be presented at the ongoing Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting. The ATOR-1017 drug candidate is in development for the treatment of metastasized cancer.

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Furthermore, the results show that treatment with ATOR-1017 activates the immune system in the tumor area but not systemically. These preclinical data support a tumor-directed activity of ATOR-1017. The aim is to focus the immune attack towards the tumor in order to increase efficacy and minimize side effects for the patient. ATOR-1017 is currently about to initiate Phase I clinical study and dosing of the first patient is expected shortly.

"These preclinical data support the potential of ATOR-1017 to generate a strong and long-lasting immune response or even to induce immunity to cancer. This is our fourth asset to enter the clinic and with its unique tumor-directed profile, we continue to build a clinical pipeline of the next generation cancer immunotherapies", said Per Norlén, CEO of Alligator Bioscience.

The upcoming Phase I study will be a first-in-human, dose escalation study in patients with advanced cancer. It will be conducted at three sites in Sweden and will enroll up to 50 patients. The primary objective of the study is to assess the safety and tolerability of ATOR-1017 and to determine the recommended dose for the subsequent Phase II studies.

Karin Enell Smith, Senior Scientist at Alligator Bioscience will present a poster with the title "ATOR-1017, a 4-1BB antibody developed for tumor-directed immunotherapy of cancer" on Saturday November 9 at the SITC (Free SITC Whitepaper) 34th Annual Meeting held in National Harbor, Maryland, US. The poster presentation will be available on the Alligator web site View Source on the day of the presentation.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 2:00 p.m. CET on November 6, 2019.

About ATOR-1017
ATOR-1017 is an immunostimulatory IgG4 antibody that activates tumor-specific T cells and NK cells through the costimulatory receptor 4-1BB. T cells and NK cells have the capacity to detect and kill tumor cells, making 4-1BB a particularly attractive target for cancer immunotherapy. ATOR-1017 has a unique profile related to the fact that its immunostimulatory function is stronger in areas where immune cells are abundant, notably in tumors. This creates an opportunity for a strong immune activation, while minimizing side effects for the patient.