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Molecular Templates Announces Presentations at the American Society of Hematology (ASH) 2019 Annual Meeting

On December 9, 2019 Molecular Templates, Inc., (Nasdaq: MTEM) a clinical-stage biopharmaceutical company focused on the discovery and development of the Company’s proprietary engineered toxin bodies (ETBs), which are differentiated, targeted, biologic therapeutics, reported the presentations of two posters on its pipeline programs at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting, taking place December 7-10, 2019 in Orlando, Florida (Press release, Molecular Templates, DEC 9, 2019, View Source [SID1234552122]). One of these posters includes final results from the Phase 1/1b study of MT-3724, in subjects with relapsed/refractory (R/R) diffuse large b-cell lymphoma (DLBCL).

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Poster Title: Monotherapy Activity with the First CD20-Targeted Immunotoxin, MT-3724, in Subjects with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
Abstract Number: 4098
Presenter: Daniel Persky MD, University of Arizona Cancer Center
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials
Time: Monday, December 9, 2019: 6:00 PM-8:00 PM ET
This is a multi-center, open-label, dose-escalation and dose-expansion study of MT-3724, the first CD20 targeted immunotoxin to enter clinical trials. The Phase 1/1b portion of the study consists of two Parts in which a total of 27 subjects with NHL were enrolled; 21 in Part 1 (dose escalation) and 6 in Part 2 (expansion cohort), both closed to enrollment. In total, 25 subjects were evaluable for efficacy, including 19 subjects with DLBCL or mixed DLBCL/follicular lymphoma.

MT-3724 competes for binding with rituximab (RTX) and other commercially available CD20-targeting monoclonal antibodies. Consistent with this competition, initial efficacy data from the dose expansion study revealed only one of eight subjects with measurable serum rituximab (RTX) levels had any suggestion of benefit (a mixed response) to MT-3724.

The expansion cohort mandated negative serum RTX levels for enrolled subjects. Of the 13 serum rituximab negative (RTX-neg) DLBCL or mixed DLBCL/FL subjects, 5 responded (38% objective response rate) across the range of 5 to 100 μg/kg doses. Of the 5 responses, 2 were complete responses (CRs) and 3 were partial responses (PRs). Three patients had stable disease (including 2 patients with 49% and 47% tumor reductions) and 5 patients had progressive disease.

Of the 5 serum RTX-neg subjects with DLBCL who received MT-3724 at 50 μg/kg, the maximum tolerated dose (MTD), 3 responded (2 CR, 1 PRs). Of all 25 subjects evaluable for efficacy, 13 developed anti-drug antibodies (ADAs) or neutralizing antibodies (NAbs); the development of ADAs or NAbs did not preclude benefit of MT-3724, consistent with what has been seen with other immunotoxins. Safety events were mostly mild to moderate, and dose limiting toxicities (DLTs) were indicative of innate immune response, including grade 2 capillary leak syndrome and grades 1-3 arthralgias and myalgias. No life-threatening toxicities were attributed to MT-3724.

A Phase 2 dose-expansion portion of the study (Part 3) has been initiated to investigate MT-3724 in serum RTX-neg subjects with DLBCL. This is actively enrolling globally. A tolerable dose and schedule for the Phase 2 has been identified: 50 μg/kg/dose with a cap of 6000 μg/dose infused over 1 hour on Days 1, 3, 5, 8, 10 and 12 of a 21-day cycle. (ClinicalTrials.gov Identifier: NCT02361346).

Poster Title: A Phase 2a Open-Label Study to Investigate Safety and Tolerability (including the MTD), Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of MT-3724 in Combination with Lenalidomide in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Presenter: Jason Tache, DO, BRCR Medical Center
Abstract #: 1597
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials
Time and Location: Saturday, December 7, 2019: 5:30 PM-7:30 PM ET
MT-3724. a novel Engineered Toxin Body (ETB), possesses specific and high affinity for CD20+ cells and causes apoptosis via a unique mechanism of action, forced internalization of the ETB bound to the receptor, retrograde transport through the cytosol, and enzymatic deactivation of ribosomal function. Therefore, combining MT‑3724 with standard cytotoxic chemotherapy and/or immune modulatory agents may provide enhanced benefit in NHL treatment algorithms. This is a multi-center, open-label, multiple-dose Phase 2a study designed to evaluate MT-3724 in combination with lenalidomide in adult subjects with histologically confirmed, relapsed or refractory NHL. The primary objective is to determine safety and tolerability, including the MTD, of MT-3724 + lenalidomide. Secondary objectives include pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and tumor response.

The study will be conducted in two parts: Part 1 will include MT-3724 dose escalation according to the modified 3+3 design to identify the MTD of MT-3724 in combination with standard doses of lenalidomide and will include up to 24 subjects with histologically confirmed NHL. Part 2 is designed to confirm the safety and tolerability of MT-3724 + lenalidomide in the MTD Expansion Cohort, where the dose declared as MTD of MT-3724 in Part 1 would be given in combination with lenalidomide in up to 40 subjects with CD20+ DLBCL. In addition, the PK, PD, immunogenicity and tumor response of MT-3724 + lenalidomide will be evaluated in Part 2.

The study is currently ongoing; eligible subjects will be identified and treated through competitive enrollment at multiple study centers (ClinicalTrials.gov Identifier: NCT03645395).

Copies of the posters presented at ASH (Free ASH Whitepaper) can be found in the Presentations section of Molecular Templates’ website at View Source

Merck to Acquire ArQule, Advancing Leadership in Oncology

On December 9, 2019 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and ArQule, Inc. (Nasdaq: ARQL) reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire ArQule for $20 per share in cash for an approximate total equity value of $2.7 billion (Press release, Merck & Co, DEC 9, 2019, View Source [SID1234552121]). ArQule is a publicly traded biopharmaceutical company focused on kinase inhibitor discovery and development for the treatment of patients with cancer and other diseases. ArQule’s lead investigational candidate, ARQ 531, is a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently in a Phase 2 dose expansion study for the treatment of B-cell malignancies.

"ArQule’s focus on precision medicine has yielded multiple clinical-stage oral kinase inhibitors that have novel and important properties," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "This acquisition strengthens Merck’s pipeline with the addition of these strategic assets including, most notably, ARQ 531, a compelling candidate for the treatment of B-cell malignancies."

BTK inhibition has been shown to prevent B-cell receptor signaling that is critical for the survival and proliferation of leukemic cells in many B-cell malignancies. ARQ 531 is a highly selective, reversible inhibitor that blocks both wild-type BTK and the C481S mutant form of the enzyme that is commonly associated with resistance to other BTK inhibitors. In early clinical trials, ARQ 531 demonstrated a manageable safety profile and early signs of anti-tumor activity for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and Richter’s Transformation. Final data from the Phase 1 study of ARQ 531 will be presented on Dec. 9, 2019 at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, Florida.

"We are proud that Merck has recognized the contributions that ArQule, together with its scientific collaborators, has made to the field of precision medicine in oncology with ARQ 531 for the treatment of B-cell malignancies and with the rest of our clinical-stage pipeline," said Paolo Pucci, CEO, ArQule. "With this agreement, ArQule’s pipeline will benefit from Merck’s vast capabilities and determined engagement to benefit the patients who we have always strived to serve."

Under the terms of the acquisition agreement announced today, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of ArQule. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of ArQule’s outstanding shares, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Upon the successful completion of the tender offer, Merck’s acquisition subsidiary will be merged into ArQule, and any remaining shares of common stock of ArQule will be canceled and converted into the right to receive the same $20 per share price payable in the tender offer. The transaction is expected to close early in the first quarter of 2020.

BofA Securities acted as financial advisor to Merck in this transaction and Covington & Burling LLP as its legal advisor. Centerview Partners acted as exclusive financial advisor to ArQule and Skadden, Arps, Slate, Meagher & Flom LLP as its legal advisor.

Important Information About the Tender Offer

The tender offer described in this press release (the "Offer") has not yet commenced. This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of ArQule, Inc. ("ArQule") or any other securities. At the time the planned tender offer is commenced, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed by Merck Sharp & Dohme Corp. ("Merck") and Argon Merger Sub, Inc., a wholly-owned subsidiary of Merck, with the Securities and Exchange Commission (the "SEC"), and a solicitation/recommendation statement on Schedule 14D-9 will be filed by ArQule with the SEC. The offer to purchase shares of ArQule common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO.

INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.

Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the Offer, which will be named in the tender offer statement. Additional copies of the tender offer materials may be obtained at no charge by contacting Merck at 2000 Galloping Hill Road, Kenilworth, N.J., 07033 or by phoning (908) 423-1000. In addition, Merck and ArQule will file annual, quarterly and current reports and other information with the SEC. Merck’s and ArQule’s filings with the SEC also will be available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov.

IMMUNOMEDICS ANNOUNCES PROPOSED PUBLIC OFFERING OF COMMON STOCK

On December 9, 2019 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported it has commenced an underwritten public offering of $250,000,000 of shares of its common stock (Press release, Immunomedics, DEC 9, 2019, View Source [SID1234552120]). In addition, Immunomedics expects to grant the underwriters a 30-day option to purchase up to an aggregate of an additional $37,500,000 of shares of common stock sold in connection with the offering at the public offering price.

Immunomedics intends to use the net proceeds from this offering primarily to accelerate commercial launch readiness, pending FDA approval, of sacituzumab govitecan in the United States in metastatic triple-negative breast cancer, continue to expand the clinical development programs for sacituzumab govitecan, invest in the broader clinical development of the platform (including IMMU-130 and IMMU-140), continued scale-up of manufacturing and manufacturing process improvements, as well as for working capital and general corporate purposes.

Goldman Sachs & Co. LLC, BofA Securities, Cowen and Company, LLC and Jefferies LLC are acting as joint book-running managers for the offering. The offering is subject to market 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.

The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 that Immunomedics filed with the Securities and Exchange Commission on June 11, 2018 and that became effective upon filing. A preliminary prospectus supplement and the accompanying prospectus relating to this offering are being filed with the SEC and will be available at the SEC’s website located at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or by email at [email protected].

ImaginAb Initiates Phase II Clinical Trial at Penn Medicine

On December 9, 2019 ImaginAb, Inc., a clinical-stage immuno-oncology imaging company, reported it has initiated its Phase II clinical trial of its lead product, CD8 tracer 89Zr-Df-IAB22M2C, at Penn Medicine in Philadelphia, PA (Press release, ImaginAb, DEC 9, 2019, View Source [SID1234552119]). Penn Medicine is one of the world’s leading academic medical centers.

89Zr-Df-IAB22M2C is a first in class imaging agent that visualizes the immune system using non-invasive, whole-body in vivo PET imaging of CD8 T cells. Using its ‘Minibody’ platform, ImaginAb’s technology targets and visualizes CD8+ T-cells to provide highly-specific, quantitative assessment of the immunological status of each cancer lesion within a patient, potentially enabling treatment to be tailored quickly and specifically to the needs of that patient.

Penn Medicine is one of ImaginAb’s active clinical sites conducting Phase II Baseline/On-Treatment clinical trial investigating the utility of 89Zr-Df-IAB22M2C to image CD8 T cells prior to (Baseline) and after (On-treatment) cancer patients receive immunotherapy-based treatment. Michael Farwell, MD, an Assistant Professor of Radiology in the Perelman School of Medicine at the University of Pennsylvania, is the study’s principal investigator.

Ian Wilson, CEO of ImaginAb, said: "ImaginAb’s goal is to provide target-specific imaging agents to evaluate immune responses in cancer patients in a safe and non-invasive manner and help realize the full potential of immunotherapy. We are delighted to add Penn Medicine to our CD8 Imaging Phase II trial and for enrollment in this ongoing clinical study."

The trial will enroll advanced and metastatic cancer patients and will study the correlation of imaging signals observed using ImaginAb’s CD8 T cell ImmunoPET imaging agent, standard-of-care scans, and immunohistochemistry analysis of CD8 in biopsied tissues. The trial will also measure changes in CD8+ T-cell distribution before and after immuno-oncology therapies.

Genmab to Hold 2019 R&D Update and ASH Data Review Meeting

On December 9, 2019 Genmab A/S (Nasdaq: GMAB) reported that it will hold an R&D Update and 2019 ASH (Free ASH Whitepaper) Data Review Meeting , December 9, 2019 at 8:00 PM Eastern Time (2:00 AM CET / 1:00 AM GMT on 10 December) (Press release, Genmab, DEC 9, 2019, View Source [SID1234552118]). The event will take place in Orlando, Florida, and will also be webcast live and archived on the company’s website. The meeting will include presentations by independent experts on data from the Phase I/II DuoBody-CD3xCD20 (GEN3013) study as well as various daratumumab studies presented at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper). Genmab speakers will also discuss the company’s pipeline, progress and key goals for 2020.

The following cancer experts and Genmab staff will speak during the event:

Independent experts:

Dr. Meletios A. Dimopoulos, National and Kapodistrian University of Athens, School of Medicine
Dr. Pieternella Lugtenburg, Erasmus University Medical Center Rotterdam
·Dr. Saad Usmani, University of North Carolina at Chapel Hill, Levine Cancer Institute

Genmab:

Dr. Jan van de Winkel, President and CEO, Genmab
Dr. Esther Breij, Senior Director, Translational Research
The event will take place at the Hyatt Regency Orlando in Orlando, Florida, in Bayhill 17-18. Those wishing to attend in person may register on site.

The event can also be attended via webcast. To view this webcast visit: View Source Webcast viewers may submit questions during the Q&A portion of the live webcast via the webcast player. An archive of the webcast will be available on Genmab’s website. The webcast will be conducted in English.

This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.