On December 9, 2019 Menarini Silicon Biosystems, the pioneer of liquid biopsy and rare cell technologies, reported that new research utilizing the company’s CELLSEARCH Circulating Tumor Cell (CTC) test will be featured at the upcoming 2019 San Antonio Breast Cancer Symposium (SABCS) (Press release, Menarini Silicon Biosystems, DEC 9, 2019, View Source [SID1234552157]).

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Researchers from Northwestern University will present the results of three studies that used the FDA-cleared CELLSEARCH system to conduct CTC testing in a total of 463 breast cancer patients. The poster presentations provide preliminary insight into the use of liquid biopsy and CTC enumeration to help clinicians better understand the metastatic process and facilitate management of patients with metastatic breast cancer (MBC).

"Liquid biopsies enable us to monitor the disease over time and more fully understand the complexity, heterogeneity and evolution of the disease, which is critical to selecting better treatments," said Massimo Cristofanilli, M.D., F.A.C.P., Associate Director for Translational Research, Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "While we need to expand these data to further prospective studies for validation, this new research marks an important step towards potentially expanding the role of liquid biopsy — particularly enumeration of CTCs and molecular analysis for accurate and real-time prediction and prognostic monitoring the metastatic process."

Dr. Cristofanilli co-authored all three CELLSEARCH studies being presented at SABCS**.

CELLSEARCH is the first and only clinically validated blood test cleared by the FDA for detecting and enumerating CTCs as an aid for physicians to manage patients with metastatic breast, prostate and colorectal cancers. The test is also approved by the Chinese National Medical Products Administration (NMPA) for use as an aid in monitoring metastatic breast cancer patients.

"There is a large body of research supporting the longstanding value of CTCs, which is one of the reasons many physicians are using CELLSEARCH in their clinics," said Fabio Piazzalunga, President and CEO of Menarini Silicon Biosystems, Inc. "Studies like these help to increase understanding of the value of liquid biopsy and CTC enumeration and play an important role in advancing precision medicine for metastatic breast cancer."

Poster Presentation Details:

Poster Session 3 – Thursday, December 12, 5:00 pm – 7:00 pm, Hall 1

Title:

Liquid biopsy methods and machine learning modeling to understand organ tropism and metastization behavior of metastatic breast cancer – P3-01-05

Authors:

Gerratana L et al.
Northwestern University, Chicago, IL; IRCCS CRO Aviano National Cancer Institute, Aviano, Italy.

Poster Session 4 – Friday, December 13, 7:00 am – 9:00 am, Hall 1

Title:

Clinical relevance of CK+/CD45+, dual-positive circulating cells (DPCells) in patients with metastatic breast cancer (MBC) – P4-01-07

Authors:

Reduzzi et al.
Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL.

Title:

Anatomical staging and value of CTCs in locally advanced breast cancer (LABC) and metastatic breast cancer (MBC) – P4-01-08

Authors:

Zhang Q et al.
Department of Medicine, University of Udine, Uniud, Italy; Department of Medicine, Northwestern University, Chicago, IL; Department of Pathology, Northwestern University, Chicago, IL.

The CELLSEARCH System is the most extensively studied CTC technology, with research published in more than 650 peer-reviewed publications. Providing valuable information to help physicians make patient-management decisions along with other clinical monitoring methods, the CELLSEARCH CTC test is performed at a reference laboratory using the CELLSEARCH System. The testing can be used throughout a given therapy for metastatic breast, colorectal, and prostate cancer to monitor a patient’s status by showing if their prognosis is favorable.

To learn more about the CELLSEARCH System, SABCS attendees can visit Menarini Silicon Biosystems at Booth #909.

SABCS will be held at the Henry B. Gonzalez Convention Center, San Antonio, Texas, Dec. 10-14, 2019.

On December 9, 2019 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, reported the pricing of its underwritten public offering of 11,115,165 common shares (the "Offering") (Press release, Aurinia Pharmaceuticals, DEC 9, 2019, View Source [SID1234552178]). The shares are being sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are expected to be approximately US$166.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses. All of the shares are being offered by the Company. The Offering is expected to close on or about December 12, 2019, subject to the satisfaction of customary closing conditions.

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Jefferies LLC and SVB Leerink LLC are acting as joint book-running managers for the Offering. H.C. Wainwright & Co. LLC, Oppenheimer & Co. Inc., and Bloom Burton Securities Inc. are acting as co-managers for the Offering. The Company has granted the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase 1,667,274 additional shares, for a period of up to 30 days.

The Offering is subject to customary closing conditions, including NASDAQ and TSX approvals. For the purposes of the TSX approval, the Company intends to rely on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ.

The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, as well as working capital and general corporate purposes.

The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on March 29, 2018 (the "Registration Statement"), and the Company’s existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated March 26, 2018. A preliminary prospectus supplement relating to the Offering has been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States (the "Preliminary Prospectus"), and a final prospectus supplement relating to the Offering (together with the Preliminary Prospectus, Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company’s profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC’s website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected].

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

On December 9, 2019 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported updated results from a Phase 1/2 dose expansion study of flotetuzumab, an investigational, bispecific CD123 x CD3 DART molecule in patients with primary induction failure and early relapsed acute myeloid leukemia (AML) (Press release, MacroGenics, DEC 9, 2019, View Source [SID1234553172]). The data were presented in an oral session at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, FL, taking place December 7-10, 2019.

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"Patients with AML who have failed primary induction therapy or relapsed early after an initial response represent a significant unmet medical need. A remission rate of 32% observed in the ongoing study of flotetuzumab in this extremely challenging patient population is noteworthy," said Geoffrey Uy, M.D., Associate Professor, Department of Medicine, Division of Oncology at the Washington University School of Medicine in St. Louis. "Importantly, by implementing a lead-in dosing schedule for flotetuzumab, as well as early intervention with tocilizumab in this study, we were able to mitigate cytokine release syndrome, known to be associated with T-cell engagers."

In the Phase 1/2 (NCT02152956) open-label, dose expansion study, 30 patients classified as primary induction failure or early relapsed AML who had received a median of four prior therapies were treated with flotetuzumab at the recommended phase 2 dose (RP2D) of 500 ng/kg/day by continuous infusion. Data were reported as of the cut-off date of November 1, 2019. The study is currently ongoing, with additional patients being enrolled.

Responses, including complete remission (CR), CRh (CR with partial hematological recovery) and CRi (CR with incomplete hematological improvement) per a modified International Working Group (IWG) Response Criteria for AML, are summarized in the table below. Four responders received allogeneic hematopoietic stem cell transplantation as consolidation therapy and remain in remission after 6 to 21 months.

The most common treatment-related adverse event (TRAE) was infusion-related reaction/cytokine release syndrome (IRR/CRS) that occurred in all (30/30) patients. However, most CRS events observed were of short duration and mild to moderate (grade 1 or 2) in severity, with only one grade 3 event reported in one patient.

"Based on the encouraging data from this study, and pending anticipated discussions with the FDA in the first half of 2020, we are planning for a potential registration-enabling study of flotetuzumab in this high unmet need population of patients with refractory AML, who have limited treatment options," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics.

A separate oral presentation described translational research that showed an inflammatory (IFN-γ-related) gene expression signature in a subset of patients with AML that correlated with a lack of response to induction chemotherapy. Furthermore, the same gene signature was associated with patients more likely to respond to flotetuzumab, supporting the mechanism being exploited by this molecule. In addition, AML patients with an immune-infiltrated tumor micro-environment show high expression of immune checkpoint molecules, including PD-L1, which provides a scientific rationale for combining flotetuzumab with checkpoint blockade as a potential mechanism for enhanced anti-leukemic activity. MacroGenics has initiated a study combining flotetuzumab with MGA012, an anti-PD-1 antibody, given the strong preclinical and translational data that indicate the combination may enhance CD123-directed T cell killing.

Flotetuzumab Presentations at ASH (Free ASH Whitepaper)

Oral Presentations

Abstract #733: Uy, et al. "Flotetuzumab, an Investigational CD123 x CD3 Bispecific DART Protein, in Salvage Therapy for Primary Refractory and Early Relapsed Acute Myeloid Leukemia (AML) Patients"
Abstract #460: Vadakekolathu, et al. "Immune Landscapes Predict Chemotherapy Resistance and Anti-Leukemic Activity of Flotetuzumab, an Investigational CD123 × CD3 Bispecific DART Molecule, in Patients with Relapsed/Refractory Acute Myeloid Leukemia"
Poster Presentations

Abstract #1410: Goodwin, et al. "Flotetuzumab (FLZ), an Investigational CD123 x CD3 Bispecific DART Protein-Induced Clustering of CD3+ T Cells and CD123+ AML Cells in Bone Marrow Biopsies Is Associated with Response to Treatment in Primary Refractory AML Patients"
Abstract #1387: Gopalakrishnapillai, et al. "Effect of Ara-C on T-Cell Function and Flotetuzumab Activity in Pediatric Acute Myeloid Leukemia"
Abstract #2662: Wei, et al: "A Phase 1 Study of Flotetuzumab, a CD123 x CD3 DART Protein, Combined with MGA012, an Anti-PD-1 Antibody, in Patients with Relapsed or Refractory Acute Myeloid Leukemia"
These slide and poster presentations are available on the Events & Presentations page on MacroGenics’ website at View Source

Conference Call & Webcast

MacroGenics management and external guest speakers will host a conference call and audio webcast today at 8:00 p.m. ET to review the flotetuzumab data presented at the ASH (Free ASH Whitepaper) Annual Meeting and discuss ongoing clinical development plans.

To participate in the MacroGenics ASH (Free ASH Whitepaper) 2019 Conference Call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 3625435. A listen-only slide and audio webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a hematopoietic stem cell malignancy characterized by differentiation arrest and uncontrolled clonal proliferation of neoplastic precursors that prevent normal bone marrow hematopoiesis. Nearly 20,000 new cases of AML are diagnosed in the U.S. each year, with a median age of 69 years at diagnosis. Approximately 40-50% of newly diagnosed patients fail to achieve a complete remission with intensive induction therapy (primary induction failure) or experience disease recurrence after a short remission duration (<6 months; early relapsed). A very small number of these patients are expected to respond to salvage therapy. In addition, although new targeted agents have been approved for the treatment of frontline or relapsed/refractory AML in recent years, approximately 50% of patients have no known targetable mutations.

About Flotetuzumab

Flotetuzumab (also known as MGD006) is a clinical-stage molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on cancer cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cancer cells.

Flotetuzumab is currently being evaluated in the U.S. and Europe in a Phase 1/2 dose expansion study designed to assess the safety, tolerability, and initial anti-leukemic activity of the molecule in patients with relapsed/refractory AML. The U.S. Food and Drug Administration has granted orphan drug designation to flotetuzumab for the treatment of AML. A Phase 1/2 study in combination with MGA012, a proprietary anti-PD-1 monoclonal antibody, in patients with relapsed/refractory AML is being conducted ex-U.S. MGA012 (also known as INCMGA00012) was exclusively licensed to Incyte Corporation in 2017 under a global collaboration and license agreement; MacroGenics retains the right to develop its pipeline molecules with MGA012. MacroGenics retains global development and commercialization rights to flotetuzumab.

On December 9, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that it has entered into definitive agreements with healthcare focused institutional investors for the issuance and sale in a registered direct offering of 14,326,648 shares of its common stock and warrants to purchase up to 7,163,324 shares of its common stock, at a combined purchase price of $0.349 per share and associated warrant, for aggregate gross proceeds of approximately $5.0 million in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Onconova, DEC 9, 2019, View Source [SID1234552124]).

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $0.287 per share and exercise period commencing immediately upon issuance and a term of five (5) years.

The offering is expected to close on or about December 10, 2019, subject to the satisfaction of customary closing conditions. Upon the closing of the offering, the Company’s stockholders’ equity is expected to exceed the minimum $2.5 million stockholders’ equity requirement for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(b)(1), and the Company intends to provide further information to Nasdaq demonstrating its ability to sustain long-term compliance. In addition, 10,443,000 common stock warrants have been exercised since November 25, 2019, resulting in additional proceeds to the Company of approximately $2.1 million.

The Company currently intends to use the net proceeds from the offering for working capital and general corporate purposes, including advancing preparations for a planned New Drug Application (NDA) filing to the FDA for intravenous rigosertib in second-line higher-risk MDS in 2020. The Company surpassed 90% of the required enrollment of the INSPIRE Trial in November 2019 and anticipates reporting topline data in the first half of 2020, following full enrollment and reaching the number of required survival events. With the additional proceeds from the offering and the proceeds from the recent warrant exercise, the Company believes that it has the sufficient funds to extend operations and ongoing trials late into the third quarter of 2020.

The securities described above are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-221684), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on December 28, 2017. The offering of the securities will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 December 9, 2019 Samyang Biopharm USA, Inc. (View Source) a global biotech subsidiary of the Samyang Pharmaceuticals Corp. (View Source), reported that the company has entered into a research collaboration with the exclusive option to a worldwide licensing agreement with Talix Therapeutics NV (Press release, Samyang Biopharmaceuticals, DEC 9, 2019, View Source [SID1234552142]). Financial terms of the agreement were not disclosed.

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Under the terms of the agreement, Talix grants Samyang research rights with the exclusive option to worldwide rights for the development, manufacturing and commercialization of Talix’s anti-CD96 antibody, a first-in-class compound currently engaged in preclinical studies.

"We are excited to establish this alliance with Talix, an innovative biotechnology company who has made great strides in the preclinical development of its lead oncology compound," said Helen Hyun Jung Lee M.D., President/CEO, Samyang Biopharm USA, Inc. "Talix shares Samyang’s passion and commitment to discovering breakthrough medicines with the potential to improve the lives of cancer patients worldwide and this collaboration provides our company with a promising preclinical candidate to add to our emerging pipeline of Immuno-Oncology candidates."

Talix discovered the co-stimulatory role of human CD96 on T cells and NK cells, including Tumor Infiltrating Lymphocytes (TILs). Antibodies to CD96 have been reported to protect mice from tumors by activating T cells. In vivo data indicate such antibodies can synergize with PD-1 checkpoint blocking molecules.

"Talix is very enthusiastic with the prospect of Samyang’s research and development team advancing the Talix’s anti-CD96 antibody and we feel that the company has the established management experience and proven scientific acumen within oncology to deliver a drug candidate with great promise," said Jack Elands, CEO of Talix.

Samyang’s collaboration with Talix Therapeutics is the second partnership disclosed by the company in recent weeks. On December 2, Samyang announced a global partnership with CanCure LLC in the immune-oncology therapeutic area which included the license of a first in class immune stimulatory monoclonal antibody targeting soluble MHC class 1 chain-related protein (sMIC). [View Source/downloads/Samyang-USA-CanCure-Collaboration.pdf]