On November 6, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported that initial data from its ongoing Phase 1 dose-escalation study of XmAb13676, a CD20 x CD3 bispecific antibody, in patients with B-cell malignancies will be presented in a poster session during the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida on Monday, December 9, 2019 (Press release, Xencor, NOV 6, 2019, View Source [SID1234550532]).

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"Initial results from dose-escalation cohorts demonstrate encouraging clinical activity in heavily pretreated patients with several subtypes of non-Hodgkin lymphoma, as well as chronic lymphocytic leukemia. The most common treatment-related adverse event has been fever. Cytokine release syndrome, the second most common adverse event, has been generally manageable with premedication," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor.

Key Highlights from the Abstract

The abstract with accepted data from the study are available through the ASH (Free ASH Whitepaper) website. Updated results will be shared at the ASH (Free ASH Whitepaper) Annual Meeting.

At data cut off on June 28, 2019, 36 patients with relapsed/refractory non-Hodgkin’s lymphoma (r/r NHL) and 8 patients with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) had received XmAb13676. The study was designed in two parts: Part A to establish an initial priming dose and Part B to escalate dosing on subsequent administration. Prophylactic treatment for cytokine release syndrome (CRS) was mandated prior to each administration of XmAb13676.
Patients with r/r NHL (n=36) had a median age of 61.5 years, a median of 3.5 prior therapies and had been diagnosed a median of 24.6 months prior to treatment. In the efficacy evaluable population and at doses ranging from 80 to 125 mcg/kg, objective responses were observed in 33% of patients (n=6/18), including 42% of DLBCL patients (n=5/12). CRS occurred in 42% of patients (n=15/36), and one patient receiving an initial dose of 125 mcg/kg experienced Grade 4 CRS. A priming dose of 45 mcg/kg was chosen for Part B.
Patients with r/r CLL (n=8) had a median age of 76 years, a median of 4.5 prior therapies and had been diagnosed a median of 76.1 months prior to treatment. There was one complete response (Richter transformation) in five patients treated at the 20 mcg/kg dose level, the highest dose administered in the ongoing Part A of the study. CRS occurred in 25% of patients (n=2/8), and one patient experienced Grade 3 CRS.
Presentation Details

Abstract: 4079
Title: Preliminary Safety and Anti-tumor Activity of XmAb13676, an Anti-CD20 x Anti-CD3 Bispecific Antibody in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Krish Patel, M.D., Director of the Lymphoma Program at Swedish Cancer Institute
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III
Date & Time: Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. EST
Location: Orange County Convention Center, Hall B
About XmAb13676

XmAb13676 is a tumor-targeted antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3) in a Phase 1 clinical trial for the treatment of B-cell malignancies. An XmAb bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture on XmAb13676. CD20 is highly expressed on B-cell tumors, including in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Engagement of CD3 by XmAb13676 activates T cells for highly potent and targeted killing of CD20-expressing tumor cells.

On November 6, 2019 Sierra Oncology, Inc. (Nasdaq: SRRA), a late-stage drug development company focused on the development and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported that it intends to offer and sell shares of Series A convertible preferred stock, together with Series A warrants and Series B warrants, each to purchase shares of common stock, in an underwritten public offering (Press release, Sierra Oncology, NOV 6, 2019, View Source [SID1234550548]). All of the securities to be sold in the offering will be offered by Sierra Oncology. 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.

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Sierra Oncology intends to use the net proceeds from the public offering to fund MOMENTUM, its planned Phase 3 clinical trial of momelotinib, as well as for general corporate purposes.

Each share of Series A preferred stock will be initially convertible into that number of shares of common stock equal to the purchase price of the Series A preferred stock divided by the conversion price of the Series A preferred stock. Each share of Series A preferred stock will automatically convert to shares of common stock upon the fifth day of trading following the announcement of stockholder approval of the first reverse stock split following the offering, subject to certain beneficial ownership limitations. Each share of Series A preferred will be entitled to vote together with the common stock on an as-converted basis, subject to certain limitations, without regard to the beneficial ownership limitation, until such time that the shares of Series A preferred stock automatically convert to common stock. Following the automatic conversion described above, the Series A preferred stock will be non-voting.

Each share of Series A preferred stock will be accompanied by (i) a Series A warrant to purchase shares of common stock that will equate to 100% warrant coverage, and (ii) a Series B warrant to purchase shares of common stock that will equate to 33% warrant coverage. Each Series A warrant and Series B warrant will have an exercise price equal to the initial conversion price of the Series A preferred stock, and will become exercisable following stockholder approval of an increase in authorized common stock sufficient to allow for the exercise of the warrants, subject to certain beneficial ownership limitations. The Series A warrants will expire five years from the date they first become exercisable and the Series B warrants will expire on the 75th day anniversary following the announcement of top-line date from Sierra Oncology’s planned Phase 3 clinical trial of momelotinib.

Jefferies is acting as the sole book-running manager for the offering.

The securities described above are being offered by Sierra Oncology pursuant to a registration statement on Form S-3 (File No. 333-225650) that was declared effective by the Securities and Exchange Commission ("SEC") on June 21, 2018. A preliminary prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an 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 MEDx (Suzhou) Translational Medicine, and Singapore-based Lucence – a leading genomic medicine company reported an agreement to pursue a strategic partnership in China to co-develop cancer-care tests that would benefit patients and pharmaceutical companies (Press release, MedX Health, NOV 6, 2019, View Source [SID1234550594]).

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By melding MEDx’s industry-leading biomarker discovery, cancer molecular diagnostics, high-throughput sequencing and bioinformatics platforms; with Lucence’s proprietary technology platform that identifies PD-L1 rearrangement, as well as multiplex immunofluorescence that allows better prediction of anti-PD1/PD-L1 treatment outcomes, this partnership is poised to go from strength to strength in this sunrise industry of precision medicine.

"Immunotherapy is becoming more and more popular for drug development and personalized medicine in China. A good companion diagnosis is needed to complement immunotherapy. We believe through this strategic partnership with Lucence, we will achieve better outcomes for cancer diagnosis and treatment selection for cancer patients," said Dr. Nick Zhang, Chairman and CEO of MEDx (Suzhou) Translational Medicine.

"The complementary strengths of Lucence and MEDx to co-develop cancer-care tests in China will ensure that patients have access to non-invasive, cost-effective, faster and better diagnosis. With our steadfast focus on reducing avoidable cancer deaths, coupled with MEDx’s deep experience and wide presence in China, we are confident that this partnership will drive better cancer care in China," said Dr. Min-Han Tan, Founder and CEO of Lucence.

On November 6, 2019 Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company, reported third quarter 2019 financial results and recent business highlights (Press release, Sangamo Therapeutics, NOV 6, 2019, View Source [SID1234550640]).

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"We continue to prioritize and progress our clinical development programs, as demonstrated by the accepted ASH (Free ASH Whitepaper) poster presentations for our two most advanced programs, SB-525 hemophilia A gene therapy and ST-400 beta thalassemia cell therapy. Patients are currently being screened for enrollment into the clinical study evaluating ST-920, our wholly owned Fabry disease gene therapy, and we expect to enroll a first patient by the end of the year. We have also recently submitted a CTA for the clinical trial of our CAR-Treg, TX200, in mismatched renal transplantation," said Sandy Macrae, CEO of Sangamo. "As it is important that we continue to articulate our drug development, research, and partnership strategies, we will host a Sangamo R&D day in New York on December 17, 2019. At this meeting, we will provide updates across our various genomic medicine programs, offer our perspective on the clinical data at ASH (Free ASH Whitepaper), share improvements across our technology platforms, and provide an overview of the manufacturing strategy to support our clinical and commercial supply."

Recent Highlights

Clinical

Earlier today, announced the upcoming poster presentation of three abstracts at the 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Florida:
Updated follow-up of the Phase 1/2 Alta Study assessing SB-525 gene therapy in adult patients with severe hemophilia A in partnership with Pfizer.
Preliminary information from the Phase 1/2 THALES Study assessing ST-400 ex vivo gene-edited cell therapy in patients with transfusion-dependent beta thalassemia in partnership with Sanofi.
In vitro results of zinc finger nuclease-mediated disruption of BCL11A erythroid enhancer in erythroid cells derived from patients with sickle cell disease.
Significant progress made on advancing the transfer of SB-525 development to our partner Pfizer, who will run the Phase 3 registrational clinical trial, including completing manufacturing technology transfer and initiating transfer of the investigational new drug application (IND). Pfizer announced it has enrolled its first patient in the 6-month lead-in study, which is expected to serve as a baseline control for the patients who are enrolled into the Phase 3 study.
Activated a fourth US clinical site for the STAAR study evaluating ST-920, an investigational gene therapy candidate for Fabry disease. Sangamo is currently screening patients in the US for enrollment into the clinical study and expects to enroll the first patient this year.
Received approval of the clinical trial authorization application (CTA) for ST-920, allowing expansion of the study into the UK. Additionally, the FDA granted Orphan Drug Designation to ST-920 for the treatment of Fabry disease.
Following the dosing of a third patient in the THALES Study, Sangamo achieved a $6.0M milestone with Sanofi and received $2.1M from the California Institute for Regenerative Medicine (CIRM). Enrollment of all 6 patients in the Phase 1/2 study is expected to be completed in 2019.
Sanofi is currently recruiting patients into the Phase 1/2 PRECIZN-1 trial evaluating BIVV003 gene-edited cell therapy for the treatment of sickle cell disease.
Filed the CTA for TX200, a CAR-Treg product candidate, in HLA-A2 mismatched kidney transplantation.
Kite, a Gilead Company, is planning to initiate a clinical study of KITE-037, an allogeneic anti-CD19 CAR-T cell product, in 2020.
Corporate

Announced Sangamo R&D day to be held in New York City on December 17, 2019.
Hired Sung Lee as Executive Vice President and Chief Financial Officer.
Hired Bettina Cockroft as Senior Vice President and Chief Medical Officer.
Promoted R. Andrew Ramelmeier to Executive Vice President, Technical Operations.
Third Quarter 2019 Financial Results

For the third quarter ended September 30, 2019, Sangamo reported a consolidated net loss of $27.3 million, or $0.24 per share, compared to a net loss of $12.8 million, or $0.13 per share, for the same period in 2018. As of September 30, 2019, the Company had cash, cash equivalents, and investments of $408.3 million.

Revenues for the third quarter ended September 30, 2019 were $22.0 million, compared to $23.6 million for the same period in 2018. The decrease of $1.6 million was primarily driven by the decrease of $7.0 million in revenues related to Pfizer and $1.4 million related to royalty revenues offset by increases of $6.5 million in revenues related to Sanofi as the Company achieved a $6.0 million milestone upon dosing the third subject in the Phase 1/2 THALES study in August 2019.

As anticipated, operating expenses increased in the third quarter, reflecting the Company’s growth through increased U.S. headcount in support of growth of the clinical development programs and preclinical pipeline, and manufacturing-readiness activities. Total operating expenses for the third quarter ended September 30, 2019 were $51.2 million, compared to $39.8 million for the same period in 2018. Research and development expenses were $36.3 million for the third quarter of 2019, compared to $28.8 million for the same period in 2018. The increase is primarily due to higher compensation costs from headcount growth, higher facility expenses related to our new Brisbane facility, and higher manufacturing expenses related to our clinical activities. General and administrative expenses were $14.9 million for the third quarter of 2019, compared to $11.0 million for the same period in 2018. The increase was primarily due to increased compensation costs due to headcount growth and increased facility expenses. Construction of our in-house manufacturing capability in Brisbane is proceeding on schedule, and we still expect to commence Good Manufacturing Practice (GMP) qualification procedures early next year.

Financial Guidance for 2019

Operating Expense: Sangamo expects operating expense of $210.0 to $220.0 million for the year ending December 31, 2019.
Cash and Investments: Sangamo projects that current cash, cash equivalents, and investments should provide funds for operations through year end 2021.
Conference Call

Sangamo will host a conference call today, November 6, 2019, at 5:00 p.m. Eastern Time, which will be open to the public. The call will also be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 7276749. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 7276749.

On November 6, 2019 Antengene Corporation reported that it has entered into a licensing agreement with AstraZeneca (LSE/STO/NYSE: AZN) under which Antengene has been granted the exclusive global rights to further develop and commercialize AZD0364 (Press release, Antengene, NOV 6, 2019, View Source [SID1234550689]). Antengene Corporation is a China-and-U.S. based clinical-stage biopharmaceutical company focused on discovery and development of novel drugs for treatment of oncology. AstraZeneca is a global, science-led, innovative biopharmaceutical company. AZD0364 is a potent and selective small molecule extracellular signal–regulated kinases 1 and 2 (ERK1/2) inhibitor with an open U.S. investigational new drug (IND) application.

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ERK is a key component of the Ras-Raf-MEK-ERK (RAS/MAPK) pathway, which is frequently altered in cancer and promotes tumour cell growth and survival. AZD0364 is a potent and selective inhibitor of ERK1/2 discovered by AstraZeneca. Any existing agreement regarding the licensing of AZD0364 has been nullified in advance of this agreement between Antengene and AstraZeneca.

Jay Mei, Founder and Chief Executive Officer of Antengene Corporation commented, "We are delighted to have the opportunity to work with AstraZeneca. ERK/RAS/MAPK is a key pathway excessively activated in cancers. AZD0364 is a strategic fit to our pipeline and pre-clinical studies demonstrated promising synergistic effects of AZD0364 in combination with other pipeline assets of Antengene targeting critical pathways in cancer treatment. We look forward to a close collaboration with AstraZeneca to bring more novel therapies to patients with unmet medical needs."

Susan Galbraith, Senior Vice President and Head of Research and Early Development, Oncology R&D, AstraZeneca said: "This collaboration will leverage Antengene’s scientific expertise related to ERK biology and sophisticated development capabilities to further explore AZD0364’s potential benefits to meet unmet medical needs."