On July 17, 2019 Pyxis Oncology ("Pyxis"), a newly formed immuno-oncology company, reported with a focus on developing a new family of antibody-based immunotherapies derived from novel insights into the biology of the tumor microenvironment, reported leaps by Bayer led the Company’s USD 22 million Series A financing and was joined by additional institutional and strategic investors including Agent Capital, Ipsen and Longwood Fund (Press release, Pyxis Oncology, JUL 17, 2019, View Source [SID1234550089]). Pyxis was founded by Thomas Gajewski, MD, PhD, professor of Medicine, Pathology and the Ben May Cancer Institute at the University of Chicago Medicine; Longwood Fund; and John Flavin, seasoned life sciences executive and entrepreneur; with the support of the University of Chicago Polsky Center for Entrepreneurship and Innovation.

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For more than two decades, Dr. Gajewski has studied the role of T cells in the body’s defense against cancer. His work has led to a new understanding of the tumor microenvironment and unlocked multiple new avenues to restore activity to dysfunctional T cells and turn immunologically "cold" tumors "hot." Pyxis is applying these insights to develop a pipeline of antibodies aimed at newly discovered immuno-oncology targets. This could potentially create a new way to treat patients that don’t respond to currently available therapies.

"With our systematic approach for understanding the immunobiology of the tumor microenvironment, which is distinct from other inflammatory disease settings, we have uncovered multiple novel molecules that regulate immune responses against cancer," said Dr. Gajewski. "These molecules represent promising immuno-oncology targets, both for T cell-inflamed tumors and also for non-T cell-inflamed or ‘cold’ tumors, for which there is a large unmet need."

Unlike traditional immuno-oncology development programs, which in many cases originated from infectious disease inflammation models, Pyxis’s approach centers on the most relevant tumor-reactive T cells from the core of growing tumors. By focusing on the unique biology of T cells within tumors, Pyxis identified immunoregulatory targets tied directly to biology of the tumor microenvironment. Pyxis has generated data on these targets through genetic and interventional preclinical proof of concept studies that suggest the potential for new effective foundational monotherapies or use in combination with other cancer therapies.

The ultimate goal of curing or preventing cancer is an area of engagement and investment for Leaps by Bayer, as these therapies in oncology represent one of today’s most important health challenges. Dr. Juergen Eckhardt, head of Leaps by Bayer, said: "We are very excited about the potential of Pyxis’s platform. This is a powerful approach that could lead to the discovery of new targets and therefore novel drugs that can overcome current limitations in the oncology field."

Pyxis is led by an experienced management team and Board of Directors and has assembled a world-class Scientific Advisory Board (SAB) made up of leading authorities in immunology and cancer research. Leaps by Bayer will be actively participating in the Pyxis investment via two representatives on the company’s Board, Dr. Lucio Iannone and Dr. Jak Knowles. In addition, Dr. Vemuri of Agent Capital has also joined the Board in conjunction with the financing. The Board of Directors will be chaired by John Flavin and David Steinberg, Partner at Longwood Fund, will serve as Pyxis’s Chief Executive Officer.

"Immunotherapies have revolutionized the way many cancers are treated, yet they have not been successful in addressing large groups of patients," said Steinberg. "We believe the antibodies we develop directed against T cell and tumor targets will have the potential to help new patient populations not currently served by today’s therapies."

Pyxis’s SAB will be chaired by Dr. Gajewski and will include:

Michael B. Atkins, MD, Deputy Director of the Georgetown-Lombardi Comprehensive Cancer Center and the Scholl Professor and Vice Chair of the Department of Oncology at Georgetown University School of Medicine.
Lisa H. Butterfield, PhD, Vice President of the Parker Institute for Cancer Immunotherapy and Adjunct Professor of Microbiology and Immunology at the University of California, San Francisco.
Alan Korman, PhD, Senior Vice President of Human Immunology at Vir Biotechnology and Former Vice President of Immuno-Oncology Discovery at Bristol-Myers Squibb.
Jason Luke, MD, FACP, Associate Professor of Medicine and Director of the Cancer Immunotherapeutics Center at the University of Pittsburgh School of Medicine.
About Gajewski and the Polsky Center for Entrepreneurship and Innovation
Dr. Gajewski developed the concept for Pyxis in partnership with the technology commercialization team at the University of Chicago’s Polsky Center for Entrepreneurship and Innovation. The Polsky Center works closely with researchers to help them transform their ideas and discoveries into products, services, and ventures. Gajewski has been working with the Polsky Center for more than 10 years, licensing a variety of discoveries and being involved with a number of successful life sciences startups.

On July 17, 2019, Atreca, Inc. (the "Company") reported that it has entered into a Lease Agreement (the "Temporary Lease") between the Company and ARE-EAST JAMIE COURT, LLC (the "Temporary Landlord") for the lease of approximately 74,788 rentable square feet of office space located at 450 East Jamie Court, South San Francisco, California (the "Jamie Court Property") (Filing, 8-K, Atreca, JUL 17, 2019, View Source [SID1234540076]). The Jamie Court Property is intended to serve as the Company’s temporary headquarters, office and laboratory space, replacing its existing office space at 500 Saginaw Drive, Redwood City, California, while the Company’s permanent headquarters, office and laboratory space is under construction.

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The term of the Temporary Lease will commence on the date that the Temporary Landlord delivers the premises of the Jamie Court Property to the Company and is targeted for August 1, 2019, and will end on the earliest of (1) 90 days following the substantial completion of certain tenant improvements and construction on the San Carlos Property (as defined below), (2) 90 days following notice from the Temporary Landlord to the Company in the event that certain tenant improvements on the San Carlos Property have not been substantially completed prior to the Rent Commencement Date (as defined below) for any reason other than delays caused by the 835 Industrial Landlord (as defined below), and (3) 90 days following the termination of the 835 Industrial Lease (as defined below) if the 835 Industrial Lease terminates prior to the Rent Commencement Date. The "Rent Commencement Date" is the earlier of (1) 10.5 months following the date that the 835 Industrial Landlord delivers the premises of the San Carlos Property to the Company to begin certain tenant improvements thereto and (2) the date that certain tenant improvements on the San Carlos Property are substantially completed.

The Company’s base rent for the Temporary Lease is $280,455.00 per month, with annual increases of 3% multiplied by the base rent payable of the preceding year. In addition, the Company is responsible for 100% of the operating expenses for the Jamie Court Property (and 45.79% of the project operating expenses) as set forth in the Temporary Lease.

The Temporary Lease also contains customary provisions allowing the Temporary Landlord to terminate the Temporary Lease if the Company fails to remedy a breach of certain of its obligations as set forth in the Temporary Lease within specified time periods, or upon bankruptcy or insolvency of the Company.

Permanent Lease

On July 17, 2019 and concurrently with the execution and delivery of the Temporary Lease, the Company entered into a Lease Agreement (the "835 Industrial Lease") between the Company and ARE-SAN FRANCISCO NO. 63, LLC (the "835 Industrial Landlord") for the lease of approximately 99,557 rentable square feet of office space located at 835 Industrial Road, San Carlos, California (the "San Carlos Property"). The San Carlos Property is intended to serve as the Company’s permanent headquarters, office and laboratory space following the completion of construction on the San Carlos Property.

The term of the 835 Industrial Lease will commence on the date that the 835 Industrial Landlord delivers the premises of the San Carlos Property to the Company for construction of certain tenant improvements and is targeted for August 1, 2020, and will end on the date that is 144 months from the first day of the first full month after the Rent Commencement Date. The Company has the right to extend the term of the 835 Industrial Lease once for five years on substantially the same terms and conditions of the 835 Industrial Lease, subject to market-rate adjustment of the Base Rent pursuant to the terms of the 835 Industrial Lease, by giving the 835 Industrial Landlord written notice at least 9 months but not more than 15 months prior to the expiration of the initial term of the 835 Industrial Lease.

The Company’s base rent for the 835 Industrial Lease is $557,519.20 per month, with annual increases of 3% multiplied by the base rent payable of the preceding year. In addition, the Company is responsible for certain operating expenses as set forth in the 835 Industrial Lease. The Company is also obligated to provide a security deposit of $1,115,038.40.

The first time after the 835 Industrial Landlord leases the leasable space located on the second floor of the building at the San Carlos Property (the "ROFR Space") to another third party that the 835 Industrial Landlord intends to accept another bona fide written proposal to lease the ROFR Space (the "Intended Lease"), the 835 Industrial Landlord shall deliver notice to the Company of the Intended Lease, and the Company shall have a one-time right of first refusal to elect to lease the ROFR Space on the same general terms and conditions of the 835 Industrial Lease, as modified to reflect the terms and conditions of the Intended Lease.

The 835 Industrial Lease also contains customary provisions allowing the 835 Industrial Landlord to terminate the 835 Industrial Lease if the Company fails to remedy a breach of certain of its obligations as set forth in the 835 Industrial Lease within specified time periods, or upon bankruptcy or insolvency of the Company.

The foregoing descriptions of the Temporary Lease and the 835 Industrial Lease are only summaries and are qualified in their entirety by reference to the complete terms and conditions of the Temporary Lease and the 835 Industrial Lease, which are attached as Exhibits 10.18 and 10.19 to this Current Report on Form 8-K and incorporated herein by reference.

On July 17, 2019 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported the pricing of an underwritten public offering of 2,300,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase up to 2,300,000 shares of the Company’s common stock (Press release, Xenetic Biosciences, JUL 17, 2019, View Source [SID1234537586]). Each share of common stock is being sold together with one warrant to purchase one share of common stock at a combined price to the public of $6.50 per share and warrant. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $15.0 million.

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The warrants will be immediately exercisable at a price of $13.00 per share of common stock and will expire five years from the date of issuance. The warrants are expected to begin trading on the Nasdaq Capital Market on July 19, 2019 or as soon thereafter as practicable, under the symbol "XBIOW." The warrants also provide that if the weighted-average price of common stock on any trading day on or after 30 days after issuance is lower than the then-applicable exercise price per share, each warrant may be exercised, at the option of the holder, on a cashless basis for one share of common stock. The shares of common stock and the accompanying warrants, can only be purchased together in the offering, but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about July 19, 2019, subject to customary closing conditions.

Maxim Group LLC is acting as sole book-running manager in connection with the offering.

Xenetic also has granted to the underwriter a 45-day option to purchase up to an additional 345,000 shares of common stock and/or warrants to purchase up to 345,000 shares of common stock, at the public offering price less discounts and commissions.

The offering is being conducted pursuant to the Company’s registration statement on Form S-1 (File No. 333-231508) previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). A prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the prospectus relating to this offering, when available, may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.

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

On July 17, 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 that it plans to advance the development of flotetuzumab, its investigational bispecific CD123 x CD3 DART molecule, in patients with primary refractory acute myeloid leukemia (AML), a difficult-to-treat patient population (Press release, MacroGenics, JUL 17, 2019, View Source [SID1234537584]).

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To date, MacroGenics has enrolled 50 patients at the recommended Phase 2 dose (RP2D) in the Phase 1 monotherapy study, including 30 patients with primary refractory AML. The updated clinical data from this study will be submitted for presentation at the 2019 American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. MacroGenics plans to meet with the FDA in the third quarter to discuss future development of flotetuzumab, and to define a potential registration path for this molecule as monotherapy.

In parallel, MacroGenics plans to initiate a study in relapsed or refractory AML patients combining flotetuzumab with MGA012, a proprietary anti-PD-1 antibody, as a potential means to both broaden and lengthen the duration of response of AML patients on flotetuzumab. The combination is supported by a strong scientific rationale based on data previously reported by MacroGenics. The Company is positioned to begin to enroll patients imminently.

MacroGenics and Laboratoires Servier will terminate their collaboration and license agreement, with an effective date of January 15, 2020, unless sooner agreed to by the parties. As a result, MacroGenics will regain full global rights to develop and commercialize flotetuzumab. MacroGenics entered into an agreement with Servier in September 2012 to develop and commercialize flotetuzumab and other earlier stage DART molecules, in all regions other than North America, Japan, South Korea and India. Servier recently informed MacroGenics of its intention to terminate the agreement.

"We have made significant progress to advance flotetuzumab during our collaboration with Servier and we thank them for their participation," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "As MacroGenics has been leading the ongoing multi-national clinical effort, we anticipate no disruption or impact to our continued development of flotetuzumab and are excited about the potential of the program going forward."

About Flotetuzumab

Flotetuzumab is a clinical-stage bispecific DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, is over-expressed on cancer cells in a wide range of hematological malignancies, including AML and myelodysplastic syndromes (MDS). 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. Data from 31 patients were presented at the ASH (Free ASH Whitepaper) Annual Meeting in December 2018, demonstrating anti-leukemic activity in patients with relapsed/refractory AML. In 27 response evaluable patients, the overall response rate (ORR) was 26% (7/27), with a complete response (CR) rate (a composite of both CR and CRi responses) of 19% (5/27). Notably, in primary refractory patients, an extremely challenging population to treat, the ORR was 35% (6/17) with a CR rate of 29% (5/17). The most common treatment-related adverse event (TRAE) was infusion-related reaction/cytokine release syndrome (IRR/CRS), and occurred in 93% (29/31) of patients. Grade 3 or greater IRR/CRS was observed in 13% (4/31) of patients.

The U.S. Food and Drug Administration has granted orphan drug designation to flotetuzumab for the treatment of AML.

On July 17, 2019 Marker Therapeutics, Inc. (NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported it will host a conference call and webcast with a question-and-answer session on Monday, July 22, 2019 at 5:30 a.m. PDT/ 8:30 a.m. EDT to review data from an investigator-sponsored Phase 1/2 clinical trial with its MultiTAA therapy in patients with pancreatic adenocarcinoma (Press release, Marker Therapeutics, JUL 17, 2019, https://www.prnewswire.com/news-releases/marker-therapeutics-to-host-conference-call-and-webcast-to-review-interim-results-from-phase-12-clinical-trial-with-its-multitaa-t-cell-therapy-in-patients-with-pancreatic-adenocarcinoma-300886184.html [SID1234537582]). The data will also be reviewed in plenary and poster sessions on Saturday, July 20 at a cell therapy conference hosted by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in San Francisco by Brandon G. Smaglo, M.D., FACP, Assistant Professor, Medical Director of Hematology/Oncology at the Baylor College of Medicine, Houston, Texas.

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The live conference call and webcast will be accessible in the Investors section of the Company’s website at www.markertherapeutics.com. The archived webcast will be available for replay on the Marker website following the event.