On May 27, 2020 Tetraphase Pharmaceuticals, Inc. (Nasdaq:TTPH), a biopharmaceutical company focused on commercializing its novel tetracycline XERAVA (eravacycline for injection) to treat serious and life-threatening infections, reported that it has entered into an amendment to the Agreement and Plan of Merger, dated March 15, 2020, to which the Company is a party with AcelRx Pharmaceuticals, Inc. ("AcelRx") and its merger subsidiary (the "Merger Agreement"), to increase the consideration payable to Tetraphase shareholders (Press release, Tetraphase, MAY 27, 2020, View Source [SID1234558540]).

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Under the amended Merger Agreement, Tetraphase stockholders will receive, for each share of Tetraphase common stock, (1) $0.2434 in cash and 0.7217 of a share of AcelRx common stock, representing approximately $1.43 in upfront per share value, based on the closing price of AcelRx’s common stock as of the close of trading on May 26, 2020, in each case subject to downward adjustment in the event that the Company’s closing net cash is less than $5.0 million, and (2) one contingent value right ("CVR"), which would entitle the holders to receive potential aggregate payments of up to $14.5 million in cash upon the achievement of certain future XERAVA net sales milestones starting in 2021. Under the terms of the Merger Agreement prior to the amendment, upon the consummation of the transaction, Tetraphase stockholders were entitled to receive for each share of Tetraphase common stock, 0.6303 of a share of AcelRx common stock, subject to downward adjustment in the event that the Company’s closing net cash is less than $5.0 million, and one CVR, which would have entitled the holders to receive potential aggregate payments of up to $12.5 million in cash or AcelRx stock, at AcelRx’s option upon the achievement of future XERAVA net sales milestones starting in 2021.

AcelRx proposed the amendment to the Merger Agreement in response to a proposal from Melinta Therapeutics, Inc. ("Melinta"), on May 21, 2020, to acquire Tetraphase for $27.0 million in cash (or $1.21 per share of Tetraphase common stock), plus an additional $12.5 million in cash potentially payable under CVRs upon the achievement of certain future XERAVA net sales milestones starting in 2021.

The boards of directors of Tetraphase and AcelRx have each approved the amendment to the Merger Agreement. Tetraphase’s board of directors has determined that as a result of the amendment to the Merger Agreement with AcelRx, Melinta’s proposal is not superior and recommends the Merger Agreement, as amended by the amendment, to its stockholders.

Based on the closing price of AcelRx stock on May 26, 2020, the total upfront consideration to be received by Tetraphase equityholders is valued at approximately $31.9 million, with approximately $16.5 million of this amount allocated to the Company’s outstanding common stock warrants. In the merger, Tetraphase stockholders would also be entitled to receive, for each share of Tetraphase common stock, one non-tradeable CVR, the holders of which will be entitled to receive potential payments of up to an additional $14.5 million in cash in the aggregate upon the achievement of net sales of XERAVA in the United States, payable as follows: (i) $2.5 million upon annual net sales of $20.0 million during 2021, (ii) $4.5 million upon annual net sales of $35.0 million during any year ending on or before December 31, 2024 and (iii) $7.5 million upon annual net sales of $55.0 million during any year ending on or before December 31, 2024.

Tetraphase continues to plan to hold its special meeting of stockholders to approve the pending transaction on June 8, 2020. The transaction is expected to close in June 2020, subject to specified closing conditions, including Tetraphase having a minimum amount of net cash as of the closing and approval by Tetraphase stockholders. Upon the closing of the transaction, Tetraphase will become a privately held company and shares of Tetraphase’s common stock will no longer be listed on any public market. Subject to certain limited exceptions, the CVRs will be non-transferable.

Janney Montgomery Scott LLC is acting as financial advisor to Tetraphase and Wilmer Cutler Pickering Hale and Dorr LLP is acting as legal advisor.

On May 27, 2020 Gilead Sciences, Inc. (NASDAQ: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapeutics, reported that the companies have entered into a 10-year partnership to co-develop and co-commercialize current and future therapeutic product candidates in Arcus’s pipeline (Press release, Gilead Sciences, MAY 27, 2020, View Source [SID1234558539]). The agreement will also provide ongoing funding to support Arcus’s research and development programs.

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Arcus is building an extensive and diverse portfolio of investigational products that target important mechanisms involved in tumor evasion of the immune system, as well as developing drug candidates that target cell-intrinsic pathways important for cancer growth and metastasis. In addition to small molecule products, Arcus is also advancing antibody products that target immune checkpoint receptors, including PD-1 and TIGIT. Arcus currently has a clinical-stage pipeline of four immuno-oncology programs, as well as an active oncology discovery pipeline with six preclinical compounds that target critical biological pathways. A core component of Arcus’s strategy is the development of intra-portfolio combinations that include small-molecule and antibody product candidates. Arcus has 10 ongoing clinical studies of molecules in its portfolio, including a randomized Phase 2 study in first-line non-small cell lung cancer evaluating combinations of three Arcus product candidates: AB154, an investigational anti-TIGIT monoclonal antibody; AB928, an investigational A2aR/A2bR antagonist; and zimberelimab (AB122), an investigational anti-PD-1 monoclonal antibody.

"We are very pleased to build on Gilead’s growing presence in immuno-oncology with this important new strategic collaboration with Arcus," said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. "Gilead is committed to accessing the world’s best innovation in immuno-oncology and our agreement with Arcus further demonstrates that commitment. By gaining access to its broad, diverse pipeline and Arcus’s clear strengths in discovery and development, we believe that our partnership with Arcus will significantly accelerate our progress in developing transformative new therapies for cancer."

"We believe Gilead is an ideal partner for Arcus with its focus on thoughtful and purposeful science, vision to provide transformational therapies in the oncology setting and deeply experienced scientific leadership," said Terry Rosen, PhD, Chief Executive Officer, Arcus. "This collaboration will allow us to act as one team to maximize the clinical and commercial potential of Arcus’s therapeutic development candidates, greatly amplifying and expediting the opportunities in our pipeline and discovery programs. At the same time, this partnership structure facilitates Arcus’s path to becoming an independent, fully integrated biopharmaceutical company."

Terms of the Partnership

Under the terms of the agreement, Arcus will receive $375 million upon closing, consisting of a $175 million upfront payment and a $200 million equity investment from Gilead. Arcus is eligible to receive up to $1.225 billion in opt-in and milestone payments with respect to its current clinical product candidates. Gilead will gain access to Arcus’s current and future investigational immuno-oncology products through the agreement, as Gilead continues to expand its presence in the field. This includes immediate rights to zimberelimab, as well as the right to opt-in to all other current Arcus clinical candidates, which include AB154, AB928 and AB680, upon payment of an opt-in fee that ranges from $200 million to $275 million per program, after delivery of a qualifying data package. If Gilead opts-in to the AB154 program, Arcus is eligible to receive up to $500 million in potential future U.S. regulatory approval milestones.

Gilead will receive the right to opt-in to all other programs that emerge from Arcus’s research portfolio over the next 10 years, upon payment of an opt-in fee of $150 million per program after Arcus’s delivery of a qualifying data package.

Upon Gilead’s exercise of its option for a program, unless Arcus opts out according to terms of the agreement, the companies will co-develop and share global development costs and will co-commercialize and share profits in the United States. Gilead will obtain exclusive rights to commercialize any optioned programs outside of the U.S., subject to any rights of Arcus’s existing partners, and for which Gilead will pay to Arcus tiered royalties ranging from high-teens to low twenties. Gilead will further provide ongoing research and development support of up to $400 million over the collaboration term.

Gilead will have the right to appoint two individuals to Arcus’s Board of Directors upon closing of the transaction.

Terms of the Equity Investment

Gilead’s $200 million equity investment will be at a price per share of $33.54. Additionally, Gilead will have the right to purchase additional shares from Arcus, up to a maximum of 35% of the outstanding voting stock of Arcus over the course of the next five years, at a 20% premium at the time Gilead exercises such option, or, if greater, at the initial purchase price per share.

This transaction, which is expected to close in the third quarter of 2020, is subject to applicable antitrust clearance under the Hart-Scott Rodino Antitrust Improvements Act and other customary closing conditions.

Cowen and Morgan Stanley & Co. LLC are acting as financial advisors to Gilead. Citi is acting as financial advisor to Arcus. Covington & Burling LLP, Skadden, Arps, Slate, Meagher & Flom LLP and Venable LLP are serving as legal counsel to Gilead and Cooley is serving as legal counsel to Arcus.

Zimberelimab, AB928, AB680 and AB154 are investigational and not approved anywhere globally. Their efficacy and safety have not been established. More information about clinical trials with zimberelimab, AB928, AB680 and AB154 is available at www.clinicaltrials.gov.

Arcus Conference Call

At 5:00 a.m. Pacific Time/8:00 a.m. Eastern Time today, Arcus’s management will host a conference call and a simultaneous webcast to discuss the transaction. A live webcast of the call can be accessed by visiting the "Investors" section of Arcus’s website at www.arcusbio.com. Please connect to the website at least 15 minutes prior to the start of the call to allow adequate time for any software download that may be required. Alternatively, please call (877) 209-6698 (U.S.) or (825) 312-2373 (International) and dial the conference ID 1827008 to access the call. A replay of the webcast will be available approximately two hours after the call through 14 days following the live event.

On May 27, 2020 Synlogic (Nasdaq: SYBX) reported that will host its first Virtual R&D Event which will include presentations from members of the Synlogic executive team providing an in-depth review of Synlogic’s Synthetic Biotic platform and programs for the treatment of metabolic diseases, inflammatory and immune disorders, and cancer (Press release, Synlogic, MAY 27, 2020, View Source [SID1234558538]). In addition, guest speaker David S. Goldfarb, M.D., Professor of Medicine and Physiology, NYU School of Medicine, Clinical Chief, Nephrology Division, NYU Langone Health, Chief, Nephrology Section, New York VA Medical Center, will present an overview of enteric hyperoxaluria and a patient perspective.

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Registration information for the event can be accessed under "Event Calendar" in the Investors & Media section of the Synlogic website. The R&D Event presentations are scheduled to begin at 12:30 pm ET today, May 27, 2020. A live audio webcast of the presentation and a slide deck will be available via the company’s Investor Relations website. Following the live webcast, an archived version will be available on the website for 90 days.

On May 27, 2020 John Theurer Cancer Center (JTCC), at Hackensack Meridian Health Hackensack University Medical Center in New Jersey, and Genomic Testing Cooperative (GTC), Irvine, CA, reported an agreement to establish a state-of-the-art, next generation sequencing (NGS) laboratory for molecular profiling (Press release, Genomic Testing Cooperative, MAY 27, 2020, View Source [SID1234558537]). This NGS laboratory, located at John Theurer Cancer Center, will serve all physicians within Regional Cancer Care Associates (RCCA), a network of cancer care professionals in New Jersey, Connecticut, and Maryland.

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As a leading cancer institute and a member of the NCI-approved Georgetown Lombardi Comprehensive Cancer Center Consortium, John Theurer Cancer Center will perform molecular profiling of all cancers in its patients with solid tumors or blood cancers. The results of such profiling will facilitate precision medicine: matching patients with therapies that target the molecular abnormalities driving the growth of their cancers. Furthermore, this molecular profiling will drive the expansion of the cancer center’s innovation and dedication to advancing the science of oncology practice in the community.

The John Theurer Cancer Center NGS laboratory will adapt highly validated tests developed by GTC for DNA and RNA profiling. Paired DNA and RNA profiling is increasingly employed in genomics research to uncover molecular mechanisms underlying the development and progression of disease and to explore personal genotype and phenotype correlations.

"Collaborations such as these demonstrate the commitment of the Hackensack Meridian Health system to improving the care of people with cancer, one of the country’s most common illnesses and a leading cause of death in the United States," noted Robert C. Garrett, FACHE, chief executive officer, Hackensack Meridian Health. "Technologies such as NGS with DNA and RNA profiling put us at the forefront of cancer care and research."

"The sophisticated algorithms and artificial intelligence software used for analyzing sequencing data and linking them to clinical data are based on deep knowledge in technical and clinical needs," added Andre Goy, MD, physician-in-chief for Oncology at Hackensack Meridian Health and chair of John Theurer Cancer Center.

"We are delighted to be working with the team at GTC. We selected GTC tests because of the significant diligence and scientific rigor used in their development," said David S. Siegel, MD, PhD, chief, Myeloma Division at John Theurer Cancer Center and founding director, Institute for Multiple Myeloma at the Hackensack Meridian Center for Discovery and Innovation. "We believe that profiling both RNA and DNA in cancers is crucial — not only for increasing accuracy and providing thorough evaluation, but also for innovation and the development of new clinical research approaches."

"Given the increasing number of novel therapies, particularly targeted therapies in solid tumors, having the ability to identify ‘mutation drivers’ that help us make healthcare decisions is becoming an increasingly routine practice in oncology," said Martin Gutierrez, MD, head of Phase I and Thoracic Oncology at John Theurer Cancer Center. "Real world experience have shown that this genomic information should be used more frequently to improve patients’ outcomes."

Maher Albitar, MD, chief executive officer and chief medical officer at GTC, stated, "Working with John Theurer Cancer Center to establish an NGS laboratory at a patient care site aligns with our mission as a cooperative company focused on making high-quality molecular profiling available and affordable for every patient with cancer. Furthermore, this collaboration will allow GTC to co-develop new tests with John Theurer Cancer Center by utilizing clinical and outcomes data from John Theurer Cancer Center, which will accelerate innovation in oncology and result in better patient care."

"When you help one person overcome cancer, you make life better for their families, friends, and coworkers, too," explained Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center and executive vice president of Population Health, Hackensack Meridian Health. "Bringing a tool like NGS into the routine care of people with cancer can improve lives — and by extension, entire communities."

"Cancer affects many residents and their loved ones in northern New Jersey. Having NGS at John Theurer Cancer Center, coupled with the technologies of GTC, puts our doctors in a strong position to better understand what is driving the growth of their patients’ cancers so they can match them with the most effective therapies," said Ihor Sawczuk, MD, FACS, Regional President of the Northern Market. "We are incredibly fortunate to have this resource right here in Hackensack."

More than 30,000 new cancer patients are treated by RCCA physicians annually. John Theurer Cancer Center participates in more than 350 ongoing clinical trials.

About Hackensack Meridian Health

Hackensack Meridian Health is a leading not-for-profit health care organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care.

Hackensack Meridian Health comprises 17 hospitals from Bergen to Ocean counties, which includes three academic medical centers – Hackensack University Medical Center in Hackensack, Jersey Shore University Medical Center in Neptune, JFK Medical Center in Edison; two children’s hospitals – Joseph M. Sanzari Children’s Hospital in Hackensack, K. Hovnanian Children’s Hospital in Neptune; nine community hospitals – Bayshore Medical Center in Holmdel, Mountainside Medical Center in Montclair, Ocean Medical Center in Brick, Palisades Medical Center in North Bergen, Pascack Valley Medical Center in Westwood, Raritan Bay Medical Center in Old Bridge, Raritan Bay Medical Center in Perth Amboy, Riverview Medical Center in Red Bank, and Southern Ocean Medical Center in Manahawkin; a behavioral health hospital – Carrier Clinic in Belle Mead; and two rehabilitation hospitals – JFK Johnson Rehabilitation Institute in Edison and Shore Rehabilitation Institute in Brick.

Additionally, the network has more than 500 patient care locations throughout the state which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, urgent care centers and physician practice locations. Hackensack Meridian Health has more than 34,100 team members, and 6,500 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

The network’s notable distinctions include having four hospitals among the top 10 in New Jersey by U.S. News and World Report. Other honors include consistently achieving Magnet recognition for nursing excellence from the American Nurses Credentialing Center and being named to Becker’s Healthcare’s "150 Top Places to Work in Healthcare/2019" list.

The Hackensack Meridian School of Medicine at Seton Hall University, the first private medical school in New Jersey in more than 50 years, welcomed its first class of students in 2018 to its On3 campus in Nutley and Clifton. Additionally, the network partnered with Memorial Sloan Kettering Cancer Center to find more cures for cancer faster while ensuring that patients have access to the highest quality, most individualized cancer care when and where they need it.

Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

For additional information, please visit www.HackensackMeridianHealth.org.

About the Center for Discovery and Innovation

The Center for Discovery and Innovation, a newly established member of Hackensack Meridian Health, seeks to translate current innovations in science to improve clinical outcomes for patients with cancer, infectious diseases and other life-threatening and disabling conditions. The CDI, housed in a fully renovated state-of-the-art facility, offers world-class researchers a support infrastructure and culture of discovery that promotes science innovation and rapid translation to the clinic.

On May 27, 2020 GT Biopharma, Inc. (OTCQB:GTBP) (GTBP.PA) an immuno-oncology company focused on NK cell engager (TriKE) technology. GT reported that the second patient of the lowest dose of an ascending dose finding study has begun treatment of the GTB-3550 TriKE (Press release, GT Biopharma, MAY 27, 2020, View Source [SID1234558535]). The patient will be evaluated following completion of the third cycle of GTB-3550 TriKE therapy. The clinical trial is being conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis. Additional clinical trial sites are now being processed.

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The first patient of the Phase I/II study achieved stable disease and increased NK cell production with no adverse side effects. The first patient elicited an encouraging initial efficacy marker response.

The TRIKE clinical trial evaluates GTB-3550 in patients with acute myeloid leukemia or advanced systemic mastocytosis, and will determine safety and tolerability as well as the pharmacologically active dose and maximum tolerated dose of GTB-3550.

TriKE is a multi-targeted immuno-oncology protein-based therapeutic drug. The TriKE addresses the patient delivery and administration issues of liquid tumor cell therapies and NK engagers. Pre-clinical data shows that The TriKE platform technology works in both liquid and solid tumors.

About GTB-3550 Trispecific NK cell Engager (TriKE)

GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. The Company is currently in a clinical trial with GTB-3550 in CD33 positive leukemia for acute myeloid leukemia (AML), and is studying myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies along with other solid tumor candidates.