On August 1, 2019 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported that the Company will release its second quarter 2019 financial results after the market closes on Thursday, August 8, 2019 (Press release, Synlogic, AUG 1, 2019, View Source [SID1234538020]). The press release will be followed by a conference call at 5:00 pm ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

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The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 6968273. Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.

On August 1, 2019 I-Mab Biopharma (I-Mab), a China and U.S.-based clinical stage biopharmaceutical company exclusively focusing on the discovery and development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases, and TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, jointly reported that TRACON has dosed the first patient in a U.S. Phase 1 first-in-human clinical trial of I-Mab’s proprietary CD73 antibody TJD5, also known as TJ004309, in patients with advanced solid tumors (NCT identifier number: NCT03835949) (Press release, Tracon Pharmaceuticals, AUG 1, 2019, View Source [SID1234538036]). TJD5 will be dosed in the Phase 1 trial both as a single agent and in combination with TECENTRIQ (atezolizumab), a PD-L1 antibody marketed by Roche. I-Mab entered into a research collaboration with Roche in April 2019 where Roche agreed to supply TECENTRIQ to I-Mab for use in clinical study in combination with TJD5.

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The multicenter, open-label, dose escalation Phase 1 study will evaluate safety and tolerability of TJD5, and determine a recommended dose for further clinical studies of its efficacy and safety as a single agent and in combination with standard dose TECENTRIQ in patients with advanced or metastatic cancer who are refractory to or intolerant of all available therapy.

TJD5, a novel, differentiated humanized antibody against CD73, is from I-Mab’s proprietary discovery pipeline being co-developed through a corporate collaboration between TRACON and I-Mab signed in November 2018. The two companies have a second broader strategic partnership to develop up to five bispecific antibodies from I-Mab’s immuno-oncology portfolio.

"TJD5 builds on earlier successes of I-Mab’s proprietary innovative pipeline and is the third internally discovered drug candidate to enter clinical studies in the U.S. This clinical milestone is the result of our well-executed ‘Fast-to-PoC (proof of concept) Global Approach’ to advancing our proprietary innovative drug candidates towards clinical validation in the United States, and a testament to the productive strategic partnership with TRACON," said Joan Shen, M.D., Ph.D., Head of R&D of I-Mab. "Treatment resistance to PD-1/PD-L1 is one of the major challenges across cancer types. We hope the combination of TJD5 and TECENTRIQ will provide a novel treatment option to address the unmet medical needs."

"Submitting the IND and dosing the initial cancer patient with TJD5 following the signing of our first partnership agreement with I-Mab is an important milestone, as we have both expanded our pipeline in immuno-oncology and further demonstrated TRACON’s product development capabilities designed to reduce the cost and time of clinical development for our partners," commented Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We will continue to work with I-Mab to optimize the clinical development of TJD5, an antibody with global best-in-class potential."

About TJD5 (TJ004309)

TJD5 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJD5 is in a Phase 1 clinical trial in the US to assess the tolerability and preliminary efficacy as a single agent and in combination with TECENTRIQ, a PD-L1 antibody marketed by Roche, in patients with advanced solid tumors. The antibody is also expected to be studied in clinical trials in China sponsored by I-Mab.

On August 1, 2019 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the second quarter and six months ended June 30, 2019 (Press release, CTI BioPharma, AUG 1, 2019, View Source [SID1234538052]).

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"We remain focused on advancing our development program for pacritinib in the U.S. for the treatment of myelofibrosis patients with severe thrombocytopenia," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "In June, we met with the U.S. Food and Drug Administration (FDA), and following that meeting, plan to evaluate the 200 mg twice-daily dose of pacritinib in the new PACIFICA Phase 3 trial. We have submitted for FDA review an amendment to the PAC203 protocol to allow a rapid transition to the PACIFICA Phase 3 trial, which we expect to initiate in the third quarter of 2019. In addition, based on multiple requests from physicians, in May we made the decision to undertake a pacritinib Expanded Access Program (EAP) for patients in the PAC203 trial. To facilitate this, we have extended the PAC203 trial to enable the patients to continue to receive uninterrupted treatment through the start of the EAP. In light of this change, we now intend to first report results from the PAC203 Phase 2 trial at a scientific conference before the end of the year."

Recent Updates
Following a Type B, End-of-Phase-2a meeting with the FDA in June, the Company announced that it plans to evaluate 200 mg of pacritinib administered twice daily (BID) compared to Physician’s Choice in a Phase 3 trial of 180 patients with myelofibrosis and severe thrombocytopenia (platelet counts of less than 50,000 per microliter).

In July 2019, the Company submitted an amendment to the PAC203 trial protocol to allow a transition to the new PACIFICA Phase 3 trial. The Company plans to initiate the PACIFICA Phase 3 trial in the third quarter of 2019.

Expected 2019 Milestones

Initiate PACIFICA Phase 3 trial of pacritinib in myelofibrosis patients with severe thrombocytopenia – Q3 2019
Report safety and efficacy data from the PAC203 Phase 2 trial at a scientific conference before the end of 2019
Second Quarter Financial Results
License and contract revenues for the three and six months ended June 30, 2019 were $0.4 million and $1.1 million, respectively, compared to $0.6 million and $11.5 million for the respective periods in 2018. The decrease in license and contract revenues for the three months ended June 30, 2019 compared to the comparable period in 2018 is primarily due to a decrease in development services revenue from our partners Les Laboratoires Servier and Institut de Recherches Internationales Servier. The decrease in license and contract revenues for the six months ended June 30, 2019 compared to the same period in 2018 is primarily due to the recognition of $10.0 million in milestone revenue in 2018 from Teva Pharmaceutical Industries Ltd. related to the achievement of a milestone for FDA approval of TRISENOX (arsenic trioxide) for first-line treatment of acute promyelocytic leukemia. There were no such revenues for the comparable period in 2019.

Operating loss was $11.0 million and $21.5 million for the three and six months ended June 30, 2019, respectively, compared to operating loss of $14.0 million and $18.3 million for the respective periods in 2018. Operating loss during the three-month period ended June 30, 2019 as compared to the comparable period in 2018 resulted primarily from a decrease in research and development expenses. Operating loss for the six months ended June 30, 2019 as compared to the same period in 2018 resulted primarily from the decrease in license and contract revenues as mentioned above, as well as a decrease in research and development expenses.

Net loss attributable to common stockholders for the three months ended June 30, 2019 was $11.0 million, or $(0.19) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $11.3 million, or $(0.20) for basic and diluted loss per share, for the same period in 2018. Net loss attributable to common stockholders for the six months ended June 30, 2019 was $21.8 million, or $(0.38) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $15.4 million, or $(0.29) for basic and diluted loss per share, for the same period in 2018.

As of June 30, 2019, cash, cash equivalents and short-term investments totaled $53.7 million, compared to $67.0 million as of December 31, 2018.

On August 1, 2019 Pfizer Inc. (NYSE: PFE) reported the closing of its joint venture with GlaxoSmithKline plc (NYSE: GSK) to combine the parties’ respective consumer healthcare businesses to create the world’s largest over-the-counter (OTC) business with robust iconic brands (Press release, Pfizer, AUG 1, 2019, View Source [SID1234553276]). As previously announced, under the terms of the transaction, Pfizer owns a 32% equity stake in the joint venture and GSK owns 68%. The combined business, which will operate globally as GSK Consumer Healthcare, will be led by CEO Brian McNamara.

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"The successful closing of the joint venture represents an important and exciting step in forming a world-class pure-play consumer healthcare business," said Albert Bourla, Chief Executive Officer, Pfizer. "It also furthers Pfizer’s evolution to be a more focused, global leader in science-based, innovative medicines that delivers breakthroughs that change patients’ lives and creates long-term value for shareholders."

The combined brand portfolio forms the world’s largest OTC business with leadership positions in pain relief, respiratory and vitamins, minerals and supplements, and therapeutic oral health. In addition, operating together, the two business will hold the number one OTC position in the U.S. and the number two OTC position in China – the two biggest OTC markets in the world.

As part of the agreement, three out of the nine members of the joint venture’s board have been appointed by Pfizer and include John Young, Group President, Chief Business Officer; Douglas Giordano, Senior Vice President, Worldwide Business Development and Bryan Supran, Senior Vice President, Deputy General Counsel. The transaction is expected to deliver $650 million in peak cost synergies and to be slightly accretive on a full-year basis for Pfizer in each of the first three years following the closing.

GSK intends to separate the joint venture as an independent company via a demerger of its equity interest to its shareholders and a listing of the joint venture on the UK equity market. GSK will have the sole right to decide whether and when to initiate a separation and listing for a period of five years following the closing. GSK may also sell all or part of its stake in the joint venture in a contemporaneous IPO.

Should a separation and listing occur during the first five years after closing, Pfizer has the option to participate through the distribution of its equity interest in the joint venture to its shareholders or the sale of its equity interest in a contemporaneous IPO. After the fifth anniversary of the closing, both GSK and Pfizer will have the right to decide whether and when to initiate a separation and public listing of the joint venture.

On August 1, 2019 Nektar Therapeutics (Nasdaq: NKTR) and Bristol-Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb’s Opdivo(nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma (Press release, Bristol-Myers Squibb, AUG 1, 2019, View Source [SID1234538005]). The Breakthrough Therapy Designation is based on clinical data which were recently reported at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from the cohort of patients with metastatic melanoma that were treated with the doublet therapy in the ongoing PIVOT-02 Phase 1/2 clinical study.

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FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines aimed at treating a serious or life-threatening disease where there is preliminary clinical evidence that the investigational therapy may offer substantial improvement over existing therapies on at least one clinically significant endpoint.

Bempegaldesleukin, Nektar’s lead immuno-oncology candidate, is an investigational CD122-preferential IL-2 pathway agonist designed to provide activation and proliferation of cancer-killing immune cells, known as CD8+ effector T cells and natural killer (NK) cells. A Phase 3 clinical trial evaluating bempegaldesleukin in combination with nivolumab versus nivolumab in first-line advanced melanoma patients is currently recruiting patients (NCT03635983).

"In collaboration with our partner Bristol-Myers Squibb, we plan to work closely with FDA as we continue to advance our development program of bempegaldesleukin in combination with nivolumab in advanced melanoma patients," said Dr. Stephen Doberstein, SVP, Research and Development and Chief R&D Officer of Nektar Therapeutics. "Our teams are encouraged by the deepening of responses we observed in patients with previously untreated advanced melanoma who received the doublet therapy in our PIVOT-02 study. We look forward to continuing to provide updated results at a future medical meeting as the data mature further in this ongoing cohort of melanoma patients."

In February 2018, Bristol-Myers Squibb and Nektar executed a global strategic development and commercialization collaboration for bempegaldesleukin.

About Bempegaldesleukin (NKTR-214)
Bempegaldesleukin is designed to stimulate cancer-killing immune cells in the body by targeting CD122 receptors found on the surface of these immune cells. CD122, which is also known as the Interleukin-2 receptor beta subunit, is a key signaling receptor that is known to increase proliferation of these effector T cells.1 In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.2,3