On August 19, 2018 Harbour BioMed reported it has entered into an exclusive strategic partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech) to develop and commercialize A167, an anti-PD-L1 antibody in Phase 2 clinical development, worldwide outside of the Greater China region (Press release, Harbour BioMed, AUG 19, 2018, View Source [SID1234528980]). The companies will also collaborate in developing combination therapies of A167 with other agents for commercialization in their respective territories. The potential value of the partnership exceeds $350 million in addition to royalties.

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"Anti-PD-L1 therapy has been validated in many clinical trials in the Immuno-Oncology area. A167 has significant potential as a single agent and as the foundation for combination therapy with other innovative drugs. We are delighted to advance A167 globally and work closely with Kelun-Biotech to achieve its therapeutic potential," said Dr. Jingsong Wang, Harbour BioMed’s founder, Chairman and Chief Executive Officer. "We plan to conduct A167-based combination trials globally by ourselves, including with innovative compounds we are developing, or in collaboration with our partners, to find better therapeutic options against a wide range of tumor types." Dr. Wang noted that the partnership with Kelun-Biotech, Harbour’s first global development alliance, is an important step that accelerates our plan to build a highly innovative, clinical-stage portfolio for worldwide markets.

"A167 is one of the important compounds in our portfolio," said Dr. Tongtong Xue, Chief Executive Officer of Kelun-Biotech. "We are glad to enter this collaboration with Harbour BioMed which is based on trust in our partner’s capabilities and expertise. The Harbour team brings extensive global clinical development experience that will accelerate clinical trials with A167, especially in the area of combinational therapies." Dr. Xue noted that the collaboration is the second alliance Kelun-Biotech entered with Harbour this year. "We entered a strategic partnership with Harbour to co-discover, co-develop and commercialize antibodies against innovative targets, based on Harbour’s leading fully human antibody discovery platforms. We have made significant progress in our joint discovery programs against multiple targets in oncology and immunological diseases."

A167 is an immune-oncology investigational antibody developed by Kelun-Biotech. It binds to immune checkpoint protein PD-L1 and reactivate T cells in the body against cancer cells. The antibody has potential usage in a broad range of solid tumor and hematological malignancies in monotherapy and in combination with other agents. A167 is currently in multiple Phase 1 and Phase 2 clinical trials in China targeting lymphoma and solid tumors.

Under the agreement, Kelun-Biotech will receive upfront, development and regulatory milestones, and commercial milestones based on preset goals, with a potential value of more than $350 million, in addition to royalties based on annual net sales. Harbour will have exclusive rights to develop, manufacture and commercialize A167 in regions outside of Greater China. Both companies will share data generated from their own research and clinical trials to support mono and combination therapies of A167 with other agents for both parties’ development and registration.

On August 17, 2018 ITUS Corporation (NASDAQ: ITUS) reported that CEO, Dr. Amit Kumar, will be presenting at the Next Generation Dx Summit in Washington, D.C., being held on August 20th-24th (Press release, Anixa Biosciences, AUG 17, 2018, View Source [SID1234530492]). Dr. Kumar’s presentation, "Liquid Biopsy based on Flow Cytometry and Artificial Intelligence to Detect the Existence of a Solid Tumor," is scheduled at 2:50 PM EDT, Wednesday, August 22nd. Dr. Kumar will discuss ITUS’s latest data on its Cchek diagnostic development, including studies on breast cancer and prostate cancer, as well as data from the collaborative study with Memorial Sloan Kettering and Serametrix.

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"This conference is focused on a number of diagnostic technologies including liquid biopsy and early cancer detection. This is the first commercial conference where we will be presenting our technology to a concentrated audience of industry players," stated Dr. Kumar. "We are pleased with the scientific progress achieved thus far with Cchek, and we remain confident that we will begin preliminary regulatory discussions with the FDA by the end of the year," added Dr. Kumar.

Dr. Kumar further stated, "With both of our programs–Cchek cancer diagnostic and CAR-T treatment for ovarian cancer—heading toward initial FDA discussions by the end of the year, we are excited about the impact we could have on the fight against cancer. Any day now, we are expecting to hear back from the FDA regarding the request, by us and our partner Moffitt Cancer Center, for a pre-IND meeting about our CAR-T therapy. We believe that the next few months will be a very exciting period for the Company, for our shareholders, and for cancer patients."

On August 17, 2018 Taiho Pharmaceutical Co., Ltd. reported that it applied to the Japanese Ministry of Health, Labour and Welfare for an additional indication for unresectable advanced or recurrent gastric cancer for its anticancer agent LONSURF combination tablet T15, T20 (trifluridine and tipiracil) (Press release, Taiho, AUG 17, 2018, View Source [SID1234529758]).

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This application is based on the results of a Phase III TAS-102 Gastric Study (TAGS) trial that compared trifluridine/tipiracil plus best supportive care (BSC) versus placebo plus BSC, in patients with previously treated metastatic gastric cancer refractory to standard therapies.

In the TAGS trial, the primary endpoint of overall survival (OS) was extended significantly with trifluridine/tipiracil compared to placebo, and no new safety signals were observed with the study drug.

Taiho Pharmaceutical anticipates that, if approved, LONSURF will provide a new oral treatment option for patients with gastric cancer.

About Gastric Cancer
In Japan, gastric cancer is the most common cancer by site, with 131,893 people newly diagnosed per year (2013)*1 and 45,531 people losing their lives to it in 2016*2. Gastric cancer is the fifth most common cancer worldwide and the third most common cause of cancer-related deaths (after lung and liver cancer), with an estimated 723,000 deaths annually*3. In recent years, the outcome for gastric cancer has improved remarkably, and survival has increased dramatically over the past 10 years. As gastric cancer progresses, treatment options become limited as numerous complications can restrict the usable drugs and preclude intensive chemotherapy. Accordingly, new therapeutic drugs which prolong survival and relieve symptoms in late-stage treatment of metastatic gastric cancer are considered valuable in the treatment of the disease.

About TAGS
The TAGS (TAS-102 Gastric Study) trial is a Taiho-sponsored pivotal Phase III multinational, randomized, double-blind study evaluating LONSURF (trifluridine and tipiracil), plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. The primary endpoint in the TAGS trial was overall survival (OS), and secondary endpoint measures included progression-free survival (PFS), and safety and tolerability, as well as quality of life. The TAGS trial enrolled 507 adults 18 years and older with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. Amongst other locations, the TAGS trial was conducted in Japan, North America, Europe, Russia and Turkey.

Please see ClinicalTrials.gov for additional details regarding the TAGS trial.
View Source

About LONSURF
LONSURF is an oral anticancer drug, which utilizes the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD‐degrading enzyme, thymidine phosphorylase.

In Japan, Taiho Pharmaceutical has been marketing LONSURF for the treatment of metastatic advanced or recurrent colorectal cancer since 2014. In the United States, beginning in 2015, Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical, began marketing the drug for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. In parts of Asia outside of Japan, Jeil Pharmaceutical and TTY Biopharm, which are Taiho Pharmaceutical’s business

On August 17, 2018 Emergent BioSolutions Inc. (NYSE: EBS) reported that a member of the company’s senior management team will participate in the following investor conferences during the third quarter and early portion of the fourth quarter of 2018 (Press release, Emergent BioSolutions, AUG 17, 2018, View Source;p=RssLanding&cat=news&id=2364006 [SID1234529226]):

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Three Part Advisors – 2018 Midwest IDEAS Investor Conference
Chicago, IL
August 29-30, 2018

Wells Fargo Securities – 2018 Healthcare Conference
Boston, MA
September 5-6, 2018

Robert W. Baird & Co. – 2018 Global Healthcare Conference
New York, NY
September 5-6, 2018
Morgan Stanley – 16th Annual Global Healthcare Conference
New York, NY
September 12-14, 2018
Janney Montgomery Scott – Healthcare Conference 2018
New York, NY
September 17-18, 2018
Cantor Fitzgerald – Global Healthcare Conference 2018
New York, NY
October 1-3, 2018
Presentation dates and times will be updated on the Emergent website www.emergentbiosolutions.com under "Investors" as the information becomes available.

For these conferences, the company will be webcasting its presentation, which may include a discussion of the company’s recent business developments as well as its most recently reported financial results and guidance. The webcasts will be available both live and by replay, accessible from the Emergent website.

On August 17, 2018 Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, reported its financial results for the first quarter ended March 31, 2018 and highlights its pipeline of Phase II and Phase III clinical trials (Press release, Akari Therapeutics, AUG 17, 2018, View Source [SID1234529061]).

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"We are excited by the range of clinical opportunities that we are currently exploring. We look forward to providing initial clinical data from these trials starting in the fourth quarter of 2018," commented Clive Richardson, acting Chief Executive Officer of Akari Therapeutics. "Akari does not intend to develop all of these programs through to commercialization on its own but rather, intends to partner one or more of its programs. To that end, a robust business development program has been in progress since early 2018 led by Mike Grissinger, an Akari non-executive director and pharmaceutical industry veteran who spent 22 years at Johnson & Johnson in business development leadership roles."

Clinical Development Programs Highlights

Akari’s clinical program is divided into two separate workstreams targeting two different sets of clinical conditions. One group of diseases is where the combined inhibition of the complement and leukotriene pathways provides a potential new treatment solution for a wide range of currently poorly treated orphan inflammatory conditions. The second group of diseases are those where complement dysregulation is the primary driver.

Dual C5 and Leukotriene B4 Program

The increasing recognition that LTB4 may combine with complement dysregulation in the etiology of many autoimmune and autoinflammatory conditions has focused Akari’s clinical development on a number of poorly treated conditions where Coversin’s dual C5 and LTB4 binding provides a potential novel therapeutic solution. These programs include bullous pemphigoid (BP), an inflammatory skin disease in which current treatment is limited to steroids, and immunosuppressants and atopic keratoconjunctivitis (AKC), an eye surface inflammatory disease which can lead to permanent vision loss and for which there are few effective treatment options. Both are rare conditions for which Akari is seeking orphan designation.

Complement Program

Patient treatment in CAPSTONE, the Phase III trial in naïve PNH patients, has commenced. We anticipate introducing a new pen injector in 2019 to facilitate patient use which will accommodate a week’s supply of medication. Within the program to treat patients with a polymorphism that makes them resistant to treatment with Soliris, Akari recently began treating a second PNH patient under an investigational new drug application (IND) in the U.S. This patient has responded well (LDH <1.5xULN at day 28). In all, three Soliris resistant patients have now been treated with Coversin; two with PNH and a third with a thrombotic microangiopathy (TMA). All PNH patients remaining on treatment have the option of entering into the Akari long term safety program. Nine PNH patients have been treated in aggregate for over 11 patient years with no drug related SAEs to date.

Akari has also opened a clinical program targeting thrombotic microangiopathies (TMA) including atypical haemolytic syndrome (aHUS). We expect to provide an update on Akari’s TMA program in Q4 2018.

First Quarter 2018 Financial Results

As of March 31, 2018, the Company had cash of $23.8 million, as compared to cash of $28.1 million as of December 31, 2017.
Operating expenses, which include research and development (R&D) expenses and general and administrative (G&A) expenses, were $4.3 million in the first quarter of 2018, as compared to $8.3 million in the same quarter the prior year.
R&D expenses in the first quarter of 2018 were $1.0 million, as compared to $6.0 million in the same quarter the prior year. The decrease was due primarily to an R&D tax credit of approximately $3.8 million received in the first quarter of 2018 and lower manufacturing costs of $1.4 million associated with Coversin clinical trial material, offset by an increase in clinical trial expenses.
G&A expenses in the first quarter of 2018 were $3.3 million, as compared to $2.3 million in the same quarter last year. This increase was due primarily to higher legal, accounting and other professional service fees.
Total other income for the first quarter of 2018 was $3.0 million, as compared to total other expense of $4.3 million in the first quarter of 2017. This change was primarily attributed to $2.9 million of other income in the first quarter of 2018 compared to $4.3 million of other expense in the same period in 2017 related in both instances to the change in fair value of the stock option and warrant liabilities.
Net loss for the first quarter of 2018 was $1.3 million, compared to a net loss of $12.6 million for the same period in 2017. This year over year decrease in net loss was due primarily to lower R&D expenses in the first quarter of 2018 when compared to the same period in 2017.