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 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.

On August 17, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported that two posters will be presented by Endocyte scientists at the ACS National Meeting & Exposition being held in Boston, MA from Aug. 19 – 23, 2018 (Press release, Endocyte, AUG 17, 2018, View Source [SID1234528962]).

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Presentations are as follows:

Abstract # MEDI 425
Title: Pro-Pyrrolobenzodiazepine (pro-PBD) bioconjugates, part 3: Design and synthesis of pro-PBD conjugates containing a self-immolative substituted disulfide linkers
When: August 22, 2018, from 7:00 pm to 9:00 pm
Session ID: General Poster Session
Location: Galleria, Westin Boston Waterfront

Abstract # MEDI 426
Title: Pro-Pyrrolobenzodiazepine (pro-PBD) bioconjugates, part 4: Design of novel oxime-based pro-PBD conjugates that release active drug via intramolecular diazepine-ring-closure
When: August 22, 2018, from 7:00 pm to 9:00 pm.
Session ID: General Poster Session
Location: Galleria, Westin Boston Waterfront

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

On August 16, 2018 Immatics, a leading company in the field of cancer immunotherapy, reported that it has initiated enrollment of patients into a phase I trial of IMA202, its second T-cell Receptor (TCR)-transduced adoptive cell therapy program. IMA202 is an investigational immunotherapy which uses Immatics’ proprietary ACTengine approach and is based on genetic engineering of the patient’s own T cells to express an exogenous TCR (Press release, Immatics Biotechnologies, AUG 16, 2018, View Source [SID1234569550]). The goal is to redirect and activate the T cells to treat solid tumors. The single-center clinical study is now open for enrollment at The University of Texas MD Anderson Cancer Center in Houston, Texas.

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The study (IMA202-101) will include approximately 12 patients with relapsed and/or refractory solid tumors, including but not limited to advanced non-small cell lung cancer and hepatocellular carcinoma, for which no standard of care therapy is available.

Immatics’ ACTengine approach engineers the patients’ own T lymphocytes (a type of white blood cell) to express a novel, exogenous T-cell receptor (TCR) which is targeted to a site on the tumor identified by Immatics’ proprietary XPRESIDENT target discovery platform. ACTengine combines several innovative features:

TCRs specifically recognizing the XPRESIDENT-identified target are selected via Immatics’ proprietary high-throughput TCR discovery platform from the natural, human T-cell repertoire. The TCR used in this trial has been selected for highest specificity from more than one hundred TCRs using Immatics’ XPRESIDENT-guided on- and off-target toxicity screening.
The novel TCR recognizes its target with optimal affinity for an adoptive cellular therapy (ACT) approach.
The TCR-transduced T cells are activated and multiplied outside the body before being infused into the patient.
Patients are eligible for ACTengine cell therapy if the target of interest is present on the patient’s tumor as demonstrated by biomarker profiling.
The primary objective of the study is to evaluate the safety and tolerability of the ACTengine approach, and specifically IMA202, in target-positive solid cancer patients. The secondary objectives include the evaluation of feasibility, the persistence of T cells in vivo, and the assessment of anti-tumor activity and biomarkers. The IMA202 phase I trial will be conducted by the Department of Thoracic Oncology, the Department of Gastrointestinal Medical Oncology and the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center in Houston, Texas.

Stephen L. Eck, M.D., Ph.D., Chief Medical Officer of Immatics US, commented: "Regulatory approval to start our second clinical study in our ACTengine-based cell therapy program is a significant step for Immatics. This study exemplifies Immatics’ XPRESIDENT target discovery capability and TCR discovery pipeline which are industry-leading cancer immunotherapy platforms. We are very excited to combine these capabilities in a trial led by the world-class investigators from MD Anderson Cancer Center in order to develop exciting new treatment options for cancer patients."

On August 16, 2018 Synthorx, Inc., a biotechnology company using a first-of-its-kind Expanded Genetic Alphabet platform to discover and develop innovative protein therapeutics for cancer, autoimmune disorders and other serious diseases, reported the appointment of Joseph Leveque, M.D., as chief medical officer (Press release, Synthorx, AUG 16, 2018, View Source [SID1234528935]). Dr. Leveque brings over 20 years of biotechnology management and therapeutic development experience to Synthorx, with a particular focus on immuno-oncology (IO).

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"Dr. Leveque joins us with a deep-rooted knowledge of the immuno-oncology space, notably with his experience at ARMO BioSciences leading the pivotal Phase 3 trials of the company’s lead IO drug candidate, as well as his involvement in the development and commercialization of Opdivo, Yervoy, and Bavencio, during his time at Bristol-Myers Squibb and Merck KGaA," said Laura Shawver, Ph.D., chief executive officer of Synthorx. "Dr. Leveque is an invaluable addition to our leadership team as we advance our Synthorin cytokine pipeline, including moving our IL-2 Synthorins into clinical trials, where we expect to demonstrate proof of clinical activity in our initial studies in oncology and autoimmune indications."

Dr. Leveque joins Synthorx from his previous role as chief medical officer of ARMO BioSciences, a late-stage immuno-oncology company that was acquired by Eli Lilly in May 2018. Prior to this, he was chief medical officer of EMD Serono, the North American subsidiary of Merck KGaA and the vice president and head of U.S. medical oncology at Bristol-Myers Squibb, where he was involved in the development and commercialization of the first generation of immuno-oncology therapeutics. Before his role at Bristol-Myers Squibb, Dr. Leveque was the vice president of medical and scientific affairs at Onyx Pharmaceuticals. Earlier in his career, he served as vice president of medical and scientific affairs at Cephalon Oncology and as medical director at Amgen, where he worked on several therapeutic programs for solid tumor and hematological malignancies.

Dr. Leveque earned a Medical Doctorate from The University of Texas School of Medicine in Houston, TX and completed his post-graduate medical training in internal medicine at the Cedars-Sinai Medical Center, a teaching affiliate of the University of California, Los Angeles (UCLA). In addition, Dr. Leveque holds a Master of Business Administration from the Wharton School of the University of Pennsylvania.