On July 2, 2018 Boston Scientific Corporation (NYSE: BSX) reported that it will webcast its conference call discussing financial results and business highlights for the second quarter ended June 30, 2018 on Wednesday, July 25, 2018 at 8:00 a.m. EDT (Press release, Boston Scientific, JUL 2, 2018, View Source [SID1234527600]). The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the second quarter on Wednesday, July 25, 2018, prior to the conference call.

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A live webcast of the conference call will be available on the Investor Relations section of the website at investors.bostonscientific.com under the Events heading.

A replay of the webcast will be archived and available at investors.bostonscientific.com beginning approximately one hour following the completion of the meeting.

On July 2, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has entered into the following agreements (Press release, Athenex, JUL 2, 2018, View Source;p=RssLanding&cat=news&id=2356730 [SID1234527595]):

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Establishment of a joint venture with Xiangxue Life Sciences, a wholly-owned subsidiary of Guangzhou Xiangxue Pharmaceutical Co., Ltd. (Xiangxue Pharmaceutical), for the research, development and commercialization of T-cell receptor-engineered T cells (TCR-T), a cancer immunotherapy technology, based on the novel approach on high-affinity TCR developed by Xiangxue Life Sciences;
In-licensing of worldwide rights to a pegylated genetically modified human arginase from Avalon PolyTom (HK) Limited (PolyTom), a subsidiary of Avalon Biomedical Management Limited; and
A strategic investment of US$100 million from Perceptive Advisors, an institution dedicated to supporting the most promising technologies in healthcare.
Expansion into TCR-T Immunotherapy

Xiangxue Life Sciences is a wholly-owned subsidiary of Xiangxue Pharmaceutical, a long term partner of Athenex for the development of KX-02 for glioblastoma multiforme in China. Xiangxue Life Sciences is a Chinese biopharmaceutical company focused on TCR-based therapies for cancer and has developed a new generation TCR-T, named HATac, which consists of the expression of high binding affinity soluble T-cell receptors on the engineered T-cells to target HLA-antigenic peptide complex on certain types of cancer cells. Early clinical studies in China demonstrated a good safety profile in patients.

Axis Therapeutics Limited, a new joint venture to be established and owned initially as 55% by Athenex and 45% by Xiangxue Life Sciences, has in-licensed the worldwide (excluding mainland China) rights of all the intellectual properties and know-how of the TCR-T immunotherapy technology from Xiangxue Life Sciences, subject to certain closing conditions and approvals. Pursuant to the terms of the license agreement and shareholders agreement, Athenex will issue US$5 million worth of Athenex common stock to Xiangxue Life Sciences as an upfront payment and Athenex will contribute US$30 million in cash to the joint venture. Axis Therapeutics will also pay various clinical and regulatory milestones of up to US$110 million to Xiangxue Life Sciences. Xiangxue Life Sciences will retain the mainland China rights to the technology and there will be royalties on net income payable to Axis Therapeutics upon successful commercialization in mainland China. Additional new TCR-T technologies developed by Axis will also be partnered with Xiangxue Pharmaceutical in the future for the mainland China rights.

Expansion into Biologics for Oncology

Athenex has strategically in-licensed a pegylated genetically modified human arginase, or Pegtomarginase, which was initially developed by the Hong Kong Polytechnic University and subsequently licensed to PolyTom. Through extensive research, a single isomer of pegylated genetically modified human arginase with a favorable pharmacokinetic and potency profile was identified and preclinical work demonstrated that the molecule represents a promising clinical candidate. The anti-cancer mechanism of this biologic product lies in that some cancers do not express either ornithine transcarbamylase (OTC) and/or argininosuccinate synthetase (ASS), two enzymes critical for the synthesis of arginine in the urea cycle pathway. As cancer cells will not be able to synthesize arginine, they will have to depend on external supply of arginine for tumor survival and growth. This treatment approach shows specificity as the depletion of circulating arginine will starve such OTC-/ASS- deficient cancer cells, while normal cells can synthesize arginine intracellularly through urea cycle for their survival.

Strategic Investment by Perceptive Advisors

Perceptive Advisors, an investment manager with a deep history in supporting biotechnology companies, will provide a combination of equity and debt financing to support Athenex’s operations and continued development, including pipeline expansion initiatives. Perceptive Advisors will invest US$100 million in Athenex, comprised of US$50 million in equity and US$50 million in debt.

Dr. Johnson Lau, Chairman and CEO of Athenex, commented, "Given our confidence in our two Phase III programs in Oraxol for metastatic breast cancer and KX-01 ointment for actinic keratosis, we are delighted to have this opportunity to further expand our product pipeline. The additions of TCR-T based cancer immunotherapy in collaboration with our long term business partner, Xiangxue Pharmaceutical and its subsidiary Xiangxue Life Sciences, and of an anti-cancer biologic will further complement and enhance our Oncology Innovation Platform. We are particularly excited about the potential synergies that can be created between the new therapies and our existing pipeline. We have developed a business strategy to fully explore the potential of all these platforms. We are also grateful to have Perceptive Advisors as our financial partner."

Mr. YongHui Wang, CEO of Xiangxue Life Sciences and Chairman and CEO of Xiangxue Pharmaceutical, said, "Athenex has been an excellent partner of ours, as evidenced by our successful KX-02 collaboration in China. We have witnessed the tremendous growth of Athenex and their effective execution in research and development as well as business expansion. We are a strong believer in the Athenex team and are delighted to form this new Joint Venture with Athenex to take the leadership in exploring a new and promising immunotherapy technology in the global scene. HATac is a breakthrough technology. The combination of this technology in conjunction with the Athenex pipeline and the business plan of Axis Therapeutics holds great promise for the treatment of solid tumors."

Mr. Joseph Edelman, CEO and Portfolio Manager, Perceptive Advisors, added "TCR-engineered cellular therapy represents a potential paradigm shift in the treatment of solid tumors by working with a patient’s own immune system to target specific cancer peptides in the context of presentation by the patient’s HLAs. We are also excited about the metabolic treatment of cancer through the depletion of arginine, which could enable novel future therapies by selectively killing cancer cells through starvation. These two new additions, coupled with the exciting existing clinical pipeline provide an opportunity for synergy creation across Athenex’s business. We are excited to have this strong oncology product pipeline in the hands of a proven management team that has consistently demonstrated an ability to deliver in both clinical studies and commercialization execution. We look forward to continuing our support for their initiatives going forward."

Mr. Sam Chawla, Portfolio Manager, Perceptive Advisors, stated, "We are impressed by Athenex’s robust clinical stage product pipeline and its unique business model. The management team has continually demonstrated strong execution capabilities, as evidenced by the clinical development timelines for its two lead Phase III assets and the rapid build-out of its commercial platform to support the future launch of Athenex’s proprietary products. Athenex has also been successful in securing non-dilutive government funding in the U.S. and Asia to build manufacturing facilities. We are excited to have the opportunity to partner with Athenex to enable the continued growth and expansion strategies of the Company."

As an oncology focused biopharmaceutical company, Athenex has a pipeline of seven clinical stage products, two of which are in Phase III clinical studies. Oraxol, a novel oral formulation of paclitaxel combined with a novel oral non-absorbable P-glycoprotein inhibitor, has completed the recruitment of 180 patients for the second interim analysis to be conducted in the third quarter of 2018 of a Phase III clinical trial for metastatic breast cancer. KX-01 ointment for the treatment of actinic keratosis has already completed recruitment for two Phase III clinical studies.

Laidlaw & Company (UK) LTD served as the sole placement agent to Athenex in relation to the strategic investment by Perceptive Advisors.

Conference Call and Webcast Information:

The Company will host a conference call to discuss the transaction today, July 2, 2018, at 8:30 a.m. eastern time. To participate in the call, dial (855) 227-0567 (domestic) or (612) 979-9912 (international) fifteen minutes before the conference call begins and reference the conference passcode 9794249. A replay will be available approximately one hour after the recording through Monday, July 9, 2018 and can be accessed by dialing (855) 859-2056. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at www.athenex.com. An archive will be available at this website until August 2, 2018.

On July 2, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company") is reported that it has submitted its Investigational New Drug ("IND") application to the United States Food and Drug Administration ("FDA") for eftilagimod alpha ("efti" or "IMP321") in June 2018 (Press release, Immutep, JUL 2, 2018, View Source [SID1234527552]).

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If granted by the FDA, the IND application will allow Immutep to ship efti across U.S. State borders to U.S. clinical investigators participating in the Company’s planned TACTI-002 Phase II clinical study, making it an important step in the clinical trial preparations. This is the first IND application for efti in the U.S. following the encouraging pre-IND meeting in November last year.

The IND application incorporates information pertaining to completed pharmacology and toxicology studies for efti, along with manufacturing information and proposed clinical protocol for the TACTI-002 trial.

The Company continues to progress its preparations for the TACTI-002 clinical trial in the United States, Europe and Australia. Immutep expects to commence the TACTI-002 trial in the second half of 2018 and to report the first data from the trial in 2019.

About the TACTI-002 clinical trial

Up to 120 patients will be recruited for the TACTI-002 (Two ACTive Immunotherapies) Phase II study which will take place across approximately 15 study centres in the U.S., Europe and Australia. The trial is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). It will evaluate the safety and efficacy of the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in patients with two different types of cancers, non-small cell lung cancer and head and neck cancer. It will be a Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Patients participating in the trial will be given the combination treatment for 12 months using a 30 mg s.c. efti dosing every 2 or 3 weeks.

On July 2, 2018 TRIGR Therapeutics, a US-based Biopharmaceutical company, and ABL Bio Corporation, a South Korean biotechnology company, jointly reported that it had entered into a binding agreement for TRIGR to license the global commercial rights to ABL Bio’s pipeline of novel therapeutic antibodies to treat cancer (Press release, TRIGR Therapeutics, JUL 2, 2018, View Source [SID1234527550]). These therapeutic antibodies include ‘blood-brain barrier (BBB)’ penetrating bispecific antibodies (BsAb) (VEGF/undisclosed BBB target BsAb, undisclosed target/undisclosed BBB target BsAb); immune cell engaging bispecific antibodies (4-1BB/undisclosed target BsAb, 4-1BB/ undisclosed target BsAb); and a monoclonal antibody against undisclosed target.

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Under the terms of the agreement, TRIGR will pay a total upfront fee of USD $4.3 million to license global rights (except for South Korea) to 5 antibodies currently under development by ABL Bio. ABL Bio will also receive research, regulatory and sales-based milestones of more than USD $550 million in total plus royalties. In addition, TRIGR shall share the licensing revenue with ABL Bio in the event of out-licenses to a 3rd party. The deal is expected to close before the end of July.

George Uy, TRIGR founder and CEO, commented that "we are honored to be chosen as the partner of ABL Bio for their oncology pipeline. These assets include: a) BsAbs designed to cross the blood brain barrier more efficiently combating brain tumors and b) immuno-modulating BsAbs engineered for dual engagement of the body’s immune cells (T cells and NK cells) against tumor-associated antigens in the tumor microenvironment. The antibodies truly represent the next wave in cancer immunotherapy. It is TRIGR’s mission to identify and develop novel and paradigm-shifting immunotherapies. The delivery of antibodies into the brain, a privileged tissue in the human body and one of the last frontiers of drug delivery, to treat malignant gliomas and other brain cancers might enable TRIGR to bring new desperately-needed therapies to patients and their caregivers. Our new portfolio of unique immuno-modulatory BsAbs designed to activate patient T cells as well as NK cells in the tumor will allow TRIGR to establish itself as a leading biotechnology company. The BsAbs should also be valuable agents for combination therapies with cellular immunotherapies, such as CAR-T cell therapies and NK cell therapies."

Dr. Sang Hoon Lee, CEO of ABL Bio added, "ABL Bio is at the cutting-edge discovery of novel therapeutic antibodies with unique therapeutic applications. Our blood-brain barrier penetrating antibodies are potentially best-in-class in the industry globally. With a staff of over 40 scientists and years of global research and development experience-based working with the world’s foremost pharmaceutical companies and academic institutions, ABL Bio will accelerate the development of these oncology candidates to IND filing in the US beginning next year while working closely with the TRIGR team. In our discussion with George and his team, we were impressed by their commitment to identifying and developing innovative immunotherapies as well as their vast experience in and passion for drug development of therapies addressing unmet medical needs. We look forward to a productive and successful partnership."

On July 2, 2018 NewLink Genetics Corporation (NASDAQ:NLNK), reported that updated Phase 1 data evaluating indoximod plus front-line radiation and maintenance chemotherapy for the treatment of pediatric patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) were presented Sunday, July 1, at the International Symposium of Pediatric Neuro-Oncology (ISPNO) 2018 Annual Meeting in Denver (Press release, NewLink Genetics, JUL 2, 2018, View Source [SID1234527548]).

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Data were presented on ten newly diagnosed DIPG patients, all of whom had initiated therapy at the time of this assessment. All (10/10) demonstrated initial symptomatic improvement. Eight of ten had completed radiation, with the remaining 2 of 10 patients continuing radiotherapy. While a subset of the patient cohort developed inflammatory and other adverse symptomology, a common occurrence in this patient population, these symptoms were actively managed. Currently, 9/10 patients remain on study, with the longest time on study of 8.5 months. These data include more mature follow-up on the 6 patients previously presented at AACR (Free AACR Whitepaper) 2018.

"These data continue to demonstrate the potential for indoximod plus radiochemotherapy as a combination treatment regimen which may improve disease related symptoms for these pediatric patients with an otherwise dire prognosis," said Dr. Theodore S. Johnson, M.D., Ph.D., Associate Professor of Pediatrics at Augusta University, lead investigator for the trial. "We remain encouraged and look forward to additional data as the study proceeds."
This DIPG cohort is a subset of NLG2105, a Phase 1 study evaluating indoximod, NewLink’s IDO pathway inhibitor, in combination with radiation and chemotherapy for pediatric patients with malignant brain tumors. The DIPG cohort has been expanded from an initial pilot study based on early safety and efficacy data and is currently enrolling with a target of 30 DIPG patients.

About Diffuse Intrinsic Pontine Glioma (DIPG)
Diffuse intrinsic pontine glioma, or DIPG, is a rare, aggressive brain tumor found in the brain stem that almost exclusively affects children. Every year in the United States, approximately 200-400 children, ages ranging from 4 to 11, are diagnosed with DIPG. As the tumor grows, it puts pressure on the nerves that control essential bodily functions. Children experience symptoms including, but not limited to: vision issues, arm and leg weakness and difficulty speaking, breathing and heartbeat resulting in death. The median survival time is 9 months, with only 1% of all children diagnosed with DIPG surviving more than 5 years.1
1 Defeat DIPG Foundation

About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.