On August 16, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported updates from its clinical collaborations with The University of Texas MD Anderson Cancer Center (MD Anderson) and Moffitt Cancer Center (Moffitt) (Press release, Iovance Biotherapeutics, AUG 16, 2018, View Source;p=RssLanding&cat=news&id=2363888 [SID1234528960]). Under the MD Anderson collaboration, the company announced that the first patient was dosed with LN-145 in the Phase 2, multi-arm clinical trial (NCT03449108). The company also announced that preliminary data from an investigator-sponsored Non-Small Cell Lung Cancer (NSCLC) study with Moffitt will be presented at the upcoming IASLC 19th World Conference on Lung Cancer (WCLC) on September 24, 2018 in Toronto, Canada.

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"The start of patient dosing in the study at MD Anderson allows for exploration of TIL as a platform for treatment of multiple new solid tumors. Furthermore, this targeted patient population is left with very few treatment options and therefore is an unmet medical need. We are extremely pleased to be collaborating with MD Anderson as we investigate the potential of LN-145 to treat these patients with sarcomas and ovarian cancer," said Dr. Maria Fardis, PhD, MBA, president and chief executive officer of Iovance Biotherapeutics. "We are also pleased that the preliminary data from the investigator-sponsored study at Moffitt has been accepted for presentation at the upcoming World Lung Conference in September. We look forward to further exploring the possibility of TIL as a potential treatment option for patients with lung cancer."

The first MD Anderson study will enroll up to 54 patients. The endpoints for the trial are safety and efficacy of Iovance-manufactured LN-145 for the treatment of patients with soft tissue sarcoma, osteosarcoma and platinum-resistant ovarian cancer. The trial utilizes Iovance’s Gen 2 manufacturing process. A second clinical study is also in start-up under the collaboration using TIL manufactured by MD Anderson and using urelumab as a co-stimulatory agent during the manufacturing process. Additional information on this study is available at www.clinicaltrials.gov using the identifier number NCT03610490.

The ongoing investigator-sponsored study in NSCLC is currently underway in collaboration with Moffitt, Stand Up To Cancer, and other collaborators and is designed to allow dosing of the combination of TIL manufactured by Moffitt and nivolumab in NSCLC patients. An abstract titled, Safety and Clinical Activity of Adoptive Cell Transfer Using Tumor Infiltrating Lymphocytes (TIL) Combined with Nivolumab in NSCLC, has been accepted for presentation at the upcoming WCLC. The full details of the presentation are expected to be released in September. Additional information on this study is available at www.clinicaltrials.gov using the identifier number NCT03215810.

On August 16, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported that a KRAS G12C poster will be presented by scientists from Mirati and Array BioPharma at the 255thAmerican Chemical Society (ACS) National Meeting & Exposition being held in Boston, MA, August 19-23, 2018 (Press release, Mirati, AUG 16, 2018, View Source [SID1234529038]). The poster will focus on the discovery and preclinical characterization of covalent inhibitors of KRAS G12C that have demonstrated potent pathway inhibition in cells and efficacy in tumor xenograft models.

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"We are looking forward to the first public presentation of our orally-active series of covalent inhibitors of KRAS G12C. We will describe the identification of novel lead matter and the structure-based approach that led to increases in potency. Further, we will present in vivo data for an early lead molecule that resulted in regressions in a xenograft tumor model. These results led us to our lead candidate, MRTX849, that has a planned IND (investigational new drug) filing in Q4 2018," said Matt Marx, Ph.D., Vice President of Drug Discovery.

Details for the poster presentation are listed below.

Poster Title: Structure-based drug discovery of a selective, covalent KRAS G12C inhibitor with oral activity in animal models of cancer
Poster Number: MEDI 144
Date and Time: Sunday, August 197:00 PM
Location: Exhibit Hall B1, Boston Convention & Exhibition Center

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.

On August 16, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that it has been invited to present at the BioCentury 25th Annual NewsMakers in the Biotech Industry Conference on Friday, September 7, 2018, at the Millennium Broadway Hotel & Conference Center in New York City (Press release, Immutep, AUG 16, 2018, View Source [SID1234529023]).

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Marc Voigt, CEO of Immutep, is scheduled to present a corporate overview and business update at 11:30 am ET on Friday, September 7, 2018, with one-on-one meetings held throughout the day.

Hosted by BioCentury, only 48 companies are handpicked to present their stories to institutional investors in the Biotech sector. At the NewsMakers conference held in 2017, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $600 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.

On August 16, 2018 VBL Therapeutics (Nasdaq: VBLT) reported financial results for the second quarter ended June 30, 2018 and provided a corporate update (Press release, VBL Therapeutics, AUG 16, 2018, View Source [SID1234528950]).

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"VBL is well capitalized, with more than $58 million in cash, which will enable us to continue the development of VB-111 in ovarian cancer, and to advance our innovative pipeline, including our exciting VB-600 platform targeting MOSPD2, for more than the next three years," said Dror Harats M.D., Chief Executive Officer of VBL Therapeutics.

"We continue to have high conviction in the promise of VB-111 and are focused on executing the ongoing Phase 3 OVAL trial, evaluating VB-111 in platinum-resistant ovarian cancer. We plan to conduct an interim efficacy analysis of this trial in the fourth quarter of 2019."

"We are excited about our MOSPD2 platform and are very encouraged by the emerging data which highlights the potential of this novel target in the treatment of both cancer and inflammatory disease such as multiple sclerosis. Our goal is to file the first IND from this program by year-end 2019," continued Prof. Harats.

VBL will present more data on MOSPD2 at the European Committee for Treatment and Research in Multiple Sclerosis (or ECTRIMS) conference on October 11th in Berlin.

Second Quarter and Recent Corporate Highlights:

Closed a $15.5 million registered direct offering, which will enable the Company to continue the development of VB-111 in ovarian cancer, and to advance the pipeline, including the VB-600 platform targeting MOSPD2, for the next three years.

Continued to treat patients in the ongoing Phase 3 OVAL trial, evaluating VB-111 in platinum-resistant ovarian cancer. An efficacy interim readout is expected to occur in the fourth quarter of 2019.

Conducted analyses of the VB-111 Phase 3 GLOBE trial in recurrent glioblastoma (rGBM). We are particularly investigating the possibility that the treatment regimen of the GLOBE trial, which was performed under a pre-agreed Special Protocol Assessment (SPA), may have impaired the activity of VB-111. Our analyses have not revealed any other risk factor that can explain the difference in outcome compared with the prior Phase 2 trial. The Company plans to present additional data on GLOBE at the Society for Neuro-Oncology, or SNO meeting, in November 2018.
Presented positive new data on the Company’s MOSPD2 platform technology in oncology and inflammation in international conferences, and published a paper highlighting MOSPD2 as a potential new target for therapy of solid tumors such as breast cancer.

° Presented a late-breaking study demonstrating a novel bi-specific antibody that induces immune-cell mediated killing of cancer cells through binding to a tumor membrane receptor, MOSPD2, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 annual meeting.

° Presented data on the role of MOSPD2 in oncology and inflammation at the 2018 BIO international convention. VBL research has shown that knocking out the MOSPD2 gene in mice can protect the animals from developing certain inflammatory diseases. The Company has generated antibodies that block immune cell migration and show efficacy in a model of multiple sclerosis.

° A paper published in the International Journal of Cancerfeatured VBL data showing that MOSPD2 can play a major role in breast cancer cell migration and metastasis, and that targeting MOSPD2 may be a viable therapeutic strategy to prevent the spreading of breast cancer cells. VBL’s data indicate that knock-out of MOSPD2 in tumor cells may reduce metastasis by up to 95% in certain settings.

° VBL is developing the VB-600-MOSPD2 platform of biologic drug candidates for oncology and inflammatory indications. The Company plans to file the first IND in this program by year-end 2019.
Second Quarter Ended June 30, 2018 Financial Results:

Revenues: revenues related to our collaboration in Japan in the amount of $0.2 million were recognized in the period.

Cash Position: Cash, cash equivalents and short-term bank deposits at June 30, 2018, were $58.5 million. Working capital at June 30 was $54.7 million. The Company estimates that, based on current projections, the current cash, cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements for more than 3 years.

R&D Expenses: Research and development expenses for the quarter ended June 30, 2018, were approximately $2.9 million, compared to approximately $3.2 million in the comparable period in 2017. R&D expenses are shown net of grants from the Israel Innovation Authority (IIA).

G&A Expenses: General and administrative expenses for the quarter ended June 30, 2018 were $1.2 million, compared to $1.9 million for the comparable period in 2017.

Comprehensive Loss: The Company reported a comprehensive loss for second quarter ended June 30, 2018 of $4.1 million, or ($0.13) per share, compared to a net loss of $4.9 million, or ($0.18) per share in second quarter ended June 30, 2017.

Conference Call:

Thursday, August 16th @ 8:30am Eastern Time
US Domestic: 877-222-6394
International: 703-925-2702
Conference ID: 3572709
Webcast: View Source

Replays, Available through August 30, 2018
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Conference ID: 3572709