1stOncology™: Cancer Intelligence Service – Page 14264 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

F-star to Present New Preclinical Data on FS118,
a First-in-Class Immuno-Oncology Bispecific Antibody,
at the AACR 2018 Annual Meeting

On April 9, 2018 F-star, a biopharmaceutical company developing novel bispecific antibodies, reported that new preclinical data from its lead immuno-oncology programme FS118 will be highlighted at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, US from 14 – 18 April 2018 (Press release, f-star, APR 9, 2018, View Source [SID1234526828]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

FS118 is a first-in-class bispecific antibody that simultaneously blocks LAG-3 (Lymphocyte -Activation Gene 3) and PD-L1 (Programmed Death-Ligand 1) two key pathways in tumours evading the immune system. The new preclinical data show evidence of FS118’s efficacy both in primary human T cell assays and syngeneic tumour models. Specifically, FS118 is able to suppress LAG-3 expression on T cells in the tumour microenvironment and to promote a potent CD8+ T cells-mediated anti-cancer immune
response.

Neil Brewis, CSO of F-star commented: "Despite major advances on the PD-1/PD-L1 axis, many patients remain unresponsive to or relapse following treatment. FS118 preclinical data suggest that it can improve both efficacy and response rate compared to monotherapies or monotherapy combinations. It is a very exciting time for F-star, as these studies support the potential for FS118 to provide significant clinical benefits to cancer patients."

The new data will be published in a poster entitled "Dual blockade of PD-L1 and LAG-3 with FS118, a unique bispecific antibody, induces CD8+ T cell activation and modulates the tumour microenvironment to promote anti-tumour immune responses".

Details are below:

Session Title: Immune Checkpoints 2
Session Start Time: Monday, 16th April at 1pm
Session End Time: Monday, 16th April at 5pm
Location: Poster Section 32
Poster Board Number: 11
Poster Number: 2719

In June 2017, Merck and F-star entered into a new strategic collaboration that provides Merck with an exclusive option to acquire several immuno-oncology bispecific assets, including FS118, through the acquisition of F-star Delta Ltd

For further information, please contact:
At F-star For media enquiries
Pierre Peotta
Communications Manager
+44 (0)7392 080 279
[email protected]
Instinctif Partners (EU & RoW)
Sue Charles/Ashley Tapp
+44 (0)20 7866 7923
[email protected]
Lazar Partners (USA)
Glenn Silver
+1 (0)212 867 1762
[email protected]

Immunomedics appoints Dr. Robert Iannone head of Research & Development and Chief Medical Officer

On April 9, 2018 Immunomedics, Inc., (NASDAQ:IMMU) ("Immunomedics" or the "Company"), a leader in the field of antibody-drug conjugates (ADCs), reported the appointment of Robert Iannone, M.D., M.S.C.E., as Head of Research & Development and Chief Medical Officer, effective today (Press release, Immunomedics, APR 9, 2018, View Source [SID1234525811]). In his new role, Dr. Iannone will oversee and lead all clinical development, regulatory, pre-clinical, translational research and medical affairs strategies and activities of the Company. Dr. Iannone brings more than thirteen years of experience in clinical drug development, including the approval of several targeted and immuno-oncology medicines at AstraZeneca/MedImmune and Merck & Co.

"Rob is not only a highly accomplished oncology drug developer but also is deeply rooted in science with outstanding development experience and an established track record in a number of disease settings of interest to Immunomedics. We are thrilled that Rob is bringing his strong industry, medical, scientific and strategic leadership to Immunomedics," commented Michael Pehl, President and Chief Executive Officer. "Through his unique expertise, Rob will be instrumental in aggressively advancing development of our programs with the right drug combinations and in the most appropriate patient segments. I look forward to working closely with Rob to unlock the full potential of our ADC platform and further strengthen Immunomedics as a leader in this field."

Dr. Iannone comes to Immunomedics from AstraZeneca/MedImmune where he oversaw the development of Imfinzi and was, most recently, Senior Vice President and Head of Immuno-oncology, Global Medicines Development. He joined AstraZeneca/MedImmune in July 2014 as Global Products Vice President. Prior to AstraZeneca/MedImmune, Dr. Iannone served as Executive Director, Clinical Research, and Section Head of Oncology at Merck Research Laboratories and was a development leader for Keytruda.

"Immunomedics has a unique and highly differentiated ADC pipeline and platform technology. I am very excited to be joining the Company to help develop sacituzumab govitecan and other pipeline assets, to be foundational therapies in a wide variety of hard-to-treat solid cancer indications, in both early- and late-line settings, including the potential for combining with immune checkpoint inhibitors and other targeted cancer therapies," remarked Dr. Iannone.

Dr. Iannone received his M.D. from Yale University School of Medicine with Alpha Omega Alpha honors and a Master of Science in Clinical Epidemiology from the University of Pennsylvania School of Medicine. Dr. Iannone completed his Residency at Johns Hopkins

Hospital, where he also served as Chief Resident for one year and completed his Pediatric Hematology and Oncology Fellowship. Dr Iannone is the author or co-author of numerous articles in peer-reviewed journals and has served on the Biomarkers Consortium of the Cancer Steering Committee of the Foundation for the National Institutes of Health since 2011.

RedHill Biopharma Provides Semi-Annual Business Update

On April 9, 2018 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal diseases and cancer, reported that business update of its main activities and key highlights expected in 2018, including two Phase III readouts (Press release, RedHill Biopharma, APR 9, 2018, View Source [SID1234525807]).

Key Highlights:

Top-line results from the ongoing Phase III study with RHB-104 for Crohn’s disease (MAP US study) are expected in mid-2018. Enrollment of all 331 subjects in the study has been completed and the last patient to reach the primary endpoint assessment (remission at week 26) is expected by early May 2018.

Top-line results from the ongoing confirmatory Phase III study with TALICIA (RHB-105)1 for H. pylori infection (ERADICATE Hp 2 study) are expected in H2/2018. To date, approximately 60% out of a planned total of 444 subjects have been enrolled in the study. TALICIA was previously granted QIDP fast-track designation by the FDA, including an extended market exclusivity period, if approved.

Amendment to RHB-106 agreement with Salix Pharmaceuticals. RedHill and Salix recently amended their 2014 worldwide license agreement relating to the
RHB-106 encapsulated bowel cleanser, as well as additional related rights. The amendment clarifies the development efforts to be used by Salix, as well as provides for enhanced involvement by RedHill in certain intellectual property matters. In addition, the parties have agreed to increase the lower end of the range of royalty payments to be paid to RedHill on net sales from low single digits to high single digits, such that the potential royalties now range from high single digits up to low double digits. Milestone payments remain unchanged.

Expected continued quarterly revenue growth. Net revenues in the fourth quarter of 2017 were $2 million, an increase of 31% over the third quarter of 2017. RedHill expects continued quarter over quarter net revenue growth. RedHill’s sales force of approximately 40 sales representatives is calling on thousands of gastroenterologists across the U.S.

Continued cost reduction in 2018. Cash to be used in operating activities is expected to continue to gradually decrease on average to approximately $8.5 million per quarter during 2018. RedHill’s cash position was approximately $46 million at the end of 2017, with no debt.
Additional Updates:

First five patients enrolled in the single-arm Phase IIa study with YELIVA (ABC294640) for the treatment of cholangiocarcinoma (bile duct cancer); Enrollment is expected to be completed by the end of 2018. The Phase IIa study was recently initiated at Mayo Clinic major campuses in Arizona and Minnesota, University of Texas MD Anderson Cancer Center and the Huntsman Cancer Institute, University of Utah Health, and is planned to enroll up to 39 patients. YELIVA was granted Orphan Drug designation by the FDA for the treatment of cholangiocarcinoma.

Ongoing discussions with the FDA on planned Phase III development programs for BEKINDA (RHB-102) for acute gastroenteritis and for IBS-D. Following the positive results of the Phase III study with BEKINDA 24 mg for acute gastroenteritis (GUARD study) and guidance provided by the FDA, RedHill is currently in discussions with the FDA on the design of a confirmatory Phase III study to support a potential New Drug Application (NDA). Following positive results of the Phase II study with BEKINDA 12 mg for IBS-D, RedHill plans to meet with the FDA in the second quarter of 2018 to discuss the design for one or two pivotal Phase III studies.

A pivotal Phase III study with RHB-104 for the treatment of nontuberculous mycobacteria (NTM) infections (QIDP fast-track designation, including an extended market exclusivity period, if approved) is expected to be initiated in H2/2018, subject to completion of a supportive non-clinical program and additional input from the FDA. RHB-104 is planned to be assessed as a first-line treatment of NTM disease caused by mycobacterium avium complex (MAC) infection.

Innovation Pharmaceuticals Phase 2 Oral Mucositis Trial Additional Data Show Brilacidin-OM Demonstrated A Significant Reduction in the Incidence of Severe Oral Mucositis in Patients with Head and Neck Cancer (HNC) Receiving Aggressive Chemotherapy Regimen

On April 9, 2018 Innovation Pharmaceuticals, (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported that further data analysis from its successfully completed Phase 2 clinical trial of Brilacidin-OM (see NCT02324335) for the indication of decreasing the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, APR 9, 2018, View Source [SID1234525806]).

Brilacidin-OM Subgroup Analysis (by Chemotherapy Regimen)

Brilacidin-OM was more effective in decreasing the incidence of SOM in HNC patients receiving the more aggressive chemotherapy regimen—cisplatin administered in a higher concentration (80-100 mg/m2), every 21 days—as compared to lower concentrations of cisplatin (30-40 mg/m2) administered weekly.

For the Modified Intent-to-Treat (mITT) population, Brilacidin-OM in the aggressive chemotherapy regimen reduced the incidence of SOM by 65.0% ([incidence control- incidence active]/incidence control) as compared with placebo (Brilacidin: 25.0%; placebo: 71.4%; p=0.0480). For the Per Protocol (PP) population, Brilacidin-OM in the aggressive chemotherapy regimen similarly reduced the incidence of SOM by 80.3% as compared with placebo (Brilacidin: 14.3%; placebo: 72.7%; p=0.0249). Treatments appeared well-tolerated with good safety.

These data, with additional analysis forthcoming based on the Clinical Study Report, further support Brilacidin’s potential as a promising, and clearly differentiated, late-stage OM drug candidate and will help inform the planning and design of future trials. Brilacidin-OM is being developed under FDA Fast Track Designation.

"We are delighted to see Brilacidin-OM demonstrate such high, statistically significant efficacy in patients receiving aggressive treatment for HNC," said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "Reducing incidence of SOM sets the gold standard and is key to capturing the large HNC market currently lacking any approved drugs. With this new expanded information on the effectiveness of Brilacidin-OM, coupled with our previously reported successful primary results, we think our novel compound continues to raise the bar as the leading SOM drug in development."

Alerts

Sign-up for Innovation Pharmaceuticals email alerts is available at:

View Source

ONCOLOGY VENTURE SWEDEN AB: ONCOLOGY VENTURE EXERCISES OPTION TO IN-LICENSE DOVITINIB A PHASE 3 MULTI TYROSINE KINASE INHIBITOR

On April 9, 2018 Oncology Venture AB (OV:ST) ("OV" or the "Company") reported that it has entered into an agreement with Novartis Pharma AG (Basel, Switzerland) for the exclusive global rights to develop and commercialize dovitinib (TKI258), a small molecule, multi- tyrosine kinase inhibitor (TKI) (Press release, Oncology Venture, SEP 9, 2018, View Source [SID1234525604]). Novartis will receive an upfront payment, development milestones, and royalties on sales. Today’s announcement follows on an earlier agreement between the companies, that included an option for OV to in-license dovitinib at predetermined conditions. As part of the agreement, Novartis will be issued a convertible debt-to-equity note in a spinout company that OV has created to advance clinical development of the drug. Further terms of the agreement were not disclosed. In a Phase 3 trial in metastatic renal cell carcinoma, dovitinib achieved therapeutic equivalence with the current standard of care, sorafenib. Earlier stage studies explored its potential utility in multiple therapeutic indications including liver cancer, breast cancer and various solid tumors. OV intends to advance the compound in clinical trials together with a validated, drug-specific DRP biomarker as a companion diagnostic.

"Dovitinib has demonstrated clinically relevant efficacy in renal cancer and breast cancer and good efficacy in several other solid tumors, and we are excited to accelerate the development of the compound. We are confident that, by using our Drug Response Predictor (DRP) biomarker for dovitinib to select likely responder patients – and the recent success with a combination of a TKI and a PD-1 inhibitor (Keytruda) in renal cancer – we will raise the chances of success for dovitinib in further clinical development. The Dovitinib DRP biomarker could then be consequentially filed together with the Marketing Authorisation Application and used as a predictive companion diagnostic to select likely responders," said Peter Buhl Jensen, M.D., CEO of Oncology Venture.

During the prior option period, OV validated its proprietary DRP biomarker for the compound against anonymized biopsy data from the Novartis Phase 3 renal cancer study. A consistent signal was seen indicative of this biomarker’s ability to predict clinical benefit of dovitinib.

Under the global license agreement, OV will further refine the Dovitinib DRP biomarker to hone its predictive ability by analyzing data from additional biopsies and genomic data sets from other previous, relevant clinical studies with this promising compound. Dovitinib DRP will then be used to prospectively select patients most likely to respond to the compound for inclusion in a planned Phase 2 trial of the drug for the treatment of breast and liver cancer.

Oncology Venture recently announced positive interim results from another DRP-guided oncology program. In a prospective Phase 1/2 study of LiPlaCis (a targeted liposomal formulation of cisplatin) in heavily pre-treated breast cancer patients, in which enrollment was guided by the LiPlaCis DRP biomarker, clinical benefit was shown in 7 out of 10 evaluable patients. By comparison, conventional cisplatin treatment of metastatic breast cancer has reported a response rate of only 10 percent in previously conducted trials. This suggests that the LiPlaCis DRP successfully identified likely responders for inclusion into the clinical trial.

For further information, please contact

Ulla Hald Buhl, COO and Chief IR & CommunicationsMobile: +45 2170 1049E-mail: [email protected] Or Peter Buhl Jensen, CEOMobile: +45 21 60 89 22E-mail: [email protected]
About the Drug Response Predictor – DRP Companion Diagnostic

Oncology Venture uses the Medical Prognosis Institute (MPI) multi gene DRP to select those patients who by the genetic signature of their cancer are found to have a high likelihood of responding to the drug. The goal is developing the drug for the right patients, and by screening patients before treatment the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. DRP is based on messenger RNA from the patient’s biopsies.

The DRP platform, i.e. the DRP and the PRP tools, can be used in all cancer types and is patented for more than 70 anti-cancer drugs in the US. The PRP is used by MPI for Personalized Medicine. The DRP is used by Oncology Venture for drug development