On October 2, 2018 LSK BioPharma (LSKB, Company) reported that the South Korean Ministry of Food and Drug Safety (MFDS) has approved a Phase I/IIa study protocol to investigate the combination of rivoceranib and paclitaxel, "A Phase I/IIa Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Rivoceranib in Combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer" (Press release, LSK BioPharma, OCT 2, 2018, View Source [SID1234530136]). The study will take place at Asan Medical Center in South Korea under the direction of Dr. Yoon-Koo Kang.

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!

"Asan Medical Center has been a key site in our pivotal Phase 3 gastric cancer trial for advanced and metastatic patients. We are excited to add this combination therapy trial at the same center with Professor Kang to investigate the use of rivoceranib in earlier stage patients," said Dr. Sung Chul Kim, LSKB President.

The study is expected to enroll its first patients in October 2018.

About Rivoceranib (Apatinib)
Rivoceranib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma, which holds the global rights (ex-China). The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

On October, 2018 Pandion Therapeutics reported that it has been named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Pandion Therapeutics, OCT 2, 2018, View Source [SID1234529780]).

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!

Pandion is developing a new class of drugs to treat diseases with high unmet medical need, including inflammatory bowel disease, autoimmune liver disease, kidney diseases, type 1 diabetes, and autoimmune skin conditions. Pandion’s approach is shifting the paradigm from systemic immunosuppression to therapies that act locally at the site of disease to restore immune homeostasis.

"We are delighted to be recognized by FierceBiotech as one of their Fierce 15," said Dr Anthony Coyle, CEO and President of Pandion. "We are building an exciting, energetic and bold company with a dynamic and diverse team, and we are privileged to be making new drugs that we believe will meaningfully impact the lives of many patients."

The Fierce 15 celebrates the spirit of being "fierce"—championing innovation and creativity, even in the face of intense competition. This is FierceBiotech’s 16th annual Fierce 15 selection.

An internationally recognized daily report reaching a network of over 285,000 biotech and pharma industry professionals, FierceBiotech provides subscribers with an authoritative analysis of the day’s top stories. Every year FierceBiotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.

On October 2, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported that Dr. Alain Algazi, Associate Professor of Medicine at UCSF, will present data from OncoSec’s OMS-100 study of TAVO (intratumoral tavokinogene telseplasmid) as a monotherapy treatment for metastatic melanoma in an oral presentation during the Melanoma Bridge Conference being held on November 29 – December 1 in Naples, Italy (Press release, OncoSec Medical, OCT 2, 2018, View Source [SID1234529888]).

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!

Dr. Algazi’s recently accepted presentation, entitled Intratumoral tavokinogene telseplasmid induces abscopal clinical responses in metastatic melanoma patients, will describe the OMS-100 Phase 2 multicenter, single-group study which evaluated the efficacy and safety observed after repeat dosing and different intervals between TAVO cycles. The primary endpoint was overall response rate (ORR) by modified "skin" Response Evaluation Criteria In Solid Tumors (mRECIST). Dr. Algazi, the primary investigator, is a leading expert in oncology research as well as a Clinical Strategic Advisor and a Clinical Advisory Board member for OncoSec.

The new data will demonstrate that local treatment with TAVO alone led to whole-body immune responses associated with regression of untreated lesions in half of the 50 patients treated on the study.

"We were grateful to Dr. Algazi and the Melanoma Bridge Conference for the opportunity to share this important TAVO monotherapy data demonstrating abscopal clinical responses with the clinicians, biotechnology executives, and industry opinion leaders in attendance," said Daniel J. O’Connor, OncoSec President and Chief Executive Officer. "Having Dr. Algazi present data from our OMS-100 study at the Melanoma Bridge Conference is an exciting opportunity for OncoSec as it serves to highlight our clinical work investigating TAVO as a monotherapy in the treatment of metastatic melanoma, as well as bring added visibility to our Phase 2b PISCES/KEYNOTE-695 clinical trial combining TAVO with pembrolizumab in metastatic melanoma for patients that have failed all available treatment options, including anti-PD-1 immunotherapy."

Details of the presentation are as follows:

Session Title: Mechanisms of resistance and drivers of response
Presentation Title: Intratumoral tavokinogene telseplasmid induces abscopal clinical responses in metastatic melanoma patients will address
Date and Time: Friday, November 30, 2018; 4:50 PM – 5:05 PM CEST (10:50 AM – 11:05 AM ET)
Location: Naples, Italy

The 2018 Nobel Prize in Physiology or Medicine has been awarded jointly to James P. Allison and Tasuku Honjo for their almost 30 year old discovery of cancer therapy by inhibition of negative immune regulation. It was in the 1990s, when Dr James P. Allison’s laboratory at the University of California, Berkeley studied the T-cell protein CTLA-4. He was one of several scientists who had made the observation that CTLA-4 functions as a brake on T cells. In 1992, a few years before Allison’s discovery, Tasuku Honjo discovered PD-1, another protein expressed on the surface of T-cells. His research showed that PD-1, similar to CTLA-4, functions as a T-cell brake, but operates by a different mechanism.

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!

Fast forwarding to today and cancer immunotherapy is the established 4th pillar of cancer therapy and encompasses a highly diverse portfolio of treatment strategies from the early interferon-α/interleukin-2 therapies to the current progress of immune-checkpoint inhibitors and CAR-T therapies to make the immune system fight cancer.

The first approved immune-checkpoint inhibitor was Bristol-Myers Squibb’s ipilimumab (Yervoy) back in 2011 for the treatment of adult patients with previously-treated advanced melanoma. Then followed the approval of Opdivo (nivolumab) and Keytruda (pembrolizumab) in rapid succession. Currently there are seven approved immune-checkpoint inhibitors for the treatment of sixteen different tumor types, see table below. Just last Friday Regeneron and Sanofi reported that the U.S. Food and Drug Administration (FDA) has approved Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

These approved drugs are just the tip of the iceberg with more than 500 immune-checkpoint drugs being developed world-wide for the treatment of cancer. No less than twenty of these are in late stage development.

The event of immune-checkpoint drugs such as nivolumab (Opdivo) and pembrolizumab (Keytruda) have dramatically changed the possibility to harness the power of the immune system in fighting cancer not only as a monotherapy but, maybe more importantly, also as a combination therapy.

On October 1, 2018 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, and Zai Lab Limited (Nasdaq: ZLAB), a Shanghai-based innovative biopharmaceutical company, reported dosing of the first patient in the Phase 3 FIGHT pivotal trial of bemarituzumab (FPA144), an isoform-selective FGF receptor 2b (FGFR2b) antibody, in combination with chemotherapy in patients with previously untreated, advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer (Press release, Five Prime Therapeutics, OCT 1, 2018, View Source [SID1234529684]). The first patient was dosed at a participating investigative site in China on Sept. 28.

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!

"We are very pleased to have dosed the first patient in our FIGHT gastric cancer trial in China, where Zai Lab is responsible for the regulatory and development timeline for this global study," said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. "Tumors overexpressing FGFR2b are associated with a poor prognosis, and a targeted therapy that provides improved efficacy when added to standard therapy could transform treatment options for these patients. Bemarituzumab has demonstrated encouraging monotherapy activity in the late-line setting, and we hope to provide greater benefit by combining with chemotherapy in the front-line setting."

"This is the first time that the first patient dosed in a global registrational trial came from China as a result of the collaboration between a U.S. biotechnology company and a Chinese biotechnology company," said Dr. Yongjiang Hei, CMO of Zai Lab. "Gastric cancer is the fifth most common cancer in the world and the second most common in China. There is an urgent need globally, and particularly in China, where we are responsible for both development and commercialization, for more effective and well-tolerated targeted therapies for gastric cancer patients. We are pleased that the clinical trial application (CTA) was approved three months ahead of schedule, which will help accelerate the global FIGHT trial in our collaboration with Five Prime."

About the FIGHT Trial

The double-blind randomized and controlled Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment)trial will evaluate 15 mg/kg of bemarituzumab or placebo given every two weeks combined with modified FOLFOX6 (mFOLFOX6) chemotherapy in approximately 550 patients with GC or GEJ cancer whose tumors overexpress FGFR2b. The Phase 3 global registration trial is the first prospective FGFR2b-specific front-line gastric study and will include approximately 250 sites in the U.S., Europe and Asia, including China, South Korea, Taiwan and Japan, where the incidence of gastric cancer is among the highest worldwide. Zai Lab and Five Prime have a strategic development collaboration under which Zai Lab will manage the Phase 3 portion of the FIGHT trial in China, where approximately half of the patients in the trial are expected to be enrolled.

The primary endpoint of the FIGHT trial is overall survival (OS), with key secondary endpoints being progression-free survival (PFS), objective response rate (ORR), safety and pharmacokinetic (PK) parameters.

Unmet Need in GC and GEJ

GC, including GEJ cancer, is the fifth most common cancer worldwide and third leading cause of cancer death. Gastric cancer is the second most common cancer in China.

Current first-line chemotherapy treatment delays progression by approximately six months compared to best supportive care, but median OS remains poor with literature-reported ranges of approximately 10 to 11 months and PFS of approximately six months. The presence of FGFR2b overexpression is present in approximately 10% of patients with GC/GEJ and is associated with a worse prognosis. Few treatment options following progression are available after first-line chemotherapy, and a significant unmet need remains in the treatment of GC/GEJ worldwide.

Five Prime is developing companion diagnostics to identify FGFR2b overexpression using an immunohistochemistry (IHC) test and FGFR2 gene amplification using circulating tumor DNA (ctDNA) analysis. Five Prime will use both assays to select patients for the FIGHT trial.

About Bemarituzumab

Bemarituzumab is a first-in-class, isoform-selective, humanized monoclonal antibody in clinical development as a targeted immunotherapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. Bemarituzumab blocks FGFs 7, 10 and 22 from binding to FGFR2b, and has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Clinical results to date suggest that the specificity of bemarituzumab avoids the dose-limiting toxicities that have been seen with less selective pan-FGFR tyrosine kinase inhibitors that act on multiple FGFRs, including FGFR2.

In December 2017, Five Prime and Zai Lab announced a strategic collaboration for the development and commercialization of bemarituzumab in Greater China.