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.

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"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]).

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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]).

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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.

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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 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully determined the modified site and chromosome location of the cytochrome P450-2B1 gene in the DNA of the genetically altered human cells known as 22P1G that will be encapsulated and used together with the cancer prodrug ifosfamide in PharmaCyte’s upcoming clinical trial (Press release, PharmaCyte Biotech, OCT 1, 2018, View Source [SID1234529683]). The cytochrome P450-2B1 gene is responsible for producing the enzyme that activates the ifosfamide into its cancer-killing form. The "integration site" information from this study was another requirement requested by the FDA. The site of integration was to be defined and included in PharmaCyte’s Investigational New Drug Application (IND) before the start of the clinical trial for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "This study answers one of the key questions that was raised in our pre-IND meeting with the FDA. It represents the culmination of a long, complicated and expensive series of experiments as well as interpretation of a plethora of data that was generated over the last 12 months and is congruent with earlier data that we generated. Without these findings, we would be unable to submit our IND to the FDA, so this completed study moves us a significant step closer to submitting our IND to the FDA."

The study was an exceedingly complicated one that involved the latest cutting-edge techniques such as Next Generation Sequencing (NGS) as well as more classical techniques of polymerase chain reaction (PCR) analysis and DNA sequencing. The comprehensive and voluminous set of data that was generated from these tests was subjected to a robust and multi-faceted analysis. In addition to providing a better characterization of the cells at the DNA level, this analysis has revealed that the cytochrome P450-2B1 expression construct is located on human chromosome 9 in PharmaCyte’s 22P1G cell line. Additional analyses have revealed that the location of the construct is in a benign region of the human genome that should be "safe." This supports the previous conclusion that the 22P1G cells have a good safety profile.

The data obtained from the in-depth analyses also confirm data that has been previously announced by PharmaCyte that concerned enzymatic assays and Southern blotting analyses (a method used in molecular biology for detection of specific DNA sequence in DNA samples) of the 22P1G cells.