On October 2, 2018 Pieris Pharmaceuticals, Inc presented the Cantor Fitzgerald Global Healthcare Conference presentation (Presentation, Pieris Pharmaceuticals, OCT 2, 2018, View Source [SID1234529837]).

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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 2, 2018 Nordic Nanovector ASA (OSE: NANO) reported that an abstract reporting data from the Phase 1/2a LYMRIT 37-01 study investigating Betalutin (177Lu-lilotomab satetraxetan) in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma (iNHL) has been accepted for a poster presentation at the 60th Annual Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (1-4 December 2018, San Diego, CA) (Press release, Nordic Nanovector, OCT 2, 2018, View Source [SID1234553494]).

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Title: LYMRIT 37-01: A phase I/II study of 177Lu-lilotomab satetraxetan (Betalutin) antibody-radionuclide-conjugate (ARC) for the treatment of relapsed non-Hodgkin’s lymphoma (NHL) – Analysis with 6-month follow-up

Authors: A. Kolstad, et al.

The Company will also have two non-clinical posters: one presenting Betalutin and one presenting the investigational anti-CD37 radioimmunoconjugate 212Pb-NNV003, which is under evaluation in a research collaboration between Nordic Nanovector and Orano Med (formerly AREVA Med).

Cell Cycle Kinase Inhibitors Potentiate the Effect of 177Lu-lilotomab Satetraxetan in Treatment of Aggressive Diffuse Large B-Cell Lymphoma

Authors: G.R. Rødland et al.

Targeted Alpha Therapy with 212Pb-NNV-003 for the Treatment of CD37 Positive B-Cell Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin Lymphoma (NHL)

Authors: A. Saidi et al.

The abstracts will be published on 1 November 2018 at 09:00am Eastern time at View Source

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