On October 2, 2018 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, 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, Tmunity Therapeutics, OCT 2, 2018, View Source [SID1234529776]).

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Tmunity was founded on an exclusive collaboration and license agreement with the University of Pennsylvania, offering proprietary technologies and the unparalleled expertise in first-in-patient cell and gene therapies of its scientific founders, led by Carl H. June, MD. Today, Tmunity is uniquely positioned to integrate the best technologies and pursue multiple approaches to engineered T cell therapies simultaneously in order to advance treatments into the clinic rapidly, optimize and scale manufacturing, pursue regulatory approvals aggressively, and thus deliver them effectively to patients.

"We are honored to receive this recognition for our approach in creating smarter T cells to overcome current challenges and deliver breakthrough medicines to patients, faster and with better outcomes," said Usman "Oz" Azam, MD, President and Chief Executive Officer of Tmunity. "This has been a transformational year for our company with the expansion of our management, scientific and manufacturing teams, moving our novel science into the clinic and preparing for commercial success. We congratulate all of the companies in the 2018 ‘Fierce 15’ class and support their efforts to develop medicines that offer hope to 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 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 Kite, a Gilead Company (Nasdaq: GILD), and HiFiBiO Therapeutics, a biotechnology company focused on the discovery of therapeutic antibodies through single B cell screening and analysis, reported the companies have entered into a research collaboration and license agreement to develop technology supporting the discovery of neoantigen-reactive T cell receptors (TCRs) for the potential treatment of various cancers, including solid tumors (Press release, Kite Pharma, OCT 2, 2018, View Source [SID1234537506]).

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Kite and HiFiBiO intend to adapt HiFiBiO’s proprietary single cell technology platform to create a high throughput approach that will potentially allow for the in-depth screening of TCR repertoires from patient samples to identify shared antigen and neoantigen TCRs for use in adoptive cellular therapies. Neoantigens arise from tumor-specific mutations that are unique to each patient’s cancer, offering the potential for more targeted antitumor activity.

Under the terms of the agreement, HiFiBiO will receive a $10 million upfront payment and will be eligible for additional payments based on the achievement of certain research milestones. Kite will have an exclusive option to license HiFiBiO’s platform to screen T cell repertoires and to identify TCRs for use in TCR engineered T cell therapies with a corresponding payment to HiFiBiO.

"Neoantigen-based cell therapy is a very exciting, yet complex, area of research that has the potential to transform the way we treat many solid tumors," said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. "We are excited about this collaboration with HiFiBiO, which will build upon our existing capabilities focused on discovering cell therapies which target patient-specific tumor neoantigens."

"Kite is a recognized leader in the cell therapy field," said Liang Schweizer, PhD, President and Chief Executive Officer, HiFiBiO Therapeutics. "We are proud that our proprietary single cell technology platform, which is utilized to support the rapid progression of our novel antibody therapeutics pipeline, will now also be implemented by Kite for the development of novel cell therapies targeting neoantigens."

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.