On September 16, 2019 EdiGene, Inc., which develops genome editing technologies into novel therapeutics for a broad range of diseases and into creative solutions to advance drug discovery, reported the successful completion of raising approximately $11 Million in a Series pre-B2 financing (Press release, EdiGene, SEP 16, 2019, View Source [SID1234539565]). EdiGene’s Series A lead investor IDG Capital and Series pre-B lead investor Lilly Asia Ventures (LAV) invested in this round.

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Separately, EdiGene has formed research collaboration with a clinical stage biopharmaceutical company developing novel T-cell therapies to explore new allogeneic T-cell therapeutic approaches for cancer. Company name and deal terms are not disclosed.

"Allogeneic T-cell therapeutics has tremendous potential in China and beyond, by offering innovative T-cell therapies "off the shelf" with more effective quality control and lower cost. We have been building the Allogeneic CAR-T Platform and this new research collaboration further demonstrates our commitment to develop such therapeutics to help the cancer patients in need," said Dong Wei, Ph.D., MBA, CEO of EdiGene. "We are pleased to complete the new round of financing by our lead investors IDG and LAV. We look forward to working with them and other current investors to advance our exciting portfolio into the next stage."

On September 16, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the investigational agent enfortumab vedotin and granted Priority Review for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting (Press release, Astellas, SEP 16, 2019, View Source [SID1234539549]). The filing is based on results from the first cohort of patients in the EV-201 pivotal phase 2 clinical trial that were presented as a late-breaking oral presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June 2019. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of March 15, 2020. Enfortumab vedotin is a novel investigational antibody-drug conjugate (ADC) that targets Nectin-4, a protein that is highly expressed in urothelial cancers.1

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The FDA granted enfortumab vedotin Breakthrough Therapy designation in March 2018, for patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following checkpoint inhibitor therapy.

"The FDA’s filing of the application for enfortumab vedotin and granting of Priority Review is a significant milestone toward offering a new treatment to patients with advanced urothelial cancer who have a clear unmet need," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.

"If approved, enfortumab vedotin will likely play an important role in the treatment of advanced urothelial cancer, and we look forward to working with the FDA as the review process advances," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas.

About the EV-201 Trial

EV-201 is an ongoing single-arm, pivotal phase 2 clinical trial of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy and who are ineligible for cisplatin (cohort 2). In cohort 1, 128 patients were enrolled at multiple centers internationally.2 The primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability. EV-201 continues to enroll patients in cohort 2.

More information about enfortumab vedotin clinical trials can be found at clinical trials.gov.

About Urothelial Cancer

Urothelial cancer is the most common type of bladder cancer (90 percent of cases). In 2018, more than 82,000 people were diagnosed with bladder cancer in the United States.3 Globally, approximately 549,000 people were diagnosed with bladder cancer last year, and there were approximately 200,000 deaths worldwide.4

About Enfortumab Vedotin

Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule that is expressed on many solid tumors, and that has been identified as an ADC target by Astellas.

The safety and efficacy of enfortumab vedotin are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval or become commercially available for the uses being investigated.

On September 16, 2019 PPF reported the acquisition of a 19.2% stake in Autolus Therapeutics plc, a leader in next-generation T cell programming technologies (Press release, PPF , SEP 16, 2019, View Source [SID1234539566]). The shares were acquired in the market through NASDAQ.

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Autolus Therapeutics plc ("Autolus") is a leader in T cell programming technologies and is developing a pipeline of next generation T cell therapies targeting both hematological cancers and solid tumors. Focused on the development of precisely targeted, controlled and highly active CAR-T cell products, Autolus aims to provide T cell therapies with very favorable safety profile and enhanced clinical efficacy to better recognize cancer cells, break down their defense mechanisms, and attack and kill these cells. The lead program AUTO1 is expected to enter a pivotal phase II study in patients with adult relapsed or refractory acute B lymphocytic leukemia ("adult ALL") later this year with an anticipated filing for marketing authorization in 2021.

With the investment into Autolus, PPF Group N.V. ("PPF") significantly increased its commitment to the healthcare sector. Next to Autolus, PPF’s majority-owned biotechnology company SOTIO a.s. ("SOTIO") is aiming to become a fully-integrated oncology specialty pharma company. Together with SOTIO, PPF have built a biotechnology portfolio through in-house research and development, investments, acquisitions and in licensing of products with companies like NBE-Therapeutics, Cellestia Biotech, Cytune Pharma or Lead Discovery Center. SOTIO is developing its proprietary dendritic cell-based cell therapy platform DCVAC and has a significant manufacturing and regulatory expertise in the domain of cellular therapies. SOTIO also recently initiated a Phase I/Ib clinical trial with its interleukin-15 superagonist SO-C101.

"We are very excited by our investment into Autolus. The data published by Autolus on their CAR-T programs is very promising and their long-term ambitions are a perfect match with PPF’s strategy in healthcare," said Ladislav Bartonicek, shareholder of PPF responsible for the biotechnology sector. "Our investment in Autolus confirms the long term commitment of PPF and SOTIO to build a strong biotechnology portfolio developing a broad range of its own oncology products and investing in various biotech companies with promising new therapies."

On September 16, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported its sponsored research at MD Anderson Cancer Center has resulted in the filing of a new patent on behalf of MD Anderson Cancer Center covering the combination of its immune-stimulating/transcriptional-modulator, WP1066, with well-known immune checkpoint inhibitors (Press release, Moleculin, SEP 16, 2019, View Source [SID1234539550]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"We had previously announced preliminary preclinical data showing beneficial therapeutic effect from WP1066 when used in combination with PDL-1 and CTLA-4 immune checkpoint inhibitors in pancreatic cancer models," commented Walter Klemp, Moleculin’s Chairman and CEO. "We are pleased to report the filing of a patent on behalf of MD Anderson Cancer Center for this new discovery that opens new potentially effective approaches to utilize check point inhibitors for treatment of pancreatic cancer and other types cancers that are unresponsive to current immunotherapies. These studies were supported by our sponsored research agreement with MD Anderson Cancer Center. Pursuant to the terms of our Sponsored Research Agreement, we intend to add this to our already diverse list of technology licenses."

On September 16, 2019 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported that Robert Wasserman, MD, has joined the Rgenix management team as its new Chief Medical Officer (Press release, Rgenix, SEP 16, 2019, View Source [SID1234539567]). Dr. Wasserman takes on his new role after a 20-year career that includes senior positions at large pharma companies including Roche, Novartis and Merck.

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In his new role, Dr. Wasserman will have oversight of clinical development for Rgenix’s two lead clinical programs, RGX-104 and RGX-202. In particular, he will oversee the imminent launch of a Phase 1b/2 trial of Rgenix’s lead therapy, RGX-104, a first-in-class oral LXR agonist that has demonstrated anti-tumor activity as a single agent and in combination with other therapies – including chemotherapy and checkpoint blockade – in patients with refractory cancers.

For the Phase 1b/2 trial, RGX-104 will be tested in combination with the standard-of-care regimen consisting of chemotherapy (carboplatin/pemetrexed) plus the checkpoint inhibitor immunotherapy pembrolizumab as a first-line treatment in non-small cell lung cancer (NSCLC) patients whose tumors lack expression of the PD-L1 protein (<1% expression). NSCLC patients whose tumors lack PD-L1 expression have significantly lower response rates to standard-of-care in the first line setting, and thus represent a patient population of high unmet need. Resistance to standard-of-care immunotherapy has been associated with the presence of high levels of immunosuppressive myeloid cells known as MDSCs. RGX-104 has demonstrated broad-spectrum depletion of MDSCs in refractory cancer patients – including NSCLC patients – and therefore represents a novel approach to overcome drug resistance. As part of the Phase 1b/2 trial, RGX-104 will also be tested in patients with small cell lung cancer (SCLC/HG-NET) in combination with docetaxel chemotherapy as a second line treatment.

"Bob’s vast experience in oncology and clinical research is a perfect fit for Rgenix given our expanding clinical programs and pending milestones," said Masoud Tavazoie, MD, PhD, Chief Executive Officer and co-founder of Rgenix. "As we prepare to launch Phase 1b/2 studies for our first-in-class compounds RGX-104 and RGX-202, we are eager to leverage his knowledge and expertise to help expand our efforts for patients with cancers considered to have high unmet need."

"I look forward to working with the team at Rgenix to develop novel treatments for these patients by applying the company’s unique platform technology and methodology to discover drivers of cancer growth. With its roots in strong science and its dedication to a novel approach, Rgenix’s reputation as a premier innovator in the oncology space is growing and I’m excited to be a part of such a dynamic effort at this key stage for the company," said Dr. Wasserman.

Dr. Wasserman started his career in the industry working with major pharmaceutical companies. His last large pharma appointment was at Roche, where he ended a six-year period at the company as the Chairman of the Clinical Biomarker Leadership Team and where he also served for a time as the Global Head of Oncology Translational Medicine (Early Clinical Development) for Roche Pharma Research/Early Development. Prior to Roche, he was the Deputy Global Head of Oncology Biomarkers at Novartis and, before that at Merck.

His most recent biotech role was as the Chief Medical Officer at Northern Biologics, a Canadian company developing first-in-class immuno-oncology products. He currently maintains a position as an Advisory Board Member of Sectoral Asset Management out of Montreal.

Dr. Wasserman earned his B.A. from the University of Pennsylvania and his MD from the Johns Hopkins University School of Medicine. He completed his pediatric residency and pediatric hematology-oncology fellowship training at The Children’s Hospital of Philadelphia, at the University of Pennsylvania and then was on faculty as an Assistant Professor