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.

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!

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]).

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!

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.

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!

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

On September 16, 2019 AstraZeneca reported that it will unveil a series of breakthrough data across multiple cancer types in its mission to one day eliminate cancer as a cause of death at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona, Spain, 27 September to 1 October 2019 (Press release, AstraZeneca, SEP 16, 2019, View Source [SID1234539503]).

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!

With 63 abstracts, including 7 oral presentations, the Company will demonstrate its leadership in precision medicine and immunotherapy. Highlights include results of three Phase III clinical trials featured in the ESMO (Free ESMO Whitepaper) Presidential Symposia across three cancer types:

In lung cancer, new data from the Phase III FLAURA trial will highlight the superior overall survival (OS) benefit of Tagrisso (osimertinib) compared with previous standard-of-care (SoC) treatments erlotinib or gefitinib for patients with epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC) (Abstract #LBA5_PR). FLAURA is the first and only global Phase III trial to demonstrate a statistically-significant OS benefit in this setting.
In ovarian cancer, progression-free survival (PFS) results from the Phase III PAOLA-1 trial, including key subgroup analysis, will illustrate the benefit of adding Lynparza (olaparib) to SoC bevacizumab in the 1st-line maintenance treatment of women with advanced ovarian cancer (Abstract #LBA2_PR). PAOLA-1 is the second positive Phase III trial for Lynparza in 1st-line advanced ovarian cancer.
In metastatic castration-resistant prostate cancer (mCRPC), results from the Phase III PROfound trial will detail the improvements in radiographic PFS observed with Lynparza. Patients in the trial had progressed on prior treatment with new hormonal anticancer treatments and had mutations in homologous recombination repair (HRR) genes, such as BRCA1/2 and ATM, which are a common trait in cancer cells that can interfere with normal cell DNA repair mechanisms (Abstract #LBA12_PR). These data show the value of genomic testing beyond just BRCAm and make Lynparza the first PARP inhibitor to achieve positive Phase III results in four different cancer types (breast, ovarian, pancreatic and prostate).
Dave Fredrickson, Executive Vice President, Oncology, said: "The practice-changing data we are presenting at ESMO (Free ESMO Whitepaper) 2019 demonstrates our commitment to make prolonged survival a realistic outcome. By using biomarkers to define optimal treatment and match innovative precision medicines to the patients who can best benefit from them, our dynamic Oncology pipeline and pioneering research continue to deliver new potential medicines across multiple deadly cancers."

José Baselga, Executive Vice President, Oncology R&D, said: "At ESMO (Free ESMO Whitepaper) 2019 we will see key components of our next-generation Oncology pipeline, including innovative platform studies and early data for the next wave of therapies designed to preferentially kill cancer cells and regulate the immune response to cancer."

Improving overall survival across lung cancers

In addition to the FLAURA OS results, key presentations include:

Results from the Phase III CASPIAN trial showing improved OS with better quality of life for patients taking Imfinzi (durvalumab) in combination with SoC chemotherapy vs. SoC (Abstract #LBA89).
New data from the Phase III PACIFIC trial demonstrating that treatment benefit with Imfinzi vs. placebo was maintained regardless of the occurrence of pneumonitis (Abstract #1459PD).
An oral presentation of data from the Phase I/II 1108 study in patients with solid tumours, including NSCLC, showing that reinitiating treatment with Imfinzi restored antitumour efficacy without disease progression in previously-treated patients who had progressed after a planned treatment interruption (Abstract #1175O).
Results from the real-world ASTRIS study of EGFR T790M mutation positive advanced NSCLC patients with central nervous system (CNS) metastases (Abstract #1521P).

Breaking treatment boundaries in ovarian cancer

In addition to the PAOLA-1 results, key presentations include:

Subanalyses from the Phase III SOLO-1 trial of Lynparza in newly-diagnosed advanced ovarian cancer patients, assessing time to second subsequent therapy (Abstract #995PD), patient-reported outcomes (Abstract #996PD) and health-related quality of life (HRQoL) (Abstract #998PD).
Updated results from the Phase II MEDIOLA trial of Lynparza and Imfinzi in germline BRCAm platinum-sensitive relapsed ovarian cancer (Abstract #1191PD).
Data from the Phase II BAROCCO trial of Lynparza and cediranib with a continuous or intermittent schedule in advanced platinum-resistant ovarian cancer (Abstract #LBA58).

Establishing new therapeutic landmarks in multiple tumour types

Presentations beyond the PROfound trial results include:

Subanalyses from the Phase III POLO trial of Lynparza in germline BRCAm metastatic pancreatic cancer patients, including HRQoL (Abstract #675PD) as well as time to treatment discontinuation and time to subsequent therapies (Abstract #693P).
An oral presentation of data from the Phase Ib BISCAY trial, an adaptive, biomarker-directed platform study of Imfinzi in combination with multiple targeted therapies in metastatic bladder cancer (Abstract #902O).
Preliminary results from the Phase I PATRIOT study of ATR inhibitor AZD6738 as monotherapy in advanced solid tumours (Abstract #450PD).
Safety data from a Phase I/II trial of Imfinzi plus monalizumab, bevacizumab and SoC combination chemotherapy in patients with metastatic microsatellite-stable colorectal cancer (Abstract #1201P).
Updated results from the MEDIOLA Phase II study of Lynparza and Imfinzi in germline BRCAm metastatic breast cancer (MBC) (Abstract #1191O).

On September 16, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that it will present at the Sachs 19th Annual Biotech in Europe Forum for Global Partnering & Investment (Press release, Actinium Pharmaceuticals, SEP 16, 2019, View Source [SID1234539551]). The forum is being held at the Congress Center Basel in Basel, Switzerland on September 25-26, 2019. The event is expected to attract more than 700 delegates from across the globe. Details of Actinium’s presentation are as follows:

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!

(PRNewsfoto/Actinium Pharmaceuticals, Inc.)

Date: Wednesday, September 25, 2019
Time: 4:50 PM CEST
Venue: Congress Center Basel in Basel, Switzerland
Track: F

Members of Actinium’s Executive team will be available for one-on-one meetings with conference attendees. Those interested in scheduling a meeting with Actinium may do so by contacting David Gould, MD, Senior Vice President, Corporate Development and Affairs via email at [email protected].

About the Sachs 19th Annual Biotech in Europe Forum

The 19th Annual Biotech in Europe Forum is recognized as a leading international stage for those interested in investing and partnering in the biotech and life science industry. The event draws together a cross-section of early-stage/pre-IPO, late-stage and public companies with leading investors, analysts, money managers and pharma licensing executives. Supported and designed by leading figures within Europe’s pharmaceutical and biotech industry, the event is expected to attract more than 700 delegates and over 100 presenting companies. To learn more about the event, please click here: View Source