Peptomyc appoints Manuela Niewel, M.D. as Chief Medical Officer

On September 26th, 2019 Peptomyc S.L., a biotech company specialized in the development of protein and peptide therapeutics for cancer treatment, reported it has appointed Manuela Niewel, M.D., as Chief Medical Officer (CMO) (Press release, Peptomyc, SEP 26, 2019, View Source [SID1234555332]). Dr. Niewel will assume responsibility for leading Peptomyc’s overall clinical development, regulatory and medical affairs activities.

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«We are very excited to have Manuela joining us and we warmly welcome her to Peptomyc. With her compassion for patients, her expertise in drug development in oncology and her clear leadership skills, she will definitely be a very strong asset in our team,» saidLaura Soucek, co-founder and CEO of Peptomyc.

Dr Niewel is an MD educated oncologist, who has focused nearly her entire career within the Oncology space, from first in men through registration of oncology drugs. She started as a resident within Oncology hospitals in Germany, working very closely with cancer patients. She then moved into the industry to focus her work within the Clinical Development setting. She joins Peptomyc from Rigontec, a start-up biotech acquired by Merck Sharp & Dohme in October 2017 for up to 464 M€ (shorturl.at/yKY03), where she served as Senior Vice President for Clinical Development since 2015, bringing their compound very quickly and successfully into the clinic. Dr. Niewel also acted as a clinical development consultant for several biotech companies and held Senior Medical Director positions at Chiltern International and Pharmanet, and led Clinical Research groups at PFK Oncology Services, Nycomed and Synthelabo Research. She obtained her M.D. diploma and doctoral degree at the University Munich and her Diploma in Pharmaceutical Medicine at DGPharMed Munich, Germany.

"As an oncologist and drug developer, I am very excited at having the opportunity to lead the clinical development of Omomyc, which acts against a target still considered undruggable" said Manuela Niewel, who also added: "I am very pleased about being part of this dedicated and dynamic team focused on advancing a promising treatment option for many underserved patients".

Dr. Niewel joins Peptomyc at a crucial time, as the company is preparing for a phase

I/II clinical study with its first-in-class anti-MYC lead compound, OMO103. "We are convinced that Manuela’s deep experience in innovative drug development and valuable input to our clinical development plan and regulatory strategy will contribute to the successful implementation of our clinical trials in 2020", adds Marie-Eve Beaulieu, co-founder and CSO of the company.

Peptomyc is currently completing its pre-clinical safety studies with OMO103, its first-in-class peptide compound against MYC, an oncoprotein deregulated in most –if not all- types of cancer. OMO103 has demonstrated its anti-tumor activity in multiple types of mouse models of cancer. The company’s prime focus areas are Non-Small-Cell Lung Cancer and Triple Negative Breast Cancer, but Peptomyc’s products could in the future apply to many more indications that still represent significant unmet needs within the oncology field.

About Peptomyc

Peptomyc is a spin-off from VHIO – the Vall d’Hebron Institute of Oncology – and ICREA – the Catalan Institute of Research and Advanced Studies -, in Barcelona, Spain.

It develops peptide therapeutics for the treatment of cancer patients. Its lead compound, OMO103, is a cell penetrating peptide against MYC, one of the most-wanted targets in cancer therapy, for which no inhibitor is available in the clinic yet. Phase I/II clinical trials testing safety and efficacy of OMO103 are planned to begin in 2020, with a specific focus on Non-Small-Cell Lung Cancer and Triple Negative Breast Cancer patients. Peptomyc counts on the support of private funding by Alta Life Sciences, Healthequity and business angels, and public grants (such as a recent SME Instrument Phase II by the European Commission, or the ENISA loan, from the Spanish Government’s Ministry of Industry, Commerce and Tourism).

Entry into a Material Definitive Agreement

On September 26, 2019 On September 26, 2019, XOMA (US) LLC (the "Company"), a wholly-owned subsidiary of XOMA Corporation, reported that it has entered into a royalty purchase agreement (the "Purchase Agreement") with Palo Biofarma, S.L. ("Palo"), a company organized and existing under the laws of Spain (Filing, 8-K, Xoma, SEP 26, 2019, View Source [SID1234552230]). Pursuant to the Purchase Agreement, the Company acquired the rights to potential royalty payments in low single digit percentages of aggregate Net Sales (as defined in the Purchase Agreement) associated with six drug candidates in various clinical development stages, targeting the adenosine pathway with potential applications in solid tumors, asthma/chronic obstructive pulmonary disease, inflammatory bowel disease, idiopathic pulmonary fibrosis, lung cancer, psoriasis and nonalcoholic steatohepatitis and other indications (the "Licensed Products") that are being developed by Palo. Novartis Pharma AG is a development partner on one of the Licensed Products (the "Licensee") and such Licensed Product is being developed pursuant to a license agreement between Palo and the Licensee.

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Under the terms of the Purchase Agreement, the Company will pay Palo $10 million (the "Payment") for the rights to potential royalty payments on future sales of the Licensed Products. The Company plans to partially finance the Payment by drawing a $5 million term loan under its Loan and Security Agreement with Silicon Valley Bank dated May 7, 2018, as amended on March 4, 2019, as previously filed as an exhibit to the Company’s Quarterly Reports on Form 10-Q for the three month period ending June 30, 2018 and the three month period ending March 31, 2019.

The Purchase Agreement also contains customary representations, warranties, covenants and indemnities. The Purchase Agreement will terminate six (6) months following the full satisfaction of any amounts due under any of the License Agreements (as defined in the Purchase Agreement) and receipt by the Company of all payments to which it is entitled under the Purchase Agreement.

The description of the Purchase Agreement contained herein does not purport to be complete, and is qualified in its entirety by reference to such Purchase Agreement, together with the exhibits thereto, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending September 30, 2019.

Ascendis Pharma A/S Announces Upcoming Investor Presentation in October

On September 26, 2019 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that the company will participate at the 2019 Cantor Global Healthcare Conference in October (Press release, Ascendis Pharma, SEP 26, 2019, View Source [SID1234551450]). Company executives will provide a business overview and update on the company’s pipeline programs.

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Details

Event 2019 Cantor Global Healthcare Conference
Location New York
Date Wednesday, October 2, 2019
Time 3:35 p.m. Eastern Time

A live webcast will be available in the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

Precision BioSciences to Present at Upcoming Industry and Investor Conferences

On September 26, 2019 Precision BioSciences, Inc. (Nasdaq: DTIL), a genome editing company dedicated to improving life through the application of its pioneering, proprietary ARCUS platform, reported that members of its senior leadership team will participate in three industry and investor conferences focused on gene editing and gene therapy in October (Press release, Precision Biosciences, SEP 26, 2019, View Source [SID1234539929]). Presentations will consist of corporate overviews and a panel discussion. Participation at the Jefferies Gene Therapy Summit will be limited to private meetings.

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Alliance for Regenerative Medicine Cell & Gene Meeting on the Mesa
Date: October 2-4, 2019
Presentation Time: October 3, 4:15 p.m. PT
Panel Time: October 4, 9:45 a.m. PT
Location: Carlsbad, CA
Speaker: Michael Dombeck, Senior Vice President, Corporate Development

Chardan Genetic Medicines Conference
Date: October 7-8, 2019
Presentation Time: October 8, 8:30 a.m. ET
Location: New York, NY
Speaker: Matt Kane, Chief Executive Officer

Jefferies Gene Therapy Summit
Date: October 8, 2019
Location: New York, NY
Matt Kane, Chief Executive Officer (investor meetings)

A live audio webcast of the Chardan presentation will be available here (webcast link) and up-to-date details for each event can be found on the "Events & Presentations" page in the Investors section of the Precision BioSciences website (www.precisionbiosciences.com). A replay of the Chardan presentation will also be archived for 30 days on the Events & Presentations page.

BeiGene Announces Clinical Data on Tislelizumab and Pamiparib to Be Presented at the European Society for Medical Oncology (ESMO) Congress 2019

On September 26, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported that clinical data on its investigational anti-PD-1 antibody tislelizumab and its investigational PARP inhibitor pamiparib will be presented in five poster presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2019, taking place September 27 – October 1, 2019 in Barcelona, Spain (Press release, BeiGene, SEP 26, 2019, View Source [SID1234539857]).

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Poster Presentations:

Title: Population Pharmacokinetics of Tislelizumab in Patients with Advanced Tumors
Presentation #: 483P
Date: Saturday, September 28
Time: 12:00 – 13:00 CEST
Location: Poster Area (Hall 4)
Presenter: Chi-Yuan Wu, Ph.D., BeiGene

Title: Tislelizumab Exposure-Response Analyses of Efficacy and Safety in Patients with Advanced Tumors
Presentation #: 482P
Date: Saturday, September 28
Time: 12:00 – 13:00 CEST
Location: Poster Area (Hall 4)
Presenter: Chi-Yuan Wu, Ph.D., BeiGene

Title: Updated Results of the PARP1/2 Inhibitor Pamiparib in Combination with Low-dose Temozolomide in Patients with Locally Advanced or Metastatic Solid Tumors
Presentation #: 451PD
Date: Saturday, September 28
Time: 16:30 – 18:00 CEST
Location: Alicante Auditorium (Hall 3)
Presenter: Agostina Stradella, M.D., Catalan Institute of Oncology, Spain

Title: Safety, Antitumor Activity, and Pharmacokinetics of Pamiparib, a PARP1/2 Inhibitor, in Patients with Advanced Solid Tumors: Updated Phase 1 Dose-Escalation/Expansion Results
Presentation #: 452PD
Date: Saturday, September 28
Time: 16:30 – 18:00 CEST
Location: Alicante Auditorium (Hall 3)
Presenter: Mark Voskoboynik, MBBS, FRACP, Nucleus Network, Australia

Title: First Report of Efficacy and Safety from a Phase 2 Trial of Tislelizumab, an Anti-PD-1 Antibody, for the Treatment of PD-L1+ Locally Advanced or Metastatic Urothelial Carcinoma in Asian Patients
Presentation #: 920P
Date: Monday, September 30
Time: 12:00 – 13:00 CEST
Location: Poster Area (Hall 4)
Presenter: Dingwei Ye, M.D., Ph.D., Fudan University Cancer Institute, China