On October 3, 2019 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of drugs known as DARPin therapies*, reported that the first patient has been enrolled and dosed in a Phase 1 first-in-human study of MP0310 as a single agent in patients with advanced solid tumors (Press release, Molecular Partners, OCT 3, 2019, View Source [SID1234655788]). The trial, entitled MP0310-CP101, will evaluate the optimal dose range of MP0310 in preparation for planned combination studies with Amgen’s oncology pipeline products.
MP0310 is the first product candidate in Molecular Partners’ DARPin immuno-oncology pipeline. It is designed to activate immune cells specifically in the tumor and not in the rest of the body, potentially delivering greater efficacy with fewer side effects. Preclinical studies of MP0310 have demonstrated immune T cell activation restricted to solid tumor tissues, and strong CD8 T cell activation and expansion in vitro and in vivo. Additionally, preclinical data show MP0310 avoids strong systemic activation of CD8 T cells and, therefore, has lower risk of the systemic side effects and toxicities.

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"We are delighted to have reached this important milestone in the development of our first immuno-oncology DARPin therapeutic candidate. MP0310’s tumor-localized activation offers promising therapeutic potential both as a monotherapy and in combinations, where it may act to widen the therapeutic window of combination agents," said Nicolas Leupin, M.D., Chief Medical Officer of Molecular Partners. "We look forward to the emerging clinical data and to progressing this therapy to patients in need."
MP0310-CP101 intends to enroll up to 54 patients at three sites in France. The open-label, dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of MP0310 administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to patients with locally advanced or metastatic solid tumors. Patients will be treated until disease progression or trial discontinuation for any other reason.
"This is an important milestone as we jointly investigate MP0310 in preparation for future combinations with Amgen’s immuno-oncology pipeline products with the goal of bringing innovative immunotherapies to patients with cancer," said Dirk Nagorsen, Vice President, Early Oncology Development, Amgen.

For more information, visit: View Source

Financial Calendar
October 31, 2019 Interim Management Statement Q3 2019
December 12, 2019 R&D Day in New York
February 6, 2020 Publication of Full-year Results 2019 (unaudited)
April 29, 2020 Annual General Meeting
View Source

*DARPin is a registered trademark owned by Molecular Partners AG

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates can engage more than five targets, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapeutics have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology and is advancing a proprietary pipeline of DARPin drug candidates in oncology and immuno-oncology. The most advanced global product candidate is abicipar, a molecule currently in phase 3, in partnership with Allergan. Several DARPin molecules for various ophthalmic indications are also in preclinical development. The most advanced DARPin therapeutic candidate wholly owned by Molecular Partners, MP0250, is in phase 2 clinical development for the treatment of solid and hematological tumors. MP0274, the second-most advanced DARPin candidate owned by Molecular Partners, binds to Her2 and inhibits downstream signaling, which leads to induction of apoptosis. MP0274 is currently in phase 1. The company’s lead immuno-oncology product candidate MP0310 is a FAP x 4-1BB multi-DARPin therapeutic candidate designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator). Molecular Partners has closed a collaboration agreement with Amgen for the exclusive clinical development and commercialization of MP0310. MP0310 is expected to enter into the clinic in H2 2019. Molecular Partners is also advancing a growing preclinical and research pipeline in immuno-oncology that features its "I/O toolbox" and additional development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On Oct. 03, 2019, PDS Biotechnology Corporation ("PDS Biotechnology") (Nasdaq: PDSB), a clinical-stage immuno-oncology company pioneering the development of multi-functional immunotherapeutic products, reported a modification of the clinical trial collaboration agreement with a subsidiary of Merck (known as MSD outside the United States and Canada) to evaluate the combination of PDS’s lead Versamune-based immunotherapy, PDS0101, with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase II clinical trial (Press release, PDS Biotechnology, OCT 3, 2019, View Source [SID1234583939]). The planned clinical trial will now evaluate the efficacy and safety of the combination as a first-line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection and is expected to be initiated in the first quarter of 2020.

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The modification to the clinical trial design now allowing evaluation of PDS0101 in combination with KEYTRUDA as first-line treatment comes as a result of Merck’s recent approval by the FDA on June 10, 2019 for KEYTRUDA as monotherapy in patients whose tumors express PD-L1 (CPS ≥1) or in combination with platinum and fluorouracil (FU) for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma.

"We are honored to collaborate with Merck, a proven leader in the field of immuno-oncology to evaluate novel investigational combination therapies that have the potential to further improve the lives of cancer patients," said Dr. Lauren V. Wood, Chief Medical Officer of PDS." The recently updated clinical outcome findings of the PDS0101 phase 1 human clinical trial demonstrate unique in-vivo systemic induction of high levels of granzyme-b inducing HPV-specific killer T-cells associated with observed clinical responses (regression/ elimination of pre-cancerous lesions) in the majority of evaluable patients treated with PDS0101 monotherapy, and a lack of dose limiting toxicities at all tested doses (PDS press release September 19, 2019). Preclinical data demonstrating the novel multi-functional mechanism of action of the Versamune platform technology and the resulting superior T-cell induction and unique regression of advanced tumors were published in the June 2019 issue of the Journal of Immunology.

PDS Biotechnology’s lead product candidate, PDS0101 (Versamune-HPV) is a proprietary clinical stage immunotherapeutic administered by subcutaneous injection being developed to treat HPV-associated cancers. These include cancers such as head and neck cancers and anal cancers, both of which are widely reported to be increasing in frequency over the last decade, and cervical cancer.

Details of the collaboration were not disclosed.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Versamune is a registered trademark of PDS Biotechnology Corporation, Berkeley Heights, NJ, USA.

On October 3, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that pre-clinical data on AUTO6NG, the company’s next generation GD2-targeting CAR T cell therapy, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting (Press release, Autolus, OCT 3, 2019, View Source [SID1234550685]). The meeting will be held from November 6 to November 10, 2019, at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.

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Poster Presentation

Abstract #: P146
Abstract Title: "AUTO6NG: Next generation GD2-targeting CAR T-cell therapy with improved persistence and insensitivity to TGFb and checkpoint inhibition for relapsed/refractory neuroblastoma", Achkova, D., et al.
Session Date: Saturday, November 9
Session Time: 7:00 am – 8:30 pm Eastern Time

About AUTO6NG

AUTO6NG is a next generation programmed T cell product candidate in pre-clinical development. AUTO6NG builds on preliminary proof of concept data from AUTO6, a CAR in clinical development for the treatment of neuroblastoma, which has the ability to target GD2-expressing cancers with a chimeric antigen receptor (CAR). AUTO6NG uses the clinically-derisked CAR of AUTO6 and incorporates additional programming modules designed to enhance the efficacy, safety and persistence of the CAR T therapy. With the enhanced properties of AUTO6NG, it may be suitable for the treatment of GD2-expressing solid tumors, including neuroblastoma, osteosarcoma, melanoma, small cell lung cancer, and soft tissue sarcoma.

AUTO6 is currently in a Phase 1 clinical trial for pediatric neuroblastoma conducted by Cancer Research UK in collaboration with University College London. Autolus has worldwide commercial rights to the GD2-targeting programmed T cell product candidate.

On October 3, 2019 AMN Healthcare Services, Inc. (NYSE: AMN), healthcare’s leader and innovator in workforce solutions and staffing services, reported that it has scheduled a conference call to discuss its third quarter 2019 financial results on Thursday, October 31, 2019 at 5:00 p.m. Eastern Time (Press release, AMN Healthcare Services, OCT 3, 2019, View Source [SID1234540062]). The same day, the Company also expects to issue an earnings news release after market close at approximately 4:15 p.m. Eastern Time.

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A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (800) 288-8960 in the U.S. or (612) 234-9960 for international callers. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available beginning at 7:30 p.m. Eastern Time on October 31, 2019, and can be accessed until 11:59 p.m. Eastern Time on November 14, 2019 by calling (800) 475-6701 in the U.S. or (320) 365-3844 internationally, with access code 472944.

On October 3, 2019 Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, reported it has entered into an exclusive distribution agreement for its non-opioid metastatic cancer pallion drug, Strontium-89 Chloride Injection USP (Strontium-89)/Metastron, with Jubilant Radiopharma for the United States market (Press release, Q BioMed, OCT 3, 2019, View Source [SID1234540053]). Jubilant Radiopharma is an industry leading pharmaceutical company specializing in nuclear medicine focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents on a global scale.

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Strontium-89 is an FDA-approved non-opioid radiopharmaceutical indicated for the treatment of painful skeletal metastases caused by cancer. The product is administered intravenously once every three months as an alternative to opioid analgesics and plays a critical role in the treatment of metastatic bone pain.

The partnership between Q BioMed and Jubilant Radiopharma means that once the FDA approves the Q BioMed contract manufacturer, the large population of potential Strontium-89 patients in the United States will again have the opportunity to access the drug. Denis Corin, CEO of Q BioMed, said of the deal, "Our partnership with Jubilant Radiopharma is an essential component of our upcoming commercial launch and means that we’ll be able to reach providers and patients across the country through a scalable, highly-efficient program, thereby re-establishing supply of this life-changing therapy to those suffering from this debilitating pain."

Jubilant Radiopharma operates the second largest commercial radiopharmacy network in the United States. Pramod Yadav, CEO, Jubilant Pharma Limited stated, "Jubilant Radiopharma is committed to improving lives through Nuclear Medicine by providing healthcare professionals access to high quality, FDA approved products that enable better patient outcomes. We are pleased to partner with Q BioMed to bring this important cancer pain therapy to healthcare providers and patients who so desperately need choices in cancer pain treatment."

Q BioMed and Jubilant Radiopharma intend to announce further details regarding availability of Strontium-89 later this year.