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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

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On November 30, 2020 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that Dr. Patrick Amstutz, CEO of Molecular Partners, will participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on Tuesday, December 1, 2020 at 3:55 – 4:25 PM Eastern Time (9:55 PM CET) (Press release, Molecular Partners, NOV 30, 2020, https://www.molecularpartners.com/molecular-partners-to-participate-in-the-evercore-isi-3rd-annual-healthconx-conference/ [SID1234571989]).

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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

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The event will take place virtually, and audio webcast of the fireside chat will be webcast live and will be made available on the company’s website www.molecularpartners.com under the Investors section. The replay will be available for 90 days following the presentation.

About DARPin therapeutics
DARPin therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin candidate can be built to engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin therapeutics have been clinically validated through to the registrational stage. The DARPin platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin is a registered trademark owned by Molecular Partners AG.

On November 30, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will host a webcast on Monday, December 7, 2020 at 4:30pm EST (Press release, Regeneron, NOV 30, 2020, View Source [SID1234572005]). Management will discuss data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting as well as provide updates on the Company’s broader oncology and hematology portfolio.

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

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Conference Call Information
To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 7442859. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On November 30, 2020, Anixa Biosciences, Inc. (the "Company") reported that it entered into an exclusive license agreement (the "Agreement") with The Cleveland Clinic Foundation, a nonprofit Ohio corporation (the "Licensor") (Filing, 8-K, Anixa Biosciences, NOV 30, 2020, View Source [SID1234572027]). Pursuant to the Agreement, the Company has been granted (i) an exclusive worldwide license to certain patents and patent applications (the "Licensed Patents") pertaining to the use of vaccines for the therapeutic treatment or prevention of ovarian cancer and other types of cancers which express the anti-mullerian hormone receptor 2 protein, including an anti-mullerian hormone receptor 2 protein containing an extracellular domain (the "Fields") and (ii) a non-exclusive worldwide license to use certain know-how related to the Licensed Patents that was not previously known by the Company (the "Licensed Know-How" and collectively, with the Licensed Patents, the "Licensed Technology") to make, have made, use, offer to sell, sell and import Licensed Products (as hereinafter defined) in the Fields. The Licensor has also granted the Company the right to sublicense the Licensed Technology in certain circumstances upon receipt of Licensor’s written consent.

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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

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In consideration of its license of the Licensed Technology to the Company, the Company will pay to the Licensor a non-refundable cash fee for the issuance of the license. In addition, the Company has agreed to pay to the Licensor a royalty on the "net sales" (as such term is defined in the Agreement) on (i) any product or part of a product in the Fields the making, use, sale, offer to sell, or import of which infringes or would be expected to infringe a valid claim on the Licensor’s rights, but for the license granted in the Agreement (a "Licensed Patent Product") and (ii) any product or part of a product in the Fields that is sold, transferred, or otherwise disposed of in a jurisdiction where (1) a Licensed Patent has expired; (2) patent protection is not pursued, but the product or part of a product sold, transferred, or otherwise disposed of would be expected to infringe any valid claim on the Licensor’s rights; or (3) that was derived from, utilizes, uses, is used, or made through use of, embodies, contains, incorporates (in each case, in whole or in part), or uses any element of any of the Licensed Know-How (a "Licensed Know-How Product," and collectively with any Licensed Patent Product, the "Licensed Products"). The Company has also agreed to pay to the Licensor a lesser royalty on "net sales" on any Licensed Product that is sold, transferred or otherwise disposed of in a particular territory where no valid claim exists covering the sale of such Licensed Product in such territory.

In addition to the foregoing consideration, the Company will also pay to the Licensor certain cash payments following the completion of certain regulatory milestones with respect to each Licensed Product. Following the first commercial sale of any Licensed Products, the Company will be required to make certain minimum annual royalty payments to the Licensor. In addition, the Company has agreed to pay to the Licensor an annual maintenance fee related to the Licensed Technology. In the event that the Company sublicenses any of the Licensed Technology in accordance with the Agreement, the Company will pay to the Licensor a percentage of revenue received from any sublicense based upon certain milestones.

The Agreement is effective as of October 20, 2020 and will remain in effect, unless earlier terminated, until the later of (i) the five (5) year anniversary of the expiration of the last to expire valid claim that the Licensor has with respect to the Licensed Patents or (ii) the ten (10) year anniversary of the first commercial sale in each jurisdiction. The Licensor may also terminate the Agreement if, among other things, the Company fails to make certain payments under the Agreement, becomes insolvent, or breaches certain of the terms and provisions of the Agreement (subject, in certain circumstances, to a cure period). The Company has the right to terminate this agreement upon any material breach of the Agreement by the Licensor.

The Company has also agreed to certain commercialization and development milestones with respect to the Licensed Technology. If the Company fails to meet these milestones (including following any permissible cure period or following a mutually agreed upon extension), and such failure is not the result of an unforeseeable event, the Agreement may be terminated by the Licensor.

The Licensor is responsible for prosecution of the Licensed Patents, provided that the Company is responsible for all costs associated with such prosecution. The Company is also responsible for all other patenting costs associated with the Licensed Patents and has agreed to reimburse the Licensor for certain costs incurred prior to the Agreement related to the Licensed Patents.

The Company and Licensor will work in tandem to develop Licensed Products. The Company will be responsible for paying the costs associated with any additional development of Licensed Products.

The Company has agreed to indemnify the Licensor in connection with the Agreement and has also agreed to maintain certain insurance.

The Agreement contains typical representations, warranties and covenants. Pursuant to the Agreement, Licensor retains the right to continue to conduct research relating to the License Products in the Fields, provided that the Licensor does not have the right to practice or use the Licensed Technology in connection with the commercial sale of any product or service. Licensor also retains the right to publish the results of its research, even if such research contains Licensed Know-How, provided that the Company has the right to review and delay the publication if there is patentable subject matter in the research such that the Company can file a patent application over such matter.

On November 30, 2020 Istari Oncology, Inc., a clinical-stage biotechnology company, reported the first patient was dosed in the LUMINOS-101 Phase 2 clinical trial, assessing the safety and efficacy of PVSRIPO in combination with the immune checkpoint inhibitor pembrolizumab (Keytruda) in patients with recurrent glioblastoma multiforme (rGBM) (Press release, Istari Oncology, NOV 30, 2020, View Source [SID1234571967]).

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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

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PVSRIPO is a novel viral immunotherapy that activates a patient’s innate and adaptive immunity to facilitate a targeted anti-tumor immune response. The study seeks to determine whether PVSRIPO and pembrolizumab will be able to generate anti-tumor response in patients with rGBM, given their complimentary mechanisms of action.

"The initiation of this Phase 2 trial represents a significant milestone in the advancement of PVSRIPO and our quest to treat this formidable opponent," said Matt Stober, President and Chief Executive Officer at Istari Oncology. "Currently the treatment options for patients with rGBM are limited and outcomes are grim, so following the encouraging results of our Phase 1 trial, we are eager to see the effectiveness of PVSRIPO in combination with pembrolizumab."

"Combining PVSRIPO’s ability to generate antitumor immune response with a checkpoint inhibitor holds the promise of more effective therapy for this devastating disease," said W. Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. "Achieving rapid disease control is critical in patients with rGBM, one of the most aggressive and treatment-refractory tumors."

LUMINOS-101 is a Phase 2, single arm trial (clinicaltrials.gov NCT04479241) in patients with rGBM that aims to characterize the safety, tolerability and initial efficacy of PVSRIPO intratumoral infusion followed by intravenous pembrolizumab 14 to 28 days later, and every three weeks thereafter.

LUMINOS-101 follows a Phase 1 trial of PVSRIPO in rGBM, conducted at the Preston Robert Tisch Brain Tumor Center at Duke University Medical Center, that found survival rates were significantly higher in rGBM patients who received an intratumoral infusion of PVSRIPO compared to similar patients receiving standard treatment. Overall survival among patients who received PVSRIPO plateaued at 21 percent, 24 to 36 months after injection based on a publication of the interim trial results (Desjardins, et al., 2018 NEJM). The overall survival rate was sustained at 36 months in these patients. A multicenter Phase 2 study of PVSRIPO in patients with rGBM (n=120) completed enrollment in June 2020; follow-up of those patients is ongoing.

The Phase 2 LUMINOS-101 trial will be conducted across multiple research sites, including Ohio State University Comprehensive Cancer Center, University of California San Francisco, Baptist MD Anderson Cancer Center, Duke University Medical Center, Oregon Health and Science University and University Hospitals Seidman Cancer Center (UHSCC) in Cleveland, Ohio. The first patient has been dosed at UHSCC, which treated seven patients with rGBM as part of the previous Phase 2 trial.

"The Phase 1 trial of PVSRIPO yielded survival rates like we’ve never seen before," says Andrew E. Sloan, MD, FACS, Director of the Brain Tumor & Neuro-Oncology Center and the Center of Excellence in Translational Neuro-Oncology at UH Seidman Cancer Center and UH Neurological Institute, and Professor and Vice Chairman, Department of Neurosurgery at Case Western Reserve University School of Medicine. "Glioblastoma is one of the most aggressive tumors known to man. Following the encouraging results of PVSRIPO to date, we are very interested to see if those results improve further in combination with pembrolizumab."

For more information about Istari Oncology and their ongoing clinical trials, visit istarioncology.com.

About PVSRIPO
PVSRIPO is a virus based on the live attenuated Sabin type 1 polio vaccine that has been genetically modified for safety. Unlike other viral immunotherapies, PVSRIPO has a distinct target (the poliovirus receptor CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, PVSRIPO targets tumors with two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) engaging innate and adaptive antitumor immune responses via sublethal infection of antigen presenting cells in the tumor, which unleashes an inflammatory cascade resulting in sustained systemic antitumor immunity. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma.

About Glioblastoma
Glioblastoma is the most common and aggressive form of brain cancer, comprising 52% of patients with primary brain tumors. There are approximately 13,000 patients diagnosed with GBM in the United States annually and approximately 18,000 in the European Union. Despite aggressive treatment, survival for newly diagnosed glioblastoma patients is usually less than 20 months, and for patients with recurrence, which occurs in 98% of patients, survival is usually less than 12 months.