On December 18, 2019 Exelixis, Inc. ("Exelixis") reported that it has entered into a joint clinical research agreement (the "Clinical Collaboration Agreement") with F. Hoffmann-La Roche Ltd. ("Roche") for the purpose of evaluating the combination of cabozantinib (CABOMETYX) with atezolizumab (TECENTRIQ) in patients with locally advanced or metastatic solid tumors, including in three planned phase 3 pivotal trials in advanced non-small cell lung cancer, castration-resistant prostate cancer and renal cell carcinoma (Filing, 8-K, Exelixis, DEC 18, 2019, View Source [SID1234552502]). If a party to the Clinical Collaboration Agreement proposes any additional combined therapy trials beyond the initial three planned phase 3 pivotal trials, the Clinical Collaboration Agreement provides that such proposing party must notify the other party and that if agreed to, any such additional combined therapy trial will become part of the collaboration, or if not agreed to, the proposing party may conduct such additional combined therapy trial independently, subject to specified restrictions set forth in the Clinical Collaboration Agreement.

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Pursuant to the terms of the Clinical Collaboration Agreement, each party granted to the other a non-exclusive, worldwide (excluding, in the case of Exelixis, territory already the subject of a license by Exelixis to Takeda Pharmaceutical Company Ltd.), non-transferable, royalty-free license, with a right to sublicense (subject to limitations), to use the other party’s intellectual property and compounds solely as necessary for the party to perform its obligations under the Clinical Collaboration Agreement. The parties’ efforts will be governed through a joint steering committee established to guide and oversee the collaboration and the conduct of the combined therapy trials. Each party will be responsible for supplying drug product for all combined therapy trials, and the cost of such drug product supply will be borne by such party. The clinical trial expenses for each combined therapy trial agreed to be conducted jointly under the Clinical Collaboration Agreement, including the initial three planned phase 3 pivotal trials, will be shared equally between the parties, and the clinical trial expenses for each additional combined therapy trial not agreed to be conducted jointly under the Clinical Collaboration Agreement will be borne by the proposing party, except that the cost of drug product supply for all combined therapy trials will be borne by the party that owns the applicable drug product.

Unless earlier terminated, the Clinical Collaboration Agreement provides that it will remain in effect until the completion of all combined therapy trials under the collaboration, the delivery of all related trial data to both parties, and the completion of any then agreed-upon additional analyses. The Clinical Collaboration Agreement may be terminated for cause by either party based on any uncured material breach by the other party, bankruptcy of the other party or for safety reasons. Upon termination by either party, the licenses granted to each party will terminate upon completion of any ongoing activities under the Clinical Collaboration Agreement.
The description of the Clinical Collaboration Agreement in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Clinical Collaboration Agreement, a copy of which will be included as an exhibit to Exelixis’ Annual Report on Form 10-K for the fiscal year ending January 3, 2020, to be filed with the Securities and Exchange Commission.

On December 18, 2019 Monopar Therapeutics Inc. reported that it has priced an initial public offering of 1,111,112 shares of its common stock at $8.00 per share (Press release, Monopar Therapeutics, DEC 18, 2019, View Source [SID1234552492]). The shares are expected to begin trading on the Nasdaq Capital Market on December 19, 2019 under the symbol "MNPR." The offering is expected to close on December 23, 2019, subject to the satisfaction of customary closing conditions. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 166,666 shares.

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JonesTrading Institutional Services LLC acted as Lead Bookrunning Manager and Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as Co-Manager for the offering.

The offering of these securities will be made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from JonesTrading Institutional Services LLC by calling (212) 907-5332, or by e-mailing [email protected].

A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these shares in any state in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any state.

On December 18, 2019 Phoenix Solutions reported that at the Drug Development Unit at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust in London, the first patient in Phoenix’s first in human "ACTivate Trial" (NCT04021277) has received ACT in combination with chemotherapy for treatment of hepatic metastases associated with colorectal and pancreatic cancer (Press release, Phoenix Solutions, DEC 18, 2019, View Source [SID1234552490]).

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CEO Dr. Per Sontum: "We are extremely pleased to announce that Phoenix Solutions is now initiating the clinical development of ACT. After six years of technical work and pre-clinical development with Prof. Jeff Bamber’s Ultrasound and Optics Team at the ICR, and Prof. Catharina de Lange Davies at The Norwegian University of Science and Technology, the transition to the clinical phase is a very exciting moment for all of us, team and collaborators. We look forward to moving to the next phase of the ACTivate study whose goal is to evaluate the clinical benefits of ACT, then also including Haukeland and Oslo University hospitals as clinical sites."

Vice-chairman Sir Bill Castell, who joined the board of Phoenix over a year ago, further comments: "Whilst pursuing clinical development in combination with chemotherapy, we continue to explore with collaborators globally pre-clinical developments in new areas including cancer immuno-therapy, infectious diseases and enhancing drug delivery across the blood brain barrier. 2020 will be tremendously exciting in revealing the potential of ACT as a technology platform… ".

Chief Investigator Prof. Udai Banerji, Deputy Head of Drug Development at The Institute of Cancer Research, London, and The Royal Marsden said: "At our joint Drug Development Unit, we are very excited to start the clinical evaluation of ACT. This represents an entirely novel approach to targeted drug delivery and is designed to significantly enhance the therapeutic efficacy of a number of chemotherapies used in the treatment of multiple cancers."

The "ACTivate Trial" feature in BBC Breakfast, see: View Source

The "ACTivate Trial" featured at ICR’s website, see: View Source

The "ACTivate Trial" featured at RMH’s website, see: View Source

About Phoenix Solution and ACT

Phoenix Solutions AS is a privately held, Norwegian biotech company spun out from GE Healthcare, developing a proprietary technology platform for ultrasound mediated, targeted drug delivery – Acoustic Cluster Therapy (ACT). ACT comprises a unique microbubble /microdroplet formulation (PS101) for i.v. injection which, in combination with localized insonation with regular medical ultrasound, induces biomechanical effects that enable localized, controlled opening of the vascular barrier, leading to improved extravasation, distribution and uptake of co-administered drugs (e.g. chemotherapeutics) in the targeted tissues. Pre-clinical Proof of Concept studies have shown that ACT improves markedly the efficacy of a wide range of therapeutic molecules and nano-drugs, in a wide range of disease models.

About the ACTivate Trial

ACTivate is a Phase I/Ib trial aimed to evaluate the safety and tolerability of ACT (PS101 combined with local US insonation plus Standard of Care chemotherapy), for treatment of hepatic metastases from colon rectal and pancreatic cancer. Asides standard safety end points, the trial will evaluate the clinical efficacy of ACT with the primary end point being a differential analysis of RECIST response by CT, between insonated and non-insonated lesions in the same patient after 8-12 weeks. Additional end points include DW- and DCE-MRI examinations. In addition to PS101 and ultrasound, patients with metastases from colon cancer will be dosed with standard regimens of either FOLFOX or FOLFIRI, whereas patients with metastases from pancreatic cancer will be dosed with nab-paclitaxel plus gemcitabine.

Colorectal cancer is the third most common cancer worldwide and approx. 30% of patients with CRC will develop liver metastases during the course of their disease. Only some 25% of these are amenable to curative-intent treatment through metastatectomy. For this disease, targeted treatment of hepatic metastases with ACT has a range of potential applications including: as a part of a neo-adjuvant regime prior to resection to improve survival outcome, to downstage and increase the fraction of patients amenable for curative resection and, finally, to improve on survival outcome and palliation for non-resectable conditions.

On December 18, 2019 OBI Pharma, a Taiwan biopharma company (TPEx: 4174), reported the initiation of a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT04084366) of OBI-999, an antibody drug conjugate (ADC) targeting Globo H, a glycolipid antigen overexpressed in multiple tumor types (Press release, OBI Pharma, DEC 18, 2019, View Source [SID1234552488]). Patients with solid tumors including gastric, pancreatic, colorectal and esophageal cancer are planned to be enrolled. The objective of the trial is to verify the safety and preliminary efficacy profile of OBI-999 in these patient populations.

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Patients have initiated treatment in the first-in-human Phase 1/2 study of OBI-999-001 at the University of Texas MD Anderson Cancer Center, Houston, TX, with Dr. Apostolia M Tsimberidou as the Principal Investigator. These patients have been diagnosed with the per protocol tumor types, including pancreatic and colorectal, cancers of high unmet medical need. Treatment with OBI-999 is continuing with no observable safety concerns or trends to date.

Apostolia Tsimberidou, MD, PhD. noted, "We are excited to treat the first patients with OBI-999, a novel first-in-class antibody-drug conjugate and with the unique potential that this drug brings to patients with multiple tumor types. The aberrant expression of the glycolipid Globo-H in epithelial tumors makes it an attractive target and this ADC holds the promise to induce clinically meaningful responses."

Tillman Pearce, MD, CMO, OBI Pharma added, "The initiation of patient enrollment in this Phase 1/2 study is a milestone for OBI Pharma. High potency across multiple xenograft models and the availability of a Globo H immunohistochemistry assay for selection of patients with high Globo H expression in the phase 2 portion of the study support our enthusiasm for OBI-999."

About OBI-999

OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment that is based on Globo H, an antigen expressed in up to 15 epithelial cancers. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. This Globo H targeting antibody, OBI-888, is currently in a Phase 1/2 clinical trial (ClinicalTrials.gov Identifier: NCT03573544) to test its safety and efficacy as an immune-oncology therapy. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, lung, gastric, and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-999 was well-tolerated, and achieved a favorable safety margin which warrants further clinical development. OBI Pharma owns global rights to OBI-999.

On December 18, 2019 Kleo Pharmaceuticals, Inc., an immuno-oncology company developing next-generation, fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics, reported that its Chief Executive Officer Doug Manion, MD, will present at Biotech Showcase 2020, to be held January 13-15, 2020 at the Hilton San Francisco Union Square in San Francisco (Press release, Kleo Pharmaceuticals, DEC 18, 2019, View Source [SID1234552487]).

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During his presentation, Dr. Manion will provide an overview of Kleo’s development strategy for its pipeline of small molecule and synthetic peptide compounds that function similar to highly complex biologics, while offering multiple potential advantages. The overview will also outline Kleo’s key value drivers including its proprietary technology platforms that drive in-house drug development and partnership opportunities, the multiple in-house and collaborative channels through which it is building its immuno-oncology pipeline and its discovery collaboration with PeptiDream. Human studies are anticipated in 1H 2020 for Kleo’s first product candidate to move into the clinic, CD38-ARM, a CD38 targeting antibody recruiting molecule (ARM) to treat multiple myeloma.

Dr. Manion will also discuss another platform technology at Kleo, which uses site-directed, chemical conjugation of off-the-shelf antibodies to enhance or add functionality. Monoclonal antibody therapy enhancers (MATEsTM) offer a number of opportunities to optimize or repurpose biologics currently in development.

Details of the presentation are as follows:

Event:

Biotech Showcase 2020

Date:

Wednesday, January 15, 2020

Time:

9:30 a.m. PST

Location:

Hilton San Francisco Union Square, San Francisco

Room:

Franciscan C (Ballroom Level)