PhoreMost and Boehringer Ingelheim enter multi-project drug discovery collaboration

On January 7, 2020 PhoreMost Limited, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, reported it has entered into a multi-project drug discovery collaboration with Boehringer Ingelheim, one of the world-leading pharmaceutical companies developing innovative therapies for diseases with unsatisfactory treatments (Press release, PhoreMost, JAN 7, 2020, View Source [SID1234552798]). Under the terms of the agreement, PhoreMost will receive an upfront payment and research funding together with downstream success-based milestones. Further financial terms are not disclosed.

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PhoreMost will deploy its in-house expertise and next-generation phenotypic screening platform, SITESEEKER, towards disease relevant pathways nominated by Boehringer Ingelheim. Novel targets identified will be further validated and characterised by Boehringer Ingelheim as part of its internal Discovery Research pipeline. Boehringer Ingelheim’s Research programme is active in the fields of immunology and respiratory diseases, cardiometabolic diseases, oncology research and immuno-oncology, as well as diseases of the central nervous system.

The SITESEEKER platform is based on PhoreMost’s core proprietary protein interference, or ‘PROTEINi’, technology. Using SITESEEKER, PhoreMost probes the entire proteome in a live cell environment for novel druggable targets linked to any chosen disease, using the vast 3-D shape diversity of natural protein fragment (sub-domain) libraries. This enables the systematic unmasking of cryptic druggable sites, directly linking them to useful therapeutic functions.

Dr Chris Torrance, CEO of PhoreMost, said: "We are delighted that Boehringer Ingelheim has chosen to work with PhoreMost to enhance its drug discovery pipeline with attractive biological starting points. The collaboration is further recognition of the ability of PROTEINi and SITESEEKER to identify novel targets, and we look forward to working with the Boehringer Ingelheim team on these projects."

Danaher Schedules Fourth Quarter 2019 Earnings Conference Call

On January 7, 2020 Danaher Corporation (NYSE: DHR) reported that it will webcast its quarterly earnings conference call for the fourth quarter 2019 on Thursday, January 30, 2020 beginning at 8:00 a.m. ET and lasting approximately 1 hour (Press release, Danaher, JAN 7, 2020, View Source [SID1234552816]).

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The call and an accompanying slide presentation will be webcast on the "Investors" section of Danaher’s website, www.danaher.com, under the subheading "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation and will remain available until the next quarterly earnings call.

You can access the conference call by dialing 866-503-8675 within the U.S. or +1 786-815-8792 outside the U.S. a few minutes before 8:00 a.m. ET and notifying the operator that you are dialing in for Danaher’s earnings conference call (access code 5867674). A replay of the conference call will be available shortly after the conclusion of the call until February 13, 2020. You can access the replay dial-in information on the "Investors" section of Danaher’s website under the subheading "Events & Presentations."

Danaher’s earnings press release, the webcast slides and other related presentation materials will be posted to the "Investors" section of Danaher’s website under the subheading "Quarterly Earnings" beginning at 6:00 a.m. ET on the date of the earnings call and will remain available following the call.

Clinical update: 4D announces a new study of MRx0518 in pancreatic cancer

On January 7, 2020 4D pharma plc (AIM: DDDD), a pharmaceutical company that leads the development of Live Biotherapeutics, reported the opening of a clinical study to assess clinical safety and efficacy of MRx0518 in combination with preoperative radiotherapy in 15 patients with resectable pancreatic cancer (Press release, 4d Pharma, JAN 7, 2020, https://www.prnewswire.com/news-releases/actualizacion-clinica-4d-anuncia-un-nuevo-estudio-de-mrx0518-en-cancer-pancreatico-828920161.html [SID1234552748]).

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The study is being conducted at The University of Texas MD Anderson Cancer Center and is the second open as part of a strategic collaboration to evaluate the Live Biotherapeutic oncology line of 4D in a number of cancer centers. Cullen M. Taniguchi , MD, Ph.D., assistant professor of radiation oncology at MD Anderson, is the lead investigator of the study.

Subjects will receive their daily treatment with MRx0518 for one week before and during radiotherapy, up to 24 hours before surgical resection. In addition to the main conclusion of safety and tolerability, the study will evaluate the preliminary clinical efficacy of the combination, including the evaluation of the main pathological response, progression-free survival and overall survival. Additional secondary and exploratory findings will evaluate changes in tumor infiltration lymphocytes (TILs) and the intestinal microbiome.

Alex Stevenson , 4D scientific director, commented:

"Pancreatic cancer carries a poor prognosis and remains a field of important need not covered. Prompted by promising initial signs in our other clinical studies, we believe that MRx0518 has the potential to offer new treatment options and dramatically improve outcomes for patients with pancreatic cancer. This third study demonstrates 4D’s current commitment to oncology. "

4D recently announced clinical observations of its current open label study of MRx0518 in combination with KEYTRUDA (pembrolizumab) in patients with solid tumors that have progressed in previous therapy of control inhibitors with no known alternative treatment options. The combination is well tolerated without side effects related to the drug and currently has partial induced responses in two of six evaluable patients and stable disease in a third patient.

Leap Therapeutics Announces Closing of Previously Announced Equity Financing

On January 7, 2020 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the closing of its previously announced equity financing to issue 1,421,801 shares of newly designated Series A mandatorily convertible preferred stock to a lead institutional investor, at a price of $10.54 per share, and an aggregate of 1,137,442 shares of newly designated Series B mandatorily convertible preferred stock to BeiGene and Perceptive Advisors, at a price of $10.55 per share (Press release, Leap Therapeutics, JAN 7, 2020, View Source [SID1234552783]). The preferred stock price reflects a common stock equivalent price of $1.055 per share, the closing price for Leap’s common stock on the Nasdaq Global Market on the day of pricing, January 2, 2020 and, in the case of the Series A mandatorily convertible preferred stock, reflects a per share reduction equal to the exercise price of the pre-funded warrant issued upon conversion of the Series A mandatorily convertible preferred stock. The holder of Series A mandatorily convertible preferred stock also received a share of a newly designated special voting preferred stock that will entitle it to elect one member of Leap’s Board of Directors.

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Upon approval by the stockholders of Leap, the Series A mandatorily convertible preferred stock will automatically convert into pre-funded warrants to purchase 14,218,010 shares of common stock and the Series B mandatorily convertible preferred stock will automatically convert into 11,374,420 shares of common stock, plus that number of additional shares of common stock representing payment of an 8% per annum accruing dividend on each share of preferred stock as of the conversion date. Upon stockholder approval and conversion of the preferred stock, the investors will also receive warrants to purchase up to an equal number of shares of common stock at an exercise price of $2.11 per share. The aggregate gross proceeds to Leap from this offering are approximately $27 million, before deducting placement agent fees and estimated offering expenses payable by Leap, and excluding proceeds from the exercise of any warrants.

Raymond James & Associates, Inc. was the placement agent for the equity financing.

The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Leap has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon conversion of the preferred stock and exercise of the warrants issued in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

Bicycle Therapeutics and Cancer Research UK to Collaborate on Development of New Bicycle® Immuno-oncology Candidate, BT7401

On January 7, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported a second collaboration with Cancer Research UK, the world’s largest independent funder of cancer research, in which Cancer Research UK will fund and sponsor development of BT7401, a multivalent Bicycle CD137 agonist, through a Phase IIa clinical study (Press release, Bicycle Therapeutics, JAN 7, 2020, View Source [SID1234552799]).

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"The modular nature of the Bicycle platform enables a number of opportunities to generate new therapeutics that could address unmet need in oncology and other serious diseases," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle. "This new collaboration marks yet another initiative designed to help us bring a potentially important Bicycle-based therapy to patients more efficiently. We are excited to extend our relationship with Cancer Research UK by collaborating with them on BT7401. Cancer Research UK is a partner of choice, with a broad network of collaborators and extensive expertise in cancer treatment. Through our collaboration, we believe we will be able to characterize the biologic and therapeutic profile of BT7401, which we’re pleased to add to our growing portfolio of novel immuno-oncology assets."

Dr. Nigel Blackburn, Cancer Research UK’s director of drug development, said: "We’re delighted to be partnering again with Bicycle, building on our continuing relationship. Based on the preclinical data, we believe that BT7401 could offer improved anti-tumor activity with fewer side effects compared with antibody-based approaches, which so far have been limited by toxicity."

Dr. Blackburn continued: "Looking to the future, we believe BT7401 has the potential to open up new treatment options for the large numbers of patients who stop responding to checkpoint inhibitors, and we look forward to working with Bicycle in this new endeavor."

BT7401 is a chemically synthesized, multivalent small molecule agonist of CD137, comprised of Bicycles connected by stable linkers through a central hinge. Though prior programs using antibodies to agonize CD137 have demonstrated robust and durable anti-tumor effects, they have been limited by severe hepatotoxicity observed in clinical trials. Preliminary toxicology studies suggest BT7401 may circumvent this limitation. In addition, BT7401 has shown significant pharmacologic activity in preclinical models. These findings indicate that BT7401 may offer an improved therapeutic index compared to that of antibody-based approaches.

Under the terms of the Clinical Development Partnerships agreement, Cancer Research UK’s Centre for Drug Development will fund and sponsor development of BT7401 from current preclinical studies through the completion of a Phase IIa trial. Bicycle retains the right to advance the BT7401 program further, at which point an undisclosed payment split between cash and equity, success-based milestones and royalty payments would be made to Cancer Research UK.