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pH Pharma and Immunome Enter into Collaboration and License Agreement to Develop and Commercialize Multiple Novel Antibody Drug Conjugates in Oncology

On October 21, 2019 pH Pharma Co. Ltd., a clinical-stage biopharmaceutical company advancing a diverse pipeline which includes therapeutic candidates for oncology, ophthalmology and NASH, and Immunome, Inc., a biotechnology company developing first-in-class antibodies as cancer therapeutics by harnessing the human immune response, reported the companies have entered into a collaboration and license agreement to discover unique antibody-drug conjugates (ADCs) against multiple oncology targets (Press release, pH Pharma, OCT 21, 2019, View Source [SID1234632577]).

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Under the terms of the agreement, Immunome will conduct the initial antibody discovery and prioritization work with its proprietary platform. pH Pharma will conjugate the antibody candidates to its proprietary ADC payloads and test the ADC candidates for efficacy and safety.

"By combining Immunome’s ability to simultaneously identify novel targets and first-in-class human antibodies that work against them, and with pH Pharma’s capabilities in toxin payloads, there is tremendous potential to yield truly new and highly differentiated ADCs," said Purnanand Sarma, Ph.D., chief executive officer of Immunome. "pH Pharma’s innovative payloads act via a novel mechanism, and the resulting ADCs are expected to improve the potency of a subset of Immunome antibodies against a wide variety of cancer types."

Hoyoung Huh, M.D. Ph.D., chief executive officer of pH Pharma said, "This partnership offers a truly unique opportunity to bring together two proprietary platform technologies in order to create beneficial medicines for cancer patients. The Immunome platform represents an innovative approach to identify targets and antibodies in the immune repertoire of cancer patients that specifically contribute to positive health outcomes. Research collaborations such as this provide important validation of pH Pharma’s payload and ADC capabilities and are an important part of our strategy for building a leading global healthcare company."

The agreement terms state that pH Pharma will have the right to develop and commercialize the first development candidate generated in the collaboration with a selection process to determine rights to subsequent candidates. The company that develops and commercializes the candidate(s) will pay certain development, regulatory and commercial milestones to the other company worth up to $100 million for each product, with the potential for multiple candidates to be developed and commercialized. Royalties on net sales will be paid to the party that does not have commercial rights. Both parties will share in any revenue realized through sublicensing to third parties.

Vertex to Announce Third-Quarter 2019 Financial Results on October 30

On October 21, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its third quarter 2019 financial results on Wednesday, October 30, 2019 after the financial markets close (Press release, Vertex Pharmaceuticals, OCT 21, 2019, View Source [SID1234542413]). The company will host a conference call and webcast at 5:00 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

Exicure to Present at 2019 BIO Investor Forum

On October 21, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that its chief financial officer, David Snyder, will give a company update on Tuesday, October 22, 2019 at 11:00am PT at the 2019 BIO Investor Forum in San Francisco (Press release, Exicure, OCT 21, 2019, View Source [SID1234542394]).

A live audio webcast will be available on the Investors section of Exicure’s website: www.exicuretx.com. The webcast will be archived for approximately 30 days following the event.

Rheos Medicines Appoints Barbara S. Fox as Chief Executive Officer

On October 21, 2019 Rheos Medicines, a biopharmaceutical company harnessing insights in immunometabolism to create a new class of therapeutics for patients with severe autoimmune disorders, inflammatory diseases and cancer, reported the appointment of industry veteran Barbara S. Fox, Ph.D., to Chief Executive Officer (Press release, Rheos Medicines, OCT 21, 2019, View Source [SID1234542393]). Dr. Fox succeeds interim Chief Executive Officer, Abbie Celniker, Ph.D., a partner at Third Rock Ventures, who will remain Chairman of Rheos Medicines’ board of directors.

"Rheos’ scientific founders and passionate scientists are leaders in the field, and their groundwork has established an incredible foundation on which to build upon. I look forward to working with the Rheos team as we leverage the Company’s proprietary immunometabolism product engine to unlock a new frontier in drug discovery."

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"We are delighted to welcome Barbara to the team and believe her track record makes her an ideal fit as Rheos Medicines’ Chief Executive Officer," said Dr. Celniker. "We are confident that Barbara’s expertise in building and leading organizations will be an indispensable asset for Rheos and will propel the Company as it develops precision medicines for autoimmunity and other immune-mediated diseases."

Dr. Fox brings more than 25 years of biopharmaceutical leadership expertise to Rheos Medicines. She joins the Company from Tilos Therapeutics, a Lexington, MA-based biotech company developing antibody-based therapies for oncology and immune-mediated diseases. Dr. Fox served as Chief Executive Officer at Tilos and led the successful acquisition of the company by Merck in June of this year. Previous positions include Entrepreneur-in-Residence at Partners Innovation Fund, Founder and Chief Executive Officer of Avaxia Biologics, Founder and Chief Scientific Officer of Recovery Pharmaceuticals, and VP, Discovery and Immunology at ImmuLogic Pharmaceutical Corp. Prior to ImmuLogic, Dr. Fox was an Associate Professor of Rheumatology at the University of Maryland School of Medicine. Dr. Fox received her A.B. in Chemistry from Bryn Mawr College, her Ph.D. in Chemistry from the Massachusetts Institute of Technology and trained as a post-doc in Cellular Immunology at the National Institutes of Health.

"Rheos Medicines is pioneering and industrializing the emerging field of immunometabolism, and I am thrilled to be joining at such a pivotal time in the Company’s evolution," said Dr. Fox. "Rheos’ scientific founders and passionate scientists are leaders in the field, and their groundwork has established an incredible foundation on which to build upon. I look forward to working with the Rheos team as we leverage the Company’s proprietary immunometabolism product engine to unlock a new frontier in drug discovery."

Sophiris Bio Receives Positive Feedback from FDA Regarding Phase 3 Localized Prostate Cancer Clinical Trial Design

On October 21, 2019 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported that following an End of Phase 2/ Pre-Phase 3 meeting with the United States Food and Drug Administration (FDA), there is agreement regarding the design of a single Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer (Press release, Sophiris Bio, OCT 21, 2019, View Source [SID1234542392]).

The Phase 3 study design agreed upon with the FDA is consistent with the design previously agreed upon with the European Medicines Agency, as reported in June of this year. The study will enroll approximately 700 patients with a confirmed diagnosis of localized intermediate risk disease, to be equally randomized to receive a single administration of either topsalysin or placebo. The primary endpoint for the study will be the proportion of patients at 12 months who have failed treatment, defined as histological progression of disease, resulting in the need for alternative therapy, as assessed by an independent central adjudication panel. In addition, the FDA has indicated that in order to receive approval, Sophiris will evaluate all patients that progress to alternative treatments for an additional 12 months, for a total of 24 months of data, post the administration of study drug.

"The meeting with the FDA was positive, confirming the proposed Phase 3 study design is an acceptable approach to targeted focal therapy in the proposed patient population. The FDA’s request to provide data on patients progressing to alternative therapy for an additional 12 months – for a total of 24 months – will, we believe, strengthen the overall data package for approval, providing valuable information on the durability of response following targeted focal therapy with topsalysin," said Professor Hashim Ahmed, Faculty of Medicine Department of Surgery & Cancer, Chair in Urology, Imperial College of London & Imperial College Healthcare NHS Trust and a member of the Scientific Advisory Board at Sophiris.

"The meeting with the FDA was productive and it was clear that if the proposed study were positive and the safety profile were to continue as observed in clinical trials to date, a single study has the potential to provide the clinical data to support regulatory approval in both the US and Europe," said Professor Scott Eggener, Faculty of Surgery and Radiobiology University of Chicago Medicine and a member of the Scientific Advisory Board at Sophiris.

"Now that there is a clear and agreed upon regulatory pathway forward for localized prostate cancer, we can now focus on our plan to fund this study and the Company going forward," said Randall E. Woods, our president and chief executive officer. "With the uncertainty of the regulatory pathway removed, we are advancing our discussions with multiple parties capable of funding the continued development of topsalysin."

About Localized Prostate Cancer

Prostate cancer is the second most common form of cancer in men in the United States with an estimated 175,000 new cases in 2019. Approximately 77 percent of patients in the United States are diagnosed with localized disease. Research has shown that patients with early, localized disease have a low likelihood of the cancer spreading beyond the confines of the prostate; however, many men with clinically-significant localized disease choose to undergo radical treatment. Radical therapies include surgery to remove the entire prostate and/or radiation. Potential toxicities from radical treatments can be significant and permanent and include erectile dysfunction, urinary incontinence and rectal toxicity.

About Topsalysin

Topsalysin (PRX302), an innovative, "First-in-Class" transmembrane pore-forming protein, was genetically modified to be activated only by enzymatically-active PSA, which is produced in large quantities within the prostate of men with prostate cancer. The targeted focal treatment of prostate cancer is in line with current treatment trends for solid tumors such as breast and liver, where the goal is to remove the tumor and preserve as much of the organ and organ function as possible.

Topsalysin has the potential to provide a targeted focal therapy for the ablation of localized prostate cancer lesions while potentially avoiding many of the complications and side effects associated with whole gland radical treatments. The increasing use of multiparametric magnetic resonance imaging (mpMRI) and advances in software to co-register previously obtained mpMRI images with real-time three-dimensional ultrasound images enables urologists to more accurately locate tumors within the prostate when taking biopsies. This increases the accuracy with which men with clinically significant lesions are identified. It also enables the injection of an ablative agent, such as topsalysin, directly into previously identified clinically significant tumors located within the prostate.