PolyProx Therapeutics Raises an Additional £1 Million Seed Financing From New Investor, LifeArc, to Validate Polyproxin® Drug Leads in Oncology

On March 2, 2020 PolyProx Therapeutics, a biotechnology company focused on the discovery and development of novel biopharmaceuticals for the treatment of cancer, reported that it has raised an additional £1 million seed capital from new investor, LifeArc (Press release, PolyProx Therapeutics, MAR 2, 2020, View Source [SID1234555070]).

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The additional funding will be used to deliver in vivo proof of concept data for polyproxin molecule leads against two oncology drug targets. This data will form the basis for Series A financing in 2021. LifeArc joins existing investors, Cambridge Innovation Capital, RT Capital and Cambridge Enterprise.

PolyProx Therapeutics is developing polyproxin molecules that target and remove disease-causing proteins using the natural degradation machineries contained within the cell. Its initial focus is to develop polyproxin molecule candidates for use in the treatment of cancers, targeting aberrant proteins that have previously proven difficult to target using conventional drug classes, such as small molecules or monoclonal antibodies.

A spin out from the Department of Pharmacology at the University of Cambridge, PolyProx Therapeutics is based on over a decade of research and intellectual property from Founder Professor Laura Itzhaki’s laboratory. Serial Cambridge biotech entrepreneurs Kevin Moulder (Chief Operating Officer) and Andrew Sandham (Executive Chairman), lead the team.

Independent medical research charity, LifeArc, is focused on translation; helping to turn promising science into benefits for patients by advancing medical research towards patient treatments and diagnostics. LifeArc’s investment in PolyProx Therapeutics has been made via the LifeArc Seed Fund, a £25 million fund focused predominantly on opportunities in the UK with the objective of optimising the chances of bringing transformative science to the clinic.

Enrique Millan, Investment Principal, LifeArc Seed Fund, who will sit on the PolyProx Therapeutics board commented: "LifeArc’s Seed Fund was established to help translate promising medical research into patient benefit. We are excited to be working with the PolyProx team on the development of a novel, first-in-class therapeutic modality that could potentially address some of the challenges in cancer treatment."

Andrew Sandham, Executive Chairman, PolyProx Therapeutics added: "We are delighted to welcome LifeArc as an investor which enables us to expand our drug discovery resources following our recent move to new laboratories in Cambridge. We have made exciting progress on our polyproxin drug discovery projects in oncology and look forward to sharing proof of concept data with prospective investors and partners later this year."

Inovio Pharmaceuticals to Report Fourth Quarter and Full Year 2019 Financial Results on March 12, 2020

On March 2, 2020 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported that fourth quarter and full year 2019 financial results will be released after the market close on March 12, 2020 (Press release, Inovio, MAR 2, 2020, View Source [SID1234555069]). Following the release, the Company will host a live conference call and webcast at 4:30 p.m. ET, to provide a general business update and financial results for the fourth quarter and full year 2019.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll free) or 412-317-0088 (international toll) using replay access code 10139836.

Sangamo Therapeutics Announces Participation at Upcoming Investor Conferences

On March 2, 2020 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that management will present at the following investor conferences (Press release, Sangamo Therapeutics, MAR 2, 2020, View Source [SID1234555068]):

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Cowen 40th Annual Health Care Conference
Presentation Date: Wednesday, March 4th at 10:00 a.m. Eastern Time
Location: Boston, MA
Barclays Global Healthcare Conference
Presentation Date: Wednesday, March 11th at 8:30 a.m. Eastern Time
Location: Miami, FL
Presentations will be webcast live and may be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. The presentation will also be available on the Sangamo website after the event.

UroGen Pharma Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Corporate Developments

On March 2, 2020 UroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, MAR 2, 2020, View Source [SID1234555067]).

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"At UroGen, we are eagerly awaiting potential approval of our lead product candidate, UGN-101, for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). The significant progress on key clinical, regulatory and commercial milestones in 2019 places us in a position of strength as we prepare to deliver the first non-surgical therapy for the treatment of LG UTUC. Our experienced commercial team has been working tirelessly to ensure we are prepared for launch, and we look forward to providing these patients with a new treatment option," said Liz Barrett, President and Chief Executive Officer (CEO) of UroGen. "We are also advancing multiple pipeline candidates in development for areas of unmet need in both low-grade and high-grade bladder cancer, including UGN-102 and UGN-302, respectively. As our team pioneers new treatments to improve patient care in specialty cancers and urologic diseases, we look forward to maximizing patient and shareholder value through the exciting events on the horizon".

2019 and Recent Highlights

UGN-101 (mitomycin gel) for instillation for Patients with LG UTUC Progress

Reported positive updated durability and complete response data from the pivotal Phase 3 OLYMPUS trial in September 2019. The data were consistent with previously reported results in May 2019 and January 2019.
Completed a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).
Received FDA filing acceptance and Priority Review of the NDA for UGN-101, with a PDUFA goal date of April 18, 2020. If approved, UGN-101 will be the first non-surgical, chemoablative treatment option for LG UTUC.
UGN-101 Commercial Readiness

Hired an internal team with a track record of success in urology and oncology as well as a veteran sales force leadership team with deep uro-oncology relationships.
Implemented innovative solutions around patient identification, reimbursement and seamless logistics to enhance physician adoption upon launch. Based on recent market research, 88% of urologists desire a new and differentiated treatment option for their patients.
Executed agreements with 3PL, a specialty distributor and a national partner to provide prepared admixture to urology clinics.
Pipeline Expansion and Developments

UGN-102 (mitomycin gel) for intravesical instillation for patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR NMIBC)
Completed enrollment ahead of schedule and reported positive interim results from the single-arm, open-label Phase 2b OPTIMA II trial of investigational UGN-102 for patients with LG IR NMIBC.
LG IR NMIBC is defined as those patients with one or two of the following criteria: multifocal disease, large tumors and rapid rates of recurrence. This is a patient population whereby the current standard of care, transurethral resection of bladder tumor, or TURBT, is used repeatedly to address chronic recurrence of disease. These patients experience what can be viewed as a form of surgical failure and many undergo multiple surgical procedures during life to "manage" bladder cancer recurrences.
There are no drugs currently approved by the FDA as first-line treatment for LG IR NMIBC. UGN-102 has the potential to provide a non-surgical treatment alternative for approximately 80,000 patients diagnosed with LG IR NMIBC.
UGN-201 (TLR7/8 agonist) for patients with high-grade non muscle invasive bladder cancer (HG NMIBC)
Shared nonclinical data of investigational UGN-201 (a TLR7/8 agonist) as a monotherapy and in combination with checkpoint inhibitors.
In murine models, UGN-201 in combination with local anti-CTLA-4 increased survival.
Entered into an exclusive worldwide license agreement with Agenus Inc. to develop and commercialize zalifrelimab (AGEN1884, anti-CTLA-4 antibody) via intravesical delivery in combination with UGN-201 for the treatment of high-grade urinary tract cancers, initially targeting HG NMIBC. The combination of UGN-201 and zalifrelimab is referred to as investigational agent UGN-302.
Corporate Achievements

Strengthened the Company’s financial position with a follow-on offering of approximately $162 million in January 2019.
2020 Anticipated Milestones and Product Development Plans

UGN-101

Publication of the final results of the primary endpoint from the OLYMPUS trial in patients with LG UTUC in 1H
UGN-101 potential approval and launch in Q2
UGN-102

Updated durability and complete response data from UGN-102 Phase 2b Study
Initiation of pivotal Phase 3 Study in 2H
UGN-302

Advancement to first in human clinical study following formulation and dose optimization
Fourth Quarter and Full Year 2019 Financial Results; 2020 Guidance

As of December 31, 2019, cash, cash equivalents and marketable securities totaled $195.6 million, excluding restricted cash.
Research and development expenses for the three months ended December 31, 2019 were $20.1 million, including non-cash share-based compensation expense of $1.9 million. Research and development expenses for the year ended December 31, 2019 were $49.3 million, including non-cash share-based compensation expense of $8.3 million. The research and development expenses for the three months and year ended December 31, 2019 included an in-process research and development charge of $10.0 million associated with the execution of the Agenus licensing agreement.
General and administrative expenses for the three months ended December 31, 2019 were $19.7 million, including non-cash share-based compensation expense of $6.2 million. General and administrative expenses for the year ended December 31, 2019 were $60.2 million, including non-cash share-based compensation expense of $21.7 million.
UroGen reported a net loss of $39.0 million, or basic and diluted net loss per ordinary share of $1.86, for the three months ended December 31, 2019. The Company reported a net loss of $105.1 million, or basic and diluted net loss per ordinary share of $5.12, for the year ended December 31, 2019.
The Company anticipates operating expenses in the range of $145 to $155 million for 2020. Non-cash stock-based compensation expense for 2020 is expected to be in the range of $32 to $36 million subject to market conditions, and other non-operating income for 2020 is anticipated to be approximately $2.5 million.
UroGen has 21.0 million ordinary shares outstanding.
Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 8:30 AM Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 49393633. An archive of the webcast will be available for two weeks on the Company’s website.

ERBITUX® Approved for First-line Use in China in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)

On March 2, 2020 Merck, a leading science and technology company, reported that ERBITUX (cetuximab) has been granted approval by the National Medical Products Administration (NMPA) of China for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) in combination with platinum-based therapy with fluorouracil (Press release, Merck & Co, MAR 2, 2020, View Source;839770456.html [SID1234555066]). Evidence from the pivotal Phase III CHANGE II study, on which the approval is based, shows the efficacy and safety of the EXTREME regimen (ERBITUX + cisplatin + 5-FU, followed by ERBITUX maintenance) vs platinum-based chemotherapy (cisplatin + 5-FU) alone for first-line treatment in Chinese patients with R/M SCCHN. The data showed that the addition of ERBITUX to platinum-based chemotherapy improved progression-free survival (PFS), overall survival (OS) and overall response rate (ORR), confirming the relevance of the EXTREME regimen specifically in this patient population.1

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"ERBITUX in combination with platinum-based therapy is a preferred treatment option for patients with R/M SCCHN globally and the CHANGE II study further demonstrates the benefits it can bring in the first-line setting for patients in China," said Professor Ye Guo, Shanghai East Hospital, Tongji University, China and principal investigator in the CHANGE II study. "The approval of ERBITUX in a first-line setting marks an important development for Chinese patients, who now have access to a new treatment option."

"ERBITUX and the EXTREME regimen play an important role in the treatment of patients with R/M SCCHN. We welcome the National Medical Products Administration’s decision to make it available to Chinese patients in the first-line setting," said Chris Round, Head of International Operations and Global Core Franchises, Merck, operating in China. "This approval marks a significant step forward in fulfilling our commitment as a global specialty innovator, including bringing medicines to markets with high unmet medical needs."

The approval is based on the CHANGE II study of 243 randomized patients (164 patients in the ERBITUX + platinum-based chemotherapy arm versus 79 patients in the platinum-based chemotherapy only arm) from China with R/M SCCHN, which found that adding ERBITUX to platinum-based chemotherapy improved progression-free survival (median 5.5 vs 4.2 months; hazard ratio [HR]=0.57; 95% confidence interval [CI]: 0.40–0.80), overall survival (median 10.2 vs 8.4 months; HR=0.71; 95% CI: 0.50–0.99) and overall response rate (50% vs 27%) with no new or unexpected safety findings.1

CHANGE II is the first Phase III trial in the Chinese population to prospectively evaluate an anti-epidermal growth factor receptor (EGFR) antibody in the first-line treatment of patients with R/M SCCHN. The data are consistent with previous international pivotal studies and reaffirm the efficacy of ERBITUX in combination with platinum-based therapy with fluorouracil for patients with R/M SCCHN.

In 2019, ERBITUX was made available in China for the first-line treatment of patients with RAS wild-type metastatic colorectal cancer in combination with FOLFOX or FOLFIRI, or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy.

About CHANGE II

CHANGE II is a multicenter, randomized, open-label, Phase III trial assessing the efficacy and safety of the EXTREME regimen vs platinum-based therapy for Chinese patients with first-line recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). The trial included 243 patients in China ≥18 years of age with histologically confirmed R/M SCCHN and no prior systemic chemotherapy for R/M disease. The primary objective was to demonstrate superior PFS time per Response Evaluation Criteria on Solid Tumors (RECIST).

About ERBITUX (cetuximab)

ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).

ERBITUX has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.

References

Guo Y, Luo Y, Zhang Q et al. First-line (1L) cisplatin and 5-FU ± cetuximab in Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): the randomized, Phase III CHANGE II trial. LBA6. Presented Saturday, November 24, 2018. Session Time: 3:30-4:20PM Room 311. ESMO (Free ESMO Whitepaper) Asia 2018.
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