Monopar to Present at the 34th Annual Roth Conference and Maxim’s 2022 Virtual Growth Conference

On March 08, 2022 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported that Chandler Robinson, MD, Monopar’s Chief Executive Officer, will present at the 34th Annual Roth Conference and Maxim’s 2022 Virtual Growth Conference (Press release, Monopar Therapeutics, MAR 8, 2022, View Source [SID1234609649]).

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Presentation Details:

34th Annual Roth Conference

View Source
Date: March 14, 2022
Time: 1:30pm Pacific Time
Location: The Ritz Carlton, Laguna Niguel located in Dana Point, California

Maxim’s 2022 Virtual Growth Conference

https://www.m-vest.com/home
Date: March 30, 2022
Time: 4:30pm Eastern Time
Location: https://m-vest.com/events/2022-virtual-growth-conference

UroGen Secures $100 Million Non-Dilutive Term Loan Financing with Pharmakon Advisors Allowing Funding to Cash Flow Breakeven

On March 8, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the signing of an up to $100 million term loan financing facility with funds managed by Pharmakon Advisors, L.P (Press release, UroGen Pharma, MAR 8, 2022, View Source [SID1234609648]).

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The loan facility will be available to UroGen, subject to the terms and conditions of the loan agreement, as follows:

Senior secured term loan of up to $100 million in two tranches.
$75 million is expected to be funded within 10 business days following closing.
At its option, UroGen may draw up to an additional $25 million before December 31, 2022.
The company is not required to maintain any financial covenants.
Interest will accrue at 3-month LIBOR (with a 1.25% floor) plus 8.25%.
The facility will mature five years from initial funding and be interest only for the first 48 months.
"We are pleased to have secured this loan facility which significantly strengthens our financial position. Based on our revenue projections and current financial models, we believe we have the tools to reach cash flow breakeven," said Liz Barrett, Chief Executive Officer of UroGen. "In addition to supporting our continued launch of Jelmyto, the financing will also provide capital to support our pivotal Phase 3 single-arm ENVISION study of UGN-102 and planned multi-arm Phase 1 clinical study of UGN-301."

"Pharmakon is proud to financially support UroGen’s mission of creating novel solutions to address the unmet needs in urothelial and specialty cancers," said Martin Friedman, Principal at Pharmakon Advisors. "We strongly believe in the opportunity of Jelmyto and UroGen’s pipeline and we are looking forward to our partnership with UroGen."

Cowen acted as exclusive financial advisor to UroGen on this transaction.

Following this announcement, the Company has elected to reschedule reporting of its fourth quarter and full-year 2021 financial results from March 10, 2022 to March 21, 2022, prior to the open of the stock market. The announcement will be followed by a live audio webcast and conference call at 10:00 AM Eastern Time.

Audio Webcast

The webcast will be made available on the Investors section of the Company’s website at View Source Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

INOVIO to Present at Oppenheimer’s 32nd Annual Healthcare Conference

On March 8, 2022 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help protect people from infectious diseases and help treat people with cancer and HPV-associated diseases, reported that Dr. J. Joseph Kim, President and CEO, will participate in a fireside chat and 1×1 investor meetings at Oppenheimer’s 32nd Annual Healthcare Conference on Tuesday, March 15, 2022 (Press release, Inovio, MAR 8, 2022, View Source [SID1234609647]).

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Oppenheimer’s 32nd Annual Healthcare Conference
Date: Tuesday, March 15, 2022
Time: 8:00 AM ET
Presentation Format: Fireside Chat

A webcast of the presentation will be available through the INOVIO Investor Relations Events page at View Source The presentation time is subject to change.

Teon Therapeutics Names Serge Messerlian as CEO

On March 8, 2022 Teon Therapeutics (Teon), a clinical-stage biopharmaceutical company targeting metabolic signaling pathways and pioneering the development of G-Protein Coupled Receptor (GPCR) immuno-oncology therapies in difficult-to-treat cancers, reported the appointment of Serge Messerlian as Chief Executive Officer and member of the board of directors (Press release, Teon Therapeutics, MAR 8, 2022, View Source [SID1234609646]). Mr. Messerlian has an impressive track record of success, leading organizations in complex, highly competitive US and global markets with experience across multiple scientific disciplines, therapeutic areas, stages of drug development and commercialization. Mr. Messerlian will assume the role from co-founder, acting CEO and Chief Scientific Officer (CSO), Lina Yao, MD, PhD, who remains as CSO. Dr. Yao will continue as a member of the board of directors.

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Mr. Messerlian brings to the role significant experience in the industry, across a range of roles and therapeutic areas including hematology, oncology, immunology, and rare diseases. He joins Teon from Janssen Oncology US, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, where he served as President and set the strategic direction for the organization and its key brands across hematology and solid tumors including DARZALEX, IMBRUVICA, ERLEADA, RYBREVANT and platforms including cell therapies (CARVYKTI) and bi-specifics. Previously he served in executive leadership roles as President of Actelion; Vice President, Global Portfolio Lead – Biosimilars at Baxalta; and Vice President, Global Portfolio Lead – Hematology at Baxter International. He holds a Bachelor of Science degree in Physiology and Biotechnology and a Master of Science degree in Human Genetics, both from McGill University, and an MBA from the University of Toronto.

"Recruiting a world-class biopharma executive like Serge will transform the company as we transition our programs into clinical trials, with two oncology clinical drug candidates this year," said Alan Colowick, MD, MPH, Executive Chairman of Teon. "We look forward to working with Serge to power us forward by leveraging his extensive experience in advancing drug development programs, building sustainable platforms and partnering strategies, and creating world-class organizations."

"Throughout my career I have been committed to improving the lives of people impacted by serious diseases like cancer. Supported by the pioneering groundwork done by our founders, I am confident in the future opportunities of Teon’s proprietary scientific approach and the passion and expertise of the team," said Mr. Messerlian. "Although GPCRs are the most intensively studied targets in many disease areas, their potential benefits for oncology are just beginning to be explored. Teon’s portfolio of small molecule candidates includes adenosine pathway inhibitors, as well as an oral immune checkpoint inhibitor that leverages novel GPCR biology and has us uniquely poised to bring more effective, first- or best-in-class oncology therapies to patients. I look forward to working with Lina and our remarkable scientific team, the board, and investors as we build the reputation and value of Teon."

First Patient Dosed in TT-702 Phase 1 Clinical Trial

In addition, Teon is announcing its development partner, Cancer Research UK, has successfully dosed the first patient in their Phase 1/2 trial of Teon’s first-in-class, oral adenosine A2B receptor antagonist, TT-702, for the treatment of patients with a range of difficult-to-treat cancers. TT-702 is the first of Teon’s pipeline of oral, once-daily, GPCR small molecules targeting metabolic signaling pathways to enter the clinic. TT-702 is an adenosine receptor antagonist and specifically targets the A2B receptor, which is overexpressed on various types of tumor cells and immune cells. In the study, the first cohorts of patients with a range of advanced tumors will receive increasing doses of TT-702 to define the safety and tolerability of the drug and to determine the maximum dose of TT-702 that can safely be given to patients. Additional cohorts of patients will then be treated with TT-702 in combination with PD-1 immunotherapy or hormonal therapy to determine whether TT-702 can improve the effects of these therapies.

"We are delighted to be taking this new anti-cancer drug, TT-702, into clinical trials. The drug works by fighting cancer’s ‘cloaking’ strategy and exposing it to the immune system so it can be destroyed. We will be testing TT-702 in several different cancer types to determine the best dose that can safely be given to patients," said Professor Johann De Bono, Professor of Experimental Cancer Medicine at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust.

Targeting GPCR for Oncology – Tomorrow’s Treatments

With more than 700 approved drugs currently directed at them, GPCRs are the most commonly utilized target in today’s treatment paradigm, however, their potential in oncology and moreover, immuno-oncology, has yet to be leveraged. GPCRs control a broad range of cellular processes vital to the formation and progression of tumors. Small molecules are the most prevalent modulators of GPCR-targeted therapies. Insights into the roles of GPCRs in the tumor microenvironment and how they modulate both tumor-generating signal transduction pathways as well as interactions with immune system defense mechanisms may allow the pursuit of more novel GPCR-directed therapies.

BioNTech and Regeneron Expand Strategic Collaboration to Advance Clinical Development of FixVac and Libtayo® (cemiplimab) Combination in NSCLC

On March 8, 2022 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported the expansion of its strategic collaboration with Regeneron to advance the Company’s FixVac candidate BNT116 in combination with Libtayo (cemiplimab), a PD-1 inhibitor, in advanced non-small cell lung cancer (NSCLC) (Press release, BioNTech, MAR 8, 2022, View Source [SID1234609644]). Under the terms of the agreement the companies plan to jointly conduct clinical trials to evaluate their combination in different patient populations with advanced NSCLC. Lung cancer is worldwide one of the most common diagnosed malignant cancer types and the leading cause of cancer death. 1 NSCLC is the most common type of lung cancer, making up about 85% of all lung cancers.

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"Advancing the sixth FixVac product candidate based on uridine mRNA into clinical development underlines the versatility and potential of this platform. Advanced NSCLC still has a five-year survival rate of only 25% leaving patients with very limited treatment options. We believe that a potent vaccine that induces strong T cell responses against shared tumor associated antigens combined with PD-1 blockade that further enables the activated T cell repertoire will help to address the high unmet medical need in this indication," said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "We look forward to further building on our successful collaboration with Regeneron to accelerate the clinical development of BNT116 in our growing mRNA oncology pipeline."

The investigational mRNA-based cancer vaccine BNT116 is based on BioNTech’s FixVac platform. It consists of a fixed combination of shared tumor-associated antigens that were identified to be frequently expressed in NSCLC. The companies plan to develop the collaboration beginning with Phase 1/2 clinical trials in the first-line treatment setting in advanced NSCLC. Under the terms of the agreement, BioNTech and Regeneron will equally share development costs for the trials. In addition, under a separate agreement, BioNTech plans to conduct and sponsor a Phase 1 clinical trial (LuCa-MERIT-1) evaluating the combination of BNT116 and Libtayo in further subpopulations with NSCLC.

"We are delighted to expand our collaboration with BioNTech to a third tumor type – advanced NSCLC – and investigate whether combining Libtayo with BNT116 will further enhance the efficacy and safety we’ve demonstrated with Libtayo in this cancer as both a monotherapy and in combination with chemotherapy," said Israel Lowy, M.D., Ph.D., Senior Vice President, Clinical Development, Oncology, at Regeneron. "Combining PD-1 inhibition with mRNA-based vaccines is an exciting, yet still emerging, approach in oncology. This collaboration provides an opportunity for us to conduct scientifically sophisticated and pioneering clinical research in this space and investigate whether this novel combination may help drive a multi-faceted activation of the immune system against advanced NSCLC."

The agreement follows the company’s existing collaboration evaluating the combination of BioNTech’s FixVac candidate BNT111 with Libtayo in advanced melanoma. BNT111 was granted U.S. FDA Fast Track Designation in November 2021 and is currently investigated in a randomized Phase 2 trial. The trial was initiated in June 2021, following encouraging data from an exploratory interim analysis of the ongoing Phase 1 Lipo-MERIT study with BNT111 as monotherapy and in combination with PD-1 blockade, which was published in Nature. In addition, BioNTech is investigating and sponsoring a Phase 1 clinical trial evaluating the combination of Libtayo with the Company’s FixVac candidate BNT112 in prostate cancer.
Libtayo is being jointly developed by Regeneron and Sanofi.

About FixVac
BioNTech’s FixVac platform candidates consist of a fixed combination of mRNA-encoded non-mutated antigens shared across patients with a defined cancer type. They feature the Company’s proprietary RNA-lipoplex platform for intravenous administration that consists of mRNA optimized for translation efficiency and stability and a formulation that specifically targets dendritic cells. The vaccine antigens trigger a strong and precise innate and adaptive immune response against cancer cells overexpressing the respective antigens.