On March 8, 2022 Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines designed to bring the curative power of stem cell transplants to more patients, reported financial results for the fourth quarter and full-year ended December 31, 2021, and recent program highlights (Press release, Magenta Therapeutics, MAR 8, 2022, View Source [SID1234609650]).

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"We expect 2022 will be a year of trial execution and value-creating data readouts, and we are particularly pleased to have dosed our first patient in the MGTA-117 clinical trial," said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. "The first patient has completed the initial safety assessment period which allows for additional patients to be dosed in the cohort. We anticipate sharing further information on this dose-escalation trial in 2022. Earlier this year, we announced our second targeted conditioning program, a CD45 antibody-drug conjugate, and expect to provide important IND-enabling preclinical data for the program in the second half of 2022. We are also advancing our preparations for the MGTA-145 stem cell mobilization program in sickle cell disease and optimization of dosing and administration. We believe our portfolio of programs has the potential to address a broad spectrum of diseases including hematology-oncology, rare genetic diseases, and autoimmune diseases and we look forward to advancing them for improved patient outcomes."

2021 Highlights and Recent Program Progress:

MGTA-117: Targeted Conditioning

The first patient has been dosed and has completed the initial safety assessment in the Phase 1/2 clinical trial in patients with relapsed/refractory acute myeloid leukemia and myelodysplasia-excess blasts. Additional patients may now be dosed in the first cohort of this dose-escalation clinical trial, which is open for recruitment at multiple centers. The trial will evaluate the tolerability, pharmacokinetics, pharmacodynamics, and safety following a single dose of MGTA-117, which includes target engagement, drug clearance, cell depletion, and safety measurements. Data are expected this year.

2021 Data Highlights:

2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: An oral presentation described a successful anti-CD-117 antibody-drug conjugate (ADC) targeted conditioning regimen contributed to a successful transplant of gene-modified stem cells in primates with durable engraftment. A poster presentation described preclinical mouse data that supports the use of a CD117-targeted ADC in combination with lymphodepletion to condition prior to allogeneic hematopoietic stem cell (HSC) transplant.
2021 Transplantation and Cellular Therapy (TCT) Annual Meeting and the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting: Announced preclinical data showing MGTA-117 increased median survival in murine models of acute myeloid leukemia as compared head-to-head with a multi-day, standard-of-care regimen using cytarabine.
CD45-ADC: Second Targeted Conditioning Program

Magenta has initiated investigational new drug (IND) application-enabling studies with data from a dose-ranging toxicology study expected in the second half of 2022. Due to the expression of CD45 on stem cells and immune cells, Magenta’s CD45-ADC is designed to selectively target and deplete stem cells and lymphocytes, which could allow patients with autoimmune diseases and blood cancers to avoid the use of chemotherapy prior to stem cell transplant.

2021 Data Highlights:

2021 TCT Annual Meeting: A poster presentation showed conditioning with single-agent CD45-ADC enabled complete chimerism in a full mismatch allogeneic HSC transplant murine model.
MGTA-145: Stem Cell Mobilization and Collection for Hematopoietic Stem Cell Transplantation and Gene Therapy

We are currently advancing our preparations for the MGTA-145 stem cell mobilization program in clinical trials in sickle cell disease and optimization of dosing and administration in healthy subjects with data expected in the second half of 2022.

2021 Data Highlights:

2021 ASH (Free ASH Whitepaper) Annual Meeting: A poster presentation described a Phase 2 investigator-initiated clinical study with multiple myeloma patients that showed MGTA-145, in combination with plerixafor, mobilized a sufficient number of stem cells for autologous transplantation. All patients who underwent transplantation had successful engraftment and all patients followed to day 100 post-transplantation showed durable engraftment. The regimen was generally well-tolerated.
Upcoming Events:

Participating in the Cell Therapy Panel Discussion at the Cowen Healthcare Conference on Wednesday, March 9, 2022, at 9:10 am. A live webcast will be available on the Investors & Media section of Magenta’s website at View Source
Presenting at EBMT Annual Meeting on March 22, 2022, two encore posters:
Single Agent CD117-Targeted Antibody Drug Conjugate in Combination with Lympho-Depleting Antibodies Enables Allogenic Hematopoietic Stem Cell Transplantation in Mice without Chemotherapy or Radiation, Program code P688
CD117 Antibody Drug Conjugate-Based Conditioning Enables Efficient Engraftment of Gene-Modified CD34+ Cells in a Rhesus Gene Therapy Model, Program code P689
Presenting at the TCT Meeting, April 26, 2022, an oral encore presentation entitled:
MGTA-145 + Plerixafor Provides GSCF-Free Rapid and Reliable Hematopoietic Stem Cell Mobilization for Autologous Stem Cell Transplant in Patients with Multiple Myeloma: A Phase 2 Study
Financial Results:

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2021, were $176.9 million, compared to $148.8 million as of December 31, 2020. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into the fourth quarter of 2023.

Research and Development Expenses: Research and development expenses were $13.1 million in the fourth quarter of 2021, compared to $12.3 million in the fourth quarter of 2020. The increase was driven primarily by increased process development activities to support future manufacturing for MGTA-145 offset by a decrease in manufacturing costs related to activities supporting our IND application that was filed in June 2021. The increase was also due to an increase in research and development headcount.

General and Administrative Expenses: General and administrative expenses were $7.0 million for the fourth quarter of 2021, compared to $6.8 million for the fourth quarter of 2020.

Net Loss: Net loss was $19.3 million for the fourth quarter of 2021, compared to net loss of $18.2 million for the fourth quarter of 2020.

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

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.

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.

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.