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IMAGO BIOSCIENCES RAISES $80 MILLION IN SERIES C FINANCING

On November 19, 2020 Imago BioSciences, Inc. ("Imago") a clinical-stage biopharmaceutical company developing innovative treatments for myeloproliferative neoplasms reported the close of an $80 million Series C financing round (Press release, Imago BioSciences, NOV 19, 2020, View Source [SID1234571432]). Farallon Capital Management, LLC led the round, with participation from new investors including funds and accounts advised by T. Rowe Price Associates, Inc., funds and accounts managed by Blackrock Advisors, LLC., Surveyor Capital (a Citadel company), Irving Investors and Kingdon Capital Management. Existing investors also participating in the financing include a fund managed by Blackstone Life Sciences, Frazier Healthcare Partners, Omega Funds, Amgen Ventures, MRL Ventures Fund, HighLight Capital, Pharmaron Investments Ltd., Greenspring Associates and Xeraya Capital.

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Imago will use the proceeds to complete a Phase 3 study of bomedemstat for the treatment of myeloproliferative neoplasms. Bomedemstat (IMG-7289) is an orally available small molecule that inhibits lysine-specific demethylase 1 (LSD1), an enzyme shown to be vital in self-renewal of cancer stem cells and hematopoiesis. Bomedemstat is being investigated in a Phase 2b clinical trial for the treatment of myelofibrosis, and a Phase 2b clinical trial for the treatment of essential thrombocythemia. The FDA has granted Fast Track Designation and Orphan Drug Designation to bomedemstat in both indications and the EMA has given bomedemstat PRIME designation for the treatment of myelofibrosis.

"The support of this group of elite health care investors enables us to pursue our bold vision of developing transformative medicines to treat people living with devastating cancer of the bone marrow with our first efforts focused on bone marrow neoplasms including the myeloproliferative diseases," said Hugh Young Rienhoff, Jr. M.D., CEO at Imago BioSciences. "This financing allows us to take bomedemstat through the next set of late stage clinical trials in multiple indications."

About Bomedemstat

Bomedemstat is being evaluated in open-label Phase 2 clinical trials for the treatment of advanced myelofibrosis (MF), essential thrombocythemia (ET), and polycythemia vera, bone marrow cancers that alter the production of blood cells. MF patients who are resistant to, intolerant of, or ineligible for a Janus Kinase (JAK) inhibitor are eligible for the study of bomedemstat as monotherapy. Interim data will be presented in an oral session at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Congress on December 5, 2020.

Bomedemstat is an orally available small molecule discovered and developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, bomedemstat demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. Bomedemstat is an investigational agent currently being evaluated in multiple ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185, NCT04262141, NCT04254978 and NCT04081220). Bomedemstat has U.S. FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis and essential thrombocythemia, Orphan Drug Designation for treatment of acute myeloid leukemia and PRIME designation by the European Medicines Agency for the treatment of MF.

Phio Pharmaceuticals to Participate in the 3rd Annual Evercore ISI HealthCONx Conference

On November 19, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that its chief executive officer, Dr. Gerrit Dispersyn, will present at the upcoming 3rd Annual Evercore ISI HealthCONx Conference, which is being held virtually this year from December 1-3, 2020 (Press release, Phio Pharmaceuticals, NOV 19, 2020, View Source [SID1234571431]).

Dr. Dispersyn is scheduled to participate in a fireside chat on Thursday, December 3rd, at 3:05 p.m. ET. Interested parties may access a live webcast of the presentation at View Source

An archived version of the webcast will be made available on the "Investors – Events and Presentations" section of the Company’s website after the live event.

MannKind Receives Fourth $12.5 Million Milestone Payment from United Therapeutics

On November 19, 2020 MannKind Corporation (NASDAQ:MNKD) reported that it has achieved the final development milestone under its licensing and collaboration agreement with United Therapeutics for the development and commercialization of a dry powder formulation of treprostinil (Press release, Mannkind, NOV 19, 2020, View Source [SID1234571430]).

Treprostinil Technosphere ("TreT") is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension (PAH). All current clinical trials are now fully enrolled, including the BREEZE study in patients with PAH and a pivotal pharmacokinetics study in healthy subjects, both of which are being conducted by United Therapeutics, as well as a human factors study being conducted by MannKind. In addition, MannKind’s stability program for TreT has reached the milestone required for a regulatory filing.

"We are looking forward to working with United Therapeutics during the first part of 2021 to prepare an FDA submission for TreT," said Michael Castagna, Chief Executive Officer of MannKind.

MannKind has now received all of the milestone payments that were specified in its agreement with United Therapeutics. MannKind remains entitled to receive low double-digit royalties on net sales of TreT. MannKind will also manufacture supplies of TreT for United Therapeutics and will earn a manufacturing margin.

Bio-Path Holdings Announces First Patient Dosed in Phase 1 Clinical Trial of BP1002

On November 19, 2020 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the enrollment and dosing of the first patient in a Phase 1 clinical trial evaluating the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia (CLL) patients (Press release, Bio-Path Holdings, NOV 19, 2020, View Source [SID1234571429]).

BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with relapsed CLL or with relapsed, aggressive non-Hodgkin’s lymphoma. Preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and the Company believes that its benign safety profile should enable BP1002 combination therapy with approved agents.

A total of six evaluable patients will be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The treatment cycle consists of two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The primary objectives of the study include safety and tolerability of escalating doses of BP1002, recommended Phase 2 dose of BP1002, pharmacokinetics of BP1002 and BP1002 activity on Bcl-2 expression. Secondary endpoints include several efficacy measurements of tumor response.

"This study will mark a critical step in understanding the potential benefits that BP1002 may bring to patients suffering with advanced lymphoid malignancies," said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board. "Importantly, BP1002 activity is based on blocking the Bcl-2 messenger RNA and not the BH3 domain, as is the case with venetoclax. As a result, we believe BP1002 may provide a much-needed alternative for patients with malignancies that relapsed or are refractory to venetoclax."

"We are delighted to initiate this first-in-human clinical study of our second drug product candidate derived from the DNAbilize platform. Given the encouraging pre-clinical data and safety profile seen to date, we are very excited to begin this study, which is expected to demonstrate safety and to show initial efficacy signals in these indications with significant unmet medical need," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.

Ian W. Flynn, M.D. will serve as the national coordinating Principal Investigator for the Phase 1 trial. Dr. Flynn is the director of lymphoma research at the Sarah Cannon Research Institute. Other sites for the clinical trial include the Georgia Cancer Center at Augusta University and The University of Texas M.D. Anderson Cancer Center.

Zymeworks Receives Orphan Drug Designation from the European Commission for HER2-Targeted Bispecific Antibody Zanidatamab in Patients with Gastric Cancer

On November 19, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that the European Commission (EC) has granted Orphan Drug designation for zanidatamab, the company’s investigational HER2-targeted bispecific antibody, in patients with gastric cancer (Press release, Zymeworks, NOV 19, 2020, View Source [SID1234571428]).

"We are encouraged by the European Commission’s and European Medicines Agency’s recognition of the benefit that zanidatamab can provide in the treatment of HER2-expressing gastric cancers as we continue to expand our clinical development globally," said Diana Hausman, M.D., Chief Medical Officer at Zymeworks.

The EC grants Orphan Drug designation to therapies that represent a significant benefit over existing treatments, are intended for the treatment, prevention or diagnosis of a life-threatening or chronically debilitating disease, and where prevalence of the condition in the European Union (EU) is less than 5 in 10,000 persons. Orphan drug designation gives companies certain benefits, including 10 years of market exclusivity following regulatory approval, reduced regulatory fees, clinical protocol assistance, and access to research grants.

"While gastric cancer is a rare disease, European countries experience the highest incidence rates among all Western countries" said James Priour, Senior Vice President, Commercial, at Zymeworks. "The European Commission’s granting of Orphan Drug designation for zanidatamab represents an important step towards bringing this promising investigational medicine to patients in Europe and around the world."

Zymeworks previously received Orphan Drug designations for zanidatamab in gastric, biliary tract and ovarian cancers from the US FDA, as well as two Fast Track designations from the FDA for zanidatamab.

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding, and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and registration-enabling clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The US FDA has granted two Fast Track designations to zanidatamab, one as a single agent for refractory BTC and one in combination with standard of care chemotherapy, for first-line Gastroesophageal Adenocarcinoma (GEA). Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers from the US FDA, in addition to Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.