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Armata Pharmaceuticals Announces Closing of Second and Final Tranche of $20 Million Private Placement with Innoviva

On March 17, 2021 Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, reported that, following a vote in favor of the transaction by the Armata shareholders, the Company has completed the closing of the second and final tranche of the Company’s $20 million private placement of its common stock with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva, Inc. (NASDAQ: INVA) (together, "Innoviva") (Press release, AmpliPhi Biosciences, MAR 17, 2021, View Source [SID1234576786]). In connection with the second closing, Armata issued 4,285,935 common shares and 4,285,935 warrants with an exercise price of $3.25 per share, at a per unit price of $3.25 per unit, in exchange for gross proceeds of approximately $13.9 million. Approximately 99% of the Armata shares represented and voting at the special meeting of shareholders voted in favor of the transaction.

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The Company and Innoviva closed an initial tranche of the investment on January 26, 2021, which raised gross proceeds of approximately $6.1 million through the issuance of 1,867,912 common shares and warrants to purchase an additional 1,867,912 common shares at a strike price of $3.25 per share.

As of March 17, 2021, and following the second closing, Armata has 24,940,442 shares outstanding and warrants exercisable for 16,649,465 shares of common stock.

Armata was represented in the transaction by Thompson Hine LLP, and Ladenburg Thalmann & Co. Inc. acted as Armata’s financial advisor.

Willkie Farr & Gallagher LLP represented Innoviva in the transaction.

This release does not constitute an offer to sell or the solicitation of an offer to buy any security. The shares offered have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the securities act and applicable state securities laws or an applicable exemption from registration requirements.

Ambrx Granted Orphan Drug Designation for ARX788 for the Treatment of Gastric Cancer

On March 17, 2021 Ambrx, a clinical stage biopharmaceutical company using an expanded genetic code to create Engineered Precision Biologics, reported that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for ARX788 for the treatment of patients with HER2-positive gastric cancer, including cancer at the gastroesophageal junction (Press release, Ambrx, MAR 17, 2021, View Source [SID1234576785]).

The FDA’s Office of Orphan Drug Products grants orphan status to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan drug designation for ARX788 for gastric cancer provides Ambrx with certain benefits, including an exemption to FDA prescription drug user fees and tax credits for qualified clinical trials. Orphan drug designation also confers eligibility for seven years of market exclusivity to an orphan drug post-approval, subject to receiving marketing approval from the FDA.

"The ongoing Phase 1 ACE-Gastric-01 trial has shown promising anti-tumor activity in HER2-positive advanced gastric patients who have been previously treated with trastuzumab and chemotherapy in the metastatic setting," said Feng Tian, Ph.D., President and CEO of Ambrx. "Receiving orphan drug designation from the FDA is an important milestone in our ongoing efforts to develop ARX788 for a wide range of HER2-positive cancers. We are proud to be targeting a rare disease that is currently severely underserved by advancing ARX788 into additional clinical trials."

The company anticipates the release of additional Phase 1 data from the ACE-Gastric-01 trial by the end of 2021 and initiation of ACE-Gastric-02, a global Phase 3 trial for HER2-positive gastric cancer, in the second half of 2021. ACE-Gastric-02 is currently planned to be a randomized trial of ARX788 versus physician’s choice of treatment in second line HER2-positive gastric cancer and HER2-positive cancer at the gastroesophageal junction.

About ARX788
ARX788 is a homogeneous and highly stable antibody drug conjugate (ADC) targeting the HER2 receptor. ARX788 is an Engineered Precision Biologic ADC that consists of two cytotoxic payloads site-specifically conjugated to a Herceptin (trastuzumab)-based antibody. ARX788 was designed to maximize potential anti-tumor activity by optimizing the number and position of the payloads and the chemical bonds that conjugate the cytotoxic AS269 payloads to the antibody. AS269 is a proprietary tubulin inhibitor specifically designed to form a highly stable covalent bond with our synthetic amino acids, a fundamental step in the creation of an Engineered Precision Biologic ADC. Ambrx licensed the China rights to ARX788 to its partner NovoCodex.

About HER2-positive Gastric Cancer
Human epidermal growth factor receptor 2 (HER2) is a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells. Gastric cancer with HER2 overexpression has shown aggressive biological behavior, with higher frequencies of disease recurrence in HER2-positive tumors. The frequency of HER2 overexpression in gastric cancer, and cancer at the gastroesophageal junction, range widely with an average of 20% expression. The heterogeneity within gastric tumors and poor treatment options shows an unmet medical need for patients with HER2-positive advanced gastric cancer.

West Announces Participation in Upcoming Investor Conference

On March 17, 2021 West Pharmaceutical Services, Inc. (NYSE: WST) reported that management will present virtually at the KeyBanc Capital Markets Life Sciences & MedTech Investor Forum at 10:00 AM ET on Wednesday, March 24, 2021 (Press release, West Pharmaceutical Services, MAR 17, 2021, View Source [SID1234576779]).

A live audio webcast of the presentation and a copy of the presentation will be accessible from the Company’s website at www.westpharma.com/en/investors.

Vaccitech Completes $168 Million Series B Financing to Advance Three Clinical Programs Through Phase 2 Results

On March 17, 2021 Vaccitech Ltd ("Vaccitech"), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer, reported that it has raised $168 million in a Series B financing (Press release, Vaccitech, MAR 17, 2021, View Source [SID1234576778]). This includes $43 million in convertible loan notes previously issued by Vaccitech that converted into Series B shares.

The Series B financing round was led by M&G Investment Management (part of M&G plc), with further participation from new investors including Tencent, Gilead Sciences, Monaco Constitutional Reserve Fund, and Future Planet Capital among others. The Series B financing round was also supported by existing investors, including Oxford Sciences Innovation.

"We expect this financing to enable us to reach key value inflection points for our lead programs," said Bill Enright, Chief Executive Officer of Vaccitech. "We now look forward to advancing key programs towards generating proof-of-concept data in indications with significant need of effective new treatments."

The proceeds from the financing will support the continued development of three infectious disease and immuno-oncology programs. The programs include:

A Phase 1/2 clinical trial of VTP-300 in patients with chronic hepatitis B virus (HBV) infection. The first patient in the trial was dosed in February 2021.
A Phase 1/2 clinical trial of VTP-200 in patients with persistent, high-risk human papillomavirus (HPV) infection.
A Phase 1/2 clinical trial of VTP-850 in combination with a checkpoint inhibitor in patients with prostate cancer.
Vaccitech’s proprietary prime-boost platform combines modified simian adenoviral vectors (known as ChAdOx1 or ChAdOx2) to prime a targeted immune response with the Modified Vaccinia Ankara virus (MVA) to boost the targeted immune response against cells infected with a virus or tumor cells. Vaccitech’s heterologous prime-boost approach has been demonstrated to drive powerful immune responses, including the leading CD8+ T cell stimulation profile in humans, to date. In addition to the HBV, HPV and prostate cancer programs, Vaccitech’s pipeline includes product candidates targeting infectious disease (including MERS coronavirus and Herpes Zoster) and cancer (including non-small cell lung cancer).

"Vaccitech is aiming to address serious global public health challenges in both infectious disease and cancer with their T cell inducing immunotherapy platform," said Jack Daniels, Chief Investment Officer of M&G plc. "We believe their innovative approach, based on foundational research performed at the Jenner Institute at the University of Oxford, could provide a solution for many serious diseases."

Navidea Biopharmaceuticals to Host Fourth Quarter 2020 Earnings Conference Call and Corporate Update

On March 17, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Wednesday, March 24, 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the fourth quarter ended December 31, 2020 (Press release, Navidea Biopharmaceuticals, MAR 17, 2021, View Source [SID1234576775]).

Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Joel Kaufman, Chief Business Officer, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.