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Altimmune Announces $3.7 Million in Additional BARDA Funding to Advance NasoShield™ Clinical Development

On August 21, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that the Biomedical Advanced Research and Development Authority (BARDA) is modifying its existing anthrax vaccine development contract with Altimmune by awarding an additional $3.7 million (Press release, Altimmune, AUG 21, 2019, View Source [SID1234551236]). The increase in funding is primarily directed toward a Phase 1b clinical trial of NasoShield to evaluate alternative methods of intranasal dosing in humans.

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In 2018, BARDA awarded Altimmune $2.5 million for further NasoShield development including a comparison of different methods of administration of the vaccine in preclinical models. The data from this study demonstrated that a simple modification to the method of intranasal dose administration had a dramatic impact on the resulting immunogenicity. These results suggest that the 2018 Phase 1 study of NasoShield in healthy adults might have shown a more robust immunogenic effect had a modified administration method been employed. The planned Phase 1b clinical trial will evaluate modified methods of intranasal dosing on NasoShield safety and immunogenicity and is expected to start in 2019.

"We are extremely pleased that BARDA has made this additional funding available for a clinical study to advance this potentially transformative anthrax vaccine," said Dr. Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "BARDA has been an outstanding partner for NasoShield and we are excited to continue its development with their support."

About NasoShield

In contrast to the currently licensed vaccine that requires three injected doses of vaccine over one month for protection, NasoShield is being developed as a single-dose, intranasal anthrax vaccine. The NasoShield product characteristics may also provide for greatly improved logistics in distribution and administration allowing it to be used more effectively than the currently approved vaccine in the event of an anthrax incident. The NasoShield program is funded through a contract with BARDA (HHSO100201600008C), with a total potential value of $133.7 million if all options in the contact are exercised.

Helix BioPharma Corp. Closes $7.0 Million Private Placement

On August 21, 2019 Helix BioPharma Corp. (TSX: "HBP") ("Helix" or the "Company"), an immunooncology company developing innovative drug candidates for the prevention and treatment of cancer, reported it has closed a private placement financing of 13,725,000 units of the Company and the disposition of a 25% stake of its wholly-owned Polish subsidiary for aggregate gross proceeds of CAD $7,000,005 (Press release, Helix BioPharma, AUG 21, 2019, View Source [SID1234538933]).

The terms of the placement are for the purchase of units at $0.455 per unit. Each unit is comprised of one common share and one common share purchase warrant. Each common share purchase warrant will entitle the holder to purchase one common share at an exercise price of $0.72 and have an expiry of five years from the date of issuance. In addition, the terms of the private placement also include the disposition by the Company of shares of its Polish subsidiary, Helix Immuno-Oncology S.A. ("HIO"), representing 25% of the outstanding shares of HIO.

Mr. Jerzy Wilczewski ("Mr. Wilczewski"), acquired 13,725,500 units of Helix in the private placement. Following closing, Mr. Wilczewski’s holdings, including previously held common shares and common share purchase warrants of the Company ("Warrants"), represent approximately 15.70% of the issued and outstanding common shares of the Company on a non-diluted basis and 26.14% on a partially diluted basis, assuming the full exercise of all Warrants that Mr. Wilczewski beneficially owns or exercises control or direction over.

"My family wants to contribute to cancer research development," said Mr. Wilczewski. "I decided to make this sizeable investment in Helix because I believe in the social objective and the uniqueness of the Company’s technology. An additional motivation for me is the ongoing research and development work that the Company is carrying on in Poland."

"On behalf of Helix, I thank Mr. Wilczewski for his confidence and contribution," said Dr. Heman Chao, Helix’s Chief Executive Officer.

The issuance of the units under the private placement would ordinarily require shareholder approval under the requirements of the Toronto Stock Exchange (the "TSX"), since the aggregate number of common shares issuable (including through the exercise of Warrants) in successive private placements within the last three months exceeds 25% of the issued and outstanding common shares of the Company prior to the first such placement and since Mr. Wilczewski would potentially become a "control person" of the Company on exercise of the Warrants. However, Mr. Wilczewski has undertaken not to exercise any Warrants where the exercise would result in him owning 20% or more of Helix’s outstanding common shares unless disinterested shareholder approval, or the approval of the TSX, has been obtained.

The Company intends to seek shareholder approval for the creation of Mr. Wilczewski as a control person at its annual general meeting to be held later this year. 2 The Company intends to use the net proceeds of the private placement for working capital and research and development activities.

ACM Alpha Consulting Management AG provided financial advisory services to Helix in connection with the private placement.

Constellation Pharmaceuticals to Participate in Two Investor Conferences

On August 21, 2019 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that the Company will participate in two investor conferences on September 5. Jigar Raythatha, CEO, will meet with investors at the Citi 14th Annual Biotech Conference at the Four Seasons Hotel in Boston (Press release, Constellation Pharmaceuticals, AUG 21, 2019, View Source [SID1234538930]). Emma Reeve, CFO, will present at the Baird Global Healthcare Conference at the InterContinental Hotel in New York at 11:25 am EDT. A live audio webcast of Ms. Reeve’s presentation and an archive for replay will be available on the Investor Relations section of Constellation’s website at View Source The audio webcast replay will be available for 90 days following the live presentation.

corporate presentation

On August 21, 2019 Anixa Biosciences, Inc presented the corporate presentation (Presentation, Anixa Biosciences, AUG 21, 2019, View Source [SID1234538929]).

Genmab Announces Preliminary Data to be Presented at IASLC 2019 World Conference on Lung Cancer

On August 21, 2019 Genmab A/S (Nasdaq: GMAB) reported that preliminary data from the Phase I/II trial of enapotamab vedotin in advanced non-small cell lung cancer (NSCLC) has been accepted for oral presentation at the International Association for the Study of Lung Cancer 2019 World Conference on Lung Cancer (IASLC 2019 WCLC) taking place from September 7-10, 2019 in Barcelona, Spain (Press release, Genmab, AUG 21, 2019, View Source [SID1234538927]). Meeting abstracts are currently accessible form the IASLC 2019 WCLC website, View Source

"We are honored that early data from enapotamab vedotin was chosen for oral presentation at the IASLC 2019 WCLC. The selection of this data for presentation also supports our belief in the potential of this first-in-class compound for patients with advanced non-small cell lung cancer progressing on chemotherapy and a checkpoint inhibitor; we look forward to more advanced and complete data becoming available in the future" said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Enapotamab vedotin abstract to be presented:
First-in-human Phase 1/2 trial of anti-AXL antibody–drug conjugate enapotamab vedotin in advanced NSCLC – Oral presentation, Sunday, September 8, 2019, 11:15 AM – 11:25 AM CEST. Full abstract available here.