Propanc Biopharma Receives Granted US Patent Covering Additional Composition Claims for PRP

On August 21, 2019 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that it has received a granted US patent from the United States Patent and Trademark Office (USPTO) covering composition of matter claims involving trypsinogen and chymotrypsinogen (Press release, Propanc, AUG 21, 2019, https://ir.propanc.com/news/detail/92/propanc-biopharma-receives-granted-us-patent-covering-additional-composition-claims-for-prp [SID1234538906]). The additional composition claims are a continuation from the original foundation patent in the U.S., and as a result, both method of treatment and composition claims now protects the Company’s lead product candidate, PRP, a pharmaceutical composition consisting of two proenzymes, trypinsogen and chymotrypsinogen, for treating cancer.

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The granted patent issued by the USPTO now confers exclusive rights to the Company’s lead product, PRP, by demonstrating that compositions comprising trypsinogen and chymotrypsinogen exhibit a synergistic ability to inhibit the growth of various cancer cell lines.

"We continue to grow and strengthen our intellectual property portfolio and it is pleasing to receive additional patent claims for PRP in one of our most important global jurisdictions," said James Nathanielsz, Propanc’s Chief Executive Officer. "Presently, we have 65 patents either in force, or pending, in major global regions around the world, and this is very significant as we advance PRP towards human trials."

"We continue to fund research programs with our university partners, and plan to file additional patent applications in the future," said Dr Julian Kenyon, Propanc’s Chief Scientific Officer. "Intellectual property lies at the heart of any early stage Biotech company and we look forward to expanding our portfolio covering further aspects of our invention related to PRP, especially as we advance further down the clinical development pathway."

BioInvent Will Conduct Phase l/lla Trial With BI-1206 in Combination With Pembrolizumab (Keytruda) in Solid Tumors

On August 21, 2019 BioInvent International AB (publ) (OMXS: BINV), a company focused on the discovery and development of novel and first-in-class immuno-modulatory antibodies to treat cancer, reported that the earlier communicated phase l/lla clinical trial in solid cancer will be conducted with BI-1206, one of BioInvent’s proprietary anti-FcγRllB antibodies, in combination with pembrolizumab (Keytruda), a leading anti-PD1 antibody (Press release, BioInvent, AUG 21, 2019, View Source [SID1234538922]). In July 2019 this trial received IND acceptance by FDA.

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BioInvent’s CEO Martin Welschof said, "Expanding BI-1206’s clinical development to solid tumors in combination with pembrolizumab, one of the most powerful and successful immune-oncology drugs, constitutes a major step for BioInvent. The program is based on our recent preclinical data demonstrating the ability of BI-1206 to address an important mechanism of resistance to PD1 inhibition, providing a way to enhance anti-tumor immune responses in patients with solid tumors. We believe that inhibition of FcγRIIb will become a key component in the treatment of solid and hematological malignancies."

The Phase l/lla clinical trial will evaluate the drug combination in patients with advanced solid tumors, who have been previously treated with anti-PD1 or anti-PD-L1 antibodies, and is a multicenter, dose-finding, consecutive-cohort, open-label trial.

BI-1206 is currently being investigated in non-Hodgkin lymphoma and chronic lymphocytic leukemia.

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.

Entry into a Material Definitive Agreement

On August 20, 2019, Vical Incorporated (the "Company") reported that it entered into an amendment (the "Amendment") with Brickell Biotech, Inc., a Delaware corporation and clinical-stage medical dermatology company ("Brickell"), and Victory Subsidiary, Inc., a Delaware corporation and wholly owned subsidiary of the Company ("Merger Sub"), to the Agreement and Plan of Merger and Reorganization dated as of June 2, 2019 by and among the Company, Brickell and Merger Sub (the "Merger Agreement") (Filing, 8-K, Vical, AUG 21, 2019, View Source [SID1234538907]). Pursuant to the Merger Agreement, as amended, and upon the terms and subject to the satisfaction of the conditions described in the Merger Agreement, as amended, Merger Sub will be merged with and into Brickell (the "Merger"), with Brickell surviving the Merger as a wholly owned subsidiary of the Company.

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Pursuant to the Amendment, the parties revised the minimum Brickell net working capital closing condition from -$11.5 million to -$14.3 million, revised the Brickell valuation from $60.0 million to $50.2 million, and revised the range of Brickell closing net working capital, outside of which there will be a dollar-for-dollar adjustment to the Brickell valuation, to -$14.8 million to -$13.8 million and fixed the assumed share price for purposes of applying the treasury stock method to calculate the number of Brickell and Vical outstanding shares at $0.79 and $1.35, respectively. The amended Brickell valuation results in an ownership split between Brickell and Vical stockholders of approximately 56% and 44%, respectively (on a fully diluted basis using the treasury stock method in instances other than with respect to the NovaQuest Warrants (as defined in the Merger Agreement) and certain equity issuances by Brickell following the signing of the Merger Agreement and prior to the completion of the Merger), or 51% and 49%, respectively (on a fully diluted basis using the treasury stock method), subject to further adjustment pursuant to the terms of the Merger Agreement, as amended by the Amendment. Other than as set forth in the Amendment, the terms of the Merger Agreement are unchanged.

NeuroVive Pharmaceutical AB Interim Report January – June 2019

On August 21, 2019 NeuroVive Pharmaceutical reported that Interim Report January – June 2019 (Press release, NeuroVive Pharmaceutical, AUG 21, 2019, View Source;june-2019-300904966.html [SID1234538923]).

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Important events April – June

The US Food and Drug Administration, FDA, approves NeuroVive’s IND (Investigational New Drug) application, enabling clinical studies in the US with the company’s drug candidate NeuroSTAT.
The Supreme Court delivers its ruling concerning arbitration between NeuroVive and CicloMulsion AG. The Supreme Court rejects NeuroVive’s appeal.
Annual General Meeting in NeuroVive was held on 25 April in Lund.
Important events after the reporting period

NeuroVive initiates second part of its ongoing KL1333 Phase Ia/b clinical study.
NeuroSTAT has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.
Financial information Second quarter (April-June 2019)

Net revenues: KSEK 85 (0)
Other operating income: KSEK 1 000 (1 278)
Loss before tax: KSEK -20,769 (-25,481)
Loss per share*: SEK -0,14 (-0,40)
Diluted loss per share**: SEK -0,14 (-0,40)
Financial information First six months (January-June 2019)

Net revenues: KSEK 85 (0)
Other operating income: KSEK 1,000 (1,452)
Loss before tax: KSEK -34,591 (-38,534)
Loss per share*: SEK -0,23 (-0,61)
Diluted loss per share**: SEK -0,23 (-0,61)
* Profit/loss for the period divided by average number of shares before dilution at the end of the period.
** Profit/loss for the period divided by average number of shares after dilution at the end of the period.

Please find the complete interim report attached, or through our website www.neurovive.com.

The information was submitted for publication, through the agency of the contact person set out below, at 08:30 a.m. CEST on 21 August 2019.