On August 27, 2019 Harbour BioMed (HBM), a global clinical-stage biopharmaceutical company, and Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), reported a strategic collaboration to develop HBM’s innovative therapeutics in the fields of oncology and immunology (Press release, PPD, AUG 27, 2019, View Source [SID1234539014]).

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The selection of PPD as a preferred CRO partner enables HBM, which has operations in the United States, the European Union and China, to conduct global clinical studies on its internal research pipeline. HBM and PPD recently completed an Australian ethics committee (EC) submission for HBM4003, an anti-cancer immunotherapy to target solid tumors. The companies achieved the key milestone ahead of schedule, on the path to Phase I trials in Australia and the United States.

HBM has been developing a robust pipeline in oncology and immunology since the company was established in late 2016. Its portfolio includes five clinical-stage, in-licensed compounds and a rapidly emerging set of therapeutics generated by its internal discovery efforts, as well as co-discovery/development collaborations with academic institutions and biopharmaceutical companies.

"As a rapidly growing, medium-sized biotech company with global operations, we value the way PPD’s global capabilities and biotech-friendly approach both complement and extend our team’s decades of expertise in running global trials," said Jingsong Wang, M.D., Ph.D., founder, chairman and chief executive officer of HBM. "I’m pleased that our collaborative partnership already has enabled us to achieve the important milestone of our first global EC submission, and ahead of our aggressive schedule. We look forward to entering the clinical trial phase of our development programs with PPD as we pursue our global vision and ambition of delivering next-gen therapeutics to fulfill patient needs around the world."

HBM is leveraging the services of PPD Biotech, which combines the global capabilities of PPD with the hands-on approach, dedication and innovative mindset that drive the success of biotech companies.

"Our enthusiasm for the opportunity to support the development of HBM’s innovative assets is equaled by our shared commitment to helping accelerate the delivery of life-changing therapies to patients," said Anshul Thakral, executive vice president and global head of PPD Biotech. "We believe pairing an innovative biotech mindset with our scalable global development services is a powerful combination for our customers."

On August 27, 2019 ESSA Pharma Inc. (NASDAQ: EPIX; TSXV: EPI) ("ESSA" or the "Company"), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, is reported that, further to its previously announced equity offering, it has closed a public offering of equity securities of the Company in Canada and a concurrent private placement of equity securities in the United States for aggregate gross proceeds of US$36 million (the "Offering") (Press release, ESSA, AUG 27, 2019, View Source [SID1234539032]). The Offering was led by Soleus Capital and included RA Capital Management as a new investor. Existing investors, including BVF Partners LP, Omega Funds, and Eventide Funds, among others, also participated in the Offering.

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The Company intends to use the net proceeds of the Offering primarily to complete the Phase 1 dose-escalation and extension studies, Phase 1 combination studies with recent anti-androgens and initiate Phase II studies. In addition, the Company plans to conduct preclinical studies with EPI-7386 in additional prostate and breast cancer models as well as to continue the development of additional Aniten molecules. According to current plans, the net proceeds combined with the company’s current cash reserves are expected to provide sufficient cash resources through 2022.

The Offering was completed in each of the provinces of British Columbia, Alberta and Ontario by way of a prospectus supplement dated August 23, 2019 to ESSA’s base shelf prospectus dated July 12, 2018 and in the United States on a private placement basis pursuant to Rule 506(c) of Regulation D under the Securities Act of 1933, as amended (the "U.S. Securities Act"). Pursuant to the Offering, ESSA issued a total of 6,080,596 common shares and 11,919,404 pre-funded warrants in lieu of common shares of the Company at a price of US$2.00 per security for aggregate gross proceeds of US$36,000,000. Each pre-funded warrant (together with the common shares, the "Securities") entitles the holder thereof to acquire one common share at a nominal exercise price for a period of 60 months following the closing of the Offering.

The Offering was undertaken on a best efforts basis pursuant to the terms and conditions of an agency agreement (the "Agency Agreement") dated August 23, 2019 between the Company and Bloom Burton Securities, Inc. ("Bloom Burton") as the Company’s sole agent for the Offering in Canada. Oppenheimer & Co. Inc. ("Oppenheimer", together with Bloom Burton, the "Agents") acted as the exclusive U.S. placement agent. The Agents were paid a cash commission equal to 7.0% of the gross proceeds of the Offering (except in respect of Securities issued to certain specified purchasers, in which case the cash commission was reduced to 3.5%).

The issuance of the common shares under the Offering constitutes a related-party transaction under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") due to the participation by certain insiders of the Company. These transactions are exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 pursuant to sections 5.5(a) and 5.7(1)(a) of MI 61-101 as neither the fair market value of any securities issued to nor the consideration paid by such persons exceeds 25.0% of the Company’s market capitalization.

The Securities have not been registered under the U.S. Securities Act or any state securities laws, and accordingly, they may not be offered or sold to, or for the account or benefit of, persons in the United States, or "U.S. persons," as such term is defined in Regulation S promulgated under the U.S. Securities Act ("U.S. Persons"), except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions therefrom.

On August 27, 2019 Presage Biosciences, a cancer biotechnology company pioneering a new cancer drug development approach using its CIVO multiplexed intratumoral microdosing platform, reported it has entered into a research collaboration with Bristol-Myers Squibb Company (NYSE: BMY) to evaluate early stage oncology targets in Phase 0 trials (Press release, Presage Biosciences, AUG 27, 2019, View Source [SID1234539015]). Presage’s CIVO platform is used to evaluate patients’ unique responses to microdoses of multiple cancer drugs.

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"We are pleased to announce another collaboration to expand the use of CIVO technology in Phase 0 trials," said Rich Klinghoffer, PhD, Presage CEO. "With CIVO we are able to directly evaluate responses to multiple drugs and combinations within a single tumor, providing a wealth of information much earlier in the drug development process with a goal to help reduce risk and accelerate the drug development timeline."

At Bristol-Myers Squibb we are seeking a more precise understanding of how treatments impact each patient to help inform tailored therapeutic strategies that will offer the greatest possible benefit," said Jonathan Leith, Head, Clinical Mechanisms at Bristol-Myers Squibb. "This collaboration may provide important insights about how our compounds work mechanistically in combination studies and help us bring forward more effective options for patients with cancer."

This is the third program Presage has partnered to utilize the innovative CIVO platform to investigate tumor cell and microenvironment responses to investigational agents in a Phase 0 clinical trial.

Specific terms and details regarding the collaboration are undisclosed.

About CIVO and Phase 0 Trials
To address the challenges inherent in cancer drug discovery, Presage is advancing a new approach to rapidly evaluate multiple drug candidates and enhance knowledge applicable for future trial design. Exploratory Investigational New Drug studies, also known as Phase 0 trials, allow for the evaluation of minute amounts of drugs in patients to assess pharmacodynamic effects. CIVO is a patented platform that enables intratumoral microdosing and analysis of multiple cancer agents.

On August 27, 2019 Genisphere LLC and University Hospitals Cleveland Medical Center reported a partnership to study and develop unique strategies to treat pancreatic cancer (Press release, Genisphere, AUG 27, 2019, View Source [SID1234539033]). According to their agreement, investigators will optimize 3DNA-based therapeutics designed to target and kill pancreatic tumors. Projects will include delivering a variety of therapeutic cargos, including small molecules and siRNA, formulated with pancreatic tumor-targeting molecules on Genisphere’s 3DNA nanocarrier.

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Jordan Winter, MD, Chief of the Division of Surgical Oncology at University Hospitals Cleveland Medical Center and Director of Surgical Services at UH Seidman Cancer Center, is the lead researcher on the project. He said "My lab studies the harsh, nutrient-deprived microenvironment of pancreatic cancer to exploit metabolic vulnerabilities. By specifically targeting these hypoxic pathways in a multifaceted approach, we can shut down tumor progression. I see our work with Genisphere leading us down a path to the clinic, and commercial development of a lead candidate for the treatment of pancreatic cancer."

Genisphere’s Chief Science Officer, Bob Getts, stated, "We are eager to take the next step from prior data generated together, to investigate alternative strategies for pancreatic cancer treatment. Dr. Winter has strong rationale and evidence for disrupting multiple points along the same biological pathway using different therapeutic molecules and Genisphere has a wide breath of success adapting the 3DNA platform to various modalities: bispecifics, siRNA, small drugs. Therefore we are aligned in this multifaceted strategy and by combining capabilities and expertise we can jointly develop a commercial asset, one will be something we take into the clinic."

On August 27, 2019 Sophiris Bio Inc. (Nasdaq: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale of 5,333,334 of its common shares (or pre-funded warrants to purchase common shares) for an effective price of $0.75 per share, for gross proceeds of approximately $4.0 million, in a registered direct offering (Press release, Sophiris Bio, AUG 27, 2019, View Source [SID1234539034]). The offering is expected to close on or about August 29, 2019, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings.

In addition to the securities described above, in a concurrent private placement, Sophiris will issue to the investor warrants to purchase up to 5,333,334 common shares, which represent 100% of the number of common shares issued in the registered direct offering, with an exercise price $0.95 per share and a five-year exercise period commencing six (6) months of the issuance date.

Sophiris currently intends to use the net proceeds from the offering for working capital and general corporate purposes.

The common shares (or pre-funded warrants to purchase common shares) (but not the warrants issued in the concurrent private placement or the common shares underlying such warrants) are being offered and sold in the registered direct offering by Sophiris pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-219887), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission (SEC) on August 30, 2017. The offering of the common shares (or pre-funded warrants to purchase common shares) will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and accompanying base prospectus may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the common shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying common shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.