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DelMar Pharmaceuticals Announces Closing of Financing

On June 5, 2019 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported the closing of its previously announced registered direct offering of 1,170,000 shares of common stock and, in a concurrent private placement, warrants to purchase 760,500 shares of common stock at a combined purchase price of $3.10 per share and related warrant (Press release, DelMar Pharmaceuticals, JUN 5, 2019, View Source [SID1234536900]). The warrants have an exercise price of $3.10 per share, are immediately exercisable and have a term of exercise of five years. The gross proceeds from the offering, prior to deducting offering expenses and placement agent fees and expenses payable by the Company, were $3.6 million.

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Maxim Group LLC acted as the lead placement agent and Dawson James Securities, Inc. acted as co-placement agent in connection with the transaction.

The shares of common stock described above were offered pursuant to an effective shelf registration statement on Form S-3, as amended (File No. 333-213601), that was previously filed with the Securities and Exchange Commission ("SEC") and declared effective on September 27, 2016. A final prospectus supplement and accompanying prospectus relating to the terms of the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may be obtained by contacting Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

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

Turning Point Therapeutics’ CEO To Present At Goldman Sachs 40th Annual Global Healthcare Conference

On June 5, 2019 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing novel drugs to address treatment resistance, reported that President and CEO Athena Countouriotis, M.D., will participate in a question and answer session at the Goldman Sachs 40th Annual Global Healthcare Conference on June 11 in Rancho Palos Verdes, Calif (Press release, Turning Point Therapeutics, JUN 5, 2019, View Source [SID1234536899]).

Dr. Countouriotis’ session is scheduled to begin at 1:20 p.m. PT/4:20 p.m. ET and will be accessible via an audio webcast through the Investors page of www.tptherapeutics.com.

Immutep Presentation at ASCO 2019

On June 5, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is reported that it was involved in two poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting, in Chicago, Illinois taking place from May 31st – June 4, 2019 (Press release, Immutep, JUN 5, 2019, View Source [SID1234536898]). The two posters related to Immutep’s lead product candidate eftilagimod alpha ("efti" or "IMP321").

The first poster (TPS2667 – #299b) provided an overview of the ongoing Phase II TACTI-002 (Two ACTive Immunotherapies) clinical trial. TACTI-002 is being conducted by Immutep in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). This multicenter Phase II clinical trial is evaluating the combination of efti with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

This poster, presented by Dr. Julio Antonio Peguero, MD of Oncology Consultants PA, 2130 W. Holcombe Blvd. 10th Floor, Houston, TX 77030, outlined the ongoing TACTI-002 clinical trial, its design and primary end points.

The second poster related to efti (TPS2651 – #291b) provided an overview of the two additional INSIGHT clinical trial stratas of the prospective investigator-initiated phase I study. Stratum D of the clinical trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. This explorative, open-labeled Phase I study will evaluate the feasibility and safety of subcutaneous efti injections combined with either standard-of-care drug therapy or BAVENCIO (or avelumab, PD-L1 inhibitor) in patients with advanced-stage solid tumors. The Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany ("IKF") will be the sponsor of the clinical trial and it will be conducted under the existing protocol of the ongoing INSIGHT clinical study. Stratum D is open for recruitment.

This poster, presented by Dr. Daniel Wilhelm Mueller, PhD, of the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany, outlined the planned two new strata of the INSIGHT clinical trial, its design and primary end points.

The ASCO (Free ASCO Whitepaper) poster regarding the Company’s TACTI-002 trial can be found at View Source

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in more than 45 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, major adverse cardiovascular events (MACE), and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Additional common adverse reactions reported in patients receiving BAVENCIO in combination with axitinib include hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. Clinical chemistry and hematology laboratory value abnormalities have been reported including but not limited to grade 3-4 lymphopenia, anemia, elevated cholesterol and liver enzymes.

For full Prescribing Information and Medication Guide for BAVENCIO, please see www.BAVENCIO.com.

About Immutep

EP4 Antagonist AAT-007 Clinical Study in Oncology Initiated in the People’s Republic of China

On June 5, 2019 Ningbo NewBay Medical Technology Co., Ltd. (Headquarters in Ningbo, China, CEO: Zhenhai Shen; NewBay), reported that NewBay initiated a Phase I clinical study of the EP4 antagonist AAT-007 (generic name: grapiprant) in the People’s Republic of China (China) on June 4, 2019 (Press release, AskAt, JUN 5, 2019, View Source [SID1234536869]). NewBay is a subsidiary of Ningbo Tai Kang Medical Technology Co., Ltd. (Tai Kang) which licensed AT-007 from AskAt Inc. for cancer therapy in China. This is the first clinical trial of AAT-007 in China targeting cancer. AskAt will receive a milestone payment from Tai Kang in conjunction with the initiation of the study.

Bayer and Arvinas to Collaborate on Human PROTAC® Therapies and Launch a Separate Joint Venture to Develop Agricultural PROTAC® Applications

On June 04, 2019 Bayer and Arvinas, Inc. (Nasdaq: ARVN), a biopharmaceutical company creating a new class of therapies to degrade disease-causing proteins, reported an agreement to leverage Arvinas’ novel PROTAC protein degrader technology to develop new human therapeutics for patients with cardiovascular, oncological, and gynecological diseases (Press release, Arvinas, JUN 4, 2019, View Source [SID1234645312]). In addition, Bayer and Arvinas will jointly launch a new company to leverage Arvinas’ PROTAC technology for agricultural applications. The overall series of arrangements includes over $110 million in upfront cash and committed funding for the human disease collaboration, the agricultural joint venture, and a direct equity investment by Bayer in Arvinas.

The multi-faceted deal will extend the application of targeted protein degradation to new therapeutic areas and outside human biology. It leverages Arvinas’ expertise in targeted protein degradation, a field the company has led since its founding in 2013, and Bayer’s decades of experience in developing both human therapies and innovative, sustainable agricultural technologies.

"As the first company founded around targeted protein degradation, we’ve been excited about the potential to improve the lives of patients since our inception," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "However, we’ve known that the potential of this technology could be broader than drug development. Through these transactions, not only do we plan to expand our reach into new therapeutic areas, but we and Bayer expect to be the first to apply this approach to agriculture, working to safely and efficiently feed the world’s growing population. It’s a natural next step in our commitment to improving human health."

"With our unique position as a leading company in both Crop Science and Pharmaceuticals, we see a great opportunity to partner with the pioneer of the PROTAC technology, to advance this technology as quickly as possible to deliver future solutions for sustainable agriculture and innovative medicines for patients," said Kemal Malik, Bayer Board member for Innovation.

Pharmaceutical Collaboration and Equity Investment
Bayer and Arvinas will collaborate to seek to develop a series of novel product candidates for diseases with serious unmet need. Arvinas will receive an upfront payment and committed R&D funding, as well as a direct equity investment in Arvinas. Combined, these committed funds exceed $60 million. Bayer will own the rights to novel lead structures generated in the collaboration. As programs progress through research, development, and commercialization, Arvinas is also eligible to receive development milestones of over $685 million and commercial royalties ranging from the mid-single digits to the low double-digits.

Agricultural Joint Venture
In launching a joint venture (JV), Bayer and Arvinas are investing in one of the greatest challenges facing the world: feeding the growing global population. PROTAC targeted protein degraders have the potential to address resistance mechanisms in plants to existing agricultural solutions, with solutions to control weeds, insects, and disease by leveraging the selectivity and other features of PROTAC protein degraders. The JV will be committed to leveraging Arvinas’ PROTAC protein degrader technology to create innovative, safe, and sustainable agricultural products. The JV will be supported by intellectual property and over $55 million in committed funding from Bayer, and by technology and intellectual property from Arvinas. Bayer and Arvinas will equally share governance and equity ownership of the JV.

Arvinas Financial Guidance
The closing of this multi-faceted deal with Bayer, including the pharmaceutical collaboration, direct equity investment, and agricultural JV, will lead to updated financial guidance for Arvinas. With the closing of the transaction, which is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions, current cash and investments are expected to be sufficient for planned operations into the second half of 2021.