On April 10, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the pricing of an underwritten public offering in the United States of 4,200,000 American Depositary Shares ("ADSs") representing 4,200,000 ordinary shares at a public offering price of $24.00 per ADS, for total gross proceeds of approximately $100.8 million (Press release, Autolus, APR 10, 2019, View Source [SID1234535111]). All ADSs sold in the offering were offered by Autolus. In addition, Autolus has granted the underwriters a 30-day option to purchase up to an additional 630,000 ADSs at the public offering price, less underwriting discounts and commissions. The offering is expected to close on April 15, 2019, subject to customary closing conditions.

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Goldman Sachs & Co. LLC and Jefferies LLC are acting as joint book-running managers for the offering. Wells Fargo Securities, LLC and William Blair & Company, L.L.C. are acting as lead managers.

The offering will be made only by means of a prospectus. When available, copies of the final prospectus related to the offering can be obtained from either of the joint book-running managers for the offering, Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at +1 866 471 2526 or by email at [email protected]; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at + 1 877 821 7388 or by email at [email protected]. For the avoidance of doubt, such prospectus will not constitute a "prospectus" for the purposes of Directive 2003/71/EC (and amendments thereto, including Directive 2010/73/EU, to the extent implemented in each relevant EU member state) and will not have been reviewed by any competent authority in any EU member state.

A registration statement on Form F-1 relating to these securities was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on April 10, 2019. Copies of the registration statement can be accessed through the SEC’s website at www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

On April 10, 2019 McKesson Corporation (NYSE:MCK) reported that it will release financial results for its fourth quarter ended March 31, 2019 on Wednesday, May 8, 2019, prior to the opening of trading on the New York Stock Exchange (Press release, McKesson, APR 10, 2019, View Source [SID1234535095]). The company has scheduled a conference call for 8:00 AM Eastern Time (5:00 AM Pacific Time), during which Brian Tyler, chief executive officer, and Britt Vitalone, executive vice president and chief financial officer, will review these results.

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The dial-in number for individuals wishing to participate on the call is 323-794-2093. Holly Weiss, senior vice president, Investor Relations is the leader of the call and the password is ‘McKesson’.

Additionally, Brian Tyler and Britt Vitalone will be participating in the Bank of America Merrill Lynch Health Care Conference on Tuesday, May 14, 2019, in Las Vegas, NV.

Audio webcasts will be available live and archived for both events on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community is available on the company’s Investor Relations website.

On April 10, 2019 I-Mab Biopharma ("I-Mab"), a clinical stage biopharmaceutical company exclusively focused on the development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases reported that it has enters into a collaboration with Roche for I-Mab’s clinical study to evaluate TJD5 in combination with atezolizumab (TECENTRIQ) (Press release, I-Mab Biopharma, APR 10, 2019, View Source [SID1234535096]).

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Roche will supply atezolizumab (TECENTRIQ) to I-Mab for use in clinical study in combination with TJD5. All rights generated in the study will belong jointly to I-Mab and Roche.

TJD5 is a proprietary innovative CD73 antibody from I-Mab’s discovery pipeline with best-in-class potential. CD73 is an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which contributes to a highly immunosuppressive tumor micro-environment. On January 18, 2019, TJD5 received IND clearance from the U.S. FDA.

Dr. Joan Shen, Head of R&D of I-Mab, commented, "We are thrilled to collaborate with Roche, a global leader of cancer immunotherapy, and we look forward to maximizing the potential of TJD5 to meet the clinical needs all over the world."

About TJD5:
TJD5 is a differentiated monoclonal antibody against another promising immuno-oncology target, CD73. It is expected to stimulate the immuno-suppressive tumor micro-environment and to work in concert with other cancer therapies such as PD-1 and PD-L1 antibodies. TJD5 acts through a unique intra-dimerization mechanism for anti-cancer activities and inhibit the target enzyme activity completely. This unique mechanism of action ensures the molecule to work normally without a "hook effect" as evident in our preclinical studies.

On April 9, 2019 NanOlogy, a clinical-stage oncology company, reported the first patient has been enrolled in a clinical trial of NanoDoce (sterile submicron particle docetaxel suspension) for treatment of bladder cancer (Press release, NanOlogy, APR 9, 2019, View Source [SID1234535081]). The Phase 1/2 dose-rising trial will evaluate the safety and preliminary efficacy of NanoDoce for patients with high-risk non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC).

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In 2019, an estimated 80,000 new cases of bladder cancer will be diagnosed in the United States and an estimated 18,000 will die from the disease. Despite being one of the top five cancer diagnoses in the U.S., the last drug FDA approved for NMIBC was more than a decade ago. Of all cancers, bladder cancer tends to have the highest lifetime treatment costs due to the frequency of recurrence, progression to MIBC often requiring removal of the bladder (cystectomy), and lifetime cost of care thereafter.

In the NanOlogy clinical trial, following transurethral resection of the bladder tumor, subjects will receive direct injections of NanoDoce into the base of the index tumor resection site in combination with an intravesical instillation of NanoDoce. Additional intravesical instillations of NanoDoce will be administered to NMIBC subjects while MIBC subjects will follow institutional standard of care.

The local delivery of submicron particle docetaxel suspension [NanoDoce] represents an important step in evaluating new therapies for the treatment bladder cancer", said Dr. Donald Lamm, MD, President of BCG Oncology and principal investigator on the trial. "Preclinical studies suggest the submicron particle technology improves both the penetration of drug into the bladder wall and its duration of activity. If this investigational drug can be proven to delay or prevent disease progression and need for cystectomy, it would contribute significantly to the quality of life of patients with this disease."

An abstract from preclinical studies of NanoDoce was presented in February at the 2019 Genitourinary Cancer Symposium. In one of the studies, NanoDoce administered via intratumoral injection resulted in prolonged, high concentration of drug in tumor tissue, significant tumor regression, and immune cell infiltration in a xenograft animal model of transitional cell bladder carcinoma. The immune cell infiltration is of particular interest to NanOlogy for future research into the role NanoDoce may play in combination with immunoncology therapy for the treatment of advanced disease.

This work is in addition to extensive preclinical and clinical development programs underway by NanOlogy in peritoneal/ovarian cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, renal cell carcinoma, non-small cell lung cancer, and cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

On April 9, 2019 Peloton Therapeutics, Inc., a clinical-stage biopharmaceutical company advancing first-in-class oral medicines for cancer and other serious conditions, reported the completion of patient enrollment in a Phase 2 clinical trial evaluating the efficacy and safety of its lead drug candidate, PT2977, to treat von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) (Press release, Peloton Therapeutics, APR 9, 2019, View Source [SID1234535082]). The clinical trial, which has enrolled 61 patients at clinical trial centers in the United States and Europe, is ongoing and the company anticipates topline results in the first half of 2020.

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This open-label Phase 2 trial will evaluate the efficacy and safety of PT2977 in patients with VHL disease-associated RCC. Key inclusion criteria are the diagnosis of VHL disease based on a germline VHL alteration, the presence of at least one measurable solid RCC tumor, and no evidence of metastatic disease. PT2977 will be administered orally at a once-daily, 120 mg dose. The primary objective of the trial is to evaluate safety and efficacy as measured by overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). Secondary objectives include other measures of efficacy, such as duration of response and progression free survival. The potential impact of PT2977 on VHL disease-associated non-RCC tumors, as well as the tolerability and pharmacokinetics of PT2977, will also be evaluated in this trial.

Further information on the clinical trial of PT2977 can be found on clinicaltrials.gov (Study identifier: NCT03401788).

About PT2977

Peloton’s lead drug candidate, PT2977, is a once-daily, oral inhibitor of hypoxia-inducible factor-2α (HIF-2α). PT2977 has demonstrated anti-tumor activity with a favorable safety profile in an early-stage clinical study in patients with solid tumors. The company is initially focused on developing PT2977 for the treatment of kidney cancer, specifically metastatic clear cell RCC and VHL disease-associated RCC.

About Von Hippel-Lindau Disease ("VHL Disease")

VHL disease is a familial cancer syndrome that commonly gives rise to renal cell tumors. VHL disease affects about one in 36,000 live births, and it is estimated that there are approximately 20,000 VHL disease patients in the United States and the European Union. The main manifestations of VHL disease include RCC as well as retinal, cerebellar and spinal hemangioblastomas. There are no approved systemic therapies for VHL disease.