On April 26, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported the submission of a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) by Janssen Pharmaceutical K.K. (Janssen) seeking approval of a new subcutaneous (SC) formulation of daratumumab, an intravenous (IV) treatment approved for patients with multiple myeloma (Press release, Halozyme, APR 26, 2020, View Source [SID1234556601]).

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"We are pleased to see this New Drug Application submission in Japan, which builds on Janssen’s prior regulatory submissions in the U.S. and EU that are currently under review," said Dr. Helen Torley, president and chief executive officer. "We are excited that patients with multiple myeloma in Japan may soon have a new therapeutic option that can be administered with a shorter infusion time when compared with a multi-hour intravenous infusion."

The NDA is supported by pivotal data from the Phase 3 COLUMBA (MMY3012) study – a randomized open label study – that included a non-inferiority comparison of daratumumab SC formulation versus daratumumab IV administration in patients with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both PI and IMiD. In addition to non-inferiority, daratumumab SC showed a lower rate of infusion-related reactions. Data from the Phase 2 PLEIADES (MMY2040) study – a non-randomized open label study conducted in newly diagnosed or relapsed or refractory multiple myeloma patients – are also included in the NDA. The subcutaneous formulation of daratumumab is co-formulated with Halozyme’s ENHANZE drug delivery technology, based on recombinant human hyaluronidase PH20 (rHuPH20).

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

On April 24, 2020 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported that it has entered into definitive agreements with, among other institutional investors, Blackcrane Capital, LLC, an investment management company employing an unconstrained, change-oriented investment approach, to purchase approximately $10.7 million of Oncocyte’s common shares in a registered offering priced "at market", which was the closing price immediately preceding the offering (Press release, Oncocyte, APR 24, 2020, View Source [SID1234556663]). This offering was completed directly with the institutional investors and the Company incurred no placement agent fees.

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"Our continued ability to attract support from healthcare focused funds stems from our remarkable progress in advancing our expanding suite of tests which now address treatment stratification and immunotherapy response prediction for lung cancer and liquid biopsy to rule out malignancy in lung nodules," said Ron Andrews, Chief Executive Officer of Oncocyte. "Our strengthened balance sheet will facilitate our continued progress and execution, now as a commercial stage company, as we work to grow our market and further expand our offerings in lung and beyond."

Daniel Kim, founder and chief executive of Blackcrane Capital, LLC, said "We are excited to partner with Oncocyte as they work to provide decisive answers for patients across the lung cancer care continuum. We see tremendous potential at Oncocyte based on their deep clinical and commercial expertise and proven track record of success. We are very excited to support Oncocyte’s management team as it continues to work towards improving lung cancer diagnosis, treatment and patient outcomes."

In connection with the offering, the Company will sell an aggregate of 4,733,700 shares of its common stock at a purchase price of $2.27 per share, the closing price of the stock on April 23, 2020, the day prior to the execution of the agreement with the investors. The registered offering is subject to customary closing conditions and is expected to close during the week of April 27, 2020.

Proceeds from the registered offering provide the strategic capital to accelerate and support the commercial launch of DetermaRx, OncoCyte’s lung cancer treatment stratification test, DetermaIO, a research use only gene expression test to identify immune checkpoint inhibitor responders, and the continued development of DetermaDx a liquid biopsy test to rule out malignancies in lung nodules as well as general corporate and working capital purposes. The Company may also use proceeds to invest in or acquire businesses or technologies that it believes are complementary, although the Company has no binding agreements with respect to any strategic transactions or acquisitions as of the date of this press release.

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

On April 24, 2020 ADC Therapeutics SA, a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from hematological malignancies and solid tumors, reported that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission relating to a proposed initial public offering of its common shares (Press release, ADC Therapeutics, APR 24, 2020, View Source [SID1234556637]). The number of shares to be offered and the price range for the proposed offering have not yet been determined. ADC Therapeutics intends to list its common shares on the New York Stock Exchange under the ticker symbol "ADCT."

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Morgan Stanley, BofA Securities and Cowen will act as joint book-running managers for the offering.

The offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained, when available, from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649 or by email at [email protected]; BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended. There is no intention to publicly offer, solicit, sell or advertise, directly or indirectly, these securities, or invest in securities of ADC Therapeutics SA, such as the common shares, in, into or from Switzerland and these securities will not be listed on the SIX Swiss Exchange or on any other exchange or regulated trading venue in Switzerland. The common shares may not be publicly offered, directly or indirectly, in Switzerland within the meaning of the Swiss Financial Services Act ("FinSA") and no application has or will be made to admit the common shares to trading on any trading venue (exchange or multilateral trading facility) in Switzerland. Neither this document nor any other offering or marketing material relating to these securities, such as the common shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares may be publicly distributed or otherwise made publicly available in Switzerland.

On April 24, 2020 AkesoBio, a Zhongshan developer of novel mono- and bi-specific antibodies, reported that $335 million Hong Kong IPO and climbed 50% higher in its first trading session (Press release, Akeso Biopharma, APR 24, 2020, View Source [SID1234556599]). The company’s general strategy is to develop bispecific antibodies using a PD-1 antibody as a backbone. It has built a portfolio of 18 mAbs that are in either CMC or clinical stages of development. Last year, Akeso formed a $100 million JV with a Sino Biopharma subsidiary to develop and commercialize AK105, its clinical-stage anti-PD-1 mAb.

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On April 24, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that an independent Data Safety Monitoring Board (DSMB) has confirmed that it is safe to start patient recruitment for the middle dose cohort for the Phase 1/2 NOX-A12 plus radiotherapy brain cancer trial (Press release, NOXXON, APR 24, 2020, View Source [SID1234556597]).

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The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. The decision to proceed followed the analysis of safety data stipulated in the study protocol after all patients in the first cohort completed at least 4 weeks of treatment.

The clinical trial centers participating in the study have therefore initiated patient recruitment for the second of three escalating dose groups who will receive NOX-A12 at a weekly dose of 400 mg/week. Once the first patient in this second cohort has received a four-week treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to recruit the remaining two patients in this cohort.

"The confirmation of the initial safety profile of NOX-A12 in combination with radiotherapy in all patients of the first cohort is very encouraging," commented Aram Mangasarian, CEO of NOXXON. "Following this analysis, the trial can progress to the second cohort as planned at the next dose level. We remain focused on reaching our goal of obtaining data from the first cohort of patients in October 2020, and from the second and third cohorts in the end of Q1 2021 and mid-2021, respectively."