On July 19, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson is reported with the recent announcement from the World Health Organisation (WHO) to include abiraterone acetate (ZYTIGA) for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in the updated Essential Medicines List, published on 9th July 2019.1,2 (Press release, Johnson & Johnson, JUL 19, 2019, View Source [SID1234537634])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The WHO’s Essential Medicines List is a core guidance document that helps countries prioritise critical health products that are recommended to be widely available and affordable throughout health systems.1

"The inclusion of abiraterone acetate in the WHO Essential Medicines List highlights the critical role that this treatment can play in improving the lives of patients living with mCRPC and their families," said Dr. Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "I am proud that we are working hard to impact survival and quality of life by developing and providing innovative medicines which are supported by the highest quality scientific evidence."

The foundation of Janssen’s scientific understanding in prostate cancer is based on the knowledge acquired through the development of innovative treatment options for mCRPC. Abiraterone acetate is an oral androgen biosynthesis inhibitor that is approved for the treatment of both mCRPC and metastatic hormone-sensitive prostate cancer, in Europe.3,4

"The addition of abiraterone acetate to the Essential Medicines List is a significant milestone for Janssen Oncology, reflecting the tireless efforts in recent years to bring optimal treatment options to patients with mCRPC," said Biljana Naumovic, Vice President Commercial Strategy Lead Oncology for Europe, Middle East & Africa, Cilag GmbH International. "This direction from the WHO further emphasises that our work is not yet over. It is critical that patients with prostate cancer have access to treatments that their clinicians feel can benefit them and that we continue to support the prostate cancer community in our common goal of making cancer a manageable and potentially one day, a curable condition."

On July 19, 2019 Genmab A/S (CSE: GEN, Nasdaq: GMAB) reported the exercise in full by the underwriters of their over-allotment option in connection with its initial public offering of American Depositary Shares ("ADSs") in the United States (the "Offering") and the listing of the ADSs on the Nasdaq Global Select Market (Press release, Genmab, JUL 19, 2019, View Source [SID1234537616]). On July 18, 2019, BofA Merrill Lynch, Morgan Stanley and Jefferies, on behalf of the underwriters, notified Genmab of the underwriters’ exercise in full of their previously announced option to purchase up to 4,275,000 additional ADSs, representing 427,500 ordinary shares, to cover any over-allotments (the "Option") at a price of $17.75 per ADS, corresponding to a subscription price of DKK 1,181.80 per underlying ordinary share at an exchange rate of DKK 6.6580 per US$1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of 10 to 1.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The exercise of the Option will increase the total gross proceeds of the Offering to $581,756,250 (DKK 3,873.3 million) and will result in a total issuance of 32,775,000 ADSs, representing 3,277,500 ordinary shares.

The 427,500 additional shares will be delivered by Genmab in the form of new shares with a nominal value of DKK 1 each (the "New Shares").

Following the registration of the New Shares with the Danish Business Authority, which is expected to take place on July 23, 2019 or early thereafter (and presuming that the 2,850,000 new ordinary shares of a nominal value of DKK 1 that were offered during the Offering will be registered with the Danish Business Authority on July 22, 2019) Genmab’s share capital will amount to DKK 64,967,643 divided into 64,967,643 shares with a nominal value of DKK 1 each.

The New Shares will rank pari passu with Genmab’s existing shares and carry the same dividend and other rights.

The New Shares are expected to be issued and registered with the Danish Business Authority on July 23, 2019 (or early thereafter) and are expected to be admitted to trading and official listing on Nasdaq Copenhagen on July 24, 2019 (or early thereafter), with the permanent ISIN code DK0010272202.

BofA Merrill Lynch, Morgan Stanley and Jefferies are acting as joint book-running managers for the Offering. Guggenheim Securities and RBC Capital Markets are acting as joint lead-managers and Danske Markets, H.C. Wainwright & Co. and Kempen are acting as co-managers for the Offering. A copy of the preliminary prospectus and, when available, the final prospectus relating to the Offering may be obtained from BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email: [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone: 1-877-821-7388, or by email: [email protected]. Copies of the preliminary prospectus and, when available, the final prospectus related to the Offering are also available, or will be available, at www.sec.gov. No Danish prospectus will be issued or offered.
This Company Announcement does not constitute an offer to sell nor a solicitation of an offer to buy, nor shall 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.

On July 19, 2019 Accuray Incorporated (NASDAQ: ARAY) reported that it will report results for its fourth quarter and fiscal year 2019 ended June 30, 2019 on Thursday, August 15, 2019 after the market close (Press release, Accuray, JUL 19, 2019, View Source [SID1234537635]). Management will host a conference call to review the results at 1:30 p.m. PT/4:30 p.m. ET on the same day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference call dial-in numbers are 855-867-4103 (USA) or 262-912-4764 (International). In addition, a dial up replay of the conference call will be available approximately one hour after the call’s conclusion for one week. The replay number is 855-859-2056 (USA), or 404-537-3406 (International), Conference ID: 3297842.

A live webcast of the call will also be available from the Investor Relations section of the Company’s website at investors.accuray.com. A webcast replay can be accessed on the website and will remain available until Accuray announces its results for the first quarter of fiscal 2020.

On July 19, 2019 Immatics Biotechnologies GmbH, a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting cancer immunotherapies, reported a comprehensive data set having completed the first cohort of the ACTolog Personalized Multi-Target T-cell Therapy Trial (Study code: IMA101-101, NCT02876510) at the AACR (Free AACR Whitepaper) Special Conference on Immune Cell Therapies for Cancer (Press release, Immatics Biotechnologies, JUL 19, 2019, http://investors.immatics.com/news-releases/news-release-details/immatics-presents-first-cohort-data-actologr-personalized-multi [SID1234569542]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ACTolog is an adoptive cell therapy (ACT) product using the patient’s own (autologous), non-genetically engineered (endogenous) T cells. "To our knowledge, this is the first time that patients are being treated with multiple defined cell therapy products directed against multiple specific tumor targets. For each of the T-cell products the actual expression of the targets is confirmed in a fresh tumor biopsy taken prior to product manufacturing. ACTolog is taking personalized cell therapy to the next level – aiming to provide effective treatments for patients with advanced solid cancers", states Dr. Harpreet Singh, CEO of Immatics.

The ACTolog approach has been pioneered by Prof. Cassian Yee at MD Anderson and expanded by Immatics to include multiple proprietary cancer targets discovered by Immatics’ XPRESIDENT platform. The trial is led by Principal Investigator Prof. Apostolia M. Tsimberidou and Co-Principal Investigator Prof. Borje S. Andersson with collaboration from other MD Anderson colleagues.

The data set will be provided in three oral presentations and two poster presentations by Prof. Tsimberidou, Dr. Nowak and Dr. Singh– for details see below.

The main conclusions from the currently available data set (N=9 patients, immune data for N=7 patients) are:

All patients entered the trial with progressive disease, having failed the previous line of therapy. Median duration of disease of the patients was 4 years (range 2-18 years) with a median of 6 previous rounds of treatment (range 3-12). Patients received a median of 2 target-specific ACTolog products (range 1-3).
ACTolog IMA101 is well tolerated. The most common adverse events, as expected, were cytopenias associated with the lymphodepleting regimen and Grade 1-2 cytokine release syndrome.
High frequencies and persistence of target-specific CD8+ T cells of up to 50% of peripheral CD8+ T cells (measured ex vivo) were observed within the blood of patients up to 12 weeks after adoptive transfer.
Comprehensive cellular immunomonitoring indicates a favorable phenotype of infused T cells.
All treated patients had stable disease by RECIST and irRECIST at 6 weeks and are alive to date after a median follow-up of 8 months.
The trial is part of a series of research programs and clinical trials conducted in a strategic alliance between Immatics and MD Anderson. The ACTolog T-cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with The University of Texas Health Science Center in Houston (UTHealth).

On July 19, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that Janssen-Cilag International NV (Janssen) has submitted an extension application to the European Medicines Agency (EMA) for the subcutaneous delivery of DARZALEX (daratumumab) for patients with multiple myeloma (Press release, Halozyme, JUL 19, 2019, View Source [SID1234537628]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased that Janssen’s filing follows quickly after its filing last week of a Biologics License Application (BLA) with the U.S. Food and Drug Administration," said Dr. Helen Torley, President and CEO. "We are particularly excited that, pending approval by the EMA, a greater number of patients with multiple myeloma may soon have a new therapeutic option that offers the potential of DARZALEX with a shorter administration time."

Janssen’s submission follows the announcement of positive results from its Phase 3 COLUMBA study, which investigated subcutaneously administered DARZALEX in comparison to intravenous DARZALEX in patients with relapsed and refractory multiple myeloma. Subcutaneous DARZALEX, using ENHANZE drug delivery technology, was found to be non-inferior to intravenous DARZALEX with regard to the co-primary endpoints of overall response rate and Maximum Ctrough concentration on day 1 of the third treatment cycle prior to dose.

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.