On March 31 2017 Johnson & Johnson (NYSE: JNJ) reported that its Swiss subsidiary, Janssen Holding GmbH ("Janssen"), published the provisional notice of the interim result of its all-cash public tender offer in Switzerland to acquire all publicly held shares of Actelion Ltd (("Actelion") SIX:ATLN) for $280 per share, payable in U.S. dollars, per the offer prospectus of February 16, 2017 (Press release, Actelion, MAR 30, 2017, View Source [SID1234518407]).

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!

At the expiration of the main offer period on March 30, 2017, 10:00 a.m. EDT, 4:00 p.m. CEST, a total of 78,629,955 Actelion shares were tendered, corresponding to 73.25% of the 107,339,642 Actelion shares covered by the tender offer. Including the Actelion shares tendered, Janssen and Actelion, a person acting in concert with Janssen, held as of the end of the main offer period 83,195,346 Actelion shares, corresponding to 77.20% of the voting rights and the share capital of Actelion.

Subject to the satisfaction of certain conditions, Janssen has declared the tender offer successful. The additional acceptance period of ten trading days (at the SIX Swiss Exchange) for the subsequent acceptance of the tender offer will commence on April 6, 2017 and expire on April 21, 2017, 10:00 a.m. EDT, 4:00 p.m. CEST.

Johnson & Johnson also announced that the applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to Janssen’s proposed acquisition of Actelion have either expired or been terminated early. The Japan Fair Trade Commission and the Israeli Antitrust Authority have cleared the proposed acquisition of Actelion.

Based on the current understanding of the regulatory approval proceedings in different jurisdictions, the settlement of the tender offer is expected to occur, subject to the satisfaction of all relevant conditions to the tender offer, including regulatory approvals, in the second quarter of 2017.

As previously announced, as part of the transaction, Actelion will spin out its drug discovery operations and early-stage clinical development assets into a newly created Swiss biopharmaceutical company ("Idorsia Ltd"). The shares of Idorsia Ltd are expected to be distributed to Actelion’s shareholders as a dividend in kind and listed on the SIX Swiss Exchange on the day of the settlement of the tender offer. Johnson & Johnson will initially hold 16 percent of the shares of Idorsia Ltd and have rights to potentially increase to 32 percent through a convertible note.

On March 30, 2017 Seattle Genetics, Inc. (Nasdaq: SGEN), a global biotechnology company, reported its broad presence at the upcoming 108th Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) being held April 1 to 5, 2017, in Washington, D.C., including 14 presentations on antibody-drug conjugate (ADC) and immuno-oncology technology advances and development programs (Press release, Seattle Genetics, MAR 30, 2017, View Source;p=RssLanding&cat=news&id=2257546 [SID1234518388]). Data in multiple presentations demonstrate potential improvements in linker technologies for multiple payloads which may enable development of novel ADCs, including the planned clinical program SGN-CD48A for multiple myeloma. The company’s SGN-2FF program was selected for an oral presentation in the New Drugs on the Horizon symposium focusing on the preclinical rationale and phase 1 trial design for this small molecule immuno-oncology agent. Seattle Genetics’ scientific leadership will also be featured in an Educational Session and a Forum focused on advances in ADC research and the value of ADCs over other drug conjugate therapeutics in the cancer treatment landscape.

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!

"Over nearly 20 years, Seattle Genetics has continued its tradition of innovation to produce industry-leading ADC and empowered-antibody technologies designed to improve outcomes for patients with cancer," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development, at Seattle Genetics. "In 14 presentations, including four orals, our new data at the AACR (Free AACR Whitepaper) Annual Meeting will highlight key improvements to linker technologies for cancer cell-killing payloads, including novel auristatins and tubulysins, preclinical combination regimens with checkpoint inhibitors, and progress with our immuno-oncology therapeutic candidates."

ADCs are targeted cancer treatments that harness the specificity of antibodies to deliver cell-killing agents directly to cancer cells. ADCETRIS, Seattle Genetics’ first commercially available product, vadastuximab talirine, a phase 3 candidate in acute myeloid leukemia (AML), and enfortumab vedotin, an advancing clinical-stage bladder cancer candidate, are three of more than 20 ADCs in clinical development using the company’s proprietary technology.

Multiple oral and poster presentations are being featured at AACR (Free AACR Whitepaper) that highlight Seattle Genetics’ ADC and immuno-oncology advances. Abstracts can be found at www.aacr.org and include the following:

Saturday, April 1, 2017

Expanding the payload scope and drug load of ADCs through drug-linker design (Session #ED03, oral presentation at 2:00 p.m. ET)
Sunday, April 2, 2017

Antibody-drug conjugates containing glucuronide-tubulysin payloads display activity in MDR+ and heterogeneous tumor models (Abstract #56, poster presentation)
Reducing toxicity of antibody-drug conjugates through modulation of pharmacokinetics (Abstract #60, poster presentation)
Elucidating the roles of antibody pharmacokinetics and maleimide stability in the toxicology of antibody-drug conjugates (Abstract #70, poster presentation)
Development of homogeneous dual-drug ADCs: Application to the co-delivery of auristatin payloads with complementary antitumor activities (Abstract #982, oral presentation at 4:05 p.m. ET)
SGN-2FF: A Novel Small Molecule Inhibitor of Fucosylation with Preclinical Antitumor Activity through Multiple Immune Mechanisms (Abstract #DDT02-02, oral presentation at 3:24 p.m. ET)
Monday, April 3, 2017

Cysteine Mutant Location Affects Chemotype Lability in Site-Specific Antibody Drug Conjugates (Abstract #LB-066, poster presentation)
Targeted Delivery Using Antibody Drug Conjugates (Session #FO01, oral presentation at 5:00 p.m. ET)
Tuesday, April 4, 2017

Therapeutic activity of effector function-enhanced, non-fucosylated anti-CD40 antibodies in preclinical immune-competent rodent tumor models (Abstract #3647, poster presentation)
Superior T cell activity of a membrane-proximal binding antibody when targeting Glypican-3 with an Antibody-Coupled T cell Receptor (ACTR) armed T cell (Abstract #3762, poster presentation; collaboration with Unum Therapeutics)
Effect of PEG Chain length on Antibody-Drug Conjugate Tumor and Tissue Distribution in Tumor Bearing Xenograft Mice (Abstract #4075, poster presentation)
Efficient targeting of BCMA-positive multiple myeloma cells by Antibody-Coupled T cell Receptor (ACTR) engineered autologous T cells in combination with an anti-BCMA antibody (Abstract #4605, poster presentation; collaboration with Unum Therapeutics)
Assessment of Myeloblast CD33 Receptor Occupancy (RO) by Vadastuximab Talirine in Patients with Acute Myeloid Leukemia (AML) Receiving Monotherapy Treatment (Abstract #CT120, poster presentation)
Wednesday, April 5, 2015

Brentuximab vedotin-driven immunogenic cell death enhances antitumor immune responses, and is potentiated by PD1 inhibition in vivo (Abstract #5588, poster presentation)

On March 30, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported a corporate update and announced 2016 financial results (Press release, Mateon Therapeutics, MAR 30, 2017, View Source [SID1234518379]).

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!

Corporate Achievements During 2016

Changed company’s name to Mateon Therapeutics, Inc. to reflect focus on combination vascular targeted therapy in orphan oncology indications
Re-invigorated Board of Directors with complete changeover of independent members during 2016, adding three experienced biopharmaceutical industry leaders: Donald R. Reynolds, Bobby W. Sandage, Jr., Ph.D., and Simon C. Pedder, Ph.D.
"2016 was a key year for execution of the business plans that we developed in the months after I started as CEO in mid-2015, as we initiated our important FOCUS study, advanced the PAZOFOS study and moved our OXi4503 study in AML into its combination-treatment phase," stated William D. Schwieterman, M.D., Mateon’s President and Chief Executive Officer. "We also rebranded the company and freshened our board, bringing in new outside board members with deep industry expertise as we made meaningful changes based on our new direction. Now, as the first quarter of 2017 nears completion, we are very encouraged by the early data in AML. We are also eagerly awaiting next month the first randomized clinical trial data from the company in years, as we conduct a scheduled interim analysis of FOCUS in platinum-resistant ovarian cancer."

Key 2016 and Recent Developments

CA4P in combination with bevacizumab for Treatment of Ovarian Cancer

• Presented new data reflecting improved survival outcomes for CA4P-treated patients from Study GOG-0186I, an open-label randomized Phase 2 clinical trial in recurrent ovarian cancer

Data demonstrated an improvement of 5.6 months in overall survival and 3.7 months in progression-free survival in patients with measurable disease
• Published positive results from Study GOG-0186I in Journal of Clinical Oncology, official journal of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Study was funded by National Cancer Institute, conducted by Gynecologic Oncology Group (GOG).

• Initiated the FOCUS Study, a Phase 2/3 clinical trial of CA4P in combination with bevacizumab (Avastin) and chemotherapy in platinum-resistant ovarian cancer

Currently have 25 sites actively recruiting patients
CA4P in combination with pazopanib for Treatment of Recurrent Ovarian Cancer

• Initiated enrollment in Phase 2 portion of the PAZOFOS Study, a Phase 1b/2 clinical trial of CA4P in combination with pazopanib (Votrient)

CA4P in combination with bevacizumab for Treatment of Glioblastoma Multiforme

• Received Orphan Drug Designation for CA4P for the treatment of glioma from U.S. Food and Drug Administration (FDA)

CA4P for Treatment of Neuroendocrine Tumors (NETs)

• Received Orphan Drug Designation for CA4P for the treatment of NETs from both the FDA and the European Commission

• Presented data from monotherapy study in NETs and announced an investigator-sponsored study in NETs using CA4P in combination with everolimus (AFINITOR)

OXi4503 in combination with cytarabine for Treatment of Relapsed/Refractory Acute Myeloid Leukemia (AML)

• Completed enrollment of first three cohorts and initiated the fourth cohort of OX1222, an open-label Phase 1b dose-ranging study of OXi4503 in combination with cytarabine

• Presented data from OX1222 at 58th Annual Meeting of American Society of Hematology (ASH) (Free ASH Whitepaper)

• Presented updated data from OX1222 at the 29th Annual ROTH Conference

Highlights include 3 patients, one from each dose cohort, experiencing complete remission
Additional Pipeline Developments

• Announced encouraging preliminary data from four syngeneic mouse models evaluating CA4P in combination with checkpoint inhibitors

Most compelling results were found combining CA4P with an anti-CTLA4 antibody in an EMT-6 mammary model – 7 of 8 mice receiving combination were tumor free at study’s completion, compared to 1 of 8 in CA4P monotherapy arm and 2 of 8 in anti-CTLA4 antibody monotherapy arm
Financial Results

For the year ended December 31, 2016, Mateon reported a net loss of $13.7 million, similar to the net loss for the year ended December 31, 2015. R&D expenses decreased to $8.8 million in 2016 compared to $9.1 million in 2015, while general and administrative expenses increased to $5.0 million in 2016 compared to $4.6 million in 2015.

At December 31, 2016, Mateon had cash and short-term investments of $12.0 million.

On March 2017 Oxford BioMedica plc ("Oxford BioMedica" or "the Group") (LSE:OXB), a leading gene and cell therapy group, reported the announcement by Novartis that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) (Press release, Oxford BioMedica, MAR 30, 2017, View Source [SID1234518317]). The priority review designation is expected to shorten the anticipated review time by the FDA.

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!

Oxford BioMedica is the sole manufacturer of the lentiviral vector expressing CTL019 for Novartis. As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products.

John Dawson, Chief Executive Officer of Oxford BioMedica, commented: "The news that the FDA has accepted the BLA for CTL019 and granted it priority review is an important development for Oxford BioMedica. We continue to work closely with Novartis in delivering the lentiviral vector expressing CTL019, a product described earlier this year by Novartis as having "blockbuster" potential."

On March 30, 2018 Redx Pharma reported that it has been awarded aUS$1 million grant by CARB-X, one of the world’s largest public-private partnerships, launched in July 2016 to accelerate global antibacterial innovation and research (Press release, Redx Pharma, MAR 30, 2017, View Source [SID1234524747]). The 11 successful projects were selected through a competitive process from 168 applications from around the world. The awarded grants were based on the merits of each of the company’s research proposals, as evaluated by the CARB-X Advisory Board and the CARB-X team.

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!

Today’s announcement by CARB-X showcases the first projects selected for the Powered byCARB-X portfolio, spotlighting Redx as a highly-respected partner of choice on a global stage. Redx will receive US$1 million over 18 months, with an option for future tiered milestone payments, to drive scientific progress against globally challenging drug resistant Gram-negativebacteria. This collaboration with CARB-X enables Redx to move its Gram-negative program into the next stage of development with a prospective partner.

Dr Neil Murray, Chief Executive Officer of Redx Pharma, said: We are delighted to be collaborating with CARB-X, a truly innovative initiative that is targeting the development of new life-saving antibacterials and diagnostics. Receiving this grant today is testament to the great science that exists at Redx. This grant cements a path forward for our recently announced strategy, to secure external partners to ensure that our high quality anti-infective science will continue whilst we sharpen our focus on the clinical development of our oncology and immunology programs.