On January 24, 2019 Nordic Nanovector ASA (OSE: NANO) ("Nordic Nanovector" or the "Company"), a biopharmaceutical company dedicated to extending and improving the lives of patients with haematological cancers through the development and commercialisation of innovative targeted therapeutics, reported the launch of a private placement of new shares representing up to approximately 10% (the "Offer Shares") of the outstanding share capital of the company (the "Private Placement") (Press release, Nordic Nanovector, JAN 24, 2019, View Source [SID1234553484]). DNB Markets and Jefferies International Limited are acting as Joint Global Coordinators and Joint Bookrunners (the "Joint Global Coordinators"), and Kempen & Co N.V. is acting as Joint Bookrunner (together with the Joint Global Coordinators, the "Joint Bookrunners") in connection with the Private Placement.

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!

Nordic Nanovector intends to use the net proceeds of the Private Placement for the following purposes:

Manufacturing development activities (including Process Validation studies) for Betalutin
A scale-up of the Company’s clinical and commercial activities in preparation for a commercial launch of Betalutin
General corporate purposes
The subscription price and the number of shares to be issued in the Private Placement will be determined through an accelerated bookbuilding process. The bookbuilding period and the application period for the Private Placement commence today at 16:30 hours CET and will close at 08:00 hours CET on 25 January 2019 (the "Application Period"). The Company and the Joint Bookrunners reserve the right to close or extend the Application Period at any time and for any reason. If the Application Period is shortened or extended, any other dates referred to herein may be amended accordingly.

The Company’s largest shareholder, HealthCap VI L.P., has informed the Company that it will participate in the Private Placement.

The minimum subscription and allocation amount in the Private Placement will be the NOK equivalent of EUR 100,000, provided that the Company may, at its sole discretion, allocate an amount below EUR 100,000 to the extent applicable exemptions from the prospectus requirement pursuant to applicable regulations, including the Norwegian Securities Trading Act and ancillary regulations, are available. Allocation of the Offer Shares will be determined at the end of the bookbuilding process, and the final allocation will be made by the Company’s Board of Directors at its sole discretion, following advice from the Joint Bookrunners.

The Offer Shares to be issued in connection with the Private Placement will be issued based on the board authorisation granted at the Company’s annual general meeting on 30 May 2018. In line with the shareholders’ approval, pre-emption rights of the existing shareholders are excluded.

The board of directors of the Company has considered alternative structures for the raising of new equity. Following careful considerations, the board of directors is of the view that the conduct of a private placement because this will, inter alia, strengthen the Company’s shareholder base in future equity raisings. Furthermore, by structuring the transaction as a private placement, the Company will be in a position to raise capital in an efficient manner in a market that is open for capital raisings, and with a lower discount to current trading price and with significantly lower risks compared to a rights issue. In addition, the Private Placement is subject to broad marketing through a pre-sounding and a publicly announced bookbuilding process. By this, a market based subscription price will be achieved.

The board of directors therefore considers a private placement to be in the best interests of the Company and its shareholders.

The Private Placement will be directed towards Norwegian and international investors, in each case subject to and in compliance with applicable exemptions from relevant prospectus or registration requirements. Notification of allotment and payment instructions is expected to be issued to the applicants on or about 25 January 2019 through a notification to be issued by the Joint Bookrunners.

The Offer Shares will be settled with existing and unencumbered shares in the Company that are already listed on the Oslo Stock Exchange, pursuant to a share lending agreement between DNB Markets (on behalf of the Joint Bookrunners), the Company and HealthCap VI L.P., in order to facilitate delivery of listed shares to investors on a delivery versus payment basis. The Offer Shares delivered to the subscribers will thus be tradable from allocation. The Joint Bookrunners will settle the share loan with new shares in the Company to be issued by the Board of Directors pursuant to the abovementioned authorisation granted at the annual general meeting held on 30 May 2018.

The Company has agreed with the Joint Bookrunners to a lock-up on future share issuances, and its Board of Directors and Executive Management have all agreed with the Joint Bookrunners to a lock-up on existing shareholdings for a period of 180 days from the closing date, subject to customary exceptions. In addition, the Company’s largest shareholder, HealthCap VI L.P. has agreed with the Joint Bookrunners to a lock-up for a period of 90 days from the closing date, subject to customary exceptions.

The Company will announce the final number of Offer Shares placed and the final subscription price in the Private Placement in a stock exchange announcement expected to be published before opening of trading on the Oslo Stock Exchange tomorrow, 25 January 2019. Completion of the Private Placement is subject to final approval by the Company’s Board of Directors.

On January 24, 2019 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it will host a webcast and conference call on February 7, 2019, at 4:30 p.m. EST to discuss its financial results for the fiscal 2019 first quarter ended December 31, 2018 (Press release, Arrowhead Pharmaceuticals, JAN 24, 2019, View Source [SID1234532898]).

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!

Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 3194897.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 3194897.

On January 24, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that the U.S. Patent and Trademark Office has issued a Notice of Allowance for the first patent covering Anixa subsidiary, Certainty Therapeutics, Inc.’s, CAR-T cancer treatment technology (Press release, Anixa Biosciences, JAN 24, 2019, View Source [SID1234532897]).

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 patent is titled "METHODS AND COMPOSITIONS FOR TREATING CANCER," and the inventors are Drs. Jose Conejo-Garcia and Alfredo Perales-Puchalt. Dr. Conejo-Garcia is the Chair of the Department of Immunology at Moffitt Cancer Center and Dr. Alfredo Perales-Puchalt is a Senior Postdoctoral Fellow in The Wistar Institute’s Vaccine & Immunotherapy Center. The patent is assigned to The Wistar Institute and Anixa Biosciences’ majority-owned subsidiary, Certainty Therapeutics, Inc. is the exclusive, world-wide licensee.

Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated, "This is a ground-breaking patent protecting our CAR-T cancer technology. This technology takes advantage of specific hormone–hormone receptor biology to address malignancies and may hold promise to be the first successful CAR-T therapy against solid tumors. While our initial focus is the treatment of ovarian cancer, the technology covered by the patent is broad and may also be effective in treating other solid tumors by exploiting an anti-angiogenesis mechanism of action."

Dr. Kumar continued, "We are pleased that our licensor and shareholder in Certainty Therapeutics, Inc., The Wistar Institute, has received this Notice of Allowance, as this patent will offer intellectual property protection for the commercialization of this CAR-T solid tumor therapy. We have other filings at various stages of prosecution, and we hope to be receiving additional patents."

"We take seriously our collaborative efforts in protecting intellectual property that is critical for the advancement of new therapies, such as Anixa’s CAR-T therapy," said Heather Steinman, PhD, MBA, Vice President of Business Development at The Wistar Institute. "We are fully aligned with Anixa to ensure that Wistar’s technology may one day be used to help cancer patients."

On January 24, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that the European Commission (EC) has approved the use of Rubraca (rucaparib) for a second indication, as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy (Press release, Clovis Oncology, JAN 24, 2019, View Source [SID1234532895]). This expands rucaparib’s indication beyond its initial marketing authorization in Europe granted in May 2018 and with this label expansion, rucaparib is now available to patients regardless of their BRCA mutation status. Rucaparib was the first PARP inhibitor licensed for an ovarian cancer treatment indication in the EU and is now the first to be available for both treatment and maintenance treatment among eligible patients.

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 EC authorization is based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.i

For the full European approved prescribing information, please refer to the Rubraca (rucaparib) Summary of Product Characteristics on the European Medicines Agency website.

Ovarian cancer is the sixth deadliest cancer among women in Europe, where more than 65,000 women are diagnosed annually.ii Moreover, the 80 to 85 percent of women diagnosed in the later stages of the disease (III and IV) have particularly poor outcomes.iii Ovarian cancer is challenging to treat, and most women will relapse after surgery and chemotherapy. Multiple studies, including the rucaparib ARIEL3 clinical trial, have demonstrated that maintenance treatment with a PARP inhibitor significantly extends median progression free survival (mPFS) as compared to observation (i.e., "watch and wait" or placebo).i

"This EC authorization of rucaparib is an important step in ensuring that it is available to all women who may potentially benefit, regardless of their BRCA status," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We believe that access to maintenance treatment is extremely important for women with relapsed platinum-sensitive ovarian cancer, and we are pleased that rucaparib can now be an option for these women. As the only PARP inhibitor that has shown further tumor shrinkage as well as prolonged progression-free survival in this maintenance setting, we believe Rubraca represents an important step forward for women with advanced ovarian cancer."

The ARIEL3 trial was a double-blind, placebo-controlled clinical trial of rucaparib that enrolled 564 women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy. Patients were randomized (2:1) to receive rucaparib tablets 600mg twice daily (n=375) or placebo (n=189).

ARIEL3 successfully achieved its primary endpoint, of extending investigator-assessed progression-free survival (PFS) versus placebo in all patients treated (intention-to-treat [ITT]), population, regardless of BRCA status; the key secondary endpoint of extending PFS as assessed by independent radiological review (IRR) was also achieved.

Parameter Investigator assessment IRR
Rucaparib Placebo Rucaparib Placebo
All patients
Patients, n 375 189 375 189
PFS events, n (%) 234 (62) 167 (88) 165 (44) 133 (70)
PFS, median in months (95% CI) 10.8 (8.3, 11.4) 5.4 (5.3, 5.5) 13.7 (11.0, 19.1) 5.4 (5.1, 5.5)
HR (95% CI) 0.36 (0.30, 0.45) 0.35 (0.28, 0.45)
p-value <0.0001 <0.0001
tBRCA Group
Patients, n 130 66 130 66
PFS events, n (%) 67 (52) 56 (85) 42 (32) 42 (64)
PFS, median in months (95% CI) 16.6 (13.4, 22.9) 5.4 (3.4, 6.7) 26.8 (19.2, NA) 5.4 (4.9, 8.1)
HR (95% CI) 0.23 (0.16, 0.34) 0.20 (0.13, 0.32)
p-value <0.0001 <0.0001

An exploratory analysis of patients in the ITT population with measurable disease at baseline showed a tumor response was reported in 18% (95% CI 12%–26%) of patients (n=26) on rucaparib compared to 8% (95% CI 3% – 17%) of patients (n=5) on placebo (p value = 0.0069), including 10 patients (7%) in the rucaparib group who achieved a complete remission.

The overall safety profile of rucaparib is based on data from 937 patients with ovarian cancer treated with rucaparib monotherapy in clinical trials. Adverse reactions occurring in ≥20% of patients were nausea, fatigue/asthenia, vomiting, anaemia, abdominal pain, dysgeusia, alanine aminotransferase (ALT) elevations, aspartate aminotransferase (AST) elevations, decreased appetite, diarrhoea, thrombocytopenia and creatinine elevations. The majority of adverse reactions were mild to moderate (Grade 1 or 2).

Grade ≥3 adverse reactions occurring in >5% of patients were anemia (23%), ALT elevations (10%), fatigue/asthenia (10%), neutropenia (8%), thrombocytopenia (6%), and nausea (5%). The only serious adverse reaction occurring in > 2% of patients was anemia (5%).

Adverse reactions that most commonly led to dose reduction or interruption were anemia (20%), fatigue/asthenia (18%), nausea (16%), thrombocytopenia (15%), and AST/ALT elevations (10%). Adverse reactions leading to permanent discontinuation occurred in 10% of patients, with thrombocytopenia, nausea, anaemia, and fatigue/asthenia being the most frequent adverse reactions leading to permanent discontinuation.

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and Europe.

Rubraca (rucaparib) EU Authorized Use and Important Safety Information

Rucaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Rucaparib is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Summary warnings and precautions: Haematological toxicity: Patients should not start Rubraca until they have recovered from haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade 1). Complete blood count testing prior to starting treatment with Rubraca and monthly thereafter is advised. Rubraca should be interrupted or dose reduced and blood counts monitored weekly until recovery for the management of low blood counts. Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML): If MDS/AML is suspected, the patient should be referred to a haematologist for further investigation. If MDS/AML is confirmed, Rubraca should be discontinued. Photosensitivity: Patients should avoid spending time in direct sunlight as they may burn more easily. When outdoors, patients should wear protective clothing and sunscreen with SPF of 50 or greater. Gastrointestinal toxicities: Low grade (CTCAE Grade 1 or 2) nausea and vomiting may be managed with dose reduction or interruption. Additionally, antiemetics may be considered for treatment or prophylaxis.

Click here to access the current Summary of Product Characteristics. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

On January 24, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune modulating antibodies, cancer vaccines, and adoptive cell therapies1, reported the closing of its immuno-oncology (I-O) partnership deal with Gilead Sciences, Inc. (NASDAQ: GILD), focused on the development and commercialization of up to five novel immuno-oncology therapies (Press release, Agenus, JAN 24, 2019, View Source [SID1234532893]).

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!

Under the terms of the agreement, Agenus receives $150 million in connection with closing, which includes a $120 million upfront cash payment and a $30 million equity investment. The agreement also includes approximately $1.7 billion in potential future fees and milestones. Gilead received worldwide exclusive rights to AGEN1423. Gilead also received the exclusive option to license two additional programs: AGEN1223 and AGEN23732. Agenus has filed the IND for AGEN1223 and has a planned IND filing for AGEN2373 in the first half of 2019. Agenus will be responsible for developing the option programs up to the option decision points, at which time Gilead may acquire exclusive rights to the programs on option exercise. For one of the option programs, Agenus will have the right to opt-in to shared development and commercialization in the U.S. Gilead also received right of first negotiation for two additional, undisclosed preclinical programs.