On January 29, 2020 AbbVie (NYSE: ABBV ), a global biopharmaceutical company based on research and development, reported the approval by the regulatory agency ANVISA of VENCLEXTA (venetoclax), in combination with obinutuzumab, for treating patients with CLL without prior treatment (Press release, AbbVie, JAN 29, 2020, View Source [SID1234553673]). 1 The combination was considered "Revolutionary Treatment" by the FDA.

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"This approval by ANVISA is a new option of therapeutic combination without chemotherapy and highlights the growing use of venetoclax for the treatment of LLC", said Karina Fontão, Medical Director of AbbVie in Brazil. "The approval was based on the results of the CLL study 14 , in which patients received treatment for 12 months. Most patients treated with venetoclax in the study did not show disease progression in an evaluation carried out two years after treatment."

CLL 14 data were presented at the EHA (Free EHA Whitepaper) (Congress of the European Association of Hematologists) 2019.

"Patients with CLL have been undergoing chemotherapy as an initial treatment," said physician Michael Hallek, principal investigator in the CLL 14 study and head of the Department of Internal Medicine and Center for Integrated Oncology at the University Hospital in Cologne, Germany. "This approval allows patients with CLL, who have not yet received treatment, to start with a fixed-term treatment, without the use of chemotherapy, which can allow them to live longer, without progression of the disease, with minimal undetectable residual disease (undetectable disease in the blood) or bone marrow) and, more importantly, allows them to complete their course of treatment in 12 months. "

The CLL 14 study demonstrated higher progression-free survival rates (period from the start of treatment to the progression of the disease or death), assessed by an independent review committee, in patients treated with the combination of VENCLEXTA and obinutuzumab compared to patients who received the combination chlorambucil and obinutuzumab, one of the commonly used treatments. With an average follow-up of 28 months (range 0.1 to 36 months), the combination with VENCLEXTA reduced the risk of progression or death in 67% of patients, compared with the combination of chlorambucil with obinutuzumab. The minimal residual disease rate was assessed as a secondary study outcome and is defined as the presence of less than one LLC cell detected in 10,000 leukocytes, using sensitive analytical methods.2 .

In the CLL 14 study, adverse events were compatible with the known safety profile of VENCLEXTA and obinutuzumab used alone.

VENCLEXTA, a BCL-2 protein inhibitor, received five Revolutionary Therapy designations from the FDA. 3,4,5,6,7

VENCLEXTA is approved in more than 50 countries, including the United States and Brazil.

In Brazil, VENCLEXTA is also approved for the treatment of relapsed / refractory LLC and acute myeloid leukemia (AML). 1

About Chronic Lymphocytic Leukemia

LLC is a slow-progressing cancer in the blood and bone marrow in which some white blood cells called B lymphocytes become cancerous and multiply abnormally. 7 In the United States, LLC adds more than 20,000 new cases each year. 8 In Brazil, according to information from INCA 2018, there are 10,800 new cases of leukemia in the year. 8

About VENCLEXTA (venetoclax)

VENCLEXTA is the first in a new class of drugs that selectively inhibits the BCL-2 protein. In some types of blood cancer and other tumors, BCL-2 prevents the natural process of cancer cell death, or a process of self-destruction called apoptosis. VENCLEXTA targets the BCL-2 protein and acts to restore the apoptosis process 1 and is also being evaluated for the treatment of patients with several other types of cancer.

VENCLEXTA is developed by AbbVie and Roche, being marketed jointly by AbbVie and Genetench, a Roche group company, in the United States, and by AbbVie, outside the United States. Together, the companies are committed to researching BCL-2 and evaluating VENCLEXTA in clinical studies for various types of blood cancer and other tumors.

On January 29, 2020 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Wednesday, February 26, at 4:30 p.m. ET to discuss fourth quarter and full year 2019 financial results and provide a general business update (Press release, BioMarin, JAN 29, 2020, View Source [SID1234553672]).

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Dial-in Number
U.S. / Canada Dial-in Number: (866) 502-9859
International Dial-in Number: (574) 990-1362
Conference ID: 9967337

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 9967337

Interested parties may access a live audio webcast of the conference call via the investor section of the BioMarin website, www.biomarin.com. A replay of the call will be archived on the site for one week following the call.

On January 29, 2020 CytRx Corporation (OTCQB: CYTR), a biopharmaceutical research and development company, reported that ImmunityBio, previously NantCell, Inc., and NantKwest announced a complete response in Metastatic Pancreatic Cancer in one patient who received its experimental Human Killer Cell combination Immunotherapy, which includes aldoxorubicin, in its Phase 1 clinical trial (Press release, CytRx, JAN 29, 2020, View Source [SID1234553671]). This result builds on the results released previously in patients with Triple Negative Breast Cancer ("TNBC"), in which two of nine patients treated with this experimental cancer therapy also had a complete response. These immunotherapies include CytRx’s aldoxorubicin as part of its innovative chemoradiation therapy. NantKwest also indicated they plan to initiate registration trials in recurrent metastatic TNBC and pancreatic cancer patients that failed standard of care.

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"We continue to be encouraged with the initial results of this promising protocol, which includes aldoxorubicin, in targeting two of the most difficult cancer types that patients have had challenges with," said Eric Curtis, President and Chief Operating Officer of CytRx.

CytRx out-licensed global development, manufacturing, and commercialization rights for aldoxorubicin to ImmunityBio Inc. in July 2017. CytRx has an agreement with ImmunityBio that will pay CytRx up to $343 million in milestones, plus single and double-digit royalties on aldoxorubicin.

On January 29, 2020 BerGenBio ASA (OSE: BGBIO) ("BerGenBio" or the "Company") reported a contemplated private placement of new shares in the Company (the "Private Placement") (Press release, BerGenBio, JAN 29, 2020, View Source;private-placement-successfully-placed-300995749.html [SID1234553669]).

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The Company is pleased to announce that the Private Placement has been successfully placed, raising gross proceeds of NOK 219,875,724 through the allocation of 12,215,318 new shares (the "Offer Shares") at a subscription price of NOK 18.00 per share (the "Subscription Price"). The Private Placement, that was over subscribed, took place through an accelerated book building process after close of market on 29 January 2020.

Arctic Securities AS and Carnegie AS acted as Joint Bookrunners and H.C. Wainwright & Co., LLC acted as Financial Advisor (together the "Managers") in connection with the Private Placement. The Private Placement attracted strong interest from existing shareholders and new institutional investors.

The Company intends to use the net proceeds from the Private Placement to continue advancing its clinical trial programs with its lead candidate bemcentinib in patients with Acute Myeloid Leukaemia (AML) and Non Small Cell Lung Cancer (NSCLC), manufacturing scale-up of bemcentinib, biomarker and companion diagnostic development, and phase 1b development of tilvestamab (formerly BGB149), as well as for general corporate purposes.

The completion of the Private Placement by delivery of Offer Shares to the applicants will be divided in two tranches. Applicants have been allocated Offer Shares in Tranche 1 and 2 on a pro-rata basis based on their overall allocation in the Private Placement, with the exception of Meteva AS which has agreed that Offer Shares allocated to it shall be delivered solely in Tranche 2. Tranche 1 consists of 5,475,136 Offer Shares ("Tranche 1") and the issuance of the Offer Shares in Tranche 1 was resolved by the Company’s board of directors at a board meeting held on 29 January 2020, based on the authorization granted to the board of directors at the Company’s annual general meeting held on 13 March 2019. Tranche 2 consists of 6,740,182 Offer Shares ("Tranche 2") and is subject to approval by the extraordinary general meeting of the Company to be held on 20 February 2020 (the "EGM") and the placement agreement entered into between the Company and the Managers not being terminated by the Managers in accordance with the terms thereof. The board of directors has resolved to summon an extraordinary general meeting to be held on 20 February 2020. If Tranche 2 is not completed (e.g. due to non-approval by the EGM), applicants will not be delivered Offer Shares in Tranche 2 and the Company will hence not receive the proceeds from Tranche 2.

Notification of allocation of the Offer Shares and payment instructions is expected to be sent to the applicants through a notification from the Managers on 30 January 2020.

The Offer Shares in Tranche 1 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 Meteva AS as lender, Arctic Securites AS (on behalf of the Managers) and the Company in order to facilitate delivery of listed shares in the Company to investors delivery versus payment on a T+2 basis. The shares in the Company delivered to the subscribers in Tranche 1 will thus be tradable immediately after delivery to the subscribers. Arctic Securities AS will settle the share loan with the Offer Shares in Tranche 1 once such shares are issued.

Following registration of the new share capital in the Company and issuance of the Offer Shares in Tranche 1 with the Norwegian Register of Business Enterprises, which is expected to take place on or about 5 February 2020, the Company will have an issued share capital of NOK 6,655,172.60 divided into 66,551,726 shares, each with a par value of NOK 0.10.

The Offer Shares in Tranche 2 will be settled after the extraordinary general meeting with existing and unencumbered shares in the Company that are already listed on the Oslo Stock Exchange, pursuant to a share lending agreement between Meteva AS as lender, Arctic Securites AS (on behalf of the Managers) and the Company in order to facilitate delivery of listed shares in the Company to investors on a delivery versus payment T+2 basis. The shares in the Company delivered to the subscribers in Tranche 2 will thus be tradable immediately after delivery to the subscribers. Arctic Securities AS will settle the share loan with the Offer Shares in Tranche 2 once such shares are issued. The Offer Shares re-delivered to Meteva AS in Tranche 2 will be issued on a separate ISIN and will not be tradable on Oslo Børs until a listing prospectus has been approved by the Norwegian Financial Supervisory Authority, expected late February 2020.

Following registration of the new share capital in the Company and the issuance of the Offer Shares in Tranche 2 with the Norwegian Register of Business Enterprises, which is expected to take place on or about 27 February 2020, the Company will have an issued share capital of NOK 7,329,190.80 divided into 73,291,908 shares, each with a par value of NOK 0.10.

The following primary insiders have been allocated Offer Shares in the Private Placement at a subscription price equal to the Subscription Price (with new holding of shares in the Company in brackets):

Meteva AS 3,291,750 (19,750,500)

Gnist Holding AS (Richard Godfrey) 5,556 (221,005)

Completion of the Private Placement implies a deviation from the existing shareholders’ pre-emptive rights to subscribe for and be allocated new shares. The board of directors of the Company has carefully considered such deviation and has resolved that the Private Placement is in the best interests of the Company and its shareholders. In reaching this conclusion the board of directors has inter alia considered the implications of an underwritten rights issue given the volatility and negative development in the Company’s share price, alternative financing sources, the dilutive effect of the share issue, the Company’s need for additional liquidity and Subscription Price.

Subject to prevailing market price of the Company’s shares being higher than the Subscription Price in a period determined by the board of directors in its sole discretion, the Company will carry out a subsequent offering of up to 1,500,000 new shares towards shareholders in the Company as of 29 January 2020 (as registered in the Norwegian Central Securities Depository ("VPS") on 31 January 2020), who (i) were not allocated shares in the Private Placement, and (ii) are not resident in a jurisdiction where such offering would be unlawful, or would in jurisdictions other than Norway require any prospectus filing, registration or similar action. If carried out, the subscription price in the subsequent offering will be the same as in the Private Placement and be conditional upon approval by the extraordinary general meeting of the Company to be held on 20 February 2020 and the approval of a listing and offering prospectus by the Norwegian Financial Supervisory Authority.

On January 29, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company"), a novel bioelectric medicine company, reported the presentation of its scientific study evaluating the clinical and histologic response of Nano-Pulse Stimulation (NPS) technology in treating challenging cases of nodular Basal Cell Carcinoma (nBCC) (Press release, Pulse Biosciences, JAN 29, 2020, View Source [SID1234553668]). These results are to be presented at the 22nd annual IMCAS (International Master Course on Aging Skin) World Congress, the gathering of international experts in dermatology, plastic surgery and aging science, taking place at Palais des Congrès, Paris, France, from January 30th to February 1st 2020.

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Dermatologist Girish Munavalli, MD, MHS, FACMS, a prominent skin cancer surgeon in Charlotte, NC, will present results that demonstrate the unique ability of NPS technology to eliminate tumor cells in nodular BCCs while sparing surrounding healthy tissue. Results will be supported by clinical photos that display a more favorable cosmetic outcome possible in a short amount of time with reduced potential for scar formation as compared to current surgical excision.

Basal cell carcinoma is the most common form of skin cancer worldwide. The nodular BCC subtype reported in this study comprises 60% of all basal cell carcinomas. For these deep nodular lesions, the current standard of care is surgical excision, which can lead to large, permanent scars.

"Early findings show promising potential for NPS technology as a new treatment option for nodular BCC. NPS technology has demonstrated equivalent therapeutic benefit and the added benefit of superior cosmetic outcomes compared to more destructive skin cancer treatment modalities, such as excision and curettage," said Dr. Munavalli of Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC.

"We are enthusiastic about the impressive results Nano-Pulse Stimulation technology is producing in Basal Cell Carcinomas and are focused on rapidly advancing its development program across multiple clinical applications," said Darrin Uecker, President and CEO of Pulse Biosciences. "Our presence at IMCAS represents the initial step in our commitment to international commercialization, which aims to extend our long-term growth platform and leverage the value proposition of our technology’s ability to clear benign and malignant lesions. "

Scheduled scientific presentation at IMCAS World Congress 2020

Podium Presentation: "Histologic and Clinical Comparison of Scar Cosmesis Using Nano-Pulse Stimulation vs Traditional Surgical Treatments of Basal Cell Carcinoma," by Dr. Girish S. MUNAVALLI, Assistant Professor at the Wake Forest University School of Medicine – Department of Dermatology and Medical Director and Founder of Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte NC.

Details: 30 January 2020, at 12:06pm in Room 143, Level 1
Skin Cancer and Photorejuvenation: The Impossible Equation: Session S011, S012
Chaired by: Dr. Mathew Avram and Pr. Merete Haedersdal.