1stOncology™: Cancer Intelligence Service – Page 12904 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Alector Announces Upsizing and Pricing of Public Offering

On January 29, 2020 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the pricing of an upsized underwritten public offering of 8,350,000 shares of its common stock at a price of $25.00 per share pursuant to a registration statement on Form S-1 filed previously with the U.S. Securities and Exchange Commission (SEC) (Press release, Alector, JAN 29, 2020, View Source [SID1234553676]). The offering was upsized to 8,350,000 shares of Alector’s common stock from the original offering size of 5,095,000 shares of common stock. The gross proceeds to Alector from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $208,750,000. The offering is expected to close on or about February 3, 2020, subject to customary closing conditions. In addition, Alector has granted the underwriters a 30-day option to purchase up to 1,252,500 additional shares of common stock. All of the shares in the proposed offering will be sold by Alector.

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!

Morgan Stanley, Goldman Sachs & Co. LLC, BofA Securities, and Cowen are acting as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with, and declared effective by, the SEC. 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.

The offering is being made only by means of a prospectus. When available, copies of the final prospectus relating to the offering may be obtained from:

Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 or by email at [email protected];
Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, or by email at [email protected];
BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email [email protected]; or
Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926.

Geneos Personalized Neoantigen-Targeting Vaccine (GNOS-PV02) to be Utilized in Innovative GT-30 Hepatocellular Carcinoma Trial

On January 29, 2020 Geneos Therapeutics reported that its personalized neoantigen-targeting vaccine, GNOS-PV02 (based on its proprietary GT-EPIC platform), will be evaluated in a clinical trial for patients with advanced Hepatocellular Carcinoma (HCC) (Press release, Geneos Therapeutics, JAN 29, 2020, View Source [SID1234553675]). GNOS-PV02 is a tumor-specific DNA plasmid product designed and manufactured for each patient based on the unique tumor variations (neoantigens) identified by sequencing each patient’s tumors. In the trial, GNOS-PV02 will be combined with a DNA plasmid encoded cytokine immunomodulator IL-12 (INO-9012) and standard of care PD-1 checkpoint inhibitor (pembrolizumab).

This innovative trial is an open-label, non-randomized, exploratory study designed to assess the safety, immunogenicity, and antitumor activity of the combination treatment in advanced HCC patients who have progressed on or are intolerant to first-line treatment with a Tyrosine Kinase Inhibitor (TKI). The primary study goals are to evaluate safety, biomarkers of immune activity, with special emphasis on CD8+ T cell responses, and clinical outcomes.

Geneos has exclusively licensed the DNA Medicines platform, INO-9012 and CELLECTRA device for in vivo delivery of DNA plasmids from Inovio Pharmaceuticals (NASDAQ: INO) for use in the development of personalized cancer treatments. The two DNA based products, GNOS-PV02 and INO-9012, will be administered to cancer patients via intradermal (ID) administration using the CELLECTRA 2000 ID device.

Dr. Niranjan Y. Sardesai, Founder and Chief Executive Officer of Geneos Therapeutics, said "We are excited about this first clinical trial for the Geneos GT-EPIC neoantigen-targeting platform. This trial will seek to demonstrate that Geneos can produce personalized neoantigen-targeting immunotherapies in a clinically meaningful time frame, which drive strong T cell responses (both CD4+ and CD8+) and that these immunotherapies can enhance the efficacy of a PD-1 inhibitor alone. Enabled by our industry leading rapid biopsy to treatment turnaround time and the unique design of this study, the Geneos personalized therapy will be initiated at the same time the patient receives the first dose of the PD-1 inhibitor – we believe this is a critical success factor for neoantigen-based combination trials."

Dr. Mark Yarchoan, Assistant Professor of Oncology at Johns Hopkins and Investigator for the GT-30 advanced HCC study said "Checkpoint inhibitors and other immunotherapies have advanced the cancer treatment field and have had a significant impact on clinical outcomes. However, every patient’s tumor is unique and in order to further improve outcomes, I believe that personalized approaches are critical. I’m excited about this clinical trial utilizing Geneos’ innovative personalized treatment approach in combination with an approved immunotherapy for the treatment of advanced HCC. HCC is one of the fastest growing cancers in the U.S., and a significant unmet need exists to find more efficacious treatments."

HCC accounts for the majority of primary liver cancers. Globally, liver cancers are the fourth most common cause of cancer-related death and rank sixth in terms of annual incidence. The rate of death from liver cancer in the U.S. has increased 43% from 2000 to 2016 and with a 5-year survival rate of 18% for advanced liver cancer, it is the second most deadly tumor behind pancreatic. To date, immunotherapies have shown limited efficacy with two PD-1 inhibitors (pembrolizumab and nivolumab) approved as second line treatments following a tyrosine kinase inhibitor.

DaVita Inc. Schedules 4th Quarter 2019 Investor Conference Call

On January 29, 2020 DaVita Inc. (NYSE: DVA), reported that it will hold its quarterly conference call to discuss fourth quarter results on Monday, February 10, 2020, at 5:00 p.m. Eastern Time (Press release, DaVita, JAN 29, 2020, View Source [SID1234553674]). The company plans to release its results after market close the same day.

This call is also being webcast and can be accessed at the DaVita IR web page. You can join this call as follows:

Monday, February 10, 2020
Starting at 5:00 p.m. EST
Dial in number: 877-918-6630
International dial in: 517-308-9042
Webcast: investors.davita.com

When calling in, please provide the operator the password "Earnings" and provide your name and company affiliation. Investors unable to listen to the conference call will be able to access a replay via our website at investors.davita.com. There will be no telephone replay.

AbbVie Announces ANVISA Approval for VENCLEXTA ™ (venetoclax) as Chemotherapy-Free and Fixed-Duration Treatment for Patients with Chronic Lymphocytic Leukemia (LLC) without Previous Treatment

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.

"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.

BioMarin to Host Fourth Quarter and Full Year 2019 Financial Results Conference Call and Webcast on Wednesday, February 26 at 4:30pm ET

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]).

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.