1stOncology™: Cancer Intelligence Service – Page 11756 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

AIVITA Biomedical to Present at Biotech Showcase 2020

On January 14, 2020 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that it will be featured as a presenting company at the annual Biotech Showcase conference taking place January 13-15 at the Hilton San Francisco Union Square in San Francisco, California (Press release, AIVITA Biomedical, JAN 14, 2020, View Source [SID1234553196]). Dr. Hans S. Keirstead, AIVITA’s Chairman and CEO, will present at the following time and location:

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!

Date: Tuesday, January 14, 2019
Time: 10:00 AM
Track: Franciscan D (Ballroom Level)

Biotech Showcase is an annual investor and networking conference that provides private and public biotechnology and life science companies with an opportunity to present and meet with investors and pharmaceutical executives.

Dr. Keirstead will be presenting details on AIVITA’s platform cancer technology, a next generation immunotherapy targeting the tumor-initiating stem cells, with strong clinical data evidencing 72% survival at 2-years, and 54% survival at 5-years post-treatment. AIVITA is currently conducting three clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

ArcherDX Personalized Cancer Monitoring (PCM) Technology Designated by FDA as Breakthrough Device

On January 14, 2020 ArcherDX, Inc., reported it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Personalized Cancer Monitoring (PCM) technology, a bespoke, minimally-invasive and highly-sensitive product intended for early-stage cancer treatment monitoring and recurrence surveillance (Press release, ArcherDX, JAN 14, 2020, View Source [SID1234553195]). ArcherDX’s technology enables healthcare providers across community and academic care settings access to genomic information in their laboratory, saving critical time and allowing world-class, cost-effective care locally.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving standards, consistent with the FDA’s mission to protect and promote public health.

The program will provide ArcherDX with enhanced communication with the FDA regarding technology validation and clinical trial protocols and could expedite the review process.

Jason Myers, ArcherDX Chief Executive Officer and co-founder said, "Fewer than 1% of cancer patients receive any genomic profiling for the monitoring of their cancer. Millions of individuals who undergo cancer treatment and the millions more who survive and achieve remission, need a sensitive, personalized means of detecting relapse earlier. We believe our bespoke product can improve both therapy monitoring and recurrence surveillance and given the substantial need, we look forward to additional collaborative interaction with regulators to deliver our PCM product to patients as soon as possible."

As part of an on-going collaboration, TRACERx1 investigators, led by Professor Charles Swanton, Group Leader, UCL and the Francis Crick Institute, and Dr. Christopher Abbosh, Principal Clinical Fellow, UCL, are utilizing ArcherDX’s technology to detect low-volume minimal residual disease at high levels of sensitivity to help achieve TRACERx’s goal of a more personalized approach to developing cancer treatments.

The PCM Breakthrough designation follows Breakthrough Device Designation for ArcherDX’s STRATAFIDE which, upon approval, would be the first pan-solid tumor device employing genomic sequencing testing technology to accept both tissue and blood that can be used in local hospital or regional reference laboratories.

Phio Pharmaceuticals Announces Reverse Stock Split

On January 14, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported that the Company’s Board of Directors has approved a reverse stock split of its shares of common stock at a ratio of 1-for-55 (Press release, Phio Pharmaceuticals, JAN 14, 2020, View Source [SID1234553194]). The reverse stock split will become effective at 12:01 a.m. Eastern Time on January 15, 2020 and the Company’s common stock will open for trading on The Nasdaq Capital Market on a post-split basis on January 15, 2020 under the Company’s existing trading symbol, "PHIO." At such time, the Company’s common stock will also commence trading with a new CUSIP number, 71880W303.

At the Company’s Special Stockholder Meeting held on January 10, 2020, Phio’s stockholders approved a reverse stock split within a range of 1-for-2 and 1-for-70. Thereafter, the Board of Directors determined to fix the ratio for the reverse stock split at 1-for-55.

The reverse stock split is being implemented to increase the per share trading price of the Company’s common stock for the purpose of ensuring a share price high enough to comply with the minimum $1.00 bid price requirement for continued listing on The Nasdaq Capital Market. At the effective time of the reverse stock split, every fifty-five (55) shares of Phio common stock issued and outstanding will be combined into one (1) share of common stock issued and outstanding, with no change to the par value of $0.0001 per share. This will reduce the Company’s outstanding common stock from approximately 36.8 million shares to approximately 0.67 million shares. No fractional shares of common stock will be issued as a result of the reverse stock split and instead holders of Phio common stock will receive a cash payment in lieu of fractional shares to which they would otherwise be entitled. The shares underlying the Company’s outstanding equity awards and warrants will also be adjusted accordingly.

The Company has retained its transfer agent, Computershare Trust Company, N.A. ("Computershare"), to act as its exchange agent for the reverse split. Shareholders with shares held in certificate form will receive from Computershare instructions regarding the exchange of their certificates. Shareholders that hold shares in book-entry form or hold their shares in brokerage accounts are not required to take any action and will see the impact of the reverse stock split reflected in their accounts, subject to brokers’ particular processes. Beneficial holders of Phio common stock are encouraged to contact their bank, broker, custodian or other nominee with questions regarding procedures for processing the reverse stock split.

Additional information regarding the reverse stock split is available in the definitive proxy statement filed with the U.S. Securities and Exchange Commission on November 22, 2019 by the Company.

Mirati Therapeutics Announces Closing Of Public Offering Of Common Stock And Full Exercise Of Underwriters’ Option To Purchase Additional Shares

On January 14, 2020 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported the closing of its previously announced underwritten public offering of 3,538,462 shares of its common stock at a public offering price of $97.50 per share (Press release, Mirati, JAN 14, 2020, View Source [SID1234553193]). This includes the exercise in full by the underwriters of their option to purchase up to 461,538 additional shares of common stock. The aggregate gross proceeds to Mirati from this offering were approximately $345.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Mirati.

Goldman Sachs & Co. LLC, SVB Leerink and Cowen and Company, LLC acted as joint book-running managers in the offering. Credit Suisse acted as lead manager in the offering. JonesTrading Institutional Services LLC acted as a co-manager in the offering.

The shares of common stock described above were offered by Mirati pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected].

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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Centene Corporation Announces Extension of Exchange Offers and Consent Solicitations for WellCare Notes

On January 14, 2020 Centene Corporation (NYSE:CNC) ("Centene") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "WellCare Notes") issued by WellCare Health Plans, Inc. (NYSE:WCG) ("WellCare") for up to $1,950,000,000 aggregate principal amount of new notes to be issued by Centene (the "Centene Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Centene on behalf of WellCare to adopt certain proposed amendments (the "Amendments") to the indentures governing the WellCare Notes (Press release, Centene , JAN 14, 2020, View Source [SID1234553192]). Centene hereby extends such expiration date from 5:00 p.m., New York City time, on January 14, 2020, to 5:00 p.m., New York City time, on January 21, 2020 (as the same may be further extended, the "Expiration Date").

On November 14, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the WellCare Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated November 1, 2019, as amended on November 12, 2019 and the related letter of transmittal and consent hereby, each as amended by the press releases dated December 2, 2019, December 18, 2019 and January 8, 2020 and as amended hereby, and are conditioned upon the closing of Centene’s acquisition of WellCare (the "Merger"), which condition may not be waived by Centene, and certain other conditions that may be waived by Centene.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and immediately prior to the closing of the Merger, which is expected to occur by the first half of 2020. As a result, the Expiration Date may be further extended one or more times. Centene will provide notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on January 14, 2020, the principal amounts of WellCare Notes set forth in the table below had been validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of WellCare Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended by the press releases dated December 2, 2019, December 18, 2019 and January 8, 2020 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated November 1, 2019 as amended on November 12, 2019 and the related letter of transmittal and consent, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470-4200 (U.S. toll-free) or (212) 430-3774 (banks and brokers). The eligibility form is available electronically at: View Source

This press release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, or the solicitation of tenders or consents with respect to, any security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful. The Exchange Offers and Consent Solicitations are being made solely pursuant to the offering memorandum and consent solicitation statement dated November 1, 2019, as amended on November 12, 2019 and as amended by the press releases dated December 2, 2019, December 18, 2019 and January 8, 2020 and as amended hereby and the related letter of transmittal and consent, and only to such persons and in such jurisdictions as are permitted under applicable law.

The Centene Notes offered in the Exchange Offers have not been registered under the Securities Act of 1933, as amended, or any state securities laws. Therefore, the Centene Notes may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act of 1933, as amended, and any applicable state securities laws.