1stOncology™: Cancer Intelligence Service – Page 12722 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Shuwen & ASK Pharma Partner to Develop Novel Companion Diagnostics for Drug Candidates

On December 18, 2019 Diagnostics firm Shuwen reported it entered into collaboration with ASK Pharma to develop a companion diagnostics (CDx) for novel targets in the oncology space (Press release, Shuwen Biotech, DEC 18, 2019, View Source [SID1234552455]).

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 diagnostics will support ASK’s various novel clinical candidates, which aims to introduce highly innovative and efficacious drugs to the domestic Chinese and international markets. The collaboration will leverage Shuwen’s mature immunohistochemistry (IHC) companion diagnostic platform and is expected to produce a number of market novel diagnostic solutions to hospitals and healthcare providers in the coming years. The collaboration also includes the use of Shuwen’s CAP-accredited central lab to test patient samples from ASK’s clinical trials from clinical sites across China.

Innovative Cellular Therapeutics Secures Equity Financing to Advance its Next Generation Liquid and Solid Tumor CAR-T Programs

On December 17, 2019 Innovative Cellular Therapeutics (ICT), a clinical stage biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for liquid and solid tumors, reported that it has closed a U.S. dollar Series B+ equity financing for an undisclosed amount (Press release, Innovative Cellular Therapeutics, DEC 17, 2019, View Source [SID1234553316]). The lead investor, LH Ventures, is a prominent venture capital firm targeting disruptive technologies in the healthcare sector and other innovations. Proceeds from the capital raise will be used to advance ICTCAR014 – ICT’s next generation CD19-targeting armored CAR-T cell therapy that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells – into a U.S. clinical trial in the first part of 2020, and to further develop ICT’s "CoupledCAR" CAR-T cell therapy platform in solid tumors.

"We are deeply impressed by the ICT team, their innovation capabilities and the response of the initial patients to the Company’s next generation armored dominant negative PD-1 CAR-T cell therapy and CoupledCAR technologies," said Xin Xie, Ph.D., Partner at LH Ventures. "We believe ICT’s platform technologies will create significant breakthroughs in the fight against both liquid and solid tumors."

"We are excited to have LH Ventures support the expansion of our global activities and help us advance the clinical development of our next generation CAR-T technologies for liquid and solid tumors in the United States," said Larry (Lei) Xiao, Ph.D., ICT’s Founder and Chief Executive Officer. "They are joined by a group of other renowned, international investors who also believe in the viability of our platform technologies."

About LH Ventures
LH Ventures is a prominent venture capital firm targeting early stage opportunities of innovation and disruptive technologies. It boasts an investment team consisting of entrepreneurs, scientists, doctors, and capital market experts. LH Ventures identifies teams and companies which have significant value potential and helps them grow into industry leaders.

About ICTCAR014
The U.S. Food and Drug Administration (FDA) has cleared ICT’s Investigational New Drug (IND) application for ICTCAR014, a next generation CD19-targeting CAR-T cell therapy that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells. ICT is moving ICTCAR014 into a U.S. clinical trial. ICTCAR014, referred to as an "armored" CAR-T cell therapy, has already shown encouraging results in proof-of-concept human trials in China. As highlighted in ICT’s presentation at the November 2019 Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting, ICTCAR014 demonstrated a 92.3% objective response rate (53.8% complete remission; 38.5% partial remission) in 13 initial patients with relapsed or refractory non-Hodgkin lymphoma. Significant tumor shrinkage and limited toxicity were observed.

Entry into a Material Definitive Agreement

On December 17, 2019, Sangamo Therapeutics, Inc. (the "Company") reported that it has entered into a letter amendment (the "Letter Amendment") to its Collaboration and License Agreement with Pfizer, Inc. ("Pfizer"), dated May 10, 2017 (the "Collaboration Agreement"), to accelerate the transfer of the Investigational New Drug application ("IND") for the Company’s SB-525 product candidate to Pfizer (the "IND Transfer") (Filing, 8-K, Sangamo Therapeutics, DEC 17, 2019, View Source [SID1234552572]). The Letter Amendment obligates the Company to cooperate and assist Pfizer with certain activities related to the IND Transfer and as of December 18, 2019, the IND had been transferred to Pfizer. In addition, the Letter Amendment changes the timing of Pfizer’s payment to the Company of a $25.0 million development milestone, and as of December 20, 2019, the Company met the conditions for earning such milestone. No other changes were made to the provisions of the Collaboration Agreement governing milestones or royalties as part of the Letter Amendment. Under the Collaboration Agreement, the Company is eligible to receive development milestone payments contingent on the achievement of specified clinical development, intellectual property, regulatory and first commercial sale milestones for SB-525 and potentially for other products, and is also eligible to receive tiered royalties with percentages starting in the low teens and up to 20% based on the annual net sales of each potential licensed product developed under the Collaboration Agreement, subject to reduction due to patent expiration, entry of biosimilar products to the market and payment made under certain licenses for third-party intellectual property.

The foregoing is only a brief description of the Letter Amendment, does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Letter Amendment. The Company intends to file a copy of the Letter Amendment with its Annual Report on Form 10-K for the year ending December 31, 2019.

Entry into a Material Definitive Agreement

On December 17, 2019, Achieve Life Sciences, Inc., a Delaware corporation (the "Company"), reported that entered into an Underwriting Agreement (the "Underwriting Agreement") with Ladenburg Thalmann & Co. Inc. (the "Underwriter"), pursuant to which the Company agreed to issue and sell, in a registered public offering by the Company (the "Public Offering"), (a) 9,577,504 Class A Units (the "Class A Units"), with each Class A Unit consisting of one share of the Company’s common stock, par value $0.001 per share (the "Common Stock"), and a warrant to purchase one share of Common Stock (each warrant exercisable for one whole share of Common Stock, a "Warrant"), with each Class A Unit to be offered to the public at an offering price of $0.60 per Class A Unit and (b) 6,256 Class B Units (the "Class B Units", and collectively with the Class A Units, the "Units"), with each Class B Unit consisting of one share of Series B Preferred Stock, par value $0.001 per share (the "Series B Preferred Stock"), convertible into 1,666 shares of Common Stock and Warrants to purchase 1,666 shares of Common Stock, with each Class B Unit to be offered to the public at an offering price of $999.60 per Class B Unit (Filing, 8-K, OncoGenex Pharmaceuticals, DEC 17, 2019, View Source [SID1234552557]).

In addition, pursuant to the Underwriting Agreement, the Company granted the Underwriter a 45 day option (the "Overallotment Option") to purchase up to 3,000,000 additional shares of Common Stock and/or Warrants to purchase up to 3,000,000 shares of Common Stock solely to cover over-allotments. The Overallotment Option was exercised in full on December 17, 2019. The Class A Units and Class B Units were not certificated and the shares of Common Stock, Series B Preferred Stock and Warrants comprising such Units were immediately separable and were issued separately in the Public Offering. The Units were offered by the Company pursuant to (i) the registration statement on Form S-1 (File No. 333-234530), and each amendment thereto, which was initially filed with the Securities and Exchange Commission (the "Commission") on November 6, 2019 and declared effective by the Commission on December 17, 2019 (the "Registration Statement").

On December 19, 2019, the Company issued and sold (i) 12,577,504 shares of Common Stock (which includes 3,000,000 shares of Common Stock sold pursuant to the exercise of the Overallotment Option), (ii) 6,256 shares of Series B Preferred Stock and (iii) 23,000,000 Warrants (which includes 3,000,000 Warrants sold pursuant to the exercise of the Overallotment Option) pursuant to the Registration Statement and the Underwriting Agreement. The net proceeds to the Company, after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company will be approximately $12.4 million.

Each Warrant is immediately exercisable, expires on the five (5) year anniversary of the date of issuance and is exercisable at a price per share of Common Stock of $0.60, subject to adjustment in the event of subsequent equity sales of common stock or securities convertible into common stock for an exercise price per share less than the exercise price per share of the warrants then in effect, provided, however, that the exercise price of the warrants cannot be reduced to an amount less than $0.06 per share of Common Stock. Additionally, subject to certain exceptions, if, after the closing date of the Public Offering, (i) the volume weighted average price of the Common Stock for each of 30 consecutive trading days (the "Measurement Period"), which Measurement Period commences on the closing date, exceeds 300% of the exercise price (subject to adjustments for stock splits, recapitalizations, stock dividends and similar transactions), (ii) the average daily trading volume for such Measurement Period exceeds $500,000 per trading day and (iii) certain other equity conditions are met, and subject to a beneficial ownership limitation, then the Company may call for cancellation of all or any portion of the Warrants then outstanding.

The foregoing summaries of the Underwriting Agreement and the Warrants do not purport to be complete and are subject to, and qualified in their entirety by, such documents attached as Exhibits 1.1 and 4.1, respectively, to this Current Report on Form 8-K, which are incorporated herein by reference.

BIOGEN TO PRESENT AT THE 38TH ANNUAL J.P. MORGAN HEALTHCARE CONFERENCE

On December 17, 2019 Biogen Inc. (Nasdaq: BIIB) reported that it will present at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Biogen, DEC 17, 2019, View Source [SID1234552474]). The webcast will be live on Monday, January 13, 2020 at 3:30 p.m. PT, 6:30 p.m. ET. To access the live webcast, please visit Biogen’s Investors section at www.biogen.com/investors. An archived version of the webcast will be available following the presentation.