On December 15, 2020 Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that it has withdrawn the proposed underwritten offering of American Depositary Shares ("ADS") due to market conditions (Press release, Cellectis, DEC 15, 2020, View Source [SID1234572875]).

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The Company believes that it is not in the best interest of its stockholders to raise the equity capital in the current market environment. Cellectis remains well capitalized with a cash position at the end of the third quarter of 2020 of $308 [1] million to fund its key programs into 2022.

Cellectis is well positioned on all fronts, and the entire team remains steadfast in its mission to develop innovative product candidates to benefit cancer patients.

[1] Cash position includes cash, cash equivalents and current financial assets and restricted cash. Restricted cash was $26 million as of September 30, 2020.

On December 15, 2020 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported four projects selected to receive funding for clinical evaluation of axitinib (Press release, NCCN, DEC 15, 2020, View Source [SID1234572895]). Axitinib, a small molecule indazole derivative, is an oral multi-targeted tyrosine kinase inhibitor of Vascular Endothelial Growth Factor (VEGF) Receptors 1, 2, and 3. NCCN issued the initial Request for Proposals and convened a Scientific Review Committee from across NCCN Member Institutions to select projects. The studies will receive funding and oversight from Pfizer.

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The following projects were selected:

Phase II Study of Axitinib + Ipilimumab in Advanced Melanoma
Zeynep Eroglu, MD, Moffitt Cancer Center
Single-arm Phase II Study of Axitinib, Avelumab, and Bavituximab in Advanced HCC
David Hsieh, MD, UT Southwestern Simmons Comprehensive Cancer Center
Phase II Study of Axitinib + PD-1 Blockade in Mucosal Melanoma with Adaptive Phase I Escalation in Select Progressors
Alexander Shoushtari, MD, Memorial Sloan Kettering Cancer Center
Phase I-II Study of Hepatic Chemoembolization With Irinotecan-Loaded Drug-Eluting Microspheres (DEBIRI) Plus Axitinib and Hydrochlorquine for Liver-Dominant Metastatic Adenocarcinoma Of The Colon And Rectum
Michael Soulen, MD, Abramson Cancer Center at the University of Pennsylvania
"We’re particularly interested in learning more about the efficacy of axitinib in combination with various other anti-cancer agents, that may exploit its specific pharmacokinetics," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "These innovative studies will add to our knowledge base for treating challenging cancer presentations, as part of our ongoing exploration into how to improve patient outcomes. All of the selected researchers should be commended for their meritorious proposals."

The projects are set to begin by August 2021.

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database. For more information, visit NCCN.org/orp.

On Tuesday December 15, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported the closing of an underwritten public offering of 6,095,000 shares of its common stock, including the exercise in full by the underwriters of their option to purchase up to an additional 795,000 shares of common stock, at a public offering price of $45.25 per share (Press release, Forma Therapeutics, DEC 15, 2020, View Source [SID1234572869]). The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $275.8 million. All of the shares in the offering were offered by Forma.

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Jefferies, SVB Leerink and Credit Suisse acted as joint book-running managers for the offering. Oppenheimer & Co acted as lead manager for the offering.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or 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.

Registration statements relating to these securities became effective on December 10, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].

On December 15, 2020 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that MediciNova will be added to the NASDAQ Biotechnology Index (NASDAQ: NBI) effective prior to the market open on Monday, December 21, 2020 (Press release, MediciNova, DEC 15, 2020, View Source [SID1234572876]).

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The NASDAQ Biotechnology Index (NBI) is designed to track the performance of a set of securities listed on the NASDAQ Stock Market (NASDAQ) that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. The addition of MediciNova to the NBI is a result of the annual reconstitution of the index.

The NASDAQ Biotechnology Index is the benchmark index for the iShares Nasdaq Biotechnology ETF (exchange-traded fund) (NASDAQ: IBB), which has net assets of $10.2 billion, as well as for other biotechnology-focused ETFs and mutual funds.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, "We are excited that MediciNova has been added to the NASDAQ Biotechnology Index and we believe that our inclusion in this index will raise our profile in the investment community. We consider this milestone to be a substantial accomplishment as it validates our tireless work to create value for the company. We remain focused on our mission to develop promising new therapies for diseases with high unmet medical needs and we continue to manage our expenses efficiently."

On December 15, 2020 Nektar Therapeutics (NASDAQ:NKTR) reported that the first patient has been dosed in the Phase 1/2 trial of NKTR-255, Nektar’s investigational IL-15 pathway agonist, in patients with relapsed or refractory (R/R) head and neck squamous cell carcinoma (HNSCC) or colorectal cancer (CRC) at the START Center for Cancer Care in San Antonio, TX (Press release, Nektar Therapeutics, DEC 15, 2020, View Source [SID1234572897]). The study is evaluating NKTR-255 plus cetuximab in up to 80 patients at approximately 15 investigator sites in the United States and European Union.

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NKTR-255 is designed to activate the IL-15 pathway and expand Natural Killer (NK) cells as well as promote the survival and expansion of CD8+ T cells without inducing suppressive regulatory T cells. Cetuximab is a monoclonal antibody against epidermal growth factor receptor (EGFR) and is approved for the treatment of advanced HNSCC and CRC.

"An NK-cell agent such as NKTR-255 is a perfect and unique complement to monoclonal antibody therapies which induce antibody-dependent cellular cytotoxicity," said Wei Lin, MD, Head of Development at Nektar. "Our body of preclinical and clinical data for NKTR-255 demonstrates that this novel agent not only induces NK cell proliferation but also enhances their cytotoxic immune effector function. With this new Phase 1/2 study in HNSCC and CRC, we are excited to expand our NKTR-255 development program beyond the hematological setting into solid tumors."

Nektar recently presented the first clinical data for NKTR-255 at the most recent 2020 Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November. The data demonstrated that NKTR-255 was well tolerated and biologically active, and treatment resulted in consistent expansion of lymphocytes, with durable and sustained increases in NK and CD8+ T cells in a highly refractory population of patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL).

The new Phase 1b/2 study will test the combination of NKTR-255 with cetuximab in two groups of patients. One group will consist of R/R head and neck cancer patients who have progressed after treatment with platinum-based chemotherapy and a checkpoint inhibitor. The second group will include patients with metastatic colorectal cancer who have received two prior treatments for metastatic disease. The trial will begin with a dose-finding portion for the combination, which will then be expanded into dedicated cohorts for head and neck and colorectal cancer patients.

About NKTR-255

NKTR-255 is an investigational IL-15 receptor agonist designed to activate the IL-15 pathway and expand NK cells and promote the survival and expansion of memory CD8+ T cells without inducing suppressive regulatory T cells. Through optimal engagement of the IL-15Rα/IL-2Rβγ receptor complex, NKTR-255 enhances functional NK cell population and formation of long-term immunological memory, which may lead to sustained anti-tumor immune response. NKTR-255 is uniquely designed to overcome the challenges of recombinant IL-15 and other IL-15 agonists, which are rapidly cleared from the body and have shown diminishing response to successive doses.1 NKTR-255 is wholly-owned by Nektar.