On June 15, 2020 AVEO Oncology (Nasdaq: AVEO) reported that it has commenced an underwritten public offering of $40.0 million of shares of its common stock (Press release, AVEO, JUN 15, 2020, View Source [SID1234561111]). In connection with the offering, AVEO intends to grant the underwriters a 30-day option to purchase up to an additional $6.0 million of shares of its common stock. All of the shares in the offering are to be sold by AVEO. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including funding commercialization activities relating to tivozanib.

SVB Leerink and Stifel are acting as joint bookrunning managers for the offering. Baird and H.C. Wainwright & Co. are acting as co-lead managers for the offering.

The shares are being offered by AVEO pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on November 30, 2017 and declared effective by the SEC on December 15, 2017. A preliminary prospectus supplement relating to, and describing the terms of, the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov.

Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering can be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6218 or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, 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.

On June 15, 2020 Codiak BioSciences, Inc., a company at the forefront of advancing engineered exosomes as a new class of biologic medicines, reported that it will present new preclinical data on its exoASO-STAT6 and exoASO-C/EBPβ programs via an oral presentation at the American Association For Cancer Research (AACR) (Free AACR Whitepaper) 2020 Virtual Annual Meeting II on June 23, 2020 (Press release, Codiak Biosciences, JUN 15, 2020, View Source [SID1234561110]).

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Codiak’s exoASO program utilizes its proprietary engEx Platform to engineer exosomes exogenously loaded with an antisense oligonucleotide (ASO). These exosomes are designed to selectively reprogram M2 immunosuppressive macrophages to an M1 pro-inflammatory phenotype by targeting and decreasing the expression of the immunosuppressive transcription factors STAT6 and C/EBPβ.

"These new data are encouraging because they demonstrate that both exoASO-STAT6 and exoASO-C/EBPβ showed significant efficacy when administered intravenously in an aggressive orthotopic model of hepatocellular carcinoma," said Sriram Sathy, Ph.D, Senior Vice President, Preclinical Development at Codiak BioSciences. "We are excited to continue to advance this program through IND-enabling preclinical studies."

Oral Presentation:

Genetic reprogramming of TAMs by engineered exosomes results in potent single agent anti-tumor activity
Abstract Number: 4723
Presentation Number: 5696
Session Title: Novel Immunotherapies and Mechanisms
Date/Time: Tuesday June 23, 2020 from 9:35-9:50 AM ET

About engEx Platform

The engEx Platform is Codiak’s proprietary exosome therapeutic engine for engineering and manufacturing novel exosome product candidates designed to target multiple pathways throughout the body. Using this platform, Codiak can design exosomes with precisely engineered properties, incorporate various types of biologically active molecules and direct them to specific cell types and tissues. These exosomes engage targets by cellular uptake, membrane-to-membrane interaction or a combination of both mechanisms and are designed to change the biological functioning of the recipient cells in order to produce the intended biological effect. Codiak is building a broad pipeline of engEx product candidates that may have a transformative impact on the treatment of many diseases.

On June 15, 2020 Shattuck Labs, Inc. ("Shattuck"), a clinical-stage biotechnology company advancing its proprietary Agonist Redirected Checkpoint (ARC) platform to develop a novel class of biologic medicines for the treatment of cancer and autoimmune disease, reported the closing of a $118 million Series B equity financing. Redmile Group was the lead investor, with other new investors including Janus Henderson Investors, Fidelity Management & Research Company, LLC, EcoR1 Capital, Hatteras Venture Partners, Avidity Partners, Partner Fund Management, Emerson Collective, and Piper Sandler & Co., as well as participation from existing investors (Press release, Shattuck Labs, JUN 15, 2020, View Source [SID1234561109]).

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"Over the past four years we have pioneered the development of our proprietary ARC technology platform, which consolidates checkpoint blockade and tumor necrosis factor receptor superfamily (TNFRSF) agonism into single therapeutics, tackling many of the risks associated with a new biologics platform along the way," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. "The support from this syndicate of experienced life science investors will accelerate clinical development of multiple programs aimed to establish ARC therapeutics as an entirely new class of biologic medicine."

The proceeds from the financing will be used to support the continued clinical development of SL-172154 (SIRPα-Fc-CD40L), a wholly-owned fusion protein that combines CD47 inhibition with CD40 co-stimulation, and SL-279252 (PD1-Fc-OX40L), Shattuck’s lead PD1 asset being developed in collaboration with Takeda Pharmaceuticals. Shattuck anticipates adding another clinical program in 2021 and continuing the development of an innovative pipeline of compounds for the treatment of cancer and autoimmune disease.

On June 15, 2020 Solasia Pharma K.K. (TOKYO:4597, Headquarters: Tokyo, President & CEO: Yoshihiro Arai, hereinafter "Solasia"), a specialty pharmaceutical company based in Asia, reported the positive results from the pivotal Phase 2 study with SP-02 (a new anti-cancer drug, international generic name: darinaparsin, hereinafter "darinaparsin") for relapsed or refractory peripheral T-cell lymphoma (hereinafter "PTCL") in Asia (Press release, Solasia, JUN 15, 2020, View Source [SID1234561108]).

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The primary endpoint (antitumor effect) was achieved.
No new safety concerns were identified in the safety analysis.
This study was conducted as the final registration trial for the indication of relapsed or refractory PTCL. Solasia begins preparing for the NDA Filing.
Darinaparsin is a novel mitochondrial targeting drug (organic arsenic compound) that has been developed for the treatment of various hematological cancers and solid cancers. This study was conducted as a multinational, multicentre, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of darinaparsin monotherapy in relapsed or refractory patients with PTCL in Japan, South Korea, Taiwan and Hong Kong.

Solasia holds an exclusive worldwide license to develop and commercialize darinaparsin. For Japan market, Solasia has already entered into an exclusive license agreement with Meiji Seika Pharma Co., Ltd., for the commercialization of darinaparsin, and for Latin America, with HB Human BioScience SAS. Based on these positive results, Solasia will actively seek licensing partners for the United States, Europe and other regions.

About darinaparsin (SP-02)

Darinaparsin is a novel mitochondrial-targeted agent (organoarsenic) being developed for the treatment of various hematologic and solid cancers. In a US Phase 2 study, darinaparsin demonstrated evidence of clinical activity in lymphoma, in particular PTCL. Furthermore, the Phase 1 study done in US, and the Pan-Asian Phase 1 study both demonstrated positive efficacy and safety. Darinaparsin has been granted orphan drug designation in US and EU.
For more information, please see at View Source

About peripheral T-cell lymphoma (PTCL)

Malignant lymphoma is a general term to describe tumors that have developed from lymphocytes, mainly in the immune tissue (lymph nodes). A variety of clinical pathological characterizations present in malignant lymphoma. Malignant lymphoma is classified as Hodgkin Lymphoma (HL) and Non-Hodgkin’s Lymphoma (NHL). NHL mainly consists of B-cell lymphoma and T-cell lymphoma. It is reported that relatively higher incidence of T-cell lymphoma rather than B-cell lymphoma in Japan and Asia. PTCL is a major subtype of T-cell lymphoma with a high incidence rate. Although there is no standard treatment established to treat PTCL, CHOP therapy is widely used as front line treatment. However, there is a large need for more effective and safer therapies as the clinical efficacy of CHOP to treat PTCL is limited. In addition, there are no standard salvage therapies for PTCL, and new, breakthrough therapies are needed.

On June 15, 2020 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed pharmaceutical products and development-stage pharmaceutical product candidates, reported that Lindsay Rosenwald, M.D., Chairman, President and Chief Executive Officer, will present a company overview and host one-on-one investor meetings at the Raymond James Human Health Innovation Conference (Press release, Fortress Biotech, JUN 15, 2020, View Source [SID1234561107]). The presentation will take place on Thursday, June 18, 2020, at 11:00 a.m. EDT. The conference will be held in a virtual meeting format.

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