On February 12, 2019 Ascletis Pharma Inc. (Ascletis, 1672.HK) and 3-V Biosciences, Inc. (3-V Biosciences) jointly reported that Ascletis, through its subsidiary, and 3-V Biosciences have entered into an exclusive license agreement for 3-V Biosciences’ FASN (fatty acid synthase) inhibitor TVB-2640 (Ascletis code: ASC40), a first-in-class, Phase 2-ready drug candidate for non-alcoholic steatohepatitis (NASH), in Greater China (Press release, Ascletis, FEB 12, 2019, View Source [SID1234577322]).

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In conjunction with the license agreement, 3-V Biosciences raised US$18 million in a Series E financing led by new investor Ascletis, through its subsidiary. Ascletis is joined in this financing by new investor Qianhai Ark (Cayman) Investment Co. Limited and existing investors New Enterprise Associates, Inc. (NEA) and Kleiner Perkins (KP). All investors have committed to fund an additional US$7 million in a subsequent financing. 3-V Biosciences expects to use the proceeds of the financing to support the continued development of TVB-2640, including its Phase 2 trials for NASH in the United States and China.

Under the terms of the license agreement, 3-V Biosciences granted Ascletis an exclusive license to develop, manufacture and commercialize ASC40 (TVB-2640) and related compounds in Greater China. 3-V Biosciences is eligible to receive development and commercial milestones as well as tiered royalties on future net sales of ASC40 (TVB-2640).

"We are excited about this strategic collaboration with 3-V Biosciences. Results from the phase 1b trial showed significant decrease in liver fat synthesis and indicate that ASC40 (TVB-2640) may be a promising treatment for NASH," said Jinzi J. Wu, PhD, Founder, Chairman and CEO of Ascletis, "There are no approved therapies today for NASH in China and globally. We’re thrilled to develop ASC40 (TVB-2640) for NASH in Greater China and support 3-V Biosciences’ Phase 2 multi-center trials in the United States and China."

"3-V Biosciences is excited about our partnership with Ascletis; Ascletis brings expertise and capabilities that can accelerate the advancement of TVB-2640 (ASC40) on a global scale for this important emerging disease," said George Kemble, PhD, CEO of 3-V Biosciences.

"The partnership with Ascletis, a leading expert in liver diseases, will accelerate the development of TVB-2640. We are delighted to welcome Dr. Wu to the board, and I look forward to working with him," said Beth Seidenberg, MD, board director of 3-V Biosciences and managing director of KP, an existing shareholder.

According to Dr. Rohit Loomba, MD of Univ. California San Diego, Director, NAFLD Research Center, and Principal Investigator of the upcoming Phase 2 study of TVB-2640, "I am excited to see the advancement of this compound; lipid synthesis is an important driver of NASH. This study will evaluate the impact of TVB-2640 on liver fat using advanced imaging techniques that are expected to predict the ability of this drug to address this unmet medical need."

"In 2016, there were approximately 243 million people in China with non-alcoholic fatty liver disease (NAFLD). By 2030, this is expected to increase to approximately 314 million people, of which 2.3 million will have cirrhosis," said Professor Wei Lai, MD, Director, Peking University Hepatology Institute, Chair, NAFLD and Alcoholic Liver Disease Special Interest Group (ALD SIG), Past-immediate President, Chinese Society of Hepatology of the Chinese Medical Association. "Inhibition of FASN is a promising mechanism of action for NASH. It is encouraging that Chinese biotech takes on the challenge to develop the first-in-class drug for such unmet medical need."

About TVB-2640 (ASC40).

TVB-2640 is an orally bioavailable, first-in-class inhibitor of FASN. FASN is a key enzyme in the de novo lipogenesis (DNL) pathway and catalyzes the biosynthesis of palmitate, which can then undergo further modifications into other fatty acids and complex lipids. Dysregulation of FASN activity is found in a number of different diseases, including liver diseases and cancer. NAFLD and the more advanced disease of NASH can progress to significant liver diseases, including cirrhosis and hepatocellular carcinoma.

On February 12, 2019 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, has previously reported a 72% 2-year survival rate and a 54% 5-year survival rate in patients treated with its cancer stem cell-targeting immunotherapy, ROOT OF CANCER (Press release, AIVITA Biomedical, FEB 12, 2019, View Source [SID1234533264]). AIVITA announced new data indicating that non-responders to its immunotherapy had, on average, 150,000 times more pre-existing PD-1 proteins in their bloodstreams than responders. These findings suggest a means to optimize patient inclusion criteria in AIVITA’s trials evaluating ROOT OF CANCER. Further, these findings indicate that the use of anti-PD-1 checkpoint inhibitor drugs in combination with AIVITA’s cancer stem cell-targeting immunotherapy could improve outcomes in previously unresponsive patient populations.

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PD-1 is a protein on the surface of cells which regulates the immune response and suppresses T cell inflammatory activity. PD-1 levels were monitored in cancer patient samples obtained in a randomized Phase 2 clinical trial by observing concentrations of a plasma biomarker consisting of soluble fragments of the PD-1 checkpoint protein that are shed by the patient’s T cells. The biomarker can be used to predict immune response to AIVITA’s personalized cancer immunotherapy.

"Exorbitantly high levels of PD-1 appear to be interfering with T cell activation in the non-responsive 28% of our treated patients," said Dr. Gabriel Nistor, Chief Science Officer at AIVITA. "This suggests anti-PD-1 checkpoint inhibitors could be used to counter this inhibiting effect, and allow our immunotherapy to work in patient populations that would otherwise be unresponsive."

"These data underscore a natural partnership, in which a combination therapy would be greater than either of its parts," said Dr. Hans Keirstead, CEO of AIVITA.

AIVITA has recently received IND clearance to begin a Phase 1B clinical trial testing this combination approach. AIVITA’s open-label, single-arm, phase 1B treatment study will establish safety and track efficacy of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma.

About ROOT OF CANCER

AIVITA’s treatment is a platform technology applicable to most solid tumor types and consists of autologous dendritic cells loaded with autologous tumor antigens from purified autologous self-renewing tumor-initiating cells.

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 cancer stem 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.

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

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the cancer stem 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).

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

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with the cancer stem 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.

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.

On February 12, 2019 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, reported that it has entered into a private placement with certain existing and new investors providing for the purchase of up to approximately $39.2 million of its common stock and warrants to purchase shares of Genocea common stock, in two closings (Press release, Genocea Biosciences, FEB 12, 2019, View Source [SID1234533283]).

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In the first closing, Genocea will offer 25.6 million shares of common stock and 4.25 million pre-funded warrants to purchase common stock, along with accompanying warrants to purchase 0.25 shares of common stock for each share of common stock or pre-funded warrant purchased by an investor, for expected aggregate gross proceeds to Genocea of approximately $15.0 million (before deducting fees to the placement agents and other offering expenses payable by Genocea). The warrants will be exercisable immediately upon issuance, in whole or in part, at an exercise price of $0.5656 per share and will have a five-year term. The first closing of the private placement is expected to occur on or about February 14, 2019, subject to customary closing conditions.

Contingent on satisfactory top-line immunogenicity results from the ongoing Phase 1/2a clinical trial for GEN-009, Genocea’s neoantigen vaccine candidate, expected in late second quarter or early third quarter of this year, Genocea will have the option to conduct a second closing and sell up to an additional $24.2 million of shares of common stock to the investors who participated in the first closing at a purchase price per share equal to the greater of $0.4713 per share and a per share price that is derived from the volume weighted average price of the common stock for the period between the public release of the Phase 1/2a data and Genocea’s exercise of its option to proceed with the second closing. An investor in the first closing that does not purchase at least 50% of the shares that it specified it would purchase in the second closing will forfeit any unexercised warrant purchased in the first closing.

Genocea intends to use the net proceeds from the offering to support the ongoing clinical study of GEN-009, advancing GEN-011, a neoantigen adoptive T cell therapy candidate for the treatment of cancer, toward an Investigational New Drug Application with the U.S. Food and Drug Administration, and for working capital and other general corporate purposes.

The securities sold in the offering have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Genocea has agreed to file a resale registration statement with the Securities and Exchange Commission (the "SEC") within 60 days of the closing of the offering for purposes of registering the resale of the shares of common stock issued or issuable in connection with the offering.

This notice is issued pursuant to Rule 135c under the Securities Act and does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On February 12, 2019 Yuhan Corporation (000100.KS; Yuhan) and Sorrento Therapeutics (Nasdaq: SRNE) reported that ImmuneOncia, a joint venture formed in September 2016, has completed a private equity financing of $40 million USD at a pre-money valuation of $95 million USD, which was led by Paratus SP (Private Equity Fund) (Press release, Sorrento Therapeutics, FEB 12, 2019, View Source [SID1234533284]).

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The proceeds of the transaction will be utilized to advance ImmuneOncia’s Phase I and II clinical studies of IMC-001, a PD-L1 monoclonal antibody, as well as to support its earlier stage programs. As a result of this financing, ImmuneOncia is expected to be sufficiently funded in preparation for an initial public offering, which is expected to occur in 2021.

This investment from Paratus SP was made in recognition of ImmuneOncia’s R&D capabilities, strong management team and its growth potential based on the market trends in the global immuno-oncology landscape.

"Our R&D and clinical studies have been progressing on schedule. This cash infusion allows us to move IMC-001 forward to the next stage of development," said Yun Jeong Song, M.D., CEO of ImmuneOncia Therapeutics, Inc.

"We are pleased with the continued progress made by our joint venture over the past year," added Dr Henry Ji, Chairman and CEO of Sorrento Therapeutics. "This latest $40 million USD investment by Paratus SP validates the potential of our antibody therapies in international markets."

As of the closing of the financing, equity stakes in ImmuneOncia include Yuhan at 36.1%, Sorrento at 34.6% and Paratus SP at 29.3%.

About IMC-001 (PD-L1 monoclonal antibody)

IMC-001 is a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting natural killer (NK) cells and other effector cells against the tumor and potentially further strengthening the anti-tumor effect of the antibody.

On February 12, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported that will report its fourth quarter and full year 2018 financial results on Tuesday, February 26, 2019, after the U.S. financial markets close (Press release, Dynavax Technologies, FEB 12, 2019, View Source [SID1234533267]).

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Dynavax will host a conference call and live audio webcast on Tuesday, February 26, 2019, at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events &Presentations" page in the "Investors" section of the company’s website at www.dynavax.com. Alternatively, participants may dial (877) 423-9813 (domestic) or (201) 689-8573 (international) and refer to conference ID 13687416.

The archived conference call will be available on Dynavax’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.