On January 15, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will participate in a fireside chat during the B. Riley Securities Oncology Investor Conference being held virtually (Press release, TG Therapeutics, JAN 15, 2021, View Source [SID1234574054]). The fireside chat is scheduled to take place on Wednesday, January 20, 2021 at 10:00 AM ET.

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A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source A replay of the webcast will be available on TG’s website following the event.

On January 15, 2021 VBL Therapeutics (Nasdaq: VBLT), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for areas of unmet need in cancer and immune/inflammatory indications, reported that it has entered into an Ordinary Share Purchase Agreement with Aspire Capital Fund, LLC (Press release, VBL Therapeutics, JAN 15, 2021, View Source [SID1234574055]). Proceeds from any sales of ordinary shares pursuant to the Purchase Agreement will be used for working capital and for general corporate purposes.

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Under the Agreement, Aspire has committed to purchase up to $20 million of the Company’s ordinary shares at VBL Therapeutics’ discretion from time to time during a 30-month period at prices based on the market price at the time of each sale. VBL Therapeutics will retain full control as to the timing and amount of any sale of ordinary shares to Aspire, subject to certain limitations specified in the Purchase Agreement. The Purchase Agreement does not contain any restrictions on the use of any of the proceeds or future financings and there are no financial covenants, participation rights, rights of first refusal, or penalties. There are no warrants or other derivative securities associated with the transaction. VBL Therapeutics has the right to terminate the Purchase Agreement at any time without any additional cost or penalty.

"We believe that VBL Therapeutics has cultivated a promising yet underappreciated pipeline of anti-cancer and anti-inflammatory agents underpinned by robust in-house manufacturing capabilities. Given the positive initial reports and noteworthy enrollment progress with OVAL, we are very enthusiastic about VB-111’s prospects in ovarian cancer and are looking forward to the study’s results. We’re also eager to support the progress of VBL’s antibodies targeting MOSPD2, especially following the exciting results reported in 2020 at major medical meetings including AACR (Free AACR Whitepaper) and EULAR," stated Steven G. Martin, Managing Member of Aspire Capital.

"We are excited to enter into this transaction with Aspire Capital, a healthcare-focused institutional investor," added Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "This Purchase Agreement provides VBL the opportunity to access capital at the Company’s discretion, in a reasonable and efficient manner, to support our ongoing OVAL phase 3 study of VB-111 in patients with platinum-resistant ovarian cancer. We recently announced the expansion of OVAL into Europe and reported that the study has surpassed 200 patients enrolled, and will undergo its third DSMC review this quarter. The capital we have access to under this Purchase Agreement will help us maintain a strong balance sheet through top-line results from OVAL, as well as readouts from additional ongoing studies of VB-111 in colorectal cancer and recurrent glioblastoma by the NCI and Dana Farber, respectively. Importantly, this added financial flexibility may help us to advance development of VB-601, a first-in-class anti-MOSPD2 monoclonal antibody, which has potential across multiple chronic inflammatory indications."

A more complete and detailed description of the Purchase Agreement and the related registration rights agreement is set forth in VBL Therapeutics’ Current Report on the Form 6-K, filed today with the U.S. Securities and Exchange Commission.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will 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 registration or qualification under the securities laws of any such state or other jurisdiction.

About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal potential registration clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies.

On January 15, 2021 Affimed N.V. ("Affimed" or the "Company") (Nasdaq: AFMD), a clinical stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported the closing of its previously announced public offering of 16,666,667 common shares, at the public offering price of $6.00 per share, and the exercise in full by the underwriters of their option to purchase an additional 2,500,000 common shares (Press release, Affimed, JAN 15, 2021, View Source,16%2C666%2C667%20common%20shares%2C%20at%20the [SID1234574057]). The exercise of the option to purchase over-allotment shares brought the total number of common shares sold by Affimed to 19,166,667 common shares and increased the gross proceeds raised in the offering, before deducting underwriting discounts and commissions and estimated expenses of the offering payable by Affimed, to $115 million.

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Jefferies LLC, SVB Leerink LLC and Credit Suisse Securities (USA) LLC are acting as joint book-running managers and Laidlaw & Company (UK) Ltd. is acting as co-manager. A shelf registration statement relating to these securities filed with the Securities and Exchange Commission (the "SEC") was declared effective by the SEC on December 30, 2020. The offering was made only by means of a prospectus and prospectus supplement. A prospectus supplement and accompanying prospectus related to the offering have been filed with the SEC and are available at the SEC’s website located at www.sec.gov. Copies of the prospectus supplement and accompanying prospectus related to the offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or 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], or 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]

This press release shall not constitute an offer to sell or a 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 January 15, 2021 NANOBIOTIX (Paris:NANO) (NASDAQ:NBTX) (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company"), a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform cancer treatment, reported positive first results from the complete phase Ib part of a phase Ib/II study evaluating NBTXR3 (PEP503) activated by radiotherapy with concurrent chemotherapy (Press release, Nanobiotix, JAN 15, 2021, View Source [SID1234574058]). This study is sponsored and administered by PharmaEngine, Inc. in Taiwan pursuant to a License and Collaboration agreement with the Company. The data were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI 2021).

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A NEW RADIOENHANCER, PEP503 (NBXTR3), IN COMBINATION WITH CONCURRENT CHEMORDIATION IN LOCALLY ADVANCED OR UNRESECTABLE RECTAL CANCER: THE DOSE-FINDING PART OF A PHASE IB/II TRIAL
Authors: Jaw-Yuan Wang, Ching-Wen Huang, Ming-Yii Huang, Huang-Ming Hu, Wen-Hung Hsu, Hsiang-Yao Shih, Chiao-Yun Chen, Chou-Pin Chen, Jeffrey Yung-Chuan Chao, You-Hsin Chiu

Abstract Number: 66

Background

Radiotherapy, chemotherapy and surgery are elements of the standard of care for patients with rectal cancer. Concurrent chemoradiation (CCRT) followed by surgery, if possible, is the recommended option for patients with resectable (surgically removable) T3 to T4 tumors, or who have locally unresectable or inoperable disease. Better response to CCRT, prior to surgery, may be associated with better long-term treatment outcomes.

The potential efficacy of tumor-agnostic NBTXR3 in increasing tumor shrinkage—as observed in phase I head and neck cancer, and phase I liver cancer studies—may result in tumor downstaging and lead to an improvement in surgical outcomes.

Study Design

The complete dose-finding part of this phase Ib/II study evaluated the safety, feasibility and recommended phase II dose of NBTXR3 for patients with locally advanced (T3 to T4) or unresectable rectal cancer. The study enrolled 20 patients: with seven, four, three, and six patients at the 5%, 10%, 15%, and 22% dose levels, respectively.

Topline Results

Intratumoral injection of NBTXR3 with CCRT was feasible and the product candidate was well tolerated at all dose levels, and no adverse events (AEs) or serious adverse events (SAEs) associated with NBTXR3 were observed in the study. One dose-limiting toxicity associated with the injection procedure was observed (urinary tract infection). The most frequently reported AEs were diarrhea (approximately 45%), leukopenia (approximately 40%), and dermatitis (approximately 25%), however all were grade one or grade two.

More than 70% of patients in the study showed objective tumor response after CCRT. Around 90% of patients underwent total mesorectal excision (surgery); and 17.6% achieved pathological complete response (pCR). 50% of patients receiving surgery in the study had good tumor regression (tumor regression grade 0 or 1 according to modified Ryan scheme).

The RP2D has been defined as 22% of tumor volume and the extension phase II is ongoing in Taiwan.

About NBTXR3
NBTXR3 is a novel, potentially first-in-class product candidate designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.

On January 15, 2021 AVEO Oncology (Nasdaq: AVEO) reported the presentation of results from the Phase 1b portion of the Phase 1b/2 DEDUCTIVE clinical trial of tivozanib (FOTIVDA), AVEO’s vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) drug candidate, in combination with IMFINZI (durvalumab), AstraZeneca’s (LSE/STO/Nasdaq: AZN) human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with advanced or metastatic hepatocellular carcinoma (HCC) (Press release, AVEO, JAN 15, 2021, View Source [SID1234574059]). The results are being presented today in a poster session at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (ASCO GI) Cancers Symposium being held virtually.

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A total of seven patients with advanced or metastatic HCC were enrolled in the Phase 1b portion of the study, which was designed to determine the recommended Phase 2 dose and assess preliminary safety and efficacy of the tivozanib/durvalumab combination. Patients received 1.0 mg of tivozanib for 21 days followed by 7 days off therapy combined with 1500 mg of durvalumab every 28 days. The combination was well tolerated, with no dose-limiting toxicities. The combination demonstrated a 29% partial response (PR) rate and 71% disease control rate (PR + stable disease). Completion of enrollment in the ongoing Phase 2 portion of the study, which is expected to enroll up to an additional 30 subjects, is anticipated later this year.

"With a five-year survival rate of less than 5%, advanced or metastatic HCC represents an area of high unmet need," said Renuka Iyer, M.D., Professor of Oncology and Co-Director, Liver and Pancreas Tumor Center, Roswell Park Comprehensive Cancer Center. "These data demonstrated the tolerability of the tivozanib and immunotherapy combination, and I look forward to its further evaluation in the Phase 2 portion of the study."

"We believe that data observed in the Phase 1b portion of the DEDUCTIVE study continue to support tivozanib’s potential to serve as an attractive VEGFR TKI to use in the immunotherapy combination setting," said Michael Bailey, president and chief executive officer of AVEO. "As we await a decision on our New Drug Application for single agent tivozanib in relapsed or refractory renal cell carcinoma (RCC), we remain focused on executing on our combination strategy, including in metastatic RCC and HCC."

About Tivozanib (FOTIVDA)

Tivozanib is an oral, once-daily, next-generation VEGFR TKI discovered by Kyowa Kirin Co. and approved as FOTIVDA for the treatment of adult patients with advanced RCC in the European Union and other countries in the territory of the Company’s partner, EUSA Pharma (UK) Limited (EUSA territory). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib is being studied in the TIVO-3 trial, which is supporting a regulatory submission of tivozanib in the U.S. seeking marketing approval as a treatment for adult patients with relapsed or refractory advanced RCC. Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC.4 Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers. Tivozanib is also being studied by partner Kyowa Kirin Co. in non-oncology indications.