On March 4, 2021 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that members from the Replimune management team will present and host one-on-one meetings at the following three virtual investor conferences (Press release, Replimune, MAR 4, 2021, View Source [SID1234576069]).

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H.C. Wainwright Global Life Sciences Conference
Date: March 9-10, 2021
Pre-Recorded Formal Presentation will be made live: Tuesday, March 9, 2021 at 7:00 am ET

Barclays Global Healthcare Conference
Date: Thursday, March 11, 2021
Fireside Chat Presentation Time: 9:10 am ET

33rd Annual Roth Conference
Date: Wednesday, March 17, 2021
Presentation Time: 1:30 pm ET

A simultaneous webcast of the fireside chat presentation at the Barclays Global Healthcare Conference will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for approximately 90 days following the conference.

On March 4, 2021 VBL Therapeutics (Nasdaq: VBLT) reported the online publication of positive results of the pre-specified interim analysis of the OVAL study, a Phase 3 registration enabling study of VB-111 (ofranergene obadenovec) in recurrent platinum-resistant ovarian cancer (Press release, VBL Therapeutics, MAR 4, 2021, View Source [SID1234576056]). The analysis showed a CA-125 GCIG response rate of 58% or higher in evaluable patients in the VB-111 treatment arm. Based on the results of the interim analysis, the Data and Safety Monitoring Committee (DSMC) recommended continuing the trial as planned. The results were published online in the international peer reviewed journal Gynecologic Oncology (View Source).

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"The goal of this interim analysis was to get a signal of drug activity, using CA-125 as a validated biomarker," said Bradley J. Monk, M.D., FACOG, FACS, Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Head of the OVAL steering committee and author on the manuscript. "The intention was to reduce the risk of a negative trial and increase the chance of success. New and novel approaches that have the potential to significantly extend progression free survival or survival are eminently required in platinum-resistant ovarian cancer. VB-111, with its very unique mechanism of action, could be one of those novel approaches and I look forward to the progress of the OVAL trial, which is well designed to test this hypothesis."

The article reported results of the pre-specified interim analysis in the OVAL study, which reviewed unblinded data and assessed CA-125 response, measured according to the GCIG criteria, in the first 60 enrolled subjects evaluable for CA-125 analysis. Based on the overall response rate in the first 60 patients across both arms of 53%, and assuming balanced randomization and an absolute advantage of 10% or higher to the VB-111 arm, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) was calculated to be 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate was 69%. The futility rule determined for this analysis was that the response rate of VB-111 must be greater than the response rate of placebo by at least 10% in order to continue the study. This rule was successfully met.

"We believe VB-111’s unique dual mechanism of action has the potential to prolong life and possibly turn certain cancers into manageable chronic diseases," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "The encouraging trajectory of the OVAL trial, not only as reported in this paper but also based on the pre-specified DSMC reviews, makes us hopeful that VB-111 may have a meaningful impact on ovarian cancer."

About the OVAL study (NCT03398655)
OVAL is an international Phase 3 randomized pivotal registration enabling 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.

About VB-111 (ofranergene obadenovec)
VB-111 is an investigational first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that uses a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 studies. VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. VB-111 demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970).

On March 4, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that that it plans to host a conference call on Thursday, March 11, 2020, at 8:30 a.m. ET to discuss its financial results for the quarter and full-year ended December 31, 2020, and recent operational highlights (Press release, Selecta Biosciences, MAR 4, 2021, https://selectabio.gcs-web.com/news-releases/news-release-details/selecta-biosciences-host-conference-call-and-webcast-discuss-3 [SID1234576055]).

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Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10147796. Investors and the public can access the live and archived webcast of this call via the Investors & Media section of the company’s website, www.selectabio.com.

On March 4, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported through a subsidiary, a cash tender offer to purchase all outstanding shares of common stock of Pandion Therapeutics, Inc. (Nasdaq: PAND) (Press release, Merck & Co, MAR 4, 2021, View Source [SID1234576054]). On Feb. 25, 2021, Merck announced its intent to acquire Pandion.

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Upon the successful closing of the tender offer, stockholders of Pandion will receive $60 in cash for each share of Pandion common stock validly tendered and not validly withdrawn in the offer, without interest and less any required withholding taxes. Following the purchase of shares in the tender offer, Pandion will become a subsidiary of Merck.

Merck will file today with the U.S. Securities and Exchange Commission (the "SEC") a tender offer statement on Schedule TO, which provides the terms of the tender offer. Additionally, Pandion will file with the SEC a solicitation/recommendation statement on Schedule 14D-9 that includes the recommendation of the Pandion board of directors that their stockholders accept the tender offer and tender their shares.

The tender offer will expire at one minute past 11:59 pm Eastern Time on March 31, 2021, unless extended in accordance with the merger agreement and the applicable rules and regulations of the SEC. The closing of the tender offer is subject to certain conditions, including the tender of shares representing at least a majority of the total number of Pandion’s shares of fully-diluted common stock, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the first half of 2021.

Additional Information About the Tender Offer

This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Pandion Therapeutics, Inc. ("Pandion") or any other securities. A tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed today by Merck Sharp & Dohme Corp. and Panama Merger Sub, Inc., a wholly-owned subsidiary of Merck, with the SEC, and a solicitation/recommendation statement on Schedule 14D-9 will be filed today by Pandion with the SEC. The offer to purchase shares of Pandion common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO.

INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.

Investors and security holders may obtain a free copy of these statements and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the offer, which will be named in the tender offer statement. Additional copies of the tender offer materials may be obtained at no charge by contacting Merck at 2000 Galloping Hill Road, Kenilworth, N.J., 07033 or by phoning (908) 423-1000. In addition, Merck and Pandion file annual, quarterly and current reports and other information with the SEC. Merck’s and Pandion’s filings with the SEC are also available to the public from commercial document-retrieval services and at the SEC’s website at www.sec.gov.

On March 4, 2021 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported the publication of pre-clinical data highlighting the potential of its alternating 2-vector, intravenously administered cancer therapeutics in the peer-reviewed journal, Cell Reports Medicine (Press release, Hookipa Pharma, MAR 4, 2021, View Source [SID1234576053]). The publication, which is available online now, will appear in the 16 March print issue.

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"The pre-clinical data published in Cell Reports Medicine underscore the potential of our engineered arenavirus platform to redefine success in cancer immunotherapy. Specifically, our alternating 2-vector approach delivered a substantial tumor-specific response, resulting in tumor cures and long-term anti-tumor immunity in a pre-clinical setting," said Joern Aldag, Chief Executive Officer at HOOKIPA. "The data in this peer-reviewed publication provide the scientific substantiation for the ongoing clinical trial of the alternating 2-vector therapy for Human Papillomavirus 16-positive (HPV16+) cancers as well as for advancing to prostate cancer."

Pre-clinical data featured in the article showed that intravenous, alternating administration of two different replicating arenaviral vectors that express the same antigen induces potent T cell response, exceeding 50% of the circulating T cell pool, and robust anti-tumor activity. The anti-tumor activity and very high T cell generation were demonstrated both with onco-viral antigens and also with a cancer self-antigen, illustrating the ability of the arenaviral platform to break tolerance.

Other key highlights from the paper include:

Single-vector and alternating 2-vector therapy did not induce vector-neutralizing antibodies, supporting repeated intravenous administration
Mice that cleared tumors after therapy were protected from tumor re-challenge
Expanding on the data observed with single-vector therapy, alternating 2-vector therapy induced an even higher T cell response and more efficient tumor control
The study on which this publication is based, was conducted and led by an international group of researchers at the University of Basel.

HOOKIPA is evaluating its single-vector and alternating 2-vector technologies in the ongoing Phase 1/2 clinical trial of its lead oncology candidates, HB-201 and HB-202. HB-201 and HB-202 use the LCMV and PICV arenaviral backbones, respectively, while expressing the same antigen, an E7/E6 fusion protein derived from HPV16. Interim Phase 1 monotherapy data on HB-201 for the treatment of advanced HPV16+ cancers showed promising anti-tumor activity and favorable tolerability. Data demonstrated responses and stable disease in head and neck cancer patients who failed prior standard of care therapy, platinum therapy, PD(L)1 inhibitor, or both. Initial data on HB-201 and HB-202 as a replicating 2-vector therapy are anticipated by mid-2021. HOOKIPA’s HB-300 program for prostate cancer also uses the LCMV and PICV arenaviral backbones directed against three validated antigens for prostate cancer: PAP, PSA, and PSMA.