On April 10, 2023 Sanofi reported that it has withdrawn and refiled its Premerger Notification and Report Form under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the "HSR Act"), in connection with Sanofi’s pending acquisition of Provention Bio, Inc (Press release, Sanofi, APR 10, 2023, View Source [SID1234629915]). As previously announced on March 24, 2023, Sanofi commenced a cash tender offer to purchase all outstanding shares of common stock of Provention Bio, Inc. (the "Shares"), for $25.00 per Share, to the seller thereof in cash, without interest and subject to any withholding taxes required by applicable law.

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Sanofi has elected to withdraw and refile its Premerger Notification and Report Form, which was initially filed on March 24, 2023, to provide the Federal Trade Commission (the "FTC") with additional time for review. Following such refiling, the waiting period under the HSR Act will expire at 11:59 P.M., Eastern Time, on April 25, 2023. The acquisition is expected to close in the second quarter of 2023.

Consummation of the tender offer remains subject to, among other conditions, the expiration or termination of the applicable waiting period under the HSR Act. As a result, Sanofi is extending the tender offer, which was previously scheduled to expire at one minute after 11:59 P.M., Eastern Time, on April 20, 2023, until one minute after 11:59 P.M., Eastern Time, on April 26, 2023. The tender offer may be extended further in accordance with the merger agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission (the "SEC"). All other terms and conditions of the tender offer will remain unchanged during the extended period.

Innisfree M&A Incorporated is acting as information agent for the tender offer. Requests for documents and questions regarding the tender offer may be directed to Innisfree M&A Incorporated by telephone, toll-free at (877) 800-5195 for shareholders, or collect at (212) 750-5833 for Banks and Brokers.

On April 10, 2023 OBI Pharma, Inc. (TPEx: 4174) reported preclinical data demonstrating significant synergistic effects of OBI-999 and pembrolizumab (anti-PD1 mAb) in four different cancer models, as well as the potent antitumor effect of a chimeric antigen receptor T-cell (CAR T) immunotherapy targeting Globo H (Press release, OBI Pharma, APR 10, 2023, View Source [SID1234629913]). These data will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from 14th-19th April, 2023 in Orlando, Florida (USA).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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OBI’s Chief Scientific Officer, Ming-Tain Lai, Ph.D. commented that "Our scientific data suggest OBI-999 creates a tumor microenvironment that can significantly enhance the function of pembrolizumab. This potentiated anti-tumor effect was evident in four different xenograft models (breast, gastric, colorectal, and small cell lung cancer) that expressed Globo H and PD-1. These findings support the clinical study of combination therapeutic strategies that pair OBI-999 with anti PD-1/PD-L1 cancer therapeutics. OBI has also developed the first CAR T-cell therapy (OBI-R007) targeting Globo H, which demonstrates a strong and specific anti-tumor effect on Globo H-expressing tumor cells. These encouraging results warrant further development of this novel cellular therapy."

Title: OBI-999, an anti-Globo H antibody drug conjugate, exhibits synergistic anti-tumor effect in combination with pembrolizumab
Authors1: Chun-Chung Wang, Chi-Huan Lu, Jhih-Jie Yang, Wan-Fen Li, Ming-Tain Lai.
Session Title: Tumor-Stromal Cell (Including Immune Cell) Interactions and Therapy Responses
Location: Section 7
Poster Board Number: 5946/7
Abstract Presentation Number: 5946
Session Date and Time: Wednesday Apr 19, 2023, 9:00 AM – 12:30 PM

Title: Globo H-targeted CAR T cell cancer immunotherapy
Authors1: Jiann-Shiun Lai, Shiou-Ling Jian, Woan-Eng Chan, Ming-Tain Lai.
Session Title: CAR T-cell Therapy 2
Location: Section 23
Poster Board Number: 4084/3
Abstract Presentation Number: 4084
Session Date and Time: Tuesday Apr 18, 2023, 9:00 AM – 12:30 PM

1 OBI Pharma, Inc., Taipei, Taiwan.

The e-posters will be available for browsing at the AACR (Free AACR Whitepaper) Annual Meeting beginning at 12:00 PM ET on April 14, as well as on the OBI Pharma website (www.obipharma.com) beginning on April 20.

On April 10, 2023 Humane Genomics reported that it is presenting at the AACR (Free AACR Whitepaper) annual meeting for the first time (Press release, Humane Genomics, APR 10, 2023, View Source [SID1234629905]). AACR (Free AACR Whitepaper) is the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and its meeting is the largest in the world of cancer research. Last year, over 20,000 scientists, clinicians and other health care professionals, and survivors and patient advocates from around the world traveled to New Orleans. The AACR (Free AACR Whitepaper) meeting for 2023 is held in Orange County Convention Center, Orlando, Florida and we have been invited to do a poster presentation of our work. The abstract of the poster has been published by AACR (Free AACR Whitepaper). Humane Genomics will be presenting the poster on Sunday April 16th from 10am – 3pm local time. If you are at the meeting and want to meet with us, please stop by.

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On the poster, we introduce our platform for synthetic oncolytic viruses. We show data validating components for targeting GPC3 and our replication switch, based on an aptazyme. We also present data from our oncolytic virus, made using our platform. It shows great efficacy against Hepatoblastoma cells, and great safety in off target tumor cells and healthy cells. We also present our first mouse data (safety).

We hope to meet other researchers in the field and we hope to meet future collaboration partners on other indications – we are actively searching! In short, we are excited for our first in person opportunity of this scale to get the word out on our work and we cannot wait to see what the reactions will be.

On April 10, 2023 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the company plans to release its first quarter 2023 financial results after the close of the U.S. financial markets on May 9, 2023 (Press release, Exact Sciences, APR 10, 2023, View Source [SID1234629904]). Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

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First quarter 2023 webcast & conference call details

Date:

Tuesday, May 9, 2023

Time:

5 p.m. ET

Webcast:

The live webcast can be accessed at www.exactsciences.com

Telephone:

Domestic callers, dial 888-330-2384
International callers, dial +1 240-789-2701
Access code for both domestic and international callers: 4437608

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-770-2030 domestically or +1 647-362-9199 internationally. The access code for the replay of the call is 4437608. The webcast, conference call, and replay are open to all interested parties.

On April 4, 2023, or the Effective Date, Eagle Pharmaceuticals, Inc., or the Company, entered into a definitive settlement agreement, or the Settlement Agreement, with Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc., or collectively, Dr. Reddy’s, relating to the Company’s product BENDEKA (rapidly infused bendamustine hydrochloride), or the Company Product (Filing, 8-K, Eagle Pharmaceuticals, APR 10, 2023, View Source [SID1234629903]). This settlement resolves patent litigation (subject to U.S. Federal Trade Commission and U.S. Department of Justice review) brought by the Company, and its marketing partners Teva Pharmaceuticals International GmbH and Cephalon, LLC, or collectively, Teva, relating to the alleged infringement of Orange Book listed United States Patent Nos. 11,103,483 and 9,572,887, or the Patents-In-Suit, with respect to Dr. Reddy’s 505(b)(2) New Drug Application, or NDA, No. 215668, submitted to the U.S. Food and Drug Administration, or FDA, seeking approval for the manufacture and sale in the United States of bendamustine hydrochloride injection solution in a 100 mg/4 mL (25 mg/mL) dosage strength for intravenous infusion over ten (10) minutes from a 50 ML infusion bag and used for the treatment of chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, or the Dr. Reddy’s Product. The Settlement Agreement includes customary representations, warranties and agreements by the parties and the following terms:

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Settlement of Patent Infringement and Antitrust Lawsuits and Antitrust Review

Within five days after the Effective Date, the parties to the litigation, or the Parties, will file a joint motion to dismiss all claims, defenses and counterclaims with prejudice in relation to litigation, or the Patent Infringement Lawsuit, concerning the alleged infringement by Dr. Reddy’s of the Patents-In-Suit, resulting from the filing by Dr. Reddy’s of NDA, No. 215668, and the related certification pursuant to 21 U.S.C. § 355(b)(2)(A)(iv).

In addition, within ten business days after the Effective Date, the Parties will submit the Settlement Agreement to the U.S. Federal Trade Commission and U.S. Department of Justice for federal antitrust review.

Mutual Release and Covenant Not to Sue

The Parties each release the counterparty or counterparties from any and all claims relating to (i) the Dr. Reddy’s Product and the Dr. Reddy’s NDA or its filing, (ii) the Patents-In-Suit or (iii) the Patent Infringement Lawsuit.

The Company and Teva and their respective affiliates also covenant not to sue, assert any claim or otherwise participate in any action or proceeding against, Dr. Reddy’s or its affiliates, for infringement of the Patents-In-Suit or any other patents owned or controlled by the Company or Teva now or in the future, subject to certain exceptions.

Limited License

The Company and Teva grant to Dr. Reddy’s and its affiliates a non-exclusive and revocable license under the Patents-In-Suit, including any corrections, extensions, reissues or reexaminations, to manufacture, have manufactured, use, sell, offer to sell, and import the Dr. Reddy’s Product in the United States beginning on the License Effective Date of November 17, 2027 (subject to FDA approval), or earlier under certain circumstances.

The foregoing description of the Settlement Agreement is not intended to be complete and is qualified in its entirety by reference to the full text of the Settlement Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K.