On May 19, 2022 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that it received notification of Bayer’s intention to end the exclusive worldwide licensing agreement for next-generation mesothelin-directed CAR T-cell therapies (Press release, Atara Biotherapeutics, MAY 19, 2022, View Source [SID1234614889]).

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The collaboration included the funding and development of ATA3271, an armored allogeneic T-cell immunotherapy, and an autologous version, ATA2271, for high mesothelin-expressing tumors such as malignant pleural mesothelioma and non-small-cell lung cancer. Both ATA2271 and ATA3271 incorporate Atara’s novel inclusion of armoring in the form of a PD-1 DNR construct to overcome checkpoint inhibition and a 1XX costimulatory domain on the CAR to enhance expansion and functional persistence of the CAR T-cells. ATA3271 leverages Atara’s EBV T-cell platform and is currently in IND (Investigational New Drug)-enabling studies.

"We acknowledge Bayer’s decision to end our collaboration following Bayer’s strategic review and asset-level prioritization of its pipeline, including cell and gene therapy," said Jakob Dupont, M.D., Head of Global Research & Development at Atara. "Based on the clinical and pre-clinical data generated to date, we remain confident in the potential of ATA2271 and ATA3271 to address patient need in solid tumors and are re-assessing our strategy on how best to generate value from the programs moving forward."

Upon termination of the agreement in September 2022, the rights and licenses granted by Atara to Bayer under the collaboration will be returned to Atara, and Atara will have full rights to continue the clinical development and future commercialization of its programs worldwide. Atara will continue to support the ongoing ATA2271 Phase 1 study, which is being conducted by Memorial Sloan Kettering Cancer Center (MSK) who has voluntarily paused enrollment of new patients in the study on a temporary basis. Atara and MSK expect to provide a Phase 1 data update for ATA2271 in H2 2022. Atara will also continue to lead IND-enabling studies and process development for ATA3271.

"Atara remains focused on the upcoming interim analysis of our Phase 2 EMBOLD study of ATA188 in June, and we look forward to continued progress with tab-cel including EMA’s review in Europe and further engagement with FDA on an appropriate BLA pathway," said Pascal Touchon, President and Chief Executive Officer of Atara. "Given the exciting developments on ATA188 and tab-cel, and our continued progress toward submitting an IND for ATA3219 in Q4 2022, we plan to focus our resources accordingly while we re-assess our strategy for our mesothelin CAR T program. Consequently, we will postpone the anticipated IND filing for ATA3271 beyond the fourth quarter of 2022. We are also maintaining our cash runway guidance into Q4 of 2023."

On May 19, 2022 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, reported that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series D Preferred Stock, par value $0.01 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 pm Eastern Time on May 20, 2022 (Press release, CytRx, MAY 19, 2022, View Source [SID1234614888]). The outstanding shares of Series D Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a proposal to give the Company’s Board of Directors discretion to implement a reverse stock split in connection with satisfying the initial listing requirements of a national securities exchange, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the reverse stock split, and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series D Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series D Preferred Stock).

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All shares of Series D Preferred Stock that are not present in person or by proxy at the meeting of stockholders held to vote on the reverse stock split as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company. Any outstanding shares of Series D Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by the Company’s Board of Directors or automatically upon the approval by the Company’s stockholders of an amendment to the Company’s certificate of incorporation effecting the reverse stock split at such meeting.

The Series D Preferred Stock will be uncertificated, and no shares of Series D Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series D Preferred Stock equal to the number of shares of the Company’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.

Further details regarding the Series D Preferred Stock will be contained in a report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.

On May 19, 2022 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that Duncan Peyton, Chief Executive Officer of 4D pharma, will present at the H.C. Wainwright Global Investment Conference (Press release, 4d Pharma, MAY 19, 2022, View Source [SID1234614887]). The presentation will be available for on-demand viewing starting Tuesday, May 24, 2022 at 7:00 a.m. ET.

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A replay webcast of the presentation will be available via the ‘Events’ section of the 4D pharma website at www.4dpharmaplc.com for 90 days following the presentation.

On May 19, 2022 CANbridge Pharmaceuticals Inc. (HKEX:1228), a China-based global biopharmaceutical company committed to the research, development and commercialization of transformative rare disease and rare oncology therapies, reported that it will participate in the Morgan Stanley Virtual China Summit 2022 to be held on May 24-26, 2022 (Press release, CANbridge Life Sciences, MAY 19, 2022, View Source [SID1234614886]).

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On May 19, 2022 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported that it will present preclinical research supporting its planned second clinical indication, bile duct cancer, also known as cholangiocarcinoma, at the Global Embolization Oncology Symposium Technologies (GEST) 2022, in New York City (Press release, Renovorx, MAY 19, 2022, View Source [SID1234614885]). The study demonstrates the potential utility of RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform for the treatment of cholangiocarcinoma.

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Cholangiocarcinoma is a rare and aggressive cancer that forms in the bile ducts — thin tubes that carry a digestive fluid, called bile, from the liver to other digestive organs. Most people with cholangiocarcinoma do not have symptoms until the disease becomes more advanced, making early diagnoses difficult. Like pancreatic cancer, which the Company is evaluating in a Phase 3 study, bile duct tumors that grow outside of the liver lack tumor feeder blood vessels, which provide a pathway between the blood stream and the tumor. Tumor feeders are critical to the effectiveness of systemic chemotherapy. Published research supports that without direct access to the tumor, systemic chemotherapy circulates through the body, without a significant amount of chemotherapy reaching the tumor.

RenovoRx plans to launch a Phase 2/3 study in cholangiocarcinoma in the second half of 2022. The Company also received Orphan Drug Designation for this clinical indication in April 2021.

"We are pleased to present our preclinical research data studying RenovoTAMP’s utility in cholangiocarcinoma at this peer-reviewed, scientific meeting – GEST 2022," said Dr. Ramtin Agah, Chief Medical Officer and Co-Founder at RenovoRx. "To be effective, chemotherapy must be able to reach the tumor. RenovoTAMP was designed to bring the chemotherapy to the tumor when there is no other pathway available. Through localized delivery of chemotherapy, we are hoping to provide a more effective treatment option for cancer patients, reduce the debilitating side effects typical of standard of care systemic chemotherapy and improve patient survival for cancers like cholangiocarcinoma."

The purpose of the preclinical study was to compare the effectiveness of delivery of a chemotherapeutic agent inside the bile duct via the gall bladder versus intra-arterially, into the tissue surrounding the bile duct (RenovoTAMP). This study determined that delivery via the gallbladder resulted in zero tissue penetration. In comparison, intra-arterial delivery resulted in extensive tissue penetration, confirming the Company’s plan to utilize RenovoTAMP in its planned Phase 2 study.

The abstract and poster for the study, "Localized Delivery of Chemotherapy Through the Bile Duct Using a Double Balloon Catheter in A Porcine Model," are available on RenovoRx’s website: View Source

RenovoTAMP is currently being investigated in the Phase 3 TIGeR-PaC clinical trial as a potential treatment option for patients with unresectable locally advanced pancreatic cancer. RenovoRx received Orphan Drug Designation for pancreatic cancer in 2018.