On February 2, 2022 miReven scientists reported that it awarded an Australian competitive NHMRC Development grant for 2022-23 (Press release, MiReven, FEB 2, 2022, View Source [SID1234607598]). Prof Leedman and the team were successful in being awarded a Development Grant for two years to help drive the further development of mRx-7 into a therapy for liver cancer.

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On February 2, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported the successful completion of the three-patient safety run-in for the pancreatic cancer cohort of the phase 1/2 GOBLET study following evaluation by the study’s Data Safety Monitoring Board (DSMB) (Press release, Oncolytics Biotech, FEB 2, 2022, View Source [SID1234607617]). The DSMB noted no safety concerns in these patients and recommended the study proceed as planned. The safety run-in for the trial’s third-line metastatic colorectal cancer cohort remains ongoing.

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The GOBLET study is being managed by AIO, a leading academic cooperative medical oncology group based in Germany, and is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study remains ongoing and is expected to enroll patients at 14 clinical trial sites across Germany.

"This positive safety evaluation adds to a robust body of evidence demonstrating the favorable safety profile of pelareorep-checkpoint inhibitor combinations across multiple indications," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "It also represents an important step in the development of these combinations for the treatment of pancreatic cancer and builds on prior clinical proof-of-concept data in this indication. These data highlight the potential of pelareorep to benefit patients with pancreatic and other gastrointestinal cancers by reversing immunosuppressive tumor microenvironments that limit the effectiveness of checkpoint inhibitors. We believe adding pelareorep to treatment regimens will improve clinical response rates in these patients, and we look forward to evaluating this hypothesis through successfully advancing the GOBLET study."

The GOBLET study’s pancreatic cancer cohort extends previously reported clinical data demonstrating the synergy and anti-cancer activity of pelareorep combined with checkpoint inhibition in pancreatic cancer patients who progressed after first-line treatment (link to PR, link to poster). It also builds on prior early clinical data that showed a greater than 80% increase in median progression-free survival in pancreatic cancer patients with low levels of CEACAM6 expression who received pelareorep in combination with chemotherapy (link to PR, link to poster). In addition to evaluating the safety and efficacy of pelareorep-atezolizumab treatment, GOBLET also seeks to demonstrate the potential of CEACAM6 and T cell clonality as predictive biomarkers, which may increase the likelihood of success of future registrational studies by allowing selection of the most appropriate patients.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:
1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic pancreatic cancer patients (n=12);
2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on internal oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Gastrointestinal Cancer
Excluding skin cancers, colorectal cancer is the third most common cancer, with an estimated 104,270 new cases of colon cancer and 45,230 new cases of rectal cancer expected to be diagnosed in the U.S. in 20211. Also, for the 2021 year, the American Cancer Society estimates there will be 60,430 new cases of pancreatic cancer2 and 9,090 new cases of anal cancer3 in the U.S.

On February 2, 2022 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company") reported that it has entered into a securities purchase agreement with a single institutional investor to purchase 3,374,242 shares of its common stock (or pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Titan Pharmaceuticals, FEB 2, 2022, View Source [SID1234607648]). In a concurrent private placement, Titan has also agreed to issue and sell to the investor 1,289,796 pre-funded warrants, at the same purchase price as in the registered direct offering. In addition, the Company has agreed to issue to the investor in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,664,038 shares of common stock. The combined offering price of each share or pre-funded warrant and each warrant will be $1.18. The warrants will be immediately exercisable, will expire on the five year and six month anniversary of the issuance date and will have an exercise price of $1.14 per share.

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The aggregate gross proceeds to the Company of both offerings is expected to be approximately $5.5 million. The offerings are expected to close on or about February 4, 2022, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the exclusive placement agent in connection with the offerings.

The shares of common stock (or pre-funded warrants in lieu thereof) in the registered direct offering are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-230742), which was declared effective by the United States Securities and Exchange Commission ("SEC") on April 24, 2019. The pre-funded warrants and warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock (or pre-funded warrants in lieu thereof) issued in the registered direct offering will be filed by Titan with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

On February 2, 2022 Navitor Pharmaceuticals, LLC ("Navitor"), reported that Janssen Pharmaceuticals, Inc. ("Janssen"), one of the Janssen Pharmaceutical Companies of Johnson & Johnson has acquired Anakuria Therapeutics, Inc., ("Anakuria"), a company recently formed by Navitor to advance its novel class of selective rapamycin analog mTORC1 inhibitors (Press release, Navitor Pharmaceuticals, FEB 2, 2022, View Source [SID1234607727]). Anakuria’s lead Phase 1 ready program, AT-20494 provides Janssen with a first-in-class opportunity in autosomal dominant polycystic kidney disease, or ADPKD. This deal was facilitated by Johnson & Johnson Innovation.

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Under the terms of the agreement, Janssen has acquired all outstanding shares of Anakuria, which is now a wholly owned subsidiary of Janssen.

Tom Hughes, president and chief executive officer of Navitor Pharmaceuticals LLC commented, "We are thrilled that the potential value and substantially differentiated profile of Anakuria’s mTORC1 inhibitor program can be explored with Janssen. With decades of experience in developing, manufacturing and commercializing innovative therapies for patients suffering from a broad range of diseases and conditions, Janssen is ideally positioned to rapidly advance our program in the clinic. We also are very pleased that the program has come full circle within the Johnson & Johnson Family of Companies: Johnson & Johnson Innovation – JJDC, Inc., the strategic venture arm of Johnson & Johnson, was one of Navitor’s founding investors and the company also was one of the initial startups incubated in JLABS @ LabCentral, Cambridge, MA."
Goodwin Proctor LLP acted as legal advisor to Navitor on this transaction.

About AT-20494
AT-20494 is an orally bioavailable small molecule that selectively inhibits activity of mTORC1, the master modulator of cellular metabolism, which is overactive in multiple chronic diseases including autosomal dominant polycystic kidney diseases. AT-20494 is a member of a novel class of rapamycin analogs discovered by Navitor scientists, and will be the first fully selective inhibitor of mTORC1 to be studied in humans. Preclinical studies of AT-20494 have shown that it reduces the burden of cysts and kidney volume in mice carrying mutations in the PKD1 gene, and also reduces signatures of fibrosis and inflammation upon chronic administration.

About mTORC1
Complex 1 of the mechanistic target of rapamycin (mTORC1) activity governs the pace and ability of the cell to synthesize protein and other cellular components. Increased mTORC1 activity contributes to a broad array of diseases of aging by increasing protein misfolding and driving cellular stress, inflammation, and fibrosis.

On February 2, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that Dr. Neal Walker, President and CEO of Aclaris, will participate in a fireside chat at the SVB Leerink Virtual 11th Annual Global Healthcare Conference on Wednesday, February 16, 2022 at 9:20 a.m. ET (Press release, Aclaris Therapeutics, FEB 2, 2022, View Source [SID1234607600]). Management will be available February 16th throughout the day for virtual 1×1 meetings.

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A webcast of the fireside chat may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.