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Jounce Therapeutics Regains Worldwide Rights to JTX-8064 from Bristol Myers Squibb

On June 4, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it has regained the worldwide rights to JTX-8064 from Bristol Myers Squibb (Press release, Jounce Therapeutics, JUN 4, 2020, View Source [SID1234560826]). JTX-8064 is a highly-selective, potential first-in-class antibody that targets the Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) on macrophages, and was licensed to Celgene in July 2019. As part of its Celgene integration process, Bristol Myers Squibb is streamlining its pipeline and addressing areas of overlap. As a result, Bristol Myers Squibb notified Jounce that the JTX-8064 License Agreement is being terminated.

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"We are thrilled to regain the rights to JTX-8064 and we view this as a significant opportunity for Jounce. Though we highly valued our longstanding partnership with Celgene, now a Bristol Myers Squibb company, having an additional wholly-owned program enables us to further our mission to discover new immunotherapies from a variety of important immune cell types, and develop them for patients who are not well served by today’s therapies," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "The discovery and development of JTX-8064 showcases the strength of our Translational Science Platform in target identification, and our ability to move programs towards the clinic in a rapid manner. In particular, we believe that LILRB2 may function as an immune checkpoint for macrophages and based on our body of existing preclinical data, JTX-8064 has the potential to re-program tumor-associated macrophages within the tumor microenvironment and enhance anti-tumor immunity. We are eager to advance this program into the clinic and will make every effort to do this expeditiously.

License Agreement
In July 2019, Jounce and Celgene, which is now a Bristol Myers Squibb company, announced an exclusive License Agreement for the worldwide rights to JTX-8064. Under the terms of the agreement, Jounce received a $50.0 million non-refundable license fee from Celgene. Effective, June 3, 2020, the License Agreement is terminated. Beyond transition costs and efforts, neither Bristol Myers Squibb or Jounce have any further financial or service obligations to one another. All Jounce intellectual property rights pertaining to JTX-8064 and licensed to Celgene have been reacquired by Jounce.

About JTX-8064
JTX-8064 is an anti-LILRB2 antibody and is the first tumor-associated macrophage candidate to emerge from Jounce’s Translational Science Platform. Preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supports the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity.

Moleculin Announces Submission to Expand Clinical Sites in European AML Trial

On June 4, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates, reported that it has submitted requests to Polish regulatory authorities for approval to open two additional clinical sites for its Phase 1/2 clinical study of Annamycin for the treatment of acute myeloid leukemia ("AML") (Press release, Moleculin, JUN 4, 2020, View Source [SID1234560825]).

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"We are pleased to report that the Annamycin trial in AML continues forward despite the disruptions from the COVID-19 pandemic," commented Walter Klemp, Chairman and CEO of Moleculin. "Two additional hospitals in Poland, one in Szczecin and one in Kielce, have been moving quickly to participate in this trial. Assuming these requests are granted in a timely manner, we expect both sites to begin recruiting in the third quarter."

Moleculin currently has 5 clinical sites for the Annamycin AML clinical trial operating in Europe. The addition of sites in Szczecin and Kielce would bring this total to 7.

Can-Fite Concludes Successful Meeting with European Medicines Agency (EMA) Regarding Phase III Trial and Registration Plan for Namodenoson in the Treatment of Liver Cancer

On June 4, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has successfully concluded a meeting with the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) regarding Phase III development of its drug candidate Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, JUN 4, 2020, View Source [SID1234560824]).

Namodenoson is Can-Fite’s adenosine A3 receptor (A3AR) agonist which has recently been shown to prolong median overall survival (OS) in a selected patient population with HCC in a Phase II clinical trial. Can-Fite sought scientific advice from the EMA to complement previous input from the U.S. Food and Drug Administration (FDA) in its recent End-of-Phase II meeting regarding plans for a Phase III registration trial of Namodenoson in patients with HCC and Child Pugh Class B7 (CPB7) cirrhosis. Having completed its meeting with the SAWP, Can-Fite now has sufficient regulatory input to conduct a registration trial in accordance with the requirements of both the U.S. and the European Union.

The planned trial, a randomized, double blind, placebo controlled trial, will enroll approximately 450 patients with HCC and underlying CPB7 cirrhosis at multiple centers worldwide. Patients will be randomized to oral treatment with either Namodenoson 25 mg or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival (OS), based on the favorable OS response seen in the Phase II trial in patients with HCC and CPB7 cirrhosis. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will be assessed.

"We appreciate the EMA’s advice which, combined with the input we received last October from the U.S. FDA along with recommendations from our academic key opinion leaders, gives us excellent guidance for conducting a successful Phase III clinical and registration program," stated Can-Fite CEO Dr. Pnina Fishman.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug recently concluded a Phase II trial which successfully achieved efficacy and safety endpoints in the treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

Bristol Myers Squibb to Take Part in 41st Annual Goldman Sachs Global Healthcare Conference

On June 4, 2020 Bristol Myers Squibb (NYSE: BMY) reported that it will take part in a fireside chat at the 41st Annual Goldman Sachs Global Healthcare Conference, which will be webcast on June 11, 2020. Chris Boerner, EVP and Chief Commercialization Officer and Nadim Ahmed, EVP and President, Hematology will answer questions about the company at 3 p.m. E.T (Press release, Bristol-Myers Squibb, JUN 4, 2020, View Source [SID1234560823]).

Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

Alligator Bioscience and Scandion Oncology sign preclinical agreement to explore combination therapies for chemotherapy and immuno-oncology

On June 4, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) and Scandion Oncology (Spotlight, Sweden: SCOL), reported signing of a collaboration agreement (Press release, Alligator Bioscience, JUN 4, 2020, View Source [SID1234560822]). The two companies have agreed to explore the anti-tumor efficacy of the CD40 antibody mitazalimab (Alligator Bioscience) in combination with SCO-101 (Scandion Oncology) as an addition to chemotherapy in resistant preclinical tumor models. The expectation is that SCO-101 will revert chemotherapy resistance and thereby further strengthening the anti-tumor effects of mitazalimab.

Immuno-oncology (IO) drugs have proven very effective in subsets of cancer patients. Recently, data from large clinical trials have shown that the combination of IO drugs and standard chemotherapy results in additive anti-tumor effects and more durable remissions in cancer patients. However, many cancers develop resistance to chemotherapy and consequently, no additive effects will be expected in these patients.

The Alligator Bioscience drug candidate mitazalimab enhances presentation of antigens released by cancer cells and is thought to be beneficial in combination with chemotherapy, where large amounts of antigens are being released by dying tumor cells. Scandion Oncology’s drug candidate SCO-101 acts by blocking resistance mechanisms in cancer cells, allowing chemotherapy to kill previously resistant cancer cells. Thereby, SCO-101 would restore the release of antigens and re-activate the anti-cancer effects of the IO drugs.

"This collaboration will further validate mitazalimab’s potential in combination therapy with diverse chemotherapeutic agents, as well as the power of SCO-101 as a solution to the widespread issue of chemoresistance," said Per Norlén, CEO of Alligator Bioscience.

"This is a dream scenario for Scandion Oncology. Combinations between SCO-101, chemotherapy and an IO drug like mitazalimab could easily become the future of anti-cancer therapy" says Nils Brünner, CEO of Scandion Oncology.