On June 24, 2021 Incyte (Nasdaq:INCY) reported the outcome of a meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which reviewed the Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy (Press release, Incyte, JUN 24, 2021, View Source [SID1234584314]). The Committee voted 13-4 that a regulatory decision on retifanlimab for the treatment of advanced or metastatic SCAC should be deferred until further data are available from clinical trial POD1UM-303, a confirmatory trial in platinum-naïve advanced SCAC that is currently underway.

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The ODAC provides the FDA with independent opinions and recommendations from outside experts on marketed and investigational medicines for use in the treatment of cancer. The FDA considers the advice of the ODAC in its review but is not bound to follow its recommendations.

"While we are disappointed by the outcome of today’s ODAC vote, we will continue to work closely with the FDA as it completes its review of the BLA for retifanlimab," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. "Patients with advanced SCAC who have progressed after first-line platinum-based chemotherapy currently have no FDA-approved treatments available to them and face an extremely poor prognosis. We continue to believe that retifanlimab can provide an additional, much-needed option for these patients based on the favorable benefit/risk shown in our trial."

The BLA for retifanlimab is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in 94 previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, platinum-based chemotherapy. The FDA previously granted retifanlimab Orphan Drug Designation for the treatment of anal cancer, along with Priority Review, and set the Prescription Drug User Fee Act (PDUFA) target action date for retifanlimab as July 25, 2021.

SCAC is almost always associated with human papillomavirus (HPV) and HIV infections and accounts for nearly 3% of digestive system cancers.1 Patients with metastatic SCAC have a poor 5-year survival, and there are no FDA-approved treatments for patients who have progressed after first-line chemotherapy.2

About POD1UM-202

POD1UM-202 (NCT03597295) is an open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in 94 patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or were ineligible for or intolerant of, platinum-based chemotherapy. Retifanlimab 500mg is administered as an intravenous infusion every 4 weeks for up to 2 years.

The primary endpoint was overall response rate (ORR) as determined by independent central review using RECIST v1.1. Secondary endpoints included duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS); safety and pharmacokinetics.

For more information about the study, please visit View Source

About POD1UM

The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes Phase 1, 2 and 3 studies for patients with solid tumors both as monotherapy and in combination with Incyte’s early development portfolio. Additional indications in late-stage development include platinum-naïve squamous cell carcinoma of the anal canal (SCAC), microsatellite instability-high endometrial cancer, Merkel cell carcinoma and non-small cell lung cancer.

About Retifanlimab

Retifanlimab (formerly INCMGA0012), an investigational intravenous PD-1 inhibitor, is currently under evaluation in Phase 1, 2 and 3 studies for patients with solid tumors both as monotherapy and in combination with Incyte’s early development portfolio. Additional indications in late-stage development include platinum-naïve squamous cell carcinoma of the anal canal (SCAC), microsatellite instability-high endometrial cancer, Merkel cell carcinoma and non-small cell lung cancer.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer. A Marketing Authorization Application for retifanlimab is also under review by the European Medicines Agency.

In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

On June 24, 2021 GT Biopharma, Inc. ("GT Biopharma" or the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager (TriKE) protein biologic technology platform, reported that GT Biopharma CEO, Tony Cataldo will be presenting as a VIP speaker at the upcoming Sir Anthony Ritossa’s Global Family Office Investment Summit in Monaco from June 30 to July 2, 2021 (Press release, GT Biopharma, JUN 24, 2021, View Source [SID1234584313]).

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The Sir Anthony Ritossa’s Global Family Office Investment Summit in Monaco is one of a series of international summits held annually as a platform for exceptional networking between Family Offices and Thought Leaders from all over the world. Summit delegations consist of prestigious family offices, private investors, sheikhs, royal families and leading businesses from 30+ countries representing more than $4.5 trillion in wealth.

On June 24, 2021 EQRx, a company committed to developing and delivering important new medicines to patients at radically lower prices, and Exscientia, an AI-driven pharmatech company with a mission to radically improve how drugs are discovered, reported a strategic research and development collaboration agreement (Press release, EQRx, JUN 24, 2021, View Source [SID1234584312]). The collaboration will leverage the AI capabilities of Exscientia to accelerate the discovery of small molecule therapeutic drug candidates in multiple therapeutic areas, including oncology and immunology, further expanding the breadth of EQRx’s pipeline of novel therapies.

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This innovative collaboration is focused on creating significant improvements in the traditional drug discovery and development processes by improving the probability of success through each company’s unique capabilities to accelerate the delivery of innovative new medicines—from discovery to commercialization.

Under the terms of the agreement, the strengths of both companies will be leveraged throughout the drug development process. Exscientia will lead the discovery phase through to Investigational New Drug application (IND) filing, while EQRx will be responsible for clinical development, regulatory and commercialization efforts. EQRx and Exscientia will equally share in the discovery, development and commercialization costs.

"Exscientia is a leader in AI-driven drug discovery, and of particular note, has now brought multiple AI-engineered drug candidates to clinical trials. We believe that our aligned focus on efficiency and quality sets a truly unique course to bring the next generation of innovative medicines to patients faster and at a fraction of the cost," said Alexis Borisy, chairman and chief executive officer of EQRx. "This is a significant step in building EQRx’s robust, sustainable and industry-leading pipeline of important new medicines and substantially accelerates our early-stage research capabilities."

"We are impatient for patients. EQRx and Exscientia are partners who are equally focused on re-engineering the way we create and distribute drugs for better outcomes for more patients. This exciting new collaboration brings together technologies through a new model that has the potential to truly disrupt how we think about efficiently creating innovative new medicines for all patients," said Andrew Hopkins, chief executive officer of Exscientia. "Together with the team at EQRx we look forward to building a successful partnership, to enable more patients to access better drugs, faster."

On June 24, 2021 Bio-Techne Corporation (NASDAQ: TECH) and Catamaran Bio reported an expansion of their collaboration for the development of cell engineering and cell process technologies for use by Catamaran in the manufacturing of CAR-NK cell therapy products (Press release, Bio-Techne, JUN 24, 2021, View Source [SID1234584311]).

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The companies have now broadened the scope of their collaboration to include the development of novel cell expansion technologies for use in the manufacturing of CAR-NK cell therapy products. In addition, Catamaran has secured a broad worldwide license to Bio‑Techne’s rights related to the TcBuster transposon system for use in the research, clinical and commercial manufacturing of next generation allogeneic cell therapy products. Catamaran has integrated the TcBuster transposon system, a non-viral cell engineering technology that enables multiple gene editing and efficient delivery of large genetic payloads, into its TAILWIND Platform for CAR-NK cell therapies.

The initial collaboration between Catamaran and Bio-Techne, which began in 2020, has been focused on optimizing the application of the TcBuster transposon system to CAR-NK cell engineering. The TcBuster transposon system was developed at B-MoGen Biotechnologies by a team that included Catamaran’s scientific co-founder, Branden Moriarty, PhD, Assistant Professor in the Department of Pediatrics, Division of Hematology/Oncology at the University of Minnesota. Bio-Techne acquired B-MoGen Biotechnologies in 2019.

"Our agreements with Catamaran open the path for Bio-Techne’s cutting-edge cell engineering and process technologies to deliver gene-modified CAR-NK cell therapies for cancer," said Dave Eansor, President of Bio-Techne’s Protein Sciences Segment. "We are delighted to expand our relationship with Catamaran and increase our impact in the cell therapy space."

"We have established a successful track record of collaborating with Bio-Techne to optimize technologies for use in CAR-NK cell engineering and manufacturing. This collaboration and license exemplify our strategy to access technologies that provide important advantages in the cell therapy manufacturing process, as we position Catamaran as a leader in developing off-the-shelf CAR-NK cell therapies for solid tumors," said Alvin Shih, MD, President and Chief Executive Officer of Catamaran Bio.

Through the collaboration, the Catamaran and Bio-Techne teams are focused on developing and enhancing technologies for scalable and robust manufacturing of allogeneic CAR-NK cell therapies. Bio-Techne will contribute innovative cell expansion technologies and both companies will contribute know-how to enable large-scale production of functional CAR-NK cells.

"We are excited to be making advances with innovative technologies that enable Catamaran to achieve scalable and robust manufacturing processes for our CAR-NK cell therapies. We are committed to incorporating transformative technologies into our TAILWIND Platform as we advance our product candidates toward the clinic and enable allogeneic CAR-NK cell therapies to reach their therapeutic potential," said Vipin Suri, PhD, Chief Scientific Officer of Catamaran Bio.

On June 24, 2021 Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported that it is set to join the Russell Microcap Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on June 28, 2021 (Press release, Aileron Therapeutics, JUN 24, 2021, View Source [SID1234584309]).

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Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

"Protection against chemotherapy-induced toxicities represents a significant, largely unaddressed need in the oncology space, and one for which there is now increasing progress and momentum," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "Precision medicine has truly revolutionized cancer treatment. In line with that transformation, our use of the p53 biomarker gives us the potential to selectively chemoprotect healthy cells in a very large number of patients given that nearly one million cancer patients are annually diagnosed with a p53-mutated cancer in the United States alone. Our inclusion in the Russell Microcap Index will expand our investor base as we work to transform the experience of cancer patients undergoing chemotherapy."

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider. For more information on the Russell Microcap Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.