On March 10, 2022 Morningside Ventures reported the launch of Adiso Therapeutics, a clinical-stage biotechnology company advancing a pipeline of novel therapeutics targeting inflammatory diseases. Morningside has financed the Adiso development plans to date, with plans to further support the company’s rapid growth moving forward.

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Adiso is advancing an innovative pipeline of small molecules with novel mechanisms of action and single strain live biotherapeutic products (SS-LBP), pursuing lead indications in ulcerative colitis (UC), and C. difficile infection (CDI). In addition to two Phase 1 programs (UC & CDI) and a Phase 2 program (UC), Adiso is developing a novel inflammasome program in the discovery phase which is being initially explored in respiratory inflammation, with multiple future potential therapeutic areas to pursue.

The company is comprised of 25 employees who previously, under the Morningside umbrella, successfully opened three Investigational New Drug (INDs) and have filed numerous patents as well as attaining U.S. FDA Fast Track Designation, ultimately leading to the formation of Adiso. Adiso will operate under the leadership of recently appointed Chief Executive Officer, Scott Megaffin. Mr. Megaffin possesses over 30 years of industry experience and a successful track record in senior leadership roles at Bristol-Myers Squibb, Pfizer, Schering-Plough, Adolor, Onconova, and Churchill. Most recently, Mr. Megaffin served as CEO of Adastra Pharmaceuticals, an oncology clinical-stage development company, where he guided the company to a successful transaction with Cothera Bioscience in October 2021.

"Critical unmet medical needs exist for new therapies that target the underlying biology of inflammatory diseases without causing systemic immunosuppression," said Jason Dinges, Morningside Technology Advisory and Adiso Board Member. "Adiso is sprinting out of the gate with three very promising clinical programs for the treatment of ulcerative colitis and the prevention of recurrent CDI. We believe that under Scott’s leadership and with a highly talented team of drug developers, Adiso is poised for success."

"At Adiso we are tackling inflammatory diseases with diverse mechanisms and a bold approach. We envision a new reality for patients, leveraging known advances of inflammatory therapeutics which promise to recalibrate the immune system of the host, so that the underlying inflammatory disease is neither overactivated nor does the patient become immunocompromised," said Scott Megaffin, CEO of Adiso Therapeutics. "I’m honored to be leading such an exceptional, world-class, and dedicated team at Adiso in the development of these highly unique therapies designed to precisely halt the dysregulation generated by inflammation."

(Press release, Adiso Therapeutics, MAR 10, 2022, View Source [SID1234670864])

On March 10, 2022 Genetic Leap reported a research collaboration agreement with Astellas Pharma, Inc. to develop novel RNA-targeted small molecule therapeutic candidates against an undisclosed oncology target (Press release, Genetic Leap, MAR 10, 2022, View Source [SID1234654443]).

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Under the terms of the agreement, Genetic Leap will deploy its platform to discover and validate RNA-targeted small molecules against an undisclosed oncology target selected by Astellas. The agreement provides Astellas with certain rights to intellectual property on candidates discovered and developed under the collaboration that are directed against the program target. Further details of the collaboration were not disclosed.

On March 10, 2022 Genetic Leap reported a research collaboration agreement with Astellas Pharma, Inc. to develop novel RNA-targeted small molecule therapeutic candidates against an undisclosed oncology target (Press release, Genetic Leap, MAR 10, 2022, View Source [SID1234654443]).

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Under the terms of the agreement, Genetic Leap will deploy its platform to discover and validate RNA-targeted small molecules against an undisclosed oncology target selected by Astellas. The agreement provides Astellas with certain rights to intellectual property on candidates discovered and developed under the collaboration that are directed against the program target. Further details of the collaboration were not disclosed.

On March 10, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported that it has entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company for Lilly’s anti-EGFR antibody cetuximab (ERBITUX) (Press release, Erasca, MAR 10, 2022, View Source [SID1234639380]).

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This agreement will support the ongoing Phase 1b/2 HERKULES-3 trial, a clinical proof-of-concept study evaluating ERAS-007, an oral ERK1/2 inhibitor, in various combinations, including with the BRAF inhibitor encorafenib (BRAFTOVI) and cetuximab for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC). Erasca will sponsor the study, and Lilly will supply cetuximab at no cost. The two companies will form a joint committee to review the clinical trial results.

"We are grateful to Lilly for their collaboration as we explore the therapeutic potential of adding ERAS-007, our intermittently-dosed ERK1/2 inhibitor, to the current standard of care regimen for this patient population," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "We expect the long-term benefits seen with current standard of care may be limited due to resistance mechanisms, particularly through MAPK reactivation. ERAS-007 inhibits the terminal node of the MAPK pathway and, based on preclinical models, offers more robust inhibition of MAPK reactivation over MEK and other ERK inhibitors. Additionally, ERAS-007’s pharmacokinetic and tolerability profile positions it well for combinations."

There are approximately 180,000 people, representing approximately 10% of all patients with CRC globally, who have BRAF V600E mutations. The combination of encorafenib plus cetuximab significantly improved overall survival in patients with mCRC with a BRAF V600E mutation compared to the control arm. Those clinical results also showed that 20% of patients experience an objective response and half of these responses last more than four months. Therefore, emergence of resistance is a major therapeutic barrier to long-term clinical benefit. Erasca is exploring whether ERK inhibition with ERAS-007 in combination with encorafenib plus cetuximab can reduce the emergence of resistance and further improve treatment benefit for patients with BRAF V600E CRC.

About ERAS-007
ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the MAPK pathway as part of our MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. ERAS-007 is being investigated across a series of four HERKULES clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 in advanced solid tumors. HERKULES-2 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with non-small cell lung cancer. HERKULES-3 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with gastrointestinal cancers. HERKULES-4 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with hematologic malignancies.

On March 10, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to ALLO-316, the Company’s first AlloCAR T solid tumor clinical candidate for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma (RCC) (Press release, Allogene, MAR 10, 2022, View Source [SID1234613688]). The FDA granted FTD based on the potential of ALLO-316 to address the unmet need for patients with difficult to treat renal cell carcinomas (RCC) who have failed standard RCC therapies.

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RCC is a disease in need of innovation as current therapies are based on a few mechanistic targets and complete response rates are low. The five-year survival rate for patients with advanced kidney cancer is less than 15%1.

"Metastatic solid tumors have historically been a challenge to treat regardless of treatment modality, creating a large unmet need for patients and a necessity for scientific innovation," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "We have our sights set on confronting solid tumors where the need is unquestionably high. We remain optimistic for the potential of our AlloCAR T platform to address the challenge and we look forward to generating data from our ongoing Phase 1 trial."

ALLO-316 targets CD70, which is highly expressed in RCC with limited normal tissue expression, making it an attractive CAR T. CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC.

Fast Track designation is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available.