On January 11, 2022 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported that the company entered into an agreement with the National Cancer Institution (NCI), an institute of the National Institutes of Health (NIH), for worldwide exclusive commercial rights to the NIH’s CD22 chimeric antigen receptor (CAR) with a fully-human binder for use in certain in vivo gene therapy and ex vivo allogeneic CAR T applications for B cell malignancies (Press release, Sana Biotechnology, JAN 11, 2022, View Source [SID1234598584]).

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Engineered CAR T cell therapies for B cell malignancies use binders to target proteins expressed on the surface of B cells. One such protein, CD19, has been the target of all approved autologous CAR T therapies for B cell lymphoma and B cell acute lymphoblastic leukemia to date. Unfortunately, incomplete responses or relapses occur in over 50% of CD19 CAR T-treated patients, often due to CD19 antigen loss. CD22, which is also a B cell surface protein, has emerged as an alternative to address failure to achieve durable complete responses with CD19-directed CAR T therapy. Multiple academic clinical trials using this CD22 CAR have shown complete responses in a substantial number of patients in the relapse setting after treatment with a CD19-directed CAR T therapy for patients with B malignancies.

"We are thrilled to enter an agreement with the NIH for an exclusive license to this fully-human CD22 CAR, particularly given the clinical data with this specific construct to date. One of Sana’s primary goals has been to meaningfully expand the number of patients that benefit from CAR T therapies, with an initial focus on B cell malignancies, including leukemia and lymphoma," said Terry Fry, M.D., Sana’s Head of T Cell Therapeutics. "Combining this CD22 CAR with Sana’s platforms gives us the potential to improve the overall rate of durable complete responses for patients with B cell malignancies – including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia – and expand the number of patients who can receive these therapies."

Under the terms of the agreement, Sana agreed to pay the NIH an upfront amount, certain milestone payments, and royalties on net sales of royalty-bearing products.

On January 11, 2022 BeyondSpring Pharmaceuticals (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported an organizational streamlining initiative focused on prioritizing the Company’s highest value business activities, extending its cash runway and preserving long-term sustainability (Press release, BeyondSpring Pharmaceuticals, JAN 11, 2022, View Source;utm_medium=rss&utm_campaign=beyondspring-announces-organizational-streamlining [SID1234598583]).

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As part of the reorganization, BeyondSpring is reducing its U.S. workforce by 35%, including reassignment of certain personnel to subsidiaries, which is expected to result in cost savings that will extend the cash runway. The reorganization follows BeyondSpring’s receipt of a Complete Response Letter from the U.S. Food and Drug Administration for the New Drug Application (NDA) seeking approval of plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia (CIN) on November 30, 2021.

"The reorganization of BeyondSpring is a necessary step forward for the Company to deliver on its mission to develop innovative cancer therapies and improve clinical outcomes for patients who have high unmet medical needs globally," said Dr. Lan Huang, BeyondSpring’s co-founder, chief executive officer and chairwoman. "This reorganization will enable BeyondSpring to reduce operating expenses and extend its cash runway. We express sincere appreciation to colleagues impacted by this decision, and thank our team members for their contributions."

Going forward, BeyondSpring intends to prioritize the following clinical and regulatory activities:

Continued advancement of the regulatory process of plinabulin in CIN in China and the U.S.
NDA filing and regulatory process of non-small cell lung cancer (NSCLC) in the U.S. and China
Advancement of immune-oncology (IO) trials with plinabulin in triple combination IO therapy in various cancers.

The Company remains committed to optimizing the value of the plinabulin franchise through further clinical development in areas of unmet medical need.

On January 11, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers, reported progress across its pipeline of targeted therapeutics spanning its RAS(ON) Inhibitor and RAS Companion Inhibitor portfolios (Press release, Revolution Medicines, JAN 11, 2022, View Source [SID1234598582]). These updates were announced in a corporate presentation delivered by Mark A. Goldsmith, M.D., Ph.D., the company’s chief executive officer and chairman, at the 40th Annual J.P. Morgan Healthcare Conference.

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RAS(ON) Inhibitors

As a centerpiece of this presentation, Dr. Goldsmith provided updates on the company’s expanding portfolio of innovative RAS(ON) Inhibitors. The company is on track to file investigational new drug (IND) applications in the first half of 2022 for its two most advanced RAS(ON) Inhibitors, RMC-6236 (RASMULTI) and RMC-6291 (KRASG12C), both of which have shown attractive preclinical profiles including strong anti-tumor activity.

Dr. Goldsmith also introduced two new mutant-selective RAS(ON) Inhibitors that Revolution Medicines has advanced into IND-enabling development. RMC-9805 is an oral, mutant-selective, covalent inhibitor of KRASG12D, which is the primary tumor driver in more than 50,000 new patients with colorectal, pancreatic or lung cancer annually in the United States. Evaluation in preclinical in vivo cancer models has demonstrated best-in-class potential for RMC-9805, and the company aims to file an IND application in the first half of 2023.

RMC-8839 is an oral, mutant-selective, covalent inhibitor of KRASG13C. Revolution Medicines believes that RMC-8839 is the first compound to directly target KRASG13C, an important therapeutic target primarily for lung and select colorectal cancer patients who are not currently served by any targeted RAS drug. This first-in-class development candidate has demonstrated strong anti-tumor responses in in vivo cancer models and the company aims to file an IND application in the second half of 2023.

In addition to its four development-stage RAS(ON) Inhibitors, the company disclosed that it has ongoing discovery programs pursuing additional mutant-selective compounds for various cancer mutations at RAS hotspots G12, G13 and Q61, with the goal of nominating a fifth development candidate in the second half of 2022.

RAS Companion Inhibitors

Dr. Goldsmith also provided updates on the company’s class-leading, clinical-stage RAS Companion Inhibitors: RMC-4630, the company’s investigational SHP2 inhibitor, and RMC-5552, the company’s potent, selective inhibitor of mTORC1.

The first patient has been dosed in RMC-4630-03, a global, multicenter, open-label Phase 2 study evaluating the efficacy, safety, tolerability, and pharmacokinetics of RMC-4630 in combination with Lumakras (sotorasib), Amgen’s KRASG12C inhibitor, in subjects with advanced non-small cell lung cancer. Revolution Medicines is sponsoring the RMC-4630-03 study under its global partnership with Sanofi and conducting the trial in collaboration with Amgen, which is supplying sotorasib to study sites globally. The study’s first patient was enrolled and dosed at Sarah Cannon Research Institute in Nashville, Tennessee, by study investigator Melissa Johnson, M.D., Director of the Lung Cancer Research Program.

The company also reported initial findings from the ongoing dose escalation portion of its Phase 1/1b clinical trial of RMC-5552, including preliminary evidence of clinical activity against advanced tumors with mutations associated with hyperactive mTORC1 signaling. To date, all four efficacy evaluable patients treated with 6 mg per week have experienced disease control, including one patient exhibiting a confirmed partial response with a 63% reduction from baseline and the other three with stable disease. A strategic priority is to evaluate RMC-5552 in combination with RAS(ON) Inhibitors in patients carrying both RAS and mTOR pathway mutations, representing approximately 30,000 new patients per year in the United States.

"We begin 2022 with strong momentum in our efforts to serve critical unmet medical needs for patients with diverse RAS-addicted cancers," said Dr. Goldsmith. "We now have four development-stage RAS(ON) Inhibitors with compelling preclinical profiles, the first two of which are expected to enter the clinic this year and the other two advancing toward IND filings in 2023. In addition, both of our clinical-stage RAS Companion Inhibitors have now shown encouraging initial single agent clinical activity and are continuing in monotherapy and/or combination treatment studies. Our cohesive portfolio of development-stage assets is designed to inhibit the cancer drivers of all major RAS-addicted forms of human lung, colorectal and pancreatic cancer, and we remain optimistic that the era of targeted treatment for patients with these cancers is within reach."

On January 11, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report fourth quarter and full year 2021 financial results on Thursday, February 3, 2022, before the market opens (Press release, Quest Diagnostics, JAN 11, 2022, View Source,-2022 [SID1234598581]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 800-839-9317 for domestic callers or 203-369-3605 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on February 3, 2022 until midnight Eastern Time on February 17, 2022.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On January 11, 2022 iTeos Therapeutics, Inc. (the "Company") Presented the Corporate Presentation (Presentation, iTeos Therapeutics, JAN 11, 2022, View Source [SID1234598580]).

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