On January 11, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for its MasterKey inhibitor BDTX-1535, an irreversible, mutant selective, brain-penetrant inhibitor of oncogenic mutations of epidermal growth factor receptor (EGFR) expressed in glioblastoma multiforme (GBM) and intrinsic and acquired resistance EGFR mutations in non-small cell lung cancer (NSCLC) (Press release, Black Diamond Therapeutics, JAN 11, 2022, View Source [SID1234598586]). The Company expects to initiate the Phase 1 study of BDTX-1535 in the first quarter of 2022 and expects to provide a clinical update in the second half of 2023.

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"We are incredibly pleased to announce the FDA allowance of our IND, representing a significant milestone for Black Diamond as we continue to mature our pipeline of MasterKey therapies," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "Based on the unique approach of our MAP discovery engine platform, we believe that BDTX-1535 is well positioned to address the unmet needs of EGFR mutant GBM and NSCLC with robust brain penetration to ensure adequate CNS exposure and potent and selective inhibition of EGFR mutations that drive intrinsic and acquired resistance to current generation tyrosine kinase inhibitors, coupled with favorable drug-like properties seen in preclinical models. We look forward to the upcoming initiation of the Phase 1 Study in the first quarter of 2022."

In pre-clinical studies, Black Diamond has demonstrated that oncogenic alterations of EGFR, particularly those associated with GBM, result in distinct conformations which impart unique pharmacology and drug resistance. In cell-based assays, BDTX-1535 achieved potent and selective inhibition of a range of EGFR mutations expressed in GBM and NSCLC, including canonical, non-canonical, and drug-resistance mutations, such as EGFR-C797S that can arise following treatment with third generation EGFR inhibitor. BDTX-1535 demonstrated a favorable brain-penetrant pharmacokinetic (PK) profile in animal models. In a range of tumor models, including intracranial GBM models and lung cancer drug resistance models expressing the targeted EGFR mutations, BDTX-1535 showed dose-dependent tumor growth inhibition and achieved complete regression without impact on body weight.

About BDTX-1535

BDTX-1535 is designed as an irreversible, mutant selective, brain-penetrant MasterKey inhibitor of oncogenic mutations of epidermal growth factor receptor (EGFR) expressed in glioblastoma multiforme (GBM) and intrinsic and acquired resistance EGFR mutations in non-small cell lung cancer (NSCLC). In pre-clinical studies, Black Diamond has demonstrated that oncogenic alterations of EGFR, particularly those associated with GBM, result in distinct conformations which impart unique pharmacology and drug resistance. It is estimated that approximately 50% of GBM patients harbor an oncogenic EGFR alteration that has the potential to be addressed by BDTX-1535, representing a potential patient population of greater than 60,000 patients annually across the US, EU, Japan and China. It is estimated that across the US, EU, Japan and China there are approximately 20,000 patients who are diagnosed annually with non-small cell lung cancer (NSCLC) harboring an EGFR intrinsic or acquired resistance mutation.

On January 11, 2022 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that it anticipates reported and organic revenue growth for the fourth quarter of 2021 of approximately -1% and -12%, respectively, versus the same period a year ago (Press release, PerkinElmer, JAN 11, 2022, View Source [SID1234598585]).
. Adjusted earnings per share from continuing operations is expected to be at least $2.40 for the fourth quarter ended January 2, 2022.

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The stronger than expected results in the fourth quarter of 2021 were driven by upside in both non-COVID and COVID product lines relative to management’s previous guidance. Non-COVID organic revenue growth in the fourth quarter is expected to be approximately 10% which would result in full year 2021 non-COVID organic revenue growth of approximately 16%. The Company also expects to report fourth quarter 2021 COVID related revenues of approximately $320 million. This will bring the full year 2021 contribution from COVID related products and services to over $1.5 billion.

For the full year 2021, the Company now expects total revenues of approximately $5.0 billion, with approximately $2.9 billion coming from its Diagnostics segment and approximately $2.1 billion coming from its Discovery and Analytical Solutions segment.

PerkinElmer will release its fourth quarter and full year 2021 financial results after market close on Tuesday, February 1, 2022. The Company will also host a conference call the same day at 5:00 p.m. ET to discuss these results. Prahlad Singh, president and chief executive officer, and Jamey Mock, senior vice president and chief financial officer, will host the conference call.

To access the call, a live audio webcast of the call will be available via this registration form or on the Investors section of the Company’s website at www.perkinelmer.com.

A replay of the webcast will be available beginning at 7:00 p.m. ET, Tuesday, February 1, 2022 through the Investors section of the Company’s website.

Factors Affecting Future Performance

This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities, acquisitions and divestitures. Words such as "believes," "intends," "anticipates," "plans," "expects," "estimates", "projects," "forecasts," "will" and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on management’s current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) markets into which we sell our products declining or not growing as anticipated; (2) the effect of the COVID-19 pandemic on our sales and operations; (3) fluctuations in the global economic and political environments; (4) our failure to introduce new products in a timely manner; (5) our ability to execute acquisitions and license technologies, or to successfully integrate acquired businesses and licensed technologies into our existing business or to make them profitable, or successfully divest businesses; (6) our ability to compete effectively; (7) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (8) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services; (9) disruptions in the supply of raw materials and supplies; (10) our ability to retain key personnel; (11) significant disruption in our information technology systems, or cybercrime; (12) our ability to realize the full value of our intangible assets; (13) our failure to adequately protect our intellectual property; (14) the loss of any of our licenses or licensed rights; (15) the manufacture and sale of products exposing us to product liability claims; (16) our failure to maintain compliance with applicable government regulations; (17) regulatory changes; (18) our failure to comply with healthcare industry regulations; (19) economic, political and other risks associated with foreign operations; (20) the United Kingdom’s withdrawal from the European Union; (21) our ability to obtain future financing; (22) restrictions in our credit agreements; (23) discontinuation or replacement of LIBOR; (24) significant fluctuations in our stock price; (25) reduction or elimination of dividends on our common stock; and (26) other factors which we describe under the caption "Risk Factors" in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

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."