Alpha and Omega "announced that its board approved a leadership transition plan in which Dr. Mike Chang, currently Chief Executive Officer and Chairman of the Board, will serve as Executive Chairman of AOS, and he will transition the role of Chief Executive Officer to Mr. Stephen Chang, currently the President of AOS. The leadership transition will be effective on March 1, 2023. As a full-time Executive Chairman, Dr. Chang will continue to be deeply involved in AOS by focusing more on strategic matters such as key relationships with critical partners and customers of AOS and technology development essential to ensure sustained and long-term growth. Dr. Chang will also continue to serve as Chairman of the Board."

Kite Pharma, Inc., a Gilead (GILD) Company and Daiichi Sankyo (DSNKY) "jointly announced the revision of their 2017 partnership agreement, which gave Daiichi Sankyo exclusive rights to develop, manufacture and commercialize Yescarta. axicabtagene ciloleucel, in Japan. Kite was acquired by Gilead Sciences, Inc. later in 2017 after the Daiichi Sankyo partnership agreement. Daiichi Sankyo and Kite have now agreed that the Marketing Authorization for Yescarta will be transferred to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc., in 2023. A Kite Cell Therapy Business Unit at Gilead Sciences K.K. will manage the sales and promotion activities of the product in Japan after the Marketing Authorization transfer. Kite's manufacturing facility in El Segundo, California, U.S., has been approved by Japanese regulatory authorities to manufacture Yescarta for the Japanese market, and it is expected that supply will commence in early 2023. The first axicabtagene ciloleucel treatment center in Japan was authorized in December 2021, and there are now six hospitals in Japan authorized to administer the therapy."

NGM Biopharmaceuticals announced the presentation of preliminary data from the Phase 1 Part 1a monotherapy dose escalation arm of the ongoing Phase 1/2 trial of NGM707 in patients with advanced or metastatic solid tumors at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Annual Congress, which is taking place December 7 - 9, 2022 in Geneva, Switzerland. In the poster presentation titled, "First-in-Human Study of NGM707, an ILT2/ILT4 Dual Antagonist Antibody in Advanced or Metastatic Solid Tumors: Preliminary Monotherapy Dose Escalation Data" (#174P), NGM707 was generally well tolerated across all dose cohorts and demonstrated promising early signals of anti-tumor activity. Of 24 response-evaluable patients in the Part 1a arm, best overall responses as of November 23, 2022 are partial response in one patient, stable disease in six patients and non-complete response/non-progressive disease in one patient. Six patients had reduced target lesion size including a maximum decrease in one patient of 70%. "NGM707 is designed to reprogram immune-suppressive ILT4- and ILT2-expressing myeloid cells and ILT2-expressing lymphoid cells in the tumor microenvironment into immune-stimulatory cells that will promote anti-tumor activity. We're pleased to present these initial data demonstrating a favorable tolerability profile for NGM707 as well as early, yet promising signals that this mechanistic approach may translate to clinical benefit," said Dan Kaplan, Ph.D., Head of Translational Immuno-Oncology at NGM Bio. "We're particularly encouraged to see clinical benefit in certain patients in response to monotherapy treatment with NGM707, and we look forward to evaluating NGM707's potential effect when combined with T cell checkpoint inhibition in Part 1b of the study, which is now underway."

In an interview on CNBC's Mad Money, Mark Clouse said many of Campbell's brands are well-positioned in this inflationary environment. The range of its offerings is appealing to a broader audience, he noted. Clouse indicated that the supply chain is now a 'real strength' whereas previously it had been a challenge.

In a regulatory filing, Juniper disclosed that its CEO Rami Rahim sold 18,750 shares of common stock on December 5th in a total transaction size of $604K.

In an interview on CNBC's Mad Money, Alan Shaw said, "Our focus on service is a competitive advantage." The company is targeting the trucking and logistics market, he noted. Shaw is seeing a trend towards onshoring amid geopolitical and energy risk, and is "really confident" about Norfolk Southern's future.

G1 Therapeutics provided initial results from a 24 patient Phase 2 mechanism of action - MOA - trial showing favorable alterations in the tumor microenvironment from a single dose of trilaciclib monotherapy as measured by increases in the proportions of CD8+ T cells compared to T regulatory cells in patients with early-stage triple negative breast cancer - TNBC -. CMO Raj Malik said, "These are the first data to show the beneficial effect of a single dose of trilaciclib, one week after administration, on the tumor microenvironment. These results show that trilaciclib monotherapy can improve the ratio of CD8+ T cells to Tregs and thus may enhance the overall antitumor immune response and confirm the trends we observed in preclinical studies and in peripheral blood in our Phase 2 trial in TNBC. We look forward to the pathologic complete response data in 2Q23 which we believe will clarify the ability of trilaciclib to improve anti-tumor efficacy for TNBC patients in this early-stage treatment setting, particularly in combination with a checkpoint inhibitor." Initial safety and tolerability results from the treatment phase are consistent with historical safety data from the standard of care neoadjuvant regimen with potential observed reductions in certain hematologic adverse events. There were no instances of grade 3/4 diarrhea in patients receiving trilaciclib in this trial. The new Phase 2 MOA initial clinical results reinforce those from two nonclinical studies presented at SITC, which showed that trilaciclib upregulates key processes within the cancer immunity cycle. Both the clinical and nonclinical data elucidate the immunologic mechanisms underlying the significant survival benefit shown in the previous Phase 2 trial of metastatic triple negative breast cancer patients who received trilaciclib prior to gemcitabine/carboplatin. Additionally, the combined data sets offer proof of principle data that trilaciclib may confer multidimensional clinical benefits across different tumor types and classes of drug.

Puma Biotechnology presented updated findings from the Translational Breast Cancer Research Consortium Trial 022 at the ongoing 2022 San Antonio Breast Cancer Symposium in San Antonio, Texas. The poster, entitled "Neratinib and ado-Trastuzumab-Emtansine for HER2+ Breast Cancer Brain Metastases: Translational Breast Cancer Research Consortium Trial 022," was presented by Rachel A Freedman, MD, MPH, Breast Oncology Center, Susan F. Smith Center for Women's Cancers, Dana Farber Cancer Institute, at Spotlight Poster Session 7 on December 7 from 5:00 p.m. - 6:15 p.m. CT. TBCRC-022 is a prospective, multicenter, Phase II study to evaluate the effect of neratinib plus T-DM1 in patients with HER2-positive breast cancer brain metastases. This presentation outlined updates from three cohorts: 4A - patients with previously untreated BCBM; 4B - patients with BCBM progressing after prior local CNS-directed therapy without prior T-DM1 exposure; and 4C - patients with BCBM progressing after prior local CNS-directed therapy with previous T-DM1 exposure. Data from previous cohorts from this study were reported at the 2017 ASCO Annual Meeting. Patients with measurable HER2-positive BCBM received neratinib 160 mg orally once daily plus T-DM1 3.6 mg/kg intravenously every 21 days in the three parallel-enrolling cohorts. Diarrhea prophylaxis with colestipol and loperamide was required during cycle 1. All enrolled patients underwent a brain MRI plus CT scan of the chest/abdomen/pelvis every 6 weeks for 18 weeks, followed by every 9 weeks thereafter. The primary endpoint, Response Assessment in Neuro-Oncology-Brain Metastases, was evaluated in each cohort separately. The efficacy results from the trial showed that CNS Objective Response Rate by RANO-BM was 33.3% of patients in cohort 4A, 29.4% in cohort 4B, and 28.6% in cohort 4C. Rates of response + stable disease greater than or equal to 6 months were 50% in cohort 4A, 35.3% in cohort 4B, and 33.3% in cohort 4C. Intracranial activity was observed for the combination of neratinib plus T-DM1 in all three cohorts, including in patients with prior T-DM1 exposure, suggesting a reversal of resistance to T-DM1. Overall, the most frequently observed adverse event was diarrhea, grade 2 (32%) and grade 3 (23%). These data provide additional evidence for the consideration of neratinib-based combinations in patients with HER2-positive BCBM.

Google (GOOG), Oracle (ORCL), Amazon (AMZN) and Microsoft (MSFT) have all been awarded a hybrid contract with a ceiling of $9B. No funds are being obligated at the time of award; funds will be obligated on individual orders as they are issued. The purpose of this contract is to provide the Department of Defense with enterprise-wide, globally available cloud services across all security domains and classification levels, from the strategic level to the tactical edge. The Joint Warfighting Cloud Capability will allow mission owners to acquire authorized commercial cloud offerings directly from the Cloud Service Providers contract awardees. Joint Warfighting Cloud Capability is a multiple award contract. The work will be performed in Reston, Virginia. The estimated completion date is June 8, 2028. Washington Headquarters Services, Arlington, Virginia, is the contracting activity.