Stockwinners Market Radar for October 25, 2020 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:19 EDT Coca-Cola European Partners announces proposed acquisition of Coca-Cola Amatil - Coca-Cola European Partners (CCEP) announced it has made a non-binding proposal to acquire Coca-Cola Amatil (CCLAY). The Board of Directors of CCEP has made a non-binding offer to acquire 69.2% of the entire existing issued share capital of Coca-Cola Amatil, which is held by shareholders other than Coca-Cola, to be effected by means of a scheme of arrangement; and has entered into a non-binding heads of terms and cooperation letter with Coca-Cola (KO), setting out the terms on which Coca-Cola European Partners proposes to acquire Coca-Cola's 30.8% interest in Coca-Cola Amatil, conditional upon Australian regulatory approvals and the implementation of the scheme of arrangement. If confirmatory due diligence is completed by Coca-Cola European Partners, other conditions satisfied and an acceptable scheme implementation deed is negotiated, the Board of Directors of Coca-Cola Amatil - excluding Coca-Cola's nominee directors -, intends to unanimously recommend the scheme to Independent Shareholders, in the absence of a superior proposal and subject to an independent expert concluding, and continuing to conclude, that the scheme is fair and reasonable and in the best interests of Independent Shareholders. Coca-Cola Amatil's Independent Shareholders would receive A$12.75 per share in cash. Coca-Cola would receive A$9.57 per share in cash for part of their shareholding, which comprises 10.8% of Coca-Cola Amatil's shares. Coca-Cola European Partners will work with Coca-Cola to acquire all of Coca-Cola's remaining 20% shareholding in Coca-Cola Amatil, in connection with which Coca-Cola European Partners may satisfy part of the consideration for these Coca-Cola Amatil shares by the issue of Coca-Cola European Partners shares at an agreed conversion ratio.

16:10 EDT Mirati reports preliminary results from mutant KRAS selective inhibitor programs - Mirati Therapeutics announced preliminary results from the company's mutant KRAS selective inhibitor programs. The preliminary results included updated clinical data of adagrasib, the company's KRAS G12C inhibitor, presented at the 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Therapeutics and initial preclinical in vivo data of MRTX1133, the company's selective and potent potential first-in-class KRAS G12D inhibitor. In a pooled assessment of 110 patients harboring a G12C mutation in NSCLC, CRC and other solid tumors, monotherapy adagrasib has been well tolerated. 4.5% of treatment-related adverse events led to discontinuation. Over 50 patients have been treated with adagrasib in combination with either pembrolizumab in NSCLC, cetuximab in CRC and TNO-155 in NSCLC or CRC. Each combination has been well tolerated. The pembrolizumab and cetuximab combination cohorts are ongoing and each have cleared the dose limiting toxicity evaluation period at the full dose of each commercial agent and at a 600 mg BID dose of adagrasib. The TNO-155 combination dose escalation and expansion cohorts are ongoing at a 600 mg BID dose of adagrasib. Regarding preliminary efficacy data as of August 30, 2020 in patients with advanced NSCLC treated with adagrasib as a monotherapy at a 600 mg BID dose: Patients had a median of two prior systemic treatments, including all patients receiving prior treatment with platinum-based chemotherapy regimens and 92% of patients receiving prior treatment with an anti-PD-1 /L1 inhibitor. 4 of 6 responders have a duration of treatment for greater than 11 months and all 4 patients remain on treatment. Preliminary explorative correlative analysis of co-mutations of KRAS G12C and STK11 in advanced NSCLC showed a 64% ORR across pooled Phase 1/1b and Phase 2 cohorts. Approximately 30% of all KRAS G12C mutant NSCLC patients have a STK11 co-occurring mutation. Co-occurring KRAS and STK11 mutations have been shown to be significantly correlated with poor clinical outcomes when treated with immunotherapy and platinum-based chemotherapy regimens. In a case study presented from the ongoing clinical trial of adagrasib as a monotherapy, a heavily pre-treated NSCLC patient with an unirradiated, active brain metastases observed a 67% reduction in tumor volume including the disappearance of a metastatic brain lesion. Preclinical studies demonstrate dose-dependent brain and cerebrospinal fluid exposure. The Phase 2 cohort of adagrasib as a monotherapy is currently enrolling additional NSCLC patients with active brain metastases to further explore this patient population which has a high unmet medical need. In a case study presented from the ongoing clinical trial of adagrasib in combination with TNO-155 in collaboration with Novartis, a heavily pre-treated NSCLC patient treated in the combination trial of adagrasib and TNO-155 observed a 60% reduction in tumor volume.

15:55 EDT Essa Pharma presents therapeutics potential of EPI-7386 - Essa Pharma presented new preclinical data on ESSA's clinical candidate, EPI-7386, at the 32nd EORTC-NCI-AACR Annual Symposium on Molecular Targets and Cancer Therapeutics. In an in vitro cellular thermal shift assay, EPI-7386 was shown to physically interact with the both the full-length and the splice variant form of the androgen receptor. In an in vitro full-length AR-driven cellular model, RNAseq data was analyzed by pathway enrichment analysis. EPI-7386 demonstrates largely similar modulation of AR-regulated genes compared to enzalutamide, but with additional unique elements. EPI-7386 exhibits superior activity to enzalutamide in the AR-V7-driven cellular models LNCaP95 and 22Rv1 by modulating AR-driven gene expression with or without the addition of an external androgen.

15:46 EDT Turning Point Therapeutics presents initial data from Phase 1 SHIELD-1 study - Turning Point Therapeutics reported initial clinical data from the ongoing Phase 1 dose finding portion of its SHIELD-1 study of drug candidate, TPX-0022, a potent inhibitor of MET and the associated cancer signaling pathways of SRC and CSF1R. The initial data highlighted preliminary clinical activity, including objective responses across multiple tumor types and a generally tolerable safety profile. Twenty-two patients were treated across four dose levels from Sept. 2019 to the data cut-off date of Oct. 15, 2020. Patients included those with MET-altered non-small cell lung cancer, colorectal cancer, gastric or gastroesophageal junction cancer and glioblastoma. The median number of prior therapies was three, with all patients having received at least one prior line of chemotherapy and/or immunotherapy and the majority of patients having received multiple rounds of prior combination chemotherapy. Sixty-eight percent of patients had a baseline ECOG performance score of 1. Preliminary efficacy data was available for 15 evaluable patients with baseline measurable disease and at least one post-baseline scan. TPX-0022 was generally well tolerated, with the most frequent treatment emergent adverse event being Grade 1 or 2 dizziness. Of 10 MET TKI-naive patients, five achieved a partial response, including three with GC or GEJ cancer, one with CRC, and one with NSCLC. All three evaluable patients with gastric or GEJ tumors achieved a response. Of the five responses, three patients achieved a confirmed response, and two patients remained on treatment in a response awaiting confirmation at the time of the data cut-off. Of the five MET TKI-pretreated NSCLC patients, three patients treated with multiple rounds of prior therapy achieved a best response of stable disease with two patients showing tumor measurement improvements. Nine of 15 patients achieved clinical benefit. Six of 15 patients remained on treatment with duration of treatment ranging from 7.6+ to 34+ weeks. The company anticipates initiating Phase 1 dose expansion after determining the recommended Phase 2 dose. Turning Point plans to discuss the ongoing Phase 1 SHIELD-1 study with the Food and Drug Administration to potentially modify the trial into a registrational Phase 1/2 design. The company is targeting initiation of the Phase 2 portion in the second half of 2021, pending FDA feedback. In parallel, based on the SHIELD-1 study initial findings, a combination study with TPX-0022 and an epidermal growth factor receptor tyrosine kinase inhibitor in patients with EGFR mutated MET-amplified NSCLC is also planned for initiation in the second half of 2021. In addition, preclinical data for the company's lead drug candidate repotrectinib were reported in two poster presentations. The first poster expanded on previous work presented in June at AACR 2020 with additional preclinical data of repotrectinib in combination with the KRAS-G12C inhibitor, AMG-510, in a NSCLC xenograft tumor model. In preclinical studies, repotrectinib significantly enhanced efficacy of AMG-510 and showed a marked survival benefit in a KRAS G12C xenograft model when compared to AMG-510 alone. Repotrectinib previously showed synergy in preclinical models with AMG-510 and inhibited KRAS G12C tumor cell proliferation, suppressed receptor tyrosine kinase upregulation induced by AMG-510, and reduced KRAS G12C tumor cell cytokine release. Similar results have since been obtained with other KRAS G12C inhibitors. With the new results presented in a KRAS G12C xenograft tumor model, and previous data shown with repotrectinib in combination with a MEK inhibitor, the company now plans to initiate a clinical combination study in KRAS mutant NSCLC in mid-2021. Further details on the design will be shared at the time of study initiation. The second poster showed preclinical studies of repotrectinib as monotherapy and in combination with irinotecan and temozolomide in neuroblastoma cell lines and pediatric patient-derived xenograft models. Repotrectinib combined with chemotherapy demonstrated increased anti-tumor activity compared to chemotherapy alone in an ALK-mutant neuroblastoma PDX model.

15:34 EDT Syros presents initial data from Phase 1 trial of SY-5609 - Syros Pharmaceuticals announced initial safety, pharmacokinetics and pharmacodynamics data from the ongoing dose-escalation portion of its Phase 1 clinical trial of SY-5609 in patients with select solid tumors. SY-5609 is a highly selective and potent oral cyclin-dependent kinase 7 inhibitor. These early data demonstrate proof of mechanism in patients with advanced solid tumors and establish a maximum tolerated dose for continuous daily dosing. The data was presented in a poster session at the 32nd EORTC-NCI-AACR Symposium. The study also includes a cohort evaluating SY-5609 in combination with fulvestrant in CDK4/6 inhibitor-resistant HR-positive breast cancer patients. As of August 21, 17 patients had been enrolled in the trial and were eligible for safety, PK and PD analysis. Patients were either treated with continuous daily dosing of single-agent SY-5609 at 1, 3, 4 or 5 mg, or for three weeks on and one week off at 3 mg in combination with fulvestrant. The median age of the patients enrolled in the study was 64. Patients were heavily pretreated with a median of four prior therapies. The MTD for continuous daily dosing was achieved at 3 mg. The data showed that SY-5609 demonstrated dose-dependent increases in POLR2A mRNA expression, a PD marker being used in the trial to measure CDK7 biological activity. Notably, increases in POLR2A in patients treated at 3 mg daily reached levels associated with tumor regressions in preclinical models, as well as with levels of CDK7 target engagement at which a clinical response and apoptosis were observed in a trial of patients treated with a first-generation IV CDK7 inhibitor. SY-5609 demonstrated approximately dose-proportional PK as both a single agent and in combination, minimal accumulation with repeat dosing, and a steady state half-life compatible with once-daily dosing. The majority of adverse events reported with SY-5609 as a single agent were low grade. The most common AEs were nausea, diarrhea, fatigue, platelet count decrease, and vomiting. The safety profile of SY-5609 in combination with fulvestrant was consistent with that of single-agent SY-5609. Five of the 13 patients treated with single-agent SY-5609 were response evaluable, and of those, three achieved stable disease and two had progressive disease; one of the four patients treated in the combination cohort was response evaluable and had progressive disease. The Phase 1 trial continues to actively enroll patients with select solid tumors, including the recently expanded single-agent cohort in lung cancer patients and combination cohort in breast cancer patients, to further evaluate the 3 mg daily dose in focused patient populations. The trial has also been opened to patients with advanced pancreatic cancer, another tumor type that has demonstrated sensitivity to SY-5609 in preclinical models. Additional cohorts are evaluating alternate regimens, supported by preclinical data showing that intermittent regimens of SY-5609 induced tumor regressions. Syros expects to report additional dose-escalation data, including clinical activity data, in mid-2021.

15:13 EDT Momo announces Yan Tang as Executive Chairman, Li Wang as new CEO - Momo announced that its board of directors has approved Yan Tang to step down from the position of Chief Executive Officer, and promoted Li Wang to this position, effective on November 1, 2020. Wang is a director of the Company, currently serving as the President and Chief Operating Officer of Momo. Starting from November 1, 2020, Yan Tang will become the executive chairman of the board of directors of Momo, in which role he will continue to be integrally involved in setting the strategic priorities and directing new business initiatives for Momo.