On May 12, 2021 Labcorp (NYSE: LH) ("Labcorp") reported that it plans to offer, subject to market and other conditions, senior notes that are expected to be issued in two tranches (the "Notes") (Press release, LabCorp, MAY 12, 2021, View Source [SID1234579790]). The Notes will be senior unsecured obligations and will rank equally with Labcorp’s existing and future senior unsecured debt.

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Labcorp expects to use the net proceeds of the Notes offering to redeem, prior to maturity, its outstanding 3.20% Senior Notes due Feb. 1, 2022 and 3.75% Senior Notes due Aug. 23, 2022.

The joint book-running managers for the offering are BofA Securities, KeyBanc Capital Markets, and Wells Fargo Securities. The offering will be made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-234633) filed with the Securities and Exchange Commission (the "SEC") on Nov. 12, 2019. A copy of the prospectus and related prospectus supplement may be obtained without charge from the SEC. Alternatively, a copy of the prospectus and related prospectus supplement may be obtained from BofA Securities by calling toll-free 1-800-294-1322, from KeyBanc Capital Markets by calling toll-free 1-866-227-6479, or from Wells Fargo Securities by calling toll-free 1-800-645-3751.

This announcement does not constitute an offer to sell or a solicitation of an offer to buy the Notes or any other securities, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The offering of these securities may be made only by means of the prospectus supplement and the accompanying prospectus.

On May 12, 2021 Bluestar Genomics, an innovative company leading the development of next-generation epigenomic approaches to early cancer detection, reported the company had raised $70 million in new equity funding (Press release, Bluestar Genomics, MAY 12, 2021, View Source [SID1234579824]). Led with the increased funding by the current investor, Mattias Westman, founding partner of Prosperity Capital Management, the oversubscribed Series C round includes several existing investors and multiple new investors: Pathology Asia Holdings Pte Ltd (Pathology Asia), the largest independent medical diagnostics group in Southeast Asia, as well as a venture fund based in San Francisco, CA, and a large, diversified asset manager on the west coast, among others. VAHOCA Pte Ltd acted as a financial advisor to Bluestar Genomics.

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Separately, the company announces the expansion of its Scientific Advisory Board, with the appointment of Drs. Felix Feng, professor of radiation oncology, urology, and medicine, University of California San Francisco, and Craig Venter, Ph.D., chairman and CEO of the J. Craig Venter Institute. With the new appointment, Feng and Venter are joining Alan Ashworth, Ph.D., FRS, president, Helen Diller Comprehensive Cancer Center, University of California, San Francisco.

"As we continue to champion the development of next-generation non-invasive cancer detection, we welcome Drs. Feng and Venter to our team. Their leading scientific and clinical expertise will help accelerate our development and commercialization efforts," said Samuel Levy, Ph.D., chief executive, and chief scientific officer at Bluestar Genomics. "Collectively, these milestones will extend our ability to deliver on our promise to improve on existing cancer screening and provide a new solution where none exists."

Series C investments and scientific advisory board membership expansion are largely inspired by Bluestar Genomics’ groundbreaking technology platform that employs state-of-the-art machine learning coupled with the 5-hydroxymethylcytosine (5hmC) as a screening method to detect cancer in multiple organs in men and women. The company’s novel approach has recently demonstrated positive results in two studies published in Nature Communications and earned the FDA’s breakthrough device designation for the company’s proprietary non-invasive pancreatic cancer detection test.

"The convergence of innovative technologies has pushed the cost of multi-cancer screening down by 20-fold, allowing for continued optimization of cancer detection via routine blood draw to improve patient early treatment options," said Venter. "With the multi-cancer screening market projected to scale to more than $100 billion in the U.S. alone, Bluestar Genomics’ technology is uniquely positioned to address the needs of over 60 million patients. I am excited to become part of such a pivotal contribution to improving patient lives through completely unlocking the full potential of genomics."

On May 12, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results for the first quarter 2021 and business highlights, including an update on its progress with fadraciclib and CYC140, Cyclacel’s novel CDK2/9 and PLK1 inhibitors, respectively (Press release, Cyclacel, MAY 12, 2021, View Source [SID1234579849]).

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"During the quarter, we have made significant progress in bringing our two oral targeted development candidates into mid-stage clinical development. Following recent FDA authorization of our IND for oral fadraciclib, we will finalize contract discussions with sites and open our multi-cohort Phase 1b/2 study in patients with solid tumors," said Spiro Rombotis, President and Chief Executive Officer. "We believe fadraciclib is establishing a strong position among compounds in clinical development that specifically address cancer resistance mechanisms, including suppression of MCL1, MYC and cyclin E. A recent publication identified potential utility of CDK9 inhibitors in KRAS mutant colorectal cancer, one of the tumor types in our study. Together with our oral CYC140 PLK1 inhibitor program, which has shown in preclinical models that KRAS mutant cancers are sensitive to CYC140 inhibition, we hope to provide valuable alternatives to patients with these difficult to treat malignancies. After strengthening our balance sheet in the quarter, we are executing a precision medicine strategy to achieve multiple milestones and data read outs over the next two years."

Key Corporate Highlights

CYC065-101 Phase 1b/2 oral fadraciclib in advanced solid tumors – announced that the U.S. Food & Drug Administration (FDA) has authorized Cyclacel’s Investigational New Drug (IND) application for oral fadraciclib to proceed. This Phase 1b/2 registration-directed trial includes multiple cohorts defined by histology thought to be sensitive to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in MCL1, MYC and cyclin E amplified cancers. The cohorts include breast, colorectal (including KRAS mutant), endometrial/uterine, ovarian cancers and certain lymphomas. The study design also includes a basket cohort which will enroll patients with relevant biomarkers to the drug’s mechanism regardless of histology.

A recent publication by researchers led by Frank McCormick, PhD of University of California San Francisco and NCI’s Frederick National Lab for Cancer Research reported that overactive KRAS mutants are impeded by CDK9 inhibition1. These data expand on previous findings, which show that dual CDK2/9 inhibition is an optimal strategy to treat colorectal cancer2, that KRAS mutant pancreatic cancer is sensitive to CDK9 inhibition3, and that fadraciclib showed efficacy against KRAS mutant lung cancer in preclinical PDX models4. Collectively these publications suggest the potential for the therapeutic use of fadraciclib in KRAS-mutated cancers, including colorectal, lung and pancreatic.

CYC140 PLK1 inhibitor program – commenced IND-directed activities and manufacturing of clinical trial supplies for oral CYC140. Initial data in preclinical models show that KRAS mutant cancers are sensitive to oral CYC140 inhibition.

Phase 1b/2 Investigator Sponsored Trial (IST) of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer – investigators reported that out of 9 patients enrolled, 5 have achieved partial response (PR), 3 stable disease (SD), and one patient has progressed.

Announced the closing of an underwritten public offering for net proceeds to the Company of approximately $13.5 million, after deducting placement agent fees and other offering expenses. Existing and new institutional investors participated in the offering. In addition, the Company received approximately $4.5 million in the quarter through warrant exercises.

Key Near-Term Business Objectives and Expected Timeline

1H 2021

First patient dosed with oral fadraciclib in Phase 1b/2 advanced solid tumor study
2H 2021

First patient dosed with oral fadraciclib in Phase 1b/2 leukemia study
First patient dosed with oral CYC140 in Phase 1/2 advanced solid tumor study
1H 2022

First patient dosed with oral CYC140 in Phase 1/2 leukemia study
Phase 1 data with oral fadraciclib in advanced solid tumor study
Update data from the Phase 1b/2 IST of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators
Financial Highlights

As of March 31, 2021, cash and cash equivalents totaled $47.8 million, compared to $33.4 million as of December 31, 2020. The increase of $14.4 million was primarily due to $18.0 million of net cash provided by financing activities, offset by net cash used in operating activities of $3.6 million. There were no revenues for each of the three months ended March 31, 2021 and 2020.

Research and development expenses were $2.6 million for the three months ended March 31, 2021 as compared to $1.1 million for the same period in 2020. Research and development expenses relating to the CDK inhibitor program increased by approximately $0.8 million for the three months ended March 31, 2021 as clinical evaluation of fadraciclib is progressing.

General and administrative expenses for the three months ended March 31, 2021 were $1.7 million, compared to $1.3 million for the same period of the previous year due to an increase in legal and professional expenses and recruitment costs.

Total other income, net, for the three months ended March 31, 2021 was $0.1 million, compared to $0.9 million for the same period of the previous year. The decrease of $0.8 million for the three months ended March 31, 2021 is primarily related to income received under an Asset Purchase Agreement with Thermo Fisher Scientific Inc.

United Kingdom research & development tax credits were $0.7 million for the three months ended March 31, 2021, as compared to $0.3 million for the same period in 2020 as a direct consequence of increased qualifying research and development expenditure.

Net loss for the three months ended March 31, 2021 was $3.5 million, compared to $1.2 million for the same period in 2020.

The Company raised net proceeds of approximately $13.5 million from an equity financing in March 2021. The Company also received an additional $4.5 million of proceeds from warrant exercises.

The Company estimates that cash resources of $47.8 million as of March 31, 2021 will fund currently planned programs through early 2023.

On May 12, 2021 Prescient Therapeutics reported that it has inked a new deal with leading research organisation Peter MacCallum Cancer Centre to advance work on its revolutionary OmniCAR platform (Press release, Prescient Therapeutics, MAY 12, 2021, View Source;utm_medium=rss&utm_campaign=peter-maccallum-cancer-centre-signs-agreement-with-asx-listed-prescient-therapeutics [SID1234579900]).

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Under the terms of the deal, Peter MacCallum senior research fellow Professor Philip Darcy will lead a team of researchers undertaking preclinical development of Prescient’s OmniCAR programs.

OmniCAR is a next generation CAR-T platform designed to improve the safety, effectiveness, and control of existing CAR-T treatments.

CAR-T treatments involve extracting and genetically modifying T cells within a patient’s immune system to better identify and attack cancerous cells.

The modified cells are then ‘expanded’ (replicated to create more) and infused back into the patient, where they recognise and eliminate cancer.

Professor Darcy said: "We are excited by the opportunity and potential offered by the OmniCAR platform to make headway into solid tumours and other blood cancers, and to greatly enhance and improve the clinical control and efficacy of existing CAR-T cancer therapies."

This agreement will see the two organisations focus on developing next generation CAR-T products using the OmniCAR technology for three types of cancer: acute myeloid leukemia (AML), Her2+ solid tumors, and glioblastoma multiforme (GBM).

Steven Yatomi-Clarke, CEO of Prescient, said the company is committed to completing the development work both quickly, and to the highest standards.

"Our latest research program with Peter Mac is an important part of our development plans, which include institutional and commercial laboratories," he said.

"We continue to work very closely with Professor Darcy and the team at Peter MacCallum as we progress this exciting development of controllable and adaptable next generation CAR-T therapies."

The resulting intellectual property will be owned by Prescient Therapeutics.

This agreement marks the second research collaboration between the two organisations, having announced a similar agreement focusing on Cell Therapy Enhancement programs last year.

Prescient increases dosage in separate clinical trial
The deal comes hot on the heels of a dosage increase in Prescient’s Phase 1b clinical study of its oncology drug PTX-200 and cytarabine in patients with AML.

PTX-200 is a ‘novel domain inhibitor’, which works to inhibit an important tumor survival pathway known as ‘Akt’ and is currently in clinical trials for a range of cancers including HER2-negative breast cancer and persistent platinum-resistant ovarian cancer.

Three AML patients were being treated with 35mg/m2 with no ‘dose limiting’ toxicities being reported, and no other clinical responses recorded.

Following a safety review of this data, Prescient is now looking to enrol a new cohort to test the drug at a dosage of 45mg/m2.

Dr Terrence Chew, the company’s Chief Medical Officer, said the results of the 35mg/m2 tests are promising.

"AML remains a very difficult disease to treat, especially in the relapsed and refractory setting, with patients often too sick to endure vigorous treatment," he said.

"It is therefore pleasing to see the completion of this cohort without dose limiting toxicities."

AML affects approximately 158,000 people worldwide, and inhibits the formation of new blood cells.

If you would like to stay updated on all future announcements and receive invites to upcoming company investor briefings, please register your details on Prescient’s investor centre.

Reach Markets have been engaged to assist PTX with investor communications.

On May 12, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported a business update and reports financial results for the quarter ended March 31, 2021 (Press release, Panbela Therapeutics, MAY 12, 2021, View Source [SID1234583759]). Management is hosting an earnings call today at 4:30 p.m. ET.

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The first quarter 2021 was marked by meaningful clinical progress.

Q1 and Recent Highlights

Abstract accepted with poster presentation at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting June 4-8, 2021.
Partial clinical hold lifted from the company’s Phase 1 first-line study of SBP-101.
Research agreement entered into with Johns Hopkins University School of Medicine; Preclinical studies underway.
As previously announced, in April the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on the company’s Phase 1 first-line study of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for treatment of patients with metastatic pancreatic ductal adenocarcinoma. The company has agreed to include in the design of future studies the exclusion of patients with a history of retinopathy or at risk of retinal detachment and scheduled periodic ophthalmologic monitoring for all patients, and in future dose-finding studies screening for retinal toxicity will be included.

"Year to date, we have focused on advancing SBP-101 in its first indication and exploring the broader potential of polyamine metabolic inhibition," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer. "With the hold lifted, we are excited to move the pancreatic cancer program forward. Additionally, the research initiated with Johns Hopkins will help to inform development outside of pancreatic cancer as well as potentially in combination with a checkpoint inhibitor."

Based on interim data from our Phase I trial, SBP-101 demonstrated a 62% objective response rate in combination with gemcitabine & abraxane (G&A); more than double the historical standard of care for metastatic pancreatic cancer with G&A.

We believe SBP-101 has the potential to expand into other cancers with known elevated levels of polyamine metabolism.

Upcoming Milestones

Public release of additional data from phase 1 trial – ASCO (Free ASCO Whitepaper) Annual Meeting June 4-8, 2021
Initiation of randomized phase 2 study mid-year
Public release of preclinical data across tumors outside of pancreatic cancer 2H’21
First Quarter ended March 31, 2021 Financial Results

General and administrative expenses were $1.1 million in the first quarter of 2021, compared to $0.5 million in the first quarter of 2020. The change in the quarter is primarily associated with increased headcount and other increased costs associated with maintaining our common stock on the Nasdaq Capital Market.

Research and development expenses were $1.1 million in the first quarter of 2021, compared to $0.6 million in the first quarter of 2020. The change in quarter is due primarily to higher manufacturing costs in preparation for future clinical trials.

Net loss was $2.3 million, or $0.23 per diluted share, compared to a net loss of $1.8 million, or $0.27 per diluted share, in the first quarter of 2020.

Total cash was $8.1 million as of March 31, 2021. Total current assets were $8.8 million and current liabilities were $1.3 million as of the same date. The company had no debt as of March 31, 2021.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse events are being evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .