On April 7, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies (Press release, Hoffmann-La Roche, APR 7, 2021, View Source [SID1234577658]). This test is used to aid physicians to diagnose throat cancer, bowel cancer and breast cancer in patients, in conjunction with other diagnostic tests. The assay is now available for all markets accepting the CE Mark.

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"The addition of our Elecsys Anti-p53 immunoassay will help clinicians to quickly and reliably diagnose several prevalent cancers and might assist in leading to a better prognosis for many patients.", said Thomas Schinecker, CEO Roche Diagnostics. "Beyond breakthrough cancer medicines, Roche also offers a growing number of testing solutions to help physicians diagnose and treat people with cancer.

p53 is protein which, when active, helps to regulate processes which stop tumors from developing. A mutation of p53 is present in half of solid tumor cancers and is the most common genetic change identified so far in human cancers.1 Certain mutations of p53 can lead to a build up of p53 which results in the formation of anti-p53 autoantibodies. Autoantibodies are antibodies that mistakenly target and react with a person’s own tissues. Between 20-50% of patients with mutated p53 will produce anti-p53 autoantibodies.2 This mutation causes the tumor suppressive function of p53 to switch to a tumor-promoting function and thus cancer development.

Early appearance of anti-p53 antibodies during tumour development may have potential to detect malignant changes.3 The Elecsys Anti-p53 immunoassay detects these anti-p53 antibodies and, when used with other diagnostic tests, can help to diagnose certain cancers, at an earlier stage, which may help to improve patient outcomes. Determining the presence of anti-p53 antibodies may also be useful for monitoring cancerous cells that are still in the body following treatment.4 In addition, the Elecsys Anti-p53 test could aid in determining which patients may require less invasive treatment procedures, as part of their cancer treatment.

About Elecsys Anti-p53
Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 autoantibodies in human serum and plasma. Elecsys Anti-p53 is a high precision immunoassay, with a low turn-around time for testing, complementing our overall tumor marker portfolio. The new Elecsys Anti-p53 immunoassay uses the well-established electrochemiluminescence immunoassay "ECLIA" technology and is intended for use on cobas e immunoassay analyzers.

On April 7, 2021 AskAt Inc. reported that it received a notice of allowance from the U.S. Patent Office of a use patent for its EP4 receptor antagonist in immuno-oncology therapy (Appl. No. 16/385,524) (Press release, AskAt, APR 7, 2021, View Source [SID1234577623]). AskAt and Arrys Therapeutics, a wholly owned subsidiary of Ikena Oncology ((NASDAQ: IKNA) headquartered in Boston, Massachusetts), jointly filed the patent application. The patent will remain effective until April 15, 2039.

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On April 6, 2021 Global contract development and manufacturing organisation (CDMO), Sterling Pharma Solutions, reported the acquisition of ADC Biotechnology (ADC Bio), a UK based bioconjugation development services business specialising in antibody drug conjugates (ADCs) (Press release, ADC BIO, APR 6, 2021, View Source [SID1234635817]).

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This follows an announcement by Sterling in December of a strategic investment into the ADC Bio business, with a view to acquisition in 2021.

The Deeside, Wales, UK facility will rebrand to become part of the Sterling Pharma Solutions international network. Together the teams will establish a centre of excellence for bioconjugation and ADC development and manufacturing services, which combine Sterling’s 50 years of experience in cGMP manufacturing, quality processes and compliance, with the expertise of the ADC Bio team and the state of the art facilities available at Deeside.

A multi-million pound investment will support the growth of the company’s ADC capabilities, which will include growing and developing the existing bioconjugation technical services team and expanding the analytical services team particularly in the cGMP area. As well as this, the team will develop and establish cGMP bioconjugation/ADC manufacturing at Deeside in 2022.

Kevin Cook, CEO at Sterling Pharma Solutions, said: "We are delighted to confirm the acquisition of the ADC Bio business, this investment provides us with the opportunity to offer a wider portfolio of services to our customers in the fast growing ADC and bioconjugation market, as well as providing additional services to existing ADC Bio customers.

"Integrating our HPAPI capabilities with the expertise already found at Deeside mean that we will also be able to offer the development and manufacture of toxin linkers. This is an exciting time for both businesses as we embark on a period of growth and diversification to ensure we always stay ahead of the next innovation. I’d like to welcome all ADC Bio employees to the Sterling family."

Alan Raymond, Executive Chairman of ADC Bio, added: "This is fantastic news for our employees and our customers; targeted investment in both people and processes will allow the team to continue supporting important advances in drug development with additional services, and importantly with the additional support and experience from the Sterling team.

This announcement follows Sterling’s acquisition of a second US API development and manufacturing facility in Wisconsin in September last year. The UK headquartered CDMO now employs over 750 people across the UK and the US.

On April 6, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that it will present at the European Biotech Investor Days 2021, a US based online event taking place April 7-8, 2021 and hosted by Goodwin, Solebury Trout, Deutsche Bank and Nasdaq (Press release, PCI Biotech, APR 6, 2021, View Source [SID1234585154]).

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On Thursday, April 8, 2021 at 15:00 (CEST), Dr. Per Walday, CEO, will present an overview of PCI Biotech’s proprietary platform technology via a general company presentation.

The presentation can be accessed live through this link View Source

The presentation slides will be made available on PCI Biotech’s website (www.pcibiotech.com) under "Other presentations" after the event.

On April 6, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported that an abstract for SBP-101, a proprietary polyamine analogue, reported that it has been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held virtually from June 4-8, 2021 (Press release, Panbela Therapeutics, APR 6, 2021, View Source [SID1234583756]).

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Details of the presentation are as follows:
Poster Presentation

Title: SBP-101, a polyamine metabolic inhibitor, administered in combination with gemcitabine and nab-paclitaxel, shows signals of efficacy as first-line treatment for subjects with metastatic pancreatic ductal adenocarcinoma.

Session Name: Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Additional meeting information can be found on the ASCO (Free ASCO Whitepaper) website at View Source After presenting at ASCO (Free ASCO Whitepaper), the poster will be available on the Company’s website.

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 evets are being evaluated and the FDA has issued a partial clinical hold for the impacted study, pending Panbela’s evaluation and response. The safety data and PMI profile observed in the current Panbela sponsored current clinical trial generally provides potential support for continued evaluation of the compound in a randomized clinical trial, subject to Panbela’s submission of a complete response and the FDA’s removal of the partial clinical hold. For more information, please visit View Source .