On May 25, 2021 AstraZeneca reported that $39 billion acquisition of Alexion is now being investigated by the UK’s Competition and Markets Authority (CMA), to determine if the deal is anti-competitive (Press release, AstraZeneca, MAY 25, 2021, View Source [SID1234583260]). On March 17, 2021, it was reported that the U.S. Federal Trade Commission (FTC) organized a multinational working group to evaluate pharmaceutical mergers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Along with the FTC, the group included the CMA, the Canadian Competition Bureau, the European Commission Directorate General for Competition, the U.S. Department of Justice Antitrust Division, and Offices of State Attorneys General.

The commission’s goal is to "identify concrete and actionable steps to review and update the analysis of pharmaceutical mergers."

At that time, the FTC was reviewing the AstraZeneca-Alexion deal. Alexion had filed with the U.S. Securities and Exchange Commission (SEC) at the time, indicating it planned to withdraw and refile its notification and report form under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, "in order to give the FTC additional time to review the proposed transaction."

The deal has since received the greenlight from the U.S., Canada, Brazil and Russia, but decisions are still pending from the UK, the EU and Japan. The deal was announced in December 2020. AstraZeneca wanted to bolster its immunology presence.

Two weeks ago, Alexion shareholders approved the deal.

"We’re very pleased with today’s affirmative shareholder vote, which brings us one step closer to completing a transaction that will accelerate the combined company’s ability to develop and provide access to life-changing medicines for patients with rare and devastating diseases around the world," said Ludwig Hantson, Alexion’s chief executive officer, at the time.

Under the terms of the deal, Alexion shareholders would receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares (ADS), with each ADS worth half of an ordinary AstraZeneca share. That comes to about $175 per share.

AstraZeneca’s market presence has typically been on oncology, cardiovascular, renal and metabolism and respiratory diseases. It increased its immunology R&D efforts in immune-mediated diseases.

Alexion’s focus is on complement inhibition, a part of the human immune system. Its branded products focus on immune-mediated rare diseases caused by abnormal activation of the complement system. These include Soliris (eculizumab), a first-in-class anti-complement component 5 (C5) monoclonal antibody.

Soliris is approved in several countries for paroxysmal hemoglobinuria (PNH), atypical hemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica spectrum disorder. The company’s Ultomiris (ravulizumab) is a second-generation C5 monoclonal antibody. Other products include Strensiq (asfotase alfa) and Kanuma (sebelipase alfa).

If the merger is finalized, the two companies will work to advance Alexion’s pipeline of 11 molecules across more than 20 clinical programs, many in rare diseases. Alexion’s immunology expertise is expected to support AstraZeneca’s presence in immunology and rare diseases.

At the time of the announcement, Pascal Soriot, AstraZeneca’s chief executive officer, said, "Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases. This acquisition allows us to enhance our presence in immunology. We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients."

On May 25, 2021 NuCana plc (NASDAQ: NCNA) reported that Hugh Griffith, Chief Executive Officer, and Don Munoz, Chief Financial Officer, will present and host one-on-one meetings at the Jefferies Virtual Healthcare Conference being held from June 1 to June 4, 2021 (Press release, Nucana BioPharmaceuticals, MAY 25, 2021, View Source [SID1234584208]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Event: Jefferies Virtual Healthcare Conference
Date: Tuesday, June 1, 2021
Time: 9:30 AM ET

The presentation will be webcast live and available for replay under "Events & Presentations" in the Investors section of the Company’s website at www.nucana.com.

On May 25, 2021 Oxford Cannabinoid Technologies Holdings Plc, the holding company of Oxford Cannabinoid Technologies Ltd (OCT), reported that debuted on the Main Market of the LSEG (London Stock Exchange Group) on 21st May, 2021 (Press release, AskAt, MAY 25, 2021, View Source [SID1234580528]). OCT is a UK-based pharmaceutical company currently developing AAT-730 (OCT461201), a CB2 receptor agonist licensed from AskAt Inc.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

According to OCT’s prospectus, the company will allocate approximately ₤3.5 million from the offering proceeds to the development of AAT-730. Actually, AAT-730 is one of the OCT’s most advanced program and their first priority will be completing the preclinical development and CMC production of AAT-730, followed by entry into Phase 1 clinical trials in the Third Quarter of 2022.

On May 25, 2021 Invitae Corporation (NYSE: NVTA), a leading medical genetics company,reported that multiple studies in multiple cancer types at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting showing all cancer patients can benefit from germline genetic testing to guide their care (Press release, Invitae, MAY 25, 2021, View Source [SID1234580545]). The use of genetic information informs changes in cancer care, increases access to precision therapies and guides screening for high-risk individuals and their family members. Earlier detection and precision therapies are critical to increase survivorship for people with cancer, yet the oncology community has been slow to adopt routine testing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

1 in 8 people with cancer have a risk-causing change in their genes

"Cancer is a disease of genetics, yet clinical practice has struggled to keep pace with rapid advancements in research, particularly with respect to the role of germline genetics. Testing guidelines and medical policy often codify barriers, further lengthening the path to adoption of widespread testing and in some cases restricting access to precision therapies and clinical treatment trials," said Ed Esplin, M.D., Ph.D., FACMG, FACP, clinical geneticist at Invitae. "Research presented at ASCO (Free ASCO Whitepaper) shows that cancer-linked genetic changes are common across cancer types and when patients do receive germline testing, over two thirds of those with positive results are eligible for changes to their treatment plans. It’s clear that incorporating germline testing alongside tumor profiling can help oncologists better tailor treatment for each patient."

Data from 250 pancreatic cancer patients from the landmark INTERCEPT study conducted at the Mayo Clinic found that nearly one in six patients with pancreatic cancer (n=38) showed cancer-linked genetic changes and, importantly, receiving germline testing was associated with improved survival.

A separate study of prostate cancer patients confirmed similar findings in other cancer types that limiting testing deprives patients and clinicians of actionable information. In the first-ever presentation of the PROCLAIM study, which was conducted primarily in community urology clinics, of patients diagnosed with prostate cancer, a significant number of cancer-linked variants were missed if testing was done based on NCCN guidelines. Of the 532 patients with clinician-reported data, nearly half, 45% (n=239), did not meet NCCN criteria. Overall, 59 patients had a cancer-linked variant; one in 10 of them did not meet the criteria (9.6%, n=23), and 12.3% (n=36) of patients met the criteria. When a 12-gene panel was used, only 29 patients were found to have a cancer-linked variant and one third of these patients were missed by guidelines.

A third study showed simply changing medical policy is not enough to drive changes in clinician adoption. In a review of two independent datasets, including commercially insured and Medicare Advantage enrollees, only 3% (n=1,675) of the 55,595 colorectal cancer patients received germline genetic testing, despite medical policy recommending germline genetic testing for all colorectal cancer patients (consistent with the INTERCEPT colorectal cancer study). Of the patients who received testing, 18% (n=143) had a cancer-linked variant and two thirds, or 67% (n=96), of those patients were potentially eligible for precision therapy and/or clinical trials.

"The data have been available for years that show knowing what changes patients have in their genes is beneficial to treating their cancer. Yet the oncology community has been slower to adopt germline testing than tumor profiling, for reasons that are not entirely clear. These data presented at ASCO (Free ASCO Whitepaper) highlight the need for oncologists to embrace germline genetic testing as routine practice for all cancer patients," said Robert Nussbaum, M.D., chief medical officer at Invitae. "A positive germline genetic result may enable patients to enroll in clinical trials or gain access to new precision medicines. And equally important, the discovery of an inherited variant can alert relatives to seek out earlier cancer screening, helping avoid later-stage diagnoses and offering a treatment benefit if cancer develops."

Invitae aims to help overcome obstacles to the adoption of genetic testing by providing physicians with clinical consults to help interpret results and reducing cost as a barrier to genetic information. Invitae also provides patients direct access to genetic counselors, helping to integrate routine genetic testing into patient care with GIA, a HIPAA-compliant chatbot. Family members are also able to receive no-charge genetic testing if a positive result is found.

Details of the 2021 ASCO (Free ASCO Whitepaper) presentations:

Oral Abstract Session: Prevention, Risk Reduction, and Hereditary Cancer

Abstract #10504: Underdiagnosis of germline genetic prostate cancer: Are genetic testing guidelines an aid or an impediment? Presented by Neal Shore, M.D.
On-demand discussion will take place on June 4, 2021 from 9:00 – 11:30 a.m. ET.
Poster Discussion Session: Prevention, Risk Reduction, and Hereditary Cancer

Abstract #10514: Clinical impact of medical policy supporting universal germline testing for patients with colorectal cancer. Presented by Sarah Nielsen, M.S., L.C.G.C
Abstract #10515: Limitations of direct-to-consumer (DTC) genetic testing for hereditary breast and ovarian cancer. Presented by Neelam V. Desai, M.D.
On-demand poster discussions will take place on June 4, 2021 from 9:00 – 10:00 a.m. ET.
Poster Session: Prevention, Risk Reduction, and Hereditary Cancer

Abstract #10534: Germline alterations among Hispanic men with prostate cancer. Presented by Justin Shaya, M.D.
The poster will be available on-demand beginning June 4, 2021.
Poster Session: Gastrointestinal Cancer–GastroesophageaI, Pancreatic, and Hepatobiliary

Abstract #4118: Clinical impact of pathogenic germline variants in pancreatic cancer: Results from a multicenter prospective universal genetic testing study. Presented by Pedro L. Uson Junior, M.D.
The poster will be available on-demand beginning June 4, 2021.

On May 25, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported that Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer, and other members of the executive team will present at the following virtual banking and industry conference (Press release, Synlogic, MAY 25, 2021, View Source [SID1234580561]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Jefferies Virtual Healthcare Conference: Dr. Brennan will participate in a Fireside Chat at 1:30 pm on Tuesday, June 1, 2021.
This is a virtual event. A live webcast of the presentation, if available, can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived copy of the webcast will be available on the Synlogic website for approximately 30 days after the event.