On February 21, 2022 The Sistema Group company (LSE: SSA, MOEX: AFKS), Binnopharm Group, one of the leading pharmaceutical production companies in Russia via its affiliate Joint Stock Company ‘Alium’, and Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s"), an integrated global pharmaceutical company, reported the signing of a deal that will allow Binnopharm Group to acquire anti-bacterial medicines under the Ciprolet and Levolet brands from Dr. Reddy’s in Russia, Uzbekistan and Belarus (Press release, Dr Reddy’s, FEB 21, 2022, View Source [SID1234608345]). The portfolio includes various dosage forms such as tablets, solution for infusions and eye drops.

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Rustem Muratov, CEO of the Binnopharm Group said: "The acquisition of Ciprolet and Levolet is an important step to enhance our position in the antibiotics market, one of the key market segments for Binnopharm Group. These strong brands have already had the trust of millions of consumers – according to independent analyst estimation they are leaders in their market segments. They will be a valuable complement to our portfolio of antibacterial products. We are also acquiring rights to these products in Belarus and Uzbekistan in line with our strategic goal to strengthen presence in the international markets."

M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), said: "Our Russia and CIS markets continue to be strong performers for the company. This deal is a step towards divesting brands in non-core areas in order to consolidate and strengthen our play further in our key focus therapy areas of gastro-enterology, pain management, cold and flu, allergy, oncology, neurology, paediatrics and women’s health. This will help us accelerate access to affordable and innovative medicines in the region in these segments in keeping with our purpose of ‘Good Health Can’t Wait’."

During the transition period, Dr. Reddy’s will continue to supply the product to Binnopharm Group to ensure availability in the market.

On February 21, 2022 Foundation Medicine, Inc. reported that it received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic to identify patients with Microsatellite Instability High (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s KEYTRUDA (pembrolizumab) (Press release, Foundation Medicine, FEB 21, 2022, View Source [SID1234608361]). FoundationOne CDx is the first and only FDA-approved companion diagnostic to aid in identifying patients with MSI-H solid tumors for whom treatment with KEYTRUDA may be appropriate.

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In tumors that are defined as MSI-H, the DNA repair mechanisms are faulty, and as a result, tumor cells can acquire a significant number of mutations that can make them recognizable by the immune system. MSI-H status is more commonly found in colorectal, endometrial and gastrointestinal cancers, but it can also be seen in other types of cancer.1 KEYTRUDA was granted accelerated approval to treat certain patients with MSI-H solid tumors in May 2017, making it the first targeted therapy approved to treat patients based on a genomic signature, instead of where the tumor originated in the body.

"Immunotherapy has huge promise as a potential treatment option for patients with advanced cancer; however, identifying those who may benefit is complex and requires high-quality diagnostics," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "Not only could this approval allow more patients to benefit from KEYTRUDA, but it also underscores an important shift toward tumor-agnostic cancer care."

Foundation Medicine is committed to providing oncologists and patients with the insights they need to make informed treatment decisions. This FDA approval of FoundationOne CDx to identify patients with MSI-H solid tumors, and its previous approval of the test to identify patients with TMB-H solid tumors who may benefit from treatment with KEYTRUDA, reinforces the assay’s analytical and clinical validity for guiding immunotherapy treatment decisions and therapy development. This is the third tumor agnostic companion diagnostic approval for FoundationOne CDx, which now has 26 companion diagnostic claims and two group claims across 27 targeted therapies.

"We’re proud to see this collaboration with Foundation Medicine, which drew on the deep scientific expertise of both organizations, result in another companion diagnostic approval for use in identifying patients who may be appropriate for KEYTRUDA," said Eric Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories.

On February 21, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported that it has closed its acquisition of Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products (Press release, LabCorp, FEB 21, 2022, View Source [SID1234608347]). The addition of PGDx and its technology complements and accelerates Labcorp’s existing liquid biopsy capabilities and expands Labcorp’s leading oncology portfolio of next-generation sequencing (NGS)-based genomic profiling capabilities, positioning Labcorp at the forefront of driving better patient outcomes in oncology.

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The definitive agreement for the transaction was announced on Dec. 23, 2021.

On February 21, 2022 Silence Therapeutics plc, Nasdaq: SLN ("Silence" or "the Company"), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid ("siRNA") therapeutics for the treatment of diseases with significant unmet medical need, reported that Craig Tooman, previously Chief Financial Officer ("CFO"), has been appointed President, Chief Executive Officer ("CEO") and Board member of Silence, and Mark Rothera has stepped down as President, CEO and Board member, effective immediately (Press release, Silence Therapeutics, FEB 21, 2022, View Source [SID1234608362]). Rhonda Hellums, previously Vice President, Finance, has been appointed CFO.

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"On behalf of the Board, I would like to thank Mark for his contributions over the last 18 months and we wish him well," said Iain Ross, Chairman at Silence. "Craig is a seasoned leader who understands all aspects of our corporate strategy and the immediate need to maximize our potential going forward. With Craig as CEO and Dr. Giles Campion leading our exceptional research and development efforts, I am confident that Silence is now well-positioned to capitalize appropriately on the positive data we recently reported with SLN360 and ensure long-term shareholder value."

Craig Tooman, President and CEO, commented, "I am extremely pleased to have the opportunity to lead Silence and have come to appreciate the strong stewardship of Iain Ross as Chairman of the Board. I look forward to working with Giles, the executive team, and full Board, to take Silence through its next exciting stage of growth."

Craig Tooman joined Silence in January 2021, and brings more than 30 years of operational, financial and merger and acquisition ("M&A") experience. Most recently, he was Chief Operating Officer and CFO at Vyome Therapeutics, and prior to this was CEO of Aratana Therapeutics where he successfully negotiated a merger with Elanco. Before Aratana, Mr. Tooman was the CEO of Avanzar Medical Inc., a private oncology company, and CFO of Enzon Pharmaceuticals until its acquisition by Sigma Tau. Prior to that he led the $1.1 billion M&A initiative and integration of ILEX Oncology and Genzyme Corporation. He also held key positions at Pharmacia and Upjohn. Mr. Tooman currently serves on the Supervisory Board and Audit Committee of CureVac, which accomplished a successful initial public offering on Nasdaq in August of 2020. He holds a BA in Economics from Kalamazoo College and an MBA from the University of Chicago.

Rhonda Hellums has over 25 years of corporate finance, accounting, strategic planning, M&A, treasury management, investor and public relations. Prior to joining Silence in April 2021, she held management positions at several large healthcare companies, including KCI (now 3M+KCI) and Genzyme Corporation. She previously served as CFO of Deer Oaks Mental Health and prior to that, CFO of Aratana Therapeutics, a publicly traded pet therapeutics company. Ms. Hellums received her BBA degree in Accounting and Information Systems and MBA from the University of Texas at San Antonio.

On February 21, 2022 Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of autoimmune diseases and cancer, reported its unaudited half-year results for the six months ended 31 December 2021 and provides an update on significant post-period developments (Press release, Sareum, FEB 21, 2022, View Source [SID1234608348]).

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The Company will be holding a presentation to investors on Monday, 28 February 2022, immediately following the planned extraordinary general meeting, via the Investor Meet Company platform – please click on this link to register to attend:

View Source

OPERATIONAL HIGHLIGHTS (including post-period updates)

Proprietary Programmes – Selective TYK2/JAK1 Inhibitors

SDC-1801 (autoimmune diseases and severe Covid-19)

Progress made advancing SDC-1801 towards clinical development as a potential treatment for autoimmune diseases and the acute respiratory symptoms of Covid-19
Final toxicology and safety studies required to file for an exploratory Clinical Trial Authorisation ("CTA") were successfully completed in Q4 2021, and the final report is expected in Q1 2022
Preliminary findings from these studies continue to support Sareum’s plans to enter SDC-1801 into a first-in-human (Phase 1a) clinical study in healthy volunteers, and allow selection of an initial dose range
The CTA is expected to be filed during mid-2022
The synthesis of SDC-1801 drug substance under GMP conditions for formulating as an oral capsule is nearing completion. Development of the capsule formulation, also under GMP, intended for use in the Phase 1 trial is progressing to plan
Planning for first clinical study is underway and the trial is expected to begin in H2 2022, subject to CTA approval and drug product supply
SDC-1802 (cancer immunotherapy)

Translational studies underway to define the optimal cancer application prior to completing toxicology and manufacturing studies
New US patent granted (September 2021) strengthening patent protection for SDC-1802, which is now in place across all major territories
Licensed Programmes

SRA737: A Selective Chk1 inhibitor (cancer)

During the second half of 2021 and early 2022, Sierra Oncology, Inc. ("Sierra"), the licence holder for SRA737, noted it is finalising the design of several potential clinical trials to advance its pipeline candidates, including SRA737, which could start in 2022. These trials are expected to investigate SRA737 in combination with other agents in haematologic and solid tumour indications
The dosing of the first patient with SRA737 in any new clinical trial would result in a $2.0m payment from Sierra under the amended $290m licensing deal on SRA737 between Sierra and CRT Pioneer Fund LP. Under the amended agreement, Sareum continues to be eligible to receive a 27.5% share of this and any future milestone payments as well as royalties on any future sales
FINANCIAL HIGHLIGHTS (unaudited)

Raised £3.9m before expenses in the second half of 2021 largely through three subscriptions by high-net-worth individuals, bringing the total raised before expenses in 2021 to £6.3m
Cash at bank as of 31 December 2021 of £5.6m (£2.7m as of 30 June 2021; £1.3m as of 31 December 2020)
R&D tax credit of £0.2m received in December 2021
Loss on ordinary activities (after taxation) for the six months ended 31 December 2021 of £0.9m (2020: loss of £0.5m), reflecting the increased R&D expenditure required for preclinical development
Post Period End

On 4 February 2022, the Company published a circular containing details of the proposed adoption of new articles of association (the "New Articles") and a proposed 50:1 consolidation of the Company’s Ordinary Shares (the "Consolidation"). Implementation of the Consolidation and adoption of New Articles are both conditional upon approval by the Company’s shareholders at an extraordinary general meeting to be held at 2:30 p.m. on 28 February 2022 at The City Centre, 80 Basinghall Street, London EC2V 5AG. Copies of the Circular and Notice are available at www.sareum.com
Dr Tim Mitchell, CEO of Sareum, commented:

"We continue to advance SDC-1801 towards its first clinical trial as a potential new treatment for autoimmune diseases including the acute respiratory symptoms of Covid-19. The preliminary findings from the safety and toxicology studies completed in late 2021 were highly encouraging and give us confidence in the promising safety profile of SDC-1801. We look forward to receiving the final report in the coming weeks, and to progressing our plan to begin the first clinical trial with SDC-1801 during H2 2022 – an important and exciting milestone for Sareum and supported by the substantial additional funding raised during 2021. These new funds will also enable us to accelerate the preclinical development of SDC-1802 through preclinical development.

"Furthermore, we are also very encouraged that Sierra Oncology is considering several clinical combination studies with SRA737 and that these may begin in the first half of 2022. We look forward to further updates on the clinical development of this candidate as the programme progresses."