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:

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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."

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 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 Chimeric Therapeutics Limited (ASX:CHM) (Chimeric or Company) reported to conduct a $18.1 million equity raising via an accelerated 1 for 3.15 non-renounceable entitlement offer of fully paid ordinary shares in Chimeric (New Shares) to raise approximately $18.1 million (before costs of the offer)(Entitlement Offer) (Press release, Chimeric Therapeutics, FEB 21, 2022, View Source [SID1234608344]).

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The offer price for the Entitlement Offer will be $0.17 per share (Offer Price). The Offer Price represents:

• a 11.8% discount to the theoretical ex-rights price (TERP);2
• a 18.3% discount to the 5-day volume weighted average price (VWAP), and
• a 15.0% discount to the last traded price of Chimeric shares.

Under the Entitlement Offer, eligible shareholders will be able to subscribe for 1 new ordinary share in Chimeric for every 3.15 existing shares (and 1 new option for every New Share issued with an 1 Before costs of the offer 2 The theoretical ex-rights price of $0.193 is calculated using Chimeric’s closing price on 18 February 2022 assuming proceeds from the Entitlement Offer of $18.1 million. TERP is the theoretical price at which shares should trade immediately after the ex-date for the Entitlement Offer assuming 100% take-up of the Entitlement Offer. TERP is a theoretical calculation only and the actual price at which shares trade immediately after the ex-date for the Entitlement Offer will depend on many factors and may not be equal to the TERP. CHIMERIC THERAPEUTICS LIMITED ACN 638 835 828 LEVEL 3, 62 LYGON STREET CARLTON VIC 3053 AUSTRALIA exercise price of $0.255 per new option and exercisable on or before 31 March 20243) held at 7pm (AEDT) on Wednesday, 23 February 2022(Record Date) at the Offer Price (Entitlements).

The Entitlement Offer includes an institutional component (Institutional Entitlement Offer) and a retail component (Retail Entitlement Offer).

The Entitlement Offer has been managed by Bell Potter Securities Limited. Bell Potter will receive fees for its lead manager and other services, to be settled in cash.

The Board intends to use the proceeds of the Entitlement Offer to fund payments under the Company’s licence and sponsored research agreements as well as Phase I clinical trials. Funds will also be applied for ongoing working capital and the costs of the Entitlement Offer.

Institutional Entitlement Offer

Eligible institutional shareholders will be invited to participate in the institutional component of the Institutional Entitlement Offer, which is being conducted today, Monday, 21 February 2022. Eligible institutional shareholders can choose to take up all, part or none of their Entitlement. Institutional Entitlements cannot be traded on ASX or transferred. Institutional Entitlements that eligible institutional shareholders do not take up by the close of the Institutional Entitlement Offer, and institutional Entitlements that would otherwise have been offered to ineligible institutional shareholders, will be offered to new institutional investors and existing institutional shareholders concurrently with the Institutional Entitlement Offer. Chimeric’s shares will remain in a trading halt pending completion of the Institutional Entitlement Offer.

Retail Entitlement Offer Eligible retail shareholders in Australia and New Zealand will be invited to participate in the Retail Entitlement Offer at the same Offer Price and offer ratio as the Institutional Entitlement Offer. The Retail Entitlement Offer will open on 28 February 2022 and close at 5:00pm (Sydney time) on 11 March 2022. Further details about the Retail Entitlement Offer will be set out in the Retail Entitlement Offer prospectus (Prospectus), which Chimeric expects to lodge with ASX and dispatch to eligible retail shareholders on 28 February 2022. The Prospectus will also enclose personalised entitlement and acceptance forms.

The Entitlements are non-renounceable and will not be tradeable on ASX or otherwise transferable. Shareholders who do not take up their Entitlements will not receive any value for those 3 Institutional Shareholders must, at the issuance date of new Options, hold at least the number of New Shares they subscribed for under the Institutional Entitlement Offer. CHIMERIC THERAPEUTICS LIMITED ACN 638 835 828 LEVEL 3, 62 LYGON STREET CARLTON VIC 3053 AUSTRALIA Entitlements that they do not take up. Shareholders who are not eligible to receive Entitlements will not receive any value for the Entitlements they would have received had they been eligible. Approximately 106.5 million new ordinary shares in Chimeric will be issued as part of the Entitlement Offer. Shares issued under the Entitlement Offer will rank equally with existing shares.

Approximately 106.5 million options over ordinary shares in Chimeric will be issued as part of the Entitlement Offer, with full details set out in the Annexure to the Prospectus. The Retail Entitlement Offer will include a top up facility under which eligible retail shareholders who take up their full Entitlement will be invited to apply for additional shares in the Retail Entitlement Offer from a pool of those not taken up by other eligible retail shareholders. There is no guarantee that applicants under this top up facility will receive all or any of the shares they apply for under the facility. Chimeric will notify shareholders as to whether they are eligible to participate in the Retail Entitlement Offer.

Eligible retail shareholders will receive an information booklet including a personalised entitlement and acceptance form which will provide further details of how to participate in the Retail Entitlement Offer. Also, under ASX Listing Rules, Appendix 7A, Chimeric will despatch a letter about the Entitlement Offer to each holder of options to subscribe for Chimeric shares. A presentation on the Entitlement Offer has been lodged with ASX today and is able to be downloaded from ASX’s website, www.asx.com.au.

On February 20, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported the first patient dosing for its first-in-class IgG-based universal "modular" Claudin 18.2-targeting chimeric antigen receptor T (CAR-T) cell product (development code: IBI345) for the treatment of advanced Claudin18.2-positive solid tumors in an investigator-initiated-trial (IIT) (Press release, Innovent Biologics, FEB 20, 2022, View Source [SID1234608339]). Since Innovent announced its strategic cooperation with Roche on June 9, 2020, this is the first disclosure of the development milestone for the cell therapy products based on Roche’s proprietary innovative technology platform.

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The study (NCT05199519) is an investigator-initiated clinical trial with the primary objective of evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of IBI345 in subjects with Claudin18.2-positive solid tumors.

CAR-T cell therapy has established a meaningful role in the treatment of hematological tumors with 5 products approved by the FDA, and 2 by the NMPA in China, respectively; however, antitumor efficacy for solid tumors remains a challenge calling for technological breakthroughs. As the world’s first universal "modular" CAR-T cell product, IBI345 has potentially differentiated advantages over conventional CAR-T cell therapy products, including: 1) leveraging antibody function to target tumor antigens and consequently amplifying the tumor antigen signal to guide CAR-T cells to enter the tumor, thus aiding in the initiation of tumor recognition and killing; 2) controlling the functional activity of the CAR-T cells via concomitantly administered antibodies which act as a bridge between the target cell and CAR-T cell, potentially providing a better safety profile; 3) allows for the sequential or simultaneous administration of more than one antibody targeting different antigen targets without changing CAR-T cells, to treat tumors with highly heterogeneous antigen expression or relapsed tumors due to antigen-loss, thereby improving the accessibility and increasing the flexibility of CAR-T cell therapy for patients.

The principal investigator of the study, Professor Weichang Chen, the Secretary of the Party Committee and Chief Physician of the Department of Gastroenterology of the First Hospital Affiliated to Soochow University, pointed out: "As gastric and pancreatic cancer are highly aggressive tumors with high incidence rates in the world, patients are in urgent need of novel treatment options to improve clinical outcomes. IBI345, with its unique design to control CAR-T functional activity through the antibody bridging, will likely provide improved safety and efficacy. We look forward to the positive results of the safety, tolerability and efficacy data of IBI345 in patients with solid tumors, which will potentially provide a new option for the treatment of patients with advanced gastric or pancreatic cancer."

Dr. Xu Wei, VP of Innovent, R&D Head of Cell Therapy, said: "IBI345 is a highly differentiated CAR-T cell product with a new mechanism of action developed by Innovent based on Roche’s proprietary technology. As a universal "modular" CAR-T cell therapy product, equipped with a precisely targeted antibody switch, it regulates the expansion of CAR-T cells to control side effects, potentially providing an opportunity to switch to another antibody that targets different antigens to prevent recurrence and treat different tumors. Our preclinical studies have validated this "modular" CAR-T technology, which provides us with the sufficient scientific data to initiate clinical studies. In the following clinical studies, we will explore the safety, tolerability, pharmacokinetics and preliminary efficacy of IBI345, and optimize the clinical dosage and regimen to support the subsequent IND application. We firmly believe that Innovent will be able to introduce more innovative cell therapies through platform technology innovation, product transformation and in-depth collaboration with the clinical academic community that will ultimately benefit more patients and families."

About Claudin 18.2
Claudin protein is a critical component of tight junction complex molecules which play an important role in the life activities of the human body. On the one hand, tight junctions can function as a "barrier" to select the size and charge of substances, thereby regulating the transport of substances in the para-cellular pathway. For example, brain vascular endothelial cells can pass through this barrier, preventing blood from mixing with the extracellular fluid in the brain. On the other hand, tight junctions can also function as "fences", maintaining cell polarity by regulating the free diffusion of lipids and proteins between the apical and the basolateral membrane.

Claudin18.2 is a member of the Claudin protein family, which is a highly tissue-specific protein expressed only in differentiated epithelial cells on the gastric mucosa under normal physiological conditions. Previous studies have revealed that Claudin18.2 is highly expressed in multiple types of cancer such as gastric cancer, pancreatic cancer, esophageal adenocarcinoma, and colorectal adenocarcinoma. The unique feature of limited expression in normal tissues and highly specific expression in cancer makes Claudin18.2 an ideal target for developing the immunotherapeutic for solid tumors.

Globally, there is currently no therapy targeting Claudin18.2 approved for marketing, but there are many candidate therapies in clinical development. The drug modalities under development include monoclonal antibodies, bispecific antibodies, antibody-conjugated drugs and CAR-T cell products.

About Gastric and Pancreatic adenocarcinoma
Gastric and pancreatic cancer are both malignant tumors of the digestive system that seriously endanger human life and health. The latest global cancer statistics show that there will be about 1.089 million new cases of gastric cancer worldwide in 2020, accounting for 5.6% of the global cancer incidence, and about 768,000 deaths, accounting for 7.7% of the global cancer deaths. There are about 495,000 new cases of pancreatic cancer, accounting for 2.6% of the global cancer incidence, and about 466,000 deaths, accounting for 4.7% of the global cancer deaths. According to the national cancer statistics released by the National Cancer Center of China in 2019, the incidence of gastric cancer in China in 2015 was about 403,000, accounting for 10.26% of the total cancer incidence, second only to lung cancer at 20.03%, with an incidence rate of 29.31/100,000 people, and about 291,000 deaths, accounting for 12.45% of the total cancer deaths, behind lung and liver cancer, with a mortality rate of 21.16/100,000 people. In 2015, the number of cases and deaths of pancreatic cancer nationwide were 95,000 and 85,000 respectively, ranking the 10th and 6th in the incidence and mortality of malignant tumors. The mortality ratio of pancreatic cancer was 0.89, making it a true "King of Cancer". Despite the treatment progress in recent years, drug resistance, recurrence and metastasis are still inevitable. The 5-year survival rate of patients with advanced gastric cancer is about 5-20%, and the median survival rate is about 10 months. Pancreatic cancer has a worse prognosis, with a 5-year survival rate of only 6 to 8%.

About IBI345
IBI345 is the first universal "modular" CAR-T cell product developed by Innovent based on Roche’s proprietary technology. It is an internationally pioneered highly differentiated CAR-T cell product with a new mechanism of action. Different from conventional CAR-T cells that directly recognize and kill tumor cells, IBI345 comprises of two components, anti-Claudin18.2 antibodies and "modular" CAR-T cells where anti-Claudin18.2 antibody recognizes tumor antigen, thus calibrating and amplifying the antigen signal, and guides "modular" CAR-T cells to enter the tumor to initiate the cytotoxic and antitumor activity of CAR-T cells. Compared with conventional CAR-T cells, IBI345 has a variety of potential advantages, including dual effects of antibodies and CAR-T cells to increase antitumor efficacy, and flexible control of side effects by regulating CAR-T cell activity through antibodies; in addition, as having a universal CAR molecule, "modular" CAR-T cells can be easily switched to different antibodies without changing CAR-T cells, by sequentially or simultaneously administering more than one antibody targeting different antigen targets, to treat tumors with highly heterogeneous antigen expression or antigen-loss relapsed tumors, which holds a great potential to reduce the cost of CAR-T cell therapy and improve the accessibility of CAR-T cell therapy for patients.

Innovent announced that first patient dosing has been completed in February 2022 in the investigator-initiated clinical trial of IBI345 for the treatment of advanced Claudin18.2-positive solid tumors, and enrollment is currently ongoing. The safety, tolerability, pharmacokinetics and preliminary efficacy of IBI345 will be explored, and the clinical dosage and regimen will be explored to provide clinical data support for the subsequent IND application.