On July 18, 2022 GSK plc (LSE/NYSE: GSK) reported that completed the demerger of the Consumer Healthcare business from the GSK Group to form the Haleon Group (Press release, GlaxoSmithKline, JUL 18, 2022, View Source [SID1234616716]). The shares of Haleon plc (ticker "LSE: HLN") will be admitted at 8.00 a.m. today to the Premium Listing segment of the Official List and to trading on the Main Market of the London Stock Exchange ("LSE").

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It is expected that American Depositary Shares representing shares of Haleon plc (ticker: "NYSE: HLN") ("Haleon ADSs") will commence "regular-way" trading on the New York Stock Exchange (the "NYSE") at market open on Friday 22 July 2022. In addition, we expect that Haleon ADSs will begin trading on a "when-issued" basis on the NYSE from market open today up to and including Thursday 21 July 2022. Each Haleon ADS represents two Haleon ordinary shares.

GSK Share Consolidation
At the GSK General Meeting on 6 July 2022, alongside the demerger, GSK shareholders also approved the consolidation of GSK shares (the "GSK Share Consolidation"). The GSK Share Consolidation is expected to take place after the market closes today. It is expected that admission and dealings in the new GSK shares on the LSE will commence at 8.00 a.m. on Tuesday 19 July 2022. GSK will provide an update following the completion of the GSK Share Consolidation at around 7.00 a.m. on Tuesday 19 July 2022.

The ratio for the GSK Share Consolidation cannot be fixed at this time as it will depend on fluctuations in the volume and price of the GSK shares in the period between 8.00 a.m. and 4.30 p.m. today.

As at the time of this announcement, GSK’s issued share capital consists of 5,389,096,045 ordinary shares of 25 pence each (including 304,905,950 ordinary shares held in treasury). Therefore, the total number of voting rights in the Company is 5,084,190,095. If the total number of GSK shares in issue prior to the record time at 8.00 p.m. today is not exactly divisible by the denominator in the consolidation ratio, then shortly before the GSK Share Consolidation, GSK will issue up to 49 ordinary shares to ensure that following the GSK Share Consolidation there are no fractional ordinary shares outstanding.

Further information on and key dates in relation to the proposed demerger of Haleon and the GSK Share Consolidation is set out at the end of this announcement ("Expected Timetable of Principal Events") and can also be found in the Circular to Shareholders published on 1 June 2022. The Circular is available on GSK’s website at www.gsk.com/demerger.

On July 18, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its highly productive bacterial Mimicry drug discovery platform, reported that it has signed a strategic R&D collaboration and license agreement with Nestlé Health Science targeting food allergies and inflammatory bowel disease (IBD) (Press release, Enterome, JUL 18, 2022, View Source [SID1234616715]).

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The aims for the collaboration are to:

successfully develop and commercialize Enterome’s lead EndoMimics pipeline candidate EB1010. EB1010 is a potent local inducer of IL-10 designed to provide improved therapeutic outcomes for patients with food allergies and IBD. EB1010, which is due to enter clinical trials in 2023, was discovered using Enterome’s novel bacterial Mimicry drug discovery platform. The same platform will also be used to identify and develop new EndoMimics as potential novel therapies for inflammation associated with food allergies.
identify and create a pipeline of novel AllerMimics (allergen immunotherapies for food allergies) using Enterome’s Mimicry platform with an initial focus on peanut allergens as the basis for a novel class of immunotherapies that aims to suppress allergic reactions.
Under the terms of the agreement Enterome will receive €40 million upfront in cash and in equity from Nestlé Health Science and is also eligible to receive clinical and sales milestone payments for each licensed therapeutic candidate plus royalties on net sales. Enterome will be responsible for leading drug discovery activities and bear related costs up to the investigational new drug (IND) application.

"We will generate new AllerMimics candidates using our highly productive Mimicry drug discovery platform, which has already allowed us to discover multiple first-in-class small protein and peptide drug candidates in a broad range of therapeutic areas. AllerMimicsare a truly novel class of specific antigens produced by the microbiome that are similar to food allergens, and work by helping the body’s immune system tolerize to these specific allergens," said Dr. Christophe Bonny, Chief Scientific Officer of Enterome. "The collaboration will also allow us to progress the clinical development of EB1010, the first candidate originating from our EndoMimicspipeline. We believe that EB1010, administered orally as a pill, has the potential to prevent or diminish the intensity of allergic reactions in the gut. EB1010, which will also be evaluated in inflammatory bowel disease, will be applicable to many different types of food allergies, potentially in combination with selected AllerMimics."

Hans-Juergen Woerle, Chief Scientific and Medical Officer of Nestlé Health Science said, "Approximately 220 million people around the world live with food allergies, while seven million live with inflammatory bowel disease. Through this collaboration, we are aiming to develop novel therapies for these two disease areas with high unmet medical need. We are excited about the opportunity to partner with Enterome on their unique microbiome drug discovery platform striving to develop first-in-class, high-quality treatment solutions that will help patients to live a healthier life."

"We are thrilled to sign this R&D agreement to develop a new pipeline of novel AllerMimics candidates as well as further develop and commercialize EB1010, our lead EndoMimics candidate, with Nestlé Health Science, a world leader in food allergies," said Pierre Belichard, CEO of Enterome. "The signing of this collaboration further highlights both the potential and growing interest in our Mimicry platform as a source of novel immunotherapies. This milestone is all the more exciting following recent clinical and immunological validation of the mode of action of EO2401, our first-in-class off-the-shelf OncoMimics immunotherapy for Glioblastoma and Adrenal carcinoma."

Enterome’s Mimicry drug discovery platform is based on its unique ability to decode the interaction between the gut microbiome and the immune system. The Mimicry platform uses best-in-class biocomputational tools and bioassays to identify novel therapeutics for a broad range of indications from a proprietary database of 20+ million full-length gut microbiome peptides and proteins.

On July 16, 2022 EpiAxis Therapeutics is among the emerging-growth entrepreneurial companies reported that will present at youngStartup Ventures Network’s Venture Summit West 2022, which is being held in Silicon Valley from 19-20 July 2022 (Press release, EpiAxis Therapeutics, JUL 16, 2022, View Source;utm_medium=rss&utm_campaign=epiaxis-heads-to-venture-summit-west [SID1234616713]).

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The exclusive venture summit is dedicated to showcasing early-stage venture capitalists, corporate venture capitalists and angel investors committed to funding venture backed, emerging and early stage companies as well as showcasing more than 100 top innovators in the tech, fintech, cleantech, lifesciences, healthcare and medtech sectors.

More than 1000 attendees are expected at the summit, which will feature insightful discussions, the newest technologies and latest trends currently shaping the future.

EpiAxis recently published the results of its pioneering clinical trial EPI-PRIMED in leading cancer journal Frontiers of Oncology. EPI-PRIMED is the first time that an epigenetic inhibitor has been used in combination with chemotherapy to treat metastatic cancer. The findings of the EPI-PRIMED study give EpiAxis a solid foundation for its next clinical trial using its novel peptide inhibitors. The company is currently working with The Sage Group to raise US$12million to advance a candidate into an IND enabled program.

Dr Chrisp will pitch at Venture Summit West 2022 during Round III – Life Sciences/Healthcare at 1:50 pm (PDT) on 20 July 2022.

On July 15, 2022 TME Pharma N.V., a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that it has officially changed its corporate name from "NOXXON Pharma N.V." to "TME Pharma N.V." and the ticker symbol for the company’s common stock on the Euronext Growth Paris will change from "ALNOX" to "ALTME" (Press release, TME Pharma, JUL 15, 2022, View Source [SID1234626439]). Trading under the new name and ticker symbol will begin at the market opening on Tuesday, July 19, 2022. In addition to the new ticker ALTME, the ISIN will be amended from NL0012044762 to NL0015000YE1 on the share consolidation Ex-Date, July 28, 2022.

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TME Pharma also announced the launch of its new corporate website that can be viewed on www.tmepharma.com.

Aram Mangasarian, CEO of TME Pharma, commented: "Over the last several years, our company has evolved into an oncology biotech with a clear focus on advancing approaches altering the tumor microenvironment – TME – where our technology has shown strong signs of efficacy. The name change to TME Pharma marks this successful transformation for our team and our stakeholders. Our strategy will prioritize and continue to support opportunities with the fastest path to approval. Following recently reported exceptional results in our glioblastoma program, we will focus our capabilities to successfully develop our lead asset NOX-A12 and reach this milestone in this indication first."

All shares of NOXXON Pharma N.V. will become shares in TME Pharma N.V. at parity with no actions needed from the company’s current shareholders.

On July 15, 2022 Almac Diagnostics reported that it’ new partnership with AstraZeneca will see the Craigavon, UK-based company draw on its next-generation sequencing and quantitative PCR platforms and deep bench of bioinformatics talent to develop new companion diagnostic assays (Press release, Almac, JUL 15, 2022, View Source [SID1234618088]).

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The new tests, once developed, will be used for selecting patients who might best benefit from therapies for kidney disease, nonalcoholic steatohepatitis, and respiratory disease.

Michael Sloan, VP of commercial services for Almac Diagnostic Services, said via email that the firm’s companion diagnostics business "has always been a core service" for Almac, and that deals such as the one with AstraZeneca, announced last month , form a significant part of its business.

Sloan noted that companion diagnostics remain an "overarching focus" for Almac, which offers a variety of services around biomarker discovery and clinical trials, as there will always be a need to select which patients will benefit from different treatments.

"Ultimately the end goal will always be to enable biopharma partners to take it all the way through to a companion diagnostic," Sloan said.

Part of the Almac Group, Almac Diagnostic Services has partnered with biopharmaceutical partners for years and has gained experience in developing companion diagnostics for oncology programs. In recent years, though, the number of programs in chronic diseases has increased, and Sloan said that Almac is working as much in those diseases these days as in oncology.

Its technology workhorses have evolved, too. Almac Diagnostics was once heavily invested in microarray technology, and even produced a series of Disease-Specific Arrays (DSAs) focused on different indications and optimized for use on formalin-fixed, paraffin-embedded samples. The arrays were manufactured by Affymetrix, later acquired by Thermo Fisher Scientific.

In recent years though, the company, headquartered about 30 miles southwest of Belfast in Northern Ireland, has turned toward other technologies for its companion diagnostics programs.

"As a company we moved away from microarray technology to focus on qPCR and NGS technologies in line with market changes, advances in clinical practice, and demand," said Sloan.

Sloan acknowledged that DSAs are no longer listed among Almac’s platforms on its website. He said instead that next-generation sequencing is a main technology for the company for companion diagnostic development, while he characterized qPCR as "extremely important."

"In chronic disease, for example, qPCR is often the most cost-effective approach for diseases that are associated with relatively few gene variants," said Sloan.

Another perk to using qPCR is that the COVID-19 pandemic prompted laboratories worldwide to invest in new equipment to undertake SARS-CoV-2 testing, Sloan pointed out. That means there is now a significant installed base of qPCR diagnostics instruments basically everywhere, including in local hospital laboratories, systems that can support future companion diagnostics, making the technology a "very attractive option" for such assays.

Almac also works with NanoString’s platform in its genomic services business, enabling the firm to develop and optimize assays that range from single-gene and multiplex tests to small-, mid-, and large-sized panels. Genomic services support biomarker discovery and include the aforementioned platforms as well as pathology reviews and clinical support.

The company offers a clinical trial assay service in addition to its companion diagnostics service.

Sloan noted the firm has a seasoned data sciences team with expertise in bioinformatics, biostatistics, and software development, which is part of its offering for biodiscovery, as well as a sample management team.

All of these offerings interlock though, and biomarkers discovered via genomic services can be transited to its clinical trial assay services and be run from Almac’s numerous global clinical testing laboratories. The same markers can also find their way into companion diagnostics development.

Almac has locations scattered around the world, with a new EU headquarters across the border in County Louth, Ireland, and diagnostics services also based in Durham, North Carolina, and Manchester, UK.

In terms of companion diagnostics, Sloan said the company gives clients like AstraZeneca full-service support, including assistance in the development, manufacturing, and commercialization of such assays. This includes regulatory and clinical support, too, he said. Almac can also offer customers single-site and kitted commercial offerings for their companion diagnostics programs.

According to Sloan, AstraZeneca will draw on all of Almac’s services for the new collaboration and the resulting assays will be based both on qPCR and sequencing.

A spokesperson for AstraZeneca, which is headquartered in Cambridge, UK, has annual revenues of $37 billion and employs north of 76,000 people, said that the company’s focus on precision medicine led it into an alliance with Almac.

She called precision medicine an "integral part" of the company’s R&D efforts and said that more than 90 percent of the company’s pipeline now has such an approach.

"Our ambition in biopharmaceuticals R&D is to develop precision medicines for chronic diseases that make it possible to diagnose and intervene earlier," the spokesperson said.

The partnership with Almac is an outcome of this turn toward precision medicine, according to the spokesperson. She reiterated that the duo will work on specific companion diagnostics assays in certain disease areas, including kidney disease, nonalcoholic steatohepatitis, and respiratory disease.

These will later be implemented into clinical trials, where they will be used to select patients for participation. Later, the same tests could be slotted into routine clinical practice, the spokesperson added, to support the rollout of numerous new therapies worldwide.

Almac’s global sweep helped it secure the new collaboration. The spokesperson said that AstraZeneca selects its partners as part of a "rigorous process ensuring their scientific, regulatory, and commercial capabilities." By partnering with Almac, AstraZeneca aims to deliver tests that can be commercialized to enable access to treatment for chronic diseases in a manner that is "consistent with regulatory requirements, across a range of localities," the spokesperson said.

Such partnerships have paid off for AstraZeneca. The spokesperson noted that AstraZeneca and its partners have delivered more than 50 regulatory approved companion diagnostics to market to date. Such assays have been aligned to targeted medicines and in different regions, she noted.

The company has churned out a series of new companion diagnostics deals in recent months, including an agreement with Biocartis related to non-small cell lung cancer announced in June and another with Amoy Diagnostics related to therapies for breast and prostate cancers in April.

For its part, Almac also has a track record in the companion diagnostics space. In 2019, for instance, the company obtained a CE-IVD mark for a sequencing-based test for selecting molecular eligibility in a cancer drug clinical trial undertaken by Turning Point Therapeutics. The same year, the US Food and Drug Administration granted an investigational device exemption for the same diagnostic assay.

The company inked an agreement in January 2021 with Personal Genome Diagnostics to improve opportunities for clinical trial development and companion diagnostic projects. As part of that deal, Almac and PGDx agreed to provide pharmaceutical clients with access to the latter’s PGDx elio tissue complete and PGDX elio plasma resolve assays in combination with Almac’s genomic services and molecular diagnostic development expertise.