HOOKIPA to Participate in the Kempen Life Sciences Conference

On April 13, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that the company will participate in investor meetings at the Kempen Life Sciences Conference being held in Amsterdam, April 20 – 21, 2022 (Press release, Hookipa Biotech, APR 13, 2022, View Source [SID1234612125]).

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BioMarin to Host First Quarter 2022 Financial Results Conference Call and Webcast on Wednesday, April 27, at 4:30pm ET

On April 13, 2022 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Wednesday, April 27th, at 4:30 p.m. ET to discuss first quarter 2022 financial results and provide a general business update (Press release, BioMarin, APR 13, 2022, View Source,-April-27,-at-4-30pm-ET [SID1234612124]).

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Interested parties may access a live audio webcast of the conference call via the investor section of the BioMarin website, www.biomarin.com. A replay of the call will be archived on the site for one week following the call.

GSK reaches agreement to acquire late-stage biopharmaceutical company Sierra Oncology for $1.9bn

On April 13, 2022 GlaxoSmithKline plc (LSE/NYSE: GSK) and Sierra Oncology, Inc (Nasdaq: SRRA) reported that the companies have entered into an agreement under which GSK will acquire Sierra Oncology, a California-based, late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare forms of cancer, for $55 per share of common stock in cash representing an approximate total equity value of $1.9 billion (£1.5 billion) (Press release, GlaxoSmithKline, APR 13, 2022, View Source [SID1234612115]).

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Myelofibrosis is a fatal cancer of the bone marrow impacting the normal production of blood cells. Anaemia represents a high unmet medical need in patients with myelofibrosis. At diagnosis, approximately 40% of patients are already anaemic, and it is estimated that nearly all patients will eventually develop anaemia.[1],[2] Patients treated with the most commonly used JAK inhibitor will often require transfusions, and more than 30% will discontinue treatment due to anaemia.[3] Anaemia and transfusion dependence are strongly correlated with poor prognosis and decreased overall survival.[4]

Momelotinib has a differentiated mode of action with inhibitory activity along key signalling pathways. This activity may lead to beneficial treatment effects on anaemia and reduce the need for transfusions while also treating symptoms. In January 2022, Sierra Oncology announced positive topline results from the MOMENTUM phase III trial. The study met all its primary and key secondary endpoints, demonstrating that momelotinib achieved a statistically significant and clinically meaningful benefit on symptoms, splenic response, and anaemia.

Luke Miels, Chief Commercial Officer, GSK said: "Sierra Oncology complements our commercial and medical expertise in haematology. Momelotinib offers a differentiated treatment option that could address the significant unmet medical needs of myelofibrosis patients with anaemia, the major reason patients discontinue treatment. With this proposed acquisition, we have the opportunity to potentially bring meaningful new benefits to patients and further strengthen our portfolio of specialty medicines."

Stephen Dilly, MBBS, PhD, President and Chief Executive Officer, Sierra Oncology said: "Uniting with GSK creates the best opportunity for Sierra Oncology to realise its mission of delivering targeted therapies that treat rare forms of cancer while also delivering compelling and certain value for our stockholders. Now we have a partner with a global infrastructure and oncology expertise that enables us to deliver momelotinib to patients as quickly as possible and on a global scale."

Momelotinib complements GSK’s Blenrep (belantamab mafodotin), building on GSK’s commercial and medical expertise in haematology. The proposed acquisition aligns with GSK’s strategy of building a strong portfolio of new specialty medicines and vaccines. If the transaction is completed and momelotinib is approved by regulatory authorities, GSK expects momelotinib will contribute to GSK’s growing specialty medicines business, with sales expected to begin in 2023, with significant growth potential and a positive benefit to the Group’s adjusted operating margin in the medium term.

Financial considerations

Under the terms of the agreement, the acquisition will be effected through a one-step merger in which the shares of Sierra Oncology outstanding will be cancelled and converted into the right to receive $55 per share in cash. Subject to customary conditions, including the approval of the merger by at least a majority of the issued and outstanding shares of Sierra Oncology, and the expiration or earlier termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, the transaction is expected to close in the third quarter of 2022 or before.

The per share price represents a premium of approximately 39 per cent to Sierra Oncology’s closing stock price on 12 April 2022 and a premium of approximately 63 per cent to Sierra’s volume-weighted average price (VWAP) over the last 30 trading days. Sierra Oncology’s Board of Directors has unanimously recommended that Sierra’s stockholders vote in favour of the approval of the merger. Additionally, stockholders of Sierra Oncology holding approximately 28 per cent of Sierra’s outstanding shares, have agreed to vote their shares in favour of approval of the merger.

GSK will account for the transaction as a business combination and expects it to be accretive to adjusted EPS in 2024, the expected first full year of momelotinib’s sales. New GSK reaffirms its full-year 2022 guidance, the medium-term outlook for 2021-2026 of more than 5% sales and 10% adjusted operating profit CAGR* at CER**, and long-term sales ambition.

The value of the gross assets of Sierra Oncology to be acquired (as of 31 December 2021) is $109 million (£83 million at the rate of £1 = $1.312, being the 31 March 2022 spot rate). The net losses of the business were $95 million for the 12 months ended 31 December 2021 (£70 million, at the rate of £1 = $1.38, being the average rate for the period).

* CAGR: Compound Annual Growth Rate; **CER: Constant Exchange Rate

Advisors

PJT Partners is acting as financial advisor and Cleary Gottlieb Steen & Hamilton LLP is serving as legal counsel to GSK in connection with the transaction. Lazard is acting as financial advisor and Wilson Sonsini Goodrich & Rosati, is serving as legal counsel to Sierra Oncology.

EORTC presents new precision medicine research results at AACR 2022

On April 13, 2022 EORTC-SPECTA reported that New results from three research projects are being presented at this year’s annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), the world’s foremost cancer research organisation (Press release, EORTC, APR 13, 2022, View Source [SID1234612113]). This year’s annual meeting takes place in New Orleans from 8 – 13 April.

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SPECTA is a collaborative European platform, under the sponsorship of EORTC, that aims to develop translational1 research projects in cancer, including biomarker discovery. The first two presentations report results from studies investigating the enhanced use of molecular screening to identify ‘best fit’ treatments. Notwithstanding important advances in the personalisation of treatments, many patients are still unable to benefit from them because there is limited knowledge of the molecular characterisation of their cancer and/or poor access to screening platforms.

Rare cancers, defined as having an incidence lower than 6 per 100,000 cases per year, are a particular victim of these factors, mainly because rare cancers are so heterogeneous. To address this, EORTC, in collaboration with EURACAN2, has developed a project within the SPECTA platform to evaluate the molecular situation of rare cancers in Europe. By providing rare cancer patients with access to molecular screening, SPECTA can relate their potentially treatable alterations to possible therapies, and therefore advise clinicians on potential trials or new treatments for their patients.

In the SPECTA Arcagen trial3, researchers analysed the genetic material of tumour samples from patients with rare cancers via biopsies of paraffin-embedded samples or blood. At the cut-off date, molecular alterations that are involved in cancer initiation and proliferation were found in the tumours of 629 patients, of whom 421 were theoretically treatable by an existing therapy. Approved treatment in the right tumour type could be proposed in 58 cases. The researchers will now follow up the patients to see if the treatment was suitable and understand the clinical care for rare cancer in Europe.

Another SPECTA project4 set out to look for clinically relevant molecular alterations in adolescent and young adult (AYA) cancer patients. Each year there are around 45,000 new diagnoses of cancer in this age group in Europe; these cancers are also categorised as rare. Despite the great progress that has been made in the understanding the molecular landscape of cancer in children and adults, AYA cancer biology is still poorly understood.

The researchers studied tumours from 48 patients aged between 12 and 29 who had a newly diagnosed high risk sarcoma, or one that had relapsed. They identified treatable molecular variations in 81.2% of them thus, they say, confirming that there is an unmet clinical need among AYA sarcoma patients. Encouragingly, they were also able to identify ways of reducing quality control failures in the tumour samples, thus enabling more to be screened.

The third study5 presented forms part of a European project called IMMUcan, which seeks to enhance understanding of the tumour microenvironment. IMMUcan researchers report on their creation of a single cell RNA sequencing database, a cutting-edge technology to study gene expression at single cell level. While single cell RNA sequencing has been invaluable in helping to understand the cells, molecules, and blood vessels that surround a cancer cell (referred to as the tumour microenvironment), this has generated a massive amount of dispersed information which is not always presented consistently. The new database will bring it all together in one place in a user-friendly format.

Dr Marie Morfouace, an EORTC senior translational research scientist, who presented the SPECTA projects at the meeting, said: "These studies are another step along the road to making precision cancer medicine available for all patients. By understanding the molecular landscape of the tumour and its microenvironment, we can not only advise clinicians on potential targeted therapy for their patients, but we also build scientific hypotheses for the next generation of clinical trials, based on the strong molecular and cellular data generated in those projects."

1.Translational research aims to convert basic research results into results that will benefit humans directly.

2.EURACAN is the European reference network (ERN) for rare solid tumour cancers in adults. ERNS are virtual patient-centred networks bringing healthcare providers and patient representatives across Europe. Working together, they tackle complex or rare diseases and conditions that require highly specialised care and concentrated knowledge and resources.

3.View Source!/10517/presentation/16354

4.View Source!/10517/presentation/12148

5.View Source!/10517/presentation/17468

Funding:

The EORTC SPECTA platform is supported by Alliance Healthcare, a member of the AmerisourceBergen group

Arcagen is a collaboration between EORTC and Euracan and is funded by F. Hoffman-La Roche.

The AYA project is supported by the Walgreen Boots Alliance.

The IMMUcan project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 821558. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA.

NanoMab Technology Limited signs licensing agreements with Radiopharm Theranostics and Full Life Technologies

On April 12th, 2022 NanoMab Technology Limited, a privately held biopharmaceutical company focussing on cancer precision therapies is delighted to reported that over the course of the last two quarters it has taken the next steps forward in its commitment to developing next generation pharmaceuticals by forming exclusive licensing agreements with Radiopharm Theranostics (ASX: RAD) and Full Life Technologies (HK) Ltd (Press release, NanoMab, APR 12, 2022, View Source [SID1234645316]).

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The agreements grant RAD full rights to develop three of NanoMab’s single-domain antibody assets: NM-02, NM-03, and NM-04; respectively targeting HER-2 (breast cancer), TROP-2 (triple negative breast cancer), and PTK7 (multiple solid tumours) biomarkers. RAD is an ASX-listed company led by a strong global team with world-class experience, who aim to develop radiopharmaceutical products for both diagnostic and therapeutic uses in areas of high unmet medical needs. RAD is the latest venture of Australian bioentrepreneur, Paul Hopper, who is behind numerous successful companies developing oncology drugs.

Additionally, an agreement issuing the full IP right to develop NM-05 (sdAb targeting FAP) has been established with Full-Life Technologies (HK) Ltd. Full-life is a global nuclear health company seeking to tackle two core issues experienced in the radiopharmaceuticals sector; the ability to produce primarily alpha- and beta- medical radioisotopes in quantity, and the development of an innovative translational research platform for Targeted-Radiotherapy.

NanoMab believes these exclusive licensing agreements have formalised the strategic collaborations between the respective parties, which will speed up the development and commercialisation of our unique platform of immuno-oncology theranostic drugs to aid patients in the battle against aggressive cancers.