On October 12, 2020 HITGEN (688222.SH) reported that it has entered into a definitive agreement with Ligand Pharmaceuticals Inc. (NASDAQ: LGND) to acquire Vernalis (R&D) Limited, Cambridge, UK-based world leaders in fragment and structure-based drug discovery research. The acquisition is for the entire issued share capital of Vernalis (R&D) Limited, for $25M in cash. The closing of this transaction is subject to customary conditions and approvals, expected to complete before the end of 2020.

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Vernalis combines excellence in protein science and structure determination, fragment screening and biophysics with medicinal chemistry leadership to enable novel drug discovery against highly challenging targets. They are a 80-person experienced research team, working out of fully equipped laboratories in Granta Park, Cambridge, UK.

Strong synergies between HitGen’s industry-leading DNA-encoded chemical libraries (DEL) platform and Vernalis’ deep expertise in fragment and structure-based approaches and medicinal chemistry will offer a full suite of early discovery capabilities for both internal programs and external collaborations. Vernalis has a robust record in achieving out-licencing of multiple drug discovery projects, with progression to clinical stages. Building upon existing platforms and proprietary technologies, this partnership promises exciting opportunities in advancing the next generation of DEL and its applications.

Coupling HitGen DELs containing over 500 billion small molecules, and a dedicated 100-person internal programs resource, with Vernalis’ extensive experience in progressing projects from concept to clinic, will empower joint discovery efforts against hard-to-drug targets, to develop innovative therapeutics of the future. It is envisaged that close collaboration between the teams and pioneering technologies can deliver meaningful value on a faster timescale to the combined NCE portfolio, available for licensing to partners.

Through this acquisition, HitGen will join the dynamic Cambridge biopharma cluster, bringing a wealth of business development, academic, and non-profit partnership opportunities, alongside serving as a platform for further investment and expansion in the United Kingdom and Europe.

Vernalis will continue to operate in Cambridge under the current management team, committed to maintaining and growing its impressive collection of collaborations with partners which currently include Asahi Kasei Pharma, Lundbeck, Servier, and PhoreMost.

On October 12, 2020 Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that the European Patent Office has granted European Patent no 3293201 (Press release, Targovax, OCT 12, 2020, View Source [SID1234568302]). The patent covers the use of ONCOS-102 in combination with checkpoint inhibitors.

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Torbjørn Furuseth, Chief Financial Officer of Targovax, said: "We are delighted that this European patent has been granted, further strengthening Targovax’s intellectual property portfolio covering the very important combination of ONCOS-102 and anti-PD1 checkpoint inhibitors. The oncology market is ever expanding, with the immuno-oncology segment expected to see the largest growth in the coming years. Securing this patent protects our innovative oncolytic immunotherapy platform and strengthens our market position."

In 2019 Targovax reported encouraging data from part 1 of a trial in PD-1 checkpoint refractory melanoma. This trial examines how ONCOS-102 reactivates the immune system of patients that have progressed on checkpoint inhibitor treatment. The aim is to trigger relevant T-cell production and infiltration into the tumor so that patients who have become refractory can benefit from retreatment with the checkpoint inhibitor. Data from part 2 of this trial is expected later in 2020.

Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system to fight the cancer. ONCOS-102 is currently being tested in mesothelioma, melanoma ovarian and colorectal cancers and has already shown promising clinical results both as monotherapy and in combination with chemotherapy, and checkpoint inhibitors.

On October 12, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) reported that the Company has informed the European Medicines Agency, EMA, about its intention to submit an application for a conditional marketing authorization of melflufen (INN melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma (RRMM) (Press release, Oncopeptides, OCT 12, 2020, View Source [SID1234568301]).

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The decision to submit an application for conditional approval has been grounded on an in-depth analysis of the regulatory environment and is endorsed by key opinion leaders in the EU. Previously the Company intended to await the results from the ongoing randomized, phase 3 OCEAN study before submitting an application for marketing authorization. Upon completion, the outcome from the OCEAN study comparing melflufen and pomalidomide in patients with RRMM, will be submitted to regulatory authorities to potentially expand the label of melflufen.

The HORIZON study demonstrates that melflufen in combination with dexamethasone has a potential to provide a therapeutic option for patients with RRMM that are hard to treat and have a poor prognosis, including patients with triple-class refractory myeloma and patients with extramedullary disease (EMD).

"Key opinion leaders and clinics across Europe have gained extensive experience of melflufen from our clinical development program in multiple myeloma. We share a mutual interest to enable early access to this rapidly growing patient population in desperate need of new treatment options", says Klaas Bakker, CMO of Oncopeptides.

According to the European Medicines Agency, medicines are eligible for conditional approval if they are aimed at treating or preventing seriously debilitating or life-threatening diseases. Conditional marketing authorizations may be granted if; the benefit-risk balance of the product is positive, comprehensive data can be provided, there is an unmet medical need, and the benefit to public health of making the product available outweighs the risks due to need for additional data.

The US Food and Drug Administration, FDA, has granted priority review to Oncopeptides´ New Drug Application of melflufen in combination with dexamethasone for treatment of patients with multiple myeloma. The FDA has set a target date for the review of the New Drug Application, to February 28, 2021.

On October 11, 2020 CStone Pharmaceuticals ("CStone", HKEX: 2616) reported the completion of the Share Subscription Agreement through which an affiliate of Pfizer Inc. ("Pfizer",NYSE: PFE) subscribed for newly issued CStone shares at approximately US$200 million (equivalent to approximately HK$1.55 billion), bringing into effect the multifaceted strategic collaboration that the companies announced on September 30, 2020 (Press release, CStone Pharmaceauticals, OCT 11, 2020, View Source [SID1234568284]).

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The Listing Committee of the Stock Exchange of Hong Kong approved the listing of 115,928,803 additional shares subscribed by Pfizer at a price of approximately HK$13.37 per share. The shares represent approximately 9.90 percent of the issued share capital of CStone as enlarged by the allotment and issue of the shares.

CStone entered into the share subscription as part of a strategic collaboration framework with Pfizer to advance its strategic, commercial and financial objectives as it transitions into a fully integrated biopharma company. Completion of the share subscription allows the companies to proceed with the initiatives envisioned as part of this framework:

CStone has agreed to grant Pfizer an exclusive license to commercialize sugemalimab, an anti-PD-L1 monoclonal antibody and one of CStone’s core late-stage assets, in mainland China
CStone and Pfizer will collaborate on the development and commercialization of additional oncology assets in the Greater China market
CStone and Pfizer may pursue on a selected basis joint in-licensing arrangements for additional oncology assets for the Greater China market

On October 10, 2020 Antengene Corporation, a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, and WuXi Biologics ("WuXi Bio") (2269.HK) reported that they have signed a strategic cooperation Memorandum of Understanding (MoU) to co-operate in the development and production of novel drugs, and jointly promote the R&D of innovative oncology therapies (Press release, Antengene, OCT 10, 2020, View Source [SID1234568285]).

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China’s cancer incidence and mortality have been increasing in recent years. Low rates of survival and access to innovative therapies are persistent obstacles to local cancer treatment. With the vision of "Treating patients beyond borders", Antengene is committed to bringing novel mechanisms of action and cutting-edge anti-tumor therapies to patients in China, the rest of Asia Pacific and around the world. By leveraging outstanding R&D capability and applying a differentiated discovery and development strategy, Antengene has built a pipeline with 12 innovative clinical and preclinical products characterized by their high target selectivity and synergistic activity within the pipeline. Foundations have been built in oncology with the breadth of diseases in which the pipeline has shown activity also extending to viral infections, autoimmunity and other disease fields. As a leading global open-access biologics technology platform, Wuxi Biologics offers end-to-end solutions based on its sophisticated R&D system and technological platform to advance the process of promoting drug R&D from concept to commercial manufacturing. Through the collaboration, Antengene and WuXi Biologics will make full use of their extensive resources and professional capabilities to accelerate the research and development of first-in-class or best-in-class innovative cancer therapies and provide patients with high-quality and affordable treatment plans as soon as possible .

"We are very glad to launch a strategic cooperation with WuXi Biologics. This cooperation is a timely decision. WuXi Biologics has first-class biopharmaceutical capabilities and could empower us with advanced technology," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene, "At present, Antengene has carried out a comprehensive layout for the research and development of innovative cancer medicines, and continues to promote the science-oriented R&D of anti-tumor drugs such as small molecule drugs, monoclonal drugs and bispecific antibody drugs. We are looking forward to enhancing the quality of research and development and leveraging complementary strengths of both companies in order to ultimately benefit a wider range of cancer patients."

Dr. Chris Chen, CEO of WuXi Biologics, said: "We are pleased to establish a strategic cooperation with Antengene. Through our diversified and integrated biologics technology platform, WuXi Biologics will continue to empower Antengene to accelerate the R&D process of innovative oncology therapies. We look forward to working together to achieve a win-win situation based on our capabilities and advantages and make positive contribution to the health and wellness of patients in China and the world."