Aclys Bio and Genmab Enter Research and Commercial License Option Agreement to Develop Proprietary Aclys Antibodies Against an Undisclosed Target

On January 17, 2022 Aclys Bio Corp ("Aclys"), a company discovering and developing precision biologics for the treatment of cancer, earlier this month reported a new exclusive research and commercial license option agreement with Genmab A/S (Nasdaq: GMAB), an international biotech company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer (Press release, Virtici, JAN 17, 2022, View Source [SID1234608857]).

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Under the terms of the agreement, Genmab secures exclusive rights to Aclys antibodies (specific to an undisclosed target) for further research in conjunction with Genmab’s proprietary platforms. Genmab is also granted the option to advance development and commercialization of resulting products.

Aclys has built a broad range of antibodies using its PILA platform to create targeted therapeutics for solid tumors. The agreement with Genmab recognizes the capability of the Aclys PILA platform to identify novel precision targets.

"We have differentiated, high value targets, unique antibody engineering capabilities, and a team that has delivered some of the most valuable monoclonal antibodies currently in development.", said Dr. Tony Cooper, Aclys Cofounder and CEO. "This agreement with Genmab is integral to advancing our goal of delivering life-saving therapies to patients." Aclys is a leader in the emerging field of precision immune medicine. Aclys utilizes a proprietary set of patient molecular data to select differentiated targets and create precision biologics with the safety profile and response rates only achievable with precision biologics.

Evotec and Lilly enter into drug discovery collaboration in metabolic diseases

On January 18, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported that the Company has entered into a drug discovery collaboration with Eli Lilly and Company ("Lilly") in the field of metabolic diseases with a focus on kidney diseases and diabetes (Press release, Evotec, JAN 17, 2022, View Source [SID1234605514]).

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The collaboration leverages Evotec’s extensive experience and track record of delivering in the field of metabolic diseases, as well as its unique and extensive kidney disease patient database, to identify and validate promising novel targets for therapeutic intervention. Evotec will be responsible for the discovery of potential drug candidates for the treatment of diabetes and chronic kidney diseases from targets identified by Lilly or by Evotec. Lilly reserves the right to select up to five programmes developed within this partnership and to continue with any subsequent development, clinical validation and commercialisation.

The collaboration initially runs for a term of three years. In addition to an undisclosed upfront payment, Evotec will be eligible to receive success-based discovery development, regulatory and commercial milestone payments of up to US$ 180 m per programme, as well as tiered royalties on net sales of any products resulting from the collaboration, for a potential overall value up to US$ 1 bn.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are excited to enter into this research partnership with Lilly. Over a period of several years, Evotec has systematically built a proprietary patient database by conducting multi-omics analyses of biospecimens from patient biobanks covering metabolic and kidney diseases. Evotec’s patient-derived molecular data in combination with our omics-supported multimodality drug discovery platform delivers highest quality drug candidates for our partners. We are proud to collaborate with Lilly in diabetes and kidney diseases as they are one of the leading companies in these areas.

Tyligand Bioscience Receives IND Clearance from China NMPA for TSN084, a Multi-kinase Inhibitor to Address Tumor Resistance to Targeted Therapies

On January 17, 2022 Tyligand Bioscience, a clinical-stage biotechnology company developing innovative small-molecule therapeutics against drug resistant cancers, reported that its investigational new drug (IND) application of TSN084 has been approved by China’s National Medical Products Administration (NMPA) (Press release, Tyligand Bioscience, JAN 17, 2022, View Source [SID1234644991]).

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TSN084 is a first-in-class phosphorylation inhibitor targeting CDK8/19 and several other kinases implicated in tumorigenesis and immune evasions. Phase I enrollment will be conducted at the Cancer Hospital of the Chinese Academy of Medical Sciences and other clinical centers. In Oct 2021, the company has received IND approval from the US FDA for the experimental drug and dose escalation studies are expected to commence soon.

Dr. Tony Zhang, cofounder and CEO of Tyligand Bioscience, commented, "We are excited about this important milestone and the potential of TSN084 for helping patients with tough to treat tumors. Accomplishing this goal is testimonial to the quality and speed of the Tyligand team at transforming novel molecules into quality drug candidates. It is an important step toward testing our approach of selective and simultaneous inhibition of multiple factors responsible for the major hallmarks of cancer."

Jacobio Receives IND Approval for Aurora A Inhibitor JAB-2485 from FDA

On January 16, 2022 Jacobio reported that it’s self-developed global first-in-class drug Aurora A inhibitor JAB-2485 received IND (Investigational New Drug) from the FDA (Food and Drug Administration) in US (Press release, Jacobio Pharmaceuticals, JAN 16, 2022, View Source [SID1234605499]). Jacobio plans to initiate a Phase I/IIa clinical trial in patients with advanced solid tumors in the US .

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JAB-2485 is a highly selective small molecule Aurora A inhibitor. JAB-2485 can inhibit Aurora A activity at the cellular level, induce apoptosis and inhibit tumor growth. At present, there is no commercialized Aurora A inhibitor globally. Jacobio’s self-developed JAB-2485 is the third Aurora A inhibitor enter into clinical stage in the United States.

JAB-2485 has good anti-tumor activity. Preclinical data show that JAB-2485 is highly selective at biochemical and cellular levels. The inhibitory activity of Aurora A is one thousand times higher than that of Aurora B, and has potential to benefit patients with small cell lung cancer and triple negative breast cancer.

Relevant studies have shown that Aurora A and SHP2 inhibitors may be one of the therapies to solve the drug resistance of KRAS G12C inhibitors, Jacobio has these three self-developed drugs in clinical stage, including SHP2 inhibitors (JAB-3068 and JAB-3312), Aurora A inhibitor (JAB-2485) and KRAS G12C inhibitors (JAB-21822), which has potential to provide more combination therapies to patients.

Update – GSK Consumer Healthcare

On January 15, 2022 GlaxoSmithKline (GSK) plc reported that it has received three unsolicited, conditional and non-binding proposals from Unilever plc to acquire the GSK Consumer Healthcare business (Press release, GlaxoSmithKline, JAN 15, 2022, View Source [SID1234605495]). The latest proposal received on 20th December 2021 was for a total acquisition value of £50 billion comprising £41.7 billion in cash and £8.3 billion in Unilever shares. The Consumer Healthcare business is a Joint Venture between GSK and Pfizer, with GSK holding a majority controlling interest of 68% and Pfizer 32%.

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GSK rejected all three proposals made on the basis that they fundamentally undervalued the Consumer Healthcare business and its future prospects.

The Board of GSK is strongly focused on maximising value for GSK shareholders and has carefully evaluated each Unilever proposal. In doing so, the Board and its advisers assessed the proposals relative to the financial planning assessments completed to support the proposed demerger of the business in mid-2022, including the sales growth outlook set out below.

Global leader in Consumer Healthcare
The Consumer Healthcare business has been transformed since 2014 through the successful integrations of GSK’s business with the Novartis consumer health portfolio in 2015 and the Pfizer portfolio in 2019. Importantly, this transformation has also provided a platform to scale and optimise many aspects of the Consumer Healthcare business including divesting lower growth brands, introducing a new R&D/innovation model, optimising the supply chain and manufacturing network, alongside continued investment in new digital, data and analytic platforms and capabilities.

This has resulted in the creation of a leading global consumer healthcare business with annual sales of £9.6 billion in 20211. The business has an exceptional portfolio of world-class, category-leading brands; global scale with footprint and distribution capability to serve more than 100 markets; strong brand building, innovation and digital capabilities; and offers a unique proposition that combines trusted science with human understanding.

The business is led by a highly skilled management team with deep experience in consumer healthcare and FMCG with strong commitment to delivery on its purpose and growth ambitions.

Superior growth and highly attractive financial profile
The business is well-positioned to sustainably grow ahead of its categories in the years to come. The fundamentals for the £150 billion consumer healthcare sector are strong, reflecting an increased focus on health and wellness, significant demand from an ageing population and emerging middle class, and sizeable unmet consumer needs.

Over the period 2019-2021 the Consumer Healthcare business delivered a 4% organic sales growth CAGR2 outpacing its categories and despite the adverse impact of the COVID pandemic.

Superior sales growth for the business is expected to result from a strategy that puts the consumer at the heart of the business to better address every-day health and wellness needs, in particular by increasing household penetration of its leading brands and capitalising on new and emerging growth opportunities arising from innovation and the use of new technologies and digital platforms, all underpinned by continued strong execution and financial discipline. Over the medium term, superior sales growth is expected to be primarily driven by continued momentum of key brands in Oral Care, VMS, and Pain Relief; accelerating innovation in the US and China; and further growth in emerging markets.

Reflecting these trends, and the investments made and planned for the business, the Board of GSK is confident that the Consumer Healthcare business can sustainably deliver annual organic sales growth in the range of 4-6% (CER) over the medium term.

The combination of superior organic sales growth, operating margin expansion and consistent high cash generation will, we believe, offer both existing and prospective shareholders a highly attractive financial profile that facilitates continued investment in growth, the delivery of attractive returns and the opportunity of continued participation in long-term value creation.

Proposals fundamentally failed to reflect the intrinsic value of the business and its potential
The Board of GSK unanimously concluded that the proposals were not in the best interests of GSK shareholders as they fundamentally undervalued the Consumer Healthcare business and its future prospects.

The Board of GSK therefore remains focused on executing its proposed demerger of the Consumer Healthcare business, to create a new independent global category-leading consumer company which, subject to approval from shareholders, is on track to be achieved in mid-2022.

Capital Markets event
GSK intends to share further details of the strategy, brands, capabilities and operations, including detailed financial information and future growth ambitions for the new Consumer Healthcare business at a virtual Capital Markets Day for investors and analysts on Monday 28th February 2022.