Adaptimmune and Astellas to Co-Develop Allogenic CAR-T and TCR T-Cell Therapies

Shares of Adaptimmune have skyrocketed since the opening bell on Jan. 13. The stock closed up 200% Monday after the company announced positive results with its SPEAR-T cancer program and has continued to rise this morning after it struck a deal with Astellas Pharma.

Investors have boosted Adaptimmune’s stock another 50% in premarket trading today following the announcement of a co-development agreement with Astellas to bring new stem-cell-derived allogeneic T-cell therapies to people with cancer. The collaboration will leverage Adaptimmune’s target identification and validation capabilities for generating target-specific T-cell Receptors (TCRs), chimeric antigen receptors (CARs), and HLA-independent TCRs that recognize surface epitopes independently of the HLA profile of the tumor cell. The collaboration will also utilize Astellas’ Universal Donor Cell and Gene Editing Platform it obtained through the acquisition of Seattle-based Universal Cells. The two companies will combine their strengths and focus on up to three targets and develop T-cell therapy candidates aimed at them. These targets will exclude target-specific T-cell products in pre-clinical or clinical trials or those developed for other partners at Adaptimmune, the company said.

Helen Tayton-Martin, Adaptimmune’s chief business officer and co-founder, said the partnership with Astellas builds upon and extends an existing collaboration focused on gene editing of iPSC cells. The new deal with Astellas could include both CAR-T and TCR T-cell approaches, and has a chance to bring in the company’s novel HLA-independent TCR (HiT) platform, Tayton-Martin said.

“It brings together highly complementary skills and expertise across the two organizations, and will enable the accelerated development of new, off-the-shelf T-cell therapy products for people with cancer,” she added in a statement.72602b87-7b2d-4c95-aa4c-1305ad63d690

Under current terms of the deal, Astellas will fund research up until completion of a Phase I trial for each candidate. When those Phase I trials are complete, the two companies will then determine whether to continue development together or allow one of the companies to proceed on their own under a licensing agreement. If all goes well, Adaptimmune stands to receive up to $897.5 million in payments, including a $50 million upfront payment. There are two different pay structures for Adaptimmune depending on how the assets are developed following the Phase I trials. In addition, Adaptimmune will receive research funding of up to $7.5 million per year.

Astellas will also have the right to select two targets and develop allogeneic cell therapy candidates independently. Astellas will have sole rights to develop and commercialize these products, subject to necessary licenses and the payment of milestones and royalties.

Immuno-oncology is one of Astellas’ core areas of focus. Last month, the company, along with its development partner Seattle Genetics, won approval from the U.S. Food and Drug Administration for its metastatic urothelial bladder cancer treatment Padcev, a first-in-class antibody-drug conjugate. The company also boosted its IO pipeline with the late 2019 acquisition of Xyphos Biosciences. In that deal, the company gained the ACCEL (Advanced Cellular Control through Engineered Ligands) technology platform, to develop new and potentially better ways to use the immune system to destroy targeted cells throughout the body.

Naoki Okamura, who serves as both chief strategy officer and chief financial officer at Astellas, said the deal with Adaptimmune “will enable us to create new stem-cell-derived allogeneic T-cell therapies for a variety of cancers, including solid tumors, in the future. We will continue to dedicate our efforts in delivering novel treatments for diseases with high unmet medical needs, pursuing cutting-edge science and technological advances.”

For Adaptimmune, the deal with Astellas comes one day after the company announced two confirmed partial responses in a liver cancer patient and melanoma patient who were both treated with the company’s SPEAR-T platform for solid tumors. Additionally, Adaptimmune said it observed two partial responses in a patient with gastroesophageal junction cancer and one in a patient with head and neck cancer. The company said these data further confirm the potential of its SPEAR T-cell platform for patients with multiple solid tumors.

Gilead Backs Startup Kyverna Therapeutics with Financing, Collaborative Agreement

Gilead Sciences is boosting support for a Bay Area startup looking to develop a new class of therapies for autoimmune diseases. Gilead, along with two venture capital groups, provided Kyverna Therapeutics with an infusion of $25 million and also struck a collaboration with the fledgling company.

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On Monday, Kyverna announced it had closed a $25 million Series A investment from Gilead, Vida Ventures and Westlake Village BioPartners, which will be used to advance the company’s platform that combines advanced T cell engineering and synthetic biology technologies to suppress and eliminate autoreactive immune cells at the root cause of inflammatory disease. In addition to the cash, Gilead and Kyverna entered into a collaboration and license agreement to develop engineered T cell therapies for the treatment of autoimmune disease based on Kyverna’s synthetic Treg platform and synNotch technology from Gilead subsidiary Kite Pharma. Kyverna will be responsible for conducting research activities and initial clinical studies through proof-of-concept. Gilead will be granted an option to continue to develop and potentially commercialize any product that comes from the research.

Under terms of this agreement, Gilead will pay Kyverna $17.5 million in upfront cash. Kyverna could earn an additional $570 million in development and commercialization milestones, depending on how the research goes.

Dominic Borie, chief executive officer of Kyverna, called it one of the most exciting times in the industry when “a new modality has the potential to become the backbone of treatment for a variety of severe immune-related diseases.” Borie is an immunologist and transplant surgeon who joins Kyverna from Horizon Therapeutics where he served as head of External Research and Development. Prior to Horizon, Borie served in numerous leadership functions within Genentech focused on global clinical development of immunology therapies including two anti-CD20 molecules (rituximab and obinutuzumab) in development for orphan immunology indications. Before that, Borie was with Amgen where he served as Medical Director and Global Development Leader for Inflammation.

In addition to Borie, the Kyverna team includes Jeffrey Greve, who will serve as the company’s chief scientific officer. Prior to Kyverna, Greve founded and served as CSO of Delinia, an autoimmune disease company acquired by Celgene in 2017.

As part of the $25 million Series A, Fred Cohen, co-founder and senior managing director of Vida Ventures will serve as chairman of Kyverna’s board of directors.

“We are just beginning to see the potential for cell therapy and the opportunity to change the course of disease… At Vida, we have a long-standing commitment to advancing cell therapy. We believe the team at Kyverna, under Dominic’s stewardship and in partnership with Dr. Greve, the architect of the Kyverna scientific platform, has the ability to develop a new class of therapies for serious autoimmune diseases,” Cohen said in a statement.

MorphoSys gets $750m from Incyte for anti-CD19 cancer drug

Incyte has agreed a deal with Germany’s MorphoSys to license an antibody that could be an alternative to therapies for blood cancers sold by Amgen, Novartis and Gilead Sciences.

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Incyte is paying $750 million upfront for the antibody – called tafasitamab – which is heading for a decision at the FDA later this year in combination with Bristol-Myers Squibb/Celgene’s Revlimid (lenalidomide) in diffuse large B-cell lymphoma (DLBCL), a form of non-Hodgkin’s lymphoma (NHL).

$150 million of the upfront fee is in the form of an equity stake in MorphoSys, and there is another $1.1 billion in potential milestone payments.

The deal comes as Delaware-based Incyte is still stinging from a failure for one of its key pipeline drugs – JAK inhibitor itacitinib – in graft-versus host disease (GVHD) earlier this year.

Tafasitamab binds to CD19, a protein on the surface of B-cells that is also targeted by Amgen’s bispecific antibody Blincyto (blinatumomab) for acute lymphoblastic leukaemia (ALL), as well as two CAR-T therapies – Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) – that are already approved for DLBCL and other B-cell cancers.

In the phase 2 L-MIND trial reported last year, tafasitamab (formerly MOR208) given alongside Revlimid achieved an overall response rate of 60%, including 43% complete responses which the investigators said was in the same ballpark as CAR-T therapies for DLBCL.

There’s one fundamental difference between the two treatment approaches, however. With tafasitamab, patients could avoid the lengthy process of harvesting, modifying and growing the T cells used in CAR-T, as well as the hard-to-tolerate chemotherapy conditioning regimen that allows them to expand and proliferate in the body.

Incyte and MorphoSys are hoping that tafasitamab will offer a cheaper, off-the-shelf treatment for DLBCL that can be delivered more quickly and might be suitable for older, more frail patients who wouldn’t be eligible for CAR-T therapy.

They are also testing the antibody in a head-to-head trial against the CD20-targeting antibody rituximab – sold by Roche as Rituxan/MabThera – both given in combination with bendamustine.

That passed a futility analysis in November and if positive would expand the market opportunity for tafasitamab, which is also in earlier-stage testing for chronic lymphocytic leukaemia, another B-cell cancer.

Under the terms of the deal, both companies will develop and commercialise tafasitamab in the US, while Incyte will have exclusive commercial rights elsewhere, paying MorphoSys royalties on sales.

The US biotech will also stump up 55% of the development costs of the antibody’s global and US studies, whilst paying all the cost of trials in other countries.

One of the draws for Incyte is the potential to combine tafasitamab with its PI3K-delta inhibitor parsaclisib, with studies planned in two other forms of NHL – follicular lymphoma and marginal zone lymphoma – as well as CLL.

Clovis Oncology’s Rubraca® (rucaparib) Granted FDA Priority Review for Advanced Prostate Cancer

Clovis seeks U.S. approval for rucaparib as monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer

FDA submission based on data from TRITON clinical program in advanced prostate cancer

FDA has assigned PDUFA date of May 15, 2020

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BOULDER, Colo.–(BUSINESS WIRE)– Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Rubraca® (rucaparib) and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020. Clovis submitted the sNDA submission for rucaparib as a monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer in November 2019.

“Recently presented data suggests that Rubraca may play a meaningful role in the treatment of patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer, and this filing represents an important milestone for Clovis as it brings us one step closer to potentially making this valuable therapy available,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We are encouraged by the FDA’s decision to grant priority review to the Rubraca application, which focuses on eligible patients with advanced prostate cancer, for whom new treatment options are very much needed.”

A priority review designation is granted to proposed medicines that the FDA has determined have the potential, if approved, to offer a significant improvement in the safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. Priority designation shortens the review period from the standard 10 months to six months.

 

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Rubraca U.S. FDA Approved Indications

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutations (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Charles River and Takeda Enter Multi-Year Drug Discovery Deal

Takeda Pharmaceutical has been on a tear over the past few weeks, striking deals to develop new therapies for various diseases. On Monday, the Japan-based pharma powerhouse announced a multi-year drug discovery deal with Charles River Laboratories.

Charles River will use its strengths to help develop potential drug candidates across Takeda’s four core therapeutic areas—oncology, gastroenterology, neuroscience and rare disease. The goal will be for Takeda to take the preclinical candidates into the clinic and develop them. The two companies remained quiet on what the targets in those core therapeutic areas would be.

Charles River will use its drug discovery expertise and combine it with Takeda’s investments in human data and translation to deliver transformative medicines for patients. In its announcement, Charles River said it will “leverage its end-to-end drug discovery and safety assessment platform to explore potential therapeutic approaches and progress these programs towards candidate status.” The two companies will then have the option to advance those candidates into the clinic.

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Under the terms of the agreement, Takeda will pay Charles River an undisclosed upfront fee. Charles River will be eligible to receive development payments with a potential value of over $50 million per program in preclinical and clinical milestones for candidates that progress to the clinic. The agreement also includes additional potential commercial milestones of up to $120 million, plus royalties on launched products, Charles River said in its announcement.

“By utilizing an integrated drug discovery and development approach, our goal is to deliver quality preclinical candidates to Takeda, helping to drive forward their innovative work in key therapeutic areas,” Birgit Girshick, head of Discovery & Safety Assessment, Biologics Testing Solutions, and Avian Vaccine Services at Charles River, said in a statement.

James C. Foster, chairman, president and chief executive officer of Charles River, said the company is pleased to expand its relationship with Takeda. He expects the strengths of the two companies will “prove to be a powerful combination in delivering novel drug candidates.”

Steve Hitchcock, global head of research at Takeda, agreed with Foster. He said the two companies have a long history of working together across the drug discovery and development portfolio. Hitchcock said he is confident that the experience of Charles River will benefit the deal.

For Takeda, the deal with Charles River comes hard on the heels of two deals struck in December. Takeda forged a collaboration worth up to $1 billion with Turnstone Biologics to tackle a number of cancer indications using that company’s vaccinia virus platform. The two companies will pair up to advance Turnstone’s lead program, RIVAL-01 in multiple cancer studies and will also work together to identify additional novel product candidates based on Turnstone’s vaccinia virus platform for future independent development.

One day before the Turnstone deal was announced, Takeda and Cerevance teamed up to tackle diseases of the gastrointestinal tract that have their roots in the central nervous system. The two companies will pair up to identify novel target proteins expressed in the central nervous system for the development of therapies targeting GI disorders, the companies announced at the time.

GSK’s CEO Walmsley aiming for six new approvals in 2020

GlaxoSmithKline’s CEO Emma Walmsley has said the company hopes to get at least six new drug approvals in the next year.

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In an interview at the JP Morgan Healthcare Conference in San Francisco with CNBC, Walmsley said there is a lot of data expected in 2020.

Walmsley said in the interview that the next year could see “at least six approvals of new medicines or new indications”.

GSK is asking for approval for belantamab mafodotin, a treatment for multiple myeloma, a potential first-in-class drug that binds to the B cell maturation antigen (BCMA) that is also targeted by CAR-T therapies in clinical development.

A look at GSK’s pipeline shows its novel two-drug HIV treatment is top of the list, although this last month suffered a knock-back from the FDA.

The combination of cabotegravir and rilpivirine developed by its ViiV Healthcare joint venture with Pfizer and Shionogi is unlikely to need further trials for approval as the FDA cited issues with manufacturing controls in its rejection letter.

Also in registration phase is GSK’s asthma triple therapy Trelegy (fluticasone furoate+umeclidinium+vilanterol), which last year produced results in the CAPTAIN study showing it was better at improving lung function in uncontrolled asthma than the company’s two drug combo Relvar/Breo (fluticasone+vilanterol).

At the time of the results last May GSK’s R&D chief Hal Barron said Trelegy was on course for a filing in uncontrolled asthma.

Also in registration stage is Zejula (niraparib), the PARP inhibitor added to GSK’s portfolio following its $5.1 billion acquisition of Tesaro.

This is already approved in late line ovarian cancer by the FDA since October, with other regulators possibly following suit soon.

In Japan daprodustat for anaemia associated with chronic renal disease is under review, and there are around a dozen other drugs in late stage development, ranging from therapies for bacterial infections, rheumatoid arthritis, and HIV.

Walmsley added that despite the focus on a mean-but-lean R&D operation, the company would still focus on bringing returns to shareholders.She said: “We want to make sure that that innovation is being brought to patients but our commitment to the dividend remains extremely strong and there’s no change to our policy around that.”

AbbVie’s Skyrizi Beats Out Novartis’ Cosentyx in Plaque Psoriasis

AbbVie reported that its Skyrizi met both primary and all ranked secondary endpoints in its Phase III trial that went head-to-head with Novartis’ Cosentyx in plaque psoriasis.

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The Phase III, multicenter, randomized, open-label, efficacy assessor-blinded, active-comparator trial studied the safety and efficacy of Skyrizi compared to Cosentyx in adults with moderate to severe plaque psoriasis. Patients were divided evenly to receive Skyrizi as two 75 mg subcutaneous injections at baseline, four weeks later and every 12 weeks afterwards, or 300 mg Cosentyx as two 150 mg subcutaneous injections at baseline, weeks 1, 2, 3 and 4, then every 4 weeks after.

The two primary endpoints were non-inferiority at week 16 and superiority at week 52, both determined by Psoriasis Area and Severity Index (PASI 90). Skyrizi met both primary endpoints.

There were three ranked secondary endpoints, PASI 100 at week 52, sPGA 0/1 at week 52 and PASI 75 at week 52.

Skyrizi demonstrated significantly higher rates of skin clearance compared to Cosnetyx, with at least a 90% improvement from baseline in PASI 90 at week 52. Of the patients receiving Skyrizi, 87% hit PASI 90 compared to 57% of the patients receiving Cosentyx. At week 16, Skyrizi also hit the other primary endpoint of non-inferiority to Cosentyx with 74% of patients hitting PASI 90 compared to 66% of the patients receiving Cosentyx.

The safety data in the trial was consistent to what had been observed in other studies, with no new safety signals. The adverse event rates between the two drugs were comparable. The most common adverse events were nasopharyngitis, upper respiratory tract infection, headache, joint pain and diarrhea. Adverse events so severe that they led to discontinuing the drug were 1.2% in the Skyrizi group and 4.9% in the Cosentyx group.

“In this study, Skyrizi showed superior efficacy compared to Cosentyx in helping patients achieve and maintain high levels of skin clearance at week 52,” said Michael Severino, vice chairman and president of AbbVie. “Head-to-head data like these are crucial to help patients and their doctors make informed treatment decisions. We are pleased to add these results to the growing body of evidence supporting Skyrizi as a differentiated treatment option for adults living with psoriasis.”

Skyrizi has been approved for moderate to severe plaque psoriasis in adults by the U.S. Food and Drug Administration in April 2019. It has also been approved for that indication in Europe.

AbbVie is on something of a roll this year and analysts expect it to be a great buy for investors. It will close on its acquisition of Allergan early this year, and in December, the FDA approved its Ubrelvy for migraines. Ubrelvy has a few advantages over other migraine therapies on the market, including that it can be taken orally. It can also be taken after the headache stars, rather than ahead of time. The FDA itself noted at the time, “Ubrelvy represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication.”

The drug is expected to hit the market in the first quarter of this year, which will likely give the company revenues a boost, which has been consistent with about 8% growth over the last two years. Ubrelvy will be facing some competition, including Eli Lilly’s Reyvow, which was approved in October 2019, and Amgen and Novartis’ Aimovig.

Once the Allergan deal is complete, AbbVie plans to let Allergan Aesthetics operate as an individual business unit, while integrating the rest of the business into its operations.

Eli Lilly Bags Dermatology Company Dermira for $1.1 Billion

Not waiting for the start of the annual J.P. Morgan Healthcare Conference, Eli Lilly announced it will acquire California-based Dermira, Inc. in an all-cash deal for $1.1 billion. The acquisition will allow Eli Lilly to expand its immunology pipeline with a late-stage treatment for atopic dermatitis.

Lilly has its eyes set on two Dermira assets, lebrikizumab, a novel, investigational, monoclonal antibody designed to bind IL-13, which is believed to be a driver of signs and symptoms of atopic dermatitis. That therapy is currently in two Phase III trials for the treatment of moderate-to-severe atopic dermatitis in adolescent and adult patients, ages 12 years and older. Lebrikizumab was granted Fast Track designation from the U.S. Food and Drug Administration in December. In a Phase IIb trial, Lebrikizumab demonstrated dose-dependent improvements across endpoints spanning the range of atopic dermatitis signs and symptoms, including skin lesions and pruritus, when administered once every two or four weeks.

“People suffering from moderate-to-severe atopic dermatitis have significant unmet treatment needs, and we are excited about the potential that lebrikizumab has to help these patients,” Patrik Jonsson, president of Lilly Bio-Medicines said in a statement.

In addition to lebrikizumab, Eli Lilly will gain Qbrexza (glycopyrronium) cloth, a medicated cloth approved by the FDA for the topical treatment of primary axillary hyperhidrosis (uncontrolled excessive underarm sweating).0ea3738e-212e-4c04-8132-9bb76e8ac3e7

Jonsson said the acquisition of Dermira strengthens Lilly’s pipelines and is in line with the company’s strategy to bolster is internal research through the acquisition of clinical phase assets in its core therapeutic areas. Additionally, Jonsson said the deal will leverage the company’s development expertise and commercial infrastructure to bring new medicines to patients.

“This acquisition provides an opportunity to add a promising Phase 3 immunology compound for atopic dermatitis, while also adding an approved dermatology treatment for primary axillary hyperhidrosis. We look forward to completing the acquisition and continuing Dermira’s excellent work,” Jonsson said.

Tom Wiggins, chairman and chief executive officer of Dermira, said the company has, since its inception, been focused on finding new ways to treat some of the most common skin conditions that people deal with. He said the company is excited that Eli Lilly has seen the progress made by the company, particularly with lebrikizumab and Qbrexza.

“We share with Lilly a common interest in helping patients through the development of innovative treatments and believe that patients and physicians will benefit from the resources that Lilly can bring to maximize the potential of our programs. We also believe this proposed transaction is in the best interests of Dermira and our stockholders and affirms the dedication and important groundwork established by Dermira’s talented employees since the founding of the company nearly 10 years ago,” he said in a statement.

Under terms of the deal, Eli Lilly will acquire Dermira for $18.75 per share, or about $1.1 billion. The company’s stock closed at $18.34 on Thursday and has jumped to $19.15 in premarket trading. The deal is expected to close by the end of the first quarter of this year. Lilly said it will provide an update to its 2020 financial guidance as part of its full-year 2019 financial results, which will be announced at the end of this month.

Blueprint gets first approval as FDA backs stomach cancer drug

US biotech Blueprint Medicines has its first approved drug, after the FDA backed its oncology drug Ayvakit for a certain kind of stomach cancer.

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The regulator approved Ayvakit (avapritinib) on the basis of high response rates seen in phase 1 trial results in gastrointestinal stromal tumour (GIST), with a platelet-driven growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.

There are no approved drugs in this indication, and the FDA is also reviewing another set of data in fourth-line GIST, where a decision is due midway through next month.

This review is likely to be extended to allow Massachusetts-based Blueprint to submit top-line data from the phase 3 trial testing avapritinib against Bayer’s Stivarga (regorafenib).

Blueprint plans to make Ayvakit available through certain specialist pharmacies in the US within the week, with a list price of $32,000 for a 30-day supply regardless of dosage.

The price patients will pay will vary according to their individual insurance arrangements.

The FDA granted a full approval to Ayvakit based on efficacy results from the phase 1 NAVIGATOR clinical trial, as well as combined safety results from multiple clinical trials for avapritinib.

Efficacy of Ayvakit was established from 43 patients in the NAVIGATOR trial with unresectable or metastatic GIST with those particular mutations.

In patients with PDGFRA exon 18 mutant GIST, Ayvakit had an overall response rate (ORR) of 84% and a median duration of response (DOR) was not reached.

GIST is a rare, genomically driven sarcoma of the gastrointestinal (GI) tract. Approximately 6% of patients with newly diagnosed GIST have PDGFRA exon 18 mutations.

The most common PDGFRA exon 18 mutation is the D842V mutation, which is resistant to all other approved therapies.

A retrospective study showed that no patients whatsoever who harboured this mutation responded to Novartis’ Gleevec (imatinib), a standard therapy for stomach cancer.

 
 

AI specialist Exscientia signs drug discovery tie-up with Bayer

UK artificial intelligence company Exscientia has added another big pharma company to its partner roster, with Bayer seeking to use its platform to find new cardiovascular and cancer drugs.

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Bayer is pledging up to €240 million ($266 million) in upfront fees, ongoing research funding and clinical milestone payments under the terms of the three-year deal.

The collaboration will use AI to accelerate discovery of small molecule drug candidates against targets in oncology and cardiovascular disease, with Bayer claiming rights to the compounds and Dundee-based Exscientia eligible for royalties on sales if they reach the market.

Cancer and heart disease are at the forefront of Bayer’s R&D focus along with women’s health, haematology and ophthalmology.

For eight-year-old Exscientia, Bayer joins a growing list of drugmakers who see its AI platform as a way to accelerate drug discovery and improve drug development productivity, potentially trimming years off the current 12 to 15 year cycle from early research to marketed product.

It has similar pharma partnerships with Bristol-Myers Squibb’s Celgene unit, Sanofi, GlaxoSmithKline, Roche and Sumitomo Pharma, as well as co-development alliances with smaller biotech players including Evotec, Apeiron and Rallybio.

Some of those partnerships are already generating candidates for further development and potentially entry into clinical testing, and the total value of the deals has climbed well in excess of $1 billion.

Last year, Sanofi took up an option on a bispecific small molecule coming out of an alliance focusing on inflammatory and fibrotic disease, and the UK biotech also delivered a lead molecule for GlaxoSmithKline targeting a novel pathway for the treatment of chronic obstructive pulmonary disease (COPD). Both projects started up just two years earlier.

Bayer’s head of R&D Dr Joerg Moeller said the deal was part of a drive towards digital transformation of R&D, “as we believe that digital technologies such as AI can simplify and speed up the discovery and development of new drugs for patients.”

Deploying an AI approach can speed up projects but also provide “more precise identification of suitable drug targets and lead structures,” he added.

Deloitte’s Centre for Health Solutions estimated at the end of 2018 that the projected returns on investment in pharma R&D have fallen to 1.9%, the lowest level since 2010.

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