Category: Immuno-Oncology

  • BMS cuts $3.15bn deal with Century for cancer cell therapies

    Bristol-Myers Squibb chief executive Giovanni Caforio has promised to invest in the company’s pipeline at the virtual JP Morgan Healthcare Conference, and demonstrated that commitment by licensing up to four cancer cell therapy candidates from Century Therapeutics. BMS is paying $150 million upfront in cash and equity to kick off the alliance with another $3 […]

  • J&J goes after another FDA approval for a cancer bispecific

    Johnson & Johnson’s much-touted crop of bispecific antibodies for cancer generated its first commercial product in May, and the drugmaker has now filed for FDA approval of a second candidate. The latest to reach the regulatory stage is teclistamab, one of two bispecifics for multiple myeloma in the late-stage pipeline of J&J’s Janssen division stemming […]

  • FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag

    Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The designation – which is awarded to  therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength […]

  • Sanofi buys US immuno-oncology biotech Amunix for $1 billion

    Sanofi has bolstered its immuno-oncology pipeline with a $1 billion agreement to acquire Amunix Pharma of the US – its fourth bolt-on deal of 2021. South San Francisco-based Amunix specialises in T-cell engager and cytokine-based treatments for solid tumours, and is planning to advance its lead programme AMX-818 – a cell-based therapy which targets HER2-expressing […]

  • Novartis taps immuno-oncology partner BeiGene for TIGIT drug

    Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. The Swiss pharma group is paying BeiGene $300 million upfront for an option on ociperlimab, a TIGIT antibody in phase 3 testing for non-small cell lung cancer (NSCLC), with another […]

  • ASH: Trial backs Gilead’s Yescarta CAR-T in first-line lymphoma

    Gilead Sciences has taken a big step towards positioning its CAR-T therapy Yescarta as an option for previously-untreated large B cell lymphoma (LBCL) with updated results from the ZUMA-12 trial at the ASH congress this week. The phase 2 trial showed that 78% of high-risk LBCL patients treated first-line with Yescarta (axicabtagene ciloleucel) had a […]

  • ASH: Gilead, BMS CAR-Ts square off in relapsed lymphoma

    A pair of trials have suggested that CAR-T therapies could offer an improved option for patients with large B cell lymphoma (LBCL) who have relapsed after or haven’t responded to first-line treatment. The results of the ZUMA-7 and TRANSFORM trials, reported at the American Society of Haematology (ASH) congress, could see Gilead Sciences’ Yescarta (axicabtagene […]

  • Roche builds case for TIGIT combo in untreated lung cancer

    Roche’s closely-watched combination of anti-TIGIT antibody tiragolumab and PD-L1 inhibitor Tecentriq has shown long-term efficacy in an ongoing trial in lung cancer, adding to the evidence that two immunotherapies may be better than one. Like PD-L1, TIGIT is thought to act as a molecular brake that stops T cells from attacking tumours, and tiragolumab is […]

  • Henlius claims win for PD-1 drug in small cell lung cancer

    China’s Shanghai Henlius Biotech says its experimental PD-1 inhibitor serplulimab has extended survival when added to chemotherapy in a phase 3 trial as first-line therapy for extensive stage small cell lung cancer (ES-SCLC), setting up regulatory filings. The trial compared serplulimab (formerly HLX10) plus carboplatin and etoposide chemotherapy in previously untreated patients with ES-SCLC, and […]

  • Milestone as EMA starts review of Atara’s ‘off-the-shelf’ cell therapy

    Atara Biotherapeutics’ tabelecleucel (tab-cel) has become the first ‘allogeneic’ cell therapy – in other words one which doesn’t involve harvesting cells from patients – to be evaluated by a regulatory agency anywhere in the world. The EMA has started a review of the off-the-shelf therapy as a treatment for patients with a rare form of […]

  • Gilead foregoes buyout, but pledges $725m to Arcus’ cancer drugs

    Gilead Sciences has forged closer ties to its cancer drug partner Arcus Biosciences , although a licensing deal doesn’t go as far as the takeover that some market commentators have been predicting. Gilead has exercised options on four drug candidates as part of its $2 billion, 10-year alliance that kicked off last year, with the […]

  • Merck wins FDA nod for Keytruda as adjuvant kidney cancer treatment

    Merck & Co has chalked up another win in drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, after the FDA greenlit use of the drug as post-surgery (adjuvant) therapy for renal cell carcinoma (RCC). The checkpoint inhibitor has been approved for use after surgery in patients with RCC – the […]

  • Blackstone revs up Autolus’ CAR with $250m fuel injection

    Private equity firm Blackstone has agreed to provide up to $250 million in financing to UK biotech Autolus Therapeutics, to help it take acute lymphoblastic leukaemia (ALL) CAR-T therapy obe-cel through late-stage development. The deal includes a $100 million equity stake, $50 million in financing as soon as it closes, and another $100 million on […]

  • First launch for Daiichi Sankyo’s oncolytic virus Delytact in Japan

    Daiichi Sankyo has launched its oncolytic virus therapy Delytact in Japan – its first world market – as a treatment for malignant glioma, an aggressive form of brain cancer. Delytact (teserpaturev) is a genetically engineered oncolytic herpes simplex virus type 1 (HSV-1) that was approved for marketing in Japan earlier this year, and received pricing […]

  • Gilead tags Merck for first-line triple negative breast cancer trial

    Take two recently-approved immunotherapies for triple negative breast cancer (TNBC), put them together, and what do you get? Hopefully a new standard of care for the aggressive disease, according to partners Gilead Sciences and Merck & Co. Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy (sacituzumab govitecan) will be paired with Merck’s PD-1 inhibitor Keytruda (pembrolizumab) in […]

  • Takeda buys GammaDelta to boost cancer cell therapy credentials

    Japanese drugmaker Takeda has said it will exercise its option to buy UK-based GammaDelta Therapeutics, a specialist in ‘off-the-shelf’ cell therapies for solid tumours and blood cancers. The two companies have been working together since 2017, with Takeda pledging $100 million to help GammaDelta advance its cell therapy platform as part of a “build-to-buy” arrangement. […]

  • AZ/Daiichi partner with Merck on first-line lung cancer trial

    The dominance of Merck & Co’s Keytruda in the treatment of previously-untreated non-small cell lung cancer (NSCLC) means it will be hard to dislodge – so AstraZeneca and Daiichi Sankyo have forged an alliance in the hope of piggy-backing on that success. AZ and Daiichi Sankyo have agreed to partner with Merck on a second […]

  • AZ’s Imfinzi is first immunotherapy to raise survival in biliary tract cancer

    AstraZeneca’s checkpoint inhibitor Imfinzi has become the first cancer immunotherapy to improve survival in previously-untreated patients with biliary tract cancer (BTC), a rare and aggressive group of gastro-intestinal tumours. In the TOPAZ-1 trial, PD-L1 inhibitor Imfinzi (durvalumab) added to standard chemotherapy extended overall survival compared to chemo alone, raising the hope of a new option […]

  • Merck gets EU approval for Keytruda in triple-negative breast cancer

    Merck & Co has claimed EU approval for Keytruda in triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. The European Commission has cleared Keytruda (pembrolizumab) in combination with chemotherapy as a first-line treatment for locally recurrent, unresectable or metastatic TNBC involving tumours with a PD-L1 expression score of 10 or more. The […]

  • BMS strikes back against Merck in EU oesophageal cancer market

    Merck & Co’s Keytruda become the first cancer immunotherapy to be approved as a first-line oesophageal cancer treatment in the EU earlier this year, but will now face competition from Bristol-Myers Squibb’s Opdivo. The European Commission has given a green light to Opdivo (nivolumab) with chemotherapy for previously-untreated patients with HER2-negative oesophageal, gastric and gastroesophageal […]

  • UK startup Leucid raises £11.5m for solid tumour CAR-T therapies

    CAR-T therapies have revolutionised the treatment of some blood cancers, but so far haven’t been able to repeat that success in solid tumours. UK startup Leucid Bio hopes to change that – and has just raised £11.5 million in first-round financing to take its plans forward. The London-based biotech has been set up to develop […]

  • Good news for Lilly as sintilimab hits the spot in lung cancer again

    Eli Lilly made a late entry into the checkpoint inhibitor market when it licensed ex-China rights to Innovent’s sintilimab last year, and a new trial in lung cancer will raise its hopes of getting a good return on its investment. PD-1 inhibitor sintilimab has been shown to extend progression-free survival (PFS) in patients with EGFR-mutated […]

  • Roche scores early adjuvant lung cancer approval for Tecentriq

    Roche has claimed an earlier-than-expected FDA approval for its checkpoint inhibitor Tecentriq in non-small cell lung cancer (NSCLC), giving the drug a lead in early-stage cases that can be treated with surgery. The US regulator has cleared Tecentriq (atezolizumab) as adjuvant treatment after surgery and platinum-based chemotherapy in patients with tumours in which 1% or […]

  • Medical Wearables for Biosensors USA Conference 2021

    SMi Group Proudly Presents… Medical Wearables for Biosensors USA Conference 2021 Conference: 25 – 26 October 2021 Virtual Conference: Online Access Only Website: Exploring therapeutic applications of connected on-body devices The global wearable biosensors market is a rapidly expanding industry with increasingly growing potential for applications in healthcare and technological advances. With potential in […]

  • Scotland backs Cabometyx combo for kidney cancer, amid stalled NICE review

    Patients in Scotland with newly-diagnosed advanced kidney cancer can now access a therapy combining Bristol-Myers Squibb’s immunotherapy Opdivo with Ipsen’s targeted drug Cabometyx, ahead of the rest of the UK and most other countries in the world. The Scottish Medicines Consortium (SMC) has backed Opdivo (nivolumab) plus Cabometyx (cabozantinib) as a first-line therapy for people […]

  • FDA halts Allogene CAR-T trial after safety scare

    A phase 1 trial of Allogene’s of-the-shelf CAR-T for lymphoma has been placed on hold by the FDA, after a “chromosomal abnormality” was seen in a patient receiving the cell therapy. Shares in the California biotech were hit hard after the news emerged, losing more than a third of their value as investors fretted that […]

  • J&J bulks up in bispecifics with $1.3bn Xencor alliance

    Fresh from claiming its first bispecific antibody approval, Johnson & Johnson has delved deeper into the category with a deal to license a drug for B-cell cancers developed by Xencor. J&J’s Janssen Biotech unit is paying $100 million upfront to Xencor and making a $25 million equity investment in the biotech in return for rights […]

  • 3rd Inflammasome Therapeutics Summit

    Discover the Intricacies of Inflammasome Regulation, Leverage Inflammasome Proteins as Biomarkers & Accelerate Novel Inflammasome Therapeutics into Proof-Of-Concept Clinical Trials & Beyond Built with Ventus Therapeutics, Inflammasome Therapeutics, Merck & more, the Inflammasome Therapeutics Summit returns for its third year as the only industry-dedicated forum to discover the intricacies of inflammasome regulation and accelerate novel […]

  • Kite claims a first for CAR-T Tecartus in adult leukaemia

    The FDA has approved Kite Pharma’s Tecartus as a treatment for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL), making CAR-T therapy an option for an entirely new group of patients. The regulator cleared Tecartus (brexucabtagene autoleucel) for the new indication after a swift review that focused on the ZUMA-3 trial, which […]

  • GSK bails on $4.2bn partnership with Merck on cancer drug

    GlaxoSmithKline has ended its collaboration with Germany’s Merck KGaA’s cancer treatment bintrafusp alfa, after a trio of failed clinical trials. Given the disappointments the decision to part ways on the programme comes as no surprise, but is nevertheless a setback for GSK which had looked to the drug to revitalise its flagging oncology business. It […]

  • NICE clears NHS use of Roche’s Tecentriq in bladder cancer

    NICE has recommended routine NHS access to Roche’s cancer immunotherapy Tecentriq for some bladder cancer patients, four years after it was first made available via the Cancer Drugs Fund (CDF). The PD-L1 inhibitor was initially turned down by NICE for a form of bladder cancer called urothelial carcinoma (UC), but Roche was encouraged to make […]

  • Keytruda’s liver cancer approval secured by new study

    Merck & Co’s FDA approval for Keytruda in advanced liver cancer looks secure, after an Asian clinical trial found that the cancer immunotherapy improved survival in these patients. Keytruda (pembrolizumab) was cleared by the FDA as a second-line therapy for the hepatocellular carcinoma (HCC) form of liver cancer in 2018. The drug’s accelerated approval looked […]

  • Boehringer buys Abexxa, bolstering its immuno-oncology pipeline

    Boehringer Ingelheim says it has agreed to buy US biotech Abexxa Biologics, its second acquisition in the cancer immunotherapy area in the space of a year. Texas-based Abexxa has been on the Boehringer’s radar since it was set up, as it provided seed funding for the preclinical-stage company in 2016, buying into its approach of […]

  • ESMO21: Libtayo extends survival in first-line NSCLC, challenging Keytruda

    There’s no shortage of cancer immunotherapies trying to knock Merck & Co’s Keytruda off the top of the tree in previously-untreated non-small cell lung cancer (NSCLC). Sanofi and Regeneron have reported new data for Libtayo that suggests the drug could be a contender. Libtayo (cemiplimab) given in combination with chemotherapy looks broadly to have matched […]

  • Keytruda backed by NICE for late-stage oesophageal cancer

    MSD’s Keytruda has become the first immunotherapy cleared by NICE for previously-untreated patients with advanced oesophageal cancer, making it an option for routine NHS treatment. Keytruda (pembrolizumab) has been given the green light for use alongside platinum- and fluoropyrimidine-based chemotherapy in patients with locally advanced or metastatic oesophageal cancer that cannot be treated with surgery. […]

  • First FDA filing for Novartis’ latecomer PD-1 drug tislelizumab

    Novartis has filed for FDA approval of tislelizumab – a PD-1 inhibitor licensed from Chinese biotech BeiGene earlier this year – as a second-line treatment for oesophageal cancer. The Swiss pharma giant licensed ex-China rights to tislelizumab in February for $650 million upfront ad up to $1.55 billion in milestones, shortly after its own PD-1 […]

  • Roche dives further into cancer cell therapy with Adaptimmune deal

    Roche has largely been a spectator on the side lines as other drugmakers have embraced cell therapies for cancer, but it has made a big play now, pledging $150 million upfront to an alliance with Adaptimmune Therapeutics. The Swiss drugmaker is backloading the five-year deal with around $3 billion in milestones, as the two companies […]

  • Targeting COVID-19 and cancer with immunotherapy advancements

    Anna Biosciences’ Dr Anthony Rullo discusses the drug development company’s immunotherapy platform. Over the last 30 years, we have seen dramatic improvements in patient outcomes due to the emergence of biologics – particularly monoclonal antibodies – as therapies for a wide variety of diseases and infections. Monoclonal antibodies (mABs) are highly specific therapies associated with […]

  • Novartis’ bid to extend Kymriah into earlier use hits a roadblock

    Novartis’ CAR-T therapy Kymriah racked up back-to-back approvals in acute lymphoblastic leukaemia and large B-cell lymphoma a few years ago, but hasn’t added to its label since. Now, a bid to move it onto earlier-stage use in lymphoma has ended in failure. In the phase 3 BELINDA trial, Kymriah (tisagenlecleucel) was unable to extend event-free […]

  • Third strike for GSK/Merck as bintrafusp alfa flubs again

    GlaxoSmithKline’s big gamble on Merck KGaA’s bintrafusp alfa has gone from bad to worse, after the drug failed yet another mid-stage trial. The latest disappointment has come from the phase 2 [email protected] BTC 055 study of the drug alongside chemotherapy as a first-line treatment for patients with locally advanced or metastatic biliary tract cancer (BTC), […]

  • Pfizer vaults into CD47 arena, buying Trillium for $2.3 billion

    Pfizer is the latest big pharma company to take a position on drugs that target CD47 – a ‘don’t eat me’ signal that protects cancer cells from being attacked by the immune system. The drugmaker has agreed a $2.3 billion deal to buy Canadian biotech Trillium Therapeutics and its two lead candidates – TTI-622 and […]

  • GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli

    The FDA has approved GlaxoSmithKline’s latecomer PD-1 inhibitor Jemperli for a second use that will significantly extend the patient population eligible for treatment with the drug. Jemperli (dostarlimab) can now be used to treat adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours – regardless of where they are located in the body – […]

  • FDA starts speedy review of Keytruda for adjuvant kidney cancer

    Merck & Co is looking at a decision from the FDA in December on its application to market Keytruda as a post-surgery treatment for people with kidney cancer, after a priority review. The drugmaker – known as MSD outside the US and Canada – is seeking approval of Keytruda (pembrolizumab) as an adjuvant treatment for […]

  • Kite takes the ‘Appian way’ to off-the-shelf cell therapies for cancer

    Gilead Sciences’ Kite Pharma has mapped out another route to the development of allogeneic or ‘off-the-shelf’ cell therapies for cancer, using technology developed by Appia Bio, a US startup focusing on haematopoietic stem cells (HSCs). The partnership will combine Kite’s experience in chimeric antigen receptor (CAR) therapies with Appia’s platform, which involves using HSCs to […]

  • BMS claims first EU okay for adjuvant oesophageal cancer immunotherapy

    Bristol-Myers Squibb is in a battle with Merck & Co for position in the upper gastrointestinal cancer immunotherapy market, and has just reinforced its position with an EU approval in the post-surgery (adjuvant) setting. The European Commission has approved Opdivo (nivolumab) as the first-ever adjuvant immunotherapy for patients with oesophageal or gastroesophageal junction (GEJ) cancer, […]

  • After false start, Merck claims Keytruda approval in early breast cancer

    Merck & Co’s Keytruda has just picked up its 30th approval from the FDA, and it is a good one – early-stage triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. The FDA has given a green light to the use of Keytruda (pembrolizumab) pre-surgery alongside chemotherapy in the neoadjuvant setting, as well […]

  • BMS pulls speedy Opdivo approval for liver cancer in US

    Bristol-Myers Squibb has withdrawn its US marketing approval for PD-1 inhibitor Opdivo as a second-line, single-agent treatment for hepatocellular carcinoma, a common form of liver cancer, in people previously treated with Bayer/Onyx’s Nexavar. Opdivo (nivolumab) was awarded an accelerated approval in 2017 for second-line HCC treatment on the strength of mid-stage data, but failed to […]

  • Arcus’ CMO Grossman jumps ship to join Gilead’s cancer push

    Gilead Sciences just forged even closer ties with its cancer drug partner Arcus Biosciences, enticing the biotech’s chief medical officer Bill Grossman to a new role as its head of oncology clinical research. The two companies entered into a 10-year alliance last year, with Gilead claiming certain rights to Arcus clinical and preclinical immuno-oncology candidates […]

  • BioNTech grows in cell therapies, buying Kite’s TCR platform

    BioNTech has found a use for some of the windfall cash it has raked in from its COVID-19 vaccine, agreeing a deal to buy Kite Pharma’s entire neoantigen T cell receptor (TCR) platform for solid tumours, and an associated manufacturing plant. There’s no value attached to the deal – even though BioNTech is a publicly […]

  • GSK cancer head Hoos exits, takes top role at biotech Scorpion

    GlaxoSmithKline’s head of oncology Axel Hoos has resigned from the company, and will take up a new role as chief executive of US biotech Scorpion Therapeutics.  Hoos is leaving GSK after nine years, a period that saw a complete revamp of the unit including the wholesale divestment of cancer drugs to Novartis in a $16 […]

  • Imugene HER2 vaccine hits target in stomach cancer trial

    A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. The interim readout from the 39-patient HERIZON trial found 50% of patients treated with the HER-Vaxx (IMU-131) vaccine on top of chemotherapy achieved a partial response […]

  • Merck pulls Keytruda’s FDA nod for third-line stomach cancer

    Merck & Co will voluntarily withdraw a US marketing approval for cancer immunotherapy blockbuster Keytruda in gastric cancer, after studies intended to confirm its efficacy in this setting were a bust.  The decision comes after FDA advisors voted six to two in April that Keytruda (pembrolizumab) should not stay on the market as a treatment […]

  • Gilead combs Shoreline for NK cell therapies in $2.3bn alliance

    Gilead Sciences’ cell therapy Kite Pharma has bulked up its position in natural killer (NK) cell therapies, pledging up to $2.3 billion for a partnership with Shoreline Bioscience focusing on off-the-shelf therapies for haematological cancers. The two companies will collaborate on the development of targeted NK cell and macrophage cells derived from induced pluripotent stem […]

  • GSK joins ant-TIGIT push with $625m upfront iTeos deal

    GlaxoSmithKline has staked a claim to the fast-moving category of cancer therapies targeting the TIGIT immune checkpoint, agreeing a $2 billion plus licensing agreement with iTeos Therapeutics for an antibody candidate in early clinical development. The deal includes $625 million in upfront fees to secure rights to EOS-448, which is currently in a phase 1 […]

  • Daiichi Sankyo claims first okay for oncolytic virus in Japan

    Daiichi Sankyo has made a little bit of pharma industry history, becoming the first drugmaker to win approval in Japan for a therapy for cancer based on a virus that selectively kills malignant cells. Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted a conditional approval to the company’s Delytact (teserpaturev) for the treatment […]

  • J&J backs out of $1.6bn blood cancer antibody alliance with Argenx

    Belgian biotech Argenx has lost its development partner for acute myeloid leukaemia antibody cusatuzumab, after Johnson & Johnson backed away from the alliance after two and a half years. J&J’s Cilag unit – part of its Janssen pharma division – said this morning that it had decided not to continue the collaboration after a “review […]

  • Genmab takes aims at immuno-oncology antibody conjugates with Bolt Bio

    Genmab has enlisted the help of Bolt Biotherapeutics to develop a new class of immune-boosting antibody conjugates for cancer in a deal that could be worth up to $880 million. Denmark-based Genmab is paying $10 million upfront to its US counterpart and making a $15 million equity investment to get the project started, funding R&D […]

  • FDA sets November review date for J&J’s multiple myeloma CAR-T cilta-cel

    Johnson & Johnson has secured a six-month FDA review for its multiple myeloma CAR-T therapy ciltacabtagene autoleucel (cilta-cel), narrowing the lead for Bristol-Myers Squibb and bluebird bio’s rival Abecma. The US regulator is now scheduled to complete its review of cilta-cel by 29 November for adults with relapsed and/or refractory multiple myeloma who have previously […]

  • Straight after its first cancer bispecific OK, J&J highlights two more at ASCO

    With the ink barely dry on the FDA’s approval of Johnson & Johnson’s Rybrevant, its first bispecific antibody for cancer, the drugmaker is already showcasing others in its pipeline.  Two of its earlier-stage bispecifics – both in development for the blood cancer multiple myeloma – will feature at the American Society of Clinical Oncology (ASCO) […]

  • NICE says no to Merck Serono’s Bavencio in bladder cancer

    Merck Serono’s Bavencio is the only checkpoint inhibitor to be approved for first-line maintenance treatment of bladder cancer in Europe, but UK cost-effectiveness agency NICE says it is too expensive to justify routine NHS use.  Bavencio (avelumab) was approved in the UK earlier this year for locally advanced or metastatic urothelial carcinoma (UC) – the […]

  • Janssen files its first CAR-T therapy cilta-cel in Europe

    Johnson & Johnson’s Janssen unit has filed for approval of its multiple myeloma CAR-T ciltacabtagene autoleucel in Europe, chasing after a rival therapy from Bristol-Myers Squibb.  The BCMA-targeting CAR-T – also known as cilta-cel – has been filed with the EMA as a treatment for adults with relapsed/refractory multiple myeloma, an incurable form of blood […]

  • Keytruda should lose stomach cancer indication, says ODAC

    The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to strip Merck & Co’s Keytruda of its accelerated approval in gastric and gastroesophageal junction (GEJ) cancer, despite a lack of treatment options in these patients.  The panel voted 6 to 2 that Keytruda (pembrolizumab) should not stay on the market for PD-L1–positive gastric or GEJ […]

  • ODAC votes to keep bladder cancer labels for Keytruda, Tecentriq

    Merck & Co’s Keytruda and Roche’s Tecentriq should stay on the market as first-line treatments for bladder cancer, at least until new clinical data becomes available next year.  That was the conclusion at the second day of a meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC), convened to discuss three immuno-oncology drugs granted conditional […]

  • Pieris Out-licenses PRS-342 to Boston Pharmaceuticals for ~$363M

    Shots: Pieris to receive $10M upfront and is eligible to receive $353M in development, regulatory, and commercial based milestones along with royalties on sales of PRS-342. Pieris will also contribute an undisclosed amount for manufacturing activities Boston to get exclusive worldwide rights to develop PRS-342 and will be primarily responsible for the development of the […]

  • FDA looks at pulling speedy approvals for three cancer drugs

    FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market.  The Oncologic Drugs Advisory Committee (ODAC) is scheduled to look at the data for the three drugs – Merck & Co’s Keytruda (pembrolizumab), Bristol-Myers Squibb’s Opdivo (nivolumab) and Roche’s Tecentriq […]

  • Exscientia starts trials of first AI-derived cancer immunotherapy

    Exscientia was the first company to start human trials of a new drug designed using artificial intelligence (AI) last year, and now says it has started testing of the first AI candidate for immuno-oncology.  Oxford, UK-based Exscientia has been working with German biotech Evotec on the adenosine A2a receptor antagonist, which is being tested as […]

  • Cancer Research UK spinout Achilles raises $175.5m in IPO

    UK biotech Achilles Therapeutics has completed its initial public offering (IPO) in the US, raising $175.5 million that will be used to take its personalised T cell therapy for lung and skin cancers through proof-of-concept trials. The new funding will also be used to advance two more T cell programmes for head and neck and […]

  • BMS and PsiOxus Therapeutics Expand their 2016 Immuno-Oncology Collaboration

    Shots: In the P-I SPICE study, the companies will evaluate the clinical combination of BMS’ Opdivo with PsiOxus’ NG-641 and optimize the combination IV dosing regimen in late-stage cancer patients to treat a range of tumor types PsiOxus will be responsible to conduct P-I study with patient recruitment expected to initiate in Q3’21 NG-641 is […]

  • Merck KGaA Exercises Third Option in its Immuno-Oncology Collaboration with F- star

    Shots: F-star to receive option exercise payment and will be eligible to get milestones and royalties on net sales of therapies resulting from the collaboration Merck KGaA exercises its third option to develop an additional bispecific program under the ongoing collaboration with F-star Merck KGaA will be responsible for the development and commercialization of the […]

  • Sanofi, Regeneron prep filings for Libtayo in cervical cancer

    Sanofi and Regeneron’s checkpoint inhibitor Libtayo has become the first immunotherapy to improve survival when used as a second-line therapy in cervical cancer, setting up regulatory filings later this year. A phase 3 trial of the PD-1 inhibitor in cervical cancer patients who had progressed after first-line chemotherapy has been stopped early after an interim […]

  • Nektar lifted by Merck alliance for bempeg, new trial funding

    Nektar Therapeutics is waiting on multiple data readouts for its lead drug bempegaldesleukin paired with strategic partner Bristol-Myers Squibb’s checkpoint inhibitor Opdivo, but that hasn’t stopped it signing up to test the drug with rival Keytruda from Merck & Co.  Merck will pair Keytruda (pembrolizumab) with bempegaldesleukin (NKTR-214) – known as bempeg for short – […]

  • Onward Signs a Worldwide Exclusive License and Co-Development Agreement with Biomunex for Immuno-Oncology

    Shots: Biomunex to receive up front, development, regulatory & sales milestones, equity investment along with royalties on sales of therapies Onward get the right to pursue development, manufacture & commercialize first-in-class bispecific Ab. The companies will jointly develop the Ab during the preclinical and early clinical program Biomunex is responsible for early preclinical development, while […]

  • Merck gets a leg-up for Keytruda in first-line kidney cancer

    New phase 3 data have shored up the position of Merck & Co’s cancer immunotherapy Keytruda in the increasingly competitive first-line kidney cancer market.  The data from the KEYNOTE-581/CLEAR study reveal that the combination of PD-1 inhibitor Keytruda (pembrolizumab) with Eisai’s targeted tyrosine kinase inhibitor Lenvima (lenvatinib) reduced the risk of disease progression of death […]

  • Heat Bio’s shares ignite on Opdivo combination data in NSCLC

    The pairing of Heat Biologics’ lead drug HS-110 with Bristol-Myers Squibb’s blockbuster checkpoint inhibitor Opdivo has boosted survival in patients with non-small cell lung cancer (NSCLC), sending the biotech’s share price skywards.  Interim data from a phase 2 trial of Heat’s off-the-shelf cell therapy with Opdivo (nivolumab) showed that patients treated with the duo as […]

  • Cash round sets up trial of InteRNA’s microRNA for cancer

    Dutch biotech InteRNA Technologies has raised €18.5 million ($22 million) in second-round financing as it prepares to start clinical trials of its lead drug candidate INT-1B3 for solid tumours. The Series B funding has come more than five years after InteRNA’s first-round, which raised just over $10 million in 2015, and nine months after the […]

  • BMS finally gets FDA OK for liso-cel, sets $410k launch price

    Bristol-Myers Squibb finally has FDA approval for its CAR-T therapy liso-cel, which has been cleared by the US regulator as Breyanzi for certain forms of large B-cell lymphoma. The green light comes too late for holders of the contingent value right (CVR) BMS offered as a sweetener to its takeover of Celgene, which lapsed because […]

  • Incyte makes bid to join the checkpoint inhibitor club

    Incyte has filed its PD-1 inhibitor retifanlimab with the FDA, seeking approval to treat a form of anal cancer associated with human papillomavirus (HPV) and HIV infections. The application covers the use of the intravenous PD-1 inhibitor for adults with advanced squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who […]

  • Merck, Pfizer get EU nod for Bavencio as bladder cancer maintenance

    Pfizer and partner Merck KGaA now have approval on both sides of the Atlantic for their checkpoint inhibitor Bavencio as a first-line maintenance therapy for bladder cancer, stealing a march on rival drugs in a highly competitive market. The European Commission has cleared Bavencio (avelumab) for locally advanced or metastatic urothelial carcinoma (UC) – the […]

  • Lilly bolts on cancer bispecifics with $1.6bn Merus alliance

    Always a big player in oncology, Eli Lilly has fallen behind some of its rivals when it comes to cancer immunotherapy, but a new R&D alliance with Dutch biotech Merus is further evidence of its fightback. Lilly is tapping into Merus’ expertise in bispecific antibodies, specifically antibodies that target cancer cells with one end of […]

  • Oxford BioTherapeutics to research cell therapies for Gilead’s Kite

    Gilead Sciences’ Kite unit has teamed up with the UK’s Oxford BioTherapeutics (OBT) to develop a new clutch of cell therapy products for solid tumours and blood cancers. The partnership covers up to five oncology targets identified by OBT using its discovery platform, and the UK firm will try to develop antibodies against them. Kite […]

  • Roche nabs breakthrough tag for TIGIT cancer immunotherapy

    Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Like PD-L1, TIGIT is thought to act as a molecular brake that stops T cells from attacking tumours, and tiragolumab is currently leading the pack among drugs targeting the immune checkpoint. The FDA’s […]

  • Chasing BMS, J&J files BCMA CAR-T for multiple myeloma to FDA

    Johnson & Johnson’s Janssen unit has filed a rolling submission for its multiple myeloma CAR-T ciltacabtagene autoleucel (cilta-cel) to the FDA, in hot pursuit of Bristol-Myers Squibb’s delayed rival therapy. Cilta-cel – which targets B-cell maturation antigen (BCMA) – has been submitted as a treatment for patients with relapsed or refractory myeloma, an incurable form […]

  • Merck cuts $1bn deal with Janux for cancer T-cell therapies

    In a deal that could top $1 billion, Merck & Co has teamed up with US biotech Janux Therapeutics to bring T-cell immunotherapies to cancer patients. The agreement sees San Diego-based Janux in line for around $500 million in milestones apiece for two T-cell engager therapies – which bind to a tumour cell and recruit […]

  • Catamaran joins the CAR-NK fleet, raising $42m in first round

    Catamaran Bio has weighed anchor with a $42 million first-round financing that will be used to pull its off-the-shelf natural killer (NK) cell therapies for cancer through early-stage development. The Cambridge, Massachusetts-based biotech is the latest player in the emerging field of chimeric antigen receptor (CAR) NK cell therapies, which unlike the current generation of […]

  • TGFB for Immuno-Oncology Drug Development Summit

    Are you interested in finding the next breakthrough in immuno-oncology preclinical or clinical development? Recent scientific, clinical breakthroughs and high-profile industry deals have reignited the race to find the next blockbuster TGF-ß inhibitor for immuno-oncology applications. As such, the TGFß for Immuno-Oncology Drug Development Summit (January 26-28) is the ONLY industry-focused meeting dedicated to pharma, biotech, and academia who […]

  • Five Prime eyes financing after positive results with stomach cancer drug

    Shares in US biotech Five Prime Therapeutics more than tripled after it reported promising trial results with stomach cancer drug candidate bemarituzumab, returning the stock to levels not seen since 2018. The phase 2 FIGHT trial testing bemarituzumab plus chemotherapy as a front-line therapy for advanced gastric and gastroesophageal junction cancer met all its efficacy […]

  • Genprex cancer gene therapy paired with AZ, Merck lung cancer drugs

    An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective drug classes in the treatment of non-small cell lung cancer (NSCLC). The two phase 1/2 trials are zeroing in on NSCLC patients with specific molecular biomarkers, to see if adding […]

  • FDA sets Feb decision date for Libtayo lung cancer challenge to Keytruda

    The FDA has started a priority review of Regeneron and Sanofi’s checkpoint inhibitor Libtayo in first-line non-small cell lung cancer (NSCLC), based on data they hope will carve out a niche for the drug in a highly-contested market. PD-1 inhibitor Libtayo (cemiplimab) impressed oncologists earlier this year with results from a trial in previously-untreated NSCLC […]

  • NICE changes stance on Keytruda for first-line head and neck cancer

    As recently as June, NICE was minded not to back routine NHS of MSD’s Keytruda as a first-line treatment for advanced head and neck cancer, but it has had a partial change of heart on the drug after the company submitted new data. Just-published draft final guidance from the cost-effectiveness agency gives a green light […]

  • David Hung’s Nuvation Bio seals merger with blank cheque firm Panacea

    Two years after quietly forming cancer start-up Nuvation Bio, ex-Axovant and Medivation CEO David Hung has agreed a big merger that will take it public – and provide more than $850 million in funding to boot. Hung’s new company is merging with Panacea Acquisition Corp, a special purpose acquisition company or SPAC – sometimes referred […]

  • FDA kicks off review of second kidney cancer combo based on BMS’ Opdivo

    Bristol-Myers Squibb could be mere months away from claiming a second US approval for an Opdivo-based combination immunotherapy that will help defend its first-line kidney cancer franchise. The FDA has started a priority review of PD-1 inhibitor Opdivo (nivolumab) alongside Exelixis’ tyrosine kinase inhibitor Cabometyx (cabozantinib) in previously-untreated advanced renal cell carcinoma (RCC) – the […]

  • BMS swoops on Forbius, snaring another immuno-oncology player

    With the ink barely dry on a deal to develop Dragonfly’s lead cancer immunotherapy, Bristol-Myers Squibb’s business development team has agreed to buy Canadian biotech Forbius and its pipeline of drugs for cancer and fibrotic diseases. Since its foundation in 2011, privately-held Forbius has been working on drugs that inhibit TGF beta 1 and 3, […]

  • Blow for Novartis as PD-1 drug spartalizumab flunks trial

    Novartis’ hopes of catching up with other companies in immuno-oncology have been dented after PD-1 inhibitor spartalizumab failed a phase 3 trial in skin cancer. Novartis had hoped the COMBI-i trial would allow it to file for approval of the ‘me-too’ PD-1 inhibitor before the end of this year as part of a triple therapy […]

  • Latecomer Lilly throws cash at Innovent PD-1 partnership

    Eli Lilly has doubled down on its partnership with Chia’s Innovent with a licensing deal for ex-China rights to Tyvyt, their PD-1 inhibitor, which some analysts think may be launched at a discount to its rivals. Lilly and Innovent co-developed Tyvyt (sintilimab) in China and launched the drug there together last year as a third-line […]

  • BMS’ Opdivo aces trial in asbestos-linked lung cancer

    Bristol-Myers Squibb’s Opdivo has improved survival in a trial involving patients with mesothelioma, a form of lung cancer, getting one up over rival checkpoint inhibitor Keytruda from Merck & Co. The results of the CheckMate-743 trial showed that a combination of Opdivo (nivolumab) with low-dose Yervoy (ipilimumab) reduced the risk of death by 26% compared […]

  • Roche’s Tecentriq flunks triple-negative breast cancer trial

    Roche’s hopes of extending the use of its PD-L1 inhibitor Tecentriq in triple-negative breast cancer (TNBC) have been dashed by a late-stage trial failure looking at the drug in combination with chemotherapy. Adding Tecentriq to treatment with paclitaxel as a first-line treatment for TNBC patients whose tumours expressed the biomarker PD-L1 did not lengthen the […]

  • Regeneron pairs with BioNTech on melanoma immunotherapy

    Regeneron and Sanofi’s PD-1 inhibitor Libtayo will be tested in tandem with a cancer vaccine developed by BioNTech in melanoma in people who have failed treatment with other checkpoint inhibitors. The two companies will carry out a phase 2 trial of Libtayo (cemiplimab) alongside BioNTech’s mRNA cancer immunotherapy BNT111, which is designed to stimulate immune […]

  • Roche’s Tecentriq claims melanoma OK, but don’t expect a sales surge

    Roche’s checkpoint inhibitor Tecentriq has been cleared for another new use in the US – in melanoma – but could struggle to displace rival drugs from Bristol-Myers Squibb and Merck & Co. The FDA has approved the PD-L1 inhibitor as a combination with two targeted drugs – MEK inhibitor Cotellic (cobimetinib) and BRAF inhibitor Zelboraf […]

  • Gilead’s Kite gains some height after second CAR-T approval in US

    Gilead’s $11.9 billion purchase of Kite Pharma in 2017 didn’t follow the script, with two big write-downs in the value of the asset since then, but a fresh approval for a CAR-T therapy could claw back some value. Late last week, the FDA approved Kite’s Tecartus (brexucabtagene autoleucel; formerly KTE-X19) as a treatment for mantle […]

  • Gilead eyes takeover of cancer biotech Tizona, despite its ties to AbbVie

    Gilead Sciences’ run of oncology-focused deals has continued with an option to buy cancer immunotherapy specialist Tizona – even though the biotech’s lead drug candidate is already partnered with AbbVie. Gilead is paying $300m for a 49.9% stake in Tizona, and taking an option to buy the company outright for another $1.25 billion. Tizona is […]

  • Merck KGaA Takes an Early Option in its Existing Immuno-Oncology Collaboration with F-star

    Shots: F-star to receive option exercise payment and will be eligible to get milestones and royalties on net sales of therapies resulting from the collaboration. Merck KGaA exercises its option to license a preclinical program in its existing agreement with F-star Merck KGaA will be responsible for the development and commercialization of the preclinical program […]

  • GenScript Signs an Agreement with Selecxine to Develop Therapies for Immuno-Oncology

    Shots: GenScript will be responsible for all pre-clinical pharmacy research and IND filling in Selecxine’s project which is based on cytokine-antibody complexes The company provided development solutions in different hosts tailored to customers and provided the preparation and purification solutions for the final complex,; further the project will test and enhance the process development capability […]