PharmaShots' Key Highlights of Fourth Quarter 2020
- The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter
- Multiple companies received regulatory bodies EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA's EUA for REGN-COV2 Ab combination while Health Canada accelerated the review for AZ's COVID-19 vaccine. Meanwhile, AZ's AZD1222 met its primary endpoint in preventing COVID-19
- Our team at PharmaShots has summarized and complied with the insights of Q4'20
Sanofi Launches Tetraxim (DTaP-IPV) for Preschoolers in India
Date : Oct 01, 2020
Product : Tetraxim
- Sanofi's Tetraxim combines four vaccines into one and provides protection against four diseases Diphtheria, Pertussis, Tetanus and Polio. The launch reduces the number of injections, increases comfort, and improves vaccination compliance for children
- Booster vaccines are designed to boost the immunity acquired during prior vaccination. With the launch, Sanofi currently protects school children in 100+ countries, with 63M doses distributed globally
- Tetraxim (DTaP-IPV) is a 4-in-1 booster vaccine and the only inactivated poliomyelitis containing combination vaccine in India that has full-dose antigenic strength of Diphtheria, Tetanus and acellular Pertussis (whooping cough) for preschoolers
Date - Oct 08, 2020
Product : Palynziq (pegvaliase-pqpz)
- The US FDA has approved the sBLA to increase the maximum allowable dose of 60mg with Palynziq for PKU. Previously, the maximum dose was 40mg
- The label expansion is based on OLE study out to 3yrs. demonstrating that 66% had a blood Phe level =360 µmol/L consistent with the Phe target ACMG recommended guidelines @2yrs. of treatment and 50% had blood Phe levels =120 µmol/L @2yrs. 75%, 66% & 48% had a blood Phe =600, 360, and 120 µmol /L, respectively @3yrs. of treatment
- Additional, safety data with over 6yrs. of follow up remains consistent with the previous safety profile of Palynziq irrespective of dose. Moreover, BioMarin has dosed the first participant in the global Phearless P-I/II study of BMN 307 for PKU
Date - Oct 08, 2020
Product : Skyrizi (risankizumab)
- The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study
- Results: ~63% of patients with moderate to severe plaque psoriasis treated with SKYRIZI achieved completely clear skin for 172 wks., as measured by 100% improvement from baseline in the PASI 100. New results from the P-III LIMMitless study were presented at the 29th EADV Virtual Congress
- Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. It is part of a collaboration between Boehringer Ingelheim & AbbVie, with AbbVie leading development & commercialisation globally
Regeneron Seeks the US FDA's EUA for REGN-COV2 Antibody Combination to Treat COVID-19
Date - Oct 09, 2020
Product - REGN-COV2
- Regeneron has submitted a request to the US FDA seeking EUA for its REGN-COV2 investigational Ab regimen to treat COVID-19. If EUA is granted, the US govt. has committed to making REGN-COV2 available in the US at no cost and would be responsible for its distribution
- The company reported that there are doses available for ~50,000 patients and expects to have doses available for 300,000 patients in total within the next few months
- REGN-COV2 is a combination of two mAbs, REGN10933 & REGN10987, designed to block the infectivity of SARS-CoV-2. The company reported that a single 8g dose of REGN-COV2 was given to President Donald Trump following a compassionate-use request from doctors as part of a treatment regimen
Date - Oct 29, 2020
Product - BI 764198
- The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct'2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission
- The therapy has shown a reduction in cellular damage and lung edema in preclinical studies and may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in P-I study in healthy adults
- BI 764198 is potent & selective inhibitor of TRPC6, focusing to reduce the need for ventilator support and to improve patient recovery rate
Date - Oct 30, 2020
Product - Tecentriq + Avastin
- The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a cohort of Chinese patients (n=194) from the same study
- Results: Tecentriq in combination with Avastin reduced the risk of OS by 56% (among Chinese patients) and 42% (global results) & the PFS risk by 40% (among Chinese patients) and 41% (global results) as compared with sorafenib
- IMbrave150 is the 1st P-III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Additionally. in May 2020, the US FDA approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy
Date - Oct 30, 2020
Product - Keytruda
- Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors
- In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as a single agent as well as in combination with an anti-PD1 mAb
- THOR-707 is currently being evaluated by Sanofi in an ongoing P-I dose escalation and expansion trial assessing THOR-707 and determining its recommended P-II dose alone and in combination with anti-PD-1 and anti-EGFR antibodies
Date - Oct 30, 2020
Product - Tremfya
- The P-II GALAXI 1 study involves assessing of Tremfya vs PBO in patients with mod. to severely active CD with intolerance to conventional therapies. In interim analyses, patients were randomized equally into 5 arms, with Tremfya (200/600/1200 mg (IV) @0, 4 & 8wks. respectively or with ustekinumab, dosed at ~6mg/kg (IV) @0wk. and dosed 90 mg (SC) @8wks. or PBO
- @12wks. (Tremfya vs PBO), reductions in CDAI (154.1, -144.3, -149.5 vs -36.0); patients achieving clinical remission vs PBO (CDAI<150): (54.0%, 56.0%, 50.0% vs 15.7%); clinical remission among conventional therapy failures & among patients who had previously failed biologic therapy, (61.6% vs 18.5% & 45.5% vs 12.5%) respectively
- @12wks, Tremfya induced greater improvement across key clinical and endoscopic outcome measures, with a safety profile consistent with approved indications. Tremfya is a mAb that selectively binds to the p19 subunit of (IL)-23 and inhibits its interaction with the IL-23 receptor
Pfizer & BioNTech Receives MHRA's EUA for BNT162b2 Against COVID-19
Date - Nov 02, 2020
Product- BNT162b2
- Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI
- The MHRA's decision is based on a rolling submission, including data from the P-III study, demonstrating 95% efficacy in participants without & with/ out prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose
- This marks the first EUA following a WW P-III trial of a vaccine to combat the pandemic. The companies are anticipating further regulatory decisions across the globe in Dec'2020
AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M
Date - Nov 02, 2020
Product- Crestor
- Grünenthal to acquire EU rights (Ex- Spain and the UK) of Crestor & its associated brands for ~$350M and will take over bulk production and packaging by 2025. The deal is expected to be closed in Q1'21
- The payments will be made in two tranches: $320M will be paid upon transaction closing and $30M as additional milestones
- Crestor is a statin, a lipid-lowering agent used to treat blood-lipid disorders & to prevent CV events, such as heart attacks & strokes, and is approved as a lipid-regulating medicine in 100+ countries
Date - Nov 02, 2020
Product- Xolair
- The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively
- Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs -0.2); no new or unexpected safety signals were identified respectively
- Xolair is the first biologic for the treatment of nasal polyps that targets and blocks IgE. In the US, Novartis & Genentech work together to develop and co-promote Xolair
Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020
Date - Nov 03, 2020
Product - CT-P17(biosimilar,adalimumab)
- The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
- Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
- Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre- filled syringe (PFS)
Date - Nov 03, 2020
Product - FPI-1434
- Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
- The collaboration leverages Fusion's TAT platform and expertise in radiopharmaceuticals with AstraZeneca's leading portfolio of Abs and cancer therapies, including DDRis
- Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion's FPI-1434) and AstraZeneca's therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets
Janssen Acquires Rights to Hemera's HMR59 for Late-Stage Age-Related Macular Degeneration
Date - Nov 03, 2020
Product- HMR59
- Janssen acquires rights to Hemera's HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy
- The acquisition will boost Janssen's eye disease portfolio & strengthens its gene therapy capabilities
- HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision. The P-I study of the therapy for patients with geographic atrophy is completed while the P-I study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate the long-term safety
Date - Nov 04, 2020
Product- Deucravacitinib
- The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis
- The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of deucravacitinib was consistent with previously reported P-II results
- Deucravacitinib (BMS-986165, PO) is the first & only novel selective TYK2 inhibitor, currently being evaluated in psoriasis, PsA, lupus, and IBD
Date - Nov 04, 2020
Product- amivantamab
- The BLA is based on the P-I CHRYSALIS study assessing amivantamab as a monothx. and in combination with lazertinib in adult patients with advanced NSCLC
- The company has established an EAP for patients in the US who may be eligible to obtain access to mivantamab during the review of the BLA
- Amivantamab is an EGFR & MET bispecific Ab with the immune cell-directing activity that targets tumors with activating & resistance to EGFR & MET mutations & amplifications. Amivantamab has received the US FDA's BTD in Mar'2020
Merck to Acquire VelosBio for $2.75B
Date - Nov 05, 2020
Product- VLS-101
- Merck will acquire all the outstanding shares of VelosBio for $2.75B in cash. The transaction is expected to be closed by the end of 2020
- The acquisition will bolster Merck's oncology pipeline with the addition of VelosBio's VLS-101, which is an investigational ADC targeting ROR1 to treat hematological malignancies and solid tumors
- In Oct'2020, VelosBio has initiated P-II study to evaluate VLS-101 for the treatment of patients with solid tumors, including patients with TNBC, HR+/HER2+ BC, and NSCLC. Additionally, VelosBio is developing a preclinical pipeline of ADCs and bispecific Abs targeting ROR1 to complement VLS-101 by offering alternative methods of tumor cell killing
Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design
Date - Nov 05, 2020
Product- N/A
- Iktos will leverage its de novo generative design technology to be used in a structure-enabled context, facilitating the rapid & cost-effective design of Merck KGaA's drug discovery program
- The collaboration follows the previous agreement of the companies signed in 2019. Merck KGaA is utilizing Iktos de novo design software platform Makya for MPO
- Iktos AI technology is based on deep generative models that help bring speed & efficiency to the drug discovery process by automatically designing virtual novel molecules having desired activities for treating a disease
Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19
Date - Nov 05, 2020
Product- NVX-CoV2373
- Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community
- The delivery will start as early as H1'21, following the completion of P-III study and the TGA's approval of the vaccine. The vaccine regimen is expected to require two doses per individual, administered 21 days apart.
- NVX-CoV2373 is evaluated in P-ll trial in the UK and 2 ongoing P-ll studies that began in Aug'2020, a P-llb trial in SA, and a P-l/ll continuation in the US and Australia. Additionally, Novavax has multiple agreements for the supply of NVX-CoV2373 directly to the US, UK, Canada, and through partnerships, supply to Japan, South Korea, and India
Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020
Date - Nov 07, 2020
Product- Hemlibra
- The 4 pivotal HAVEN studies (HAVEN-1, 2, 3, 4) included pooled data from 401 people with hemophilia A with/ out factor VIII inhibitors, with a median duration efficacy period of 120.4wks.
- Hemlibra maintained low treated bleed rates with ABR remaining low throughout the evaluation period at 1.4. The proportion of participants who experienced 0 treated bleeds (70.8-83.7%) increased with each consecutive 24wks. period
- Roche also presented the first interim analysis of the EUHASS database suggesting that the safety profile of Hemlibra in the real-world setting is consistent with the clinical trials, with no new/ emerging safety signals. Hemlibra is a bispecific factor IXa- and factor X-directed Ab
Celltrion Reports Results of CT-P59 in P-I Study for COVID-19
Date - Nov 09, 2020
Product - CT-P59
- The P-I clinical trial involves assessing CT-P59 (20/40/80 mg/kg) vs PBO in 18 patients with mild symptoms of SARS-COV-2 infection who were randomized into 3 cohorts
- Results: patients demonstrated a 44% reduction in mean clinical recovery time, while no patients required hospitalization or antiviral therapy
- Celltrion has submitted the IND application for the clinical trial globally & plans to conduct global P-II & P-III trials including Korea. Additionally, Celltrion has also initiated a post-exposure prophylaxis study assessing CT-P59 as a protective treatment, by investigating the efficacy of the treatment in those who have been in contact with confirmed SARS-CoV-2 infected patients
AstraZeneca's Calquence (acalabrutinib) Receives EU's Approval for Chronic Lymphocytic Leukaemia
Date - Nov 10, 2020
Product- Calquence (obinutuzumab)
- The approval is based on P-lll ELEVATE-TN study assessing Calquence + obinutuzumab or Calquence alone vs obinutuzumab + CT in patients with previously untreated CLL and ASCEND study assessing Calquence vs rituximab + idelalisib/ bendamustine in patients with r/r CLL
- ELEVATE-TN results: a reduction in the risk of disease progression or death (90% and 80%). ASCEND results: patients remained alive and free from disease progression @12mos. (88% vs 68%)
- Calquence is a selective inhibitor of BTK, binds covalently to BTK, thereby inhibiting its activity. The approval follows CHMP's recommendation received in Jul'2020
Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens
Date - Nov 12, 2020
Product- Abrocitinib
- The P-lll JADE REGIMEN study involves assessing of Abrocitinib (100/ 200mg) vs PBO in 1233 patients aged = 12 yrs. in a ratio (1:1:1) with mod. to sev. AD following response to initial open-label induction treatment with abrocitinib (200mg)
- Result: The study met its 1EPs i.e. probability of not experiencing a flare @52wks. (81.1%, 57.4% vs 19.1%) and 2EPs i.e. patients maintain an IGA response of clear or almost clear relative
- Following an initial 12wks. induction treatment phase, fewer patients experienced a flare at any point in the trial @40wks. Abrocitinib is a JAK inhibitor, which modulates multiple cytokines involved in the pathophysiology of AD, including IL-4, IL-13, IL-31, IL-22, and TSLP
UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio
Date – Nov 13, 2020
Product – Handl Therapeutics
- The acquisition will bolster UCB’s pipeline program, capabilities, and platforms in the gene therapy space. The Handl Therapeutics will continue to be based in Leuven, Belgium while working closely with UCB’s international research teams
- In addition, the UCB collaborated with Lacerta to focus on CNS diseases, under which Lacera will lead research, preclinical activities, and the early manufacturing process development, while UCB will complete IND-enabling studies, manufacturing, and clinical development
- The collaboration will allow UCB to access Lacerta’s expertise in AAV-based CNS targeted gene therapies, fortifying UCB’s ability to produce effective treatments for neurodegenerative diseases
Henlius report the NMPA’s Acceptance of HLX15(biosimilar, Daratumumab) to treat multiple myeloma
Date – Nov 16, 2020
Product- HLX15
- The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
- The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
- The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products
Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2
Date – Nov 20, 2020
Product- BNT162b2
- collaborate to focus at developing & commercializing transformative therapies in Greater China. Both the companies will leverage their clinical development, regulatory and commercial expertise
- Pfizer will contribute ~$70M of non-dilutive capital toward in-licensing & co-development. At LianBio’s discretion, products will be presented to Pfizer for joint development
- Pfizer will have a right of first negotiation to obtain commercial rights to jointly developed assets & each company will carry separate financial considerations. Additionally, Pfizer may provide in-kind support for marketing, development & regulatory activities
AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19
Date – Nov 23, 2020
Product – AZD1222
- Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported
- One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose of at least 1 mos. apart & another dosing regimen showed 62% efficacy when given as 2 full doses at least 1 mos. apart. The combined analysis from both dosing regimens resulted in the efficacy of ~70%
- AZ will plan regulatory submission of the data across the globe and will seek an Emergency Use Listing from the WHO for an accelerated pathway to vaccine availability in low-income countries.
Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer
Date – Dec 15, 2020
Product- Cobas PIK3CA Mutation Test
- Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark
- The IVT test is a real-time PCR test for the qualitative detection & identification of 17 mutations in exons 2, 5, 8, 10 & 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolated from FFPET and is intended to identify patients with m-BC harboring mutations
- This test reports automated results, with flexible throughput to process 30 samples/ run on the widely available cobas z 480 analyzers. The test can detect 17 mutations in the PIK3CA gene and can help clinicians to identify patients who may benefit from PI3K targeted therapy
Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark
Date – Dec 16, 2020
Product- SARS-CoV-2 IgG II Quant test
- Abbott received CE Mark for its new quantitative SARS-CoV-2 IgG lab-based serology test. The test measures levels of IgG Abs to help in the evaluation of a person’s immune response
- The study to determines the clinical performance of Abbott’s SARS-CoV-2 IgG II Quant test on its Alinity i instrument showed that it had 99.60% specificity & 99.35% sensitivity in patients tested 15 days or more after symptoms began
- The test will be available on both the Abbott ARCHITECT and Alinity i platforms. Abbott plans to submit its test for US FDA’s EUA imminently
Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine
Date – Dec 15, 2020
Product- COVID-19 vaccine
- Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use
- Following an agreement to supply 20M of doses for the Government of Canada, AstraZeneca seek out Health Canada’s clearance in Oct’2020, leading to data submission done on a rolling basis for accelerating the review process
- Health Canada is looking to give Canadians access to COVID-19 vaccines asap without compromising its safety, efficacy, and quality standards
Related Post: PharmaShots’ Key Highlights of Third Quarter 2020
Tags
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com
