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Pharma news roundup and Larvol updates

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Month: July 2020

Daily Top News – July 31, 2020

July 31, 2020

llllllllll Libtayo (cemiplimab) / Sanofi, Regeneron; BNT111 / BioNTech
BioNTech Announces Strategic Collaboration with Regeneron to Advance FixVac and Libtayo (cemiplimab) Combination in Melanoma (GlobeNewswire) – Jul 31, 2020 – “BioNTech…today announced a strategic collaboration with Regeneron for a clinical trial combining BioNTech’s BNT111 FixVac product candidate and Libtayo® (cemiplimab), a fully human anti-PD-1 therapy, for the treatment of melanoma. The companies plan to jointly conduct a randomized Phase 2 study in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV cutaneous melanoma…The companies plan to disclose more details related to the planned Phase 2 study in the third quarter of 2020, with the goal of initiating the trial in the fourth quarter of 2020….Under the terms of the agreement, development costs for the clinical trial will be shared equally and both companies will contribute their products for the trial.”

 

llllllllll Alunbrig (brigatinib) / Takeda; mobocertinib (TAK-788) / Takeda; pevonedistat (MLN4924) / Takeda; Ninlaro (ixazomib) / Takeda; TAK-007 / Takeda
Takeda Announces FY2020 Q1 Results; Confirms Management Guidance & Raises Reported Operating Profit And Reported Net Profit for the Full Year (Businesswire) – Jul 31, 2020 – “In Oncology, TAK-007 for the treatment of hematologic malignancies on an outpatient basis, with encouraging Phase 1/2 data and cohort expansion ongoing for a pivotal study planned for next year and potential approval in FY2023; Mobocertinib (TAK-788) has the potential to set a new standard of care for a subset of Non-Small Cell Lung Cancer (NSCLC) patients with EGFR exon 20 insertions; Pevonedistat (TAK-924) has the potential to be the first novel HR-MDS therapy in over a decade; anticipated Phase 3 PANTHER trial in HR-MDS readout in second half of FY2020; Reported revenue and underlying revenue growth rates for notable Q1 FY2020 contributors include: ALUNBRIG JPY 2.0 billion +26%; NINLARO JPY 22.9 billion +31%”

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Daily Top News – July 30, 2020

July 30, 2020

llllllllll Tagrisso (osimertinib) / AstraZeneca
Tagrisso granted Breakthrough Therapy Designation in the US for the adjuvant treatment of patients with Stage IB-IIIA EGFR-mutated lung cancer (AstraZeneca Press Release) – Jul 30, 2020 – “AstraZeneca’s Tagrisso (osimertinib) has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent…The FDA granted the BTD based on data from the Phase III ADAURA trial…ADAURA is a randomised, double-blinded, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC…The data readout was originally anticipated in 2022.”

 

llllllllll Lenvima (lenvatinib) / Eisai, Merck (MSD)
APPLICATION FOR ADDITIONAL INDICATION OF ANTI CANCER AGENT LENVIMA FOR UNRESECTABLE THYMIC CARCINOMA SUBMITTED IN JAPAN (Eisai Press Release) – Jul 30, 2020 – “Eisai…and MSD…announced today that Eisai has submitted an application in Japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor LENVIMA ® (generic name: lenvatinib mesylate). In June 2020, LENVIMA received orphan drug designation in Japan for unresectable thymic carcinoma. This application is based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase II study (NCCH1508) conducted in Japan…”

 

llllllllll bomedemstat (IMG-7289) / Imago BioSciences
Imago BioSciences Granted Access by European Medicines Agency to PRIME Scheme for IMG-7289 (Bomedemstat) in Myelofibrosis (Businesswire) – Jul 30, 2020 – “Imago BioSciences, Inc…announced that the European Medicines Agency (EMA) granted access to its PRIME (PRIority MEdicines) scheme for IMG-7289 (bomedemstat), a lysine-specific demethylase-1 (LSD1) inhibitor, for the treatment of intermediate-2 and high-risk patients with myelofibrosis who have become intolerant of, resistant to, or are ineligible for a Janus Kinase (JAK) inhibitor.”

 

llllllllll pevonedistat (MLN4924) / Takeda
Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS) (Businesswire) – Jul 30, 2020 – “Takeda Pharmaceutical Company Limited…announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS)…The Breakthrough Therapy Designation is based on the final analysis of the Pevonedistat-2001 Phase 2 study, which evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including HR-MDS.”

 

llllllllll Keytruda (pembrolizumab) / Merck (MSD)
Merck Announces Two US Regulatory Milestones for KEYTRUDA (pembrolizumab) in Triple-Negative Breast Cancer (TNBC) (Businesswire) – Jul 30, 2020 – “The FDA has accepted and granted priority review for a new sBLA seeking accelerated approval for KEYTRUDA in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), based on the Phase 3 KEYNOTE-355 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Nov. 28, 2020. The FDA also accepted for standard review a new sBLA for KEYTRUDA for the treatment of patients with high-risk early-stage TNBC, in combination with chemotherapy as neoadjuvant treatment, and then as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial. The PDUFA date for this application is March 29, 2021.”

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Daily Top News – July 29, 2020

July 29, 2020

llllllllll Nucala (mepolizumab) / GSK
GSK Second quarter 2020 (GSK Press Release) – Jul 29, 2020 – “Nucala granted priority review by FDA for hypereosinophilic syndrome (HES). Decision expected H1 2021….Total Respiratory sales were up 17% AER, 16% CER, with strong growth from…Nucala in all regions. International Respiratory sales grew 17% AER, 17% CER, including Nucala, up 42% AER, 31% CER…Sales of Nucala were £241 million in the quarter and grew 24% AER, 21% CER, with US sales up 28% AER, 26% CER to £150 million. Europe sales of £54 million grew 4% AER, 6% CER and International sales of £37 million grew 42% AER, 31% CER including growth of the at-home use application.”

 

llllllllll GSK2881078 / GSK
GSK delivers Q2 sales of £7.6 billion -2% AER, -3% CER (Pro-forma -10% CER*) (GSK Press Release) – Jul 29, 2020 – “GSK’078 for COPD muscle weakness was terminated as data did not support progression in this indication….Initial data of the proof-of-concept study on the COPD candidate vaccine showed it did not meet the primary endpoint. Work is ongoing to better understand the data; no progression to Phase III is planned.”

 

llllllllll Ajovy (fremanezumab) / Otsuka, Teva
Teva Announces New Drug Application Filing in Japan for AJOVY (fremanezumab) Injection (Teva Press Release) – Jul 29, 2020 – “Teva Pharmaceutical Industries Ltd….today announced Otsuka Pharmaceutical Co., Ltd. has submitted an application to the Pharmaceuticals and Medical Devices Agency of Japan to obtain manufacturing and marketing approval in Japan for AJOVY® (fremanezumab) injection for the preventive treatment of migraine.”

 

llllllllll Jay Pharma to File IND Applications to FDA for a clinical study of proprietary formulations in Radiodermatitis and a combination Therapy in Glioblastoma (PRNewswire) – Jul 29, 2020 – “AMERI Holdings, Inc…announced that its proposed amalgamation partner Jay Pharma Inc…has announced the addition of new senior staff as the Company prepares to file two new investigational new drug (IND) applications for the treatment of radiodermatitis and glioblastoma multiforme (GBM)…’We recently announced Investigational Review Board (IRB) approval for a GBM study at the Rabin Institute in Israel’….Phase I/II human clinical trials in Israel will administer the Company’s proprietary synthetic CBD formula to 40 enrollees: half of whom will be treated with the CBD formula, and the other half will be treated with the formula in combination with clomiphene, an estrogen binding site inhibitor.”

 

llllllllll MK-6482 / Merck (MSD)
FDA Grants Breakthrough Therapy Designation to Merck’s Novel HIF-2α Inhibitor MK-6482 for Treatment of Certain Patients With Von Hippel-Lindau Disease- Associated Renal Cell Carcinoma (Businesswire) – Jul 29, 2020 – “Merck…announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate in Merck’s oncology pipeline, for the treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required. The FDA also granted orphan drug designation to MK-6482 for VHL disease. These designations are based on data from a Phase 2 trial evaluating MK-6482 in patients with VHL-associated clear cell RCC, which were presented at the 2020 American Society of Clinical Oncology Annual Meeting.”

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Daily Top News – July 28, 2020

July 28, 2020

llllllllll savolitinib (HMPL-504) / AstraZeneca, Chi-Med
Chi-Med’s NDA for Savolitinib in Non-Small Cell Lung Cancer Granted Priority Review in China (Hutchison China MediTech Press release) – Jul 28, 2020 – “Hutchison China MediTech Limited (‘Chi-Med’)…announced that the China National Medical Products Administration (‘NMPA’) has granted Priority Review status to the New Drug Application (‘NDA’) for savolitinib for the treatment of non-small cell lung cancer (‘NSCLC’) with MET Exon 14 skipping mutations. This is the first NDA filing for savolitinib globally and first for a selective MET inhibitor in China.”

 

llllllllll breast cancer vaccine / Anixa Biosci
Anixa Biosciences Breast Cancer Vaccine Technology Nearing FDA Submission (PRNewswire) – Jul 28, 2020 – “Anixa Biosciences, Inc…announced that its prophylactic breast cancer vaccine is making progress towards clinical trials…Anixa and Cleveland Clinic intend to file the Investigational New Drug (IND) Application with the US Food and Drug Administration by the end of the current quarter.”

 

llllllllll CTI-1601 / Larimar Therap
Larimar Therapeutics Announces Positive Opinion on Orphan Drug Designation Received from the European Medicines Agency for CTI-1601 for the Treatment of Friedreich’s Ataxia (GlobeNewswire) – Jul 28, 2020 – “Larimar Therapeutics, Inc….today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the company’s application for orphan drug designation for CTI-1601, a potential treatment for Friedreich’s ataxia (FA)….Larimar expects that the European Commission, based on this positive opinion of the COMP, will formally grant the orphan drug designation for the European Union (EU) this year….’We look forward to working closely with EMA and continuing our U.S. Phase 1 trial of CTI-1601….We remain on track to report topline data in the first half of 2021.'”

 

llllllllll BDTX-189 / Black Diamond Therap
Black Diamond Therapeutics Granted Fast Track Designation by the FDA for BDTX-189 for the Treatment of Adult Patients with a Solid Tumor Harboring an Allosteric HER2 Mutation or an EGFR or HER2 Exon 20 Insertion Mutation (GlobeNewswire) – Jul 28, 2020 – “Black Diamond Therapeutics…announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric human epidermal growth factor receptor 2 (HER2) mutation or an epidermal growth factor receptor (EGFR) or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options. BDTX-189, an orally available, irreversible small molecule inhibitor, is the Company’s lead product candidate designed to selectively inhibit the activity of a broad range of previously unaddressed oncogenic driver mutations of the ErbB kinases in EGFR and HER2.”

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Daily Top News – July 24, 2020

July 24, 2020

llllllllll brexucabtagene autoleucel (KTE-X19) / Gilead
U.S. FDA Approves Kite’s Tecartus, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma (Gilead Press Release) – Jul 24, 2020 – “Kite, a Gilead Company…announced that the…FDA has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The approval of this one-time therapy follows a priority review and FDA Breakthrough Therapy Designation and is based on results of ZUMA-2, a single-arm, open-label study in which 87 percent of patients responded to a single infusion of Tecartus, including 62 percent of patients achieving a complete response (CR).”

 

llllllllll Arikace (amikacin liposome inhalation suspension) / Insmed
Insmed Receives Positive CHMP Opinion for ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the Treatment of NTM Lung Infections Caused by MAC in Non-CF Patients with Limited Treatment Options (PRNewswire) – Jul 24, 2020 – “Insmed Incorporated…today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending ARIKAYCE Liposomal 590 mg Nebuliser Dispersion for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC) in adults…The European Commission (EC) will review the CHMP opinion, with a final decision anticipated in the second half of 2020….The CHMP opinion is based on results from the Phase 3 CONVERT study.”

 

llllllllll Imbruvica (ibrutinib) / AbbVie, J&J; Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Janssen Receives CHMP Positive Opinion for Expanded Use of IMBRUVICA (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukaemia (CLL) (Businesswire) – Jul 24, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for IMBRUVICA® (ibrutinib) to include the combination with rituximab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)….The Positive Opinion is based on data from the Phase 3 E1912 study…”

 

llllllllll Jyseleca (filgotinib) / Gilead
GILEAD AND GALAPAGOS ANNOUNCE POSITIVE EUROPEAN CHMP OPINION FOR JYSELECA (FILGOTINIB) FOR THE TREATMENT OF ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS (GlobeNewswire) – Jul 24, 2020 – “Gilead Sciences, Inc….announced today the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Jyseleca® (filgotinib 200 mg and 100 mg tablets), an investigational, once-daily, oral, selective JAK1 inhibitor for the treatment of adults with moderate to severe rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). The CHMP positive opinion is a scientific recommendation to the European Commission to grant marketing authorization in Europe….Supported by data from the Phase 3 FINCH and Phase 2 DARWIN programs…A Commission decision is expected in the third quarter of 2020.”

 

llllllllll Breztri Aerosphere (budesonide/formoterol fumarate/glycopyrronium) / AstraZeneca
Breztri Aerosphere approved in the US for the maintenance treatment of COPD (AstraZeneca Press Release) – Jul 24, 2020 – “AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)…The approval by the US Food and Drug Administration (FDA) was based on positive results from the Phase III ETHOS trial in which Breztri Aerosphere…The approval was also supported by efficacy and safety data from the Phase III KRONOS trial.”

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Daily Top News – July 23, 2020

July 23, 2020

llllllllll VTA-110 / Vita Therap
Vita Therapeutics receives Orphan Drug Designation from FDA for new novel treatment (PRNewswire) – Jul 23, 2020 – “Vita Therapeutics…announced today that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne’s Muscular Dystrophy (DMD)…The company plans to continue to progress this treatment towards clinical trials and plans to bring it forward for other congenital muscular dystrophy diseases as well.”

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Weekly Top News – IBD – July 20, 2020

July 20, 2020

llllllllll JNJ-64304500 / J&J
JNJ-64304500: NME filing in US for Crohn’s disease between 2020-2023 (J&J) – Jul 16, 2020 – Pipeline Update: Regulatory submission in EU for Crohn’s disease between 2020-2023
[Screenshot]

llllllllll mirikizumab (LY3074828) / Eli Lilly
LUCENT-ACT: A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis (clinicaltrials.gov) – Jul 13, 2020 – P3b; N=1100; Not yet recruiting; Sponsor: Eli Lilly and Company

llllllllll mirikizumab (LY3074828) / Eli Lilly; Cosentyx (secukinumab) / Novartis
Lilly’s Mirikizumab Superior to Cosentyx (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis (Eli Lilly Press Release) – Jul 17, 2020 – P3, N=1,443; OASIS-2 (NCT03535194); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today that mirikizumab…met the primary and all key secondary endpoints versus placebo at Week 16 (superiority) and all key secondary endpoints versus Cosentyx (secukinumab) at Week 16 (non-inferiority) and Week 52 (superiority) in the OASIS-2 study….’We are pleased with the positive results observed in the mirikizumab psoriasis development program (OASIS). Mirikizumab has the potential to be a meaningful treatment option for people living with psoriasis,’ said Andrew Blauvelt, M.D….Lilly expects topline results for the Phase 3 induction data in ulcerative colitis in the spring of 2021 and for the Phase 3 Crohn’s data in 2022; Lilly will submit data from OASIS-1 and 2 to regulatory authorities around the world.”

llllllllll Tremfya (guselkumab) / J&J
Tremfya: Data from P2/3 GALAXI trial (NCT03466411) for Crohn’s disease in 2020 (J&J) – Jul 16, 2020 – Key 2020 Events
[Screenshot]

llllllllll etrasimod (APD334) / Arena
ELEVATE UC 12: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Jul 17, 2020 – P3; N=330; Recruiting; Sponsor: Arena Pharmaceuticals; Not yet recruiting –> Recruiting

llllllllll mirikizumab (LY3074828) / Eli Lilly
Lily ’Mirikizumab’ approved for Phase 3 clinical trial for Crohn’s disease [Google Translation] (Medical News) – Jul 15, 2020 – “The Ministry of Food and Drug Safety (Chief Lee Eui-kyung) approved a phase 3 clinical trial to evaluate long-term efficacy and stability of ‘Mirikizumab (LY3074828)’ of ‘Korea Lily’ on the 13th….This phase 3 trial will be conducted at Ajou University Hospital, Inje University Haeundae Paik Hospital, Seoul Asan Hospital, Yeungnam University Hospital, and Gangbuk Samsung Hospital.”

llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University; Humira (adalimumab) / Eisai, AbbVie; Rinvoq (upadacitinib) / AbbVie
Pharma’s TV ad spending level sets in June, with AbbVie, Sanofi and Regeneron leading the way (Fierce Pharma) – Jul 16, 2020 – “The top 10 TV buyers’ total spending was $141 million, almost the same as the $140 million from June 2019….Sanofi and Regeneron’s type 2 anti-inflammatory med Dupixent at $13.1 million in June TV media buys….1. Humira: Total estimated spending: $44.3 million (up from $32.5 million in May); 3. Xeljanz: Total estimated spending: $12.5 million (up from $11.5 million in May); 9. Rinvoq: Total estimated spending: $9 million (down from $12.9 million in May); 10. Skyrizi: Total estimated spending: $8.8 million (up from $8.7 million in May).” 

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Weekly Top News – Ovarian Cancer – July 20, 2020

July 20, 2020

llllllllll carboplatin / Generic mfg.; Tecentriq (atezolizumab) / Roche
Roche provides update on Phase III study of Tecentriq in women with advanced stage ovarian cancer (Roche Press Release) – Jul 13, 2020 – P3, N=1300; IMagyn050 (NCT03038100); Sponsor: Hoffmann-La Roche; “Roche…today announced that the Phase III IMagyn050 study showed that the addition of Tecentriq® (atezolizumab) to Avastin® (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival (PFS) for the front-line treatment of women with newly diagnosed advanced stage ovarian cancer….Data for the overall survival (OS) co-primary endpoint are currently immature and follow-up will continue until the next planned analysis. Results from IMagyn050 will be further evaluated in order to inform the Tecentriq gynaecologic development programme…”

llllllllll Tecentriq (atezolizumab) / Roche
Roche’s Tecentriq Disappoints In Ovarian Cancer Study (Scripintelligence) – Jul 13, 2020 – P3, N=1300; IMagyn050 (NCT03038100); Sponsor: Hoffmann-La Roche; “PD-1/PDL-1 inhibitors have not proved effective for ovarian cancer on their own or in combinations. Now Roche’s Tecentriq, combined with the firm’s blockbuster Avastin, has suffered a similar fate to Merck KGaA and Pfizer’s Bavencio in failing to improve survival.”

llllllllll pamiparib (BGB-290) / EMD Serono
BeiGene Announces Acceptance of a New Drug Application of Pamiparib in Ovarian Cancer in China (GlobeNewswire) – Jul 17, 2020 – “BeiGene, Ltd…announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of BeiGene’s investigational inhibitor of PARP1 and PARP2, pamiparib, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy….This NDA is supported by clinical results from a Phase 1/2 trial of pamiparib in patients with advanced ovarian cancer, fallopian cancer, and primary peritoneal cancer or advanced triple negative breast cancer (NCT03333915).”

llllllllll Tecentriq (atezolizumab) / Roche
Tecentriq misses mark in ovarian cancer trial (PharmaTimes) – Jul 14, 2020 – P3, N=1300; IMagyn050 (NCT03038100); Sponsor: Hoffmann-La Roche; “Roche and Genentech’s Tecentriq (atezolizumab) has failed to hit its primary goal in a late stage trial involving patients with newly diagnosed advanced stage ovarian cancer…In the Phase III IMagyn050 study, the addition of Tecentriq to Avastin (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival…”

llllllllll Imfinzi (durvalumab) / AstraZeneca, BMS; Lynparza (olaparib) / Merck (MSD), AstraZeneca
Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients. (clinicaltrials.gov) – Jul 16, 2020 – P3; N=1254; Recruiting; Sponsor: AstraZeneca; Trial primary completion date: Jan 2023 –> Jun 2023

llllllllll Keytruda (pembrolizumab) / Merck (MSD); Lenvima (lenvatinib) / Eisai, Merck (MSD)
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) (clinicaltrials.gov) – Jul 15, 2020 – P2; N=600; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Active, not recruiting –> Recruiting 

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Weekly Top News – Psoriasis – July 20, 2020

July 20, 2020

llllllllll Tremfya (guselkumab) / J&J
TREMFYA (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis (PRNewswire) – Jul 14, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for adult patients with active psoriatic arthritis (PsA)…TREMFYA is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA. The safety and efficacy of TREMFYA in PsA have been demonstrated in two pivotal Phase 3 clinical trials.”

llllllllll mirikizumab (LY3074828) / Eli Lilly; Cosentyx (secukinumab) / Novartis
Lilly’s Mirikizumab Superior to Cosentyx (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis (Eli Lilly Press Release) – Jul 17, 2020 – P3, N=1,443; OASIS-2 (NCT03535194); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today that mirikizumab…met the primary and all key secondary endpoints versus placebo at Week 16 (superiority) and all key secondary endpoints versus Cosentyx (secukinumab) at Week 16 (non-inferiority) and Week 52 (superiority) in the OASIS-2 study….’We are pleased with the positive results observed in the mirikizumab psoriasis development program (OASIS). Mirikizumab has the potential to be a meaningful treatment option for people living with psoriasis,’ said Andrew Blauvelt, M.D….Lilly expects topline results for the Phase 3 induction data in ulcerative colitis in the spring of 2021 and for the Phase 3 Crohn’s data in 2022; Lilly will submit data from OASIS-1 and 2 to regulatory authorities around the world.”

llllllllll HB0017 / Zhejiang Huahai Pharma
Huahai Pharmaceutical (600521.SH): HB0017 injection project approved for two new indications [Google translation] (Securities Star) – Jul 14, 2020 – “Huahai Pharmaceutical (600521.SH) announced that recently, the company’s subsidiaries Huabo Biomedical Technology (Shanghai) Co., Ltd. (‘Huabo Bio’) and Shanghai Huaaotai Biopharmaceutical Co., Ltd. (‘Hua’aotai’) received the ‘Clinical Trial Notification’ for the two new indications of the HB0017 injection project approved by the State Drug Administration (‘SFDA’)…HB0017 injection….Psoriatic arthritis…acceptance number: CXSL2000076….Ankylosing spondylitis…acceptance number: CXSL2000081.”

llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Jul 17, 2020 – P3; N=157; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University; Humira (adalimumab) / Eisai, AbbVie
Pharma’s TV ad spending level sets in June, with AbbVie, Sanofi and Regeneron leading the way (Fierce Pharma) – Jul 16, 2020 – “The top 10 TV buyers’ total spending was $141 million, almost the same as the $140 million from June 2019….Sanofi and Regeneron’s type 2 anti-inflammatory med Dupixent at $13.1 million in June TV media buys….1. Humira: Total estimated spending: $44.3 million (up from $32.5 million in May); 3. Xeljanz: Total estimated spending: $12.5 million (up from $11.5 million in May); 9. Rinvoq: Total estimated spending: $9 million (down from $12.9 million in May); 10. Skyrizi: Total estimated spending: $8.8 million (up from $8.7 million in May).”

llllllllll Cosentyx (secukinumab) / Novartis
pINPOINt: A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD) (clinicaltrials.gov) – Jul 14, 2020 – P3; N=90; Recruiting; Sponsor: Novartis Pharmaceuticals; Suspended –> Recruiting

llllllllll AVT02 (adalimumab biosimilar) / Cipla, Alvotech
Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Jul 15, 2020 – P3; N=448; Recruiting; Sponsor: Alvotech Swiss AG; Not yet recruiting –> Recruiting

llllllllll BI 730357 / Boehringer Ingelheim
This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is (clinicaltrials.gov) – Jul 17, 2020 – P2; N=270; Recruiting; Sponsor: Boehringer Ingelheim; Active, not recruiting –> Recruiting; N=178 –> 270; Trial primary completion date: Oct 2019 –> Jun 2021

llllllllll Otezla (apremilast) / Amgen
APRIL: Observational Study of Apremilast in Patients With Psoriasis in The Netherlands (clinicaltrials.gov) – Jul 16, 2020 – P=N/A; N=154; Completed; Sponsor: Amgen; Active, not recruiting –> Completed

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COVID-19 Top News – July 20, 2020

July 20, 2020

BNT162b1 / Fosun Pharma, BioNTech, Pfizer; BNT162b2 / Pfizer, Fosun Pharma, BioNTech
PFIZER AND BIONTECH GRANTED FDA FAST TRACK DESIGNATION FOR TWO INVESTIGATIONAL MRNA-BASED VACCINE CANDIDATES AGAINST SARS-COV-2 (Pfizer Press Release) – Jul 13, 2020 – “Pfizer Inc. (NYSE: PFE) and BioNTech…today announced that two of the companies’ four investigational vaccine candidates from their BNT162 mRNA-based vaccine program…received Fast Track designation from the U.S. Food and Drug Administration (FDA)….The Project Lightspeed vaccine development program is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities….Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial as soon as later this month and are anticipating enrolling up to 30,000 subjects….Companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.”

 

BNT162b1 / Fosun Pharma, BioNTech, Pfizer
Fosun Pharma Announces its Licensed COVID-19 Vaccine Product Receives Acceptance Notice of Clinical Trial Application by NMPA (PRNewswire) – Jul 14, 2020 – “…Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (‘Fosun Pharmaceutical Industrial’) has received the acceptance notice of clinical trial application for the licensed COVID-19 vaccine product candidate BNT162b1 (the ‘Vaccine’). The clinical trial application of the Vaccine was accepted by the National Medical Products Administration (the ‘NMPA’)….’We hope that the clinical trial will be initiated in China as soon as possible, and the global pandemic will be defeated eventually with the launch of a safe and effective vaccine.'”

 

mosedipimod (EC-18) / Enzychem Lifesci
Enzychem Lifesciences Files IND Application to FDA for Phase 2 Study of EC-18 in Preventing Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 Pneumonia (PRNewswire) – Jul 13, 2020 – “Enzychem Lifesciences…today announced that it has filed an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for a Phase 2 clinical trial of EC-18….A Phase 2 study for EC-18 in Preventing ARDS due to novel coronavirus pneumonia is currently ongoing in South Korea….The study duration is 12 months from the FDA approval date. The study plans to enroll a total of 60 subjects in total, 30 patients in the EC-18 arm and the other 30 patients on the placebo arm….’We are preparing plans for initiating the Phase 2 study upon the IND becoming active by the U.S. FDA…'”

 

Yeliva (opaganib) / RedHill
RedHill Biopharma Receives Approval for Phase 2/3 COVID-19 Study in Russia (GlobeNewswire) – Jul 16, 2020 – P=Obs, N=23; NCT04435106; “The Phase 2/3 study aims to enroll 270 subjects in up to 40 clinical sites; enrollment planned to be initiated later this month with potential submission of Emergency Use Authorization application planned for Q4/2020; In parallel, the U.S. Phase 2a study with opaganib in patients with severe COVID-19 is advancing rapidly with more than 25% of patients enrolled; Approval also received for a clinical study with opaganib in Israel in up to 50 patients with severe COVID-19; Treatment of patients with severe COVID-19 under compassionate use showed substantial benefit to such patients compared to a matched case-control group; RedHill Biopharma Ltd….today announced approval from the Ministry of Health of the Russian Federation for its Clinical Trial Authorization (CTA) application for a Phase 2/3 study evaluating opaganib…”

 

brilacidin (PMX-30063) / Innovation Pharma
Innovation Pharmaceuticals – Clinical Trial Testing of Brilacidin Against SARS-CoV-2 (COVID-19) Targeted to Commence Q4 2020 (GlobeNewswire) – Jul 13, 2020 – “Innovation Pharmaceuticals…today provides perspectives on the planned clinical trial testing of Brilacidin, administered intravenously (IV), for the treatment of COVID-19. The exigencies of the pandemic coupled with Brilacidin’s multiple therapeutic properties…have the Company working vigilantly to advance Brilacidin into human trials against COVID-19 during fourth-quarter 2020….Company has drafted a study protocol toward initiating a planned Phase 2 trial of Brilacidin for COVID-19….Company is looking to start a clinical trial with Brilacidin for COVID-19 treatment in Q4 2020.”

 

WP1122 / Moleculin, CNS Pharma, WPD Pharma
Moleculin Announces Agreement to Produce WP1122 for Expanded Development of Potential COVID-19 and Oncology Drug Candidate (PRNewswire) – Jul 15, 2020 – “Moleculin Biotech, Inc….today announced that it has entered into an agreement with Sterling Pharma USA LLC for US production of WP1122 to support its expanded development efforts in preparation for submitting a request to the US Food and Drug Administration (‘FDA’) for Investigational New Drug (‘IND’) status for WP1122 for the potential treatment of COVID-19.”

 

Akebia Announces Initiation of Investigator-Sponsored Study Evaluating Vadadustat for Prevention and Treatment of ARDS in Patients Hospitalized with COVID-19 (PRNewswire) – Jul 14, 2020 – “Akebia Therapeutics, Inc….today announced the initiation of an investigator-sponsored study evaluating the use of vadadustat, Akebia’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS)….The randomized, double-blind, placebo-controlled study is intended to evaluate the safety and efficacy of vadadustat in up to 300 adult patients….This study is being conducted under a U.S. Food and Drug Administration Investigational New Drug (IND) application.”

 

Heron Therapeutics Announces Initiation of Phase 2 Clinical Study of CINVANTI for the Treatment of COVID-19 (PRNewswire) – Jul 16, 2020 – “Heron Therapeutics, Inc….today announced the initiation of the GUARDS-1 Study, a Phase 2 clinical study evaluating CINVANTI (aprepitant) injectable emulsion in early hospitalized patients with Coronavirus Disease 2019 (COVID-19). The study initiation follows clearance from the U.S. Food and Drug Administration (FDA) of Heron’s Investigational New Drug application for CINVANTI for the treatment of COVID-19….The use of remdesivir through the Emergency Use Authorization and dexamethasone as standard of care are both permitted in the study.”

 

Daklinza (daclatasvir) / BMS
Hep C Sofosbuvir/Daclatasvir Combo Promising for COVID-19 (Medscape) – Jul 13, 2020 – “These findings are hopeful, ‘provocative, and encouraging,’ said Anthony Fauci, MD…But he cautioned that more data are needed before the sofosbuvir and daclatasvir combination can be added to the National Institutes of Health COVID-19 Treatment Guidelines, which clinicians who might be under-resourced and overwhelmed with spikes in COVID-19 cases rely on.”

 

Fauci is optimistic that a new treatment for Covid will be available by October (ThePrint) – Jul 17, 2020 – “US infectious disease expert Anthony Fauci said he expects results for a clinical trial on monoclonal antibodies, which can be used as a treatment to fight the virus….A monoclonal antibody is a laboratory-produced protein that can potentially be used to treat sick patients as well as for prophylaxis. Fauci, the top U.S. infectious disease expert, described them as ‘precise bullets’ that can be developed from antibodies from other people who’ve been infected and used as a treatment to fight the virus at multiple stages.”

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