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Month: June 2020

Weekly Top News – Ovarian Cancer – June 22, 2020

June 22, 2020

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Overview of the Updated NCCN Guidelines on Ovarian Cancer (Journal of Clinical Pathways) – Jun 17, 2020 – “The Guidelines added niraparib to maintenance therapy options for those with complete or partial remission if they have BRCA1/2 wild-type or unknown and did not use bevacizumab as primary therapy or for those with germline or somatic BRCA1/2 mutation (category 1 if bevacizumab was not used as a primary therapy, and category 2A if it was). The Guidelines modified a category of evidence for olaparib for patients with a germline or somatic BRCA1/2 mutation who did not receive bevacizumab during primary therapy…”

 

Rubraca (rucaparib) / Clovis
Rubraca: Newly added patents in Orange Book (Orange Book) – Jun 17, 2020 – Expiry on July 23, 2024, August 12, 2027, August 4, 2031 and August 17, 2035

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda; dostarlimab (TSR-042) / GSK
A Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer (clinicaltrials.gov) – Jun 18, 2020 – P3; N=1228; Recruiting; Sponsor: Tesaro, Inc.; Trial completion date: Jan 2023 –> Jul 2026; Trial primary completion date: Jul 2021 –> Feb 2023

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Weekly Top News – IBD – June 22, 2020

June 22, 2020

etrasimod (APD334) / Arena
Etrasimod: Data from P2b CULTIVATE trial (NCT04173273) for Crohn’s disease in mid-2021 (Arena) – Jun 18, 2020 – Corporate Presentation: Data from P3 trial for Crohn’s disease in H2 2022

 

etrasimod (APD334) / Arena
Etrasimod: NDA submission for ulcerative colitis in mid-2022 (Arena) – Jun 18, 2020 – Corporate Presentation

 

Stelara (ustekinumab) / J&J
Final NICE green light for Janssen’s Stelara in UC (PharmaTimes) – Jun 17, 2020 – “The National Institute for Health and Care Excellence (NICE) has now issued a final green light for NHS use of Janssen’s Stelara (ustekinumab) to treat ulcerative colitis. The decision permits NHS doctors to prescribe the drug to treat moderately to severely active ulcerative colitis (UC) in adults when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment, only if: a tumour necrosis factor (TNF)-alpha inhibitor has failed, cannot be tolerated, or is unsuitable….According to NICE, clinical trial evidence shows that Stelara is more effective than placebo for treating moderately to severely active ulcerative colitis….However, its endorsement is contingent upon Janssen providing Stelara at the same price or lower than that agreed…”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy (clinicaltrials.gov) – Jun 17, 2020 – P2/3; N=720; Recruiting; Sponsor: AbbVie; N=1536 –> 720; Trial primary completion date: Sep 2020 –> Mar 2022

 

Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
ANMAT approved the use of a medicine to treat ulcerative colitis [Google translation] (El Litoral) – Jun 17, 2020 – “The National Administration of Medicines, Foods and Medical Technology (ANMAT) approved in Argentina the use of an oral medication for the treatment of moderate to severe ulcerative colitis in adults. Approval was obtained from the results of three phase III clinical trials that integrate a global clinical development program called OCTAVE and that included more than 1,700 patients. This is a new indication for a medicine containing tofacitinib for the treatment of ulcerative colitis…”

 

Zeposia (ozanimod) / BMS
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – Jun 16, 2020 – P3; N=1012; Active, not recruiting; Sponsor: Celgene; Recruiting –> Active, not recruiting; Trial completion date: Mar 2021 –> Jun 2020; Trial primary completion date: Jun 2020 –> Mar 2020

 

To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis (clinicaltrials.gov) – Jun 17, 2020 – P3; N=274; Completed; Sponsor: Ferring Pharmaceuticals; Active, not recruiting –> Completed

 

ALPN-101 / AbbVie
Alpine Immune Sciences and AbbVie announce option and license agreement for the development and commercialization of ALPN-101 (Businesswire) – Jun 18, 2020 – “Alpine Immune Sciences…and AbbVie…announced an exclusive worldwide option and license agreement for ALPN-101, a first-in-class dual CD28/ICOS costimulation antagonist….Under the terms of the agreement, Alpine will receive an upfront payment of $60 million, and will also be eligible to receive up to an aggregate of $805 million for exercise of the option and success-based development, regulatory and commercial milestones. In addition, Alpine is eligible to receive tiered royalties on net sales of ALPN-101. In exchange, AbbVie will receive an option to an exclusive license for ALPN-101. During the option period, Alpine will conduct a phase 2 study in systemic lupus erythematosus.”

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Weekly Top News – Psoriasis – June 22, 2020

June 22, 2020

Stelara (ustekinumab) / J&J; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms (clinicaltrials.gov) – Jun 17, 2020 – P3; N=132; Not yet recruiting; Sponsor: AbbVie

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
AOTMiT: What will the Transparency Council do in July? [Google translation] (medexpress.pl) – Jun 17, 2020 – “AOTMiT published the Transparency Council’s work plan from July 1 to July 31….MEETING OF THE TRANSPARENCY COUNCIL NO. 28/2020 13 JULY 2020: Ilumetri (tildrakizumab) – CONDITIONAL Indication: as part of the drug program ‘Treatment of moderate to severe plaque psoriasis’; 30/2020 27 JULY 2020: Dupixent (dupilumabum) – CONDITIONAL Indication: as part of the drug program : ‘Treatment of severe form of atopic dermatitis (ICD-10 L20)’ Decision problem: preparation of a position on drug evaluation…”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma and Hikma enter into unique licensing settlement for Ilumya for Middle East & North Africa areas (Equitybulls) – Jun 15, 2020 – “Sun Pharmaceutical…announced that one of its wholly-owned subsidiaries and Hikma Pharmaceuticals PLC (Hikma) have entered into an exclusive licensing and distribution agreement for Ilumya…for the Middle East & North Africa (MENA) region….Hikma will be responsible for the registration and commercialization of the product in all MENA markets and Sun Pharma will be responsible for product supply…The term of this agreement is 15 years from first sale, with two years’ automatic renewal periods.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Study to Assess the Safety and Change in Disease Symptoms of Risankizumab (Skyrizi Prefilled Syringe for Injection) in Adult Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Jun 16, 2020 – P; N=3000; Not yet recruiting; Sponsor: AbbVie

 

Tremfya (guselkumab) / J&J
GULLIVER: A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis (clinicaltrials.gov) – Jun 19, 2020 – P; N=400; Recruiting; Sponsor: Janssen-Cilag S.p.A.

 

Tremfya (guselkumab) / J&J
New phase 3 data for Tremfya (guselkumab), a first-in-class IL-23 p19 subunit iInhibitor, show consistent, high levels of skin clearance through four years in adult patients with moderate to severe plaque psoriasis (Businesswire) – Jun 15, 2020 – P3, N=992; VOYAGE 2 (NCT02207244); P3, N=837; VOYAGE 1 (NCT02207231); Sponsor: Janssen Research & Development, LLC; “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new long-term plaque psoriasis data for Tremfya® (guselkumab), a first-in-class treatment showing consistent, high levels of skin clearance at week 100 and week 204 (four years)…In the open-label extension of VOYAGE 2, at four years, 80 percent of patients who were treated with guselkumab 100 mg every 8 weeks (q8w), achieved at least 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) score….These data are being shared online as an accepted poster (P15300) by the American Academy of Dermatology….Separately, data…VOYAGE 1 trial…are also being shared online as a poster (P15287)…at week 48, approximately 42 percent of guselkumab-treated patients and 23 percent of adalimumab-treated patients were symptom-free.”

 

bimekizumab (UCB4940) / UCB
BE BRIGHT: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Jun 19, 2020 – P3; N=1355; Active, not recruiting; Sponsor: UCB Biopharma S.P.R.L.; Recruiting –> Active, not recruiting

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COVID-19 Top News – June 22, 2020

June 22, 2020

hydroxychloroquine / Generic mfg.
MHRA suspends recruitment to COVID-19 hydroxychloroquine trials (GOV.UK) – Jun 16, 2020 – “The Medicines and Healthcare products Regulatory Agency (MHRA) has instructed UK clinical trialists using hydroxychloroquine to treat or prevent coronavirus (COVID-19) to suspend recruitment of further participants….We followed the emerging concerns about use of hydroxychloroquine in COVID-19, and took into consideration the results from two different trials, including the UK’s RECOVERY trial which has provided convincing evidence of no meaningful mortality benefit in hospitalised patients with COVID-19.”

 

Actemra IV (tocilizumab) / Roche, JW Pharma
Roche rheumatoid arthritis drug fails to help COVID-19 patients in Italian study (Reuters) – Jun 18, 2020 – P2, N=398; NCT04346355; “Roche’s rheumatoid arthritis drug Actemra failed to help patients with early-stage COVID-19 pneumonia in an Italian study….It is pressing ahead with testing Actemra in another trial against COVID-19….The trial, which enrolled 126 patients, about a third of the intended number, was stopped early after an interim analysis raised doubts about the anti-inflammatory medicine’s effectiveness….Meanwhile, Roche has completed enrolment of its own Actemra study in patients hospitalized with severe COVID-19 pneumonia. That ‘will provide robust evidence about the benefit/ risk profile’, a Roche spokesman said, with data expected in the next few months.”

 

remdesivir / Generic mfg.
Favipiravir and Remdesivir get approval for treatment (The Economic Times) – Jun 20, 2020 – “In a seperate development, Maharashtra’s health minister Rajesh Tope said that Cipla and Hetero have received emergency marketing approval for Remdesivir for the treatment of severe Covid-19 patients from the drug controller of India…”

 

Aclaris Therapeutics Supports Investigator-Initiated Clinical Trial of ATI-450 for Cytokine Release Syndrome in Hospitalized Patients with COVID-19 (GlobeNewswire) – Jun 17, 2020 – “Aclaris Therapeutics, Inc….today announced that the FDA has allowed an investigational new drug application to evaluate ATI-450…in hospitalized patients with COVID-19. Aclaris is supporting an investigator-initiated trial of ATI-450 for cytokine release syndrome (CRS) in 36 hospitalized patients with COVID-19, and will provide funding and clinical drug supply to the University of Kansas Medical Center (KUMC), the sponsor of the trial….The trial is a Phase 2a, randomized, double-blind, placebo-controlled trial…”

 

mavrilimumab (KPL-301) / Kiniksa
Kiniksa Announces Lancet Rheumatology Publication of Clinical Outcomes with Mavrilimumab in COVID-19 (GlobeNewswire) – Jun 17, 2020 – P=Obs, N=1000; COVID-BioB (NCT04318366); “Kiniksa Pharmaceuticals, Ltd….today announced that clinical outcomes data from the open-label treatment protocol with mavrilimumab, an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα)…The 28-day clinical outcomes data from the open-label treatment protocol with mavrilimumab are described…”

 

MetaBlok (lsalt peptide) / Arch Biopartners
FDA Grants Arch Biopartners Permission to Proceed with Phase II trial to Evaluate Metablok (LSALT peptide) for the Treatment of COVID-19 patients (GlobeNewswire) – Jun 16, 2020 – “Arch Biopartners Inc….today announced that the U.S. Food and Drug Administration (FDA) has granted permission to the Company to proceed with a Phase II trial in the U.S. for its lead drug Metablok….The Company expects to begin the Phase II trial before the end of the summer, 2020.”

 

IFX-1 / Staidson Biopharma, InflaRx
InflaRx Reports Encouraging Topline Results from the Exploratory Phase II Part of the Adaptive Randomized Phase II/III Trial of IFX-1 in COVID-19 (GlobeNewswire) – Jun 17, 2020 – P2/3, N=30; “InflaRx…announced today interim results from the first 30 patients treated in the adaptive randomized Phase II/III trial….Relative change in the oxygenation index at day 5 showed no differences between treatment groups. However, IFX-1 treatment was associated with a lower 28-day all-cause mortality when compared to the best supportive care group….InflaRx is now evaluating continuing the study in an adequately powered, placebo-controlled, double blinded, Phase III part…”

 

Decadron (dexamethasone) / Merck (MSD)
The world will soon get coronavirus vaccine, health expert Anthony Fauci hopeful (Livemint) – Jun 19, 2020 – “On the treatment front, Fauci said he was ‘very impressed’ with results from a British trial into the steroid dexamethasone, which was found to reduce deaths among COVID-19 patients on ventilators by a third. However, given it works by suppressing the abnormal immune response that damages the body’s organs, rather than attacking the virus, Fauci cautioned it should not be prescribed too soon after a person was infected.”

 

dexamethasone / Generic mfg.
WHO welcomes preliminary results about dexamethasone use in treating critically ill COVID-19 patients (World Health Organization) – Jun 16, 2020 – “‘This is the first treatment to be shown to reduce mortality in patients with COVID-19 requiring oxygen or ventilator support,’ said Dr Tedros Adhanom Ghebreyesus…’This is great news and I congratulate the Government of the UK, the University of Oxford, and the many hospitals and patients in the UK who have contributed to this lifesaving scientific breakthrough.'”

 

remdesivir / Generic mfg.
Gilead to assess remdesivir in paediatric Covid-19 patients (Clinical Trials Arena) – Jun 18, 2020 – “The trial is expected to be completed in December this year….Merdad Parsey said in a statement: ‘From the onset of the pandemic, Gilead has advanced the development of our investigational antiviral remdesivir for the treatment of Covid-19, in parallel with emerging knowledge about the disease. ‘While the novel coronavirus appears to disproportionally affect adults, especially the elderly and those with underlying health conditions, concerning reports have been documented of children and young adults being hospitalised with Covid-19 and related autoimmune symptoms.'”

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COVID-19 | Status of Scientific Conferences 2020

June 22, 2020

Over 400 healthcare and pharma conferences have changed or cancelled their upcoming meetings because of COVID-19.  We have compiled an updated list on the current status of these conferences.

 

Click Here for Full Access

 

Last Updated: June 22, 2020

 

 

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Daily Top News – June 19, 2020

June 19, 2020

Baize’an (tislelizumab) / BeiGene, BMS
BeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Combination with Chemotherapy in First-Line Advanced Non-Squamous Non-Small Cell Lung Cancer in China (GlobeNewswire) – Jun 19, 2020 – “BeiGene, Ltd…announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) of BeiGene’s anti-PD-1 antibody tislelizumab in combination with chemotherapy for first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC)…The sNDA in non-squamous NSCLC is supported by clinical results from a Phase 3 trial of tislelizumab in combination with pemetrexed and platinum chemotherapy of investigator’s choice – either carboplatin or cisplatin – in patients with previously untreated stage IIIB or stage IV non-squamous NSCLC and with no EGFR mutations or ALK translocations (NCT03663205)….Full results of the trial will be presented at an upcoming meeting.”

 

Byvasda (bevacizumab biosimilar) / Innovent Biologics, Coherus
Innovent Announces the NMPA Granted Marketing Approval for BYVASDA (Bevacizumab Biosimilar) in China (PRNewswire) – Jun 19, 2020 – “Innovent Biologics, Inc….announced that BYVASDA® (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug independently developed by Innovent, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China.”

 

ipatasertib (GDC-0068) / Roche; abiraterone (DST-2970) / DisperSol Tech
Roche’s IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints (GlobeNewswire) – Jun 19, 2020 – P3, N=1,101; IPATential150 (NCT03072238); Sponsor: Hoffmann-La Roche; “Phase III IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care (abiraterone and prednisone/prednisolone alone) plus placebo met its co-primary endpoint of radiographic progression free survival (rPFS) in patients with PTEN loss tumours….In addition to prostate cancer, ipatasertib is being studied in certain types of breast cancer including triple-negative breast cancer (TNBC) and hormone-receptor positive (HR+), HER2- negative breast cancer. Results are anticipated later in 2020.”

 

Tazverik (tazemetostat) / Epizyme, Eisai
Roche receives FDA approval for cobas EZH2 Mutation Test as a companion diagnostic for patients with follicular lymphoma (PRNewswire) – Jun 19, 2020 – “Roche…announced U.S. Food and Drug Administration (FDA) approval of the cobas® EZH2 Mutation Test as a companion diagnostic for TAZVERIK™(tazemetostat), developed by Epizyme, Inc. This molecular test detects abnormalities in the EZH2, or Enhancer of Zeste Homolog 2, gene in patients with follicular lymphoma (FL), a type of non-Hodgkin lymphoma patients who may be eligible for treatment with TAZVERIK, a cancer drug that acts as a selective EZH2 gene inhibitor….The cobas EZH2 Mutation Test is expected to be commercially available in the U.S. later this year.”

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Daily Top News – June 18, 2020

June 18, 2020

Tazverik (tazemetostat) / Epizyme, Eisai
Epizyme announces U.S. FDA accelerated approval of Tazverik (tazemetostat) for relapsed/refractory follicular lymphoma (Epizyme Press Release) – Jun 18, 2020 – “Epizyme…announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for TAZVERIK™ (tazemetostat) for the following two distinct follicular lymphoma (FL) indications: Adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies. Adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options.”

 

HQP1351 / Ascentage Pharma
Ascentage Pharma Submits Its First New Drug Application to National Medical Products Administration, for HQP1351, the First Third-Generation BCR-ABL Inhibitor in China (PRNewswire) – Jun 18, 2020 – “Ascentage Pharma…today announced that Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of Ascentage Pharma’s, has submitted a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) for HQP1351 for the treatment of patients with T315I-mutant chronic phase chronic myeloid leukemia (CP-CML) and accelerated phase CML (AP-CML).”

 

Elunate (fruquintinib) / Chi-Med
Chi-Med Announces Fruquintinib Granted U.S. FDA Fast Track Designation for Metastatic Colorectal Cancer (GlobeNewswire) – Jun 18, 2020 – “Hutchison China MediTech Limited…today announces that the U.S. Food and Drug Administration (‘FDA’) has granted Fast Track Designation for the development of fruquintinib, for the treatment of patients with metastatic colorectal cancer (‘mCRC’)…Chi-Med is initiating a Phase III registration study, known as the FRESCO-2 study, in refractory mCRC in the U.S., Europe and Japan…FRESCO-2 is expected to start enrolling patients in mid-2020…”

 

LNS8801 / Linnaeus Therap
Linnaeus Therapeutics Granted U.S. FDA Fast Track Designation for LNS8801 for the Treatment of Patients with Metastatic or Unresectable Melanoma Who Have Progressed on Anti-PD-1/L1 Therapy (PRNewswire) – Jun 18, 2020 – “Linnaeus Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LNS8801 for the treatment of patients with metastatic or unresectable melanoma who have progressed on or after anti–programmed cell death receptor or ligand (anti–PD-1/L1) therapy….Linnaeus is currently evaluating LNS8801 in a phase 1 clinical trial in patients with advanced cancer. The company expects to identify the recommended phase 2 dose this summer and to begin its phase 2 program evaluating LNS8801 as a monotherapy and in combination with targeted therapies in early fall.”

 

Brukinsa (zanubrutinib) / BeiGene, Medison
BeiGene Announces European Medicines Agency Acceptance of its Marketing Authorization Application for BRUKINSA (Zanubrutinib) for the Treatment of Patients with Waldenström’s Macroglobulinemia (GlobeNewswire) – Jun 18, 2020 – “BeiGene, Ltd…announced that its marketing authorization application (MAA) for BRUKINSA® (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy has been validated for regulatory review by the European Medicines Agency (EMA).”

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Daily Top News – June 17, 2020

June 17, 2020

umbralisib (TGR-1202) / TG Therapeutics
TG Therapeutics Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma (GlobeNewswire) – Jun 17, 2020 – “TG Therapeutics, Inc…announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting accelerated approval of umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL).”

 

Keytruda (pembrolizumab) / Merck (MSD)
FDA Approves Second Biomarker-Based Indication for Merck’s KEYTRUDA (pembrolizumab), Regardless of Tumor Type (Businesswire) – Jun 17, 2020 – “Merck…announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options…The FDA also approved FoundationOne® CDx test as the companion diagnostic to identify patients with solid tumors that are TMB-H (≥10 mutations/ megabase) who may benefit from immunotherapy treatment with KEYTRUDA monotherapy….The accelerated approval was based on data from…KEYNOTE-158 (NCT02628067), a multicenter, non-randomized, open-label trial evaluating KEYTRUDA (200 mg every three weeks).”

 

 

HB-201 / Hookipa Pharma; HB-202 / Hookipa Pharma
HOOKIPA Announces FDA Clearance of its IND Application for HB-202/201 Clinical Trial to Treat HPV-Positive Cancers (GlobeNewswire) – Jun 17, 2020 – “HOOKIPA Pharma Inc…announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application for HB-202. This IND allows HOOKIPA to initiate an additional arm in its Phase 1/2 clinical trial for HB-201 (NCT04180215) for the treatment of Human Papillomavirus 16-positive (HPV 16+) cancers…In 2021, HOOKIPA expects to also combine HB-202/201 with an approved checkpoint inhibitor…’look forward to treating the first HB-202/201 patient later this year.'”

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Daily Top News – June 16, 2020

June 16, 2020

Verzenio (abemaciclib) / Eli Lilly
Verzenio (abemaciclib) significantly reduced the risk of cancer returning in people with high risk HR+, HER2- early breast cancer (PRNewswire) – Jun 16, 2020 – P3, N=4580; monarchE (NCT03155997); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced Verzenio® (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. These results are from a pre-planned interim analysis of the Phase 3 monarchE study – making Verzenio the only CDK4 & 6 inhibitor to demonstrate a statistically significant reduction in the risk of cancer recurrence for people with high risk hormone receptor-positive…(HER2-) early breast cancer…Lilly plans to present these data at a medical meeting later this year…’ We look forward to submitting these data to regulatory authorities before the end of 2020’…The monarchE trial will continue through the completion date, estimated for June 2027.”

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COVID-19 Top News – June 15, 2020

June 15, 2020

mRNA-1273 / Moderna
Moderna advances late-stage development of its vaccine (mRNA-1273) against Covid-19 (Businesswire) – Jun 11, 2020 – “Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants enrolled in the U.S….The Company expects dosing in the Phase 3 study to begin in July….The first cohort of healthy adults ages 18-54 years (n=300) in the Phase 2 study of mRNA-1273 is fully enrolled….Funding from the Biomedical Advanced Research and Development Authority (BARDA)…partially supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273…”

 

mavrilimumab (KPL-301) / Kiniksa
Kiniksa announces 28-day clinical outcomes data from mavrilimumab treatment protocol in severe Covid-19 pneumonia and active U.S. IND for phase 2/3 clinical trial (GlobeNewswire) – Jun 8, 2020 – P=NA, N=39; “The company also announced an active investigational new drug application…for its global placebo-controlled Phase 2/3 clinical trial….Investigator-initiated placebo-controlled study in the U.S. is enrolling patients….28-day clinical outcomes data from the open-label treatment protocol….Death occurred in 0% (n=0/13) of mavrilimumab-treated patients by Day 28….Representative mavrilimumab-treated patients showed significant improvement in lung opacification on computerized tomography (CT) scans, consistent with the overall improvement in their clinical status.”

 

Yeliva (opaganib) / RedHill
Redhill Biopharma submits Covid-19 Clinical Trial Application for phase 2/3 study with opaganib (GlobeNewswire) – Jun 10, 2020 – “RedHill Biopharma Ltd….today announced that it has submitted a Clinical Trial Application (CTA) with the Ministry of Health of the Russian Federation for a Phase 2/3 clinical study evaluating opaganib (Yeliva®, ABC294640)….The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study is planned to enroll 270 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygenation.”

 

REGN10933/REGN10987 / Regeneron
Regeneron begins first clinical trials of anti-viral antibody cocktail REGN-COV2 for the treatment and prevention of Covid-19 (PipelineReview) – Jun 11, 2020 – “Regeneron Pharmaceuticals, Inc….announced initiation of the first clinical trial of REGN-COV2….The REGN-COV2 clinical program will consist of four separate study populations….The placebo-controlled trials will be conducted at multiple sites….The first two adaptive Phase 1/2/3 studies are evaluating REGN-COV2 (REGN10933+REGN10987) as a treatment for hospitalized and non-hospitalized patients with COVID-19. The Phase 1 portion will focus on virologic and safety endpoints, and the Phase 2 portion will focus on virologic and clinical endpoints.”

 

Vyrologix (leronlimab) / CytoDyn, Vyera Pharma
CytoDyn receives BLA acknowledgment letter from the FDA (GlobeNewswire) – Jun 8, 2020 – “CytoDyn Inc….announced today the U.S. Food and Drug Administration (FDA) advised the Company, subject to its ongoing review, it could receive its ‘PDUFA date’ on July 10, 2020.”

 

anti-SARS-CoV-2 hyperimmune globulin therapy / Grifols
Grifols starts production of its hyperimmune immunoglobulin as a potential passive immune therapy against Covid-19 (PRNewswire) – Jun 11, 2020 – “Grifols…today announced the start of production of its anti-SARS-CoV-2 hyperimmune immunoglobulin….The first doses are expected to be available in July 2020 as part of a clinical trial….Grifols is moving forward with its clinical trial in Spain to assess the effectiveness of high-dose intravenous immunoglobulin….Trial aims to assess the action of neutralizing antibodies…as well as determine the immunomodulatory potential…”

 

AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of Oxford
AstraZeneca to supply Europe with up to 400 million doses of Oxford University’s vaccine at no profit (AstraZeneca Press Release) – Jun 13, 2020 – “AstraZeneca has reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020. With today’s agreement, the IVA aims to accelerate the supply of the vaccine and to make it available to other European countries that wish to participate in the initiative. The IVA is committed to providing equitable access to all participating countries across Europe.”

 

PiCoVacc / Sinovac
Sinovac announces positive preliminary results of phase I/II clinical trials for inactivated vaccine candidate against Covid-19 (Businesswire) – Jun 13, 2020 – P1/2, N=743; “Sinovac Biotech Ltd….today announced positive preliminary results of phase I/II clinical trial for the Company’s COVID-19 vaccine candidate, named CoronaVac, which showed favorable immunogenicity and safety profiles….There have been no severe adverse event reported in either the phase I or phase II trials….Vaccine induces neutralizing antibodies 14 days after the vaccination with a 0,14 day schedule. The Company expects to submit…phase III clinical study protocol to China’s National Medical Products Administration…”

 

Johnson & Johnson announces acceleration of its Covid-19 vaccine candidate; Phase 1/2a clinical trial to begin in second half of July (PRNewswire) – Jun 10, 2020 – “Johnson & Johnson…has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant….Phase 1/2a study will evaluate…Ad26.COV2-S, recombinant in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study will take place in the U.S. and Belgium. The Company is in discussions…to start the Phase 3 SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, clinical trial ahead of its original schedule….The Company committed to the goal of supplying more than one billion doses globally through the course of 2021, provided the vaccine is a safe and effective.”

 

US To Fund And Conduct Key Studies On Three Possible COVID-19 Vaccines: Dr Anthony Fauci – Jun 11, 2020 – “‘The coronavirus vaccine effort is progressing very well and we expect more than one candidate vaccine to be in advanced clinical testing by early summer,’ Fauci…Fauci said the funding decision came from the Department of Health and Human Services, in consultation with the National Institutes of Health and other agencies.”

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