Pipeline

August 3, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Denali Therapeutics

Sanofi		 DNL758 (SAR443122) hospitalized adult patients with severe COVID-19 lung disease first patients dosed in phase 1b trial
AI Therapeutics LAM-002A patients with confirmed COVID-19 initiation of phase 2 trial
Apogenix asunercept patients with severe COVID-19 clearance to initiate a phase 2 trial in Russia
Constant Therapeutics TXA127 patients with COVID-19 who require oxygen but are not in the ICU initiation of phase 2 trial
Pfizer

BioNTech		 BNT162b2 vaccine candidate COVID-19 initiation of phase 2/3 trial
RedHill Biopharma opaganib (Yeliva) patients hospitalized with severe COVID-19 and pneumonia requiring treatment with supplemental oxygen initiation of phase 2/3 trial
Moderna mRNA-1273 vaccine candidate COVID-19 dosing of first patients in phase 3 trial
ReAlta Life Sciences RLS-0071 acute lung injury secondary to COVID-19 IND approved by the FDA
Color COVID-19 testing without clinical monitoring COVID-19 Emergency Use Authorization (EUA) granted by the FDA
Truvian Sciences Easy Check COVID-19 IgM/IgG antibody test COVID-19 EUA granted by the FDA
Gilead Sciences remdesivir patients 12 years and older with a body weight of at least 40 kg with severe symptoms of COVID-19 who have pneumonia and require extra oxygen to help them breathe approved by Health Canada
Other Trials and Actions
4-D Molecular Therapeutics 4D-110 choroideremia dosing of first patient in phase 1 trial
Chi-Med HMPL-306 hematological malignancies initiation of phase 1 trial
Cleave Therapeutics CB-5339 patients with relapsed/refractory acute myeloid leukemia or relapsed/refractory intermediate or high-risk myelodysplastic syndrome dosing of first patient in phase 1 trial
Pipeline Therapeutics PIPE-505 sensorineural hearing loss associated with hearing speech in noisy environments initiation of phase 1/2a trial
Repare Therapeutics RP-3500 solid tumors with specific genome instability-related genomic alterations including those in ATM gene dosing of first patient in phase 1/2 trial
Acurx Pharmaceutical ibezapolstat clostridioides difficile Infection initiation of phase 2 trial
Amgen

Arrowhead		 AMG 890 patients with elevated levels of lipoprotein (a) (Lp(a)) initiation of phase 2 trial
Iterion Therapeutics tegavivint desmoid tumors enrollment of first patients in phase 2a trial
NGM Biopharma NGM621 patients with geographic atrophy secondary to age-related macular degeneration initiation of phase 2 trial
Corcept Therapeutics relacorilant combined with nab-paclitaxel (Abraxane) metastatic, platinum-resistant ovarian cancer patient enrollment complete in phase 2 trial
Corcept Therapeutics relacorilant Cushing’s syndrome caused by adrenal adenomas or hyperplasia enrollment of first patient in phase 3 trial
Krystal Biotech beremagene geperpavec (KB103) dystrophic epidermolysis bullosa initiation of phase 3 trial
Carisma Therapeutics CT-0508 recurrent or metastatic HER2 overexpressing solid tumors after failure of approved HER2 targeted agents IND approved by the FDA
NeoImmuneTech NT-I7 (efineptakin alfa) patients with locally recurrent squamous cell carcinoma of head and neck undergoing salvage surgery IND approved by the FDA
Momenta Pharmaceuticals nipocalimab prevention of hemolytic disease of the fetus and newborn Rare Pediatric Disease designation and Orphan Drug designation granted by the FDA
Protara Therapeutics TARA-002 lymphatic malformations Rare Pediatric Disease designation granted by the FDA
Imara IMR-687 beta-thalassemia Rare Pediatric Disease designation and Fast Track designation granted by the FDA
Black Diamond Therapeutics BDTX-189 adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options Fast Track designation granted by the FDA
Checkmate Pharmaceuticals CMP-001 in combination with nivolumab or pembrolizumab initial treatment of patients with unresectable Stage III or Stage IV melanoma to prolong the time to disease progression and treatment of patients with unresectable or metastatic melanoma refractory to prior anti-PD-1 blockade to improve the overall tumor response rate Fast Track designation granted by the FDA
Sarepta Therapeutics SRP-9001 (AAVrh74.MHCK7.micro-dystrophin) Duchenne Muscular Dystrophy Fast Track designation granted by the FDA
Inovio INO-3107 recurrent respiratory papillomatosis Orphan Drug designation granted by the FDA
Merus N.V. Zenocutuzumab pancreatic cancer Orphan Drug designation granted by the FDA
Ocugen OCU400 RHO mutation-associated retinal degeneration Orphan Drug designation granted by the FDA
Regulus Therapeutics RGLS4326 autosomal dominant polycystic kidney disease Orphan Drug designation granted by the FDA
Vita Therapeutics VTA-11 Duchenne Muscular Dystrophy Orphan Drug designation granted by the FDA
Merck MK-6482 patients with von Hippel-Lindau disease-associated renal cell carcinoma with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required Orphan Drug designation and Breakthrough Therapy Drug designation granted by the FDA
Takeda pevonedistat patients with higher-risk myelodysplastic syndromes Breakthrough Therapy Drug designation granted by the FDA
AstraZeneca Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) chronic obstructive pulmonary disease approved by the FDA
Kite Pharma/Gilead Sciences Tecartus (brexucabtagene autoleucel) relapsed or refractory mantle cell lymphoma approved by the FDA
Stratus Medical Vesta RF Cannula radiofrequency heat lesion procedures for the relief of pain approved by the FDA

 

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