BPC October 07 update

Allogene ALLO -41% AH clinical hold; Merus MRUS +37% Phase 1 data

Price and Volume Movers

Allogene Therapeutics, Inc. (NASDAQ: ALLO) announced that a chromosomal abnormality in ALLO-501A CAR T cells has been reported in a patient in its Phase 1 ALPHA2 study to treat large B-cell lymphoma. The FDA has placed a hold on Allogene’s AlloCAR T clinical trials. Shares are trading down 41% at $14.40 during after-hours.

ALLO-501 is developed under a joint collaboration between Servier and Allogene and is exclusively licensed from Cellectis SA (NASDAQ: CLLS). Cellectis shares are trading down 19% at $9.75 during after-hours.

Merus N.V. (NASDAQ: MRUS) released data from its Phase 1 trial of MCLA-158 to treat solid tumors. Three of seven patients achieved partial responses (PR), and one achieved a complete response (CR). Tumor reduction was observed in all seven patients. Shares closed up 37% at $27.49.

Osmotica Pharmaceuticals plc (NASDAQ: OSMT) announced the pricing of its public offering at $2.50 per share with an accompanying warrant. The gross proceeds are to be $35 million. Osmotica also entered into a note purchase agreement for up to $100 million. Shares closed down 38% at $1.91.

Prelude Therapeutics Inc. (NASDAQ: PRLD) released data from its Phase 1 trials of PRT543 and PRT811 to treat tumors. PRT543 data noted one CR and stable disease (SD) in five patients. PRT811 data displayed one CR, one SD, and one PR. Shares closed down 40% at $17.34.

Advancers

CompanyPriceChange
PROG
Progenity Inc.
$3.00+0.51  +20.20%
CNTX
Context Therapeutics Inc.
$6.97+0.8  +12.97%
ATHA
Athira Pharma Inc.
$10.71+1.08  +11.25%
AUPH
Aurinia Pharmaceuticals Inc
$24.44+2.35  +10.64%
CMPS
COMPASS Pathways Plc
$38.67+3.36  +9.52%
EYEN
Eyenovia Inc.
$6.50+0.53  +8.88%
PTPI
Petros Pharmaceuticals Inc.
$1.85+0.15  +8.82%
KALA
Kala Pharmaceuticals Inc.
$2.06+0.16  +8.42%
RPTX
Repare Therapeutics Inc.
$24.50+1.74  +7.64%
MRTX
Mirati Therapeutics Inc.
$190.25+12.95  +7.30%

Decliners

CompanyPriceChange
MTCR
Metacrine Inc.
$1.66-2.17  -56.79%
OCUL
Ocular Therapeutix Inc.
$6.89-3.94  -36.38%
AGEN
Agenus Inc.
$3.98-1.15  -22.42%
SIOX
Sio Gene Therapies Inc.
$2.03-0.33  -13.85%
APLT
Applied Therapeutics Inc.
$13.64-2.05  -13.07%
GRCL
Gracell Biotechnologies Inc.
$10.29-1.43  -12.20%
PSTI
Pluristem Therapeutics Inc.
$2.68-0.31  -10.37%
STAB
Statera Biopharma Inc.
$3.48-0.39  -10.08%
JANX
Janux Therapeutics Inc.
$22.52-2.5  -9.99%
TPST
Tempest Therapeutics Inc.
$12.21-1.35  -9.96%

Pipeline Database Updates

Drug Price Stage Catalyst Market Cap

ABBV – AbbVie Inc.
RINVOQ (upadacitinib) - SELECT-AXIS 2
Non-radiographic axial spondyloarthritis

$109.07
+0.31  +0%
Phase 3 Phase 3 study met primary endpoint, and 12 of 14 secondary endpoints. The proportion of patients with adverse events leading to discontinuation, serious adverse events and serious infections were 2.6 percent/2.6 percent/1.3 percent for upadacitinib, respectively, noted October 7, 2021.
$192.7 billion

BBI – Brickell Biotech, Inc.
Sofpironium Bromide (Cardigan)
Axillary hyperhidrosis

$0.52
-0.03  -6%
NDA Filing NDA to be submitted by mid-2022. Phase 3 study demonstrated that dosing was generally well-tolerated, the proportion of subjects achieving at least a 2-point improvement in the HDSM-Ax1 score from baseline to EOT2 was 49.3% (n=173). Additionally the change in GSP3 from baseline to EOT was -129.5mg. Overall, 82% of patients who were randomized to the dose in the study completed the full six weeks of treatment. Five (2.9%) subjects who received the dose discontinued due to a TEAE. No treatment-related Serious Adverse Events (SAEs) were reported. Noted October 7, 2021.
$44.5 million

BCYC – Bicycle Therapeutics plc
BT5528 and OPDIVO (nivolumab)
Solid tumors

$54.46
-1.84  -3%
Phase 1/2 Phase 1 interim results from Phase 1/2 trial demonstrated anti-tumor activity observed in late line patients, with 2 partial responses out of 2 urothelial cancer patients dosed and an 80% disease control rate in ovarian cancer patients, including 1 partial response. A recommended BT5528 Phase 2 dose (RP2D) range has been established at 6.5-8.5mg/m2 every other week, a dose that is believed to be within the therapeutic range based on both preclinical studies and preliminary clinical anti-tumor activity. - noted October 7, 2021. Expansion cohorts expected to initiate in 2022.
$1.6 billion

BMY – Bristol-Myers Squibb Company
Deucravacitinib - LATTICE-UC
Ulcerative Colitis

$57.60
-0.21  0%
Phase 2 Phase 2 trial did not meet primary or secondary endpoints, October 7, 2021.
$128 billion

CLLS – Cellectis S.A.
ALLO-501A (ALPHA2)
Large B-cell lymphoma

$10.75
-0.48  -4%
Phase 1 Phase 1 data at ASCO June 4, 2021 noted overall response rate 56% (5/9). Pivotal trial to be initiated late-2021. Clinical hold placed October 7, 2021.
$488.7 million

CLVS – Clovis Oncology Inc.
FAP-2286 (LuMIERE)
FAP-positive tumors

$4.30
-0.07  -2%
Phase 1/2 Phase 1 initial data readout due in 2022. Phase 1/2 clinical trial now enrolling patients with FAP-positive solid tumors - noted October 7, 2021. Phase 2 expansion cohorts to commence in 2022.
$509.8 million

MRUS – Merus N.V.
MCLA-158
Solid Tumors

$28.36
-0.24  -1%
Phase 1 Phase 1 expansion cohort in NHSCC noted three of seven patients achieved PR, with one achieving CR. Tumor reduction was observed in all seven patients. The most frequent adverse events (AEs) were infusion related reactions; 72% any grade, 7% grade ≥ 3, noted October 7, 2021. Next Phase 1 update due in 2022.
$1.1 billion

ORIC – Oric Pharmaceuticals Inc.
ORIC-101 and XTANDI (Enzalutamide)
Prostate cancer

$15.03
-0.08  -1%
Phase 1b Phase 1b initial results showed that the dose was well tolerated, with no substantial added toxicity. PK showed no evidence of drug-drug interaction. Within the key patient population (8), 75% of patients' tumors expressed moderate to high GR and 25% of patients' tumors expressed low GR, noted October 7, 2021.
$590.9 million

PRLD – Prelude Therapeutics Incorporated
PRT543
Solid tumors

$17.45
-1.49  -8%
Phase 1 Phase 1 interim data displayed a durable CR maintained for over 18 months in a patient with HRD+ ovarian cancer and prolonged SD persisting for over six months in five patients. The most common grade 3 or higher treatment-related adverse events (AE) occurring in at least 5% of patients were thrombocytopenia (27%) and anemia (12%), both of which were reversible upon treatment interruption, noted October 7, 2021. Phase 1 data from expansion cohorts due in 2022.
$821.5 million

SCYX – SCYNEXIS Inc.
BREXAFEMME (ibrexafungerp) - oral (FURI)
Invasive candidiasis

$5.18
-0.27  -5%
Phase 3 Phase 3 analysis March 2, 2021 - 46/64 patients recorded an overall response. Phase 3 interim data noted 46 (62.1%) patients showed CR or PR, 18 (24.3%) achieved SD, and 5 (6.8%) showed PD. One patient died due to an unrelated cause. In Oropharyngeal and Esophageal Candidiasis of 24 patients, 62.5% showed CR or PR, 29.2% achieved SD and 16.7% showed PD. In Bone and Joint Candidiasis of 8 patients 62.5% showed CR or PR, 12.5% achieved SD and 12.5% showed PD, noted September 29, 2021. Phase 3 interim data presented at TIMM October 9-10, 2021.
$120.3 million

SCYX – SCYNEXIS Inc.
SCY-078 - oral - CARES
Candida Auris

$5.18
-0.27  -5%
Phase 3 Phase 3 interim analyses noted 8/10 complete responses - March 2, 2021. Phase 3 interim data presented at TIMM October 9, 2021.
$120.3 million

TMBR – Timber Pharmaceuticals Inc.
TMB-001 (CONTROL)
Congenital Ichthyosis

$0.70
-0.05  -6%
Phase 2b Phase 2b data noted that in the PP population, 100% and 40% of patients treated with 0.05% and 0.1% doses, respectively, achieved VIIS-50 compared to 40% in vehicle group. Similarly in the ITT population, 64% and 40% of patients achieved VIIS-50 compared to 33%. In PP population, 100% and 60% of patients achieved a ≥2 point improvement in the IGA at week 12 compared to 10%. In the ITT population, 55% and 40% of patients achieved a ≥2 point improvement in the IGA at week 12 compared to 8%, noted October 7, 2021. Phase 3 trial to begin in 2Q 2022.
$25.5 million

TPTX – Turning Point Therapeutics Inc.
Repotrectinib (TPX-0005) - TRIDENT-1
Non-small-cell lung cancer (NSCLC) and solid tumors

$43.01
-1.23  -3%
Phase 1/2 Phase 2 updated data from the Phase 1/2 trial noted in the population treated with one prior TKI and prior platinum-based chemotherapy the cORR was 39%. In populations with two prior TKIs without prior chemotherapy cORR was 30%. In populations with one prior TKI without prior chemotherapy the cORR was 38%. Dose modifications due to TEAEs included 27% of patients who had dose reduction and 11% who had drug discontinuation, noted October 7, 2021. Phase 2 date noted a confirmed ORR of 48% in patients with NTRK+ TKI-pretreated advanced solid tumors, 62% in NTRK+ TKI-pretreated advanced solid tumor patients with solvent front mutations and 41% in patients with NTRK+ TKI-naive advanced solid tumors, noted October 8, 2021. Breakthrough Therapy Designation announced October 4, 2021.
$2.1 billion