Here's a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs May 19)
- ESSA Pharma Inc. EPIX
- Vera Therapeutics, Inc. VERA
- Verastem, Inc. VSTM
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows May 19)
- Adverum Biotechnologies, Inc. ADVM
- Bellicum Pharmaceuticals, Inc. BLCM
- Coherus BioSciences, Inc. CHRS
- Foghorn Therapeutics Inc. FHTX
- IMV Inc. IMV
- Inhibikase Therapeutics, Inc. IKT
- Ionis Pharmaceuticals, Inc. IONS
- Iovance Biotherapeutics, Inc. IOVA (reacted to a delay in regulatory filing for cancer treatment, CEO departure)
- LogicBio Therapeutics, Inc. LOGC
- Lyra Therapeutics, Inc. LYRA
- Progenity, Inc. PROG
- Vivos Therapeutics, Inc. VVOS
- Yumanity Therapeutics, Inc. YMTX
Stocks In Focus
Allogene Reports Positive Phase 1 Results For CAR T Therapy In Non-Hodgkin's Lymphoma
Allogene Therapeutics, Inc. ALLO announced data from the Phase 1 ALPHA and ALPHA2 studies of ALLO-501 and ALLO-501A, respectively, in relapsed/refractory non-Hodgkin's lymphoma.
ALLO-501 in the ALPHA study produced durable complete responses, with the longest ongoing complete response at 15 months. The overall response rate was 75% and the complete response rate was 50% in CAR T naïve patients.
Interim Phase 1 ALPHA2 data demonstrated a comparable efficacy and safety profile for ALLO-501A relative to ALLO-501. The consolidation dose was well-tolerated and showed early promise, with four patients converting from partial response to CR following the second dose of ALLO-501 or ALLO-501A.
The company plans to initiate a pivotal trial of ALLO-501A in late 2021.
The stock gained 11.94% to $31.87 in after-hours trading.
Y-mabs Announces Deal To Distribute Antibody Therapies In Latin America
Y-mAbs Therapeutics, Inc. YMAB said it has entered into an exclusive distribution agreement with Adium Pharma to be its exclusive distributor in Latin America of the company's antibodies, Danyelza and omburtamab.
Danyelza has been approved for the treatment of patients with relapsed/refractory high-risk neuroblastoma. Omburtamab, is being evaluated for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.
Y-mabs shares moved up 10.01% to $36.91 in after-hours trading.
Lilly's Type 2 Diabetes Drug Found Superior To Insulin Glargine In SURPASS-4 Study
Eli Lilly and Company's LLY said its tirzepatide led to superior A1C and body weight reductions from baseline across all three doses in adults with type 2 diabetes who have increased cardiovascular risk compared to titrated insulin glargine. The findings were based on topline results from the company's SURPASS-4 clinical trial.
The company said the program has now met regulatory submission requirements for evaluating cardiovascular risk and that it intends to submit a registration package to regulatory authorities by the end of 2021.
The stock was down 0.51% at $195.50 in premarket trading Thursday.
Pfizer, BioNTech Agree To Supply Incremental 900M Doses of COVID-19 Vaccine To EU
Pfizer Inc. PFE and BioNTech SE BNTX announced a new agreement with the European Commission to supply 900 million doses of Comirnaty, their COVID-19 vaccine, to the European Union, with an option for the EC to request up to an additional 900 million doses.
This new agreement is in addition to the 600 million doses that have already been committed to the EU through 2021.
Separately, the companies said they have entered into an agreement with Turkey's Ministry of Health to supply 60 million additional doses of the companies' COVID-19 vaccine, with an option for an additional 30 million doses.
In premarket trading Thursday, BioNTech shares were down 1.54% at $196.02.
Voyager CEO, Chief Medical Officer To Depart
Voyager Therapeutics, Inc. VYGR announced the resignation of CEO Andre Turenne, effective in June, to pursue new opportunities. Board chairman Michael Higgins will assume the role of CEO on an interim basis.
The company also announced the resignation of Omar Khwaja from his role as chief medical officer and head of R&D, effective at the end of May. Glenn Pierce, a board director, will assume the role of interim chief scientific officer.
The company said Maria Lopez-Bresnahan, SVP of translational medicine and clinical development, will continue to lead its clinical development programs, including the Huntington's disease program.
Voyager also said it is focused on rapidly moving VY-HTT01 into clinical development for Huntington's disease and maximizing opportunities created by TRACER gene therapy technology platform and next-generation targeted AAV capsids.
The stock fell 2.96% to $4.26 in after-hours trading.
CorMedix Shares Gain On Insider Buying
CorMedix Inc. CRMD shares rose after a filing revealed that Myron Kaplan, a director of the company's board, bought 15,000 shares of the company at a price of $6.0318.
The stock rose 5.83% to $7.08 in after-hours trading.
Related Link: The Week Ahead In Biotech: Sanofi, Bristol-Myers Squibb Await FDA Decisions, Earnings News Flow Tapers Off
ASCO Abstracts
Several biopharma stocks moved on online publication of abstracts meant to be presented at the American Society of Clinical Oncology meeting, which is scheduled to be held virtually from June 4 to June 8.
Adaptimmune Therapeutics plc ADAP said initial data from SPEARHEAD-1 Phase 2 indicate that afami-cel has the potential to offer people with synovial sarcoma a promising new treatment option, with encouraging initial safety and durability data. At the time of data cut-off, the overall response rate was 39.3% and the disease control rate for people with synovial sarcoma was 86.2%.
The company said the data will support a biologic license application filing by next year.
The stock added 11.02% to $5.44 in after-hours trading.
Black Diamond Therapeutics, Inc. BDTX announced initial safety and efficacy results for BDTX-189 from the dose-escalation portion of the MasterKey-01 trial in solid tumors harboring certain mutations.
The results showed the preliminary recommended Phase 2 dose of 800mg QD of BDTX-189 elicited a confirmed partial response in one of the three evaluable EGFR Ex20ins NSCLC patients, with another exhibiting stable disease and stable disease in all three evaluable HER2 Ex20ins NSCLC patients.
BDTX-189 did not generate clinical responses in HER2 allosteric mutant tumors, but in six evaluable patients with HER2 amplified solid tumors, BDTX-189 generated two partial responses.
The company also noted that BDTX-189 demonstrated a favorable tolerability profile, with no dose-limiting toxicities at doses of ≤800 mg QD fasting and non-fasting in the dose-escalation cohorts.
The stock slumped 18.58% to $18.10 in after-hours trading.
Precision BioSciences, Inc. DTIL said additional data from its Phase 1/2a study of PBCAR0191, its off-the-shelf allogeneic CAR T candidate targeting CD19 in hematologic malignancies, showed that the investigational therapy continued to demonstrate an acceptable safety profile with no cases of graft versus host disease; no cases of Grade 3 and above cytokine release syndrome; and no cases of Grade 3 and above immune effector cell-associated neurotoxicity syndrome.
"These results continue to confirm the activity of PBCAR0191 with strategies that mitigate rejection," the company said.
In after-hours trading, the stock was up 4.48% at $9.79.
Oncternal Therapeutics, Inc. ONCT announced updated interim clinical data from the Phase 1/2 clinical trial evaluating TK216 patients with relapsed or refractory Ewing sarcoma.
Two heavily pre-treated and metastatic Ewing sarcoma patients treated at the recommended Phase 2 dose continue to demonstrate prolonged complete regression of Ewing sarcoma for greater than one and two years and have tolerated ongoing treatments well with TK216 alone or in combination with vincristine.
Separately, the company said updated Phase 1/2 clinical data with the combination of cirmtuzumab and ibrutinib remain in mantle cell lymphoma or chronic lymphocytic leukemia were very encouraging, including 83% best objective response rate and the durability of complete responses.
The stock rallied 13.13% to $6.29 in after-hours trading.
On The Radar
PDUFA Dates
The FDA will decide on the biologic license application submitted by Bristol-Myers Squibb Company BMY for Opdivo for the treatment of patients with surgically removed esophageal or gastroesophageal junction cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy.
Earnings
Precipio, Inc. PRPO (after the close)
Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates
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