The Daily Biotech Pulse: Merck, AstraZeneca, Novartis Among Early Presenters At ASCO, Sanofi Strikes Breast Cancer Study Pact

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 June 3)

BioCryst Pharmaceuticals, Inc. BCRX (announced the launch of its hereditary angioedema treatment Orladeyo in Germany)
BioNTech SE BNTX
Kindred Biosciences, Inc. KIN(moved on positive results for pivotal efficacy study of KIND-030 in dogs infected by parvovirus)
Misonix, Inc. MSON
Moderna, Inc. MRNA
Paratek Pharmaceuticals, Inc. PRTK

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 3)

Allogene Therapeutics, Inc. ALLO
Cellectis S.A. CLLS
Day One Biopharmaceuticals, Inc. DAWN (IPOed March 27)
Galecto, Inc. GLTO
Impel NeuroPharma, Inc. IMPL
Ionis Pharmaceuticals, Inc. IONS
Neoleukin Therapeutics, Inc. NLTX
Progenity, Inc. PROG
Sigilon Therapeutics, Inc. SGTX
Spruce Biosciences, Inc. SPRB
Universe Pharmaceuticals INC UPC
Vivos Therapeutics, Inc. VVOS

Stocks In Focus

The American Society For Clinical Oncology meeting gets underway, with companies either presenting at the conference or releasing data ahead of presentations scheduled over the next few days taking the spotlight.

Coherus and Partner Junshi Report Positive Late-stage Data For Toripalimab-chemo Combo In Nasopharyngeal Cancer

Coherus BioSciences, Inc. CHRS and Shanghai Junshi Biosciences announced positive results from the pivotal Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

The interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival compared to chemotherapy alone. The study also met secondary endpoints of PFS assessed by the investigator and objective response rate.

There was also a longer duration of response, a higher disease control rate and higher one- and two-year survival rates for the toripalimab arm. The safety profile of toripalimab was consistent with that observed in previously reported toripalimab clinical trials.

Coherus shares were up 9.13% to $14.23 in after-hours trading.

Bristol-Myers Squibb Announces Positive Phase 3 Results For Opdivo-combo Treatments In Esophageal Cancer

Bristol-Myers Squibb Co. BMY announced results from the Phase 3 CheckMate -648 trial, in which two Opdivo-based treatment combinations demonstrated a statistically significant and clinically meaningful overall survival benefit compared to chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, with tumor cell PD-L1 expression of one percentage or more, as well as in the all-randomized population.

Opdivo plus Yervoy is the first dual immunotherapy combination to demonstrate a superior survival benefit versus chemotherapy in this setting.

AstraZeneca-Merck's Lynparza Aces Late-stage Breast Cancer Study

AstraZeneca PLC AZN and Merck & Co., Inc. MRK announced the first presentation of data from the Phase 3 OlympiA trial, in which Lynparza demonstrated a statistically significant improvement in its primary endpoint of invasive disease-free survival versus placebo in the adjuvant treatment of patients with germline BRCA1/2 mutations and high-risk human epidermal growth factor receptor 2-negative early breast cancer following definitive local treatment and neoadjuvant or adjuvant chemotherapy.

Separately, Merck announced first-time results from the pivotal Phase 3 KEYNOTE-564 trial evaluating Keytruda for the potential adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

After a median follow-up of 24.1 months, Keytruda demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo. Additionally, a favorable trend in overall survival was observed with a 46% reduction in the risk of death.

AstraZeneca shares rose 1.24% to $56.95 in after-hours trading.

Novartis Announces Positive Results For Late-stage Studies of Radioligand Therapies

Novartis AG NVS reported the final analysis from the NETTER-1 Phase 3 study comparing treatment using targeted radioligand therapy Lutathera.

In the final analysis of overall survival, a secondary objective of the trial, treatment with Lutathera resulted in a clinically relevant prolongation in median overall survival of 11.7 months compared to the control arm.

While this analysis did not reach statistical significance the analyses of overall survival may have been impacted by multiple factors, including the crossover of patients from the control arm receiving subsequent radioligand therapy as well as heterogenous subsequent anti-cancer treatments in both study arms, the company said.

Separately, the company announced that results of the Phase 3 VISION study evaluating Lu-PSMA-617, a targeted radioligand therapy, plus best standard of care, demonstrated significant improvement in overall survival compared to standard of care, or SoC alone, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer.

Nanobiotix Announces Positive Phase 1 Data for Its Radio-enhancer Combo Therapy In Advanced Cancers

Nanobiotix S.A. NBTX announced updated data from the Phase 1 study of its NBTXR3 activated by radiotherapy for patients with advanced cancers treated with an anti-PD-1 therapy, showing NBTXR3 administration by intratumoral injection was feasible and well-tolerated.

As of the data cut-off, 16 patients in the study received NBTXR3 plus radiotherapy and 13 were evaluable for response. Tumor regression was observed in 76.9% of evaluable patients, regardless of prior anti-PD-1 exposure.

The stock rose 13.13% to $18.50 in after-hours trading.

Regeneron Gets The Nod For Half The Dose of COVID-19 Antibody Treatment Authorized Previously

Regeneron Pharmaceuticals, Inc. REGN said the FDA updated the emergency use authorization for REGEN-COV, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose originally authorized. As part of the updated EUA, REGEN-COV should be administered by intravenous infusion.

Sanofi Partners With Research Groups to Study Its Amcenestrant In Breast Cancer

Sanofi SNY said it is partnering with leading groups delivering practice-changing breast cancer research to initiate a pivotal trial of an oral selective estrogen receptor degrader in the adjuvant setting.

The Phase 3 AMEERA-6 study will evaluate the efficacy and safety of Sanofi's amcenestrant vs tamoxifen for women with estrogen receptor-positive breast cancer who were unable to continue their adjuvant aromatase inhibitor therapy.

Ortho Regenerative's Phase 1/2 Study of Drug-biologic Combo as Adjunctive Therapy For Rotator Cuff Tear Repair Placed On Hold

Ortho Regenerative Technologies, Inc. ORTIF said it has received a clinical hold letter from the FDA related to its investigational new drug application to begin a phase 1/2 clinical trial for ORTHO-R, its drug/biologic combination product candidate used as an adjunct to standard of care surgery in rotator cuff tear repair.

The FDA has requested additional chemistry, manufacturing, and control related information. The company said it is confident in its ability to address and provide the FDA with the required information and testing data over the coming four to six weeks.

On The Radar

Clinical Readouts/Presentation

Click here to access information on some key data presentations at the ASCO.

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