The Daily Biotech Pulse: Lilly Sings Metabolic Disorder Drug Pact, Moderna Reports Positive Flu Vaccine Data, Halozyme To Buy Back Shares

Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

Angion Biomedica's ANG-3777 Does Not Meet Primary Endpoint In Mid-Stage Study In Cardiac Surgery Patients At Risk Of Developing Kidney Injury

Angion Biomedica Corp. ANGN and Vifor Pharma announced results from the exploratory Phase 2 GUARD trial of Angion's ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury.

The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve. However, Angion and Vifor Pharma continue to review the data, based on the signal demonstrated in the clinically-relevant MAKE90 secondary endpoint.

Angion shares were sliding 2.78% to $3.39 in premarket trading.

OncoCyte Presents Data Supporting DetermaIO Test As A Pan-Cancer Diagnostic Test

OncoCyte Corporation OCX announced results showing the ability of its DetermaIO test, a commercially-available precision diagnostic designed to determine the likelihood of response to immunotherapies.

Data supported the use of DetermaIO as a pan-cancer diagnostic tool, now addressing an unmet need for patients with triple negative breast cancer, the most aggressive type of breast cancer. DetermaIO was also shown to work across multiple platforms, including PCR and NGS, with the potential to be used for pan-cancer diagnostic testing worldwide.

The stock was up 10.28% at $2.65 in premarket trading.

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SpringWorks Strikes A Blood Cancer Drug Collaboration With AbbVie

SpringWorks Therapeutics, Inc. SWTX announced that it has entered into a clinical trial collaboration agreement with AbbVie, Inc. ABBV to evaluate nirogacestat, its investigational gamma secretase inhibitor, in combination with ABBV-383 in patients with relapsed or refractory multiple myeloma.

Under the terms of the agreement, AbbVie will sponsor and conduct the Phase 1b study to evaluate the combination in patients with relapsed or refractory multiple myeloma, and will assume all costs associated with the study, other than expenses related to the manufacturing of nirogacestat and certain expenses related to intellectual property rights.

AbbVie and SpringWorks will also form a joint steering committee to manage the clinical study, which is expected to commence in the first half of 2022.

BeiGene Announces Positive Data For Tisleilizumab-Chemo Combo In Nasopharyngeal Cancer

BeiGene, Ltd. BGNE announced positive results from the RATIONALE 309 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer.

"We are pleased that tislelizumab in combination with chemotherapy demonstrated a statistically significant progression-free survival benefit for patients with RM-NPC over chemotherapy," said Yong Ben, chief medical officer, Immuno-Oncology at BeiGene.

Moderna's Quadrivalent Flu Vaccine Aces Early-Stage Study

Moderna, Inc. MRNA announced the first positive interim data from the Phase 1 study of its quadrivalent seasonal flu vaccine candidate, mRNA-1010. In the study, mRNA-1010 successfully boosted hemagglutination inhibition assay geometric mean titers against all strains 29 days after vaccination at all doses tested in both younger and older adults.

The company also announced that the Phase 2 study of mRNA-1010 is now fully enrolled and preparation for the Phase 3 study is underway.

Lilly Announces R&D And Licensing Pact With Regor To Develop Metaboloc Disorder Therapies

Eli Lilly and Company LLY and Regor Therapeutics announced a multi-year research collaboration and licensing agreement to discover, develop and commercialize novel therapies for metabolic disorders.

Under the terms of the agreement, Lilly will have a license to select Regor intellectual property with an option to extend the license. Lilly will be responsible for clinical development, manufacturing and commercialization worldwide, except Greater China, where Regor will maintain these rights and responsibilities.

Regor will receive an upfront payment of up to $50 million, which partially includes an equity investment by Lilly in Regor, subject to the parties entering into standard equity agreements. The company is also eligible to receive up to $1.5 billion in potential payments based on the achievement of prespecified preclinical, clinical development and commercial milestones, as well as tiered royalties from low-single to low-double digits on sales resulting from the agreement.

Halozyme Announces $750M Worth of Stock Buyback Program

Halozyme Therapeutics, Inc. HALO announced that its board has approved a new share repurchase program effective immediately, which authorizes it to purchase up to $750 million of its outstanding common stock over the next three years. The company said it plans to enter into an accelerated share repurchase program transaction with a financial institution in the coming week, subject to market conditions.

The company plans to purchase up to $250 million worth of shares by the end of 2022, including the $150 million ASR, pending market conditions and other factors.

The stock was adding 4.05% to $33.11 in premarket trading.

Earnings

Applied DNA Sciences, Inc. APDN said its fiscal-year fourth-quarter revenues climbed from $314,000 in 2020 to $3 million in 2021, ahead of the $2.94-million consensus estimate. The net loss per share narrowed from 82 cents to 60 cents.

The stock was advancing 6.69% to $5.42 in premarket trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

On The Radar

Clinical Readouts

San Antonio Breast Cancer Symposium Presentations

Puma Biotechnology, Inc. PBYI: Phase 2 data for Neratinib + fulvestrant + trastuzumab for hormone receptor-positive, HER2-mutant metastatic breast cancer and neratinib + trastuzumab for triple-negative disease

Arvinas, Inc. ARVN & Pfizer, Inc. PFE: updated safety and efficacy data from the Phase 1 dose escalation trial of ARV-471 in ER+/HER2- locally advanced or metastatic breast cancer

Jaguar Health, Inc. JAGX & Roche Holding AG RHHBY: data on crofelemer from the investigator-initiated HALT-D trial in treating cancer-related diarrhea

77th Society Of Endometriosis And Uterine Disorders Congress Presentations

ObsEva SA OBSV: results from a Phase 2b dose-ranging trial of linzagolix in endometriosis and Phase 3 data for linzagolix in uterine fibroids

14th Asia-Pacific Vitreo-Retina Society (APVRS) Congress Presentation

Outlook Therapeutics, Inc. OTLK: safety and efficacy data from the Phase 3 pivotal NORSE TWO trial evaluating ONS-5010/ Lytenava, an investigational ophthalmic formulation of bevacizumab, for use in wet age-related macular degeneration