Target $42
Monday, February 13, 2023
AstraZeneca Spin-off Aristea Folds After Safety Issues End Lead Program
Due to safety concerns, Aristea Therapeutics announced Friday it is discontinuing the development of its Phase II lead program RIST4721. As a result, the San Diego-based biotech is also dissolving its business.
After careful and extensive consideration and “exploring a range of strategic alternatives,” Aristea’s board decided that ending the company and its operations was a sound business decision, said James Mackay, Ph.D., president and CEO, Aristea, in a statement.
Aristea launched in December 2018 as an AstraZeneca spin-out. The company dove into the biopharma space with $15 million in Series A backing to rehome molecules to develop novel treatments against severe inflammatory conditions.
“Our aim here is to take molecules that have been discarded by big pharma for a variety of reasons, or from other biotechs who have taken them through preclinical development but are not equipped to take them into clinical,” Mackay told BioSpace in a January 2022 interview.
Novo Holdings, the private limited liability company under the Novo Nordisk group, backed the startup.
Aristea gained exclusive global rights to RIST4721, its lead asset, from AstraZeneca. The candidate is an antagonist of the CXCR2 protein and was set to enter Phase II assessments in palmoplantar pustulosis when the company launched. The company completed enrollment into this study in October 2019.
Palmoplantar pustulosis is a recurrent inflammatory disorder characterized by flares of neutrophil-filled pustules on the palms and feet, causing pain, itching and burning sensations at these sites. RIST4721 intended to treat this condition by suppressing CXCR2, which is chiefly responsible for recruiting neutrophils at the site of inflammation.
In July 2021, RIST4721’s potential attracted $63 million in Series B financing, which helped Aristea further advance the candidate through the clinic, build its leadership team and form new strategic partnerships. The Series B was again led by Novo Holdings, with new investors Arena Pharmaceuticals and Tekla Capital Management joining.
Concurrent with the funding round, Aristea entered into a strategic collaboration with Arena Pharmaceuticals, a Pfizer unit, giving the latter the exclusive option to acquire Aristea and all its CXCR2 programs post-Phase II in exchange for $60 million upfront and $10 million in equity investments.
However, in Friday’s announcement, Aristea revealed that safety concerns had snuffed out RIST4721’s promise. In an email to BioSpace, a company representative said they did not have additional information to provide regarding the safety concerns.
By the time Aristea folded, RIST4721 was also being trialed for hidradenitis suppurativa, familial Mediterranean fever and Behcet’s disease. The company also developed RIST5122 and RIST8309, both CXCR2 antagonists, for undisclosed indications.
G1 Therapeutics Shelves Pivotal Colorectal Trial, After Therapy Favored Placebo Arm
G1 Therapeutics Inc (NASDAQ: GTHX) announced topline results from its pivotal Phase 3 PRESERVE 1 trial in patients with metastatic colorectal cancer.
PRESERVE 1 was designed to evaluate the efficacy and safety of trilaciclib in addition to triplet therapy with FOLFOXIRI + bevacizumab.
The trial achieved its co-primary endpoints related to severe neutropenia, showing clinically meaningful and statistically significant reductions in occurrences of severe neutropenia during induction (placebo=20% vs. trilaciclib=1%) and mean duration of severe neutropenia in Cycles 1 through 4 (1.3 days vs. 0.1 days).
In addition, patients receiving trilaciclib had a clinically meaningful reduction in the rate of chemotherapy-induced diarrhea compared to placebo.
Further, patients receiving trilaciclib experienced fewer chemotherapy dose reductions and delays.
Other secondary measures of myeloprotection also favored trilaciclib, including reductions in Febrile Neutropenia (placebo=5% vs. trilaciclib=0%) and ESA administration (7% vs. 3%).
However, early anti-tumor efficacy data favored the placebo arm versus trilaciclib, including overall response rate (ORR) and preliminary survival measures (61% and 50% ORRs, respectively).
Given the differential in these anti-tumor efficacy metrics and the low likelihood of achieving the progression-free survival (PFS) and overall survival (OS) endpoints, the company will discontinue the colorectal (CRC) trial.
Other clinical trials of trilaciclib in combination with different chemotherapies in patients with extensive-stage small-cell lung cancer and triple-negative breast cancer did not demonstrate this adverse survival signal.
Frequency Misses Primary Endpoint in Sensorineural Hearing Loss Trial
FX-322-208 Study Fails to Meet Primary Endpoint, Showing No Significant Separation in Speech Perception Between FX-322 and Placebo
Company Will Now Focus on Advancing its Program in Remyelination for Multiple Sclerosis (MS)
Announces Corporate Restructuring and Will Also Explore Strategic Financing Alternatives; Net of Debt, has Cash and Marketable Securities of $68.9mm as of December 31, 2022
https://finance.yahoo.com/news/frequency-therapeutics-announces-topline-results-130500334.html
Clene Reports New Data from MS Phase 2 Study
MRI results reinforce the clinical neurological improvements previously reported
MRI results showed improved brain neuronal structural integrity, independent of an immunomodulatory effect
MRI results consistently favor CNM-Au8 improvement of neuronal integrity and myelin improvement, showing decreased brain deterioration
The brain improvements in stable MS patients on background therapy are unprecedented
Axsome's stock falls after disclosing Teva's plans to market generic Auvelity
Shares of Axsome Therapeutics Inc. (AXSM) tumbled about 10.0% in premarket trading on Monday after the company said in a securities filing that Teva Pharmaceutical Industries Ltd. (TEVA.TV) is seeking approval from the Food and Drug Administration to market a generic version of Auvelity, Axsome's depression treatment. Axsome's stock has gained 95.8% over the past year, while the S&P 500 declined 7.6%.
Insulet Acquires Insulin Pump Patents from Bigfoot Biomedical
Insulet Corporation (NASDAQ: PODD) (Insulet), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, and Bigfoot Biomedical (Bigfoot), a leader in developing intelligent connected injection support systems, today announced Insulet has acquired assets related to Bigfoot’s pump-based automated insulin delivery (AID) technologies. Insulet paid $25M for the acquisition, which includes certain Bigfoot patents related to pumps that may be used for AID therapy.
The transaction further strengthens Insulet’s intellectual property (IP) portfolio and provides Bigfoot with additional capital to expand its Bigfoot Unity® Diabetes Management System to more people in need of connected insulin injection support technologies. The transaction also includes fully paid-up licenses between the parties in their respective business fields with respect to the acquired patents and other Bigfoot patents.
https://finance.yahoo.com/news/insulet-acquires-insulin-pump-patents-110000623.html
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