CTIM-76 Phase 1 clinical trial to focus on CLDN6-positive gynecologic and testicular cancers
Company expects to enroll first patient in mid-2024
Thursday, May 2, 2024
Allarity Stenoparib Clinical Benefit, Milestone with Early Conclusion of Ovarian Cancer Phase 2
Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced the early discontinuation of its Phase 2 clinical trial of stenoparib, a novel PARP inhibitor, for the treatment of advanced recurrent ovarian cancer. The patients enrolled in the trial had been pre-screened by Allarity’s unique Drug Response predictor (DRP®) companion diagnostic (CDx) in order to treat only patients with the highest likelihood of deriving clinical benefit.
The trial, evaluating stenoparib given twice daily, has shown clear clinical benefit, including tumor shrinkage and long-term disease stability, in heavily pre-treated ovarian cancer patients who otherwise have limited life expectancy. These results have provided sufficient clinical proof of concept for stenoparib as monotherapy, prompting Allarity to halt further enrollment in this trial to enable and accelerate the development of a follow-on trial with FDA regulatory intent.
"Based on the substantial clinical benefit observed in the early stages of the trial, we have achieved proof of concept results that surpassed our initial expectations and provided the critical insights we were seeking," stated Thomas Jensen, CEO of Allarity Therapeutics. "Concluding the trial now is the most effective way to re-allocate our financial resources to develop a follow-on trial with the fastest route to regulatory submission for stenoparib. The patients enrolled in this trial are heavily pretreated, having undergone multiple prior treatments, often including PARP inhibitors. It is highly noteworthy that stenoparib, used in patients selected with the DRP® CDx, has delivered sustained clinical benefit for such very heavily pre-treated patients in the trial.”
This Company’s decision will not affect the ongoing treatment of current patients, as described in greater detail in Allarity’s March 27, 2024, press release.
Why Is Emergent BioSolutions (EBS) Stock Up
Emergent BioSolutions (NYSE:EBS) stock is taking off on Thursday after surprising investors with strong first quarter 2024 earnings results.
The life sciences company reported adjusted earnings per share of 59 cents for the quarter. That’s a massive beat compared to Wall Street’s estimate of -86 cents per share. It’s also a major improvement over the -$3.26 reported in the same period of the year prior.
Adding to that success is Emergent BioSolutions’ revenue of $300.4 million. Yet again, that blows past analysts’ estimate of $220.25 million for the quarter. It’s also an 83% increase year-over-year from $164.3 million.
Emergent BioSolutions’ outlook for Q2 2024 gives investors some ideas of what to expect from the company. This has it predicting revenue ranging from $160 million to $210 million. For comparison, Wall Street’s Q1 revenue estimate is sitting at $244.5 million.
Emergent BioSolutions also increased its 2024 revenue guidance to between $1 billion and $1.1 billion. Before this, that range was $900 million to $1.1 billion. Wall Street is looking for $1.02 billion in 2024.
https://investorplace.com/2024/05/why-is-emergent-biosolutions-ebs-stock-up-57-today/
Elevation Oncology Results, Recent Business Achievements
Enrollment ongoing in Phase 1 clinical trial of EO-3021 in the U.S. and Japan; expect to announce initial safety and efficacy data by mid-3Q 2024, with additional data in 1H 2025 --
-- Presented preclinical proof-of-concept data for HER3-ADC program at AACR Annual Meeting; on-track to nominate development candidate in 2H 2024 --
-- Raised $44.2 million year-to-date through ATM facility, extending cash runway into 2026 --
BridgeBio spinout launches with $200M for KRAS cancer drugs
A group of well-known biotechnology investors is putting $200 million into a newly launched spinout of BridgeBio Pharma developing drugs that target two common cancer genes.
BridgeBio Oncology Therapeutics, which was previously organized as a BridgeBio subsidiary called TheRas, will advance three drug candidates. Two aim at cancers driven to growth by mutations in a gene called KRAS, while the other blocks signaling between two proteins often involved in tumor development.
Comorant Asset Management led the financing, along with Omega Funds. Nine other venture firms participated, including Deerfield Management and GV.
Up until not that long ago, BridgeBio Oncology Therapeutics would have had a more difficult pitch to investors.
Cancer drug researchers for decades had sought to pin down the oncogene KRAS, errors in which were identified as common catalysts for tumors of the lungs, colon and pancreas. Their efforts were universally unsuccessful, earning KRAS a reputation as “undruggable.”
A 2013 paper by scientists at the University of California, San Francisco, helped crack the code, suggesting how to target with drugs a “pocket” on a certain kind of mutated KRAS protein. Their work led to a new wave of drug development, one which eventually produced Amgen’s Lumakras, approved in the U.S. in 2021, and Mirati Therapeutics’ Krazati, cleared the following year.
With those drugs available, BridgeBio Oncology Therapeutics doesn’t need to convince anyone that drugging KRAS is possible. Instead, its pitch centers on how to build a better KRAS drug.
Its most advanced candidate is designed, like Lumakras and Krazati, to bind to a type of mutated KRAS protein to shut down the growth signals that swell tumors. Unlike Lumakras and Krazati, the candidate, dubbed BB-8520, can bind to the protein in its active state, as well as when its inactive. (Lumakras and Krazati binding to inactive KRAS prevents the protein from cycling back on.)
“We actually inhibit the protein that signals, the active protein,” said Eli Wallace, BridgeBio Oncology Therapeutics’ CEO. “Really what’s driving the tumor is that on stage.”
Wallace noted, too, how the most common resistance mechanisms to the current KRAS inhibitors involve increased time in the active stage.
BB-8520 is already in clinical testing, with a Phase 1 study of people with lung cancer underway this month.
It has company, however. Frontier Medicines recently raised $80 million to fund, in part, development of a drug that also targets the on and off states of the KRAS protein.
Arbutus results, update
End-of-treatment data from two Phase 2a combination clinical trials with imdusiran to be presented at the EASL Congress in June 2024
Preliminary data from the single-dose portion of the AB-101-001 clinical trial show that AB-101 was generally well-tolerated and bound to the receptor target in healthy subjects
Court provides claim construction ruling in ongoing patent infringement lawsuit against Moderna; Court date scheduled for April 21, 2025
Strong financial position – expected cash runway extended through the second quarter of 2026
Conference Call and Webcast Today at 8:45 AM ET
Arbutus will hold a conference call and webcast today, Thursday, May 2, 2024, at 8:45 AM Eastern Time to provide a corporate update. To dial-in for the conference call by phone, please register using the following link: Registration Link. A live webcast of the conference call can be accessed through the Investors section of Arbutus' website at www.arbutusbio.com.
An archived webcast will be available on the Arbutus website after the event.
Astellas In 2nd CAR-T Agreement with Poseida to Develop ‘Convertible’ Cancer Therapies
Astellas Pharma on Wednesday entered into a collaboration and license agreement with Poseida Therapeutics to develop novel CAR-T therapies for solid tumors.
Under the deal, Astellas will pay an upfront fee of $50 million and has pledged up to $550 million in potential development, sales and other contingent payments. Poseida will also be eligible for up to low-double digit tiered royalties on net sales. Astellas will conduct the transaction through its subsidiary Xyphos Biosciences.
The collaboration is designed to combine “the innovative cell therapy platforms from each of the companies,” according to Wednesday’s announcement.
Poseida will contribute its proprietary allogeneic CAR-T platform, while Xyphos will lend both its ACCEL and convertibleCAR technologies. The partnership’s goal is to produce one CAR-T construct, which in turn will yield two convertibleCAR product candidates for solid tumors.
Xyphos will reimburse Poseida for costs under the agreement and will take charge of R&D activities and future commercialization of products that may arise from the partnership, according to the companies.
Designed to be a flexible cell therapy, Xyphos’ convertibleCAR technology makes use of a modified NKG2D protein, a natural human receptor that is commonly found on natural killer cells and some T-cells, and functions to facilitate immune surveillance.
According to the biotech’s website, the modifications to NKG2D allow the convertibleCAR construct to be controlled and activated with engineered molecules, such as bispecific antibodies, that can recognize binding sites on tumor cells. This approach brings tumor cells close to immune cells that have been activated to attack and destroy them.
In addition, attaching different functional moieties to the convertibleCAR construct allows them to target different antigens, which could help therapies target tumor cells that have changed to avoid detection by the immune system.
Adam Pearson, chief strategy officer at Astellas, in a statement said that the Poseida partnership “will bring synergies between the two companies’ breakthrough research and will ultimately lead to the expansion of Astellas’ portfolio and to the delivery of innovative CAR-T cell therapies to cancer patients.”
Wednesday’s announcement follows a previous agreement between the two companies, inked in August 2023, to support Poseida’s work in cancer cell therapeutics. Astellas at the time invested $50 million in Poseida, half of which was used to acquire 8.8% of Poseida’s shares, while the other half bought the right of exclusive negotiation and first refusal to license the clinical-stage CAR-T program P-MUC1C-ALLO1 for solid tumors.
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