Astex and Cardiff University Medicines Discovery Institute Announce New Drug Discovery Collaboration on Neurodegenerative Diseases

On February 13, 2023 Astex Pharmaceuticals (UK) ("Astex"), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system and The Medicines Discovery Institute, Cardiff University ("MDI") reported that they have entered into a multi-year, multimillion pound drug discovery research collaboration, aimed to identify new drugs to treat neurodegenerative diseases (Press release, Astex Pharmaceuticals, FEB 13, 2023, View Source [SID1234627097]).

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The collaboration brings together the world-leading research expertise of Dr Emyr Lloyd-Evans & Dr Helen Waller-Evans in lysosomal biology, the drug discovery capabilities of the MDI and the fragment-based drug discovery platform at Astex. The combined teams will focus on identifying compounds which modulate lysosomal activity as a way to develop potential new treatments for neurodegenerative diseases with high unmet medical need. Lysosomes are a subset of organelles that are crucial for cellular function and mutations in the genes encoding lysosomal and associated proteins are linked to a number of neurodegenerative and lysosomal storage diseases for which there are currently no effective treatments.

Under the terms of the agreement, scientists at the MDI and Astex will collaborate to carry out drug discovery research against a chosen lysosomal target with the aim to identify and optimise compounds that modulate its activity. Cardiff University will receive committed R&D funding and is eligible to receive development and regulatory payments if drug compounds progress and a royalty payment on the sales of any approved products. Further financial details are not disclosed.

Prof Simon Ward, Director, Medicines Discovery Institute commented "We are excited to be working with Astex in a way that allows each partner to play to its individual strengths and build a combined team which is greater than the sum of its parts. This is a validation of the scientific and translational capabilities we have been building at Cardiff University over the last few years and we look forward to delivering outputs that may ultimately benefit patients for whom current treatment options are so limited. This is an excellent demonstration of the power of academic and industrial teams working together to try to solve currently intractable medical problems."

Dr David Rees, FMedSci, FRSC, Chief Scientific Officer of Astex commented, "We are very excited about this opportunity to work with Cardiff University, Medicines Discovery Institute. Astex has a long tradition of effective collaborations between academia and industry which we believe is critical for the successful translation of basic science. This partnership aims to support and advance ground-breaking research with the potential to transform the lives of patients with neurodegenerative diseases."

Alligator Bioscience & Aptevo Therapeutics Announce Dosing of First Patient with ALG.APV-527 in Phase 1 Clinical Trial

On February 13, 2023 Alligator Bioscience AB ("Alligator") (Nasdaq Stockholm: ATORX) and Aptevo Therapeutics ("Aptevo") (Nasdaq: APVO) reported the dosing of the first patient in the companies’ Phase 1 trial evaluating ALG.APV-527 for the treatment of solid tumors expressing the tumor-associated antigen 5T4 (Press release, Alligator Bioscience, FEB 13, 2023, View Source [SID1234627096]). ALG.APV-527 is a bispecific antibody with a tumor-directed 4-1BB agonistic effect and the ability to specifically stimulate antitumor-specific T cells and NK cells involved in tumor control.

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"We are very pleased to announce the initiation of a clinical trial to evaluate ALG.APV-527 in patients with solid tumors with high prevalence of 5T4. For Aptevo, the initiation of a second clinical program means we are now developing therapeutics to treat both solid tumors and hematological malignancies – a strategic win for our company," said Marvin White, President, and CEO of Aptevo. "ALG.APV-527 is a compelling candidate, as preclinical studies showed it has the potential to activate key immune cell populations within the tumor microenvironment while demonstrating a favorable safety profile. We look forward to sharing preliminary results, which we anticipate will be available in 2023."

"The start of this Phase 1 first in human study is an important milestone in the development of ALG.APV-527 and demonstrates the growing strength and effectiveness of our partnership with Aptevo," said Søren Bregenholt, PhD, CEO of Alligator Bioscience. "It also marks Alligator’s third asset currently in clinical development and we are particularly excited to evaluate its tumor-directed 4-1BB function with its promise of a broad therapeutic window and, alike ATOR-1017, highly differentiated safety and efficacy profile compared to the first generation 4-1BB agonists."

The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label trial that will include six cohorts in a 3+3 design. The trial will be conducted at up to 10 sites in the U.S. among adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen, including (but not limited to) non-small cell lung cancer (NSCLC), gastric/gastro-esophageal cancer and head and neck cancer. ALG.APV-527 will be given intravenously once every two weeks. The trial will assess the safety and tolerability, pharmacokinetic, pharmacodynamic and preliminary anti-tumor activity of ALG.APV-527.

About ALG.APV-527

ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB has the ability to stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer.

Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, were recently published in the peer-reviewed publication, Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The full article is available via this link.

The information was submitted for publication, through the agency of the contact persons set out below at 2:05 p.m. CET on February 13, 2023.

IASO Bio Announces CT103A Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations by the FDA

On February 12, 2023 IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, reported that the U.S. Food and Drug Administration (FDA) has granted both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track (FT) designation to its investigational new drug BCMA CAR-T CT103A (Equecabtagene Autoleucel) for relapsed/refractory multiple myeloma (RRMM) (Press release, IASO Biotherapeutics, FEB 12, 2023, View Source [SID1234627086]).

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About CT103A

Equecabtagene autoleucel (CT103A) is a BCMA chimeric antigen receptor autologous T cell injection, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3ζ activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, and integrated in-house manufacturing process improvement, the construct of CT103A is potent and shows prolonged persistency in patients. The NMPA accepted the New Drug Application for equecabtagene autoleucel for the treatment of relapsed/refractory multiple myeloma (RRMM). Equecabtagene autoleucel also received Breakthrough Therapy Designation by the NMPA in February 2021 and Orphan Drug Designation (ODD) in February 2022 and IND approval in December 2022 by the U.S. FDA. In addition to multiple myeloma, the NMPA has approved IND application of equecabtagene autoleucel for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). IASO Bio and Innovent Biologics, Inc. (1801.HK) are jointly developing equecabtagene autoleucel for the treatment of RRMM in mainland China.

About RMAT Designation

Established under the 21st Century Cures Act, RMAT designation is intended to help the FDA facilitate an efficient development program of any drug that (1) qualifies as RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products; (2) is intended to treat, modify, reverse or cure a serious or life threatening disease or condition; and (3) has preliminary clinical evidence to indicated the drug has the potential to address unmet medical needs for such a disease or condition.

About FT Designation

Fast Track designation is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available, thus enabling drugs to potentially reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

OHSU researchers identify promising next-generation cancer treatment

On February 10, 2023 Oregon Health & Science University reported that the drugs known as PARP-1 inhibitors have emerged as an important but limited treatment option for certain cancers (Press release, Oregon Health & Science University, FEB 10, 2023, View Source [SID1234628486]). Now scientists at Oregon Health & Science University have uncovered a new class of PARP-1 inhibitors with unique and powerful anticancer properties that could make them more widely effective.

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"We think it’s going to open up therapeutic possibilities beyond what current PARP-1 inhibitors are used for," said Michael Cohen, Ph.D., associate professor of chemical physiology and biochemistry in the OHSU School of Medicine and senior author of a paper describing the discovery in Cell Chemical Biology. OHSU has exclusively optioned the potential cancer treatment to a startup company co-founded by Cohen.

Through intensive basic science, opening a new window on the workings of PARP-1 inhibitors and investigating even the smallest molecular differences between potential treatments, Cohen’s lab has discovered an exciting candidate for an anti-cancer drug — a molecule whose sticky properties make it toxic to cancer cells at very low doses. The discovery could improve both treatment for a variety of cancers, and quality of life for patients.

"This is something totally novel from what the existing compounds are doing," Cohen said. "For all intents and purposes it just locks on to its target and almost never lets go. And we think that’s why it is incredibly cytotoxic in cancer cells."

Investigating anti-cancer properties
The discovery started off with a puzzling observation by Moriah Arnold, a research assistant in Cohen’s lab and now an M.D./Ph.D. student at OHSU. In cancer-initiating cells, Arnold noted that an experimental PARP inhibitor called AZ0108 triggers DNA replication stress, which is the slowing or stalling of the process that cells use to copy their genes during cell division.

This was an eye-opening difference from the PARP-1 inhibitor drug olaparib. Like similar drugs approved by the Food and Drug Administration, olaparib targets tumors that have defects in DNA repair, and works by stopping the PARP-1 protein from helping cancer cells repair damaged DNA. These FDA-approved drugs have yet to find broad use as single agents in treating cancers that do not have DNA repair defects. They do not act by triggering replication stress in multiplying cancer cells, as AZ0108 does.

Curiosity aroused, Cohen decided his lab should dig deeper.

Control of PARP-1 activity involves an effect called "allostery": When one signaling molecule binds to the protein, it changes how that protein binds to another molecule at a distant site. When PARP-1 binds to damaged or single-stranded DNA, it causes a long-range conformational change, meaning change in shape, that allows PARP-1 to bind to its substrate molecule, NAD+, which leads to PARP-1 activation.

Allostery also works in reverse with PARP-1: Molecules that mimic the substrate molecule NAD+ increase PARP-1’s affinity for binding to DNA. Researchers have speculated that certain PARP-1 inhibitors used in cancer treatment work by means of reverse allostery, but more recent studies have shown that olaparib and other FDA-approved PARP-1 inhibitors do not.

Although the experimental PARP-1 inhibitor, AZ0108, and the FDA-approved olaparib are structurally similar molecules, they differ in how they engage the binding site on PARP-1, Cohen said. Instead, AZ0108 appeared work by reverse allostery.

In further experiments, Cohen’s team delved into the mechanism by which AZ0108 acts as a reverse allosteric inhibitor. First, they tested whether mutations in the PARP-1 protein could disable the reverse allosteric signal. They discovered that changing a single amino acid in a specific part of the protein could silence the signal. While AZ0108 still binds to the mutant PARP-1, the binding no longer triggers the allosteric change at the distant DNA binding site.

"What this says is at that particular position on PARP-1, there’s some interaction that’s key for driving this reverse allosteric change and enhancing DNA binding," Cohen said.

His team then generated a series of molecules similar to AZ0108, but with subtle changes at one site they predicted would be physically close to the position on PARP-1 that they found was critical to allosteric signaling.

"These changes didn’t much impact the ability of these compounds to inhibit the catalytic activity of PARP-1," Cohen said. "What they really impacted was this reverse allosteric enhancement of PARP-1 binding with DNA."

They also found that the extent of inhibitor-induced replication stress correlated with the magnitude of the reverse allosteric effect on DNA binding.

"The synthesis of these molecules showed that the replication stress that we see, induced by these compounds, is really due to the ability of these compounds to lock PARP-1 onto DNA by this reverse allosteric mechanism," Cohen said.

The sticky molecule
Quite unexpectedly, several of the synthesized molecules were substantially more potent than AZ0108 in inhibiting cancer cell growth. One of the synthesized molecules, dubbed Pip6, proved to be an incredible 90 times more toxic to cancer cells than AZ0108.

"This was surprising because AZ0108 and Pip6 are almost identical compounds," Cohen said.

It was hard to explain the massive difference in toxicity to cancer cells, Cohen said. Replication stress is fundamental to the toxicity of these compounds, but in measures of replication stress, Pip6 scored slightly lower than AZ0108.

"This is where things got a little bit confusing for us," Cohen said. "We thought it was a nice clean story and I was like: okay, now what?"

The explanation came as another surprise. It comes down to the stickiness of the Pip6 molecule in binding with PARP-1. Experiments showed that Pip6 stays persistently bound to the protein, which, in turn, persistently maintains the reverse allosteric signal that keeps PARP-1 bound to DNA.

Tilikum Therapeutics Inc., the startup Cohen co-founded, is aiming to develop the next generation of inhibitors of PARP-1, which is a critical target in ovarian, breast and prostate cancers.

The attributes of Pip6 make it a good candidate for an anti-cancer drug. It is toxic to cancer cells at very low doses. Its persistent binding to the target protein suggests that it could be given less frequently than existing PARP inhibitors. And its unique mechanism of action compared with clinical PARP-1 inhibitors means that it could have much broader clinical use in cancers.

The next step, Cohen said, is testing Pip6 and related molecules in animal models to assess toxic side effects, minimum dosing levels, and how often doses need to be given to maintain effectiveness.

"We’re hoping that we can dose at very low levels," he said. "And because it has this long residence time, that maybe it’s not even a daily dose that is required. Maybe it’s just every few days or once a week."

This work was supported by grants from the National Institutes of Health (P30NS061800 and P30CA065823), the St. Baldrick’s Foundation, the Sarcoma Foundation of America, the Canadian Institutes of Health Research (PJT173370), the Pew Biomedical Scholars program, the Oregon Clinical and Translational Research Institute Biomedical Innovation Program, the University Venture Development Fund, and the National Institute of Neurological Disorders and Stroke (2R01NS088629).

In the interest of ensuring the integrity of OHSU research and as part of a commitment to public transparency, OHSU actively regulates, tracks and manages relationships that our researchers may hold with entities outside of OHSU. Moriah Arnold and Michael Cohen are inventors on a patent related to the compounds in this research and OHSU has exclusively optioned the potential cancer treatment to Tilikum Therapeutics, a startup company co-founded by Cohen.

Q BioMed Inc. Chemotherapeutic Uttroside B, Receives Notice of Allowance for Patent from United States Patent Office

On February 10, 2023 Q BioMed Inc. (OTCQB: QBIO) a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector, reported asset Uttroside B – is expected to receive a patent in the United States, adding to the already issued patents in Korea, Canada and Japan (Press release, Q BioMed, FEB 10, 2023, View Source [SID1234627079]). In addition, recent results from pre-clinical pharmacokinetic testing have been very encouraging and the data supports advancing the program. Uttroside B shows tremendous value in the Liver Cancer Market. Uttroside B has also received Orphan Drug designation from the FDA.

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The America Cancer Society (www.cancer.org) reported in this year alone, an estimated 42,000 adults in the United States will be diagnosed with primary liver cancer. It is also estimated that 30,000 deaths from this disease will occur this year. The 5-year survival rate is 20%, compared to just 3% 40 years ago. For the 44% of people who are diagnosed with liver cancer at an early stage, the 5-year survival rate is 34%. There is significant demand for better therapeutic alternatives in the space.

Q BioMed announced in 2021 that it has received Orphan Drug Status from the FDA. Q BioMed Inc. is prosecuting patents in multiple jurisdictions and has received patents from Canada, Korea and Japan and has now received notice of an allowable patent in the USA. The Patent is titled "Uttroside-B and Derivatives Thereof as Therapeutics for Hepatocellular Carcinoma (HCC)". Q BioMed has the exclusive rights to the technology through an agreement with the Rajiv Gandhi Centre for Biotechnology, an Autonomous Institute under the Department of Biotechnology, Government of India, and the Oklahoma Medical Research Foundation.

The global liver cancer drug market size was valued at US$824 Million in 2020 and is anticipated to grow at a CAGR of 29.4% during forecast period 2021 to 2030. In early pre-clinical investigation Q BioMed’s Uttroside-B showed ten times the cytotoxicity against HCC, which is the toxicity caused due to the action of the chemotherapeutic agent on living cancer cells, as compared to the current standard of care drug at the time. Currently, there are only two approved first-line mono therapies and a combination first-line therapy for HCC. Challenges with current treatments include patients becoming resistant to the specific drugs, adverse side effects, and high costs.