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.

Nona Biosciences Enters into HCAb Based Antibody Discovery Collaboration Agreement with Mythic Therapeutics

On February 10, 2023 Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Limited committed to cutting edge technology innovations, and providing a total solution from "Idea to IND" ("I to ITM"), reported that it has entered into a collaboration agreement with Mythic Therapeutics, a biotechnology company focused on the development of antibody-drug conjugate-based (ADC) therapies for the treatment of a wide range of cancers (Press release, Nona Biosciences, FEB 10, 2023, View Source [SID1234627078]).

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Through the collaboration, Nona Biosciences will provide Mythic Therapeutics with access to its proprietary fully human heavy chain only antibody (HCAb) transgenic mice platform and antibody generation services to serve as input for Mythic Therapeutics’ proprietary FateControl antibody engineering approach to generate next-generation ADCs for a wide range of cancers.

"We are delighted to reach the agreement with Mythic Therapeutics to advance next-gen biotherapeutics innovation. We’ve accumulated deep knowledge of ADC drug discovery, along with our advanced therapeutic antibody platforms which have been validated by many partners worldwide. Mythic Therapeutics is a strong innovator in the research and development of ADCs in oncology with a strong foundation and a world-class team. Our cooperation is expected to further enhance the ability of target discovery, translating to advanced outcomes for unmet medical needs." said Jingsong Wang, MD, PhD, Chairman of Nona Biosciences.

About HCAb

HCAb’s patented technology generates novel "heavy chain only" antibodies, which are about half the size of a typical IgG. These antibodies carry IgG-like PK properties and Fc-domain functions without the need for additional engineering or humanization. Lack of light chain also minimizes the issue of light chain mispairing and heterodimerization. These characteristics enable the development of products with attributes not achievable by conventional antibody platforms. In addition, HCAb-derived multiple novel therapeutic antibody modalities, including single-domain antibodies, bi-, and multi-specifics, antibody-drug conjugates, CAR-Ts, or VH domain-derived diagnostic or therapeutic products, are also achievable using this platform.

Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2023 Financial Results and Provides Business Update

On February 10, 2023 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products reported business and financial results for the fiscal first quarter ended December 31, 2022 (Press release, Citius Pharmaceuticals, FEB 10, 2023, View Source [SID1234627077]).

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Fiscal Q1 2023 Business Highlights and Subsequent Developments

I/ONTAK (E7777) biologics license application (BLA) under review by the U.S. Food and Drug Administration (FDA) with Prescription Drug User Fee Act (PDUFA) target decision date of July 28, 2023;
Mino-Lok Phase 3 trial progressing with additional enrollment and events in the U.S. and India;
Phase 2b trial of Halo-Lido for the treatment of hemorrhoids on track with healthy momentum in patient recruitment; and,
On February 7, 2023, Dennis M. McGrath was elected to the Citius Board of Directors at the Annual Meeting of Stockholders, replacing Director Dr. William Kane.
Financial Highlights

Cash and cash equivalents of $36.9 million as of December 31, 2022;
R&D expenses were $3.4 million for the first quarter ended December 31, 2022, compared to $5.5 million for the first quarter ended December 31, 2021;
G&A expenses were $2.6 million for the first quarter ended December 31, 2022, compared to $2.9 million for the first quarter ended December 31, 2021;
Stock-based compensation expense was $1.2 million for the first quarter ended December 31, 2022, compared to $0.9 million for the first quarter ended December 31, 2021; and,
Net loss was $3.6 million, or ($0.02) per share for the first quarter ended December 31, 2022, compared to a net loss of $9.2 million, or ($0.06) per share for the first quarter ended December 31, 2021.
"As we entered 2023, Citius continued to build momentum across the pipeline. Our Mino-Lok Phase 3 trial is actively enrolling patients in the U.S. and India. We believe the recent uptick in recruitment at clinical sites will aid in completing the trial this year. Regarding our I/ONTAK (E7777) BLA, we anticipate the FDA’s decision in late July. Accordingly, we remain focused on ensuring that our regulatory, commercial and manufacturing activities are positioned to support a successful launch, if approved. Moreover, our team has worked diligently to align resources to support the Phase 2b Halo-Lido trial as it nears completion," stated Leonard Mazur, Chairman and CEO of Citius.

"In addition to the progress we are making on the clinical front, we continue to strengthen our corporate infrastructure. On February 7, 2023, shareholders approved the nomination of Dennis McGrath to our Board of Directors. We are very fortunate to have a seasoned leader of Dennis’s caliber join our Board. His deep public company, financial and strategic expertise will help guide our path forward. Dennis assumes the Board position formerly held by Dr. William Kane. Since March 2014, Dr. Kane has shared his expertise and insights as a valued member of our Board. We are grateful for his contributions and support through the years. With multiple value-creating catalysts anticipated this year, I look forward to updating shareholders as we work to achieve these milestones," concluded Mazur.

FIRST QUARTER 2023 FINANCIAL RESULTS:

Liquidity

As of December 31, 2022, the Company had $36.9 million in cash and cash equivalents.

As of December 31, 2022, the Company had 146,211,130 common shares outstanding.

The Company estimates that its available cash resources will be sufficient to fund its operations through February 2024.

Research and Development (R&D) Expenses

R&D expenses were $3.4 million for the first quarter ended December 31, 2022, compared to $5.5 million for the first quarter ended December 31, 2021. The decrease primarily reflects the completion of the I/ONTAK (E7777) Phase 3 trial and lower Halo-Lido Phase 2b study costs, offset by incremental Mino-Lok Phase 3 trial costs related to the expansion of the trial to include clinical sites outside the U.S.

We expect that research and development expenses will stabilize in fiscal 2023 as we focus on the commercialization of I/ONTAK and complete our Phase 3 trial for Mino-Lok and our Phase 2b trial for Halo-Lido.

General and Administrative (G&A) Expenses

G&A expenses were $2.6 million for the first quarter ended December 31, 2022, compared to $2.9 million for the first quarter ended December 31, 2021. The decrease was primarily due to reduced costs for performance bonuses and investor relations expenses. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.

Stock-based Compensation Expense

For the first quarter ended December 31, 2022, stock-based compensation expense was $1.2 million as compared to $0.9 million for the prior year. The increase reflects expenses related to new grants made under the Citius and NoveCite equity incentive plans and new grants made to employees (including new hires), directors and consultants.

Net loss

Net loss was $3.6 million, or ($0.02) per share for the year ended December 31, 2022, compared to a net loss of $9.2 million, or ($0.06) per share for the year ended December 31, 2021. The $5.6 million decrease in the net loss was primarily due to an increase in other income and a decrease in research and development expenses.