On October 18, 2022 CNBX Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported that the Company has filed a new patent application titled " COMPOSITIONS COMPRISING CANNABINOIDS AND METHODS OF USE THEREOF IN THE TREATMENT OF CANCER" under the Patent Cooperation Treaty (PCT) (Press release, CNBX Pharmaceuticals, OCT 18, 2022, View Source [SID1234622283]).

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Said patent application relates to several of the drug candidates currently under development by the Company for the treatment of various types of cancer, including Colorectal Cancer, Breast Cancer and Melanoma, and specifically to the usage of said drug candidates as a new form of Neoadjuvant Cancer Therapy.

Neoadjuvant therapy is the administration of cancer therapy prior to the main treatment, with the goal of making the main treatment more likely to have a successful patient outcome; for example, treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery (National Cancer Institute).

The company has been recruiting a group of specialized medical doctors (MDs) to complement the development process of the company’s pipeline of drug candidates, each with a specific expertise, such as Dr. Yonina Tova (Breast Cancer), Dr. Caroline Roberts (Melanoma), Dr. Sigal Tavor (Hematology), Prof. Zamir Halperin (Gastroenterology) and Prof Amos Toren (Oncology).

The company continues to put much effort in growing and maintaining its IP portfolio. This effort is led by Dr. Lior Eshdat, an organic chemist and patent attorney who specialized in IP portfolio management. The company’s portfolio includes 8 patent families, with 7 granted patents and 17 additional pending. The company’s IP portfolio is focused on cancer patients and cancer treatments, and includes claims relating to Pharmaceutical Compositions, Methods and Systems.

The company is actively pursuing the development of its core drug candidate CNBX RCC-33, under the guidance of Dr. Sigalit Arieli Portnoy, the Company’s Regulatory Affairs specialist, and in preparation of a pre-IND meeting with the FDA and with plans for conducting a First In-Human Phase l/ll(a) clinical validation study.

On October 18, 2022 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical- stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that it will report financial results for the quarter ended September 30, 2022, on Tuesday, November 1, 2022 after the close of the market, and provide a corporate update (Press release, Aptose Biosciences, OCT 18, 2022, View Source [SID1234622191]).

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*Please note the change in platform. Analysts interested in participating in the question-and-answer session will pre-register for the event from the participant registration link above to receive the dial-in numbers and a personal PIN, which are required to access the conference call. They also will have the option to take advantage of a new Call Me button and the system will automatically dial out to connect to the Q&A session.

The audio webcast can also be accessed through a link on the Investor Relations section of Aptose’s website here. A replay of the webcast will be available on the company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended September 30, 2022 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

On October 18, 2022 ABL, a pure play Contract Development and Manufacturing Organization (CDMO) with specialized expertise in the development and manufacturing of solutions for biopharma, including viruses for gene therapies, oncolytic viruses and vaccine candidates, and Imugene (ASX: IMU), a clinical stage immuno-oncology company developing a range of new treatments that seek to activate the immune system of cancer patients to identify and eradicate tumors, today announce their partnership (Press release, Imugene, OCT 18, 2022, View Source [SID1234622189]). ABL will manufacture Imugene’s oncolytic virus for its MAST (Metastatic Advanced Solid Tumors) clinical studies evaluating the safety and efficacy of the novel cancer-killing virus CF33-hNIS (VAXINIA).

ABL has a strong background in handling a broad range of viruses, such as vaccinia, which require work under BSL-2 environments and aseptic conditions. Through this collaboration, Imugene will gain access to ABL’s top-of-the-line CDMO services, providing a true end-to-end solution with comprehensive analytical support, GMP manufacturing of vaccinia viruses and fill-finish of the drug product, with customizable and flexible development and manufacturing solutions.

Imugene has started the clinical development of its oncolytic virus candidates VAXINIA and CHECKVacc (CF33-hNIS-antiPDL1). These are based on the chimeric pox vaccinia platform CF33, invented by Professor Yuman Fong, chairman of the Sangiacomo Family Chair in Surgical Oncology at the City of Hope Cancer Center in California (US). The City of Hope has shown that the oncolytic virus it developed can shrink colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models.

"Reliability of drug supply is a major hurdle for the clinical development of many modern biological oncology drug candidates. De-risking this critical component of clinical development by working with ABL is a significant milestone for Imugene," said Leslie Chong, managing director and CEO of Imugene.

"ABL is honored to have Imugene’s trust and to enter into a long-term partnership for the development and manufacturing of CF33, a new generation of oncolytic virus, for its later phase clinical trial plans," said Thierry Van Nieuwenhove, CEO of ABL.

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"We look forward to working with Imugene in this collaborative partnership based on openness and transparency. This deal strengthens ABL’s reputation as a leading service provider of GMP vaccinia-based oncolytic viruses," said Karim Pirani, strategic business development at ABL.

Access to clinical drug product supplies which match and pair the clinical trial development plans with the regulatory requirements of phase II/III and registrational trials is a critical component of drug development. Imugene first used the City of Hope’s Center for Biomedicine and Genetics (CBG) for its phase I trial. However, to support its future drug product supply needs, that require an ample drug supply for extended later phase clinical trials, it selected ABL, a CDMO that can provide added expertise and scale.

Imugene plans to work with ABL as a partner of choice over the long-term, remaining active throughout the entirety of the CF33 platform’s life cycle. Imugene is currently transferring to ABL its technology for the manufacturing and analytical processes. ABL will then deliver the first phase of the project with a cGMP batch of VAXINIA targeted to be manufactured and released in 2023.

Oncolytic viruses are designed to selectively kill tumor cells, while activating the immune system against cancer cells, with the potential to improve clinical response and survival. The rise in cancer around the globe and increased investment in R&D for effective therapies are driving the expansion of the oncolytic virus therapy market.

Effective immediately, under the terms of the agreement the collaboration is funded from existing budgets and resources. The agreement is for a five-year term, noting that the delivery of the first clinical batch of VAXINIA is anticipated within 12 months. It includes customary termination and intellectual property provisions for a contract manufacturing agreement.

On October 18, 2022 Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics (EPBs), reported a strategic reprioritization of its pipeline and provided a corporate update (Press release, Ambrx, OCT 18, 2022, View Source [SID1234622178]). The strategic assessment considered the company’s cash runway, pipeline near term value creation opportunities, and other factors. As part of this strategic update, Ambrx will streamline its organization to improve efficiency and reprioritize its development pipeline to focus on oncology assets with the greatest potential and strong competitive profiles.

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"The tough decisions we are announcing today will streamline Ambrx’s operations and provide us with the resources to pursue our development candidates that hold the greatest promise for success in people with cancer," said Kate Hermans, Interim Chief Executive Officer of Ambrx. "There has been a significant shift this past year in the HER2 metastatic breast cancer competitive landscape. As a result of our assessment, the Board has endorsed the decision that the company should pause the internal development of ARX788 and seek a partner to further its development ex-China in order to extend the cash runway into 2025. Ambrx will focus on strengthening its current partnerships, while forging new collaborations to progress both ARX788 and other pipeline assets, in various indications. In parallel, we will concentrate our internal development on earlier stage programs where we believe Ambrx offers a first-in-class or best-in-class approach, including our now lead candidate ARX517, which has the potential to be the first Prostate-Specific Membrane Antigen (PSMA)-targeting ADC."

Ms. Hermans continued, "As a result of today’s reprioritization, management expects Ambrx now has sufficient capital to fund operations into 2025. We believe these changes position Ambrx for future success and reflect both our confidence in the company’s EPB platform and our commitment to building shareholder value. We look forward to executing on this new strategy and providing further updates in due course."

"I am pleased that the Board and management of Ambrx have aligned on a strategic path forward as we navigate through the highly competitive oncology market," said Katrin Rupalla, Chair of Ambrx’s Board of Directors. "We believe that prioritizing our play-to-win ADC assets will put Ambrx in the best position to maximize shareholder value and improve the lives of people with cancer. I would like to thank all our employees and partners for their hard work, patience and tenacity as we work through these changes and toward an encouraging future for our patients and stakeholders."

Pipeline Update

In mid-August 2022, Ambrx announced that it would undertake a strategic review of its clinical development pipeline. Moving forward, the company plans to focus on leveraging its novel antibody-engineering technology to target cancer indications. Specifically, Ambrx has developed a proprietary, site-specific conjugation platform that provides homogenous ADCs with unmatched stability. With a narrower scope, Ambrx believes it is better positioned to progress future ADC assets.

Ambrx will prioritize the progression of ARX517 through the clinic as the company’s new lead asset. The company believes ARX517 has the potential to be the first ADC therapy that specifically targets Prostate Specific Membrane Antigen (PSMA) to treat prostate cancer. Prostate cancer represents a significant unmet medical need with 1.4 million new cases worldwide in 2020, representing an estimated $9.9 billion market. In August 2021, Ambrx announced the first patient was dosed with ARX517 in a Phase 1a clinical trial in subjects with PSMA-expressing tumors.

Due to changes in the HER2 competitive landscape, Ambrx will no longer directly pursue our anti-HER2 antibody-drug conjugate (ADC) asset ARX788 as its lead clinical asset. As such, the company will pause development of Ambrx-sponsored clinical trials involving ARX788. Instead, Ambrx will continue to work collaboratively with NovoCodex and seek a development partner(s) ex-China to progress ARX788.

Ambrx highly values its global partners and plans to continue working collaboratively with NovoCodex (ARX788, ARX305), Sino Biopharm (ARX102) and BeiGene (research collaboration).

Additional pipeline programs, ARX305 (anti-CD70 ADC) and ARX102 (smart PEG-IL2), will continue in development. The two assets align with Ambrx’s new development strategy of focusing on early-stage EPBs. Ambrx will leverage clinical data from its partners who are progressing the two assets to inform Ambrx-sponsored clinical trials.
Anticipated Near Term Pipeline Milestones

2H 2023: Ambrx sponsored globally (U.S.) Interim Phase 1a safety data for ARX517, leading to a recommended dose that would allow Ambrx to initiate a Phase 1b/2 trial

2H 2023: Initiation of Ambrx sponsored globally (U.S.) Phase 1a trial for ARX305 (subject to results from NovoCodex sponsored trial)

1H 2024: IND submission for ARX102 (subject to results from Sino Biopharm sponsored trial)
Corporate Update

Ambrx will streamline its organization to reflect its new pipeline development focus. The company will reduce its workforce by approximately 15% while retaining and attracting key talent to support the clinical development of ARX517 and other assets.

The company’s search for a permanent Chief Executive Officer to lead Ambrx is ongoing. Until a permanent CEO is designated, Kate Hermans will continue to serve as interim CEO overseeing the company’s new strategy.

Ambrx expects its cash, cash equivalents and marketable securities as of June 30, 2022 to fund operations into 2025.
Conference Call

Ambrx will host a webcast to discuss the corporate update today, October 18, 2022 at 5:00 p.m. EST / 2:00 p.m. PST. Individuals interested in listening to the conference call may do so by accessing the webcast link in the investor relations section of the company’s website: www.ambrx.com. To access the call by phone, please refer to the dial in details provided in the event page on the "Events and Presentations" page on the investor relations website.

On October 18, 2022 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a biopharmaceutical company developing transformational therapeutics for serious diseases with significant unmet medical need, reported the completion of a series of related recapitalization transactions designed to enhance shareholder value (Press release, Scopus BioPharma, OCT 18, 2022, View Source [SID1234622165]).

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These transactions include the elimination of warrants to purchase approximately 21 million shares of Scopus common stock. The recapitalization also independently values Duet BioTherapeutics, Scopus’ pure play immuno-oncology subsidiary, at $25 million.

Joshua R. Lamstein, Chairman of Scopus BioPharma, stated, "Highlighting the embedded value of Duet was a key driver for the recapitalization. Scopus retains an approximately 90% ownership stake in Duet. The value of this stake greatly exceeds the total current market capitalization of Scopus. We expect that completing the recapitalization should serve as a catalyst for a significant increase in the trading price of Scopus’ common stock."

Alan Horsager, Ph.D., President – Immuno-Oncology of Scopus BioPharma and President and Chief Executive Officer of Duet BioTherapeutics, stated, "The establishment of a $25 million independent, stand-alone valuation positions Duet to raise capital directly and go public in 2023."

Mr. Lamstein added, "The recapitalization transactions provide us with greater strategic flexibility. The opportunity to secure capital at both the Scopus and Duet corporate levels enables us to pursue the most attractive financing alternatives."

Dr. Horsager added, "The additional financing alternatives afforded to Duet will enhance our access to the capital necessary to accelerate the development of DUET-02, our highly promising antisense technology. Additional capital resources will also enable us to further the on-going research by Marcin Kortylewski, Ph.D., Co-Founder and Senior Scientific Advisor of Duet BioTherapeutics and Professor of Immuno-Oncology at City of Hope, into systemic delivery formulations for DUET-01. We believe that these advancements will enable Duet to go public at a valuation significantly in excess of its current $25 million valuation."