On May 18, 2021 Coeptis Pharmaceuticals, Inc., a wholly-owned subsidiary of Vinings Holdings Inc. (OTC PINK: NDYN), reported entry into two separate exclusive option agreements with VyGen-Bio, Inc., a majority-owned subsidiary of Vycellix, Inc., involving technologies being studied to potentially improve the treatment of CD38-related cancers (Press release, Coeptis Pharmaceuticals, MAY 18, 2021, View Source [SID1234580233]). The technologies are CD38-GEAR-NK, a cell therapy product being developed to protect CD38+ natural killer (NK) cells from destruction by anti-CD38 monoclonal antibodies (mAbs), and CD38-Diagnostic, an in vitro diagnostic tool being developed to analyze if cancer patients might be appropriate candidates for anti-CD38 mAb therapy. Both technologies are being developed from VyGen-Bio’s Gene-Edited Antibody Resistant NK (GEAR-NK) platform, which was discovered by scientists at the Karolinska Institutet in Sweden.

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The first option agreement involves co-development rights to CD38-GEAR-NK, which is an autologous, NK cell-based investigational therapeutic derived from a patient’s own cells and gene-edited to enable combination therapy with anti-CD38 mAbs, potentially minimizing the risks and side effects from CD38-positive NK cell fratricide. The first indication is expected to be multiple myeloma, an incurable cancer of plasma cells. Per the option agreement, Coeptis has paid VyGen-Bio a non-refundable fee for the exclusive option to purchase the co-development rights to the technology. Coeptis has until December 31, 2021 to exercise the option and pay the specified exercise consideration.

The second option agreement involves co-development rights to CD38-Diagnostic, which is an investigational in vitro screening tool to potentially pre-determine which cancer patients are most likely to benefit from targeted anti-CD38 mAb therapies, either as monotherapy or in combination with CD38-GEAR-NK. Per the option agreement, Coeptis has paid VyGen-Bio a non-refundable fee for the exclusive option to purchase the co-development rights to the technology. Coeptis has until December 31, 2021 to exercise the option and pay the specified exercise consideration.

"At Coeptis, we are focused on identifying and advancing technologies that have the potential to disrupt conventional treatment paradigms and improve patient outcomes," said Dave Mehalick, President and CEO of Coeptis Pharmaceuticals. "The option agreements with VyGen-Bio epitomize this business strategy as each technology may offer the potential to vastly improve the treatment of CD38-related cancers, including multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia, by identifying those patients who are most likely to benefit from anti-CD38 mAbs and then potentially ‘super charging’ a patient’s immune system by protecting CD38+ NK cells from destruction by anti-CD38 mAbs."

Mr. Mehalick continued, "We envision these agreements with VyGen-Bio to be an important step in support of our focus in cell and gene therapy."

On May 18, 2021 Outpace reported that the company is taking cell and gene control technology originally in-licensed by Lyell out of that company’s toolbox and into a broad partnering model it thinks could transform the field (Press release, Outpace Bio, MAY 18, 2021, View Source [SID1234637772]).

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Outpace Bio Inc. launched in March with a $30 million series A round led by Artis Ventures and Lyell Immunopharma Inc., with participation by Abstract Ventures, Civilization Ventures, Mubadala Capital, Playground Global, Sahsen Ventures and WRF Capital.

The company’s leadership and scientific teams include inventors of de novo protein design technology developed at University of Washington’s Institute for Protein Design (IPD), many of whom joined Lyell when their inventions were brought under the well-funded cancer cell therapy company’s roof. That IP is now assigned to Outpace.

"The reason we’re spinning out from Lyell is that even massively capitalized companies can’t chew on all the hypotheses we want to address while moving at full speed on internal clinical development," said Outpace co-founder and CEO Marc Lajoie. "We have a lot to offer the field, and Lyell will benefit from that."

Outpace is developing "a whole platform of control modalities" to program cell and gene therapies for greater potency and safety, said Lajoie.

That includes synthetic biology strategies using "AND" or "NOT" Boolean logic gates to recruit or exclude signaling molecules to specific subcellular locations, control protein turnover, or require a specific combination of signals to unlock a desired function.

By designing fit-for-purpose proteins that don’t exist in nature, the company can go beyond standard strategies that manipulate expression of individual genes.

"First-generation approaches have been mainly focused on over-expressing this gene, or knocking out that gene," which can face limitations when a gene is integral to cell function in one setting but hampers it in another, said Lajoie. In contrast, he said, working at the protein level gives Outpace the ability to introduce desired changes in more context-specific ways.

Rather than develop its own pipeline, which would require investing in clinical development, the company is partnering with others to develop products via milestone- and royalty-driven deals. "The opportunity here is to create a step change in the field, and to be able to do that, we needed to focus our efforts on early development," Lajoie said.

In some cases, Outpace and the partner company will jointly design the program from the bottom-up, while in others, the partner will come to Outpace and use the company’s existing technology to solve a specific problem in an ongoing program, said co-founder and CSO Scott Boyken.

While the products developed through collaborations will belong to the partner companies, the underlying control technologies developed through the process belong to Outpace. "We can leverage our progress on the products we’re working on to increase our efficiency for other projects in the future," Lajoie said.

Outpace’s most advanced program is a collaboration with Lyell to develop cell therapies with controlled expression of an undisclosed cytokine. Other programs in development include a CAR cell therapy resistant to exhaustion, and a strategy for drug-induced gene regulation; the partnering status of these programs is undisclosed.

Lajoie said that while Outpace’s technology can be applied to any cell or gene therapy, the company’s "sweet spot" is T cell therapies for cancer.

Lajoie and Boyken co-authored a 2020 Science study with Fred Hutchinson Cancer Research Center professor Stanley Riddell showing the Co-LOCKR (Colocalization-dependent Latching Orthogonal Cage/Key pRoteins) technology they developed, part of Outpace’s IP portfolio, directed T cells to kill target cells expressing precise combinations of cell surface antigens, opening the door to more selective tumor targeting.

"There’s no single antigen that really distinguishes cancer cells from healthy cells, but there are aberrant combinations of antigens. That’s the unique handle we really wanted to pursue in that collaboration," said Lajoie.

He believes the series A round will give the company approximately three years of runway.

At least two other companies have been founded to develop synthetic biology control mechanisms for partners’ cell therapies.

Cell Design Labs Inc. was acquired by Gilead Sciences Inc. (NASDAQ:GILD) for $175 million up front and $322 million in total milestones after Gilead’s 2017 acquisition of Cell Design Labs’ partner, Kite Pharma Inc. The University of California San Francisco spinout, which raised $34.4 million in venture funds, developed technology to control CAR T cell function; its UCSF founders published two Science Translational Medicine studies on the technology last month.

Senti Biosciences Inc., which raised a $105 million series B round in January and a $53 million A round in 2018, has both a pipeline strategy and a partnering model.

On May 18, 2021 Grey Wolf Therapeutics ("Grey Wolf"), a drug discovery company focused on developing first-in-class immuno-oncology agents, reported that it has been awarded £1.1M ($1.5M) in grant funding following a successful application to the prestigious Innovate UK Biomedical Catalyst (BMC) competition (Press release, Grey Wolf Therapeutics, MAY 18, 2021, View Source [SID1234580182]). Peter Joyce, CEO of Grey Wolf, noted that the company was "Delighted to receive this grant from Innovate UK, which will allow Grey Wolf to work with The University of Oxford ("Oxford") and the University of Southampton ("Southampton") to expand the ERAP1 program and accelerate the company’s path through clinical development".

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Over the past decade, immunotherapies have begun to transform cancer treatments, with significant impacts on clinical outcomes and survival rates. However, it has since become apparent that only a small subset of cancers and patient groups respond to these therapies. Clinical data suggests that one of the reasons behind this is due to low neoantigen expression at the cell surface.

In response to the urgent need for new therapeutics, Grey Wolf are developing small molecule inhibitors that target ERAP1 and ERAP2; two key enzymes in the antigen presentation pathway. Rather than targeting the immune system, this approach aims to directly alter the tumour cells to improve neoantigen expression and therefore, immune visibility.

The ERAP enzymes are responsible for trimming peptides prior to loading onto Major Histocompatibility Complex (MHC) Class I and presentation at the cell surface. These enzymes often over- or under-trim peptides in the endoplasmic reticulum, leading to a potential loss of immunogenic peptides and neoantigen presentation. Grey Wolf ERAP1 inhibitors significantly alter the neoantigen presentation on the surface of tumour cells, leading to greater recognition and destruction by the immune system.

The investment awarded through Innovate UK will be focused on identifying patient subgroups where ERAP1 inhibition could be particularly efficacious based on either cancer type or genetic background, thus providing the foundation for future breakthrough designations and accelerated approval. Collaborating with the world leading capabilities of Nicola Ternette’s group in Oxford and Edd James’ group at the Centre for Cancer Immunology in Southampton will be vital to the success of the project. The Ternette Lab are recognised leaders in the field of immunopeptidomics and the study of antigen presentation by MHC. Nicola Ternette and her team will use the technique to characterise neoantigens that are expressed following ERAP1 inhibition. As experts in ERAP biology, the James lab will examine the mechanistic effects of ERAP1 inhibition on T cell and tumour biology using a number of bespoke pharmacological models.

Peter Joyce, CEO, Grey Wolf Therapeutics: "We are delighted to have been awarded this highly competitive funding from Innovate UK which will enable us to accelerate the development of our ERAP1 inhibitor program and broaden the potential utility of this first-in-class therapy for patients. The award allows Grey Wolf to also build on our strong associations with two world class research groups at the University of Oxford and Southampton and represents a great opportunity to demonstrate the UKs leading role in global biotechnology."

Assoc. Prof. Nicola Ternette, The University of Oxford: "The funding from Innovate UKwill enable us to use Grey Wolf’s highly selective and potent ERAP1 inhibitors to mine their effects across the immunopeptidomes of different cancer types and genetic backgrounds. The truly exciting aspect of our research here will be gaining a fundamental understanding of the biology that can directly translate into clinical development of the therapy."

Prof. Edd James, University of Southampton: "We’re excited to build on our collaboration with Grey Wolf through this grant and apply our unique understanding of ERAP1 biology to exploit the translational potential of this approach."

On May 18, 2021 BiomX Inc. (NYSE American: PHGE) ("BiomX" or the "Company"), a clinical-stage microbiome company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, reported that the Company will host a conference call and a live audio webcast on Monday, May 24, 2021, at 8:00 a.m. EDT, to report first quarter 2021 financial results and provide business updates (Press release, BiomX, MAY 18, 2021, View Source [SID1234580218]). To participate in the conference call, please dial 1-877-407-0724 (U.S.), 1-809-406-247 (Israel) or 1-201-389-0898 (International). The live and archived webcast will be available in the Investors section of the Company’s website at www.biomx.com.

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On May 18, 2021 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported that notification was given to its partner and exclusive distributor, Genotests SpA by the Instituto de Salud Pública de Chile that the Marketing Authorization Application ("MAA") for Hexvix has been accepted for regulatory review (Press release, PhotoCure, MAY 18, 2021, View Source [SID1234580234]).

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During the regulatory review process, Genotests will begin to prepare for the commercial launch of Hexvix in Chile. In August 2020, Photocure entered into an agreement with Genotests, a privately held company specializing in the marketing of genetic tests for cancer and targeting cancer specialists, to exclusively market and distribute Hexvix in Chile. Under the terms of the agreement, Genotests will fund all costs to secure regulatory approval and commercialize Hexvix in Chile. Photocure will manufacture the product and support Genotests with regulatory activities, training, and promotional materials.

"Acceptance of the Hexvix MAA with Fast Track designation by the Chilean regulatory authority is a milestone for both Photocure and Genotests as we move closer to bringing this important solution to bladder cancer patients in the region," said Dan Schneider, President and CEO of Photocure. "With Genotests’ dedication and strong execution on this initiative, we are hopeful that Hexvix will become accessible to patients in Chile in the fourth quarter of this year. This partnership represents Photocure’s first step into the South American continent, and supports our strategy of expanding the availability of Hexvix into new territories to ensure that patients and urologists have access to the benefits of using blue light cystoscopy (BLC). The procedure with Hexvix, or Cysview, is recommended in consensus treatment guidelines for the management of bladder cancer around the world."

"It is a privilege to bring this fantastic product to Chile" said Oscar Varas, founder and owner of Genotests. "There are approximately 1,500 new bladder cancer cases annually in our country, an estimated 5,000 TURBT* procedures and nearly 11,000 surveillance cystoscopies. We look forward to building on our established network and the successful demonstration of Hexvix Blue Light Cystoscopy, conducted in collaboration with Karl Storz, at the Chilean Urology Conferences in 2018 and 2019, to launch blue light cystoscopy with Hexvix into the Chilean urology community as soon as possible."

*TURBT: trans-urethral resection of bladder tumors

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA

About Bladder Cancer

Bladder cancer ranks as the seventh most common cancer worldwide with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b

Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: View Source, accessed [April 2021].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. View Source

About Hexvix/Cysview (hexaminolevulinate HCl)

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe, and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Canada, Chile, Australia and New Zealand. Please refer to View Source for further information on our commercial partners.