On June 17, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported it granted an exclusive option to Amasa Therapeutics, Inc. (Amasa), a privately-held biopharmaceutical company focused on the development of novel cell-based targeted biological therapeutics to treat cancer patients with unmet need, to acquire an exclusive, royalty-bearing license to use Lineage’s HyStem technology for the development and commercialization of therapies for local treatment of solid tumors under pre-negotiated terms (Press release, Lineage Cell Therapeutics, JUN 17, 2021, View Source [SID1234584170]). Under the option agreement, Amasa will purchase certain amounts of Lineage’s existing supply of clinical-grade HyStem biomaterial and has the right to purchase additional amounts in connection with its up to 12-month option to acquire the exclusive license. Lineage will receive an upfront cash payment and, if the option is exercised, would be entitled to additional payments, including event-specific payments, royalties on net sales and sublicense fees and royalties.

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"Lineage is a clinical-stage cell therapy company supported by a vast intellectual property portfolio. From this portfolio, we continue to find opportunities to unlock value from non-core assets through option and license agreements for assets such as HyStem"

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"Lineage is a clinical-stage cell therapy company supported by a vast intellectual property portfolio. From this portfolio, we continue to find opportunities to unlock value from non-core assets through option and license agreements for assets such as HyStem," stated Brian Culley, Lineage CEO. "Many tissue engineering and regenerative cell-based therapies will require the delivery of therapeutic cells in a matrix or scaffold for accurate anatomical placement, cell retention, and engraftment. This option agreement represents an opportunity to provide Amasa with access to our clinical-grade HyStem material for future development of oncology-related products delivered via HyStem and, alongside a previously announced deal with Advanced BioMatrix, is the second HyStem-related transaction we have entered into."

HyStem is a patented biomaterial that is made from and structurally mimics naturally occurring extracellular matrix, the structural network of molecules surrounding cells in organs and tissues that is essential to cellular function and tissue structure. The technology underlying the HyStem hydrogels is based on a unique thiol cross-linking strategy. Building upon this technology, the HyStem family of hydrogels are novel biomaterials that offer unique strategies for cell therapy and bioactive molecule delivery. A distinctive feature of the HyStem hydrogel is that it allows the mixture of cells with the matrix in a liquid form such that the cells and matrix can be injected easily through a small gauge syringe, and then the matrix can polymerize around the cells to create a three-dimensional tissue within the body. When implanted in HyStem hydrogels, cells remain attached and localized within the hydrogel and slowly degrade the implanted matrix and replace it with their natural extracellular matrices. Current research at leading medical institutions has shown that HyStem is compatible with a wide variety of cells and tissue types including brain, bone, skin, cartilage, vascular and heart tissues.

"We believe use of Lineage’s clinical-grade HyStem hydrogels will allow us to quickly move candidates into the clinic with our novel approach of using receptor-targeted cell therapies to address intractable solid tumors such as glioblastoma," stated Arthur Hiller, Amasa CEO. "The physiochemical properties of the HyStem hydrogel and its ability to provide a suitable extracellular matrix give our cell therapies the best opportunity to remain viable, be retained in the targeted tumor resection cavity, and eradicate residual tumor cells," stated Khalid Shah, founder of Amasa.

About HyStem

Lineage has developed a family of hyaluronan based hydrogels (HyStem) that mimics the natural extracellular matrix and has potential applications in 3-D cell culture, stem cell propagation and differentiation, tissue engineering, regenerative medicine, cell-based therapies, and as delivery vehicles for bioactive molecules. HyStem hydrogels were designed to recapitulate the minimal composition necessary to obtain a functional extracellular matrix (ECM). The individual components of the hydrogels are cross-linkable over time, and thus may be seeded with cells prior to in vivo injection, without compromising either the cells or the recipient tissues. HyStem hydrogels have been shown to support attachment and proliferation of a wide variety of cell types in both 2-D and 3-D cultures and provide timed release of proteins and other bioactive moieties. HyStem hydrogels exhibit a high degree of biocompatibility when implanted in vivo and are readily degraded in vitro and biodegrade in vivo through hydrolysis via naturally occurring enzymes. When implanted in HyStem hydrogels, cells remain attached and localized within the hydrogel and slowly degrade the implanted matrix and replace it with their natural ECMs. When used as a delivery vehicle, bioactive molecules are released by both diffusion as well as degradation of the hydrogel. The patented technology underlying Lineage’s HyStem hydrogel products in development, such as Renevia, has been exclusively licensed to Lineage for human therapeutic uses. Since the first published report in 2002, there have been over 300 academic scientific publications supporting the biocompatibility of thiol cross-linked hyaluronan-based hydrogels and their applications as medical devices and in cell culture, tissue engineering, and animal models of cell-based therapies. Due to the unique cross-linking chemistry, HyStem hydrogels have the ability to be formulated with cells and can be injected or applied as a liquid and form a gel in situ, which allows the hydrogel to conform to a cavity or space. This property of HyStem hydrogels is expected to offer several distinct advantages over other hydrogels, including the possibility of combining bioactive materials with the hydrogel at the point of use.

On June 17, 2021 Midatech Pharma PLC (AIM: MTPH.L; Nasdaq: MTP), an R&D biotechnology company focused on improving the bio-delivery and biodistribution of medicines, reported breakthrough in vitro data which demonstrate Q-Sphera’s potential to formulate proteins into long-acting injectable products, as well as significant progress across multiple other programmes(Press release, Midatech Pharma, JUN 17, 2021, View Source [SID1234584096]).

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In the 13 months since the announcement of a Strategic Review, the Company has shut down its Bilbao operations, thereby halving its monthly cash burn rate and pivoted from a largely singular focus on one Phase III ready asset (MTD201, Q-Sphera octreotide) to "multiple shots on goal" with an expanded pipeline of nine earlier stage programmes. The Company’s strategy is to develop each programme to proof of concept before seeking licencing partners to undertake later stage development, manufacturing and commercialisation.

Q-Sphera pipeline

The Company’s Q-Sphera technology employs proprietary 3-D printing techniques to encapsulate drugs in polymer-based bioresorbable microspheres which may be injected to form depots in the body which release drug over predictable, sustained periods from one week to several months. Including:

1. Monoclonal antibody (mAb) formulation

There are no approved long-acting injectable formulations of biologic products such as mAbs or other high molecular weight proteins because they are delicate and easily de-natured in manufacture. The Company has been working on an exemplar mAb and thus far, has demonstrated encapsulation of the mAb and most importantly, preservation of functional integrity and antigen binding in vitro. The Company believes no other commercial or academic organisation has been able to successfully deliver therapeutic proteins over extended periods using methods capable of commercial scaling.

The Company believes these results could potentially open up very significant opportunities for its Q-Sphera technology. A significant number of latest generation medicines are protein based and reformulation as long-acting injectables could provide significant benefits to patients, physicians and payors. In 2020, the top 10 mAbs recorded aggregate sales of US$74.9 billion1 and all mAbs US$154 billion1 globally.

The next steps for the Company will be to further optimise the drug loading and dissolution profile for encapsulated mAbs. In parallel the Company will seek to replicate the data seen in this exemplar mAb and is evaluating multiple high value mAb therapeutics for addition to its internal pipeline.

2. MTX214 and MTX216

Both MTX214 and MTX216 are being developed under collaboration agreements with the European affiliate of a global healthcare company. The Company has manufactured and delivered proof of concept formulations of MTX214 and MTX216 to the collaboration partner who, in turn, is expected to begin dosing for in vivo studies in the next few weeks.

3. MTD211

As part of its internal pipeline, the Company has successfully developed a long-acting formulation of brexpiprazole. In in vivo studies, MTD211 was well tolerated and demonstrated that a single dose of MTD211 is expected to deliver therapeutic blood levels of brexpiprazole over a period of three months.

Marketed under the brand name Rexulti, brexpiprazole is indicated for the treatment of schizophrenia and adjunctive treatment of major depressive disorder (MDD) and is currently only available as an immediate release oral tablet. The market for anti-psychotic drugs is shifting towards long-acting formulations for reasons of improved patient compliance and lowering of payor costs associated with patient hospitalisation events. Sales of long-acting anti-psychotic products in 2020 were approximately US$5.7 billion2 globally.

The Company has initiated discussions with third parties about a potential licencing of MTD211. There can be no assurance on the timing for concluding these discussions nor any assurance that the parties will enter into definitive agreements.

MTX110

MTX110, a novel formulation of panobinostat administered through convection enhanced delivery, is in clinical development for intractable brain cancers including Diffuse Intrinsic Pontine Glioma (DIPG) and Glioblastoma Multiforme (GBM).

Following a pre-IND meeting with the FDA on 15 June 2021, the Company expects to initiate a Phase II study in DIPG later this year. The study will be open label, single arm, in 21 newly diagnosed patients. Administration of MTX110 will be via convection enhanced delivery (CED) over 48 hours in six cycles, two to four weeks apart. Primary endpoints will be safety, tolerability and overall survival at 12 months (OS12). Approximately 1,000 patients3 globally are diagnosed with DIPG per annum and median survival is approximately 10 months4.

Building on the in vivo data that were presented at the 2020 annual meeting of The Society of Neuro-Oncology which demonstrated the efficacy of MTX110 against two GBM cell lines in an ectopic tumour model, the Company has recently demonstrated the potency, at therapeutic concentrations, of MTX110 against a further four patient-derived GBM cell lines in vitro. The Company is planning a Phase I pilot study in GBM to begin enrolment later this year. There are GBM diagnoses of 2 to 3 per 100,000 population per annum5 and survival ranges from 13 to 30 months depending on MGMT methylation6.

Further to the announcement made in June 2020, the Company has received a further communication from counsel to Secura Bio, Inc. ("Secura Bio"), the owner of panobinostat patents that were formerly licenced to the Company. Secura Bio terminated the Company’s licence to the patents in June 2020. Notwithstanding that termination, the Company has recently received a letter from Secura Bio claiming material breach of the terms of the licence and is demanding, among other things, that the Company grant Secura Bio a non-exclusive, free licence to its intellectual property and know-how. The Company believes that such claims and demands are without any merit.

Contract negotiations with a third party in respect of a potential co-development deal are continuing, although at a slower pace than anticipated due to issues associated with COVID-19. There can be no assurance on the timing for concluding these discussions nor any assurance that the parties will enter into definitive agreements.

Investor Webinar

The Company will be hosting a webinar at 2.00pm BST / 9.00am EST today. The webinar is open to all existing and potential shareholders and those interested in attending may register via the following link where, following registration, they will be provided with access details:

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On June 17, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that its intellectual property portfolio around its lead Phase 3 candidate, Iomab-B, has been further strengthened internationally (Press release, Actinium Pharmaceuticals, JUN 17, 2021, View Source [SID1234584133]). In the EU, Actinium has been issued a patent covering the composition and methods administration of Iomab-B, an Antibody Radiation Conjugate (ARC) comprised of apamistamab, a CD45 targeting antibody, and the radioisotope iodine-131. The issued patent in the EU is expected to have a useful life through 2036. In addition, Actinium has been granted a patent covering the same composition and methods of administration claims in Japan.

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Dr. Dale Ludwig, Actinium’s Chief Scientific Officer, said, "We are excited to expand our already robust patent portfolio with these key patents in the EU and Japan. As the only CD45 ARC for targeting conditioning in clinical development, these international patents, together with our U.S. patents lay the foundation for aggressive development of Iomab-B for BMT conditioning and Iomab-ACT for conditioning prior to cell and gene therapies. Iomab-B is well characterized and supported by extensive clinical data across multiple clinical trials and indications. Our ARC approach has significant advantages over other approaches such as monoclonal antibodies or antibody drug conjugates that require payload internalization, making them impractical for targeting CD45. We look forward to continuing to build our leadership position in targeted conditioning led by Iomab-B and remaining at the forefront of innovation in targeted radiotherapy."

Actinium owns issued or pending patents within the United States and globally covering composition of matter, formulation, methods of use, and methods of administration with potential coverage for 19 years or longer. Importantly, Actinium owns an issued patent in the US covering composition of matter, for which the Company expects validity until 2037. In addition, the Company owns a second issued US patent that further covers composition of matter, methods of use, and methods of administration for Iomab-B.

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are delighted to now have wholly-owned issued patents in the U.S. and EU and a granted patent in Japan covering the composition and methods of Iomab-B, as these three regions represent an overwhelming majority of the global addressable market for Iomab-B. We have been aggressively building our patent portfolio and it is a major accomplishment to have IP protection on our lead asset into 2036 and 2037. In addition to IP protection, we also have orphan drug designation for Iomab-B in the U.S. and EU, providing potential market exclusivity. As we look to the future, our IP portfolio gives us great confidence in our ability to build the leading, multi-indication strategic business unit for the large and growing targeted conditioning market on a global scale."

On June 17, 2021 Xilio Therapeutics, a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, reported that the U.S. Food and Drug Administration has accepted its Investigational New Drug application (IND) to evaluate its checkpoint inhibitor product candidate, XTX101, as a potential treatment for patients with solid tumors (Press release, Xilio Therapeutics, JUN 17, 2021, View Source [SID1234584155]). XTX101 is a tumor-selective anti-CTLA-4 monoclonal antibody designed to improve upon the therapeutic index of existing anti-CTLA-4 therapies by overcoming their historical potency and tolerability limitations.

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"This first IND acceptance for Xilio represents a significant milestone for us as we transition to a clinical-stage organization," said Marty Huber, M.D., chief medical officer of Xilio Therapeutics. "It is well known that checkpoint inhibitors hold significant clinical potential; however, treatment with anti-CTLA-4 therapies has been limited because of challenging autoimmune toxicities. Using our geographically precise solutions (GPS) platform, we have engineered XTX101 with the goal of enhancing the desirable features of an anti-CTLA-4 antibody while limiting the known liabilities. We look forward to beginning Phase 1 development to evaluate the potential that XTX101 may offer as both a monotherapy and combination agent for patients in need."

Leveraging its proprietary GPS platform, Xilio designed XTX101 to be activated in the tumor microenvironment with the potential to result in localized clinical activity without dose-limiting toxicities. In preclinical studies, XTX101 exhibited tumor-selective biological activity and robust tumor growth inhibition, including complete responses in murine cancer models, with favorable tolerability. These data demonstrate enhanced activity and an improved tolerability profile compared to an analog of ipilimumab, a CTLA-4 blocking antibody approved for the treatment of certain solid tumor cancers. XTX101 has also demonstrated enhanced tumor growth inhibition and tolerability when administered in combination with an anti-PD-1 in vivo.

Xilio expects to initiate a Phase 1 clinical trial in the second half of 2021 to evaluate XTX101 as a monotherapy, as well as a combination therapy with KEYTRUDA (pembrolizumab), for the treatment of patients with solid tumors.

On June 17, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that the U.S. Food and Drug Administration (FDA) has accepted Agenus’ Biologics License Application (BLA) for balstilimab, an anti-PD-1 antibody, for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy (Press release, Agenus, JUN 17, 2021, View Source [SID1234584134]). The FDA has granted Priority Review to this submission, a designation for drugs which, if approved, may provide significant improvements in the safety or effectiveness of the treatment of serious conditions. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 16, 2021.

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About Cervical Cancer
Nearly 14,000 women are expected to be diagnosed with invasive cervical cancer in the United States this year and more than 4,000 are expected to die.1 Cervical cancer remains one of the leading causes of cancer death in women globally, annually killing more than 300,000 women worldwide.2 Despite advances in routine medical examinations and HPV vaccines, cervical cancer remains prevalent. When left undetected, recurrent or metastatic cervical cancer often develops, for which there are limited treatment options and a low chance of survival. Current therapies for recurrent or metastatic cervical cancer are limited to a small subset of patients with limited benefit.

About balstilimab
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Balstilimab is currently in clinical trials as monotherapy and in combination with Agenus’ anti-CTLA-4, zalifrelimab, in an ongoing Phase 2 study for recurrent/metastatic cervical cancer.