On January 5, 2022 PCI Biotech (OSE: PCIB), a Norwegian cancer focused biopharmaceutical company and MDimune Inc. ("MDimune"), a private South Korean biotech company developing innovative drug delivery technologies for modifying cellular and disease processes in many areas of human disease, reported a preclinical research collaboration that would offer several opportunities for future development (Press release, PCI Biotech, JAN 5, 2022, View Source [SID1234638625]).

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Commenting on the announcement, Per Walday, CEO of PCI Biotech, said: "We are very pleased to initiate a collaboration with MDimune. This collaboration is an additional mark of interest from a cutting-edge biotech company developing therapies with emerging advanced technologies, with a large potential in future medicine."

Seung Wook Oh, Chief Scientific Officer of MDimune added: "We are excited to launch this collaboration with PCI Biotech. PCI Biotech’s versatile photochemical technologies have the potential to enhance several aspects of our technologies, to make future therapies more efficient and more specific."

On January 5, 2022 Covis Pharma Group ("Covis"), a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses, reported that Covis Pharma GmbH has completed the acquisition of Eklira (aclidinium bromide), known as Tudorza in the US and marketed as Bretaris in some countries, and Duaklir (aclidinium bromide/formoterol), marketed as Brimica in some countries, from AstraZeneca (the "Acquisition") (Press release, Covis Pharmaceuticals, JAN 5, 2022, View Source [SID1234609116]). Under the terms of the Acquisition agreement, AstraZeneca received a payment of $270m from Covis. AstraZeneca will also receive payments in respect of certain ongoing development costs related to the medicines.

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In addition, Covis is pleased to announce that it has entered into an Exclusive Promotion and Distribution Agreement (the "Novartis Distribution Agreement") with Novartis Pharmaceuticals Canada Inc. ("Novartis"), whereby Covis has been appointed as Novartis’ exclusive partner to promote and distribute PrSeebri Breezhaler and PrUltibro Breezhaler in Canada.

Building upon Covis’ previous acquisition of the global rights to respiratory medicines Alvesco, Omnaris and Zetonna from AstraZeneca in 2018, the completion of the Acquisition and the entering into of the Novartis Distribution Agreement, enables the company to continue to meet one of its key strategic initiatives to become a leading respiratory company by creating a platform to offer a continuum of care for respiratory patients.

"The closing of the acquisition and the expansion of our business in Canada with the Novartis partnership enables Covis to offer a full continuum of best-in-class therapies for allergic rhinitis, asthma and COPD and demonstrates our ability to engage with, and be a partner of choice for, leading pharmaceutical companies," said Covis CEO Michael Porter. "As previously announced, as a result of the acquisition and this partnership with Novartis, Covis is firmly placed as one of the top 10 respiratory companies in the world. We are excited about our growth in this therapeutic area, and maintaining access to these important therapies for patients and physicians."

In connection with the Acquisition, Barclays acted as financial advisor to Covis and Paul, Weiss, Rifkind, Wharton & Garrison LLP acted as legal advisor to Covis. Buchanan Ingersoll & Rooney PC, Sidley Austin LLP and Fasken Martineau LLP provided regulatory and intellectual property law advice to Covis.

About the Medicines

Eklira (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the maintenance treatment of COPD. Eklira is a long-acting muscarinic antagonist (LAMA), which is marketed in the US as Tudorza and in some countries as Bretaris. Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2-agonist (LABA). It is marketed in some countries as Brimica. Both medicines are presented as a dry powder for inhalation and are delivered via a breath-actuated multi-dose dry powder inhaler, Genuair (Pressair in the US).

Seebri Breezhaler (glycopyrronium bromide) is a long-acting muscarinic antagonist (LAMA), indicated as a long-term once-daily maintenance bronchodilator treatment in patients with COPD including chronic bronchitis and emphysema. Ultibro Breezhaler (indacaterol maleate/glycopyrronium bromide) is a combination therapy that contains both a LAMA and a long-acting beta2-agonist (LABA). It is indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD), including chronic bronchitis and emphysema, and for the reduction of exacerbations of COPD in patients with a history of exacerbations. Both medicines are a dry powder presented as capsules for oral inhalation via the Breezhaler, a breath-actuated dry powder inhaler.

On January 5, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, along with LG Chem Life Sciences, reported that a key milestone in the selection of a clinical product candidate has been reached in their collaboration for CUE-102, an Immuno-STAT biologic, jointly developed to selectively target WT1-expressing cancers (Press release, Cue Biopharma, JAN 5, 2022, View Source [SID1234608263]). The milestone represents significant progress for the CUE-102 program and an important achievement in generating promising preclinical activity and data to be shared with the FDA as part of an investigational New Drug (IND) filing that is planned for the first quarter of 2022. Under the terms of the collaboration agreement, Cue Biopharma will receive a $3 million milestone payment from LG Chem Life Sciences, the life sciences division of LG Chem Ltd.

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"We are highly encouraged with the progress made in our collaboration with LG Chem, our partner and collaborator for CUE-101 and CUE-102 in certain Asia countries, and pleased to be advancing CUE-102 for a planned IND submission this year," said Daniel Passeri, chief executive officer of Cue Biopharma. "This milestone reflects ongoing progress for CUE-102, our second program from the IL-2 based CUE-100 series, and we believe provides a significant opportunity to address a high unmet need in a wide range of solid tumors and hematologic WT1-positive malignancies. The CUE-102 preclinical data continues to support and bolster the versatility and modularity of our CUE-100 series biologics and the Immuno-STAT platform, and we look forward to executing on our goal to advance this drug candidate into the clinic for patients in need."

Dr. Jeewoong Son, president of LG Chem Life Sciences added, "This significant milestone for CUE-102 underscores the spirit of the partnership and collaboration for advancing our shared vision with Cue Biopharma. We are very pleased and encouraged by the clinical data reported from the CUE-101 program and believe these data support the potential for CUE-102 to provide a significant therapeutic advancement for patients with WT1-expressing cancers."

Cue Biopharma presented preclinical data on CUE-102 and interim clinical data on CUE-101, its lead oncology asset, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting in November 2021.

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) platform biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-major histocompatibility complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo) and reinfused.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-major histocompatibility complex (pMHC) molecules along with rationally engineered interleukin 2 (IL-2) molecules. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About CUE-102
Leveraging the Immuno-STAT (Selective Targeting and Alteration of T cells) platform of targeted interleukin 2 (IL-2) therapies and the ongoing development of CUE-101, CUE-102 is being developed as a novel therapeutic fusion protein to selectively activate tumor antigen-specific T cells to treat Wilms’ Tumor 1 (WT1)-expressing cancers. CUE-102 consists of two human leukocyte antigen (HLA) molecules presenting a WT1 peptide, four affinity-attenuated IL-2 molecules, and an effector attenuated human immunoglobulin G (IgG1) Fc domain.

On January 5, 2022 Genprex reported that The FDA granted fast track designation to quaratusugene ozeplasmid (Reqorsa), an immunogene therapy, in combination with pembrolizumab (Keytruda) as a potential treatment for patients with histologically confirmed, unresectable stage III or IV non–small cell lung cancer (NSCLC) who progressed after treatment with pembrolizumab (Press release, Genprex, JAN 5, 2022, View Source [SID1234607479])

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Data that were previously presented have shown a strong synergy between quaratusugene ozeplasmid and pembrolizumab in patients with NSCLC compared with pembrolizumab alone. The data highlighted a survival benefit, as well as an increase in natural killer cells and a decrease in PD-L1 expression on tumor cells following treatment with the immunogene therapy in a population of mice with a humanized immune system and metastatic lung cancers.

On January 5, 2022 Genprex reported that The FDA has granted fast track designation (FTD) for Reqorsa Immunogene Therapy (Genprex) in combination with Keytruda (Merck) for individuals with histologically confirmed unresectable stage III or IV non–small cell lung cancer (NSCLC) whose disease progressed after treatment with Keytruda (Press release, Genprex, JAN 5, 2022, View Source [SID1234607478]).

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In the first quarter of 2022, Genprex expects to initiate its Acclaim-2 clinical trial, a multi-label, open-label phase 1/2 trial evaluating Reqorsa in combination with Keytruda for this population.

Genprex received its first FTD for Reqorsa in combination with AstraZeneca PLC’s Tagrisso for individuals with histologically confirmed unresectable stage 3 or 4 NSCLC with epidermal growth factor receptor mutations that progressed after treatment with Tagrisso.

"This fast track designation is an important step in our efforts to accelerate clinical development of Reqorsa and another validation of the potential of Reqorsa to treat the unmet medical need of patients with late-stage NSCLC. With a strong balance sheet of $42 million in cash as of the end of the third quarter of 2021 and expert clinical trial management led by Chief Medical Officer and industry veteran Mark Berger, MD, who joined Genprex in September 2021, we are well positioned to advance our Acclaim-1 and Acclaim-2 clinical trials in a meaningful way in 2022," Rodney Varner, president and CEO of Genprex, said in a statement.

Preclinical data have previously shown that Reqorsa combined with Keytruda was more effective than Keytruda alone in increasing the survival of mice with a humanized immune system that had metastatic lung cancers.

The studies in mice with a humanized immune system also documented multiple effects of Reqorsa on the immune system, such as an increase in Natural Killer cells and a decrease in PD-L1 expression on tumor cells, which is believed likely to contribute to the synergy between and Keytruda and Reqorsa.

"[The] FDA may award fast track designation if it determines that non-clinical or clinical data demonstrate the potential for a drug to address unmet medical need for a serious or life-threatening disease or condition. This provision is intended to facilitate development and expedite review of such drugs, so that a product, if approved, can reach the market expeditiously," Berger said.

"Advanced NSCLC represents a large patient population that is in desperate need of new therapies," he said.

FTD recipients may also be eligible for accelerated approval or rolling review of the recipient’s biologics license application (BLA) if other criteria are met.

Additionally, FTD product candidates could be eligible for priority review if supported by clinical data at the time of the BLA submission.

The initial intended disease indication for the development of Reqorsa is NSCLC.

Genprex is a clinical-stage gene therapy company that focuses on developing therapies for individuals with cancer and diabetes and hope to provide new therapies for large patient populations that have limited treatment options.