On July 8, 2019 McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, reported that it has been selected by Karyopharm Therapeutics, Inc. to be in the limited distribution network for XPOVIO (selinexor) (Press release, McKesson, JUL 8, 2019, View Source [SID1234537408]).

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XPOVIO is the first and only nuclear export inhibitor that blocks XPO1 and is indicated in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least five prior therapies and whose disease is refractory or intolerant to at least two proteasome inhibitors (PI), at least two immunomodulatory agents (IMiD), and an anti-CD38 monoclonal antibody (mAb).1,2 Approved on July 3, XPOVIO was previously granted both Orphan Drug designation and Fast Track designation by the FDA.

"We are excited that Biologics is included in the limited network distribution for XPOVIO," said Ann Steagall, director of Clinical Policy at Biologics. "We are pleased to be included in the distribution of a first in class XPO inhibitor. Patients who have exhausted the current standard of care therapies now have another option. It is important to us as a premier oncology pharmacy to offer patients and prescribers the newest therapies available."

Biologics is committed to and recognized for its high level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes a pharmacist with in-depth knowledge of disease states and oncology therapies available, an experienced oncology nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help cancer patients. This highly-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics team works closely with payers to ensure patients can access the specialty medications they need.

Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.

On July 8, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported the formation of Breakpoint Therapeutics GmbH, a spin-off company focusing on the development of Evotec’s DNA damage response ("DDR") portfolio, comprising discovery-stage assets and drug targets that promise broad therapeutic application in a variety of cancers (Press release, Evotec, JUL 8, 2019, View Source;announcements/press-releases/p/evotec-and-venture-capital-consortium-form-breakpoint-therapeutics-gmbh-5831 [SID1234537392]). Breakpoint Therapeutics’ mission is to develop first and best-in-class oncology drugs that interfere with DNA repair and replication stress pathways to facilitate the cure of therapy-resistant cancers.

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Breakpoint Therapeutics will initially focus on advancing multiple drug discovery programmes initiated at Evotec that address high unmet medical needs of different patient groups. The goal of the spin-off company is to accelerate early projects through discovery and pre-clinical development and expect to deliver the first IND-ready drug in 2022.

The early stage funding amounting to € 30 m will be covered by a renowned international investor consortium led by Medicxi, a life sciences-focused investment firm, Taiho Ventures, LLC ("Taiho"), the venture capital arm of Taiho Pharmaceutical, and Evotec. Evotec will hold below 50% of the company and consolidate at equity accordingly.

The company will conduct its research activities using Evotec’s fully established, validated and industrialised platforms. This highly virtual set up of Breakpoint Therapeutics achieves maximal flexibility in accessing required resource to drive projects forward at highest scientific standards and best capital efficiency.

Dr Daniel Speidel, Managing Director of Breakpoint Therapeutics, said: "We are delighted that the support of Medicxi, Taiho Ventures and Evotec has enabled us to form Breakpoint Therapeutics. Drugs that modulate DNA damage responses hold great promise for many cancer patients that don’t respond to currently existing treatments and are indeed among the most exciting new approaches to improve the success of cancer therapy. Given that so many people still die of cancer, it is absolutely vital that we turn relevant scientific concepts into new effective drugs. This is what Breakpoint Therapeutics is all about."

Dr Werner Lanthaler, Chief Executive Officer of Evotec, said: "The formation of Breakpoint Therapeutics with a core team of Evotec scientists fits well within our strategy of creating upside with an optimal risk-reward profile through participation in companies operating in selected fields of high strategic medical relevance. Creating and advancing highly capital efficient virtual biotech initiatives is one of the key advantages with the outstanding platform of Evotec."

Dr Jon Edwards, Partner at Medicxi, said: "This is a unique opportunity to leverage the longstanding Evotec R&D platform for the rapid advancement of our DNA damage response (DDR) programmes. We’re thrilled to be supporting this expert team of scientific entrepreneurs and working alongside Taiho and Evotec, both leading industry players. This is a ground-breaking field and we’re confident that our capital efficient, asset-centric approach will enable Breakpoint Therapeutics to rapidly develop differentiated medicines for the global patient population."

Sakae Asanuma, President of Taiho, said: "We are extremely excited to co-found Breakpoint Therapeutics, as a leading company of DNA damage response (DDR), together with sophisticated partners like Medicxi Ventures as well as Evotec SE. DDR is one of the most promising fields in oncology with higher interest following the current success of PARP inhibitors and we strongly believe Breakpoint’s DDR targeting programmes have the potential to deliver therapeutically impactful treatment options for a variety of cancer patients."

On July 8, 2019 OncoSenX, Inc., a late preclinical-stage company developing therapeutics to kill cancer cells based on their genetics, reported it has raised $3 million in pre-seed funding to advance its pipeline (Press release, OncoSenX, JUL 8, 2019, View Source [SID1234537409]).

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"These funds will allow us to accelerate the preclinical research necessary for us to begin phase 1 clinical development"

"These funds will allow us to accelerate the preclinical research necessary for us to begin phase 1 clinical development," said Matthew Scholz, chief executive officer of OncoSenX. "We believe our non-viral gene therapy for solid tumors represents the first in a new class of cancer therapeutics. The OncoSenX team is diligently working to bring this new approach into the clinic for the benefit of a global oncology community clearly in need of new options."

OncoSenX is developing a highly selective tumor-killing platform with two main components: a proprietary lipid nanoparticle (LNP) for cellular delivery and a highly selective DNA payload. The LNP is designed to deliver its non-integrating DNA payload to solid tumors, while an engineered promoter drives expression of a potent, inducible death protein only in the target cell population. The goal is to precisely target cell populations based on their genetic activity without harming nearby cells. The platform can be effectively programmed to implement logic gates (IF/OR/AND) to provide selectivity to any target cell based on its genetics.

"Our preclinical studies suggest the OncoSenX approach has the potential to precisely kill cancer cells based on the mutations they harbor," said John Lewis, Ph.D., chief science officer of OncoSenX. "If substantiated in the clinic, the platform could deliver reduced toxicity and improved tolerability over conventional chemotherapy, with the potential for superior targeting over biologics or even CAR-T therapy."

OncoSenX is currently preparing for its regulatory interactions and will then perform pivotal toxicology studies in anticipation of filing to begin human trials.

On July 8, 2019 ArcherDX, Inc., a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine and Ayala Pharmaceuticals, a clinical stage precision oncology company dedicated to developing targeted therapies for genomically defined, clinically underserved cancers, reported a strategic collaboration to develop companion diagnostic (CDx) tests targeting cancers bearing Notch activating mutations and fusions (Press release, ArcherDX, JUL 8, 2019, View Source [SID1234537393]).

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"As we continue our work to bring pan-Notch inhibitors to those living with cancers bearing Notch-activating mutations and fusions, we are excited to enter into this collaboration with ArcherDX, a leader in molecular technology," said Roni Mamluk, Ph.D., Chief Executive Officer at Ayala Pharmaceuticals. "We believe that through this partnership we’ll have additional tools to identify those patients most likely to respond to the Notch inhibitors that Ayala is developing."

"Working closely with biopharma partners to help bring biomarker-driven therapies to individuals diagnosed with cancer is central to our mission to improve access to genomic-based medicine. Partnerships with progressive companies such as Ayala who can leverage our unique ability to provide companion diagnostic solutions from both tissue and blood-based specimens and deploy them at scale as in-vitro diagnostics to laboratories around the world is essential to achieving this mission," said Jason Myers, Co-Founder and Chief Executive Officer of ArcherDX. "We’re proud to support Ayala in their pursuit of meaningful new precision oncology treatment options."

On July 8, 2019 Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the publication of a study in BMC Biotechnology, a Springer Nature journal, describing and evaluating the development of the SWIFF-CAR, a CAR construct with an embedded on/off-switch, which enables tight control of the CAR surface presentation and subsequent cytolytic functions using a small molecule drug (Press release, Cellectis, JUL 8, 2019, View Source [SID1234537410]). The reversible control of these engineered T-cells represents a promising approach to further mitigate the potential toxicities that are associated with CAR T-cell administration in clinical settings and to improve the process of CAR T-cell production for specific target antigens.

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"Following Cellectis’ previously developed CubiCAR system, an all-in-one CAR architecture with an embedded multi-functional tag for purification, detection and elimination of CAR T-cells, we knew that we needed an additional ‘on/off switch’ to direct T-cells to either be active or inert, without necessarily killing them," said Dr. Alexandre Juillerat, Ph.D., Project Leader and U.S. Laboratory Head, Cellectis. "The SWIFF-CAR system does precisely that, representing a major breakthrough in our ongoing efforts to develop innovative applications to treat a range of diseases, including cancer and autoimmune diseases."

"While suicide gene systems have proven to be an effective way to eliminate transduced CAR T-cells, they also potentially terminate CAR T-cell treatment altogether," added Dr. Philippe Duchateau, Ph.D., Chief Scientific Officer, Cellectis. "The capability to manipulate CAR surface presentation improves the safety of CAR-T therapies and enhances our ability to circumvent hurdles associated with manufacturing. The SWIFF-CAR system addresses both of these factors and is an important next step for Cellectis in treating deadly illnesses that affect patients globally."

Alexandre Juillerat, Ph.D. Project Leader and Senior Scientist, Cellectis

Dr. Alexandre Juillerat, Ph.D., graduated in Chemistry from the University of Lausanne, Switzerland. After receiving his Ph.D. in 2006 in protein engineering from the École Polytechnique Fédérale de Lausanne (EPFL, Switzerland), he moved to the laboratory of Structural Immunology at the Institut Pasteur in Paris, France. In 2010, he joined the R&D department of Cellectis in Paris, France, working on the development and implementation of sequence specific designer nucleases including the transcription activator-like effector nucleases (TALEN). He then joined the Cellectis facility based in New York, NY, USA, leading projects associated with the development of the T-cell chimeric antigen receptor (CAR) technology.

Modulation of Chimeric Antigen Receptor surface expression by a small molecule switch

Alexandre Juillerat1, Diane Tkach1, Brian W. Busser1, Sonal Temburni1, Julien Valton1, Aymeric Duclert2, Laurent Poirot2, Stéphane Depil2 and Philippe Duchateau2

1Cellectis Inc, 430E 29th street, NYC, NY 10016, USA
2Cellectis, 8 rue de la croix Jarry, 75013 Paris, France