On June 12, 2017 Dragonfly Therapeutics, Inc. ("Dragonfly"), reported a global strategic collaboration with Celgene Corporation and its affiliates ("Celgene") to discover, develop and commercialize innovative immuno-oncology treatment options for patients with hematological malignancies based on Dragonfly’s Natural Killer ("NK") cell based TriNKET technology platform (Press release, Dragonfly Therapeutics, JUN 12, 2017, View Source [SID1234533242]).

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The collaboration allows Celgene the exclusive option to in-license worldwide rights for up to four therapeutic candidates with potential utility in the treatment of acute myeloid leukemia, multiple myeloma, and additional hematological malignancies. The collaboration includes a $33 million upfront payment, and potential future milestone and royalty payments.

"NK-cell biology and immunotherapy are increasingly critical areas of hematologic research and we are looking forward to working with Dragonfly’s team of world-leading experts," said Rupert Vessey, FRCP DPhil, President of Research and Early Development for Celgene Corporation. "This collaboration will leverage the strengths of each company as we work together to bring innovative therapies to patients."

"Through execution of this strategic alliance with Celgene, Dragonfly is well positioned to accelerate our efforts to bring potential new immuno-oncology treatment options to patients with hematological malignancies," said Bill Haney, co-founder and CEO of Dragonfly Therapeutics. "Celgene is a preeminent biopharmaceutical company with a demonstrated history of recognizing disruptive science that may lead to new treatment options for patients with cancer. We look forward to a successful collaboration."

On December 12, 2017 Selexis SA and TeneoBio, Inc. reported that they have entered into a service agreement to advance the development of a new class of biologics, Human Heavy-Chain Antibodies (UniAbs) targeting cancer (Press release, Selexis , DEC 12, 2017, View Source [SID1234533030]). Under the agreement, TeneoBio will leverage Selexis’ proprietary SUREtechnology Platform to develop and optimize the cellular expression of multi-specific UniAbs that were discovered using TeneoBio’s proprietary sequence-based TeneoSeek discovery engine and UniRat Human Heavy-Chain Antibody Platform.

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"TeneoBio is developing a new class of multispecific biologics for treatments of multiple myeloma, lymphoma and prostate cancer," said Yemi Onakunle, PhD, vice president, business development and licensing with Selexis. "We believe in the power of the Selexis SUREtechnology Platform to help TeneoBio to rapidly and predictably achieve the high antibody expression levels and cell line stability that are needed for the cost-effective production of their unique multi-specific antibody candidates."

Selexis’ SUREtechnology platform facilitates the rapid, stable, and cost-effective production of virtually any recombinant protein, including those that are difficult to express in other systems. It also provides seamless integration of the biologics and vaccine development continuum, spanning discovery to commercialization.

Omid Vafa, chief business officer at TeneoBio, Inc., added, "This is the first of several TeneoBio bi- and multi-specific UniAb candidates that leverages our unique T-cell redirection platform to target liquid and solid tumors. We are excited to work with Selexis, a pioneer in bioproduction that offers the right balance of speed, technology, and flexibility to generate cell lines for our lead program."

On June 12, 2017 Coherus BioSciences, Inc. (NASDAQ:CHRS), reported that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for its biologics license application ("BLA") for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, under the 351(k) pathway (Press release, Coherus Biosciences, JUN 12, 2017, View Source/news-releases/news-release-details/coherus-biosciences-receives-complete-response-letter-fda-its" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-receives-complete-response-letter-fda-its" rel="nofollow">View Source [SID1234531703]).

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The CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information. The FDA did not request a clinical study to be performed in oncology patients. Additionally, the CRL does not indicate additional process qualification lots would be required or raise concerns over the GMP status of CHS-1701 bulk manufacturing and fill-finish vendors.

Coherus will work with the FDA to address the information requests.

"While we are disappointed in the delay that this additional request has caused, we remain confident in our ability to address the FDA’s requests for the purpose of obtaining approval for CHS-1701," said Denny Lanfear, President and CEO of Coherus BioSciences. "We are encouraged that a patient study has not been requested and we expect that we will be able to respond to the FDA and meet with them to define a path forward in the coming months. Neulasta is the largest selling oncology biologic in the U.S., and we anticipate CHS-1701’s approval will generate significant U.S. healthcare savings while increasing patient access."

Coherus’ management team will host a conference call on Monday, June 12 at 8:00 a.m. EDT.

Conference Call Information
Dial-in: (844) 452-6826 (domestic) or (765) 507-2587 (international)
Conference ID: 35568643
Please join the conference call at least 10 minutes early to register.
A replay of this conference call will be posted to the company’s website View Source and will be available until July 12, 2017.

Belén Garijo CEO Healthcare Luciano Rossetti Global Head of Research & Development, Biopharma Rehan Verjee Chief Marketing and Strategy Officer, Healthcare June 12, 2017 Biopharma R&D pipeline Update Complete portfolio supporting leadership in a potentially disruptive class DNA damage response (DDR) Genomic instability: a hallmark of late stage cancers 1 • DNA damage response (DDR) keeps genetic information intact • In many cancers DDR pathways are defected, leading to greater dependency on remaining functional DDR pathways • Preferentially inhibiting remaining DDR pathways can result in cancer cell death ("synthetic lethality") 26 1 Sources : O’Connor, Molecular Cell, 2015 | Benjamin et al., Current Drug Targets, 2010, 11, 1336-1340 2 "A multicenter phase I trial of the DNA-dependent protein kinase (DNA-PK) inhibitor M3814 in patients with solid tumors", Mark van Bussel, ASCO (Free ASCO Whitepaper) 2017 Acronyms: ATM: ataxia-telangiectasia mutated |ATR: ataxia telangiectasia and Rad3 | DNA-PK: DNA-dependent protein kinase | Amplifying cytotoxic effects of conventional and novel cancer treatments potentially bears combination potential 1. Inhibitor portfolio targets all three leading pathways of double stranded breaks – enabling unique synergies 2. ASCO (Free ASCO Whitepaper) 2017: leading DNA-PK-I (M3814) found safe and tolerable in a phase I study, with limited single-agent activity (20 % of patients with stable disease for at least 18 weeks) 2 3 Lead Optimization Pre-clinical Phase I Phase II Phase III 28 DNA-PK-i ATR-i ATM-i VX-970 VX-803 VX-984 M-3814 M-3541 Clinical program targets all three DDR pathways, in mono-and combination Acronyms: ATM: ataxia-telangiectasia mutated |ATR : ataxia telangiectasia and Rad3 | DNA-PK: DNA-dependent protein kinase | CT : Chemotherapy | RT: Radiotherapy | Note : timelines are event-driven and may change Phase IB expansion cohorts ongoing in combination with CT (TNBC, NSCLC, SCLC) Phase I dose escalation ongoing for mono-and combination therapy (with CT) Phase I dose escalation ongoing in combination with CT (licensed-in) Two Phase Ib /II proof-of-concept studies in combination with CT and RT ongoing Expected to enter clinic in 2017 DNA damage response (DDR) 3 29 DNA damage response (DDR) Broad combination potential across multiple mechanisms Combination with CT ATR DNA-PK ATM Combination with DDR Combination with ADC Combination with IO Monotherapy Combination with RT At least 50% of all cancer patients receive some type of RADIATION therapy (NCI 2016) At least 70% of all cancer patients receive some type of CHEMOTHERAPY (NCI 2016) Significant share of patients to be treated with CHECKPOINT INHIBITORS 4 3 30 Early stage strengthened – enabling late stage optionality across all TAs 1 Pipeline Immuno-Oncology Immunology Phase I Phase II Phase III Oncology New in pipeline Moved to next phase Maintained position BTK inhibitor RA sprifermin Osteoarthritis Avelumab RCC 1L 1 Tepotinib HCC Avelumab NSCLC 2L 2 Avelumab Gastric 1L MN 1 Avelumab Urothelial 1L MN 1 Avelumab Ovarian plat. res./ref Avelumab Ovarian 1L (Chemo) 1 BTK inhibitor SLE tepotinib NSCLC Avelumab Gastric 3L 3 Avelumab LA SCCHN Atacicept SLE Avelumab NSCLC 1L 1 Biosimilars Adalimumab biosimilar Chr. plaque Psoriasis R Registered (US) Abituzumab SSc-ILD Externalized p70S6K & Akt-i Solid tumors DNA-PK-i Solid tumors BRAF-I (Beigene) Solid tumors BTK inhibitor Hem. malignancies Avelumab Solid tumors Avelumab Hem. malignancies anti-PD-L1/TGF-b trap Solid tumors Avelumab MCC 1L Anti-IL-17 A/F Psoriasis Avelumab 5 Merkel cell (EU) R BTK inhibitor MS DNA-PK-I (VX-984) Solid tumors ATR-i 7 (VX-970) Solid tumors ATR-I (VX-803) Solid tumors Filing Cladribine Tablets RMS (EU) ATX-MS-1467 MS Avelumab + NHS IL 12 Solid tumors Avelumab+41BB/OX40 Solid tumors Avelumab comb.** DLBCL Terminated 2 Atacicept IgA Nephropathy Avelumab (mono/combo) Various ISTs 1 Since R&D Update call on June 20, 2016 | 2 Either terminated (ATX, BRAF-i) or divested (Biosimilars) | Acronyms: SLE = systemic lupus erythematosus, RRMS = relapse remitting multiple sclerosis, NSCLC = non-small cell lung cancer, HCC = hepatocellular carcinoma, STS = soft-tissue carcinoma, MCC = Merkel cell ca rcinoma, RA = rheumatoid arthritis, SCCHN = squamous cell cancer of the head and neck, SSC-ILD: Systemic sclerosis with interstitial lung disease | DLBCL: Diffuse Large B-cell Lymphoma

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On June 12, 2017 OncoSec Medical Incorporated ("OncoSec") (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, reported that they have engaged in a preclinical agreement through the OncoSec Technology Access Program (TAP) with Jounce Therapeutics, Inc., (NASDAQ:JNCE) Cambridge, MA, a company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment (Press release, OncoSec Medical, JUN 12, 2017, View Source [SID1234519503]).

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Under the agreement, Jounce can utilize OncoSec’s gene delivery technology to evaluate in vivo efficacy in murine models of intratumorally-delivered therapeutic candidates. The agreement includes the GENESIS research generator and proprietary applicators developed for research use.

"We are excited to provide a preclinical delivery solution to Jounce for early-stage research purposes and expand the data set from our delivery technologies through our Technology Access Program," said Punit Dhillon, CEO and President of OncoSec. "Through the establishment of these programs, OncoSec benefits from extensive, multi-party characterization and validation of our proprietary, state-of-the art electroporation technologies. We are pleased to be working with Jounce to help advance their preclinical programs with these technologies."

"OncoSec has developed a unique delivery technology that will enable us to rapidly assess potential candidates in preclinical models," said Debbie Law, Jounce’s Chief Scientific Officer. "We are delighted to be working with OncoSec and leveraging their technology to help us evaluate our preclinical immunotherapy programs."

About OncoSec Research Technologies and Technology Access Program:

The OncoSec GENESIS research generator was developed specifically for gene electro-transfer. It features customizable electroporation parameters for construct-specific optimization of expression, and it is the only in vivo electroporation device enabled with TRACE Technology (Tissue-Based, Real-Time Adaptive Control Electroporation.)

TRACE technology incorporates an electrochemical tissue-sensing control system to automatically adjust pulse width and treatment duration in real time during the electroporation procedure. This feature enables tissue- and therapeutic-specific delivery optimization, maximizing uptake of the therapeutic while reducing unnecessary cell ablation or damage. In research models, GENESIS with TRACE has yielded higher and more consistent in vivo protein expression versus fixed-parameter electroporation, even in heterogeneous tissues.

Potential advantages of GENESIS with TRACE for use in murine models include robust and conformationally-native in vivo expression of difficult proteins, including GPCRs and receptors that function in multimeric form. Moreover, the consistent results obtained with these technologies in heterogeneous tissues support reliable intratumoral delivery of a wide variety of DNA-encodable therapeutics across multiple syngeneic, xenograft, and PDX models. Using these technologies, OncoSec has expressed more than fifty proteins in vivo, including multimers and structurally-complex fusion proteins, and no protein tested to date has failed to successfully express.

The OncoSec Technology Access Program makes OncoSec’s electroporation technologies available to collaborators for preclinical research. Devices are available for intratumoral, intradermal, and intramuscular delivery. For more information, please contact [email protected].

For SEC reporting purposes, the agreement between OncoSec and Jounce is non-material.