On January 16, 2018 Oncoceutics Inc. and Frontida BioPharm, Inc. reported that the two companies have entered into a product development and commercialization agreement to further develop and scale-up the finished product manufacturing process for ONC201, Oncoceutics’ lead molecule (Press release, Oncoceutics, JAN 16, 2018, https://oncoceutics.com/oncoceutics-frontida-biopharm-announce-product-development-commercialization-partnership/ [SID1234558375]). ONC201 is an antagonist of the G-protein coupled receptor (GPCR) dopamine receptor D2 (DRD2) and is the first molecule designed to target this receptor specifically for oncology. The drug is currently in Phase II clinical trials for select advanced cancers, including multiple trials in high-grade gliomas, where patients treated with the compound have shown complete regressions of tumor lesions.

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As a part of this agreement Frontida will manufacture ONC201 drug product in their GMP certified facilities for clinical trials and future commercial purpose. Frontida has also made an equity investment in Oncoceutics.

"Our partnership with Oncoceutics gives Frontida an important and strategic opportunity to contribute our development and manufacturing expertise toward the commercialization of a promising oncology therapy," said Ron Connolly, Chief Operations Officer of Frontida. "Oncoceutics’ lead molecule ONC201 has yielded compelling clinical outcomes, and our team is excited to have the opportunity to contribute to its advancement to commercialization."

"We are pleased to enter into this agreement with Frontida that provides Oncoceutics with the scale of ONC201 drug product manufacturing necessary for future commercialization," said Martin Stogniew Ph.D., Chief Development Officer of Oncoceutics. "The fact that Frontida has become a manufacturer and investor makes them a partner in Oncoceutics development programs, not simply a service provider."

On January 16, 2018 Foundation Medicine, Inc. (NASDAQ:FMI) reported that the company has entered into a broad partnership with Pfizer Inc. (NYSE: PFE)(Press release, Foundation Medicine, JAN 16, 2018, View Source [SID1234523141]) . The partnership focuses on development, regulatory support and commercialization of companion diagnostics (CDx) that will be included in updates to FoundationOne CDx. FoundationOne CDx is Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that incorporates multiple companion diagnostics. Pfizer will also benefit from access to FoundationInsights, Foundation Medicine’s data analytics platform, to facilitate novel biomarker discovery and to optimize clinical trial design. The unique combination of FoundationInsights and FoundationOne CDx will potentially enable Pfizer to leverage Foundation Medicine’s platform technology to accelerate discovery and development of precision oncology therapeutics.

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Pfizer currently has 10 FDA-approved oncology medicines that treat a diverse array of solid tumors and hematologic malignancies. In addition, its oncology pipeline includes 17 assets in clinical development and 19 phase 3 studies.

"Our mission to transform cancer care includes partnering with biopharma companies to expedite development of personalized treatment options for patients. We are proud to partner with Pfizer who shares our commitment to precision oncology and biomarker-driven drug development," said Melanie Nallicheri, chief business officer and head of biopharma at Foundation Medicine. "The combination of our FDA-approved comprehensive genomic profiling platform and molecular information solutions, coupled with Pfizer’s robust oncology portfolio, enables us to enhance the impact of precision oncology to advance patient care."

FoundationOne CDx assesses all classes of genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It also reports genomic biomarkers, such as microsatellite instability (MSI) and tumor mutational burden (TMB), that can help inform the use of immunotherapies; genomic alterations in other genes relevant to patient management; and relevant clinical trial information. As such, it is designed to help streamline companion diagnostic development, mitigate risk and advance targeted therapy development. Currently FoundationOne CDx is FDA-approved as a CGP assay for all solid tumors and a broad companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies.

Concurrent with FDA approval, the Centers for Medicare & Medicaid Services (CMS) issued a preliminary National Coverage Determination (NCD) for FoundationOne CDx. The draft NCD would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage with evidence development in other solid tumor types. The final policy is expected to issue during the first quarter of 2018 following public comment on the preliminary NCD and an administrative period.

On January 16, 2018 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported that the first patient has been dosed in a Phase 1 clinical trial evaluating Leap’s GITR agonist, TRX518, in combination with gemcitabine chemotherapy or in combination with KEYTRUDA (pembrolizumab) or Opdivo (nivolumab), anti-PD-1 therapies marketed by Merck (known as MSD outside the United States and Canada) or Bristol-Myers Squibb, respectively (Press release, Leap Therapeutics, JAN 16, 2018, View Source;p=RssLanding&cat=news&id=2326652 [SID1234523143]).

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"TRX518 has demonstrated the ability to reduce immunosuppressive regulatory T cells and to activate tumor-killing T effector cells in clinical and preclinical studies. The combination of TRX518 with anti-PD-1 immunotherapy has strong scientific rationale and could act synergistically, enabling improved responses without significant additional toxicity. We look forward to evaluating the safety and efficacy of TRX518 in combination with pembrolizumab or nivolumab," commented Diwakar Davar, M.D., Assistant Professor of Medicine of the University of Pittsburgh and an investigator on the study.

"There is strong preclinical evidence for synergistic efficacy when combining immune activators targeting GITR with chemotherapy," commented Cynthia Sirard, M.D., Vice President, Clinical Development of Leap Therapeutics. "This trial represents an important step in our strategy to evaluate the combination activity of TRX518 as a backbone immunotherapy."

The TRX518-003 study is a multipart study evaluating TRX518 as a monotherapy and in combination with gemcitabine, KEYTRUDA (pembrolizumab), or Opdivo (nivolumab) in patients with advanced solid tumor malignancies.

The combination arms evaluating TRX518 with gemcitabine includes both dose escalation and dose confirmation cohorts and are designed to evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of the combination. The study will enroll patients who have metastatic or locally advanced, incurable solid malignancies for which gemcitabine is clinically appropriate (e.g., non-small cell lung, breast, ovarian, pancreatic, and renal cancer). The TRX518 + gemcitabine study will enroll approximately 32 patients.

The combination arms evaluating TRX518 with pembrolizumab or nivolumab includes both dose escalation and dose confirmation cohorts and are designed to evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of the combinations. The study will enroll patients who have received treatment with pembrolizumab or nivolumab for ≥4 months with a best response of stable disease and plans to continue treatment in accordance with package insert; or are not currently taking, but eligible for treatment with, pembrolizumab or nivolumab in accordance with the approved indications for each as referenced in the package insert. The TRX518 + PD-1 antagonist study will enroll approximately 64 patients.

About TRX518
TRX518 is a humanized monoclonal antibody with agonist activity targeting glucocorticord-inducible TNF-superfamily receptor (GITR). TRX518 is engineered to enhance immune responses to cancer. TRX518 is being studied in two ongoing repeat-dose clinical trials in patients with advanced solid tumor malignancies. Data from the trials have shown that patients receiving TRX518 monotherapy achieved durable stable disease with signs of pharmacodynamic activity including CD8+ T cell activation and modulation of immunosuppressive regulatory T cells.

On January 15, 2018 Biotecnol and University of Naples reported a study on Journal of Immunology, Volume 42 Issue 1: pg 1-10,where it was shown that T-cell recruiting bispecific antibody derivatives (TRBA) offer a more effective alternative to standard antibody therapy (Press release, Biotecnol, JAN 15, 2018, View Source [SID1234570281]). The team evaluated a panel of TRBAs targeting 3 different epitopes on the HER2 receptor either in a bivalent targeting tribody structure or as a monovalent scFv-fusion (BiTE format) for binding, cytotoxicity on Trastuzumab-resistant cell lines, and induction of cardiotoxicity. All three TRBAs did bind with high affinity to the HER2 extracellular domain and a large panel of HER2-positive tumour cells. Tribodies had an increased in vitro cytotoxic potency as compared to BiTEs. It was noted that Tribodies targeting the epitopes on ErbB2 receptor domains I and II bind and activate lysis of mammary and gastric tumour cells more efficiently than a Tribody targeting the Trastuzumab epitope on domain IV. The first 2 are also active on Trastuzumab-resistant cancer cells lacking or masking the epitope recognized by Trastuzumab. None of the Tribodies studied showed significant toxicity on human cardiomyocytes. Altogether these results make these novel anti-HER2 bispecific Tribodies candidates for therapeutic development for treating HER2-positive Trastuzumab-resistant cancer patients.

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On January 15, 2018 LIDDS AB (publ) reported that it has decided on a direct share issue to Nyenburgh Holding, a Dutch Life Science Fund that invests in selected European biotech- and pharma companies (Press release, Lidds, JAN 15, 2018, View Source [SID1234555919]). The raised capital will facilitate a faster acceleration of LIDDS’ development projects, especially in the immune-oncology field where NanoZolid based immuno-active compounds have shown very promising preclinical effects.

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The direct issue of 890 419 shares will add approx. 13,5 MSEK. Nyenburgh Holding will be the fourth biggest shareholder in LIDDS and contribute with financial strength, an excellent network and expertize within the sector. The share price of 15,12 SEK is based on volume weighted average of the share price with a 5 % discount. The share issue decision is based on the shareholders authorization on LIDDS Annual Meeting on May 11, 2017.

– The directed share issue to Nyenburgh Holding is an important validation of the NanoZolid technology. It further adds resources to reach key milestones in our development projects and give LIDDS the financial strength to conduct an effective business development process, says Monica Wallter, CEO of LIDDS.

– We are excited to make this investment in LIDDS as we see ample opportunities for LIDDS to employ this innovative technology. We believe innovation of the current healthcare system is not only coming from New Chemical Entities and biologicals but also from efficient and effective drug delivery technology. LIDDS is a logical add-on to our current portfolio" says Dave van Mastwijk from Dutch healthcare investor Nyenburgh Holding.

LIDDS total number of shares after the direct issue will be 21 871 188 and the share capital will amount to 1 159 172,96 when the new shares are registered with the Swedish Companies Registration Office, Bolagsverket. The dilution of shares is 4,1 %

LIDDS will with the raised capital accelerate the exciting development projects in immuno- oncology with the aim to build alliances, collaborations and license agreements.

The directed share issue to Nyenburgh Holding is further strengthening LIDDS owner structure and it confirms the international interest for LIDDS and the NanoZolid-technology.