On April 30, 2019 Oncology Venture A/S reported news on DRP based analyses of biopsies from clinical trials with dovitinib (Press release, Oncology Venture, APR 30, 2019, View Source [SID1234535457]). . In addition to renal, endometrial and GIST tumors Oncology Venture has now also shown in two new indications liver cancer and breast cancer that the DRP can predict the responding patients. Moreover, the first patient has been dosed with 2X‑121 at the Dana Farber Cancer Institute. Boston, US for the treatment of advanced ovarian cancer. Also, Oncology Venture has submitted an IND (Investigational New Drug Application) for LiPlaCis and its DRP to the FDA, with the intention to start a pivotal study in metastatic breast cancer.

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Dovitinib
Oncology Venture’s dovitinib DRP (Drug Response Predictor) has previously proved its ability to identify the best responders based on patient biopsies from clinical trials in renal, endometrial and GIST cancer. New analyses of biopsies from clinical trial cohorts of liver and breast cancer patients resulted in equally good predictability. Oncology Venture has thereby been able to confirm its DRP for dovitinib in five out of five of Novartis’ clinical trials and this without having to invest in own studies.

Oncology Venture aims to apply for a first FDA marketing approval of dovitinib and its companion DRP based on existing data from a pivotal study done by Novartis in patients with renal cancer.

2X-121/PARPi
The first U.S. patient has now been dosed at Dana-Farber Cancer Institute Boston with 2X-121, a PARP inhibitor in development for advanced ovarian cancer. 2X-121 has previously shown promising results in ovarian cancer patients in a phase 1 study performed by EISAI. The DRP selection aimed to find the best responding patients is expected to lift the response rate to outperform currently marketed drugs for the same indication. 2X-121 is also in development for the treatment of metastatic breast cancer.

LiPlaCis
An IND (Investigational New Drug Application) for LiPlaCis in metastatic breast cancer has been submitted to the FDA for the purpose of performing a pivotal study of LiPlaCis and its DRP in patients with metastatic breast cancer. An IDE (Investigational Device Exemption) will follow in this quarter.

In metastatic breast cancer patients with the highest DRP score (top 20%), LiPlaCis treatment resulted in a response rate of 40%. In comparison, the latest product approved by the FDA in this patient group, Halaven, showed a response rate of 12%. LiPlaCis is also being evaluated in an ongoing Phase 2 study in patients with prostate cancer.

For further information, please contact:
For investor inquiries
Ulla Hald Buhl
IR & Communications
E-mail: [email protected]
Telephone +45 21 70 10 49

For media inquiries
Thomas Pedersen
Carrotize PR & Communications
E-mail: [email protected]
Telephone +45 60 62 93 90

About the Drug Response Predictor – DRP Companion Diagnostic
Oncology Venture uses its multi gene DRP to select those patients who by the genetic signature of their cancer are found to have a high likelihood of responding to the drug. The goal is developing the drug for the right patients, and by screening patients before treatment the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. DRP is based on messenger RNA from the patient’s biopsies.
DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 29 out of 37 clinical studies that were examined and is currently demonstrating promising results in an ongoing phase 2 study prospectively using LiPlaCis and its DRP to track, match and treat patients with metastatic breast cancer.
The DRP platform, i.e. the DRP and the PRP tools, can be used in all cancer types and is patented for more than 70 anti-cancer drugs in the US. The PRP is used by Oncology Venture for Personalized Medicine. The DRP is used by Oncology Venture for drug development.

On April 29, 2021 Vibliome Therapeutics, LLC, reported that it closed a $16mm Series A round of financing to advance its proprietary technology supporting the development of small molecule therapeutics targeting clinically-relevant signaling pathways (Press release, Vibliome, APR 29, 2019, View Source [SID1234580056]).

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Deerfield Management was the sole investor in the Series A financing round and will be providing operational support. Vibliome has discovered a new systematic approach for the development of small molecule kinase inhibitors with unique profiles and a very high degree of selectivity. The company’s focus on medicinal chemistry gives it a distinct advantage in developing high quality inhibitors against exciting new targets. Vibliome’s technology also supports lead generation for improved inhibitors against validated and novel targets by taking advantage of new mechanisms of binding and dierentiated target combinations. This platform technology is ideally suited to support emerging therapeutic approaches for cancer and other diseases where selective enzyme targeting is needed.

There are over 500 kinases encoded by the human genome which control nearly all cellular functions by phosphorylating proteins. Aberrations in the control of cell metabolism, division, growth and death are hallmarks in the development of cancer, and kinase inhibitors have been shown to be eective in targeting genetic mutations and fusions that drive cancer progression. "The versatility of our chemistry platform oers many opportunities for variation while maintaining a common general architecture," said Robert Goodwin, Vibliome’s CEO. "We are very excited to leverage Deerfield’s support as we develop new therapeutic options for patients, particularly in oncology."

On April 29, 2020 Oncoceutics, Inc. reported that the United States Patent and Trademark Office (USPTO) has issued patent #10,266,533 entitled "7-BENZYL-4-(2-METHYLBENZYL)-2,4,6,7,8,9-HEXAHYDROIMIDAZO [1,2-A]PYRIDO[3,4-E]PYRIMIDIN-5(1H)-ONE, ANALOGS THEREOF, AND SALTS THEREOF AND METHODS FOR THEIR USE IN THERAPY" with an expiration date of January 29, 2036 (Press release, Oncoceutics, APR 29, 2019, View Source [SID1234558357]). This patent covers the composition of matter for ONC213, its di-salt formulation, and its use in the treatment of cancer. In addition to the claims related to ONC213, the patent also contains claims for millions of structurally-related imipridones.

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ONC213 is the fourth molecule in the company’s pipeline of "imipridone" family of anti-cancer small molecules that target G protein-coupled receptors, following ONC201, ONC206 and ONC212. As with other members of the imipridone class, ONC213 has very attractive chemical and biological properties including oral bioavailability, chemical stability and a large therapeutic index.

"We are delighted by the decision of the US Patent Office to grant Composition of Matter to the novel molecule ONC213," said Martin Stogniew, Ph.D., Chief Development Officer of Oncoceutics. "This patent paves the way for future generations of imipridones to enter the clinic and eventually benefit the lives of patients."

ONC213 has demonstrated anti-cancer activity and safety in various preclinical oncology models across hematological malignancies and solid tumors tested in the lab of Principal investigator Dr. Yubin Ge, Associate Professor of Oncology at the Karmanos Cancer Institute and Wayne State University School of Medicine. Results presented at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrated that ONC213 targets leukemic stem cells in patient-derived xenograft mouse models, is well tolerated and combines synergistically with Bcl-2 inhibitor Venetoclax. Dr. Ge recently received a grant from the Kids Without Cancer and the Children’s Hospital of Michigan Foundation to further determine the mechanism of action of ONC213 and enable biomarker selection for clinical studies.

"Our team at the Karmanos Cancer Institute is excited by the potential of ONC213 as a new type of cancer therapy," said Dr. Yubin Ge. "We look forward to continuing development of this novel agent as it makes its way towards the clinic."

On April 29, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, reported that the first patient has been dosed in a phase 3 randomized and multi-center clinical study in Taiwan to evaluate MorphoSys’s investigational human CD38 antibody MOR202/TJ202 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma (Press release, MorphoSys, APR 29, 2019, View Source [SID1234556333]). I-Mab has exclusive rights for development and commercialization of MOR202/TJ202 in China, Taiwan, Hong Kong and Macao.

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"The initiation of our first phase 3 trial represents another important milestone in advancing MOR202/TJ202 towards registration with the hope of providing more therapeutic options for multiple myeloma patients globally. With planned enrollment of 291 patients, this will be a broad trial of this second most common blood cancer worldwide," said Dr. Joan Shen, M.D., Head of R&D at I-Mab. "In parallel with our pivotal phase 2 trial of MOR202/TJ202 in combination with dexamethasone, the phase 3 study will further assess the efficacy of MOR202/TJ202 as a potential second line treatment in multiple myeloma."

Under I-Mab’s fast-to-market development strategy, the phase 3 study, if successful, could lead to a biologics license application (BLA) in Greater China. The randomized, open-label, parallel-controlled, multicenter study will be conducted in mainland China and Taiwan to evaluate the efficacy and safety of the combination of MOR202/TJ202 plus lenalidomide (LEN) and dexamethasone (DEX) versus the combination of LEN and DEX in patients with relapsed or refractory multiple myeloma who received at least one prior line of treatment. The primary endpoint is to evaluate the progression-free survival (PFS) comparing the efficacy of MOR202/TJ202 plus LEN/DEX versus LEN/DEX.

The dosing of the first patient triggers a milestone payment of USD 3 million to MorphoSys.

"We are delighted that our partner I-Mab has started a phase 3 trial of MOR202/TJ202 in combination with lenalidomide in Asia in addition to the ongoing phase 2 trial of MOR202 in combination with dexamethasone. We see a high medical need for the treatment of patients with multiple myeloma in the Chinese region and look forward to supporting I-Mab in developing this investigational compound for these patients," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG.

With MorphoSys’s support through a licensing agreement in November 2017, I-Mab is currently leading the clinical development of MOR202/TJ202 in Greater China, including mainland China, Hong Kong, Macao and Taiwan. In addition to Taiwan, I-Mab has filed an investigational new drug (IND) application to China’s National Medical Products Administration in August 2018. Previously on March 20, 2019, MorphoSys and I-Mab announced the first patient dosing of MOR202/TJ202 in a phase 2 multi-center clinical study in Taiwan in patients with relapsed or refractory multiple myeloma.

About MOR202/TJ202
MOR202/TJ202 is an investigational human monoclonal antibody derived from MorphoSys’s HuCAL antibody technology. The antibody is directed against CD38 on the surface of multiple myeloma cells, which has been characterized as one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. According to its suggested mode of action, the antibody recruits cells of the body’s immune system to kill the tumor through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The antibody does not involve complement dependent cytotoxicity, or CDC, an additional immune mechanism involved in tumor cell killing. Scientific research suggest that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on an exclusive regional licensing agreement signed in late 2017, I-Mab owns the exclusive rights for development and commercialization of MOR202/TJ202 in China, Taiwan, Hong Kong and Macao.

On April 29, 2019 NexImmune and the Multiple Myeloma Research Foundation (MMRF) reported that they have entered into a partnership to advance a promising new therapy into clinical trials for multiple myeloma patients (Press release, NexImmune, APR 29, 2019, View Source [SID1234554879]).

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The MMRF’s newly formed Myeloma Investment Fund aims to attract the most promising companies and technologies to the field to advance new therapies for myeloma patients. The MIF has made an equity investment in NexImmune to help support the initial clinical development of NEXI-002, which is one of the company’s lead product candidates, and to help further develop the Company’s Artificial Immune Modulatory (AIM) technology platform.

"Regrettably, multiple myeloma remains an incurable malignancy. Patients who are refractory to standard treatments, or who have relapsed disease after at least three prior therapies, face a very poor prognosis. Newly approved, targeted agents have significantly improved short-term outcomes for these patients, however, most will eventually develop drug resistance and succumb to their disease within one year. This highlights the need for novel therapies with curative potential," said Scott Carmer, President and CEO of NexImmune. "That’s why we are very excited to partner with the MMRF to make our AIM adoptive cellular therapy (ACT) available to this specific patient population".

NexImmune is advancing immunotherapy products based on the Company’s proprietary Artificial Immune Modulatory (AIM) nanotechnology platform. The AIM technology enables simultaneous enrichment, expansion and priming of cytotoxic CD8+ T cells directed against multiple tumor-associated antigen (TAA) targets across a broad range of both solid and hematologic malignancies.

NEX-I002 is designed to generate cytotoxic T cells directed against multiple tumor antigens associated with MM. The Company has completed pre-IND discussions with the FDA, and expects to submit an IND to support this Phase I/II clinical trial in 3Q2019.

"Investments made by the Myeloma Investment Fund underscore the commitment of the MMRF to bring the most promising immunotherapy agents to myeloma patients as quickly as possible," commented Paul Giusti, President and CEO of the MMRF. "We chose to partner with NexImmune because of the potential for this technology to benefit highly refractory patients who have limited treatment options and significant unmet need."