On October 14, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported having received a communication from the European Patent Office (EPO) informing the Company of its intent to grant a new patent strengthening the European protection of compounds sourced from its platON platform (Press release, Onxeo, OCT 14, 2019, View Source [SID1234540989]).

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This new patent strengthens the patent portfolio around AsiDNA, the Company’s first-in-class DNA Damage Response (DDR) inhibitor. It protects AsiDNA and related compounds, as such and for their therapeutic use, in particular for the treatment of cancers, alone or in combination with other agents such as radiotherapy, chemotherapy or other tumor DNA-damaging agents.

"This intent-to-grant, which was obtained very quickly after filing the application, illustrates the value of our platON platform through its ability to generate new patentable compounds and confirms the highly innovative nature of the products resulting from our technology to block the signaling pathways involved in the repair of tumor DNA," said Françoise Bono, Chief Scientific Officer of Onxeo.

This patent will provide a term of protection valid until mid-2031, which could be further extended until 2036 via the supplementary protection certificate (SPC) system. It completes the already robust set of 9 patent families securing the protection of AsiDNA and its related compounds.

On October 14, 2019 ImmunoPrecise Antibodies reported that it will attend the Festival of Biologics held at the Congress Centre, Basel October 15-19th (Press release, ImmunoPrecise Antibodies, OCT 14, 2019, View Source [SID1234540988]). The Festival of Biologics is a combination of four incredible conferences, the European Antibody Congress, the World Immunotherapy Congress, the World Biosimilar Congress, and the Clinical Trials World Congress. ImmunoPrecise Antibodies is excited to be exhibiting at the European Antibody Congress.

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Dr. Jennifer Bath and Dr. Stefan Lang will be available at booth 42 to discuss with attendees how ImmunoPrecise Antibodies’ wide range of products and services, including the new Abthena bispecific antibody discovery platform and Artemis Intelligence Metadata (AIM) can decrease turnaround time and risk while promoting clinical success.

On October 14, 2019 Femtogenix Ltd, a UK biotechnology company developing the next generation of DNA-interactive Antibody Drug Conjugate (ADC) payloads, reported data verifying the favourable toxicity profile and potent efficacy of its Pyridinobenzodiazepine (PDD) ADC payload platform in tumour cell models (Press release, Femtogenix, OCT 14, 2019, View Source [SID1234540987]). The data was presented by Professor David Thurston, Chief Scientific Officer, Femtogenix, on 11 October at World ADC 2019 in San Diego, CA.

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ADCs are capable of delivering highly cytotoxic payloads directly at the tumour site. When attached to antibodies or other targeting moieties, Femtogenix’s novel PDD platform allows reversible/irreversible DNA minor groove binding, in a sequence-interactive manner, leading to highly targeted cytotoxicity towards tumour cells. The payloads are designed to have a novel mechanism of action and IP space compared to existing DNA-interactive payloads, to have minimal hydrophobicity, and to be resistant to P-Glycoprotein pumps in tumour cells.

These new data describe details of Femtogenix’s latest payload molecules for ADC use, and demonstrate that high potency mono-alkylators derived through the PDD platform have a favourable toxicity profile in rats, coupled with potent in vivo efficacy (sub mg/kg doses) and excellent tolerability (i.e., MTDs > 10 mg/kg) when conjugated to antibodies1. Femtogenix also introduced a new class of DNA cross-linking ADC payloads at the World ADC conference, based on its proprietary PDD platform, with potent in vivo efficacy and substantially enhanced tolerability profiles compared to competing technologies.

Dr Christopher Keightley, Chief Executive Officer of Femtogenix, commented: "These data show that our PDD technology overcomes many of the limitations of existing approaches to ADC payloads. The toxicity profile and ease of conjugation of the PDD mono-alkylators, along with their novel mechanism of action and significant in vitro and in vivo efficacy, suggest they represent a promising new payload class. We are delighted with the progress as we conclude significant collaborations with pharma partners who will help us achieve the practical application of our innovative approach to a new generation of ADCs."

Femtogenix has generated extensive data on the specific interaction of these payload molecules with DNA using a variety of biophysical techniques, including DNA footprinting and FRET studies. The molecules have been designed through proprietary molecular modelling methodologies to maximise interaction within the DNA minor groove. The design methodology has led to the creation of molecules with a range of potencies and has also been used to generate novel DNA cross-linking payloads that form unique DNA adduct structures with differing modes of action. Payloads with differing potencies and modes of action may be suitable for particular uses or specific target situations.

1. Professor David Thurston, Scientific Co-Founder and Chief Scientific Officer, Femtogenix: ‘New Developments with the Pyridinobenzodiazepine (PDD) Payload Platform’, 8.40-9.10am, 11 October 2019, World ADC, as part of the talk ‘What Lies Ahead for ADCs’.

On October 14, 2019 SOTIO, together with PPF, and MaveriX Oncology, Inc., reported the investment of PPF Group in MaveriX Oncology Inc., a private biotech company with a proprietary pipeline of targeted, small-molecule cancer chemo-immunotherapeutics (Press release, SOTIO, OCT 14, 2019, View Source [SID1234540986]). PPF has committed to investing $6.5 million in MaveriX Oncology’s ongoing Series A financing contingent on key development milestones. In total, MaveriX is aiming to secure a total of $20 million in funding and the round will remain open for additional investors to join. The proceeds will enable MaveriX to advance the company’s lead program MVX-5005 through IND-enabling studies, and complete first-in-human Phase Ia/Ib clinical trials for the treatment of solid tumors in support of clinical proof-of-concept. The company will also advance further platform programs to drug candidate selection.

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In addition, SOTIO has secured an option to license and co-develop MVX-5005 and related next-generation compounds in Europe, contingent on completion of the first phase I trial. Upon exercise of the option, MaveriX and SOTIO will collaborate and share the costs for development of MVX-5005 and MaveriX will become eligible to receive up to $138 million in development, regulatory and commercial milestones if MVX-5005 is successfully developed in multiple cancer indications in Europe. Further terms on the investment and option to license are not disclosed.

MVX-5005 has been designed to selectively kill cancer cells and eradicate immune suppressive cell subsets known to cause resistance to chemotherapy and immunotherapy. MVX-5005 utilizes a proprietary targeting and activation scaffold, a Small-Molecule Drug Conjugate (SMDC) to improve on the clinical safety and efficacy of a DNA damaging agent which exhibits broad anti-tumor activity including immunomodulatory and immunostimulatory properties. Pre-clinical studies have shown that MVX-5005 exhibits broad single agent anti-tumor activity with a favorable safety profile. MVX-5005 is currently in formal IND-enabling studies. MaveriX anticipates initiating a Phase I clinical study by the end of Q4 2020.

Through the investment, MaveriX will also advance several of its innovative pipeline programs based on the SMDC platform conjugated to other established or novel therapeutics.

Dr. Steven Everett, President and CEO of MaveriX Oncology, said: "We are grateful to the PPF Group for leading the Series A round as we advance our lead program MVX-5005 into the clinic and continue to expand our differentiated SMDC platform. The strong support of PPF and SOTIO enables us to achieve our next step of growth as we aim to quickly bring new and improved treatment options to patients that suffer from cancer."

Dr. Daniel Von Hoff, Physician in Chief and Distinguished Professor at the Translational Genomics Research Institute (TGen) in Phoenix, Arizona, said: "The preclinical data of the lead program of MaveriX is encouraging. Overcoming some of the limitations of current chemotherapy as exemplified by MVX-5005 has great potential across many solid tumors. Together with our experts at TD2, we are very pleased to support development efforts of MaveriX to bring better cancer treatments to patients in need."

Dr. Radek Špíšek, Chief Executive Officer of SOTIO, said: "We believe that the MaveriX SMDC technology approach enables the selective delivery of potent anti-cancer agents directly to tumors. A depleting effect of MVX-5005 on the immunosuppressive cells in the tumor microenvironment represents an additional mechanism of action and indicates that MVX-5005 might act as an efficient chemo-immunotherapy. We are very much looking forward to supporting MaveriX in its efforts to build an innovative oncology company developing first-in-class anticancer agents."

As part of the agreement, Dr. Norbert Prenzel, Head of Business Development and Licensing of SOTIO, will join the board of directors of MaveriX Oncology Inc.

On October 14, 2019 I-Mab Biopharma ("I-Mab"), a China and U.S.-based clinical stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and autoimmune diseases and German biopharma company MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX;Nasdaq: MOR), reported that I-Mab has received Investigational New Drug (IND) clearances from the National Medical Products Administration (NMPA) of China to expand the ongoing phase II and III clinical trials of TJ202/MOR202, MorphoSys’s human monoclonal anti-CD38 antibody for the treatment of multiple myeloma (MM), also to mainland China (Press release, MorphoSys, OCT 14, 2019, View Source [SID1234540982]). I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in China, Taiwan, Hong Kong and Macao.

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I-Mab is currently conducting two clinical trials with TJ202/MOR202 in Taiwan. The phase II study, which was initiated in March 2019, is designed to evaluate the efficacy and safety of TJ202/MOR202 as third-line treatment in patients with relapsed or refractory MM. The phase III study, initiated in April 2019, assesses the efficacy and safety of the combination of TJ202/MOR202 plus lenalidomide (LEN) and dexamethasone (DEX) versus the combination of LEN and DEX in patients with relapsed or refractory MM who received at least one prior line of treatment. Under the fast-to-market development strategy, I-Mab will now be expanding these trials into mainland China.

"Receiving two IND clearances for TJ202/MOR202 from the China NMPA marks an important milestone for us and demonstrates I-Mab’s capability and commitment to the advancement of immunological technology for the market. We will move forward with the clinical development of TJ202/MOR202 in China to bring it to the market as efficiently as possible. I-Mab will continue to expand our portfolio in innovative therapeutics to benefit patients in need," commented Dr. Jingwu Zang, MD., PhD., Founder and Chairman of I-Mab Biopharma.

"We are very pleased that our partner I-Mab now also received the IND clearances for TJ202/MOR202 for China, allowing the expansion of the clinical development of TJ202/MOR202 in multiple myeloma to mainland China," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "There is a high need for alternative treatment options for patients with multiple myeloma in the Chinese region and we look forward to the further development of TJ202/MOR202 by our partner I-Mab in this indication."

About TJ202/MOR202

TJ202/MOR202 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 researche suggests that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on a licensing agreement between MorphoSys and I-Mab signed in November 2017, I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.