On July 9, 2020 Harbour BioMed (HBM) reported completion of its Series C financing of $102.8 Million to accelerate development of its growing portfolio of next generation biologics targeting cancer, immunologic diseases, and COVID-19 (Press release, Harbour BioMed, JUL 9, 2020, View Source [SID1234561794]). The financing was led by new investors, Hudson Bay Capital; followed by OrbiMed, Country Garden VC, GTJA Investment Group, Octagon Capital, and Sage Partners, with additional investment from existing investor Greater Bay Area Investment Fund. The round follows a $75 million Series B+ financing the Company completed in March 2020.

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"Participation of new and current investors underscores enthusiasm for our clinical portfolio, our antibody discovery and development engine, as well as our strategy to build a leading global biopharmaceutical company," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "We have made great progress with our clinical programs and multiple promising, bi- and monospecific antibodies from our discovery engine that are rapidly moving towards clinical trials. The funding will support final development and initial commercialization of our late stage portfolio and advancement of both our earlier stage discovery and preclinical molecules." The Company has over 30 programs in its pipeline, including an anti-CD73 monoclonal antibody (mAb), a bi-specific anti-BCMAxCD3 mAb and, newly announced, an anti-CCR8 mAb, all in preclinical development and targeted at a variety of cancers.

Ms. Jo-Wen Lin, Asian Healthcare Portfolio Manager at Hudson Bay Capital, said: "We are pleased to support Harbour BioMed and its management team to further develop its pipeline of leading immunology and oncology drugs. We believe the Company’s innovative approach, with next generation technologies that target unmet medical needs, present an exciting growth opportunity."

Ms. Iris Wang, Managing Director of OrbiMed Asia, commented, "Harbour BioMed has built an impressive clinical pipeline and at the same time created a solid foundation for next generation therapeutics through its transgenic mouse platforms. These preclinical programs along with the Company’s clinical assets create new opportunities targeting major indications with substantial global medical needs."

With a patient-centric approach to address unmet medical needs across the world, HBM currently has five products in clinical development. Key programs include:

· HBM9161 (Batoclimab) is a first-in-class fully human anti-FcRn mAb, that significantly reduces pathogenic IgG, with potential to become a portfolio-in-a-product for a variety of autoimmune indications. HBM has received IND approval from China’s National Medical Products Administration (NMPA) and is conducting clinical trials in myasthenia gravis, neuromyelitis optica spectrum disorder, immune thrombocytopenia and Graves’ ophthalmopathy.

· HBM9036 (Tanfanercept) is a novel TNF receptor-1 fragment to treat dry eye disease by inhibiting TNFα. Phase 2 clinical trials with the drug in the U.S. and China have shown promising signals for both clinical efficacy and safety in treating moderate-to-severe dry eye disease. Preparations for the Phase 3 registration trial in China are currently underway.

· HBM4003 is a next-generation anti-CTLA4 mAb in Phase 1 clinical studies in Australia for the treatment of advanced solid tumors. The molecule is the first of several fully human mAbs in development at HBM based on the Company’s heavy chain only (HCAb) technology. HBM4003 has shown extremely promising anti-tumor activity and a favorable safety profile in preclinical studies, suggesting it has potential in both mono- as well as combination therapy with other immuno-oncology drugs. The U.S. FDA recently cleared HBM’s IND to initiate US clinical trials; the NMPA has accepted an IND application for HBM4003 to begin clinical trials in China.

HBM is also building a robust COVID-19 pipeline. Along with Utrecht University and Erasmus Medical Center, HBM recently announced a research collaboration with AbbVie for a monoclonal antibody termed 47D11 for therapeutic/prophylactic use against SARS-CoV2. This fully human antibody, designed to facilitate its development and minimize immune-related side effects, targets a conserved region of the virus’ spike protein, and has been shown in studies published in Nature Communications to block infection by the SARS-CoV-2 (commonly known as COVID-19) and SARS-CoV. This cross-neutralizing feature of the antibody may have potential in mitigating diseases caused by future-emerging related coronaviruses. This and other mAbs in its COVID-19 pipeline are also being currently tested for diagnostic purposes. In addition, the Company also has an ongoing collaboration with Mt. Sinai Health System (New York) for discovering antibodies against SARS-CoV2 using its proprietary H2L2 Harbour Mice platform.

On July 9, 2020 IDEAYA Biosciences, Inc. (NASDAQ:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, reported First-Patient-In (FPI) in the Phase 1 combination study of IDE196 and binimetinib, a MEK inhibitor, in metastatic uveal melanoma (MUM) (Press release, Ideaya Biosciences, JUL 9, 2020, View Source [SID1234561806]). The clinical combination of IDE196 and binimetinib is being evaluated by IDEAYA with binimetinib being supplied by Pfizer pursuant to a clinical trial collaboration and supply agreement.

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In the MUM setting, IDEAYA’s clinical development strategy focuses on rational combinations, including MEK, and supporting studies through collaborations, such as the Pfizer clinical trial collaboration and supply agreement. IDEAYA’s strategic objective is to enhance the clinical activity of IDE196 through potential synergistic combinations. In the non-MUM GNAQ/11 hotspot mutation basket trial, including skin melanoma, IDEAYA will continue to evaluate IDE196 monotherapy and potential combinations, such as with binimetinib.

At the AACR (Free AACR Whitepaper) Virtual Annual Meeting II held on June 22-24, 2020, IDEAYA presented an abstract on the preclinical evaluation of IDE196 plus MEK combination, entitled "Analysis of drug combinations with the PKC inhibitor IDE196 support dual MEK and PKC inhibition as a rational combination in metastatic uveal melanoma."

"Our preclinical studies with IDE196 and MEK presented at AACR (Free AACR Whitepaper) support our clinical development strategy to focus on combinations as the most promising approach for the MUM indication," said Mick O’Quigley, Vice President, Head of Development Operations. "In addition, we continue to evaluate IDE196 monotherapy and potentially also combinations in the GNAQ/11 hotspot mutation basket trial, in non-MUM indications such as skin melanoma."

IDEAYA anticipates interim data from the MEK combination study in late 2021 to early 2022, at which time the company will evaluate a potential registrational path for MUM and a potential partnership.

On July 9, 2020 Sheba Medical Center at Tel HaShomer and Immunicom, Inc. reported that they are initiating a ground-breaking clinical trial to evaluate the clinical effectiveness of the Immunicom LW-02 plasma filtration device as a monotherapy and in combination with an anti-PD-1 immune checkpoint inhibitor (Press release, Immunicom, JUL 9, 2020, View Source [SID1234561805]). Sheba Medical Center, which is located in metro Tel Aviv, Israel, is the largest medical facility of its kind in the Middle East and was recently ranked as one of the top 10 Best Hospitals in the World by Newsweek magazine.

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"Immunicom is significantly accelerating its evaluation of the ImmunopheresisTM therapy by teaming up with Sheba Medical Center and its world-renowned principal oncology investigator, Professor Gal Markel. This is the first trial where we are combining our novel Immunopheresis therapy with a market-leading checkpoint inhibitor immunotherapy drug," said Amir Jafri, Founder and CEO, Immunicom, Inc.

Utilizing a process similar to dialysis, Immunopheresis therapy is a non-pharmaceutical solution for treating cancer by using the LW-02 device to remove the harmful excess of immune-suppressive cytokines inhibitors produced by cancers to block the natural immune response to kill these tumors. The LW-02 device has received Breakthrough Device designation for stage IV metastatic cancer from the U.S. Food and Drug Administration (FDA).

The 40-patient clinical study conceived and led by Principal Investigator, Professor Gal Markel, Director of the Ella Lemelbaum Institute for Immuno-Oncology at Sheba Medical Center, will treat resistant metastatic melanoma, triple-negative breast cancer, renal cell carcinoma and non-small cell lung cancer patients.

"Immunicom’s innovative treatment approach neutralizes cancer’s ability to block the patient’s natural immune defense mechanisms, which are usually exhausted when the patient is suffering from metastatic disease," said Markel. "The approach is based on selective extraction of soluble proteins that shield tumors, to activate the patient’s immune system to fight cancer aggressively. This novel methodology represents a sea change from traditional standards-of-care and offers the potential for achieving much better clinical outcomes with fewer treatment side effects. Hagit Harati, head nurse and co-founder of the newly established Immunopheresis Unit at Sheba, will be responsible of trial execution."

The trial was made possible via a grant from the Samueli Foundation, which supports integrative health initiatives in the U.S. and Israel, and funded the establishment of the Integrative Immuno-Oncology Program (I2O) at Sheba’s Ella Institute, led by Professor Markel.

Dr. Wayne Jonas, Director of Samueli Foundation’s Integrative Health Program, has had a particular interest in this therapy’s potentially unique ability to filter out some of the key biologic facilitators of cancer growth for many years. This drove Jonas and the Samueli Foundation to collaborate with Immunicom to co-fund Professor Markel’s clinical evaluation of this novel new immunotherapy approach for treating cancer.

For an overview of how this breakthrough technology works see: View Source Immunopheresis is an investigational therapy that has not yet been approved for use by the FDA or proven safe and effective for the treatment of any cancers. In addition to this new clinical evaluation of Immunopheresis at Sheba Medical Center to treat several cancers, Immunopheresis is currently being evaluated in Poland to treat triple-negative breast cancer (TNBC) in an ongoing clinical trial.

On July 9, 2020 Transgene (Paris:TNG) and Hypertrust Patient Data Care reported as a world premiere the first productive blockchain solution for clinical trials of personalized healthcare, leveraging the Hypertrust X-Chain for Clinical Trials product (Press release, Transgene, JUL 9, 2020, View Source [SID1234561804]). The cloud-based solution monitors and orchestrates the supply chain processes of Transgene’s AI-enhanced TG4050 individualized therapeutic vaccine based on the myvac technology, against ovarian, head and neck cancer providing an immutable audit trail throughout the treatment process.

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The innovative collaboration between Transgene and Hypertrust marks a milestone in the ongoing fight against cancer. The blockchain-based Hypertrust X-Chain solution supports Transgene’s personalized immunotherapies comprehensively, ensuring a trustworthy process in the background of the medical treatment. All emerging personalized treatments have a massive need for trustworthy and decentralized solutions, due to the strong cross-company collaborative nature of the production process.

Transgene’s first individualized immunotherapy product candidate is based on the myvac technology. It is currently evaluated in two ongoing clinical trials, including patients in Europe and in the USA. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) that are identified and selected using state-of-the-art artificial intelligence capabilities. myvac-based products are designed to stimulate the patient’s immune response, to recognize and destroy tumor cells based on their own mutations. This individualized immunotherapy is developed specifically for each patient.

"We have set up multiple collaborations around the world to allow each patient’s anticancer therapy to be designed in a timely manner. Blockchain technologies are a perfect tool to ensure that the patient’s genetic data are protected while ensuring that all the interventions of our partners are both smooth and tracked. We were very happy to collaborate with Hypertrust and together set up this novel process, demonstrating once again Transgene’s ability to be at the forefront of innovation", commented Eric Quéméneur, Pharm.D., Ph.D., Executive VP, Chief Scientific Officer of Transgene.

"We are very proud to present with our partner Transgene the world’s first productive blockchain solution for clinical trials of personalized healthcare. The combination of Transgene’s innovative and AI-enhanced TG4050 cancer vaccine, combined with the security and workflow orchestration features of our platform provides the optimum support for a highly personalized cancer treatment process", says Andreas Göbel, CEO of Hypertrust Patient Data Care.

Especially in clinical trials of personalized healthcare there is an essential need for an immutable audit trail, which is created by different parties throughout the supply and production process. Blockchain technologies bring a high level of trust, as it allows a total transparency on how the data were modified throughout the process and provide additional protection in an age of increasing cyberthreats.

Hypertrust X-Chain for Clinical Trials by Hypertrust Patient Data Care is a market-leading solution for the orchestration and documentation of clinical trials for personalized healthcare. It ensures the chain of identity and custody for personalized treatments in the context of clinical trials. The decentralized platform leverages blockchain technology, to provide closed-loop supply chain monitoring and orchestration, based on a workflow process definition. The solution provides an immutable and tamper-proof audit trail of all recorded data throughout the treatment. Also, it allows the migration towards the commercial scale solution "X-Chain for Commercialized Treatments".

On July 9, 2020 Indapta Therapeutics, Inc., a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf, non-engineered, allogeneic FcRγ-deficient natural killer (G-NK) cell therapy to treat multiple cancers, reported an update on its progress in advancing the development of its programs (Press release, Indapta Therapeutics, JUL 9, 2020, View Source [SID1234561803]).

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"Since we emerged from stealth mode in January and announced our founding management team, scientific advisors and strategic partnership with Lonza, we have made substantial progress in advancing our next-generation, off-the-shelf, allogeneic immuno-oncology therapy," said Guy DiPierro, founder and chief executive officer of Indapta Therapeutics. "We have achieved several preclinical, regulatory and manufacturing milestones for our G-NK program, all of which are helping us move our novel program forward towards an IND submission and the initiation of a first-in-human trial in summer 2021."

Recent Program Updates

Presented data from its G-NK cell therapy program in a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II in June. In the preclinical study, clinical models injected with human multiple myeloma cells were treated with a monoclonal antibody daratumumab or elotuzumab, which are FDA-approved for multiple myeloma, either alone or in combination with Indapta’s G-NK cells or comparator cells. In response, the G-NK cells demonstrated superior antibody-dependent cellular cytotoxicity (ADCC) and increased survival. G-NK cells show significantly enhanced expression of interferon-gamma (IFNγ) and tumor necrosis factor alpha (TNFα) compared with conventional natural killer (NK) cells.
Submitted a pre-Investigational New Drug (IND) briefing package to the U.S. Food and Drug Administration (FDA) for its G-NK cells. Indapta participated in a Type C meeting with the Agency and received written feedback outlining a clear and detailed roadmap for an IND application and for Chemistry, Manufacturing and Controls (CMC) activity.
Successfully completed the Stage 1 manufacturing transfer to Lonza, which conducted feasibility manufacturing runs at its Houston facility. Lonza will now initiate the next step of process development for the manufacturing of off-the-shelf, allogeneic G-NK cell therapy under current good manufacturing practices (cGMP) for use in the IND submission.
Indapta completed a persistence trial at the University of Houston which determined its G-NK cells remained in the body in both cryopreserved and frozen forms without any issues of functional exhaustion or phenotypic changes in vivo. Results demonstrated that Indapta’s cryopreserved G-NK cells remained in the body more than 26 times longer than cryopreserved conventional NK cells. Indapta also collected new data on cancer killing compounds including TNFα, IFNγ, CD107a, perforin and granzyme, all of which were expressed in higher amounts as a result of Indapta’s G-NK cell therapy.
Granted broad intellectual property protection through an exclusively-held patent related to manufacturing processes, G-NK cell selection and G-NK cell treatment used as a monotherapy and in combination with multiple compounds in multiple oncology and viral indications.
About Indapta’s G-NK Cell Therapy
Indapta Therapeutics is developing a universal, allogeneic G-NK cell therapy designed to substantially improve the cytotoxicity of monoclonal antibody therapy in multiple cancers. G-NK cells are a specific and potent subset of NK (natural killer) cells with specialized anti-tumor activity resulting from an epigenetic change, rather than engineering. Indapta has further enhanced G-NK cells via specific G-NK cell subset selection and its proprietary manufacturing process which, when combined, produce a G-NK cell therapy that demonstrates higher efficacy, persistence and enhanced cryopreservation.

When a monoclonal antibody binds to the tumor target and to Indapta’s G-NK cell therapy product, it initiates the release of dramatically more cancer killing compounds than conventional NK cells, allowing for increased efficacy and potentially less frequent dosing. Indapta’s off-the-shelf G-NK cell therapy is further differentiated from other NK cell therapies in that it is a cell banked product with low variability. In vivo studies have demonstrated the safety of Indapta’s G-NK cell therapy.