On January 4, 2019 OncoNano Medicine, Inc. reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for ONM-100, an intravenously administered imaging agent to detect tumors and metastatic lymph nodes in solid cancers during surgery (Press release, OncoNano Medicine, JAN 4, 2019, View Source [SID1234532467]). In addition, OncoNano received Fast Track designation from the FDA for ONM-100.

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ONM-100 is the first product from a platform based upon the OncoNano’s library of unique micelles that respond to pH variability. Specifically, ONM-100 is delivered to the tumor and subsequently fluoresces in the acidic tumor microenvironment, which will allow surgeons to visualize the tumor during surgery using existing infrared-based surgical cameras. The OncoNano micelle platform is also being used to develop therapeutics, cancer nanovaccines and immune therapies. OncoNano is currently concluding the Phase 1 clinical trial for ONM-100 in the Netherlands.

"These two positive responses from the FDA reflect the progress that we have made on ONM-100," said Kathy Rath, Vice President, Regulatory Affairs at OncoNano Medicine. "The Fast Track designation will allow us to have an ongoing, open dialogue with the FDA with the goal to make this important technology available to surgeons and their patients at the earliest possible time."

"We are excited for the opportunity to work closely with the FDA while developing this critical solution to the problems surgeons face every day," said Yalia Jayalakshmi, Vice President, Clinical Development at OncoNano Medicine. "With these responses and the emerging clinical data demonstrating the potential of the product in multiple types of solid tumors, including breast, head and neck, esophageal and colorectal cancers, we are well positioned to advance ONM-100 into a Phase 2 clinical study in 2019."

On January 4, 2019 Triumvira Immunologics Inc., reported that it will present at Biotech Showcase 2019, to be held January 7–9, during the most important week for healthcare investors at the Hilton San Francisco Union Square (Press release, Triumvira Immunologics, JAN 4, 2019, View Source [SID1234532484]).

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Paul Lammers, MD, MSc, President and Chief Executive Officer, will present at Biotech Showcase as follows:

Date: Monday, January 7, 2019
Time: 1:45PM (PST)
Room: Franciscan D, Level Ballroom
Venue: Hilton San Francisco Union Square Hotel, 333 O’Farrell Street, San
Francisco, CA (United States)
Presentation: Triumvira Immunologics Company Overview and Progress in Key Programs/Technology

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

"We are delighted that Triumvira Immunologics will be presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is the perfect platform for life science companies to showcase their innovation and seek out their next deal. We are thrilled to, once again, be hosting what we believe will be the great strategic networking opportunity of 2019."

About Biotech Showcase
Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives in one place during the course of one of the industry’s largest annual healthcare investor conferences. Investors and biopharmaceutical executives from around the world gather in San Francisco during this bellwether week which sets the tone for the coming year. Now in its eleventh year, this rapidly growing conference features multiple tracks of presenting companies, plenary sessions, workshops, networking, and an opportunity to schedule one-to-one meetings. Biotech Showcase is produced by Demy-Colton and EBD Group. Both organizations have a long history of producing high-quality programs that support the biotechnology and broader life sciences industry.

On January 4, 2019 Generex Biotechnology Corporation (OTCQB:GNBT) is reported to provide an update on operational and strategic developments at NuGenerex Immuno-Oncology (previously Antigen Express), a wholly-owned subsidiary (Press release, Generex, JAN 4, 2019, View Source [SID1234532468]).

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The protocol for the Phase II clinical trial of pembrolizumab (Keytruda) in combination with the AE37 Peptide Vaccine in patients with metastatic triple negative breast cancer is under review at the Institutional Review Board (IRB) with oversight of this NSABP Foundation managed study. Site selection has begun, and study drugs are being packaged for shipment to study sites.

"With the initiation of the AE37/PD-1 Inhibitor combination trial and the advancement of the company’s clinical development partnership with Shenzhen BioScien for AE37 in prostate cancer, we have validated the Ii-Key technology, as a viable immunotherapy platform," said Richard Purcell, SVP of R&D at Generex. "The Ii-Key can activate a CD-4 T-cell immune response against any peptide to which it is linked. Given the advances in immunotherapy in the last couple of years, and the potential combinations with checkpoint inhibitors like pembrolizumab, NuGenerex Immuno-Oncology is positioned, with years of clinical experience in immunotherapy of cancer, to explore a range of opportunities for the Ii-Key technology in personalized medicine using tumor-associated antigens and neo-antigens for tumor-specific cancer therapy. To that end, Generex has initiated partnering discussions with synergistic companies to explore co-development and collaborative R&D opportunities for immunotherapeutic product development."

NuGenerex Immuno-Oncology Spin-Out & Stock Dividend

Generex President & Chief Executive Officer Joe Moscato stated, "NuGenerex Immuno-Oncology is being established to not only advance the NuGenerex Immuno-Oncology core technology, but also to expand the Company’s portfolio in the field of immunotherapy and personalized medicine through partnerships and acquisitions. As part of our strategy, we are exploring opportunities to spin-out NuGenerex Immuno-Oncology as a separate DTC-eligible SEC registered company." Mr. Moscato stated that following the spin-out, NuGenerex Immuno-Oncology is expected to seek to list its common stock on a national stock exchange. "The spin-out of NuGenerex Immuno-Oncology into a separate, publicly traded entity has been the focus of the Generex strategic development plan in cancer drug development," Mr. Moscato indicated. "The Ii-Key technology has been underappreciated for too long, as we have advanced the immunotherapy field with the largest breast cancer vaccine study ever conducted, and now the results of that trial have led to an exciting combination Phase II trial with AE37 plus Ketruda in triple negative breast cancer. We believe this spin-out will help to unlock the true value of the Ii-Key technology for our stockholders as it creates a pure play in immunotherapy, which will foster investment and collaboration."

The spin-out will be accomplished by the issuance of one or more dividends of NuGenerex Immuno-Oncology stock to Generex stockholders. The record dates in respect of such dividends are yet to be determined and will be announced in due course. The stock dividends will enable Generex stockholders to directly participate in the promising future of NuGenerex Immuno-Oncology as well as create a large shareholder base with the potential for substantial liquidity on an immediate basis. That liquidity will be further enhanced should NuGenerex Immuno-Oncology be successful in attaining a national stock exchange listing, and should provide NuGenerex Immuno-Oncology with ready access to the capital markets to finance its on-going clinical and regulatory initiatives.

Following the issuance of stock dividends, Generex expects to retain a controlling interest in NuGenerex Immuno-Oncology, but the exact proportion of the shares to be held by Generex has not yet been determined.

Subject to market conditions and the satisfaction of regulatory requirements, it is expected that the NuGenerex Immuno-Oncology spin-out will occur sometime following the upcoming Annual Meeting of the Generex stockholders. Generex has formed a committee to seek qualified professionals to populate NuGenerex Immuno-Oncology’s Board of Directors, Scientific Advisory Board, and executive management team. Further announcements in respect of the status of the spin-out are expected to be made over the course of the coming months.

On January 4, 2019 Synaffix B.V. reported it has entered into a license agreement with Mersana Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet need (Press release, Synaffix, JAN 4, 2019, View Source [SID1234532485]). This agreement provides Mersana access to Synaffix’s industry-leading site-specific GlycoConnect ADC technology that has consistently demonstrated an ability to improve both the safety and the efficacy profiles of ADC product candidates. Synaffix is eligible to receive upfront and milestone payments on a per-target basis with a projected total deal value of $295 million, plus royalties­­.

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Under the terms of the agreement, Mersana has been granted a non-exclusive license to incorporate GlycoConnect into one of its ADC development candidates, as well as an option to expand to additional programs. This agreement follows a research collaboration between the two companies that was centered around multiple product candidates.

"After evaluating several site-specific conjugation platforms, we have chosen Synaffix’s GlycoConnect technology for use in future ADC candidates," said Anna Protopapas, President and Chief Executive Officer of Mersana. "We are excited about the potential of this technology as it is designed not to require additional antibody engineering or cell-line modifications, which would offer us the potential to create site-specific antibodies for use in our ADCs when required."

"We are particularly excited to enter into this agreement with a leading company in the field of ADCs such as Mersana," said Peter van de Sande, CEO of Synaffix, who added "This collaboration is another testimony of the additional value that GlycoConnect is able to provide to already cutting-edge ADC technologies, thereby enabling novel medicines that are uniquely positioned to address areas of unmet medical need."

Per the agreement, Mersana is responsible for the research, development, manufacturing and commercialization of any resulting ADC product while Synaffix will supply components that are specifically related to its proprietary GlycoConnect technology.

About GlycoConnect

The proprietary GlycoConnect technology of Synaffix is a platform ADC technology that utilizes proprietary enzymes and metal-free click conjugation to stably attach ADC payloads specifically to the native glycan of any antibody, a privileged site for ADC applications. This approach can be applied directly to an existing antibody without any DNA and or protein engineering and is compatible with all ADC payload classes. The growing experience of Synaffix and its collaboration partners continues to confirm the ability of GlycoConnect to consistently generate ADCs that are more effective and better tolerated when compared to the three major clinical-stage ADC conjugation technologies.

On January 4, 2019 Adaptive Biotechnologies, an immune-driven medicine company, reported that it will enter into a worldwide collaboration and license agreement with Genentech, a member of the Roche Group, to develop, manufacture and commercialize novel neoantigen directed T-cell therapies for the treatment of a broad range of cancers (Press release, Adaptive Biotechnologies, JAN 4, 2019, View Source [SID1234532469]). The collaboration will combine Genentech’s global cancer immunotherapy research and development leadership with Adaptive’s proprietary T-cell receptor (TCR) discovery and immune profiling platform (TruTCR) to accelerate a transformational new treatment paradigm of tailoring cellular therapy for each patient’s individual cancer.

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"We are thrilled that Genentech has selected Adaptive as a partner to develop neoantigen directed T-cell therapies, a personalized approach to cellular therapy," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "Genentech brings an industry-leading team of scientists and drug development experts who could potentially enable our patented TCR discovery and immune profiling platform to help as many patients as possible."

Adaptive offers a pioneering technology platform to rapidly identify T-cell receptors (TCRs) that can most effectively recognize and directly target specific neoantigens, which are proteins generated by tumor-specific mutations not present in normal tissues. Through this partnership, Adaptive will utilize the investigational TCR discovery platform to identify the optimal TCRs to most effectively target each patient’s neoantigens for treatment. Genentech will engineer and manufacture a personalized cellular medicine to deliver to each patient. The goal is to harness the vast majority of therapeutically relevant, patient-specific neoantigens and advance the next generation of cellular therapies in oncology.

"We believe targeting neoantigens could be the most effective approach for harnessing a person’s immune system to fight cancer," said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. "This partnership, which combines Adaptive’s pioneering platform for identifying T-cell receptors with Genentech’s cancer immunology expertise, has the potential to change the way cancer is treated and bring us one step closer to truly personalized healthcare."

"Cellular therapy approaches in cancer have been limited by the inability to effectively screen and translate the immune response to patient-specific neoantigens. Accurate recognition of such neoantigens is a major driver in the activity of novel immunotherapies," added Harlan Robins, Ph.D., head of innovation and co-founder of Adaptive Biotechnologies. "Given Adaptive’s unique ability to read and access the immune system at unprecedented scale and precision, Adaptive and Genentech can potentially jointly develop a patient-specific approach to treating cancer."

Under the terms of the agreement, Adaptive will receive $300 million in an initial upfront payment and may be eligible to receive more than $2 billion over time, including payments upon achievement of specified development, regulatory and commercial milestones, and royalties on sales. Genentech will have responsibility for clinical, regulatory, and commercialization efforts, and Adaptive will be responsible for patient-specific screening on a global basis.

Adaptive will continue to use its TCR discovery and immune profiling platform to collaborate in the development of cellular therapies in other disease areas, including autoimmune conditions and infectious diseases.

The completion of the agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to occur in the first quarter of 2019.

Chad Robins, Adaptive CEO, will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, January 8 at 11:30 am PT/2:30 pm ET. Robins will also participate in a panel presentation, Reinventing the Disease Continuum Through Precision Health, on January 7, 2019 at 5:00 pm PT/8:00 pm ET to discuss the impact of immune profiling on the future of immune-driven medicine.

About the TruTCR Screening Platform in this Collaboration

Adaptive’s TruTCR screening platform enables the discovery of TCRs against any type of clinically relevant antigen at high throughput. The platform can be used to identify antigens that are shared among patients as well as those that are specific to individual patients. In this collaboration, TruTCR will be used to identify and characterize clinical-grade superior TCRs for attractive antigen binding and tumor cell killing activity plus safety properties by querying hundreds of antigens simultaneously with high sensitivity. To initiate clinical development, the collaboration will first leverage Adaptive’s growing library of well-characterized antigen-specific TCRs that have been screened against thousands of known cancer antigens in patients. The ultimate goal, however, is to screen and select a patient’s own potent TCRs targeting their own most relevant neoantigens as a personalized therapy. This individual patient screening process will be implemented as part of the manufacturing process for each treated patient to custom tailor a cell therapy medicine for that specific patient’s cancer.