CELL AND GENE THERAPY

Kite and Shoreline Biosciences Form Strategic Partnership to Develop Novel Allogeneic Cell Therapies

Kite, Shoreline Biosciences | June 18, 2021

Kite, a Gilead Company, and Shoreline Biosciences, Inc., a biotechnology firm developing intelligently designed allogeneic off-the-shelf, standardized, and targeted natural killer (NK) and Macrophage cellular immunotherapies achieved from induced pluripotent stem cells (iPSC) for cancer and other serious diseases, announced a strategic partnership today to develop novel cell therapies across a variety of indications.

The collaboration will combine Shoreline’s profound experience in iPSC differentiation and genetic reprogramming with Kite’s extensive cell therapy development, commercialization, and manufacturing capabilities to develop new allogeneic candidates for a variety of hematologic malignancies. The collaboration will initially focus on chimeric antigen receptor (CAR) NK targets, with Kite having the option to expand the partnership to include an iPSC CAR Macrophage program for an undisclosed target to be picked after the deal is completed. This agreement comes on the back of Kite’s investment in Shoreline’s recent Series A financing.

“As the pioneer in cell therapy, we are focused on investing in and delivering on the most promising possibilities to improve cell therapy’s therapeutic potential further,” said Mert Aktar, Kite’s Vice President of Corporate Development and Strategy. “We are excited about the potential of Shoreline’s next-generation approach to allogeneic development, as well as how our partnership might accelerate this research across various leukemias and lymphomas.”

“Through this strong partnership, we are thrilled to strengthen our relationship with Kite, which is at the forefront of cancer immunotherapy for more than ten years,” said Kleanthis G. Xanthopoulos, Ph.D., Shoreline Co-Founder, Chairman, and CEO. “The combination of Kite’s experience in CAR T-cell therapies with our cutting-edge iPSC platform has the potential to accelerate Shoreline’s timeline to the clinic, expand our pipeline opportunities, and offer transformative cancer treatment options.”

According to the terms of the agreement, Shoreline will get an initial payment and will be eligible for further payments totaling more than $2.3 billion, as well as royalties based on the accomplishment of specific development and commercial milestones.

About Shoreline Biosciences
Shoreline is a biotechnology firm committed to developing intelligently designed allogeneic off-the-shelf, targeted, and standardized cellular immunotherapies for cancer and other severe illnesses. Shoreline is building a pipeline of natural killer (NK) cell and macrophage-cell treatment options based on its extensive knowledge of iPSC differentiation methods and genetic reprogramming of disease-relevant pathways.

About Kite
Kite, a Gilead Company, is a biopharmaceutical company headquartered in Santa Monica, California, with commercial manufacturing facilities in North America and Europe. Kite’s sole focus is on cell therapy to treat and possibly cure cancer. As the pioneer in cell therapy, Kite has more authorized CAR T indications to help more patients than any other company.

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DIAGNOSTICS

MacroGenics Uses Genedata Profiler to Improve Immunotherapy Development

MacroGenics, Genedata | April 20, 2021

Genedata, the leading supplier of enterprise software solutions for biopharmaceutical R&D, revealed today a long-term collaboration agreement with MacroGenics, a biopharmaceutical firm and emerging pioneer in discovering and commercializing innovative immune-oncology therapeutics. The agreement provides MacroGenics access to Genedata Profiler® as well as consulting services to aid in the platform's accelerated adoption and integration into MacroGenics' R&D infrastructure. The use of Genedata Profiler improves MacroGenics' ability to generate new hypotheses from combined databases from both proprietary and public sources, assisting in the interpretation of biomarker data and the design of clinical trials. The Genedata Profiler software provides MacroGenics with a comprehensive solution that solves a variety of problems while also presenting new possibilities, such as: • Aggregation and curation of dispersed clinical and non-clinical research data, in a central repository, to create an institutional memory; • Self-service access to data and easy-to-use analytical tools empowers data scientists and clinicians to run complex analyses in a controlled and secure environment; • Cross-study and cross-technology data integration and analysis unlock actionable insights and facilitate informed decision-making; and • Automated workflows for data harmonization, integration, and analytics streamlines and standardizes analytical processes, while ensuring data reproducibility. MacroGenics profits from Genedata's technical domain experience in data analytics and interpretation, IT support, and scientific consulting in addition to software while retaining sole ownership of its proprietary data. The MacroGenics science team is collaborating closely with Genedata experts to unlock the potential of their data and advance their translational and clinical research programs. MacroGenics will be able to produce new scientific insights and hypotheses due to the streamlined, data-driven approach provided by Genedata Profiler. • Accelerate the discovery and development of predictive biomarkers indicative of therapy response to define the best subpopulation of patients to benefit from their immunotherapies, • Identify drugs’ specific indications to improve clinical trials inclusion criteria, • Determine the therapeutic mechanism of action (pharmacodynamics) to strengthen the rationale of the treatment regimen. Genedata Profiler, which is already in operation, has advanced MacroGenics' internal data organization and formatting. Data integration workflows and applied analytics conducted within the system have enhanced many existing translational/clinical trials and resulted in findings for presentations at international conferences (ASCO, ASH). MacroGenics will continue to work with Genedata to improve their analytical capability to help forward and reverse translational studies. About Genedata Genedata transforms data into intelligence with innovative software solutions and domain-specific consulting services that automate complex, large-scale experimental processes and enable organizations to maximize the ROI in their R&D, spanning early discovery to the clinic. Founded in 1997, Genedata is headquartered in Switzerland with additional offices in Germany, Japan, Singapore, the UK, and the US.

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INDUSTRIAL IMPACT

Bicycle Therapeutics Announces Expansion of Genentech Immuno-Oncology Collaboration

Bicycle Therapeutics | October 26, 2021

Bicycle Therapeutics plc a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that Genentech, a member of the Roche Group, has exercised an option to initiate a new program, expanding the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle®-based immuno-oncology therapies. Bicycle and Genentech are collaborating on the discovery and pre-clinical development of novel Bicycle-based immunotherapies against multiple targets. Pursuant to the terms of the February 2020 agreement, Genentech has exercised an option to include a new program under the agreement, triggering a $10 million payment to Bicycle. None of the compounds in Bicycle’s wholly owned oncology pipeline, including its immuno-oncology candidates, are included in the collaboration. “We are pleased both with the progress achieved so far in our ongoing work with Genentech and that Genentech has elected to exercise an option to add a new program under the collaboration. We believe the expansion of our collaboration underscores the potential utility of Bicycles compared to other modalities, as well as the potential broad applicability of Bicycles in a wide-range of targets “We look forward to continuing to work closely with the preeminent immuno-oncology team at Genentech to develop potential new cancer treatments based on Bicycles.” Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics About Bicycle Therapeutics Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate (BTC™) targeting EphA2, and BT8009, a second-generation BTC™ targeting Nectin-4, a well-validated tumor antigen, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC™ that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Centre for Drug Development of Cancer Research UK. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Lexington, MA. For more information, visit bicycletherapeutics.com. Forward Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Bicycle’s collaboration with Genentech; the discovery, development and potential commercialization of potential product candidates using Bicycle’s technology and under the collaboration agreement; the therapeutic potential for Bicycles in immuno-oncology and other applications; and the potential to receive milestone payments and royalties under the strategic collaboration agreement. Bicycle may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: the risk that Bicycle may not realize the intended benefits of its technology or of the collaboration agreement with Genentech, including that Bicycle and Genentech may not successfully identify, develop and commercialize additional product candidates; the risk that Bicycle may not be able to maintain its collaboration with Genentech and realize the benefits thereof; and other important factors, any of which could cause Bicycle’s actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in Bicycle’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2021, as well as in other filings Bicycle may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Bicycle expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

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INDUSTRIAL IMPACT

TARA Biosystems Partners with Scipher Medicine®

TARA Biosystems | November 03, 2021

TARA Biosystemsa, biotechnology company harnessing human biology and data to transform cardiac drug discovery, today announced a collaboration with Scipher Medicine, a precision medicine company matching patients with the most effective therapy. The collaboration will address a critical unmet need for effective therapeutics in cardiac laminopathies. Cardiac laminopathies, associated with mutations in the LMNA gene, can result in electrical and mechanical changes in the heart. These changes can have profound clinical consequences, including cardiomyopathy, sudden cardiac death, and end-stage heart failure. At present, therapies that correct the underlying pathologies do not exist. “This collaboration demonstrates the transformative potential of combining biology-driven data with network biology to further drug discovery and development and unlock new medicines and therapeutics,” said Misti Ushio, PhD, CEO of TARA Biosystems Scipher will leverage human molecular data analyzed by its Spectra™ platform, which includes data from TARA’s BiowireTM II LMNA disease models, to identify novel targets for a stratified disease population. This approach aims to identify proteins upstream and downstream of LMNA signaling within the Spectra™ network model. The identified targets will be evaluated in TARA’s BiowireTM II platform, which consists of induced pluripotent stem cell-derived human cardiac tissue models, including a repertoire of healthy, gene-edited, patient-derived, and drug-induced phenotypes of human disease. “The Spectra platform uniquely integrates AI with the protein network of human cells to identify novel targets in highly complex and debilitating diseases such as laminopathy,” said Slava Akmaev, PhD, CTO, and Head of Therapeutics at Scipher Medicine. “By interrogating the network neighborhood of LMNA and its relationship with the proteins appropriate for targeted therapeutics we are confident that we can identify several novel and relevant drug targets.” “The TARA platform is highly versatile and can capture robust physiologic endpoints of human cardiac function, including contractility, electrophysiology, calcium signaling, structure, as well as genomic, proteomic, and metabolic profiles,” said Robert Langer, PhD, Board of Directors at TARA Biosystems. “We believe that TARA and Scipher combined efforts have the potential to lead to drug development that enables a truly personalized treatment for patients.” Under the terms of the partnership, TARA has the exclusive option to progress identified targets into drug discovery and clinical development. Scipher is eligible to receive milestone payments and royalties. TARA will retain the rights for the development, and commercialization of therapeutics for the selected targets. “The partnership with TARA is a further example of how our disease agnostic Spectra platform can be applied to where novel targets are most needed,” added Alif Saleh, CEO of Scipher. “The ability to quickly validate novel targets identified by Spectra on TARA’s human tissue model platform allows us to rapidly iterate to identify most effective targets.” About TARA Biosystems, Inc. Headquartered in New York City, TARA Biosystems harnesses innovations in stem cell biology and tissue engineering to generate in vitro biology that recapitulates human physiology with unprecedented fidelity. Our highly versatile and robust platform captures integrated physiologic endpoints of human cardiac function across a wide repertoire of cardiac disease phenotypes. 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