On February 16, 2021 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that the Company will present at the 41st Annual Cowen Health Care Conference on Monday, March 1, 2021 from 12:20 p.m. to 12:50 p.m. ET (Press release, PerkinElmer, FEB 16, 2021, https://ir.perkinelmer.com/news-releases/news-release-details/perkinelmer-present-cowen-health-care-conference [SID1234575103]).

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Prahlad Singh, president and chief executive officer of PerkinElmer, will provide an update on the Company and its strategic priorities.

A live audio webcast of the presentation will also be available on the Investors section of the Company’s website at www.perkinelmer.com. A replay of the presentation will be posted on the PerkinElmer website after the event and will be available for 90 days following.

On February 16, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that it has entered into an agreement to acquire Ashion Analytics, LLC (Ashion) from The Translational Genomics Research Institute (TGen), an affiliate of City of Hope (Press release, Exact Sciences, FEB 16, 2021, View Source [SID1234575119]). Ashion is a CLIA-certified and CAP-accredited sequencing lab based in Phoenix, Arizona with the genomics testing capabilities necessary to address the increasingly complex needs of clinical, academic, and biopharma customers focused on precision cancer treatments. The team at Ashion will help accelerate the development of Exact Sciences’ precision oncology portfolio, including minimal residual disease (MRD) and other sequencing-based tests.

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This acquisition will build upon the recent license of the TARDIS technology from TGen and strengthen the relationship between the institutions through a planned 10-year research collaboration. TARDIS is a highly sensitive, patient-specific liquid biopsy-based test that can detect small amounts of tumor DNA in blood for use in MRD testing.

"Exact Sciences continues to strengthen the robust foundation established for Oncotype to lead precision oncology," said Kevin Conroy, chairman and CEO of Exact Sciences. "We’re excited to work with Ashion to bring the TARDIS technology to patients faster and continue to develop advancements in MRD testing. We’re thrilled to collaborate with TGen and City of Hope, complementing our relationships with other world-renowned cancer research leaders including Mayo Clinic and Johns Hopkins University."

Ashion leverages the genetic information from a patient’s tumor and normal genomes to provide industry-leading oncology solutions. Ashion developed GEM ExTra, one of the most comprehensive genomic cancer tests available, and provides access to whole exome, matched germline, and transcriptome sequencing capabilities. The team at Ashion will be instrumental in incorporating the TARDIS technology into Exact Sciences’ MRD test development.

Under the agreement, Exact Sciences would also enter a 10-year collaboration, bringing in the expertise of TGen and City of Hope, to develop differentiated MRD testing capabilities for patients and establish the clinical evidence necessary to drive adoption.

"This will be a groundbreaking research collaboration for TGen and City of Hope, as we continue to advance important scientific innovations and transformative treatment approaches for cancer care," said Robert Stone, president and CEO of City of Hope. "On the heels of our recent licensing agreement for our proprietary TARDIS technology, Exact Sciences is an ideal partner for this new collaboration, which aims to provide more information to physicians and their patients worldwide when diagnosing and treating cancer."

"TGen scientists have been at the forefront of the convergence of science and technology to accelerate cancer innovation, leading to the launch of Ashion and its flagship test GEM ExTra," said Jeffrey M. Trent, Ph.D., TGen president and research director. "The research collaboration with Exact Sciences allows us to work alongside an industry leader in cancer diagnostics to help ensure future breakthroughs and technology developments will bring greater benefit to more patients at a faster pace."

TGen became a part of City of Hope in 2016 to accelerate the speed at which scientists and medical staff convert research discoveries into cures for patients. City of Hope is a National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, making it a national leader in advancing research and treatment protocols.

Additional Information
The transaction is subject to customary closing conditions and regulatory approvals and is anticipated to close during the second quarter of 2021. XMS Capital is serving as financial advisor to Exact Sciences, and K&L Gates is serving as legal advisor. Citi is serving as financial advisor to TGen and City of Hope, and Jennings, Strouss & Salmon, P.L.C. is serving as legal advisor.

On February 16, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to developing and commercializing cures for blood cancers and serious hematologic diseases, reported the sale of $75 million of 5.875% exchangeable senior notes due in 2026 (the "notes") to certain funds managed by Highbridge Capital Management, LLC (Press release, Gamida Cell, FEB 16, 2021, View Source [SID1234575138]).

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The proceeds from this sale of notes, together with the net proceeds of Gamida Cell’s sale of $75 million of ordinary shares in December 2020, are expected to provide Gamida Cell with sufficient liquidity to fund the company’s operations into the second half of 2022. These capital infusions will be used to support manufacturing, regulatory and commercial development activities for omidubicel and to further the preclinical and clinical development of GDA-201.

"Securing this financing from a respected industry investor strengthens Gamida Cell’s financials at a pivotal time for our company. It enables us to capitalize on positive Phase 3 clinical results generated from omidubicel and to fund the key activities required to bring this therapy forward to patients," said Julian Adams, CEO of Gamida Cell. "Moreover, these additional funds help us to advance clinical development of GDA-201 by enabling us to file an IND for this product candidate."

"We are pleased to be able to provide this financing to Gamida Cell, to meaningfully advance their vision of developing cures for blood cancers and serious hematological diseases," commented Jonathan Segal, Co-Chief Investment Officer of Highbridge Capital Management. "Following our extensive due diligence, we are enthusiastic about the commercial potential for omidubicel. We are also excited about the potential for GDA-201 to be an important therapy and leader in the emerging field of NK cell therapy. We look forward to continuing to work collaboratively with Gamida Cell’s management team and board" added Jason Hempel, Co-Chief Investment Officer of Highbridge Capital Management.

The notes were sold at 100% of the principal amount thereof, are senior unsecured obligations of Gamida Cell and its wholly owned subsidiary and will accrue interest at a rate of 5.875% per year. Subject to certain limitations, the holders of the notes can elect to exchange the notes for Gamida Cell’s ordinary shares at an initial exchange rate of 56.3063 shares per $1,000 principal amount of notes (equivalent to an exchange price of $17.76 per share). The initial exchange price of the notes represents a premium of approximately 50% over the closing price of Gamida Cell’s ordinary shares on February 12, 2021 and a premium of approximately 122% over the public offering price of Gamida Cell’s shares on December 17, 2020.

Gamida Cell may redeem all or a portion of the notes for cash, at its option, at 100% of the principal amount plus accrued and unpaid interest on the notes to be redeemed if the closing price of its ordinary shares has been at least 130% of the exchange price for at least 20 trading days during any 30 consecutive trading day period.

Moelis & Company served as a transaction advisor to Gamida Cell.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status by the US Food and Drug Administration. In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.12 Based on the recently completed Phase 3 clinical study, in which omidubicel achieved statistically significant and clinical meaningful results in the prespecified primary and secondary endpoints, Gamida Cell plans to submit the full Biologics License Application (BLA) to the FDA in the second half of 2021. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is currently in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.3 For more information on the clinical study of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy has not been established by the FDA or any other health authority.

On February 16, 2021 Iterion Therapeutics, Inc. ("Iterion"), a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, reported that it has raised $17 million USD in a Series B financing led by Lumira Ventures, with the participation of existing investors, including Santé Ventures, as well as new investors Venture Investors, GPG Ventures, and Viva BioInnovator (Press release, Iterion Therapeutics, FEB 16, 2021, View Source [SID1234575155]).

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Iterion plans to utilize the proceeds from this financing to advance the development of its lead clinical candidate, Tegavivint, a novel, potent and selective nuclear beta-catenin inhibitor. Tegavivint is currently being investigated in a Phase 1/2a clinical trial in patients with desmoid tumors, which are rare, non-metastasizing sarcomas that overexpress nuclear beta-catenin. Iterion has received Orphan Drug Designation for Tegavivint to treat desmoid tumors, a disease for which there are no FDA approved therapies.

In addition to desmoid tumors, Iterion is preparing to initiate clinical programs in 2021 to investigate Tegavivint in acute myeloid leukemia (AML), non-small cell lung cancer (NSCLC), and pediatric cancers, including sarcomas, lymphoma and other solid tumors. These cancers are often characterized by nuclear beta-catenin overexpression, providing potential high-value target expansions for Tegavivint.

"We envision incredible potential therapeutic benefits associated with Tegavivint, and are excited to support the Iterion team in its exploration of multiple clinical development opportunities for this potentially groundbreaking therapeutic," said Benjamin Rovinski, Ph.D., Managing Director at Lumira Ventures. "2021 is expected to be a pivotal year for Iterion as the company anticipates initiating clinical trials in AML, NSCLC and pediatric cancers, all indications in which nuclear beta-catenin signaling plays a role. By pursuing a novel mechanism of action, we believe Tegavivint has the potential to overcome challenges faced by prior drugs targeting this pathway."

Nuclear beta-catenin is a highly-studied oncology target associated with numerous cancer types. Tegavivint is unique among nuclear beta-catenin inhibitors in that it binds to TBL1 (Transducin Beta-like Protein One), a novel downstream target in the Wnt-signaling pathway. As such, Tegavivint enables silencing of Wnt-pathway gene expression without affecting other necessary Wnt/beta-catenin functions in the cell membrane, thus avoiding toxicity issues common to other drugs in this pathway.

"We are grateful to have the confidence of investors, including Lumira Ventures, Santé Ventures and others, that appreciate Tegavivint’s potential to treat a host of cancers," said Rahul Aras, Ph.D., CEO of Iterion. "Nuclear beta-catenin has historically been considered an ‘undruggable’ oncology target with prior inhibitors having been plagued by toxicity issues, greatly limiting their therapeutic use. Research suggests that these toxicity concerns can be negated by targeting TBL1, a novel downstream target in the Wnt-signaling pathway necessary for beta-catenin’s oncogenic activity. This is precisely Tegavivint’s mechanism of action and why we believe the technology holds such substantial promise."

Dr. Aras continued, "With the Series B funding, Iterion has the potential to significantly expand our clinical footprint through completion of our ongoing desmoid tumor study and initiate clinical trials in 2021 to investigate Tegavivint in AML, NSCLC, and certain pediatric cancers."

On February 16, 2021 Cend Therapeutics, Inc., a clinical-stage biotech company, and Qilu Pharmaceutical, a major Chinese pharmaceutical company, reported that the companies have entered a Collaboration and License Agreement to develop and commercialize Cend’s investigational drug, CEND-1, in Greater China (Press release, CEND Therapeutics, FEB 16, 2021, View Source [SID1234575230]).

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Cend presented favorable clinical results at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) meeting September 2020 and is advancing into Phase 2 clinical trials in pancreatic cancer with CEND-1 in combination with gemcitabine and nab-paclitaxel. The Company is planning registration clinical trials in pancreatic cancer and will explore combinations with additional therapies, including immunotherapies, as well as expansion of its programs into additional solid tumor cancers.

"This partnership with Qilu will help us bring our treatment to patients with pancreatic and other solid tumor cancers in China. This collaboration will also speed global development to bring the treatment to market expeditiously. Qilu’s excellent development team and market position will position CEND-1 for success in China," commented David Slack, CEO of Cend.

"CEND-1 has generated encouraging clinical results in combination with standard of care chemotherapy for the treatment of pancreatic cancer, which remains a significant health issue in China. We are pleased to work with Cend to advance this program and explore broader potential applications for CEND-1," commented Oliver Kong, MD, Chief Medical Officer and Corporate Vice President of Qilu.

About the Qilu-Cend Partnership

In the Collaboration and License Agreement, Qilu will gain exclusive rights to CEND-1 in Greater China, including Taiwan, Hong Kong and Macau. Qilu will take on development as well as commercialization responsibilities within Greater China. Cend will continue to retain all rights outside of Greater China. Qilu will pay Cend an up-front license fee of US$10 million. Cend will be eligible to receive up to $225 million in milestones as well as tiered double digit royalties on product sales in the region.

About CEND-1

CEND-1 is an investigational drug that modifies the tumor microenvironment. It is targeted to tumors by its affinity for alpha-v integrins, which are selectively expressed in tumors but not normally expressed in healthy tissues. CEND-1 is a cyclic peptide that, once bound to these integrins, is cleaved by protease expressed in tumors to release a peptide fragment, called a CendR fragment, which binds to a second receptor, called neuropilin, to activate a novel uptake pathway that causes anticancer drugs to more selectively penetrate solid tumors. CEND-1 has also been shown to further modify the tumor microenvironment by selectively depleting tumor-infiltrating immunosuppressive cells, including T regulatory cells, and to increase the number of cancer-fighting immune cells within the tumor, potentially enabling patients’ immune systems or immunotherapies to more effectively fight cancer.