TC Biopharm Announces Closing of $17.5 Million Initial Public Offering

On February 15, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, reported the closing of its previously announced initial public offering of 4,117,648 American Depositary Shares (the "ADSs") and warrants (the "Warrants") to purchase up to 8,235,296 ADSs. In connection with the initial public offering, the underwriters have partially exercised their option to purchase an additional 1,235,294 warrants at an exercise price of $4.25 per warrant (Press release, TC Biopharm, FEB 15, 2022, View Source [SID1234608150]). In total, the Company received aggregate gross proceeds of approximately $17.5 million, prior to deducting underwriting discounts, commissions, and other offering expenses. The issuance and sale of these additional ADSs also closed today.

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Each ADS represents one ordinary share, and each Warrant represents the right to purchase one ADS. The ADSs and Warrants will be separately issued but the ADSs and Warrants will be sold to purchasers only in a combination of one ADS and two Warrants, for a combined aggregate offering price of $4.25. Each Warrant will be immediately exercisable for one ordinary share, that will then be deposited with the custodian for the issuance of a corresponding ADS at an exercise price of $4.25 per ADS and expire six years after the issuance date.

The Company intends to use the net proceeds from the offering to finance the cost of treating patients under our proposed clinical trials OmnImmune (TCB 008-001), a phase 2b-into-pivotal (phase 3) trial for the treatment of acute myeloid leukemia) and ImmuniStim (TCB 008-002) (for the treatment of COVID-19 infections) and to continue the research and development of our proposed GD-T CAR therapies to treat sold cancers, as well as financing our operating overhead costs, capital expenditure and limited repayment of convertible loan notes.

EF Hutton, division of Benchmark Investments, LLC, acted as sole book-running manager for the offering.

A registration statement on Form F-1, as amended (File No. 333-260492), was filed with the Securities and Exchange Commission ("SEC") and was declared effective on February 10, 2022. A final prospectus relating to the offering was filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the final prospectus relating to this offering may be obtained from EF Hutton, division of Benchmark Investments, LLC, 590 Madison Avenue, 39th Floor, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 404-7002.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Arcus Biosciences to Participate in the Upcoming Investor Conferences

On February 15, 2022 Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported that management will participate at the following upcoming investor conferences (Press release, Arcus Biosciences, FEB 15, 2022, View Source [SID1234608149]):

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SVB Leerink 11th Annual Global Healthcare Conference
Date & Time: Wednesday, February 16th, 2022 at 1:20 p.m. PT
Format: Fireside Chat

Barclay’s Global Healthcare Conference
Date & Time: Thursday, March 17th, 2022 at 1:35 p.m. ET
Format: Fireside Chat

Live audio webcasts will be available by visiting the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay of the webcasts will be available for at least two weeks following the live events.

Oxford Finance Announces the Closing of a $50 Million Credit Facility With OncoResponse

On February 15, 2022 Oxford Finance LLC ("Oxford"), a leading specialty finance firm that provides senior debt to life sciences and healthcare services companies worldwide, reported the closing of a $50 million senior secured term loan with OncoResponse ("the Company"), a clinical-stage biotech company advancing immunotherapies derived from the immune systems of elite cancer responders (Press release, OncoResponse, FEB 15, 2022, View Source [SID1234608148]).

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Proceeds from the transaction will be used for general working capital and to support clinical testing of the Company’s lead drug OR2805, which is currently in clinical development.

"Our priority is to advance the clinical studies of our lead drug candidate, OR2805, across multiple tumor types. We will also use this capital to support our drug pipeline and leverage our proprietary platform to discover important new treatments for cancer. We are pleased to have this support from Oxford, in addition to that from our strong investor syndicate, to support these efforts," said Chris Russell, chief financial officer of OncoResponse.

OncoResponse is leveraging its proprietary human antibody platform to discover novel targets and identify fully human monoclonal antibodies as therapeutics for the treatment of cancer patients. The platform allows for the rapid screening of tens of thousands of antibodies made by the human immune system to identify immuno-modulatory antibodies.

"OncoResponse is led by an experienced management team that has a track record of successfully developing platform technologies and clinical-stage therapeutics," said Christopher A. Herr, senior managing director at Oxford. "Oxford is pleased to be a capital provider to OncoResponse and back its unique and compelling pipeline focused on reversing and relieving immunosuppression in the tumor microenvironment leading to better responses and more cures for cancer patients worldwide."

ImmunoGen Announces a Global, Multi-Target License Agreement of its Novel Camptothecin ADC Platform to Lilly for Up to $1.7 Billion

On February 15, 2022 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported a global, multi-year definitive licensing agreement whereby it granted Eli Lilly and Company (Lilly) exclusive rights to research, develop, and commercialize ADCs directed to targets selected by Lilly based on ImmunoGen’s novel camptothecin technology (Press release, ImmunoGen, FEB 15, 2022, View Source [SID1234608147]). ImmunoGen retains full rights to the camptothecin platform for all targets not covered by the Lilly license.

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As part of the agreement, Lilly will pay ImmunoGen an upfront payment of $13 million, reflecting initial targets selected by Lilly. Lilly may select a pre-specified number of additional targets, with ImmunoGen eligible to receive an additional $32.5 million in exercise fees if Lilly licenses the full number of targets. ImmunoGen is eligible to receive up to $1.7 billion in potential target program exercise fees and milestone payments based on the achievement of pre-specified development, regulatory, and commercial milestones. ImmunoGen is also eligible for tiered royalties as a percentage of worldwide commercial sales by Lilly. Lilly is responsible for all costs associated with research and development.

Camptothecins are an important class of anticancer drugs targeting Type I topoisomerase. ImmunoGen’s proprietary class of camptothecin linker-payloads are designed to optimize existing camptothecin technology to potentially deliver a wider therapeutic window with enhanced safety and efficacy.

"Lilly has a proven track record of bringing transformative oncology medicines to market, and we are pleased that they selected our novel camptothecin technology to integrate with their efforts to develop next-generation ADCs," said Stacy Coen, ImmunoGen’s Senior Vice President and Chief Business Officer. "This licensing agreement demonstrates ImmunoGen’s continued innovation in ADCs, creates value from our intellectual property around a proprietary platform, and further enhances our ability to re-invest in our business as we build out our pipeline and accelerate our transformation into a fully-integrated oncology company."

Foundation Medicine’s ctDNA Monitoring Assay, FoundationOne®Tracker, Granted Breakthrough Device Designation by U.S. Food and Drug Administration

On February 15, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device designation for its circulating tumor DNA (ctDNA) detection and molecular monitoring assay, FoundationOneTracker (Press release, Foundation Medicine, FEB 15, 2022, View Source [SID1234608146]). The assay uses optimized algorithms for identifying patient-specific variants and a personalized assay design that allows for the detection of ctDNA in plasma. The Breakthrough Device designation was granted for the assay’s use in the detection of molecular residual disease, commonly known as MRD, in early-stage cancer after curative therapy. This molecular detection can help guide further therapy decisions depending on MRD status and an individual’s risk of relapse.

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Developed in partnership with Natera, FoundationOne Tracker uniquely combines Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) platform with Natera’s expertise in personalized ctDNA monitoring. The companies launched the research use only version of FoundationOne Tracker in June 2021, collaborating to support biopharma and academic partners with clinical trial and companion diagnostic planning.

In addition to the indications granted through the Breakthrough Device designation, FoundationOne Tracker’s personalized technology aims to address ctDNA detection and molecular monitoring in patients with both early- and advanced-stage cancers, including assessment of a patient’s response to therapy, as well as MRD detection, surveillance, and detection of molecular residual relapse following curative intent therapy.

"Foundation Medicine continues to shape the future of clinical care and research by helping oncologists and our industry partners find the answers they need to bring precision cancer care to patients," said Brian Alexander, M.D., M.P.H., chief executive officer at Foundation Medicine. "Personalized molecular disease monitoring enables early detection of ctDNA and can monitor for risk of relapse and track therapy response to help oncologists make personalized treatment plans for their patients. We are enthusiastic about our work to accelerate development of this assay so that it can more quickly impact care decisions in the clinic."

The FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.

On the heels of data presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium last month exploring the feasibility of MRD in metastatic colorectal patients who have undergone curative intent surgical resection, Foundation Medicine will also be presenting additional MRD data at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium on February 18 on the genomics of resected early-stage bladder cancer to validate CGP-informed MRD detection in ctDNA.