Syros and Tyme Technologies Announce Stockholder Approval of Merger

On September 15, 2022 Syros Pharmaceuticals, Inc. (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, and Tyme Technologies, Inc. (NASDAQ:TYME) reported the results of the special meetings of the stockholders of Syros and TYME, respectively, each held on September 15, 2022 (Press release, Syros Pharmaceuticals, SEP 15, 2022, View Source [SID1234619596]). At TYME’s special meeting, TYME’s stockholders voted in favor of all proposals, including the proposal to adopt the agreement and plan of merger, dated July 3, 2022 (the "Merger Agreement"), pursuant to which a direct, wholly owned subsidiary of Syros will merge with and into TYME, with TYME surviving as a wholly owned subsidiary of Syros (the "Merger"). At Syros’ special meeting, Syros’ stockholders also voted in favor of all proposals, including the proposal to approve the issuance of shares of Syros’ common stock to holders of TYME’s common stock in connection with the Merger and to certain of Syros’ investors in connection with a concurrent private investment in public equity ("PIPE") financing.

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The closings of the Merger and the PIPE financing are anticipated to take place on or around Friday, September 16, 2022. Following the closing of the Merger, the combined company will trade on The Nasdaq Global Select Market under the ticker symbol "SYRS," and will be led by Syros’ existing management team, including Nancy Simonian, M.D., Chief Executive Officer of Syros, and will remain focused on advancing Syros’ pipeline of small molecule medicines for the treatment of cancer.

In addition, Syros reported that it will effect a 1-for-10 reverse stock split of its common stock that will be effective on Friday, September 16, 2022, prior to the closings of the Merger and the PIPE financing. Syros’ common stock will begin trading on Nasdaq on a split-adjusted basis when the market opens on Monday, September 19, 2022. The new CUSIP number for Syros’ common stock following the reverse stock split is 87184Q206.

On September 15, 2022, the holders of a majority of Syros’ outstanding shares of common stock also approved the reverse stock split and gave Syros’ board of directors discretionary authority to select a ratio for the split ranging from 1-for-5 to 1-for-15. Syros’ board of directors approved the reverse stock split at a ratio of 1-for-10 on September 15, 2022.

The reverse stock split affects all issued and outstanding shares of Syros common stock, as well as the number of authorized shares of Syros common stock and the number of shares of common stock available for issuance under Syros’ equity incentive plans. The reverse stock split will reduce the number of shares of the Syros issued and outstanding common stock from approximately 63 million to approximately 6.3 million (which numbers do not give effect to the shares of Syros common stock to be issued in connection with the Merger and the PIPE financing). In addition, the reverse stock split will effect a reduction in the number of shares of common stock issuable upon the exercise of stock options and warrants and upon the vesting of restricted stock units outstanding immediately prior to the reverse stock split, with a proportional increase in the respective exercise prices. The reverse stock split will proportionately reduce the number of authorized shares of Syros’ common stock from 700 million shares (which is the number of authorized shares that will be outstanding immediately prior to the reverse stock split, in connection with Syros’ receipt of the approval of its stockholders to increase the number of authorized shares from 200 million to 700 million) to 70 million shares. The reverse stock split will not change the par value of the common stock or the authorized number of shares of preferred stock of Syros.

The reverse stock split will affect all holders of common stock uniformly and (before giving effect to the shares of Syros common stock to be issued in connection with the Merger and the PIPE financing) will not alter any stockholder’s percentage ownership interest in Syros, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. No fractional shares of common stock will be issued in connection with the reverse stock split; stockholders who otherwise would be entitled to a fractional share of common stock will be entitled to receive a proportional cash payment.

Syros’ transfer agent, Computershare, is acting as the exchange agent for the reverse stock split. For those stockholders holding physical stock certificates, Computershare will send instructions for exchanging those certificates for shares held in book-entry form representing the post-split number of shares. Stockholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split. Beneficial holders are encouraged to contact their bank, broker or custodian with any procedural questions.

Thermo Fisher Scientific’s PPD Clinical Research Business Selected to Support National Cancer Institute’s Cancer Trials Support Unit

On September 15, 2022 The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, reported that it has been awarded a 10-year Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract by the National Cancer Institute (NCI), part of the National Institutes of Health, to support NCI’s Cancer Trials Support Unit (CTSU) (Press release, Thermo Fisher Scientific, SEP 15, 2022, View Source [SID1234619595]). As part of the award, the PPD clinical research business will have the opportunity to coordinate the resources and processes necessary to identify, deploy, support and maintain a platform for the collection and migration of electronic patient-reported outcomes (ePROs) and other patient-generated health data into NCI Multi-Center Organization (MCO) clinical trials supported by CTSU.

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Thermo Fisher’s PPD clinical research business has three decades of experience successfully delivering clinical research services to governmental agencies, contractors and nonprofits in conducting therapeutic, vaccine and medical device studies on a global scale across all trial phases and a broad array of therapeutic areas.

"NCI’s focus on progressing cancer research across the nation is one we all support, to advance scientific knowledge and to help all people live longer, healthier lives," said David M. Johnston, Ph.D., senior vice president and president, clinical research, Thermo Fisher Scientific. "The research that NCI champions is vital to improving the outcomes of patients battling this group of diseases. We are privileged to support NCI in those efforts."

Cancer is among the leading causes of death worldwide. In 2022, NCI estimates there will be more than 1.9 million new cases of cancer and more than 600,000 cancer deaths in the United States. Globally, the World Health Organization notes that nearly one in every six deaths can be attributed to cancer, with approximately 400,000 children developing cancer every year.

The business’ team of experts providing PPD Digital and Decentralized solutions works closely with leading research organizations around the world to navigate evolving trends in drug development, including the design and deployment of customized, remote clinical trials. The business employs innovative electronic clinical outcome assessment (eCOA) technologies to enable sites, patients and customers to share data more effectively than traditional methods. In addition, eCOAs and ePROs use digital platforms to enable direct data collection from study stakeholders, resulting in less paper documentation and more timely data, with greater consistency from patients. The business has been a guiding force in the industry, bringing long-standing expertise and establishing best practices for study teams embarking on new modes of clinical research.

The business’ oncology center of excellence provides strategic and operational oversight and promotes knowledge sharing and best practices, while its immuno-oncology center of excellence serves to deliver patient-centric solutions and collaborates with industry organizations to overcome challenges associated with immuno-oncology trials. In addition, the business’ early development oncology group features experts in the planning and operationalizing of Phase I-II studies, as well as the development of early-stage oncology compounds and the oversight of clinical programs.

The PPD clinical research business has conducted over 675 oncology and hematology studies in the past five years involving more than 114,000 patients at over 26,000 sites around the world. Those trials represent more than one-quarter of the studies the business has conducted in that time. The business’ team of experts providing PPD Laboratory services helped develop 24 of the top 25 best-selling oncology drugs of 2020.

This project will be funded in whole with federal funds from the NCI, National Institutes of Health (NIH) and Department of Health and Human Services (DHHS) under Contract No. 75N91022D00012.

ImmunoScape To Present at the 7th Annual CAR-TCR Summit

On September 15, 2022 ImmunoScape, a pre-clinical biotechnology company focused on the discovery and development of next-generation TCR-T-cell therapeutics, reported that Dan MacLeod, Ph.D., the company’s vice president of discovery, will present at the 7th Annual CAR-TCR Summit taking place September 19-22, 2022 in Boston (Press release, immunoSCAPE, SEP 15, 2022, View Source [SID1234619593]).

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The CAR TCR Summit is a multi-day, industry leading comprehensive forum that explores discovery through to commercialization to deliver safe, effective, and commercially viable CAR and TCR therapies.

At the summit, Dr. MacLeod will participate in several sessions:

Discovery of TCRs Targeting Novel Antigens Using Deep Immunomics
Wednesday, September 21 at 11:30am ET
Discovery Track: Accelerating Target Identification & Validation – Morning Session
Discussion Points:
Discovery and development of novel TCR-based therapeutics using the Deep Immunomics platform
Identification of therapeutically relevant TCRs against both well characterized and novel targets across multiple HLA types
Applying computational approaches to advance TCR Discovery for novel targets
Panel Discussion: Driving Target Discovery with Novel AI Technology
Wednesday, September 21 at 3:00pm ET
Panel Discussion: Accelerating Target Identification & Validation – Post-Lunch Session
Panelists: Dan MacLeod, ImmunoScape; Ely Porter, Rootpath; Luke Pase, Anocca
Discussion Points:
How to advance the discovery of new epitope targets for solid tumors using innovative high-throughput screening and computational AI techniques
How can we better leverage bioinformatic platforms to advance drug discovery?
ImmunoScape’s differentiated Deep Immunomics platform utilizes the company’s proprietary combinatorial barcoding technology to enable the discovery and in-depth characterization of rare cancer-specific T-cells at high resolution. ImmunoScape’s platform is able to simultaneously evaluate tens of millions of T-cells in blood samples from hundreds of cancer patients to identify clinically relevant T-cell clones. The corresponding T-cell receptors (TCRs) are currently being evaluated and prioritized to form a diverse pipeline of TCR-T-cell therapies covering multiple antigens and HLA restrictions.

To see the full summit schedule, and to register for the event, please visit https://car-tcr-summit.com/.

To set up a time to meet with Dr. MacLeod or ImmunoScape CEO Choon-Peng Ng at the summit, please email [email protected].

To learn more about ImmunoScape, please visit View Source

Candel Therapeutics Receives Orphan Drug Designation from the European Medicines Agency for CAN-2409 in Glioma

On September 15, 2022 Candel Therapeutics, Inc. (Nasdaq: CADL) (Candel or the Company), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported that the European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP) has issued a positive opinion on the Company’s application for orphan drug designation for CAN-2409 for the treatment of glioma (Press release, Candel Therapeutics, SEP 15, 2022, View Source [SID1234619592]). CAN-2409, a genetically modified adenovirus and the Company’s most advanced investigational therapy, is currently being evaluated in multiple phase 2 and phase 3 clinical trials for lung, brain, pancreatic and prostate cancers.

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The orphan drug designation follows the U.S. Food and Drug Administration (FDA) fast track designation, which was granted in June 2021, for CAN-2409 in combination with valacyclovir following standard of care treatment in newly diagnosed high-grade glioma.

Paul Peter Tak, MD, PhD, FMedSci, President and CEO of Candel, said, "Glioma, while mercifully rare, is a devastating disease with significant morbidity and mortality. The EMA’s orphan drug designation recognizes the high unmet need and the potential of CAN-2409 in this patient population. We look forward to working with the EMA and FDA in an effort to bring our investigational medicine to patients as we initiate our phase 3 clinical trial of CAN-2409 in high-grade glioma this year."

Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the EMA COMP. The EMA’s orphan drug designation is potentially available to companies developing treatments for life-threatening or chronically debilitating conditions that affect no more than five in 10,000 persons in the EU. In addition, there must be sufficient clinical or non-clinical data to suggest the product candidate may produce clinically relevant outcomes, and grounds to indicate it can provide a significant benefit over any currently authorized products. The designation can provide financial and regulatory incentives, including a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA at reduced fees during the product development phase and access to centralized marketing authorization.

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy product candidate, is a genetically modified adenovirus that is designed to encode the herpes simplex virus thymidine kinase (HSV-tk) gene. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills infected and nearby cancer cells. Intratumoral administration of CAN-2409 results in immunogenic cell death, followed by the release of tumor-specific neoantigens in the tumor microenvironment. At the same time, the adenoviral vector elicits a strong pro-inflammatory effect in the tumor microenvironment, creating the optimal conditions to induce a specific CD8+ cytotoxic T cell-mediated immune response against the injected tumor and the uninjected distant metastases. This dual mechanism of antigen unmasking and immune activation may enable CAN-2409 to generate a powerful and lasting immune response against a variety of the patient’s tumor-associated neoantigens, minimizing the possibility for immune escape and development of tolerance.

Because of its versatility, CAN-2409 may have the potential to treat a broad range of solid tumors. Encouraging activity has been shown in several preclinical and clinical settings as monotherapy as well as in combination with standard of care radiation therapy, surgery, chemotherapy, and immune checkpoint inhibitor treatment. Furthermore, more than 700 patients have been dosed to date with a favorable safety profile, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in high-grade glioma, non-small cell lung cancer, pancreatic cancer, and prostate cancer in ongoing clinical trials.

Starpharma to present at Life Sciences Investor Forum

On September 15, 2022 Starpharma (ASX: SPL, OTCQX: SPHRY) reported that a presentation by Dr Jackie Fairley, CEO, will be broadcast on Thursday 15 September 2022 (US ET) as part of the US OTCQX’s Virtual Life Sciences Investor Forum (Press release, Starpharma, SEP 15, 2022, View Source;mc_eid=bf52dd3418 [SID1234619591]).

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The Life Sciences Investor Forum is a leading investor conference that provides a forum for companies to present to tens of thousands of retail investors as well as advisors.

Details of the forum are found via this link: Virtual Life Sciences Investor Forum.

Starpharma’s pre-recorded presentation features a company overview, including:

the latest interim clinical trial results presented at ESMO (Free ESMO Whitepaper) oncology conference that show efficacy signals in 100% of prostate cancer patients assessed following DEP cabazitaxel treatment;
an overview of Starpharma’s DEP clinical-stage and preclinical assets, and corporate partnerships for its DEP drug delivery platform, including with Merck & Co., Inc (MSD) and AstraZeneca; and
a VIRALEZE overview and recent antiviral nasal spray results, including excellent protection against the SARS-CoV-2 Omicron variant, as well as updates on Starpharma’s portfolio more broadly.