Caravan Biologix, Inc. Collaborates with MDimune on Cell-Derived NanoVesicles for Cancer

On September 15, 2022 Caravan Biologix, Inc., a developer of novel cell-derived vesicle (CDV) therapeutics targeting specific cancers and gene therapy-related diseases, reported that it has entered into an agreement with Seoul-based MDimune Inc. to apply their nanovesicle technology to enhance the effects of chimeric antigen receptor-expressing natural killer (CAR-NK) cells on various solid tumor cancers. Research findings should provide important insights as Caravan continues to advance the development of its proprietary Mini-CAR platform for stand-alone therapeutics and whole-cell CAR co-therapies (Press release, Caravan Biologix, SEP 15, 2022, View Source [SID1234619599]).

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"We are pleased to establish this collaboration with MDimune, a developer of bio-extrusion and delivery," stated Tom Malcolm, Ph.D., CSO and Founder of Caravan Biologix. "Findings from this collaboration will support our mini-CAR-NK CDV program, which focuses on treating primary liver carcinomas and other human diseases."

Seung Wook Oh, Ph.D., Chief Scientific Officer of MDimune added, "We are thrilled to launch this collaboration with Caravan Biologix. By joining the advanced mini-CAR-NK technology of Caravan and the enormous therapeutic potential of our vesicle technology, we hope to be able to demonstrate that our BioDrone platform can significantly escalate the therapeutic promise of current CAR-T/NK-based therapies."

"The signing of this agreement with Caravan Biologix is another important corporate milestone for MDimune. I am very pleased that our highly innovative and detail-oriented analytical approach to produce the highest quality of cell-derived vesicles at low cost has convinced Caravan Biologix to work with us on such an important endeavor to effectively treat patients with solid tumor cancers. It is clear that new solutions are needed to properly address the complexities associated with traditional whole cell CAR therapeutics," stated Dr. Oh.

TIBSOVO® (ivosidenib) Now Available from Onco360 for the Treatment of Adult Patients with IDH1-mutant Acute Myeloid Leukemia or Previously Treated, IDH1-mutant Metastatic Cholangiocarcinoma

On September 15, 2022 Onco360, the nation’s leading independent Specialty Pharmacy, reported that it has been selected by Servier Pharmaceuticals to be a specialty pharmacy partner for TIBSOVO (ivosidenib), which is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with newly diagnosed acute myeloid leukemia (AML) in combination with azacitidine or as monotherapy in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, relapsed or refractory AML, or locally advanced or metastatic cholangiocarcinoma that has been previously treated (Press release, Onco360, SEP 15, 2022, View Source [SID1234619597]).

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"Onco360 is honored to partner with Servier Pharmaceuticals and become a specialty pharmacy provider for TIBSOVO patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "We are dedicated to supporting the highly specialized needs of patients battling IDH1-mutant AML or cholangiocarcinoma across the United States."

According to the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program, it is estimated that 20,050 new cases of AML will be diagnosed in 2022 in the United States with a corresponding 11,540 deaths in 2022. Approximately 6-9% of AML cases are found to have IDH1 mutations. The median age at the time of initial AML diagnosis is 68 years. The five-year overall survival for AML patients is only 30.5%.1,2

According to the American Cancer Society, approximately 8,000 patients are diagnosed with cholangiocarcinoma, a bile duct cancer, on an annual basis in the United States. Approximately 13% of cholangiocarcinoma cases are found to have IDH1 mutations. The average age at the time of initial cholangiocarcinoma diagnosis is 70-72 years old dependent upon tumor location. The five-year overall survival for cholangiocarcinoma patients, regardless of cancer stage, is only 9-10% dependent upon tumor location.3,4

TIBSOVO is commercialized by Servier Pharmaceuticals. Please see the full prescribing information for TIBSOVO at Tibsovopro.com.

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