On June 13, 2022 ImCheck Therapeutics reported the close of a EUR 96 million (USD 103 million) financing, co-led by Earlybird and Andera Partners (Press release, ImCheck Therapeutics, JUN 13, 2022, View Source [SID1234615917]). The Series C round (EUR 80 Million – USD 86 Million) and the last outstanding tranche of Series B converted in Series C shares (EUR 16 Million – USD 17.2 Million) solidifies ImCheck’s financial position and leadership in the gamma-delta T cell space. Invus and The Leukemia & Lymphoma Society Therapy Acceleration Program also joined the round as new investors. Existing investors including the Growth Opportunity Fund of founding investor Kurma Partners, Eurazeo, Gimv, EQT Life Sciences (previously LSP), Boehringer Ingelheim Venture Fund, Pfizer Ventures, Bpifrance through its Innobio 2 and Large Venture funds, Wellington Partners, Agent Capital, Pureos Bioventures and Alexandria Venture Investments participated.

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The proceeds will be used to support the Phase IIa expansion arms of EVICTION in solid tumors and hematologic cancers, and completion of randomized, double-blind, placebo-controlled clinical trials evaluating ImCheck’s lead candidate ICT01 in combination with a PD-1 inhibitor for multiple solid tumors. The Company also will apply the capital to investigate ICT01 in combination with other therapeutic agents, including IL-2, in the forthcoming EVICTION-2 clinical trial. The funding will accelerate the further advance toward the clinic of additional antibody candidates in immuno-oncology, auto-immune and infectious diseases. In addition, it will allow the Company to achieve pivotal study readiness for ICT01 and expand its footprint through extended clinical operations and regulatory affairs in Europe and the US.

"Since its inception, ImCheck has gained the support of a syndicate of outstanding international funds. In a highly challenging funding market, we have secured a significant fundraising through the addition of highly strategic and valuable investors from the U.S. and Europe, putting us in a position to further deliver on the immense promise of our pipeline," stated Pierre d’Epenoux, Chief Executive Officer of ImCheck Therapeutics. "We view our singular proprietary position with butyrophilins, which offer powerful immunomodulation of both the innate and adaptive immune systems, as the key to therapeutic intervention for many disease indications and we value the support we are now gaining from The Leukemia & Lymphoma Society Therapy Acceleration Program as a first investment from a cancer patient nonprofit organization."

In conjunction with the financing round, Florent Gros (Earlybird) and Raphaël Wisniewski (Andera Partners) will join the Company’s Board of Directors.

Florent Gros, Partner at Earlybird, commented,"ImCheck’s approach to immuno-oncology is highly differentiated through the clinical demonstration of gamma-delta T cell activation, an area of immunology that has huge potential and interest from the biopharmaceutical community. At Earlybird, we support companies that dare to think differently and ImCheck’s innovative concept for immunomodulation could be a game-changer for a range of indications."

Raphaël Wisniewski, Partner at Andera Partners, said, "Immune checkpoint inhibitors have heralded a new era in cancer treatments and ImCheck Therapeutics is pioneering the next generation of these immunotherapeutics. In watching their progress to date, we have seen the leadership team execute on a compelling vision for a butyrophilin-based therapeutic approach from the early development stage into a highly valuable clinical development program. We at Andera Partners are confident the company will move its groundbreaking technology forward to meet patients’ needs in a range of cancer indications with wider potential for auto-immune and infectious diseases."

ImCheck Therapeutics’ immunotherapeutic technology is capable of overcoming the tumor’s resistance to adaptive immune responses through a novel superfamily of immune checkpoint targets, butyrophilins (BTNs). BTNs can be modulated to harness a wide range of immune cells including gamma-delta T cells, CD3, CD8, NK cells and macrophages, bridging the innate and adaptive immune responses. The company’s broad pipeline is built upon immunomodulation via BTN-targeting antibodies aimed either at activating the immune system in disease indications such as cancer or infectious diseases, or down-regulating immunity in auto-immune disorders.

Hans Henrik Christensen, Chief Financial Officer of ImCheck Therapeutics, added, "ImCheck has raised a total of EUR 154 million since inception. We truly appreciate the support from existing and new investors, which extends our cash runway until 2026. This enables us to further explore the ‘pipeline in a product’ opportunity we have with our lead clinical candidate, ICT01."

Legal counsel for the Series C transaction provided by Dentons Europe and McDermott Will & Emery. Investor relations support provided by Trophic Communications. French media and communications support provided by ATCG Partners.

On June 13, 2022 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that updated interim data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T cell therapy, show a favorable safety profile, high overall response ("ORR") and complete response ("CR") rates, and CAR T persistence in patients with follicular lymphoma ("FL") (Press release, Mustang Bio, JUN 13, 2022, View Source [SID1234615937]). MB-106 is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center ("Fred Hutch") to treat patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL").

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The updated results presented during an on-site oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress ("EHA2022") by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutch and University of Washington, included interim safety and efficacy data from the cell manufacturing process that was modified to combine the culture of CD4+ and CD8+ cells. CAR-T cells were administered at one of 5 dose levels: 1×105, 3.3×105, 1×106, 3.3×106 and 1×107 CAR T cells/kg. Treatment for all patients was infused in the outpatient setting except for the first patient of each dose cohort, each of which was kept for overnight observation.

In the 18 treated patients with FL, ORR and CR were 94% (17/18) and 78% (14/18), respectively. Additionally, 17% experienced a partial response (3/18) and 5% experienced disease progression (1/18). One patient experienced pseudo-progression followed by a spontaneous CR documented at 207 days and has remained in remission since. Additionally, one patient with prior CD19 CAR-T failure experienced a CR and also remains in remission. From a safety profile perspective, cytokine release syndrome occurred in 5 patients: 4 patients with grade 1 and one patient with grade 2. No patients with FL experienced immune effector cell associated neurotoxicity syndrome of any grade. Although the persistence of CAR T cells was seen at all dose levels and was comparable by day 28, the expansion was faster at the higher dose levels.

"We continue to observe a favorable safety profile and high rate of complete response with MB-106 as exhibited by this follicular lymphoma cohort and within a wide range of other hematologic malignancies including CLL, diffuse large B-cell lymphoma ("DLBCL") and Waldenstrom macroglobulinemia ("WM")," said Dr. Shadman. "Based on the ongoing progress, MB-106 may be a suitable outpatient treatment for these patients and another immunotherapy option for patients for whom CD19-directed CAR T cell therapy is not effective. Enrollment in this study remains open to patients with CD20+ B-NHLs and CLL, including patients with prior CAR T treatment."

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "Given the ongoing positive progress presented by Dr. Shadman, we look forward to evaluating MB-106 to treat relapsed or refractory B-NHL and CLL in the multicenter clinical trial under Mustang’s IND which is now open to enrollment. MB-106 continues to demonstrate its potential as a safe, effective CAR T therapy that can address the unmet needs of a range of patients with relapsed or refractory B-NHLs, including WM and DLBCL, with outpatient administration. It is especially gratifying to see that the DLBCL patient previously reported as a PR has now improved to a CR, which therefore represents a second CR in DLBCL and a second CR in a patient previously treated with CD19-targeted CAR T therapy."

For more information on the clinical trials, please visit www.clinicaltrials.gov using the identifier NCT05360238 for the multicenter trial and NCT03277729 for the ongoing trial at Fred Hutch.

Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

About MB-106 (CD20-targeted autologous CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division at Fred Hutch, and was exclusively licensed to Mustang in 2017. The lentiviral vector drug substance used to transduce patients’ cells to create the MB-106 drug product produced at Fred Hutch has been optimized as a third-generation CAR derived from a fully human antibody, and MB-106 is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. The same lentiviral vector drug substance produced at Fred Hutch will be used to transduce patients’ cells to create the MB-106 drug product produced at Mustang Bio’s Worcester, MA, cell processing facility for administration in the planned multicenter Phase 1/2 clinical trial that is now open to enrollment under Mustang Bio’s IND. It should be noted that Mustang Bio has introduced minor improvements to its cell processing to facilitate eventual commercial launch of the product. In addition, prior to commercial launch, Mustang Bio will replace the Fred Hutch lentiviral vector drug substance with vector produced at a commercial manufacturer. Additional information on the trials can be found at View Source using the identifier NCT05360238 for the multicenter trial and NCT03277729 for the ongoing trial at Fred Hutch.

On June 13, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB) (PharmaCyte), a biotechnology company focused on developing cellular therapies for cancer, diabetes and malignant ascites using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that its Chief Executive Officer, Kenneth L. Waggoner, will represent PharmaCyte at the 2022 BIO International Convention (BIO) being held at the San Diego Convention Center in San Diego, California, June 13-16 (Press release, PharmaCyte Biotech, JUN 13, 2022, View Source [SID1234615938]).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, "We look forward to meeting a host of industry leaders, investors and organizations as we introduce and advance the Cell-in-a-Box technology and the therapies we are developing using this technology. BIO offers a unique opportunity to showcase our novel therapies for cancer, diabetes and malignant ascites to world-class clinicians and scientists who work in our field of endeavor."

The 2022 BIO convention is the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. The host, the Biotechnology Innovation Organization, is the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries. The convention will feature 100+ interactive sessions over four days covering a variety of therapeutic areas, business development, digital health, patient advocacy, public policy and next generation biotherapeutics.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch PharmaCyte’s documentary video complete with medical animations at: View Source

On June 13, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the last patient has been randomized in the Phase 3 clinical trial of trilaciclib for patients with metastatic colorectal cancer (mCRC) receiving chemotherapy (PRESERVE 1) (Press release, G1 Therapeutics, JUN 13, 2022, View Source [SID1234615921]). Enrollment is complete at 326 randomized patients; the trial was over-enrolled by approximately 10 percent to compensate for potential loss to follow up at trial sites in Ukraine.

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Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes. It is approved by the U.S. Food and Drug Administration in another indication.

"FOLFOXIRI is an important chemotherapeutic backbone for people diagnosed with CRC because it is highly efficacious and has shown a survival advantage compared to other chemotherapeutic options; however, it is also the most myelotoxic regimen, so patients may have dose delays and reductions or receive less effective chemotherapeutic regimens – both of which could impact patient outcome and survival," said Raj Malik, M.D., G1’s Chief Medical Officer. "Trilaciclib may be an important addition to this regimen due to its unique ability to preferentially protect the bone marrow from chemotherapy-induced toxicities, and its potential to preserve immune system function and improve survival. Both endpoints are being assessed in PRESERVE 1. We are happy to have completed enrollment, and look forward to presenting initial data, including the primary endpoint of the trial, in the first quarter of 2023. This is a registrational trial; if the data from the primary endpoint are positive, we would work closely with the FDA to expedite our filing for regulatory approval in this indication."

Dr. Malik continued, "I’d like to thank the patients enrolled in the trial, the clinical investigators, our CRO partners, and the G1 and Simcere teams who worked tirelessly and under extraordinarily challenging conditions to advance the trial to this stage."

PRESERVE 1 is a global multi-center, randomized placebo-controlled, line extension pivotal Phase 3 trial of trilaciclib in 326 patients with metastatic CRC receiving first line trilaciclib or placebo administered prior to FOLFOXIRI (a combination of fluorouracil (5-FU), folinic acid, oxaliplatin and irinotecan) and bevacizumab. The regimen is given for two consecutive days of every 14-day cycle. Patients are receiving trilaciclib or placebo administered prior to their chemotherapy for a maximum of 12 cycles of induction followed by maintenance therapy. Treatment is administered until disease progression.

The primary endpoint is myeloprotection as measured by duration of severe neutropenia (DSN) and the occurrence of severe neutropenia (SN) during induction. Key secondary endpoints include the effects of trilaciclib on chemotherapy-induced fatigue compared with placebo and the effect of trilaciclib on progression free survival (PFS) and overall survival (OS) compared with placebo.

About Colorectal Cancer

Colorectal cancer is the third most common cancer in men and women, excluding certain skin cancers. Globally, it is the second leading cause of cancer death, with more than 1.8 million people newly diagnosed with colorectal cancer each year. In the United States, there are approximately 150,000 new cases of colorectal cancer diagnosed each year. Chemotherapy is the standard of care for colorectal cancer, and the majority of patients in the United States, Europe and Japan receive chemotherapy – commonly 5-FU-based regimens – as part of their treatment regimen.

On June 13, 2022 Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, reported it has purchased the remaining shares of Guardant Health AMEA, Inc., held by SoftBank and its affiliates, giving the company full control over operations throughout the Asia, Middle East and Africa region (Press release, Guardant Health, JUN 13, 2022, View Source [SID1234615939]).

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More than half of the world’s estimated new cancer cases come from Asia, Middle East and Africa (AMEA).1 This acquisition will allow Guardant Health to directly address the growing cancer burden in the region by accelerating the adoption of the company’s blood tests and services used by healthcare providers to detect and manage cancer across all stages of the disease.

Guardant Health AMEA operations support 41 countries across the region. Near term, the company will prioritize bringing blood-based testing to healthcare providers and to patients with advanced cancer in Japan, where, in March 2022, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted regulatory approval of Guardant360 CDx, a liquid biopsy test for tumor mutation profiling in patients with advanced solid tumors.

"By acquiring the remaining shares of Guardant Health AMEA, we can focus on creating a unified and centralized global organization that delivers on our promise to help conquer cancer and improve patient outcomes," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "We believe our blood-based tests can play a significant role in helping address the growing incidence of cancer in the region, and we look forward to continuing to support patients facing cancer diagnoses as we expand our operations in these markets."

In May 2018, Guardant Health and SoftBank Vision Fund established the Guardant Health AMEA joint venture to expand commercialization of Guardant Health’s industry-leading liquid biopsy technology across the region. Under the terms of the parties’ joint venture agreement, Guardant Health paid approximately $177.8 million to acquire the Guardant Health AMEA equity interest held by SoftBank and its affiliates.