On April 30, 2021 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, and Cancer Focus Fund, LP, a unique venture capital fund established in collaboration with The University of Texas MD Anderson Cancer Center ("MD Anderson") to provide funding and clinical expertise to advance promising cancer therapies, reported a partnership to evaluate Mereo’s lead anti-TIGIT therapeutic antibody candidate, etigilimab, in clear cell ovarian cancer, a rare cancer that accounts for approximately 5–10% of all ovarian carcinomas in North America (Press release, Mereo BioPharma, APR 30, 2021, View Source [SID1234578872]).

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The Mereo and Cancer Focus Fund partnership will support a Phase 1b/2 clinical study of etigilimab in combination with an anti-PD-1 antibody in clear cell ovarian cancer, to be conducted at MD Anderson and led by Shannon Westin, MD, MPH, associate professor of Gynecologic Oncology and Reproductive Medicine. The study will be financed by Cancer Focus Fund, in exchange for upfront consideration of $1.5 million of Mereo shares and additional payments based on the achievement of certain milestones.

"We are honored to partner with Cancer Focus Fund on clinical studies of etigilimab in this rare and aggressive form of ovarian cancer," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "This program is the first investment made by Cancer Focus Fund since its inception. We believe that this speaks to the significant potential of etigilimab in the emerging TIGIT space. We look forward to working closely with the Cancer Focus Fund team and with Dr. Westin and her team at MD Anderson to design and execute the trial."

"Cancer Focus Fund is partnering with MD Anderson to help advance novel anticancer drug candidates through early clinical development, and we are delighted that our first investment is in support of Mereo’s anti-TIGIT antibody, etigilimab," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "The TIGIT immune receptor is a promising new target for cancer immunotherapy. We welcome the opportunity to collaborate with Mereo and MD Anderson to jumpstart the clinical assessment of etigilimab in clear cell ovarian cancer, which lacks effective treatment options once advanced."

On April 30, 2021 Immunicom, Inc., a clinical-stage biotechnology company pioneering "subtractive" advanced cancer therapies, reported that promising preliminary data from trials investigating ImmunopheresisTM therapy for metastatic, refractory, solid tumor cancer patients who previously failed multiple lines of therapy (Press release, Immunicom, APR 30, 2021, View Source [SID1234578906]). The results presented by Immunicom’s Chief Medical Officer, Dr. Robert Segal, at the 2021 ISFA/E-ISFA virtual joint conference established that Immunopheresis administered to end-stage cancer patients was generally well-tolerated and has the potential for treating refractory malignancies.

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Immunicom’s ongoing clinical trials are in the most difficult to treat, late-stage cancer patients. Immunicom’s novel Immunopheresis therapy uses its proprietary subtractive LW-02 column to selectively remove immune-suppressive cytokines produced by cancer tumors.

"Standard drug treatments are additive therapies that introduce substances into the body to treat cancers. We are developing high-affinity subtractive therapies specifically for these difficult metastatic cancers," said Immunicom’s CEO, Amir Jafri. "Our mission is to define a new era of cancer treatment that is safe and effective."

Dr. Segal’s presentation focused on results from over 600 Immunopheresis procedures conducted in 34 end-stage cancer patients from ongoing clinical trials, demonstrating the viability of this technology as a new treatment strategy. The clinical trials are evaluating the LW-02 column for treating multiple cancers, including triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma. The LW-02 column is being investigated both as a monotherapy and in combination with low-dose metronomic chemotherapy and the well-known immunotherapy checkpoint inhibitors Opdivo (Bristol-Myers Squibb) and Tecentriq (Roche). These trials are being conducted in collaboration with world-renowned research organizations and thought leaders including:

Poland – at Jagiellonian University of Krakow Hospital, under the direction of Principal Investigator, Professor Piotr Wysocki, MD, PhD;

Israel – at Sheba Medical Center’s Ella Lemelbaum Institute for Immuno-Oncology (Tel Aviv), under the direction of Dr. Ronnie Shapira, MD and Prof. Gal Markel, MD, PhD; and

Turkey – at Acıbadem Altunizade Hospital (Istanbul), a member of the Acıbadem/IHH Healthcare Group, under the direction of Principal Investigator, Prof. Dr. Gokhan Demir, MD, PhD.

Subtractive Therapy – ImmunopheresisTM and the LW-02 Column

Immunicom’s innovative Immunopheresis approach uses the LW-02 column to extract specific immune-suppressive cytokines produced by cancer tumors. Selective removal of these targeted cytokines is intended to neutralize cancer’s ability to block a patient’s natural immune defense mechanisms which are significantly compromised in late-stage, metastatic disease and thereby "re-energizes the immune system to aggressively fight cancer." Immunopheresis is a "subtractive therapy," in contrast to drugs that are "additive." Subtractive therapy is meant to avoid the side effects, toxicity and negative impact on a patient’s quality of life typical of other cancer treatments.

Immunicom believes that the LW-02 column could be used either in combination with other therapies or as a stand-alone treatment. The LW-02 Immunopheresis column has already received Breakthrough Device Designation for stage IV metastatic cancers from the U.S. Food and Drug Administration (FDA). Immunicom has obtained ISO 13485 certification for its manufacturing and related quality systems.

For an overview of how Immunopheresis breakthrough technology works, watch Immunicom’s How it Works video.

Immunopheresis and the LW-02 column is considered an investigational therapy by the U.S. FDA and other regulatory authorities. The clinical efficacy of the LW-02 column has not yet been demonstrated. Clinical investigations evaluating the clinical efficacy of the LW-02 column for TNBC are ongoing.

On April 30, 2021 PCI Biotech’s (OSE: PCIB) reported that first quarter 2021 interim report will be released on 7 May 2021 at 07.00 CEST. The interim report and presentation will be made available on www.newsweb.no and on the company’s webpage, www.pcibiotech.com (Press release, PCI Biotech, APR 30, 2021, View Source [SID1234585160]).

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A results presentation (in English) will be held through a live webcast at 08.30 CEST the same day. The webcast can be accessed through www.pcibiotech.com. There will be a Q&A session at the end of the presentation. It will be possible to post written questions through the webcast console or through a teleconference facilitated for investors intending to ask questions verbally during the Q&A session.

On April 30, 2021 Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech"), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed and/or refractory multiple myeloma (Press release, Legend Biotech, APR 30, 2021, View Source [SID1234578873]).

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Cilta-cel is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy being investigated as a treatment for multiple myeloma. The MAA is based on positive results from a Phase 1b/2 CARTITUDE-1 study, which were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Annual Meeting.1 The submission was filed to the EMA by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, Inc., Legend’s collaboration partner for cilta-cel.

"Today’s submission is a testimony to the promising results we have seen from the CARTITUDE-1 study showing the efficacy and safety of cilta-cel for treating patients with multiple myeloma who are heavily pretreated and in need of treatment options," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "We are proud of our collaboration with Janssen and look forward to bringing this personalized treatment to patients in the EU following the accelerated assessment."

The EMA’s Committee for Medicinal Products for Human Use (CHMP) granted accelerated assessment for this MAA. An accelerated assessment is granted when the CHMP determines that a medicinal product is of major public health interest and therapeutic innovation and can significantly reduce the review timelines to evaluate an MAA.2 Cilta-cel previously received a PRIority MEdicines (PRIME) designation from the EMA. A Biologics License Application (BLA) seeking approval of cilta-cel based on the CARTITUDE-1 study is currently under review with the United States Food and Drug Administration.

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed and/or refractory multiple myeloma, 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory (to at least 1 immunomodulatory drug [IMiD], proteasome inhibitor [PI] and 1 anti-CD38 antibody).3 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint.

About Ciltacabtagene autoleucel (cilta-cel)

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. Cilta-cel is a differentiated CAR-T therapy with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.4 Although treatment may result in remission, unfortunately, patients will most likely relapse.5 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.6 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.7,8 While some patients with multiple myeloma have no symptoms until later stages of the disease, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.9 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options.10

On April 30, 2021 Tessa Therapeutics Ltd. (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments for hematological malignancies and solid tumors, reported enrollment of 12 patient Pilot cohort of its Phase 2 trial (NCT04268706) in relapsed / refractory Classical Hodgkin Lymphoma (R/R cHL) (Press release, Tessa Therapeutics, APR 30, 2021, https://www.prnewswire.com/news-releases/tessa-therapeutics-announces-enrollment-of-12-patient-pilot-cohort-in-its-relapsed-or-refractory-hodgkin-lymphoma-phase-2-study-301281049.html [SID1234578907]). The next step in the two-part study is enrollment of the 82 patient Pivotal cohort to assess the safety and antitumor efficacy of Tessa’s autologous CD30 CAR-T in R/R cHL, which is planned to commence in 2H 2021.

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"Tessa’s CD30 CAR-Ts previously demonstrated excellent safety and efficacy in heavily pre-treated R/R cHL patients across two independent Phase 1/2 studies. It is exciting to see the rapid enrollment of the Pilot cohort, and we look forward to working with Tessa in the pivotal cohort of this trial. There is a high unmet need for effective treatments in R/R cHL and we are pleased to be able to advance this novel CD30 directed CAR-T cell therapy for our patients," said Sairah Ahmed, M.D., Associate Professor, The University of Texas MD Anderson, Cancer Center.

CD30 is a well validated lymphoma target with homogeneous expression in 98% of classical Hodgkin Lymphoma (cHL) and a significant proportion of subsets of non-Hodgkin Lymphomas. Tessa’s technology modifies the patient’s T-cells by introducing a CD30 directed Chimeric Antigen Receptor, or CAR, to target and kill cHL. Tessa’s CD30 CAR-T therapy, previously induced a Complete Response in 59% of heavily pretreated R/R cHL patients, with no instance of neurotoxicity or grade 3 Cytokine release syndrome (CRS) (and published in Journal of Clinical Oncology[1]). Tessa’s therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration and PRIority MEdicines (PRIME) designation by European Medicines Agency.

"The speed of enrollment of our 12 patient Pilot cohort, in less than 3 months, is testament to the strong physician and patient interest in our CD30 CAR-T therapy, and further endorses the clinical data generated under the dual Phase 1/2 studies. This marks a critical milestone as Tessa gears up to commence our Pivotal cohort in second half of the year," said Jeffrey H. Buchalter, President and CEO of Tessa Therapeutics. "We believe that Tessa’s CD30 CAR-T therapy, with its promising efficacy and excellent safety profile, addresses current gaps in the treatment of cHL, and has the potential to rapidly move to earlier lines of therapy."