On January 25, 2022 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported a presentation at the 2nd Annual TGFβ for Immuno-Oncology Drug Development Summit (January 25-27, 2022) (Press release, Scholar Rock, JAN 25, 2022, View Source [SID1234606786]).

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"Development of a Comprehensive Biomarker Strategy to Support DRAGON, a Phase 1 Clinical Trial of SRK-181, the latent TGFβ1 Inhibitor" will be presented on January 27th, 2022, at 11:00 AM EST. The presentation, led by Si Tuen Lee-Hoeflich, Director, Translational Sciences at Scholar Rock, will discuss the SRK-181 biomarker strategy in relation to the DRAGON Phase 1 proof-of-concept trial (NCT04291079). The goal of the trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with an anti-PD-(L)-1 in adult patients with locally advanced or metastatic solid tumors. The biomarker strategy will focus on the evaluation of biomarkers relevant to the mechanism of action of SRK-181 to facilitate the clinical development of Scholar Rock’s immuno-oncology (IO) program and to identify the next wave of IO biomarkers that correlate with anti-tumor response.

"We are excited to be presenting at the TGFβ for Immuno-Oncology Drug Development Summit on our biomarker strategy for SRK-181 in support of DRAGON," said Gregory Carven, Ph.D., Chief Scientific Officer. "Our biomarker efforts play an important role in advancing our understanding of the mechanisms of action of selective inhibition of TGFβ1 and for facilitating the development of SRK-181, which we hope will positively impact the lives of those affected by cancers that are resistant to checkpoint blockade."

Initial Part A data from the ongoing DRAGON trial in patients with locally advanced or metastatic solid tumors were presented by Scholar Rock at the 36th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2021, supporting dose selection and advancement into Part B. Part B will assess SRK-181 in combination with an approved anti-PD-(L)1 therapy across multiple solid tumor cohorts to test proof of concept. To learn more about DRAGON, visit clinicaltrials.gov.

For Summit information, visit: www.tgf-beta-summit.com

About SRK-181

SRK-181 is a selective inhibitor of TGFβ1 activation and is an investigational product candidate being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity (1). Scholar Rock believes SRK-181, which specifically targets the latent TGFβ1 isoform, has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing. The efficacy and safety of SRK-181 have not been established. SRK-181 has not been approved for any use by the FDA nor any other regulatory agency.

(1) Martin et al., Sci. Transl. Med. 12: 25 March 2020

On January 25, 2022 Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy, reported the successful closing of its Series A financing round, raising a total of NOK 180 million ($20 million) (Press release, Cytovation, JAN 25, 2022, View Source;utm_medium=rss&utm_campaign=cytovation-raises-20-million-in-series-a-financing-round-to-advance-clinical-development-of-cypep-1-a-first-in-class-targeted-tumor-membrane-immunotherapy [SID1234607559]).

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "We are extremely pleased with the strong support we have received during this latest investment round. We continue to make excellent progress with CyPep-1 in our Phase I/II CICILIA clinical trial and following promising data from the first monotherapy part of the study, we have begun patient dosing of CyPep-1 in combination with Keytruda in patients with a range of solid tumors. These new proceeds will enable us to further advance and expand our clinical development plans in cancer, and we look forward to reporting further data from this clinical program in 2022. Additionally, we will now have the financial flexibility to investigate opportunities to expand our CyPep-1 development pipeline."

The Series A round was led by Sandwater, a Norwegian venture capital firm that invests in groundbreaking companies across a range of industries including life sciences, and Canica, a large, privately owned investment company operating out of Norway and Switzerland focused on building highly innovative companies that aim to create value for investors and society as a whole.

The new funds will primarily be directed towards clinical development of Cytovation’s lead asset CyPep-1, a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target cancer cells. CyPep-1 eliminates cancer cells by forming pores in the plasma membrane, releasing cancer specific antigens to the immune system, promoting an inflammatory microenvironment and inducing a tumor-specific immune response by in situ vaccination. Preclinical data suggest this mode of action is highly synergistic in combination with checkpoint inhibitors.

Proceeds will be used to:
Progress the CyPep-1 oncology program to Phase II, including expansion of single-agent arms, as well as three combination arms with KEYTRUDA (pembrolizumab) in head and neck squamous cell carcinoma (HNSCC), triple negative breast cancer (TNBC), and melanoma, in collaboration with MSD
Explore opportunities for pipeline development with CyPep-1 targeting patients with high unmet medical need

Morten E. Iversen of Sandwater commented: "We are very pleased to be supporting Cytovation, a company that reflects our investment ethos of investing in innovative companies that we believe can make a real impact across society. We believe CyPep-1 has a very promising future, backed by an excellent and highly experienced management team."

Christer Kjos of Canica added: "Cytovation shares our entrepreneurial approach and willingness to take on new challenges with commitment and passion. We believe the company has reached an exciting point in its development and look forward to the time when this potential new treatment can bring benefit to a wide variety of cancer patients."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

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On January 25, 2022 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 6,023 million in 2021 (Press release, Genmab, JAN 25, 2022, View Source [SID1234606771]). Net trade sales were USD 3,169 million in the U.S. and USD 2,854 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC formulations, under the exclusive worldwide license to Janssen Biotech, Inc. (Janssen) to develop, manufacture and commercialize daratumumab. As previously announced, Janssen is reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme, cf. company announcement No. 39 of September 22, 2020.

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About DARZALEX (daratumumab)

DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat multiple myeloma and has become a backbone therapy in the treatment of this disease. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of multiple myeloma and the first and only approved treatment for patients with light-chain (AL) amyloidosis. Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death). 1,2,3,4,5,6,7

On January 25, 2022 Gilead Sciences Inc. (Nasdaq: GILD) reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms (Press release, Gilead Sciences, JAN 25, 2022, View Source [SID1234606787]). While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA.

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During the partial clinical hold, screening and enrollment of new study participants will be paused in any study investigating the combination of magrolimab with azacitidine. Patients already enrolled in these clinical studies may continue to receive magrolimab and azacitidine, or placebo, and continue to be closely monitored according to the current study protocol. Gilead is currently notifying clinical investigators and global regulatory authorities about the partial clinical hold. Other magrolimab studies, or cohorts, that are not studying the combination of magrolimab plus azacitidine, will continue without any impact by the partial clinical hold.

"The safety and well-being of people enrolled in our studies is our top priority. We will share more information with the medical and patient community as soon as we can," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "Considering the high unmet need for new medicines in myelodysplastic syndrome and acute myeloid leukemia, we will work closely with regulatory authorities worldwide to continue the magrolimab development program appropriately. We remain confident in the potential of magrolimab across a broad range of tumors, including the other, ongoing magrolimab studies. We are grateful to those participating in our studies, their families, and the investigators for their continued contributions to the clinical program for magrolimab."

Gilead is working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment for the affected studies.

The studies impacted by this partial clinical hold include:

Phase 3 ENHANCE study in myelodysplastic syndrome (MDS; NCT04313881)
Phase 3 ENHANCE-2 study in acute myeloid leukemia (AML; TP53 mutated patients; NCT04778397)
Phase 3 ENHANCE-3 study in unfit AML (NCT05079230)
Phase 1b study in MDS (NCT03248479)
Phase 2 study in myeloid malignancies (NCT04778410) *only the azacitidine combination cohorts
The studies not impacted include:

Phase 2 study in diffuse large B-cell lymphoma (NCT02953509)
Phase 2 study in multiple myeloma (NCT04892446)
Phase 2 study in head and neck squamous cell carcinoma (NCT04854499)
Phase 2 study in solid tumors (NCT04827576)
Phase 2 study in triple-negative breast cancer (NCT04958785)
Phase 2 study in colorectal cancer, planned and not currently recruiting
About Magrolimab

Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the "don’t eat me" signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers, including myelodysplastic syndrome (MDS), as well as solid tumor malignancies.

More information about clinical trials with magrolimab is available at www.clinicaltrials.gov.

On January 25, 2022 Cure Genetics of Suzhou reported that closed a $60 million Series B round to advance clinical development of its cell therapy candidates for hematological and solid tumors (Press release, CureGenetics, JAN 25, 2022, View Source [SID1234607390]). Cure was established by CRISPR pioneers in 2016 to develop therapies for difficult-to-treat cancers and genetic diseases. Its CRISPR-mediated single or multiplex gene editing platform is aimed at producing more effective or safer cell therapy products, including universal CAR-T candidates. The financing round was led by Advantech Capital and joined by Oriza Holdings, Blue Ocean Private Equity and Qiming Venture Capital

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