On April 13, 2022 CDR-Life Inc., a biotechnology company pioneering a new and differentiated class of highly tumor-specific immuno-oncology therapeutics based on its proprietary antibody-based MHC-targeting T cell engager technology, reported the closing of a $76 million Series A financing led by Jeito Capital and RA Capital Management, with participation from Omega Funds (Press release, CDR-Life, APR 13, 2022, View Source [SID1234612155]). In connection with the financing, Rafaèle Tordjman, Founder & CEO of Jeito Capital, Daniel Marks, Principal of RA Capital, and Claudio Nessi, Managing Director of Omega Funds, will join the Company’s Board of Directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CDR-Life is currently advancing its lead program, CDR404, a first of its kind dual MAGE-A4 T cell engager which targets solid tumors across multiple indications, based on the Company’s unique M-gager technology. Proceeds from the Series A financing will advance CDR404 through potential clinical proof-of-concept readout as well as expansion of the pipeline leveraging the Company’s M-gager technology for targeting intracellular antigens positioned to deliver unparalleled specificity and affinity in solid tumors.

"We are honored to have the support of these high-caliber investors, reflecting both the critical need for effective T cell engaging therapies against solid tumors and the support of the CDR-Life product engine and development pipeline," said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. "The proceeds from this financing allow us to fund our first clinical proof-of-concept opportunity with CDR404, while continuing development of novel targeted immunotherapies based on CDR-Life’s superior T cell engaging platform. We are thankful to have the opportunity of raising a significant Series A round in such challenging times with an excellent European and US co-led investor group, assisting us in advancing our pipeline and goal of empowering cancer patients with uniquely targeted immunotherapies."

"We are thrilled to invest in CDR-Life which absolutely embodies our investment strategy with its high-quality science in T cell engagers, expert leadership team which has together already built a previous successful Biotech company, strong syndicate of investors and significant capital. Jeito Capital with this 10th investment is building a diversified portfolio of the next generation of European biotech leaders with a global reach in different therapeutic areas and development stages. CDR-Life is ideally positioned to accelerate its therapies based on innovative modalities for the benefit of millions of patients with limited therapeutic options. We look forward to support CDR-Life’s success," said Rafaèle Tordjman, Founder and CEO of Jeito Capital.

"CDR-Life has the deep biologics and platform technology expertise to rapidly develop bispecific molecules against this promising, but challenging, class of intracellular targets," said Daniel Marks, Principal of RA Capital. "We’re especially pleased to be working with these leading healthcare investors and this experienced and talented leadership team."

Based in Switzerland, CDR-Life is led by an experienced team of biotech executives who have developed new medicines and closed substantial biotech deals, including Beovu and ESBATech. The Company has an ongoing partnership with Boehringer Ingelheim, advancing its program, CDR202, into preclinical stage of development targeting macular degeneration. Clinical candidate, CDR101, a next generation BCMA, CD3, and PD-L1 targeting trispecific antibody in preclinical development for the treatment of multiple myeloma (MM) has recently demonstrated increased in vitro activity compared to clinical stage-like bispecific BCMA therapies, inducing superior T cell activation in bone marrow samples of MM patients and more durable tumor eradication in a mouse xenograft model. CDR101 is ready for IND-enabling studies.

On April 13, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has deprioritized further development of ONCT-216 to reallocate resources to zilovertamab, the Company’s investigational anti-ROR1 monoclonal antibody, and its Phase 3 registrational trial that the Company expects to initiate in Q3 2022 (Press release, Oncternal Therapeutics, APR 13, 2022, View Source [SID1234612154]). As such, the Company has discontinued enrollment in the Phase 1/2 study evaluating ONCT-216 in patients with relapsed or refractory Ewing sarcoma.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This asset prioritization allows us to further sharpen our focus on hematological malignancies and prostate cancer, while deploying our capital towards meaningful catalysts as we navigate this historically challenging pandemic, geopolitical and capital markets macroenvironment," said James Breitmeyer, MD, PhD, Oncternal’s President and CEO. "We believe this focused approach, along with prudent cash management, will enable us to fund our operations well into the third quarter of 2023, as we continue to explore all potential sources of capital to enable us to reach our milestones."

The Company expects to initiate its global registrational Phase 3 Study ZILO-301 in the third quarter of 2022, taking into account the impact of geopolitical factors and COVID-19 related supply chain issues. The study will randomize patients with relapsed or refractory MCL who have experienced stable disease or a partial response after receiving four months of oral ibrutinib therapy to receive either blinded zilovertamab or placebo, and all patients will continue receiving oral ibrutinib. The novel ZILO-301 design is supported by encouraging data from the Company’s ongoing Phase 1/2 clinical trial of zilovertamab plus ibrutinib for patients with MCL or CLL, as well as by a successful End-of-Phase-2 meeting with the U.S. Food and Drug Administration (FDA).

The Company’s lead autologous ROR1-targeted CAR-T cell therapy program candidate, ONCT-808, is advancing according to plan towards an Investigational New Drug (IND) application submission expected in mid-2022, based on supportive manufacturing and preclinical data as well as a productive pre-IND meeting with the FDA earlier this year.

Finally, the Company continues to advance ONCT-534, its lead candidate in its DAARI program, and expects to initiate IND-enabling GLP toxicology studies and GMP manufacturing later this quarter. ONCT-534 has shown anti-tumor activity in preclinical studies relevant to multiple clinically important forms of resistance for patients with prostate cancer, including those involving overexpression of the androgen receptor, or expression of mutants of the androgen receptor, or splice variants such as AR-V7.

About Zilovertamab (formerly Cirmtuzumab)
Zilovertamab is an investigational, humanized, potentially first-in-class monoclonal antibody targeting Receptor tyrosine kinase-like Orphan Receptor 1 (ROR1). Zilovertamab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of patients with MCL or chronic lymphocytic leukemia (CLL), in a collaboration with the University of California San Diego (UC San Diego) School of Medicine and the California Institute for Regenerative Medicine (CIRM). In addition, Oncternal is supporting two investigator-sponsored studies being conducted at the UC San Diego School of Medicine, a Phase 1b clinical trial for patients with metastatic castration-resistant prostate cancer (mCRPC), and a Phase 2 clinical trial of zilovertamab in combination with venetoclax, a Bcl-2 inhibitor, for patients with relapsed/refractory CLL. Both are open for enrollment.

ROR1 is a potentially attractive target for cancer therapy because it is an onco-embryonic antigen, not usually expressed on adult cells, but its expression confers a survival and fitness advantage when reactivated and expressed by tumor cells. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to specifically inhibiting ROR1 expressing tumors. This led to the development of zilovertamab which binds this critical epitope of ROR1, highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when zilovertamab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells. The FDA has granted Orphan Drug Designations to zilovertamab for the treatment of patients with MCL and CLL/small lymphocytic lymphoma. Zilovertamab is in clinical development and has not been approved by the FDA for any indication.

On April 13, 2022 Phosplatin Therapeutics Inc., a clinical stage pharmaceutical company focused on oncology therapeutics, reported the first patient has been treated in a Phase 2 clinical trial of the company’s lead therapeutic candidate, PT-112, in patients with recurrent thymic epithelial tumors (TETs), specifically thymoma and thymic carcinoma (Press release, Phosplatin, APR 13, 2022, View Source [SID1234612153]). The trial is being conducted under formal collaboration with the National Cancer Institute (NCI), part of the National Institutes of Health (see NCT05104736).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 2 trial is designed to further assess the safety and efficacy of PT-112 in patients with thymoma and thymic carcinoma, and to use correlative studies to explore molecular profiles, examine parameters of immune activation and analyze immune cell infiltration in response to PT-112 treatment, as the candidate is known to promote immunogenic cell death (ICD). ICD is an immunostimulatory form of cancer cell death in the tumor microenvironment, and PT-112’s highly potent induction of ICD has been validated in relevant cancer models.

Phosplatin is providing NCI with PT-112 drug supply and support for correlative research, and NCI is overseeing enrollment and dosing of the study’s intended 53 patients. To be eligible for the study, patients must have uncommon tumors of the thymus (TETs) returned or progressed after treatment with at least one platinum-containing chemotherapy, or have refused standard treatment. The primary endpoint is overall response rate (ORR) per RECIST 1.1 criteria. The secondary endpoint measures include safety, duration of response, progression free survival, overall survival and ORR based on ITMIG-modified RECIST criteria (as established by the International Thymic Malignancy Interest Group).

"As an immunomodulatory treatment, PT-112 has performed well in early phase trials for TETs and warrants additional Phase 2 testing. Given the significant unmet need for patients with recurrent TETs, with no established immunotherapy option and no approved drug, it is important that we continue to study potential therapies," said Arun Rajan, MD, Senior Clinician in the Thoracic and GI Malignancies Branch at the NCI.

"In our Phase 1 trial of PT-112, we reported favorable safety data and observed a durable clinical response in a patient with advanced metastatic thymoma, which had the signature of potential immune involvement to the response," said Robert Fallon, Phosplatin President and Chief Executive Officer. "We are excited to work with Dr. Rajan and his outstanding team at the NCI to further study the potential of PT-112 to provide significant benefit to patients with these cancers."

Phosplatin holds an FDA Orphan Drug Designation for PT-112 in thymoma and thymic carcinoma. TETs, including thymomas and thymic carcinomas, are uncommon tumors of the thymus for which there is no FDA-approved drug. The five-year survival rate for patients with thymoma or thymic carcinoma is 55%. In cases of relapse following surgical intervention, TETs have the potential to metastasize and there are limited options for treatment.

About PT-112

PT-112 is the first small-molecule conjugate of pyrophosphate in oncology, and possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and now includes the Phase 2 proof of concept study in thymic epithelial tumors under the company’s formal collaboration with the NCI. The PD-L1 combination Phase 2a study is ongoing in a dose confirmation cohort of non-small cell lung cancer (NSCLC) patients.

On April 13, 2022 Turning Point Therapeutics, Inc. Presented the Corporate Presentation (Presentation, Turning Point Therapeutics, APR 13, 2022, View Source [SID1234612152]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On April 13, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that Cancer Research UK recently completed patient enrollment in the ongoing Phase 1 clinical trial of VAC2, an allogeneic cancer vaccine product candidate, for the treatment of non-small cell lung cancer ("NSCLC") (Press release, Lineage Cell Therapeutics, APR 13, 2022, View Source [SID1234612151]). Under the terms of an existing agreement, Cancer Research UK will complete the ongoing clinical trial and Lineage has now assumed responsibility for further clinical development of the VAC2 product candidate and any future development opportunities derived from the VAC platform.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased that Cancer Research UK has successfully completed patient enrollment in the VAC2 Phase 1 clinical study and overcame substantial challenges stemming from the COVID pandemic. We look forward to initial clinical results from this study being available later this year," stated Brian M. Culley, Lineage CEO. "Clinical data previously collected by Cancer Research UK demonstrated peripheral immunogenicity in patients with NSCLC treated with VAC2, providing support to the underlying mechanism of using allogeneic dendritic cells to present tumor-associated antigens to the body’s immune system. Simultaneous with Cancer Research UK efforts to complete enrollment in the current study, the focus at Lineage has been on making improvements and modernizations to the VAC manufacturing process, an approach which we similarly employed in the development of OpRegen. We believe our focus on manufacturing will help prepare VAC2 for additional clinical trials and provide a competitive advantage for any future VAC programs which we advance, either alone or through alliances. With Cancer Research UK having completed enrollment of the current study, the team at Lineage also has begun work towards the submission of an Investigational New Drug Application for clinical testing of VAC2 in the U.S., which we anticipate submitting to the FDA later this year."

Dr. Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, added: "We are delighted to see that this innovative VAC2 program has reached such an important milestone in its development and are extremely proud to have played an important role in establishing its tolerability in lung cancer patients. We look forward to seeing Lineage advance VAC2 under their leadership in the future."

About VAC2

VAC2 is an allogeneic, or non-patient specific "off-the-shelf," cancer vaccine product candidate designed to stimulate patient immune responses to an antigen commonly expressed in cancerous cells but not in normal adult cells. VAC2, which is produced from a pluripotent cell technology using a directed differentiation method, is comprised of a population of nonproliferating mature dendritic cells. As the most potent type of antigen presenting cell in the body, dendritic cells instruct the body’s immune system to attack and eliminate harmful pathogens and unwanted cells. Because the tumor antigen is loaded exogenously into the dendritic cells prior to administration, VAC2 is a platform technology that could be modified to carry selected antigens, including patient-specific tumor neo-antigens or viral antigens. VAC2 is currently being tested in a Phase 1 study in adult patients with NSCLC in the advanced and adjuvant settings (NCT03371485), conducted by Cancer Research UK.

About Cancer Research UK’s Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.

About Cancer Research UK’s Commercial Partnerships Team

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.