On December 7, 2020 KaliVir Immunotherapeutics LLC (CEO: Helena Chaye, Ph.D., J.D., "KaliVir") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that they entered into a worldwide licensing agreement for the research, development, and commercialization of VET2-L2, an intravenously administered oncolytic virus for Immuno-Oncology, as well as a research collaboration to generate a Second Product, a follow-on virus (Press release, Astellas, DEC 7, 2020, View Source [SID1234572335]).

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KaliVir holds its unique technology platform based on genetically modified vaccinia virus, and is developing VET2-L2, an oncolytic vaccinia virus as their lead program. VET2-L2, which is delivered by intravenous administration, reaches and destroys cancer cells and activates anti-cancer immunity through expression of therapeutic transgenes. KaliVir’s vaccinia virus-based oncolytic viral immunotherapies can be delivered intravenously to cancer patients, eliminating the need for complicated procedures of the direct intra-tumoral administration and enables access for a broader patient population. VET2-L2 is in preclinical stage.

This collaboration, which combines KaliVir’s expertise in the development of oncolytic viruses with Astellas’ capabilities in advanced drug development and its global business experience, will enable both parties to develop new Immuno-Oncology therapies.

Under the terms of the agreement, Astellas will pay to KaliVir up to US$56 million in the form of an upfront payment and other payments to support research and preclinical activities related to VET2-L2 and the Second Product. Additionally, Astellas may pay up to US$307 million and up to US$271 million for development, regulatory and commercialization of VET2-L2 and Second Product, respectively. Astellas also may make royalty payments on net sales of each licensed product.

"We are thrilled that Astellas has chosen KaliVir, and specifically VET2-L2, our lead product candidate, to add to their oncology program. VET2-L2, a multi-mechanistic, intravenously-delivered oncolytic vaccinia virus, has demonstrated strong precinical data prompting us to plan our initial clinical trial for VET2-L2," said KaliVir CEO Helena Chaye, Ph.D., J.D. "With Astellas’ excellent track record for drug development and commercialization, we believe that their commitment to collaborating with KaliVir represents strong third-party validation for our VET platform. We are commited to bringing this exciting product to cancer patients and believe that our collaboration with Astellas will expedite our ability to do this."

Naoki Okamura, Representative Director, Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer, at Astellas said, "We, at Astellas, have positioned Immuno-Oncology as one of the Primary Focuses of our R&D strategy, and we are committed to developing the next generation of Immuno-Oncology therapies through new modalities and technologies. Oncolytic viruses are one of the therapies in which we are particularly focused as we strive to provide new options for patients who have no effective treatment options. We expect this KaliVir collaboration to enhance our pipeline and further expand our cancer treatment options as we work to develop innovative medical solutions that turn innovative science into VALUE for patients."

On December 7, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported updated interim clinical data from the ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial, in which cirmtuzumab, an investigational anti-ROR1 monoclonal antibody, is being evaluated in combination with ibrutinib in patients with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) (Press release, Oncternal Therapeutics, DEC 7, 2020, View Source [SID1234572351]). The clinical trial is being partially funded by the California Institute for Regenerative Medicine. The data were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 Virtual Annual Meeting, and a copy of the poster presentation is available online at www.oncternal.com:

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Abstract Title: Cirmtuzumab, an Anti-ROR1 Antibody, in Combination with Ibrutinib: Clinical Activity in Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL) from a Phase 1/2 Study (abstract # 2942)
Session Title: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma – Clinical Studies: Poster III
Session Date and Time: December 7, 2020, 7:00 a.m. – 3:30 p.m. (Pacific Time)
"The interim data from the combination of cirmtuzumab and ibrutinib are quite promising in relapsed/refractory (r/r) MCL, with an impressive 87% best ORR that has improved over time. The time to response, depth and durability of responses make cirmtuzumab a compelling candidate for further development," said Hun Ju Lee, M.D., Associate Professor of Medicine in the Department of Lymphoma & Myeloma at the University of Texas MD Anderson Cancer Center, who is an investigator on the CIRLL clinical trial and was also the first author on the 2020 ASCO (Free ASCO Whitepaper) poster presentation.

"We are pleased that median PFS has not yet been reached after a median follow-up of over 12 months in the MCL patients, and are encouraged that both PFS and ORR have improved with longer follow-up," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We are in active dialogue with FDA on pivotal study design in order to define the path to approval in MCL."

As of the data cut-off date of October 30, 2020, 15 patients with relapsed/refractory MCL enrolled in the dose-finding and dose-expansion cohorts of this clinical trial were evaluable for efficacy:

The overall best objective response rate (ORR) was 87% (13 of 15 evaluable patients), improved over the 83% ORR reported at ASCO (Free ASCO Whitepaper) 2020.
The complete response (CR) rate, determined by Cheson criteria, remains 57% (7 of 12 evaluable patients) for Part 1 of the study, and is 47% (7 of 15 evaluable patients) for Part 1 + Part 2, including the three patients from Part 2 who have shorter followup. One of the seven patients had a complete metabolic response (CMR) as assessed by PET scan, with an indeterminate bone marrow biopsy on blinded review. All complete responses remained durable, ranging from 5-25 months as of the cutoff date, with no progressions reported after achieving a CR. Six patients (40%) achieved a partial response (PR). In addition, two patients had stable disease (SD), for a total best clinical benefit rate (CR, PR and SD) of 100%.
Median progression-free survival (PFS) was not reached, with the 95% confidence interval above 17.5 months, after a median follow-up of 12.1 months.
Patients had received a median of two prior therapies (range 1-5) before participating in this clinical trial, with 73% of patients with two or more prior lines of therapy. Four patients had received prior treatment with ibrutinib and all four achieved clinical responses in this clinical trial, with two CRs and two PRs. Fourteen of the 15 evaluable patients (93%) had high or intermediate MCL International Prognostic Index (MIPI-b) risk score at study entry.
Historical data published for single-agent ibrutinib for 370 patients with r/r MCL, who had received a median of two prior therapies, reported an ORR of 66%, CR rate of 20%, PR rate of 46%, and median PFS of 12.8 months (Rule et al., 2017, British Journal of Haematology).
As of the data cut-off date on October 30, 2020, 56 evaluable patients with CLL were enrolled in the dose-finding, dose-confirming and randomized cohorts of this clinical trial, 49 of whom were treated with the combination of cirmtuzumab and ibrutinib:

Forty-five of the 49 patients achieved a clinical response, for an overall best objective response rate of 92%, including one patient who achieved a CR. In addition, four patients had stable disease, for a total clinical benefit rate (CR, PR, and SD) of 100%.
The median PFS was not reached for patients with treatment-naïve CLL (n=19) after a median follow-up of 16.6 months, and median PFS was 29.5 months for patients with r/r CLL (n=30) after a median follow-up of 17.1 months.
The combination of cirmtuzumab plus ibrutinib has been well tolerated, with adverse events consistent with those reported for ibrutinib alone. There have been no dose-limiting toxicities and no serious adverse events attributed to cirmtuzumab alone.

About the CIRLL Clinical Trial
The CIRLL clinical trial (CIRM-0001) is a Phase 1/2 trial evaluating cirmtuzumab in combination with ibrutinib in separate groups of patients with CLL or MCL. Enrollment of the dose-finding cohorts in CLL and MCL, dose-expansion cohort in CLL and randomized Phase 2 cohort in CLL has been completed. Enrollment of the dose-expansion cohort in MCL is ongoing. Additional information about the CIRM-0001 clinical trial and other clinical trials of cirmtuzumab may be accessed at ClinicalTrials.gov.

About Cirmtuzumab
Cirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of CLL or MCL, 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, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women with metastatic breast cancer is being conducted at the UC San Diego School of Medicine.

ROR1 is a potentially attractive target for cancer therapy because it is an onco-embryonic antigen – not usually expressed on adult cells, and 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 targeting ROR1 expressing tumors. This led to the development of cirmtuzumab, that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when cirmtuzumab 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 cirmtuzumab for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma. Cirmtuzumab is in clinical development and has not been approved by the FDA for any indication.

On December 7, 2020 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it shares new data at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) showing how its GuardantINFORM real-world clinical-genomic platform can be used to gain deeper insights into patients’ treatments and associated response to support the development of more effective therapies for biomarker-defined cancers (Press release, Guardant Health, DEC 7, 2020, businesswire.com/news/home/20201207005087/en/Guardant-Health-Presents-Data-at-San-Antonio-Breast-Cancer-Symposium-Demonstrating-Utility-of-GuardantINFORM-Real-World-Platform-in-Metastatic-Breast-Cancer [SID1234572368]). The data presented highlight treatment resistance in estrogen receptor positive (ER-positive), HER-2 negative metastatic breast cancer patients.

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"While we’ve seen improved outcomes for patients with ER-positive metastatic breast cancer, many eventually develop ESR1 resistance after undergoing endocrine therapy; and new data from patients treated with CDK4/6 inhibitors suggest that clinical outcomes are impacted by a patient’s molecular subtype," said Helmy Eltoukhy, Guardant Health CEO. "The results presented during SABCS demonstrate the power of our GuardantINFORM platform to deliver real-world clinical-genomic insights to help guide more precise oncology treatments and accelerate drug development efforts for these difficult to treat breast cancers."

The abstracts, now online, show how this robust platform helps characterize molecular tumor evolution and treatment resistance mechanisms throughout each patient’s treatment journey.

Abstract PS18-15: "Real-world clinical-genomic data identifies the ESR1 clonal and subclonal circulating tumor DNA (ctDNA) landscape and provides insight into clinical outcomes" shows how the data from our Guardant360 liquid biopsy dataset demonstrate the heterogeneity of ESR1 mutations associated with endocrine therapy treatment.
Abstract PS18-28: "Genomic heterogeneity and associated clinical outcomes of breast cancers treated with CDK4/6 inhibitors: Insights from real-world clinical genomic data" suggests new potential mechanisms of acquired resistance.
Abstract OT-07-01: "Guardant360 related clinical outcomes in patients who share medical records-breast cancer (GRECO-B)" shows how Guardant Health takes a novel patient-centric approach to enrolling Guardant360 breast cancer patients into this siteless, prospective, observational health outcomes study to create a more comprehensive view of patients’ clinical journey.
The GuardantINFORM platform is an in silico platform that combines de-identified longitudinal clinical information and genomic data collected from our Guardant360 liquid biopsy test. With data from over 135,000 patients, this real-world clinical-genomic dataset of advanced cancer patients is one of the largest in oncology. Notable applications include targeted drug development, clinical trial optimization, and post-marketing studies.

On December 7, 2020 Beijing Biocytogen Co., Ltd., Biocytogen Boston Corp (collectively as "Biocytogen") reported that they have reached an agreement with Xencor, Inc., for the licensing of Biocytogen’s fully human antibody RenMab/RenLite Mouse platform to enhance Xencor’s monoclonal antibody drug discovery research (Press release, Biocytogen, DEC 7, 2020, View Source [SID1234572386]).

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The leading platform for fully human antibody generation

The RenMab Mouse was developed using Biocytogen’s unique chromosome engineering technique. In this model, the Ig genes that encode for antibody variable domains of heavy and κ light chains are fully replaced by human corresponding Ig genes . The RenLite Mouse is a genetically engineered model with complete humanization in the variable region of the heavy chains, while maintaining a single human light chain. These models can be used to fast generate and screen fully human antibody hits and thus identify therapeutic candidates with high affinities, specificities, and diversities more efficiently than by using other available technology platforms.

Xencor is a leading clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases. Xencor and Biocytogen have collaborated on preclinical pharmacology studies, and Xencor moved forward with the new licensing agreement after Biocytogen released RenLite’s robust validation data.

"We are excited to begin this collaboration," said Dr. John Desjarlais, Xencor’s CSO. "We anticipate the RenMab and RenLite platforms will extend our bispecific antibody discovery and look forward to working with the team at Biocytogen."

The agreement, reached on October 27, includes licenses for the RenMab and RenLite mouse platforms and Biocytogen’s ongoing support of Xencor’s drug development efforts to help meet the increasing global demand for effective biologic therapies.

"We are delighted that Xencor has selected the Biocytogen RenMab/RenLite mice for their development of novel fully human antibody candidates," said YueLei Shen, Founder and CEO of Biocytogen. "We are highly confident that the combination of our fully-humanized mouse model and Xencor’s proven expertise in drug discovery and development will provide the ideal collaboration for the Xencor’s discovery of clinically-relevant antibodies."

The RenMab and RenLite antibody platforms are available for licensing to pharmaceutical and biotechnology partners seeking to streamline their antibody discovery workflow. For more information on RenMab and RenLite, visit View Source

On December 7, 2020 IGM Biosciences, Inc. (NASDAQ: IGMS) reported that it intends to offer and sell $150 million of shares of its common stock and, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of common stock, in an underwritten public offering (Press release, IGM Biosciences, DEC 7, 2020, View Source [SID1234572425]). In addition, IGM intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the securities offered in the offering will be sold by IGM. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Jefferies, Stifel, Guggenheim Securities and RBC Capital Markets are acting as joint book-running managers for the offering. Baird is acting as the lead manager for the offering.

The securities in the offering will be offered by IGM pursuant to a Registration Statement on Form S-3, filed with the Securities and Exchange Commission (SEC) on November 5, 2020 and declared effective on November 12, 2020. IGM will file a preliminary prospectus supplement and accompanying prospectus relating to the proposed offering with the SEC, copies of which can be accessed for free through the SEC’s website at www.sec.gov. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. When available, copies of the preliminary prospectus supplement, the final prospectus supplement and the accompanying prospectuses relating to this offering may also be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison, 8th Floor, New York, NY 10017, by telephone at (212) 518-9658 or by email at [email protected]; or RBC Capital Markets, LLC, 200 Vesey Street, 8th Floor, New York, NY 10281-8098; Attention: Equity Syndicate; by telephone at (877) 822-4089 or by email at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.