On March 26, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported its financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on recent developments (Press release, IGM Biosciences, MAR 26, 2020, View Source [SID1234555865]).

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"2019 was a transformational year for IGM. The many highlights of the year included our successful initial public offering and the initiation of our first-in-human trial for our lead product candidate, IGM-2323, a CD20 x CD3 bispecific IgM antibody, in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL)," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We expect continued progress in 2020, with the filing of an Investigational New Drug application (IND) with the Food and Drug Administration (FDA) for our second product candidate, IGM-8444 and the presentation of initial data from our clinical trial of IGM-2323. With thanks to the IGM team, we believe we are well positioned to remain the global leader in the research and development of engineered therapeutic IgM antibodies."

Recent Highlights and Pipeline Updates

IGM-2323 – Phase 1 trial initiated: In October 2019, IGM announced dosing of the first patient in its Phase 1 clinical trial evaluating IGM-2323 in patients with relapsed/refractory B cell NHL. This Phase 1 clinical trial represents the first-in-human application of IGM Biosciences’ engineered IgM antibody technology. IGM expects to report initial data from this Phase 1 trial in the second half of 2020.

IGM-8444 – IND filing planned: IGM expects to file an IND application with the FDA for IGM-8444 in 2020, initially for the treatment of patients with solid tumors. IGM-8444 is an IgM antibody targeting the Death Receptor 5 (DR5) protein, which is broadly expressed on a broad range of solid and hematologic malignancies.

IGM-7354 – Next candidate announced: IGM nominated IGM-7354 as its third clinical candidate. IGM-7354 is a targeted IL-15 immune stimulating antibody which demonstrates another use of IGM’s novel J chain based bispecific technology. In this case, the immune stimulating IL-15 is displayed on the J chain of an anti-PD-L1 IgM antibody, which serves to display the immune stimulating IL-15 on the surface of PD-L1 positive cells, such as cancer cells. IGM expects to file an IND with the FDA for IGM-7354 in 2021.

Fourth Quarter and Full Year 2019 Financial Results

Cash and Investments: Cash and investments as of December 31, 2019 were $236.6 million.

Research and Development (R&D) Expenses: For the fourth quarter and year ended 2019, R&D expenses were $12.8 million and $35.3 million, respectively.
General and Administrative (G&A) Expenses: For the fourth quarter and year ended 2019, G&A expenses were $3.2 million and $9.2 million, respectively.
Net Loss: For the fourth quarter of 2019, net loss was $14.8 million, or a loss of $0.49 per share. For the year ended 2019, net loss was $43.1 million, or a loss of $4.80 per share.
Shares Outstanding: Weighted-average shares outstanding for the fourth quarter of 2019 were 30.5 million and for the full year of 2019 were 9.0 million shares.
2020 Financial Guidance

IGM estimates non-GAAP operating expenses for 2020 of approximately $75 – $85 million, excluding estimated non-cash stock-based compensation expense of approximately $8 million. Including non-cash stock-based compensation expense, IGM estimates GAAP operating expenses for 2020 of $83 – $93 million. IGM also expects to end 2020 with a balance of over $140 million in cash and investments.

Conference Call and Webcast

IGM will host a conference call and webcast to discuss this announcement today, March 26, at 4:30 p.m. ET. To access the live call by phone please dial (866) 649-1996 (domestic) or (409) 217-8769 (international); the conference ID is 2991398. A live audio webcast of the event may also be accessed through the "Investors" section of IGM’s website at www.igmbio.com. A replay of the webcast will be available for 30 days following the event through 11:59p.m. ET on April 25, 2020.

On March 26, 2020 IntegraGen (Paris:ALINT), a company specializing in the transformation of data from biological samples into genomic information and diagnostic tools for oncology, reported Dana-Farber Cancer Institute will utilize the company’s MERCURY cloud-based software as part of their analysis and reporting process for sequencing data obtained from tumors of cancer patients (Press release, Integragen, MAR 26, 2020, View Source [SID1234555864]). Dana-Farber plans to utilize MERCURY to assist in the analysis of sequencing data obtained from small and large targeted gene sequencing panels as well as data derived from whole exome and genome sequencing.

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"Genomic profiling of tumors can assist in the identification of pathogenic molecular alterations which drive a patient’s cancer and enable the implementation of precision medicine-based approaches to treatment," stated Annette S. Kim M.D., Ph.D., Co-Director of the Dana-Farber Cancer Institute’s new Interpretive Genomics Program within the Department of Oncologic Pathology. The program is Co-Directed by Keith L. Ligon, MD PhD, Director of the Dana-Farber Center for Patient Derived Models. "MERCURY provides us with a tool to rapidly interpret large scale and complex genomic sequencing data with the added ability of customization to meet our specific analysis and reporting needs to support clinical research and clinical trials."

"IntegraGen is excited about Dana-Faber’s decision to utilize MERCURY and look forward to interacting with another world leader in cancer care related to the utilization of our cloud-based bioinformatic tools," said Larry Yost, General Manager of IntegraGen, Inc. "We are convinced that the use of MERCURY will aid in the better understanding of the etiology of a patient’s cancer and assist with the realization of the benefits of precision medicine by transforming large-scale sequencing data into actionable results. We are also looking forward to continuing the development and expansion of our genomic interpretation software tools in North America."

MERCURY is a user-friendly genomic interpretation tool for oncology designed to assist pathologists and oncologists to rapidly transform raw data obtained via high-throughput sequencing into a clinical molecular report for clinical and research use. The cloud-based tool minimizes the complexity, time and cost associated with the clinical interpretation and identification of variants that may be of interest in the therapeutic management of patients. MERCURY utilizes the Google Cloud technology to ensure a secure environment for data analysis and storage which is compliant with the latest information security requirements.

On March 26, 2020 VBL Therapeutics (Nasdaq: VBLT) reported an encouraging outcome of the planned interim analysis in the OVAL study, a double-blind controlled potential-registration study in patients with platinum-resistant ovarian cancer (Press release, VBL Therapeutics, MAR 26, 2020, View Sourcenews-releases/news-release-details/vbl-therapeutics-announces-positive-outcome-interim-analysis" target="_blank" title="View Sourcenews-releases/news-release-details/vbl-therapeutics-announces-positive-outcome-interim-analysis" rel="nofollow">View Source [SID1234555850]). The OVAL independent Data Safety Monitoring Committee (DSMC), reviewed un-blinded data and assessed CA-125 response, measured according to the GCIG criteria, in the first 60 enrolled subjects evaluable for CA-125 analysis. The DSMC confirmed that the study met the interim pre-specified efficacy criterion, of an absolute percentage advantage of 10% or higher CA-125 response rate for the VB-111 treatment arm, and recommended the study continuance.

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The overall CA-125 response rate in the first 60 randomized evaluable patients is 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) is 58% or higher. In patients who had post-dosing fever, which is a marker for VB-111 treatment, the response rate is 69%.

"The encouraging interim readout in this randomized controlled study, together with the promising data seen in the earlier VB-111 Phase 2 are signals for the potential of VB-111 in platinum-resistant ovarian cancer, an indication with a major unmet need," said the Chairman of the OVAL study Steering Committee, Bradley J. Monk, M.D., FACS, FACOG, Co‐Director of GOG Partners, Arizona Oncology (US Oncology Network) and Professor, Gynecologic Oncology at University of Arizona, Creighton University, Medical Director of US Oncology Research Gynecology program in Phoenix, Arizona.

"We are very pleased by the outcome of this interim analysis, which demonstrates the potential benefit of VB-111 over standard-of-care in a randomized-controlled study," said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. "The OVAL Phase 3 interim data are at least as good as the CA-125 response results observed in our VB-111 Phase 2 study, which enrolled a similar patient population. This encouraging interim result adds to the promising data seen with VB-111 across our Phase 2 studies in multiple indications".

In the previously reported Phase 2 study of VB-111 in platinum resistant ovarian cancer, 58% of the patients treated with VB-111 and paclitaxel demonstrated a CA-125 response. Those patients with a CA-125 response demonstrated a median overall survival of 808 days, versus 351 days for those patients without CA-125 response. The DSMC recommendation that the OVAL trial proceed is not assurance that the trial will meet its primary endpoint. The primary endpoint of the OVAL Phase 3 study is overall survival, which currently approved therapies for platinum-resistant ovarian cancer have thus far failed to demonstrate.

Conference Call Information

VBL will host a live KOL and Update Call on the OVAL Phase 3 trial at 2:00 p.m. ET today. The conference call may be accessed by dialing 1-877-407-9208 (domestic, toll-free) and 1-201-493-6784 (toll/international) or Israel Toll Free 1-809-406-247 and referring to conference ID 13700764. A webcast of the conference call will be available by clicking here. The archived webcast will be available in the Investors Relations section of the VBL Therapeutics website at View Source after the conference call.

About the OVAL study (NCT03398655)

OVAL is an international Phase 3 randomized pivotal potential registration clinical trial that compares a combination of VB-111 and paclitaxel to placebo plus paclitaxel, in patients with platinum-resistant ovarian cancer. The study is planned to enroll approximately 400 patients. OVAL is conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies.

About VB-111 (ofranergene obadenovec)

VB-111 is a first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. VB-111 is a unique biologic agent that uses a dual mechanism to target solid tumors. Its mechanism combines blockade of tumor vasculature with an anti-tumor immune response. VB-111 is administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 studies.VB-111 has received an Orphan Designation for the treatment of ovarian cancer from the European Commission. VB-111 has also received orphan drug designation in both the US and Europe, and fast track designation in the US for prolongation of survival in patients with rGBM. VB-111 successfully demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer and recurrent platinum-resistant ovarian cancer (NCT01711970).

On March 26, 2020 Bristol-Myers Squibb Company (NYSE: BMY) reported that it will announce results for the first quarter of 2020 on Thursday, May 7, 2020 (Press release, Bristol-Myers Squibb, MAR 26, 2020, View Source [SID1234555848]). During a conference call at 8:30 a.m. ET on May 7, 2020, company executives will review financial information and address inquiries from analysts.

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Investors and the general public are invited to listen to a live webcast of the call at bms.com/investors or by dialing in the U.S. toll free 888-256-1007 or international 1-786-789-4797, confirmation code: 3261903. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 12 p.m. ET on May 7 through 12 p.m. ET on May 21, 2020. The replay will also be available through bms.com/investors or by dialing in the U.S. toll free 888-203-1112 or international 1-719-457-0820, confirmation code: 3261903.

On March 26, 2020 Bolt Biotherapeutics, Inc., a private biotechnology company developing its Immune-Stimulating Antibody Conjugate (ISAC) platform technology to harness the power of the immune system to treat cancer, reported that patient dosing has begun in the company’s Phase 1, open-label, dose-escalation and dose expansion study of BDC-1001 monotherapy for patients with HER2-expressed solid tumors (Press release, Bolt Biotherapeutics, MAR 26, 2020, View Source [SID1234555847]). BDC-1001 is an ISAC comprised of trastuzumab conjugated to Bolt’s proprietary TLR7/8 agonist payload.

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"The initiation of this study represents a significant milestone for the company as it is our first Boltbody therapeutic program to enter the clinic," stated Randall Schatzman, Ph.D., chief executive officer of Bolt. "Bolt’s leadership in the ISAC field will continue to drive the development of myeloidbased cancer therapeutics. There is a significant unmet need for patients with solid tumors that express HER2 that cannot be addressed by current immuno-oncology therapeutics."

Dr. Schatzman continued, "Based on an assessment of our ongoing program by the safety committee, we are now proceeding with the second cohort of our study. Bolt is eager to explore the potential of BDC-1001 for treating HER2-expressing cancers, which includes patients with breast and gastric cancers that are refractory to Herceptin and Kadcyla, as well as cancers for which no HER2-targeting therapies have yet been approved. We look forward to working with the medical community to bring the promise of this exciting new approach to patients and anticipate initial data will drive our future development plans."

The program has generated compelling preclinical data demonstrating complete, durable regression of established tumors resistant to trastuzumab and immunological memory providing protection against tumor cells that no longer express the HER2 antigen in syngeneic mouse cancer models.

About the BDC-1001 Phase 1 Study in HER2-Expressed Solid Tumors The Phase 1, multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and proof of mechanism of BDC-1001 in HER2-expressing solid tumors. The first portion of the study includes a monotherapy dose-escalation phase in which cohorts of patients will receive ascending intravenous doses of BDC-1001 to determine the maximum tolerated dose and/or the recommended dose for the expansion cohorts and Phase 2 based on safety and tolerability. The second portion of the study is a dose expansion phase in which patients will receive BDC-1001 monotherapy to evaluate antitumor activity of the recommended Phase 2 dose and to further evaluate the safety and tolerability of BDC-1001. Please refer to clinicaltrials.gov NCT04278144 for additional clinical trial information.

About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology The Boltbody platform consists of Immune Stimulating Antibody Conjugates (ISACs) that harness the ability of innate immune agonists to convert cold tumors into immunologically hot tumors thereby illuminating tumors to the immune system and allowing them to be invaded by tumor killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration as monotherapy in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients.