On May 9, 2022 Sutro Biopharma, Inc. ("Sutro" or the "Company") (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application ofprecise protein engineering and rational design to create next-generation cancer therapeutics, reported its financial results for the quarter ended March 31, 2022, its recent business highlights, and a preview of anticipatedselect milestones (Press release, Sutro Biopharma, MAY 9, 2022, View Source [SID1234613932]).

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!

"Sutro remains steadfastly dedicated to advancing next generation cancer therapeutics by leveraging the advantages of our proprietary platform," said Bill Newell, Sutro’s Chief Executive Officer. "We are pleased with the progress of our lead program, STRO-002, a FolRα-targeting antibody-drug conjugate. Our top priority is charting the course for a potential registrational trial for patients with advanced ovarian cancer. We are also expanding our clinical studies into endometrial cancer and have plans for non-gynecological indications, including NSCLC, to explore the possibility of treatment with STRO-002 for people who suffer from these debilitating cancers and have limited available treatment options."

Recent Business Highlights and Anticipated Select Milestones
STRO-002, FolRα-Targeting Antibody-Drug Conjugate (ADC): STRO-002 is being studied in the clinic, in both the United States and Europe, for patients with ovarian and endometrial cancers.

The Phase 1 dose-expansion cohort for patients with advanced ovarian cancer has completed enrollment and is ongoing. Sutro expects to report additional data on efficacy, safety, and durability from the dose-expansion cohort in the second half of 2022.
Regulatory discussions on a potential registrational study for patients with advanced ovarian cancer are planned for mid-year 2022.
The STRO-002 study in combination with bevacizumab for patients with advanced ovarian cancer is ongoing and the first patient was dosed in March 2022. A dose-expansion study of STRO-002 for patients with endometrial cancer continues to enroll patients.
Nonclinical data presented at the AACR (Free AACR Whitepaper) Annual Meeting 2022 in April demonstrated STRO-002’s ability to induce immunogenic cell death. Additionally, studies showed robust STRO-002 activity in endometrial and non-small cell lung cancer (NSCLC) patient-derived xenograft models with diverse levels of folate receptor alpha (FolRα) expression.
Sutro expects to initiate clinical trials for STRO-002 in NSCLC and other non-gynecologic solid tumors in the second half of 2022.
STRO-001, CD74-Targeting ADC: The Phase 1 study for patients with B‑cell malignancies, including patients withnon-Hodgkin’s lymphoma and multiple myeloma, continues in dose escalation.

Dose escalation is ongoing to achieve a recommended phase 2 dose (RP2D), with the last reported doses of 5.0 mg/kg in the multiple myeloma (MM) cohort and 5.0 mg/kg in the non-Hodgkin’s lymphoma (NHL) cohort.

Additional Pipeline Programs: Research and preclinical development are underway for several internal candidates.

Discovery and preclinical work on multiple programs are underway to determine Sutro’s next product candidates to advance to the clinic.
Sutro presented preclinical data for a novel immunostimulatory antibody-drug conjugate (iADC) at the 12th Annual World ADC Conference in March 2022. The iADC modality provides for dual mechanisms to attack the tumor, through cytotoxic killing as well as potentially building a protective immune response.
Corporate Updates: Sutro expands the strength of its leadership team with several appointments and promotions.

Venkatesh Srinivasan joined Sutro in April 2022 as Senior Vice President, Process and Analytical Development and part of the senior management team. Dr. Srinivasan brings more than 25 years of experience in bioprocess development, biologics manufacturing and tech transfer in the biopharmaceutical industry. He was most recently Vice President, Global Manufacturing Sciences & Technology at Bayer.
Kristin Bedard, Vice President of Discovery, who joined Sutro in February 2020, recently became part of the senior management team. Recent promotions within the senior management team include Brunilda Shtylla to Senior Vice President of Business Development and Annie Chang to Vice President of Investor Relations.
Collaboration Updates: Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has received from collaborators an aggregate of approximately $456 million in payments, including equity investments, through March 31, 2022.

Sutro is manufacturing initial drug supply for the potential clinical development of the first molecule in the Merck cytokine derivative collaboration; clinical trial materials for Bristol Myers Squibb’s (BMS) CC-99712, a BCMA‑targeting ADC, for treatment of multiple myeloma, in Phase 1 studies; and clinical trial materials for M1231, a MUC1-EGFR-targeting bispecific ADC, for Merck KGaA, Darmstadt, Germany, known as EMD Serono in the U.S. and Canada (EMD Serono), in Phase 1 studies.
Sutro supplies cell-free extract to Vaxcyte for the manufacture of clinical trial materials for VAX-24, which is designed to prevent invasive pneumococcal disease. Vaxcyte announced in April 2022 that the first participants were dosed in the Phase 2 portion of the clinical study of VAX-24.
Sutro plans to support BioNova Pharmaceuticals (BioNova) in clinical trial initiations for STRO-001 in the Greater China market and provide clinical drug supply as needed.
In April 2022, Sutro and Tasly Biopharmaceuticals (Tasly) amended Tasly’s exclusive license to develop and commercialize STRO-002 in Greater China. Pursuant to the amended agreement, the upfront payment due from Tasly was changed to $25.0 million and $15.0 million will become payable to Sutro based on certain regulatory milestones. The amended agreement provides for additional potential payments to Sutro totaling up to $350.0 million related to development, regulatory and commercialization milestones. Sutro plans to support Tasly for initiation of clinical development activities in Greater China and provide clinical drug supply as needed.
First Quarter 2022 Financial Highlights
Cash, Cash Equivalents and Marketable Securities

As of March 31, 2022, Sutro had cash, cash equivalents and marketable securities of $192.1 million, as compared to $229.5 million as of December 31, 2021, with projected cash runway into the second half of 2023, based on current business plans and assumptions. The above balances do not include the value associated with Sutro’s holdings of Vaxcyte common stock.

Unrealized Gain from Increase in Value of Vaxcyte Common Stock

As of March 31, 2022, Sutro held approximately 1.6 million shares of Vaxcyte common stock, with a fair value of $37.7 million. The non-operating, unrealized gain of $0.6 million in the first quarter of 2022 was due to the increase since December 31, 2021 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’sstatements of operations.

Revenue

Revenue was $5.9 million for the quarter ended March 31, 2022, as compared to $14.7 million for the same period in 2021, related principally to the Merck, BMS, and EMD Serono collaborations. Future collaboration revenue from Merck, BMS, and EMD Serono, and from any additional collaboration partners, will fluctuate as a result of the amountand timing of revenue recognition of upfront, milestones, and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the quarter ended March 31, 2022 were $45.0 million, as compared to $33.7 million for the same period in 2021. The first quarter of 2022 includes non-cash expenses for stock-based compensation of $7.0 million and depreciation and amortization of $1.3 million, as compared to $4.0 million and $1.3 million, respectively, in the comparable 2021 period. Total operating expenses for the quarter ended March 31, 2022 were comprised of research and development expenses of $30.0 million and general and administrative expenses of $15.0 million, which are expected to increase in 2022 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.

On May 9, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported financial results for the first quarter ending March 31, 2022 and provided a corporate update (Press release, VBI Vaccines, MAY 9, 2022, View Source [SID1234613948]).

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!

Jeff Baxter, VBI’s President and CEO commented: "In the first quarter of 2022, we continued to hit key milestones required for a successful commercial launch of PreHevbrio in the U.S. as well as ex-U.S. milestones required to enable broad access. In the U.S., our market access and sales field teams are deployed and PreHevbrio is now approved, available, and included on the list of CDC-recommended adult HBV vaccines. With these stage gates met, initial U.S. sales of PreHevbrio have begun in Q2 2022, and with the new CDC guidelines for adult HBV vaccination, we look forward to building momentum in the second half of the year. Outside of the U.S., we were thrilled to announce our second regulatory approval of this vaccine in about five months with the European Commission approval of PreHevbri in April 2022. As we’ve said many times in the past, we believe this 3-antigen vaccine will be a meaningful new tool in the fight against hepatitis B and we are working hard to get it into the hands of healthcare providers quickly.

"In parallel, we continue to progress our earlier stage immunotherapeutic candidates against glioblastoma and chronic hepatitis B, as well as our pan-coronavirus vaccine candidate, VBI-2901, toward exciting clinical study catalysts expected through the back half of this year and early part of 2023," Mr. Baxter continued. "Our mission has always been to develop prophylactic and therapeutic vaccines with the potential to address significant and challenging unmet medical and public health needs, and we remain steadfast in our commitment to that endeavor."

Recent Key Program Achievements and Projected Upcoming Milestones

Hepatitis B (HBV)

3-Antigen HBV Vaccine

End of March 2022: PreHevbrio [Hepatitis B Vaccine (Recombinant)] became available in the United States for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older, with the expectation that U.S. product revenue generation would begin in Q2 2022
April 2022:S. Centers for Disease Control and Prevention (CDC) published the Advisory Committee on Immunization Practices’ (ACIP) updated HBV vaccination recommendation that all adults age 19-59 be immunized against HBV – in this same publication, PreHevbrio was included in the list of recommended products for prophylactic adult vaccination against HBV infection
April 2022: European Commission (EC) granted Marketing Authorisation for PreHevbri [Hepatitis B vaccine (recombinant, adsorbed)] for active immunisation against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults
VBI expects to make PreHevbri available in certain European countries beginning at the end of 2022
Regulatory filing under review by Health Canada and by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) as part of the EC Decision Reliance Procedure (ECDRP)
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate

By Year-End 2022: Interim topline clinical data expected from Phase 2 combination study evaluating safety and efficacy of VBI-2601 (BRII-179) with BRII-835 (VIR-2218), an HBV-targeting small interfering ribonucleic acid (siRNA)
H1 2023: Interim topline results expected from two-part Phase 2a/2b combination study evaluating VBI-2601 (BRII-179) as an add-on therapy to standard-of-care treatment
COVID-19 & Coronaviruses

VBI-2900: eVLP Coronavirus Vaccine Program

April 2022: Announcement of positive data from VBI-2900 development program, including:
VBI-2902 (monovalent, ancestral): Validated pseudoparticle neutralization assay (PNA) benchmarked against the WHO reference standard demonstrated that VBI-2902 elicited neutralizing antibody responses of 176 IU50/mL in its Phase 1a study – this would predict greater than 90% efficacy, as compared with two internationally approved vaccines estimated to have 90% efficacy at 83 and 140 IU50/mL (Gilbert, PB, 2021)
VBI-2905 (monovalent, Beta): Positive Phase 1b data demonstrated well-tolerated safety and an ability to boost and broaden immunity to the Beta variant, in addition to the ancestral strain
VBI-2901 (trivalent, pan-coronavirus): In preclinical models, VBI-2901 was able to boost and broaden immune responses against all variants tested compared with immune responses elicited by VBI-2902 – including against the ancestral strain, Delta, Beta, Omicron, Lambda, and rat and pangolin coronaviruses distant to circulating human strains
Summer 2022: Expected initiation of the first clinical study of VBI-2901, with the goal of eliciting broad and durable immune responses against COVID-19 and coronaviruses
VBI-2901 will be supported through Phase 2 clinical development as part of the Company’s partnership with the Strategic Innovation Fund (SIF) of the Canadian Government, through which up to CAD $56 million was earmarked for VBI’s coronavirus vaccine development program
Glioblastoma (GBM)

VBI-1901: Cancer Vaccine Immunotherapeutic Candidate

June 2022: Updated tumor response and overall survival data from the ongoing Phase 2a study of VBI-1901 in recurrent GBM patients selected for poster display and poster discussion at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Q3 2022: Expected initiation of next phase of development in recurrent GBM setting, aiming to expand the number of patients in the ongoing Phase 1/2a study and adding a control arm, with the potential for accelerated approval based on tumor response rates and improvement in overall survival
Q4 2022: Evaluation of VBI-1901 in the primary GBM setting expected to initiate as part of the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial – data from which have potential to support an accelerated approval application
First Quarter 2022 Financial Results

Cash Position: VBI ended the first quarter of 2022 with $101.3 million in cash compared with $121.7 million in cash as of December 31, 2021.
Revenue: Revenue for the first quarter of 2022 was $0.1 million, compared to $0.3 million for the same time period in 2021. PreHevbrio was not yet available in the U.S. in Q1 2022, so the decrease in revenue was due to a decrease in product revenue outside the U.S. and in R&D services revenue earned as part of the License Agreement with Brii Bio for the development of VBI-2601.
Cost of Revenue: Cost of revenues was $2.8 million in the first quarter of 2022 as compared to $2.4 million in the first quarter of 2021. The increase in cost of revenues is due to increased labor and manufacturing costs related to the commercialization of our 3-Antigen HBV Vaccine.
Research and Development (R&D): R&D expenses for the first quarter of 2022 were $2.4 million compared to $6.8 million for the same period in 2021. The decrease in R&D expenses was a result of the decrease in regulatory fees related to our 3-Antigen HBV Vaccine, a decrease in costs related to our coronavirus development program net of reimbursement from government grants and funding arrangements, offset by an increase in R&D expenses related to continued development of our other vaccine candidates.
General and Administrative (G&A): G&A expenses for the first quarter of 2022 were $10.9 million compared to $6.7 million for the same period in 2021. The increase in G&A expense, partially offset by government grants and funding arrangements, was a result of the increase in commercial activities related to our 3-Antigen HBV Vaccine, such as the development of our commercial and distribution infrastructure, increased insurance costs, and increased professional and labor costs.
Net Cash Used in Operating Activities: Net cash used in operating activities for the three months ended March 31, 2022 was $19.9 million, compared to $6.6 million for the same period in 2021. The increase was largely due to an increase in net loss.
Cash Used for Purchase of Property and Equipment: Cash used for the purchase of property and equipment was $0.5 million in the first quarter of 2022 compared to $0.6 million for the same period in 2021.
Net Loss: Net loss and net loss per share for the first quarter of 2022 were $21.3 million and $0.08, respectively, compared to a net loss of $17.6 million and a net loss per share of $0.07 for the first quarter of 2021.
About PreHevbrio

VBI’s hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in the European Union/European Economic Area, the United States, and Israel. The brand names for this vaccine are : PreHevbri (EU/EEA), PreHevbrio (US), and Sci-B-Vac (Israel).

Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.

U.S. Indication

PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.

U.S. Important Safety Information (ISI)

Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.

Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.

PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).

On May 9, 2022 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported its financial results for the first quarter ended March 31, 2022, and provided a business update (Press release, Nuvation Bio, MAY 9, 2022, View Source [SID1234613965]).

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 encouraged by the important progress we have made so far this year across our pipeline of novel oncology therapeutic candidates for difficult-to-treat cancers. In the first quarter, we dosed the first patient in our Phase 1 study of NUV-868 in patients with advanced solid tumors and continued to advance our NUV-422 program across multiple tumor types, well positioning us to execute on multiple milestones later this year," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We believe that our NUV-422, NUV-868, and DDC development programs are our most unique and differentiated programs with the highest potential to meaningfully change the lives of cancer patients. To further focus on these programs, efficiently allocate our robust cash balance and strategically manage our pipeline, we have decided to deprioritize our early stage NUV-569 and A2A programs."

Recent Business Highlights

NUV-422, CDK 2/4/6i: GBM, aBC, mCRPC

On track for multiple milestones across tumor types in 2022. Nuvation Bio expects to share data from the Phase 1 dose escalation study of NUV-422 later this year. As supported by these data and following selection of a recommended Phase 2 dose, the Company plans to initiate Phase 2 monotherapy dose expansion cohorts in glioblastoma multiforme (GBM), advanced breast cancer (aBC), and metastatic castration-resistant prostate cancer (mCRPC) to evaluate the safety and efficacy of NUV-422. In addition, the Company is planning to initiate Phase 1b combination studies of NUV-422 plus fulvestrant in aBC and NUV-422 plus enzalutamide in mCRPC to evaluate safety and tolerability and to determine a recommended Phase 2 combination dose. The Company plans to initiate the Phase 2 monotherapy and Phase 1b combination studies before the end of the year.
NUV-868, BD2-Selective BETi: Advanced solid tumors

Dosed the first patient in the Phase 1 study of NUV-868. In January 2022, the U.S. Food and Drug Administration (FDA) cleared Nuvation Bio’s Investigational New Drug (IND) application for NUV-868 for the treatment of advanced solid tumors, including ovarian cancer, pancreatic cancer, mCRPC, and triple negative breast cancer (TNBC). The recently initiated Phase 1 study is designed to determine the safety and dose of NUV-868 to be used as a monotherapy and in combination with olaparib or enzalutamide for the Phase 2 and 2b portions of the study.
Drug-Drug Conjugate (DDC) Program: Solid tumors

Nuvation Bio is on track to select its first clinical candidate for the DDC program by the end of 2022.
First Quarter 2022 Financial Results

As of March 31, 2022, Nuvation Bio had cash, cash equivalents and marketable securities of $737.7 million.

For the three months ended March 31, 2022, research and development expenses were $20.7 million, compared to $15.9 million for the three months ended March 31, 2021. The increase was primarily due to a $5.4 million increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial, as well as a $3.1 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation, partially offset by $3.7 million related to the issuance of common stock as consideration for the purchase of in-process research and development in the prior year that did not recur in 2022.

For the three months ended March 31, 2022, general and administrative expenses were $7.5 million, compared to $4.6 million for the three months ended March 31, 2021. The increase was primarily due to a $1.9 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation, a $0.5 million increase in insurance, a $0.4 million increase in legal fees, a $0.3 million increase in professional fees, and a $0.1 million increase in other miscellaneous expenses, partially offset by a $0.4 million decrease in taxes.

For the three months ended March 31, 2022, Nuvation Bio reported a net loss of $21.3 million, or $(0.10) per share. This compares to a net loss of $20.4 million, or $(0.12) per share, for the comparable period in 2021.

On May 9, 2022 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the first quarter of 2022 and provided business updates (Press release, Caribou Biosciences, MAY 9, 2022, View Source [SID1234614000]).

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!

"Building on the momentum and significant achievements of 2021, we focused on execution and the advancement of our pipeline of genome-edited allogeneic CAR-T and CAR-NK cell therapies in the first quarter of 2022," said Rachel Haurwitz, Ph.D., Caribou’s president and chief executive officer. "We continue to enroll patients in our ANTLER Phase 1 clinical trial of CB-010 and we are slated to share initial data from patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) at EHA (Free EHA Whitepaper) next month. This year, we plan to submit an IND application for CB-011 to rapidly advance our second CAR-T program into the clinic, and we expect to share target selection for CB-020, the first solid tumor-targeted program from our CAR-NK platform."

Recent Business Highlights

Pipeline

CB-010: In April 2022, an abstract with initial clinical data from the ANTLER Phase 1 trial of CB-010 in adults with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) was accepted at EHA (Free EHA Whitepaper), being held in Vienna, Austria, June 9-17, 2022.
Caribou’s lead product candidate, CB-010, is an allogeneic anti-CD19 CAR-T cell therapy engineered using Cas9 CRISPR hybrid RNA-DNA (chRDNA) technology to insert a CD19-specific CAR into the TRAC gene and knock out PD-1 to boost the persistence of antitumor activity. More information can be found at www.clinicaltrials.gov (NCT04637763).
Caribou continues to enroll patients in ANTLER.
CB-011: Caribou is conducting IND-enabling studies to support an IND application submission in H2 2022 in patients with relapsed or refractory multiple myeloma (r/r MM).
In April 2022, promising preclinical data supporting the development of CB-011 were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a chRDNA technology to insert a BCMA-specific CAR into the TRAC gene and armor the cells with an immune cloaking strategy that includes a knockout of the endogenous B2M gene and site-specific insertion of a B2M–HLA-E fusion transgene into the B2M gene. This immune cloaking strategy is designed to blunt both T- and NK-mediated immune cell rejection, enabling more durable antitumor activity.
Corporate

In January 2022, Caribou appointed Syed Rizvi, M.D., as chief medical officer. Dr. Rizvi has more than two decades of experience in all stages of drug development, from clinical strategy and execution through regulatory submissions to support approval and commercialization of several cancer treatments, including three approved autologous CAR-T cell therapies ABECMA, BREYANZI, and CARVYKTI. Prior to joining Caribou, Dr. Rizvi served as chief medical officer of Chimeric Therapeutics and worked for Legend Biotech, Celgene Corporation (now Bristol Myers Squibb), Novartis, Merck, and Genta, Inc.
In January 2022, Zili An, M.D., joined Caribou as vice president of pharmacology. He brings over 20 years of drug development experience in multiple cancer therapeutic modalities, including CAR-T cell therapies.
Anticipated Milestones for 2022 and Beyond

CB-010: Caribou is scheduled to share initial data from its ongoing ANTLER Phase 1 trial for CB-010, an anti-CD19 CAR-T cell therapy for r/r B- NHL, at EHA (Free EHA Whitepaper) in June 2022.
CB-011: Caribou expects to submit an IND application for CB-011, an anti-BCMA CAR-T cell therapy for r/r MM, in H2 2022.
CB-020: Caribou expects to announce target selection for CB-020, an iPSC-derived CAR-NK cell therapy for solid tumors, in Q4 2022. Additionally, Caribou expects to disclose multiple armoring strategies under development for its CAR-NK platform in Q4 2022.
CB-012: Caribou expects to submit an IND application for CB-012, an anti-CD371 CAR-T cell therapy for r/r AML, in 2023.
Upcoming Meetings

May 16-19, 2022: 25th Annual Meeting of the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper). A poster with data highlighting the mechanism underlying the superior specificity of its CRISPR hybrid RNA-DNA (chRDNA) guides for genome editing of primary human T cells will be presented on Monday, May 16, 2022, 5:30 – 6:30 pm ET
June 9-17: European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress. Initial ANTLER Phase 1 clinical data for CB-010 is scheduled to be presented
June 23-24: SingHealth Duke-NUS Cell Therapy Centre (SDCT) and Regenerative Medicine Institute of Singapore (REMEDIS) Annual Conference. An encore presentation of initial ANTLER data will be presented
July 18-22: Pan Pacific Lymphoma Conference 2022. An encore presentation of initial ANTLER data will be presented
First Quarter 2022 Financial Results

Cash, cash equivalents, and marketable securities: Caribou had $390.8 million in cash, cash equivalents, and marketable securities as of March 31, 2022 compared to $413.5 million as of December 31, 2021.

Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $2.7 million for the three months ended March 31, 2022 compared to $1.6 million for the same period in 2021. The increase was primarily due to an increase in revenue recognized pursuant to the AbbVie collaboration and license agreement.

R&D expenses: Research and development expenses were $13.9 million for the three months ended March 31, 2022 compared to $10.2 million for the same period in 2021. The increase was primarily due to personnel-related expenses attributable to increased headcount, costs associated with clinical trial and preclinical study activities, and facilities expenses, partially offset by a decrease in expenses related to licensing, sublicensing revenue, and milestones.

G&A expenses: General and administrative expenses were $9.6 million for the three months ended March 31, 2022 compared to $4.6 million for the same period in 2021. The increase was primarily due to personnel-related expenses attributable to increased headcount, legal and accounting services, insurance, other expenses associated with operating as a public company, and facilities and other expenses.

Other income (expense): The Company recorded other income of $1.8 million for the three months ended March 31, 2022 compared to less than $0.1 million for the same period in 2021. This increase was primarily due to the non-cash change in fair value of the success payments liability under the Memorial Sloan Kettering Cancer Center (MSKCC) exclusive license agreement.

Net loss: For the three months ended March 31, 2022, net loss was $19.1 million compared to $13.2 million for the same period in 2021.

About Caribou’s Novel Next-Generation CRISPR Platform
CRISPR genome editing uses easily designed, modular biological tools to make DNA changes in living cells. There are two basic components of Class 2 CRISPR systems: the nuclease protein that cuts DNA and the RNA molecule(s) that guide the nuclease to generate a site-specific, double-stranded break, leading to an edit at the targeted genomic site. CRISPR systems are capable of editing unintended genomic sites, known as off-target editing, which may lead to harmful effects on cellular function and phenotype. In response to this challenge, Caribou has developed CRISPR hybrid RNA-DNA guides (chRDNAs; pronounced "chardonnays") that direct substantially more precise genome editing compared to all-RNA guides. Caribou is deploying the power of its Cas12a chRDNA technology to carry out high efficiency multiple edits, including multiplex gene insertions, to develop CRISPR-edited therapies.

On May 9, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the termination of its collaboration and license agreements with Bavarian Nordic that leverage Bavarian Nordic’s MVA-BN (Modified Vaccinia Ankara – Bavarian Nordic) technology to develop potential vaccines against the hepatitis B virus and human papillomaviruses (Press release, Janssen Pharmaceuticals, MAY 9, 2022, View Source [SID1234614062]). Janssen remains committed to its strong collaboration with Bavarian Nordic in the quest to prevent and cure infectious diseases – with collaborations in HIV and Ebola still ongoing.

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!

No clinical studies in hepatitis B have been initiated by Janssen utilizing the MVA-BN technology.

Janssen will continue to prioritize investigation of its hepatitis B combination therapies using alternative investigational vaccine platforms and therapeutics within its broad portfolio and has multiple studies ongoing. Hepatitis B remains a critical global health issue, affecting an estimated 296 million people worldwide, and claiming nearly 900,000 lives every year.[1] Through its diverse scientific approach, Janssen is determined in its pursuit of a functional cure* for chronic hepatitis B to improve health outcomes for those living with the disease.

There has been widespread uptake of effective, preventive vaccines against human papillomaviruses.[2] Due to this and the prioritization of other programs, Janssen will not be focusing R&D efforts on a therapeutic vaccine against human papillomaviruses at this time.

Janssen is committed to the research and development of transformational vaccines and therapeutics to prevent and cure infectious diseases with high unmet need. Janssen’s infectious diseases and vaccines projects span all stages of development, from discovery through late development, addressing major global health threats including COVID-19, HIV, RSV, influenza, multi-drug resistant bacterial infections and Ebola.

For more information on Janssen’s commitment to battling infectious diseases, visit www.janssen.com/infectious-diseases-and-vaccines/IDV-News/.

*A functional cure for chronic hepatitis B is defined as a loss of viral markers (hepatitis B surface antigen [HBsAg] and hepatitis B viral DNA) that is sustained after cessation of treatment.