Uncategorized – Page 5939 – 1stOncology™: Cancer Intelligence Service

PMV Pharmaceuticals Reports Second Quarter 2022 Financial Results and Corporate Highlights

On August 9, 2022 PMV Pharmaceuticals, Inc. ("PMV Pharma" Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the second quarter ended June 30, 2022, and provided a corporate update (Press release, PMV Pharma, AUG 9, 2022, View Source [SID1234617942]).

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"The highlight of the second quarter was the oral presentation at ASCO (Free ASCO Whitepaper) of positive initial data from the ongoing PYNNACLE study of PC14586, our investigational first-in-class p53 Y220C reactivator, in patients with solid tumors," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "The data provide clinical proof of concept for PC14586 as monotherapy, with meaningful clinical activity observed across multiple tumor types."

Corporate Highlights:

Initial data from the dose-escalation portion of the Phase 1/2 PYNNACLE study were featured in an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) annual meeting. Enrollment is ongoing to support the determination of a recommended Phase 2 dose.
PMV Pharma announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside the U.S. and Canada) to evaluate the combination of PC14586 with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy. The combination trial is anticipated to begin in Q4 2022.
Appointed Marc Fellous, M.D. as Vice President, Clinical Development and Medical Affairs. Prior to joining PMV Pharma, Dr. Fellous was Global Medical Affairs Head on larotrectinib, the first tumor-agnostic drug approved in the U.S. and Europe, and selitrectinib programs at Bayer. He held leadership roles at Bayer and Roche for more than 13 years, contributing to the strategy and launch of multiple successful oncology products. Dr. Fellous completed his doctorate in general medicine at the University Paris V along with a specialized master’s degree in medical management from ESCP-Europe Business School.
Continued progress on the Company’s research pipeline of its Wild-Type p53-Induced Phosphatase 1 (WIP1) inhibitor and p53 mutant programs.
Second Quarter 2022 Financial Results

As of June 30, 2022, PMV Pharma had $277.4 million in cash, cash equivalents, and marketable securities, compared to $339.0 million as of June 30, 2021. Net cash used in operations was $31.7 million for the six months ended June 30, 2022, compared to $22.1 million for the six months ended June 30, 2021.
Net loss for the six months ended June 30, 2022, was $35.7 million compared to $24.5 million for the quarter ended June 30, 2021.
Research and development (R&D) expenses were $23.3 million for the six months ended June 30, 2022 compared to $15.2 million for the six months ended June 30, 2021. The increase in R&D expenses was primarily due to increased headcount and clinical trial expenses associated with advancing our lead product candidate, PC14586, through the Phase 1/2 clinical trial.
General and administrative (G&A) expenses were $13.2 million for the six months ended June 30, 2022, compared to $9.6 million for the six months ended June 30, 2021. The increase in G&A expenses was primarily due to costs relating to operating as a public company.
About PC14586
PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. For more information about the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).

ADC Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Updates

On August 9, 2022 ADC Therapeutics SA (NYSE: ADCT) reported financial results for the second quarter ended June 30, 2022 and provided business updates (Press release, ADC Therapeutics, AUG 9, 2022, View Source [SID1234617957]).

"The ZYNLONTA launch is advancing steadily as we continue to increase awareness and advocacy. There is significant opportunity ahead and we have a focused plan in place to achieve continued growth in the coming quarters," commented Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "Our pipeline of hematology and solid tumor programs is progressing well with impressive Cami Phase 2 data in Hodgkin lymphoma presented at the EHA (Free EHA Whitepaper) Congress in June. Our recent license agreement with Sobi in Europe gives us worldwide access for ZYNLONTA. We have a strong cash runway extending into early 2025 which makes us well-positioned to execute on our key objectives."

Recent Highlights and Developments

Corporate Update

Announced an exclusive license agreement with Swedish Orphan Biovitrum AB (Sobi) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications outside of the United States, greater China, Singapore and Japan.
Appointed David Gilman as Chief Business & Strategy Officer.
Elected veteran oncology drug developer Jean-Pierre Bizzari, MD, and CEO Ameet Mallik to the Company’s Board of Directors.
Hematology Franchise

ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA generated net sales of $17.3 million in the second quarter of 2022.
Initiated LOTIS-9, the Phase 2 clinical trial of ZYNLONTA in combination with rituximab in unfit or frail first-line diffuse large B-cell lymphoma (DLBCL) patients.
Initiated LOTIS-7, the Phase 1b clinical trial of ZYNLONTA in combination with other anti-cancer agents.
Terminated LOTIS-6, the Phase 2 clinical trial of ZYNLONTA in patients with relapsed or refractory follicular lymphoma.
The Overland ADCT BioPharma joint venture enrolled the first patient in China in the global LOTIS-5 confirmatory Phase 3 clinical trial of Lonca and rituximab in second-line or later transplant ineligible DLBCL patients.
Overland ADCT Biopharma completed enrollment of the single-agent bridging study in third-line+ DLBCL, which forms the basis for submission of a marketing application in China.
Cami (camidanlumab tesirine) in Hodgkin lymphoma

Released results from the Phase 2 Hodgkin lymphoma (HL) registrational trial at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress in June. These results showed an overall response rate (ORR) of 70%, a complete response (CR) rate of 33% and a median duration of response (DOR) of 13.7 months. Safety data confirmed the manageable tolerability of Cami in these patients.
Solid Tumor Franchise

ADCT-601 (targeting AXL)

Initiated the Phase 1b combination trial in multiple solid tumors.
Upcoming Expected Milestones

Hematology Franchise

ZYNLONTA

Present LOTIS-5 safety lead-in data at an upcoming medical meeting in 2H 2022
Receive a regulatory decision for third-line DLBCL from the Committee for Medicinal Products for Human Use (CHMP), a committee of the European Medicines Agency (EMA), by 1Q 2023
Cami

Meet with the U.S. Food and Drug Administration (FDA) for HL pre-Biologics License Application (BLA) meeting in September 2022
Complete BLA submission for HL to the FDA in 2H 2023
Solid Tumor Franchise

Cami (targeting CD25)

Preliminary results of safety and clinical activity are anticipated in 2023 for the Phase 1b solid tumor trial of Cami in combination with pembrolizumab
ADCT-901 (targeting KAAG1)

Preliminary results of safety and tumor response for the Phase 1 dose escalation trial in multiple solid tumors are anticipated in 2023
Second Quarter Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $376.8 million as of June 30, 2022, compared to $466.5 million as of December 31, 2021.

Product Revenue

Product revenue (net) was $17.3 million for the quarter, compared to $3.8 million for the same quarter in 2021. Net revenues are for U.S. sales of ZYNLONTA, which received accelerated approval from the FDA on April 23, 2021.

Cost of product sales

Cost of product sales was $2.3 million for the quarter, compared to $0.1 million for the same quarter in 2021, an increase of $2.1 million associated with $1.9 million of impairment charges primarily related to the manufacturing of antibodies that was not within the Company’s specifications. The specification issues did not, and are not expected to, impact the Company’s ability to supply commercial product. In addition, cost of product sales increased due to a full second quarter of sales activity in 2022 as compared to the same period in 2021 due to the commencement of ZYNLONTA sales in May 2021.

Research and Development (R&D) Expenses

R&D expenses were $48.5 million for the quarter ended June 30, 2022, compared to $39.5 million for the same quarter in 2021. As a result of FDA approval of ZYNLONTA in April 2021, the Company reversed $6.8 million of previously recorded impairment charges during the three months ended June 30, 2021, relating to inventory costs incurred for the manufacture of product prior to FDA approval. In addition, R&D expenses increased due to clinical activities to expand ZYNLONTA’s potential market opportunities in earlier lines of therapy and advance the Company’s portfolio of solid tumor programs.

Selling and Marketing (S&M) Expenses

S&M expenses were $17.7 million for the quarter ended June 30, 2022, as compared to $15.2 million for the same quarter in 2021. The increase in S&M expenses is related to the ongoing launch of ZYNLONTA.

G&A Expenses

G&A expenses were $18.2 million for the quarter ended June 30, 2022, compared to $19.4 million for the same quarter in 2021. G&A expenses decreased primarily due to lower share-based compensation expense.

Net Loss and Adjusted Net Loss

Net loss was $64.4 million, or a net loss of $0.84 per basic and diluted share, for the quarter ended June 30, 2022. This compares to a net loss of $72.6 million, or a net loss of $0.95 per basic and diluted share, for the same quarter in 2021. The decrease in net loss for the quarter ended June 30, 2022, as compared to the same period in 2021, was primarily due to higher product revenue, partially offset by the increase in cost of product sales, R&D and S&M expenses. In addition, net loss decreased for the second quarter of 2022 as a result of income arising from changes in the fair value of derivatives associated with our Deerfield Facility Agreement, partially offset by higher interest expense associated with the deferred obligation with Healthcare Royalty Partners.

Adjusted net loss was $56.3 million, or an adjusted net loss of $0.73 per basic and diluted share, for the quarter ended June 30, 2022. This compares to $53.7 million, or an adjusted net loss of $0.70 per basic and diluted share, for the same quarter in 2021.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss second quarter 2022 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events and Presentations" in the Investors section of the ADC Therapeutics website at www.ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

BioXcel Therapeutics Reports Second Quarter 2022 Financial Results and Recent Operational Highlights

On August 9, 2022 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, reported its financial results for the second quarter ended June 30, 2022 and provided an update on key strategic initiatives (Press release, BioXcel Therapeutics, AUG 9, 2022, View Source [SID1234617875]).

"BioXcel Therapeutics made tremendous progress in its journey to becoming a fully integrated AI-driven commercial-stage company with the potential to transform the agitation treatment landscape," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "This transformation is being driven by the continued execution of our land and expand strategy within our neuroscience franchise. We are focused on the commercial launch for our recently FDA approved drug IGALMI while significantly increasing the opportunity for BXCL501 through at-home, medical setting expansion and the pursuit of multiple additional indications for our BXCL501 franchise. We believe we are well-positioned and have laid a strong foundation to drive long-term sustainable growth."

Company Highlights

Neuroscience Franchise

IGALMI (dexmedetomidine) sublingual film

IGALMI was approved by the U.S. Food and Drug Administration (FDA) on April 5, 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.2 Within these two patient populations in the U.S., up to 25 million agitation episodes occur each year.3-5

Trade and Market Access: Key focus on unlocking access and supporting unencumbered demand generation for IGALMI.
IGALMI made available in 120mcg and 180mcg doses through the Company’s third-party logistics provider and for order through wholesalers as of early July.
Engagement underway with 59 high-value Integrated Delivery Networks (IDNs) and their affiliated hospitals.
Discussions and negotiations ongoing with major national Group Purchasing Organizations (GPOs), representing over 90% of beds in target hospitals.
Institutional Sales Force: Deployed first phase of our national sales force to target high-priority accounts in late May, with expansion of commercial footprint in process. Engaging multiple stakeholders in target hospitals and progressing P&T formulary review discussions. Gathered field level market intelligence which further reinforces and augments current and future commercial strategy.
Early response to the IGALMI value proposition exceeding expectations across full spectrum of institutional and healthcare stakeholders.
Market dynamics are rapidly evolving, favoring a less invasive and voluntary approach to treating agitation.
Marketing: Strategic marketing focused on branded campaigns to support sales force activities.
Peer-to-peer speaker programs educating healthcare providers (HCPs) of the importance of early intervention to mitigate agitation episodes.
Digital marketing efforts driving significant engagement resulting in over 100,000 visits to IGALMI HCP website.
Investigating Potential Expansion of BXCL501 for At-Home Use for Agitation Associated with Bipolar Disorders and Schizophrenia: Planning SERENITY III double-blinded, placebo-controlled, pivotal study designed to evaluate BXCL501 60mcg dose for at-home use. This strategic trial decision follows successful completion of Type B meeting with FDA and observed dose-dependent responses in a prior Phase 1/2b study assessing 60mcg, 80mcg, 120mcg, and 180mcg doses. Of the approximately 25 million agitation episodes that occur in the U.S. each year related to schizophrenia and bipolar disorders, approximately one-third occur outside of the institutional setting.6
SERENITY III will consist of two parts:

First part of SERENITY III is similar to the SERENITY I and II pivotal trials and designed to assess efficacy and safety in acutely agitated bipolar and schizophrenia patients.
Primary efficacy endpoint is change from baseline in Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours after dosing compared to placebo.
Second part of SERENITY III designed to assess safety compared to placebo when self-administered at home.
SERENITY III will utilize many of the same investigators and clinical sites as SERENITY I and II and is expected to initiate in 2H 2022.

Clinical Pipeline

BXCL501, a proprietary, sublingual film formulation of dexmedetomidine, has received Breakthrough Therapy and Fast Track designation for the acute treatment of agitation associated with dementia.

Indication Expansion

Alzheimer’s Disease-related Agitation: TRANQUILITY program is designed to capture Alzheimer’s-related agitation market opportunity. There are an estimated 100 million agitation episodes in Alzheimer’s patients occurring in the U.S. annually.7
TRANQUILITY II: top-line data readout expected in 1H 2023.
TRANQUILITY III: enrollment expected to begin in 2H 2022.
Adjunctive Treatment for Major Depressive Disorder (MDD): Ongoing Phase 1 trial evaluating BXCL501 daily dosing designed to inform dose selection in future proof-of-concept study evaluating daily BXCL501 dosing in MDD patients. Over 300 million antidepressant prescriptions are filled annually in the U.S. and current treatments are limited by slow onsets of action and incomplete responses.8
Double-blind, placebo-controlled, multiple ascending dose (MAD) selection trial in healthy volunteers includes two cohorts of 18 patients, each having completed seven days of daily dosing of 30mcg or 60mcg compared to placebo.
Dose escalation in current cohort also enrolling to evaluate 80mcg.
Additional cohorts planned to evaluate safety and assess tolerability of a range of doses administered once daily and twice daily.
Top-line results expected in 1H 2023.
OnkosXcel Therapeutics

Established a wholly owned subsidiary to focus on the sustained expansion and optimization of the Company’s immuno-oncology (I-O) franchise, including its most advanced I-O program, BXCL701. BXCL701 is an investigational orally administered, systemic innate immune activator in development for the treatment of aggressive forms of prostate cancer.

Strategic Advancements: Fully functioning subsidiary dedicated to executing focused strategy and developing innovative oncology pipeline. Evaluating strategic options, which may include third party investments, aimed to fully capture unique value creation opportunity in areas of high unmet medical need.

Metastatic Castration-Resistant Prostate Cancer (mCRPC) Program: Continued ongoing Phase 2 trial for BXCL701 in combination with KEYTRUDA (pembrolizumab) in mCRPC patients with small cell neuroendocrine carcinoma (SCNC) or adenocarcinoma phenotype.
Expect to complete enrollment of 28-patient SCNC cohort in 2H 2022.
Continued enrollment in adenocarcinoma randomized trial expansion evaluating BXCL701 monotherapy vs. BXCL701-KEYTRUDA combination therapy.
Corporate Updates

Strengthened Board of Directors: Appointed Michael P. Miller to the Company’s Board of Directors, to provide strategic leadership and commercial growth expertise.
Enhanced Intellectual Property: Received two Notices of Allowance for patents (issued from patent application numbers 17/560,392 and 17/560,423) related to IGALMI to cover film formulations containing dexmedetomidine and methods of treating agitation using the films.
Second Quarter 2022 Financial Results

Research and Development Expenses: Research and development expenses were $17.9 million for the second quarter of 2022, compared to $13.5 million for the same period in 2021. The increased expenses were primarily attributable to clinical trial costs related to the Company’s TRANQUILITY program.

Selling, General and Administrative Expenses: Selling, general and administrative expenses were $18.4 million for the second quarter of 2022, as compared to $14.1 million for the same period in 2021. The increase was primarily due to personnel and costs related to the launch of IGALMI in the U.S.

Net Loss: BioXcel Therapeutics reported a net loss of $37.7 million for the second quarter of 2022, compared to a net loss of $27.6 million for the same period in 2021.

As of June 30, 2022, cash and cash equivalents totaled approximately $233.5 million. This excludes $30 million of contributions from the $260 million strategic financing announced in April. To date the Company has met the milestones and has received $100 million from the agreement.

Conference Call

BioXcel Therapeutics will host a conference call and webcast August 9, 2022, at 8:30 a.m., ET, to discuss its second quarter 2022 financial results and provide an update on recent operational highlights. To access the call, please dial 877-407-5795 (domestic) and 201-689-8722 (international). A live webcast of the call will be available on the Investors section of the BioXcel website, www.bioxceltherapeutics.com, and a replay of the call will be available through November 9, 2022.

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the "Email Alerts" option under the News/Events menu of the Investors & Media section of its website.

About TRANQUILITY II and III
Initiated in December of 2021, TRANQUILITY II and III are pivotal Phase 3 trials evaluating BXCL501 for the acute treatment of agitation in patients with probable Alzheimer’s disease (AD). The trials expand the evaluation of patients who experience agitation across diverse medical settings and across the range of dementia severity. TRANQUILITY II and III are designed to maximize the opportunity of BXCL501 for the potential treatment of the full spectrum of agitation associated with AD. Each trial will enroll approximately 150 dementia patients 65 years and older who will self-administer 40 mcg or 60 mcg of BXCL501 or placebo whenever agitation episodes occur over a three-month period. TRANQUILITY II will assess patients in assisted living or residential facilities requiring minimal assistance with activities of daily living. TRANQUILITY III will assess patients residing in nursing homes with moderate to severe dementia and require moderate or greater assistance with activities of daily living. The studies will assess agitation as measured by the changes from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) and Pittsburgh Agitation Scale (PAS) total scores. The primary efficacy endpoint for both studies is change in PEC score from baseline measured at two hours after the initial dose and subsequent doses.

Caribou Biosciences Reports Second Quarter 2022 Financial Results and Provides Business Update

On August 9, 2022 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the second quarter of 2022 and provided a business update (Press release, Caribou Biosciences, AUG 9, 2022, View Source [SID1234617911]).

"During the first half of this year, we made significant progress advancing our pipeline of genome-edited allogeneic CAR-T and CAR-NK cell therapies," said Rachel Haurwitz, Ph.D., Caribou’s president and chief executive officer. "We recently presented encouraging initial clinical data at EHA (Free EHA Whitepaper) from our Phase 1 ANTLER trial for CB-010, demonstrating a 100% complete response rate as the best response at dose level 1 in six patients with relapsed or refractory B cell non-Hodgkin lymphoma. Based on the promising initial safety and efficacy data at dose level 1, we are enrolling patients at dose level 2. The ANTLER data have exceeded our expectations and are an important step toward validating our chRDNA genome-editing platform. We are excited to advance our plans for future development of CB-010 and our broader pipeline, including CB-011 for relapsed or refractory multiple myeloma and CB-020, the first solid tumor-targeted program from our CAR-NK platform."

Recent Business Highlights

Pipeline and Technology

ANTLER trial:
Encouraging clinical data from the ANTLER Phase 1 trial of CB-010 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) were presented in a poster at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress. A 100% complete response (CR) rate (n=6) was observed as best response following a single dose of CB-010 at dose level 1 (40×106 CAR-T cells). CB-010 was generally well tolerated.
Following the EHA (Free EHA Whitepaper) poster presentation, 1 additional patient had their 6-month evaluation, which showed they maintained a CR at 6 months, resulting in an overall 50% 6-month CR rate (n=6) for cohort 1 following a single, starting dose of CB-010.
Additionally, as disclosed concurrently with the EHA (Free EHA Whitepaper) poster, the first patient treated with CB-010 maintained a CR at 12 months.
Based on the promising initial safety data and response rate at dose level 1, the ANTLER trial is currently enrolling patients at dose level 2 (80×106 CAR-T cells) and the company plans to share additional cohort 1 ANTLER data by YE 2022.
chRDNA technology:
Presentation of data on Caribou’s CRISPR hybrid RNA-DNA (chRDNA) technology at the 25th Annual Meeting of the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper). The preclinical studies highlighted the mechanism underlying the superior specificity of Caribou’s chRDNA guides for genome editing of primary human T cells.
Corporate

In May 2022, Caribou appointed David Johnson to the board of directors. Mr. Johnson, who currently serves as chief commercial officer at Global Blood Therapeutics, is a seasoned executive with 30 years of commercial and operational experience in the biopharmaceutical industry and has an impressive record of successfully building commercial infrastructure and launching new medicines for patients. Previously, Mr. Johnson worked at Gilead Sciences, Inc. for 15 years and at GlaxoSmithKline for 11 years.
Caribou recently hired several professionals with significant biotechnology and pharmaceutical industry experience:
Tonia Nesheiwat, Pharm.D., vice president of medical affairs
Daniel Poon, vice president of operations and information technology
Socorro Portella, M.D., vice president of clinical development
Saeid Yazdani, vice president of portfolio management
In July 2022, Caribou joined the American Society for Transplantation and Cellular Therapy (ASTCT) Corporate Council to engage in joint problem-solving and collaborative opportunities that will advance the cause and culture of blood and marrow transplantation and cellular therapy.
Anticipated Milestones for 2022 and Beyond

CB-010: Caribou plans to share additional data from cohort 1 of the ongoing ANTLER Phase 1 trial for CB-010, an anti-CD19 CAR-T cell therapy for r/r B-NHL, by YE 2022.
CB-011: Caribou expects to submit an IND application for CB-011, an anti-BCMA CAR-T cell therapy for relapsed or refractory multiple myeloma (r/r MM), in Q4 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 armoring strategies under development for its CAR-NK cell platform in Q4 2022.
CB-012: Caribou expects to submit an IND application for CB-012, an anti-CLL-1 CAR-T cell therapy for r/r acute myeloid leukemia (AML), in 2023.
Upcoming 2022 Meetings

September 19-22: 7th Annual CAR-TCR Summit
Syed Rizvi, M.D., Caribou’s chief medical officer, to present an encore of initial ANTLER clinical data
Justin Skoble, Ph.D., Caribou’s vice president of technical operations, to present on how Caribou’s chRDNA genome-editing technology is being applied to increase persistence and antitumor activity in preclinical models
In September and October, Caribou management plans to participate in the following investor conferences:
September 7-8: Citi 17th Annual BioPharma Conference 2022
September 12-14: Morgan Stanley 20th Annual Global Healthcare Conference
September 13: H.C. Wainwright 24th Annual Global Investment Conference
September 29-30: Jefferies Cell and Genetic Medicine Summit
October 6: BMO BioPharma Spotlight Series – Gene Editing & Therapy
Second Quarter 2022 Financial Results

Cash, cash equivalents, and marketable securities: Caribou had $366.1 million in cash, cash equivalents, and marketable securities as of June 30, 2022, compared to $413.5 million as of December 31, 2021.

Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $4.2 million for the three months ended June 30, 2022, compared to $1.5 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 $22.6 million for the three months ended June 30, 2022, compared to $12.3 million for the same period in 2021. The increase was primarily due to external activities related to the ANTLER Phase 1 clinical trial and contract manufacturing for CB-010 and additional product candidates; other research and development expenses to advance IND-enabling studies for CB-011 and preclinical research for additional programs; personnel-related expenses, including stock-based compensation, attributable to increased headcount; and facility expenses; partially offset by a decrease in expenses relating to licensing, sublicensing revenue, and milestones.

G&A expenses: General and administrative expenses were $10.0 million for the three months ended June 30, 2022, compared to $5.1 million for the same period in 2021. The increase was primarily due to personnel-related expenses, including stock-based compensation, attributable to increased headcount; facilities and other expenses; and legal, accounting, insurance, and other expenses associated with operating as a public company; partially offset by a decrease in patent cost reimbursements.

Net loss: Caribou reported a net loss of $26.7 million for the three months ended June 30, 2022, compared to $14.3 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.

Zai Lab Announces Second Quarter 2022 Financial Results and Corporate Updates

On August 9, 2022 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), a patient-focused, innovative, commercial-stage, global biopharmaceutical company, reported financial results for the second quarter of 2022, along with recent product highlights and corporate updates (Press release, Zai Laboratory, AUG 9, 2022, View Source [SID1234617927]).

"We executed well in the second quarter and delivered strong results," said Dr. Samantha Du, Founder, Chairperson and CEO, of Zai Lab. "Despite the challenging operating environment, Zai has continued to achieve all of our corporate priorities, including the BLA acceptance for efgartigimod by China’s NMPA. With the positive topline readout from the Phase 3 EMERGENT-2 trial in schizophrenia earlier this week, we believe KarXT could be a very important treatment option as the first new class of medicine in over half a century for the many patients suffering from schizophrenia in China and globally. I’m also excited that our pipeline continues to mature and demonstrate first and best-in-class potential. In addition, there were positive data readouts for adagrasib, CLN-081, repotrectinib, efgartigimod, ZEJULA and Tumor Treating Fields in the second quarter. Importantly, our commercial operations remain resilient in the face of the ongoing pandemic situation in certain regions in China. For the remainder of the year, we are on track to deliver our remaining 2022 corporate priorities, including an NDA submission to the NMPA for sulbactam-durlobactam, advancing ZL-1102 (anti-IL-17A Humabody) into full global development, as well as seeking NRDL inclusion for QINLOCK and NUZYRA. We are also very pleased to welcome Josh Smiley as our COO at this exciting time given his operational expertise, global experience, and deep understanding of Zai Lab and our industry."

"I am thrilled to be joining Zai Lab at such a pivotal time in the company’s history," said Josh Smiley, COO of Zai Lab. "Zai is working toward becoming a leading global biotech company, leveraging its commercial success in Asia and its development of global products. The advancement of Zai’s proprietary research pipeline and the diversification of its portfolio beyond its traditional strength in oncology present tremendous opportunities. I am looking forward to working with the great team and helping scale the company both in China and in the United States."

Recent Product Highlights and Anticipated Milestones

Oncology

ZEJULA (Niraparib)

ZEJULA is an oral, once-daily small-molecule poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor. It is the only PARP inhibitor approved in the United States, the European Union, and mainland China (hereinafter, "China") as a monotherapy for patients with advanced ovarian cancer, regardless of their biomarker status.

Recent Product Highlight

In June 2022, Zai Lab presented a new prespecified subgroup analysis from the Phase 3 PRIME study for niraparib in patients in China with ovarian cancer at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. This analysis examined 384 newly diagnosed stage III or IV ovarian cancer patients enrolled in the PRIME study who experienced a complete response (CR) or partial response (PR) to first-line platinum-based chemotherapy.
In the CR group: The median progression-free survival (mPFS) was 29.4 months for niraparib vs 8.3 months for placebo (HR=0.45; 95% confidence interval [CI], 0.32–0.61; P<0.001).
In the PR group: The mPFS was 19.3 months for niraparib versus 8.3 months for placebo (HR=0.45; 95% CI, 0.23–0.86; P=0.014).
The safety profile of niraparib was consistent with previous clinical trials, with no new safety issues identified in this subgroup analysis.
Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that disrupt cancer cell division. Optune and Optune Lua, commercial TTFields devices, are approved or marketed in certain countries or regions for the treatment of newly diagnosed and recurrent glioblastoma and malignant pleural mesothelioma.

Recent Product Highlights

In June 2022, Zai Lab and Novocure announced the EF-31 phase 2 pilot study, evaluating the safety and efficacy of TTFields together with standard-of-care (chemotherapy alone or in combination with trastuzumab for HER2-positive patients) as a first-line treatment in patients with gastric cancer, met its primary endpoint of objective response rate (ORR) with supportive signals across secondary endpoints.
As of June 30, 2022, Optune has been listed in 50 regional customized commercial health insurance plans guided by provincial or municipal governments (or "supplemental insurance plans").
Anticipated 2022 Partner and Zai Milestone

Last patient enrollment anticipated in the Phase 3 pivotal METIS clinical trial evaluating the efficacy and safety of stereotactic radiosurgery plus TTFields compared to stereotactic radiosurgery alone in patients with brain metastases resulting from NSCLC.
QINLOCK (Ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor engineered to broadly inhibit KIT- and PDGFRα-mutated kinases. It is the only therapeutic approved in the United States and China for advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting.

Recent Product Highlight

As of June 30, 2022, QINLOCK has been listed in 73 supplemental insurance plans since its commercial launch in China in May 2021.
Anticipated 2022 Zai Milestone

Seek National Reimbursement Drug List (NRDL) inclusion for a fourth-line GIST indication.
Adagrasib

Adagrasib is a highly selective and potent oral small-molecule inhibitor of KRASG12C for treating KRASG12C-mutated NSCLC, colorectal cancer (CRC), pancreatic cancer, and other solid tumors.

Recent Product Highlights

In July 2022, Zai Lab treated the first patient in Greater China for the global Phase 3 KRYSTAL-12 study of adagrasib in patients with KRASG12C-mutated advanced NSCLC.
In June 2022, Zai Lab treated the first patient in Greater China for the global Phase 3 KRYSTAL-10 study of the combination of adagrasib and cetuximab in patients with KRASG12C-mutated advanced CRC.
In June 2022, Zai Lab partner Mirati Therapeutics, Inc. (Mirati) presented the following information at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting:
Mirati reported full results from the registration-enabling Phase 2 cohort of the KRYSTAL-1 study evaluating adagrasib in patients with previously treated NSCLC harboring a KRASG12C mutation; these results were concurrently published in the New England Journal of Medicine. This presentation included results from a retrospective subgroup analysis from the Phase 2 NSCLC cohort of the KRYSTAL-1 study evaluating adagrasib in patients with KRASG12C-mutated NSCLC and stable, previously treated CNS metastases.
Summary of clinical results from the Phase 2 registration-enabling study (n=112): initial results showed that the ORR was 43%, the disease control rate (DCR) was 80%, the median duration of response (mDOR) was 8.5 months (95% CI: 6.2 – 13.8), the mPFS was 6.5 months (95% CI: 4.7 – 8.4). With a January 15, 2022 data cutoff, the median overall survival (mOS) was 12.6 months (95% CI: 9.2 – 19.2).
Central nervous system (CNS)-specific activity was evaluated in a subset analysis of stable, previously treated CNS metastases (n=33): results revealed an intracranial (IC) ORR of 33% (11/33).
In addition, Mirati reported updated findings from a pooled analysis from the KRYSTAL-1 study, including the registrational Phase 2 and Phase 1/1b NSCLC cohorts.
Pooled analysis of KRYSTAL-1 NSCLC cohorts (n=132): initial results showed that the ORR was 44% and the DCR was 81%. The mDOR was 12.5 months and the mPFS was 6.9 months. With a January 15, 2022 data cutoff, the mOS was 14.1 months.
In June 2022, Mirati also announced the results of a prospective analysis from the Phase 1b cohort of the KRYSTAL-1 study evaluating IC responses of adagrasib in patients with KRASG12C-mutated advanced NSCLC with active and untreated CNS metastases.
CNS-specific activity in active and untreated CNS metastases (n=19): results showed an IC ORR of 32% (6/19).
Anticipated 2022 Partner Milestones

Tolerability and ORR update for the Phase 2 KRYSTAL-7 study of adagrasib in combo with pembrolizumab in first-line KRASG12C-mutated NSCLC in the fourth quarter of 2022.
Additional clarity on the regulatory pathway of adagrasib monotherapy in first-line KRASG12C-mutated NSCLC, and next steps for tumors other than NSCLC.
Potential FDA (Food and Drug Administration) approval and commercial launch in the United States for adagrasib as the treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy; Prescription Drug User Free Act (PDUFA) target action date of December 14, 2022.
Bemarituzumab

Bemarituzumab is a potential first-in-class antibody that is being developed in gastric and gastroesophageal junction (GEJ) cancer as a targeted therapy for tumors that overexpress FGFR2b.

Recent Product Highlights

Zai Lab partner Amgen reported that the final analysis of the FIGHT study, a Phase 2 randomized, double-blind, controlled study evaluating bemarituzumab and modified FOLFOX6 (mFOLFOX6) in patients with previously untreated advanced gastric and GEJ cancer was completed. These results continued to demonstrate that bemarituzumab + mFOLFOX6 improves the clinical outcome of patients with FGFR2b expressing tumors with no new safety concerns. A greater survival benefit was observed with increasing FGFR2b expression levels.
Zai Lab partner Amgen has initiated a Phase 1b/2 study (FORTITUDE-301), evaluating the safety and efficacy of bemarituzumab monotherapy in solid tumors with FGFR2b overexpression.
Anticipated 2022 Zai Milestone

Initiate a registrational study of bemarituzumab in first-line advanced gastric and GEJ cancer in Greater China in the fourth quarter of 2022.
Odronextamab

Odronextamab is a bispecific antibody designed to trigger tumor killing by linking and activating a cytotoxic T-cell (binding to CD3) to a lymphoma cell (binding to CD20).

Anticipated 2022 Partner and Zai Milestone

Complete enrollment in a potentially pivotal Phase 2 study in B-Cell Non-Hodgkin Lymphoma (B-NHL).
Anticipated 2022 Partner Milestone

Report additional results from a potentially pivotal Phase 2 study in B-NHL, and submit a Biologics License Application (BLA) to the FDA.
Repotrectinib

Repotrectinib is a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and TRK A/B/C, with the potential to treat TKI-naïve or TKI-pretreated patients.

Recent Product Highlights

In July 2022, Zai Lab partner Turning Point Therapeutics, Inc. (Turning Point) announced receipt of positive feedback from the FDA at a pre-New Drug Application (NDA) meeting completed within the second quarter. The FDA agreed with Turning Point’s plan to provide data for ROS1+ TKI-naïve and TKI-pretreated advanced NSCLC patients with at least six months of follow-up from the first post-baseline scan at the time of NDA submission.
In June 2022, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted two Breakthrough Therapy Designations (BTDs) to repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and one prior line of platinum-based chemotherapy and for those with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 TKI and no chemotherapy or immunotherapy.
In May 2022, Zai Lab and Turning Point announced that the FDA granted an eighth regulatory designation, and third BTD, to repotrectinib, for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with one ROS1 TKI and who have not received prior platinum-based chemotherapy.
Anticipated 2022 Zai Milestones

Complete enrollment in all cohorts of the phase 1/2 registrational TRIDENT-1 study.
Discuss regulatory pathway with the NMPA at a pre-NDA meeting in the fourth quarter of 2022.
Anticipated 2022 Partner Milestones

Anticipate providing a detailed update from TRIDENT-1 utilizing BICR analyses, including intracranial activity, at an upcoming medical conference.
Provide a clinical data update from the NTRK-positive advanced solid tumor cohorts from TRIDENT-1.
CLN-081

CLN-081 is an orally available, irreversible epidermal growth factor receptor (EGFR) inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR.

Recent Product Highlight

In June 2022, Zai Lab partner Cullinan Oncology presented updated data from the Phase 1/2a study in NSCLC patients with EGFR exon 20 insertion mutations at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. Of the 39 patients in the 100 mg BID dose group:
16 (41%) had a confirmed PR.
The estimated mDOR was greater than 21 months.
mPFS was 12 months.
The safety profile of CLN-081 was amenable for long-term treatment.
Anticipated 2022 Partner Milestone

Initiate a pivotal study following the completion of a pharmacokinetic (PK) food effect study.
Elzovantinib (TPX-0022)

Elzovantinib is an orally bioavailable, multi-targeted kinase inhibitor with a novel three-dimensional macrocyclic structure that inhibits the MET, CSF1R (colony stimulating factor 1 receptor) and SRC kinases.

Anticipated 2022 Zai Milestone

Enroll the first patient in Greater China in the Phase 1 expansion portion of the global Phase 1/2 SHIELD-1 study.
Anticipated 2022 Partner Milestones

Provide a clinical data update from the Phase 1 SHIELD-1 study.
Initiate the Phase 2 portion of the SHIELD-1 study, pending FDA feedback on data from the intermediate dose level.
BLU-945

BLU-945 is a selective and potent investigational inhibitor of EGFR harboring either the activating L858R or exon 19 deletion mutations combined with the acquired T790M and C797S mutations, common on-target resistance mutations to first-generation EGFR inhibitors and osimertinib, respectively, for the potential treatment of EGFR-driven NSCLC.

Recent Product Highlight

In June 2022, Zai Lab received a Clinical Trial Application (CTA) approval from the NMPA for the BLU-945 monotherapy cohort of the global Phase 1/2 SYMPHONY study in Greater China.
Anticipated 2022 Partner Milestones

Present updated BLU-945 monotherapy data and initial dose escalation data for BLU-945 in combination with osimertinib from the Phase 1/2 SYMPHONY trial in EGFR-mutant NSCLC.
Initiate additional cohorts in the Phase 1/2 SYMPHONY trial for BLU-945 in combination with other agents across multiple patient populations, including early line therapy.
BLU-701

BLU-701 is a selective and potent investigational inhibitor of EGFR harboring either the activating L858R or exon 19 deletion mutations combined with the acquired C797S mutation, a common on-target resistance mutation to osimertinib, for potential treatment of EGFR-driven NSCLC.

Anticipated 2022 Partner Milestone

Present initial clinical data from the Phase 1/2 HARMONY trial of BLU-701 in EGFR-mutant NSCLC.
Autoimmune Diseases

VYVGART (Efgartigimod)

Efgartigimod is an antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) autoantibodies and block the IgG recycling process. It binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG from degradation.

Recent Product Highlights

In July 2022, Zai Lab announced the NMPA accepted the BLA for efgartigimod alfa injection for the treatment of adult patients with generalized myasthenia gravis (gMG) in China.
In June 2022, efgartigimod was introduced to the Hainan Bo’ao Lecheng International Medical Tourism Pilot Zone, and in July 2022, the first Chinese patient was treated with efgartigimod.
Anticipated 2022 Zai Milestones

Launch the proof-of-concept trials in two autoimmune renal diseases.
Continue to explore and advance additional indications in coordination with argenx.
Anticipated 2022 Partner Milestones

Initiate the registrational ALKIVIA trial in the third quarter of 2022 for three subtypes of idiopathic inflammatory myopathies (myositis), including immune-mediated necrotizing myopathy, anti-synthetase syndrome, and dermatomyositis; interim analysis planned of first 30 patients of each subtype.
Submit a BLA to the FDA for subcutaneous (SC) efgartigimod in gMG.
Infectious Disease

NUZYRA (Omadacycline)

NUZYRA is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Zai Lab led the China development and obtained approval by the NMPA in December 2021.

Anticipated 2022 Zai Milestones

Seek NRDL inclusion for CABP and ABSSSI indications.
Submit Zai Lab’s plan for post-approval studies.
Sulbactam-Durlobactam (SUL-DUR, Asia Pacific Rights)

Sulbactam-Durlobactam is a beta-lactam/beta-lactamase inhibitor combination that provides unique activity against Acinetobacter organisms, including carbapenem-resistant strains.

Anticipated 2022 Zai Milestone

Submit an NDA to the NMPA in the fourth quarter of 2022.
Anticipated 2022 Partner Milestone

Submit an NDA to the FDA in the third quarter of 2022.
Neuroscience

KarXT

KarXT combines xanomeline, a novel muscarinic agonist, with trospium, an approved muscarinic antagonist. In November 2021, Zai partnered with Karuna Therapeutics, Inc. (Karuna) to develop KarXT in Greater China for the treatment of schizophrenia and possibly other indications like dementia-related psychosis.

Recent Product Highlight

In August 2022, Zai Lab partner Karuna announced positive topline results from its Phase 3 EMERGENT-2 trial evaluating the efficacy, safety, and tolerability of KarXT in adults with schizophrenia. The trial met its primary endpoint, with KarXT demonstrating a statistically significant and clinically meaningful 9.6-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-21.2 KarXT vs. -11.6 placebo, p<0.0001) at Week 5. KarXT also demonstrated an early and sustained statistically significant reduction of symptoms, as assessed by PANSS total score, starting at Week 2 and maintained such reduction through all timepoints in the trial.
The trial also met its key secondary endpoints, demonstrating statistically significant reductions in positive and negative symptoms of schizophrenia, as measured by the PANSS positive, PANSS negative and PANSS Marder negative subscales.
KarXT was generally well tolerated, with a side effect profile substantially consistent with prior trials of KarXT in schizophrenia.
Anticipated 2022 Zai Milestone

Seek regulatory agreement with the NMPA on a China program in schizophrenia.
Anticipated 2022 Partner Milestone

Initiate the Phase 3 ADEPT-1 study evaluating KarXT as a treatment for psychosis in Alzheimer’s disease in the third quarter of 2022.
Global R&D Programs

ZL-1102 (IL-17 Human VH Antibody Fragment, Global Rights)

ZL-1102 is a novel human VH antibody fragment (Humabody) targeting the IL-17A cytokine with high affinity and avidity. Unlike other anti-IL-17 products, ZL-1102 is being developed as a topical treatment for mild-to-moderate chronic plaque psoriasis (CPP).

Recent Product Highlight

The results of the Phase 1 proof-of-concept study, evaluating the efficacy and safety of ZL-1102 in patients with mild-to-moderate CPP, have been accepted for an oral presentation at EADV (European Academy of Dermatology and Venereology) annual meeting on September 7-10, 2022.
Anticipated 2022 Zai Milestone

Initiate a global Phase 2 study for CPP in the fourth quarter of 2022.
Simurosertib, ZL-2309 (CDC7 Inhibitor, Global Rights)

Simurosertib, or ZL-2309, is an oral selective inhibitor of CDC7, a protein kinase with key roles in DNA replication and in bypassing DNA damage response.

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