On May 09, 2022 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported its financial results for the quarter ended March 31, 2022 and provided an update on corporate progress (Press release, Revolution Medicines, MAY 9, 2022, View Source [SID1234613913]).

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"At Revolution Medicines, we are passionately pursuing our mission to outsmart cancer with a disruptive portfolio of RAS(ON) Inhibitors in development for patients with RAS-addicted cancers," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "With compounds RMC-6236 and RMC-6291 expected to enter the clinic this year and a pipeline of other compounds behind them, we are advancing a wave of RAS(ON) Inhibitor drug candidates that could address the majority of these cancers that lack effective targeted drugs.

"Concurrently, we continue clinical evaluation of the class-leading RAS Companion Inhibitors RMC-4630 and RMC-5552 that are intended as combination agents to maximize patient benefit. Our integrated pipeline of RAS(ON) Inhibitors and RAS Companion Inhibitors enables the science-driven treatment strategies we have designed to overcome common causes of treatment failure."

First Quarter 2022 Corporate Highlights

RAS(ON) Inhibitors

RMC-6236 (RASMULTI)

RMC-6236 is a potent, oral, RAS(ON)-selective tri-complex inhibitor designed to treat patients with cancers driven by a variety of RAS mutations, including KRASG12D, KRASG12V and KRASG12R. Additionally, RMC-6236 may be deployed as a RAS Companion Inhibitor in combination with mutant-selective RAS(ON) Inhibitors.

The company has submitted an Investigational New Drug (IND) application for RMC-6236 to the U.S. Food and Drug Administration (FDA) and expects to announce dosing of the first patient in a monotherapy dose-escalation study in mid-2022. The company anticipates providing evidence of first-in-class single agent activity for RMC-6236 in 2023.
RMC-6291 (KRASG12C)

RMC-6291 is a potent, oral, selective, covalent inhibitor of KRASG12C(ON) with a differentiated preclinical profile. It is designed to serve patients with cancers driven by the KRASG12C mutant.

The company remains on track to submit an IND application for RMC-6291 to the FDA in the first half of 2022 and expects to announce dosing of the first patient in its monotherapy dose-escalation study in the second half of 2022. The company anticipates disclosing preliminary evidence of superior activity for RMC-6291 in 2023.
RMC-9805 (KRASG12D)

RMC-9805 is an oral, selective, covalent inhibitor of KRASG12D(ON), the primary tumor driver for more than 50,000 new patients annually in the United States, predominantly patients with colorectal (CRC), pancreatic or non-small cell lung cancer (NSCLC). The company believes this compound is the first covalent oral inhibitor of KRASG12D.

The company expects to announce dosing of the first patient in a monotherapy dose- escalation study of RMC-9805 in mid-2023.
RMC-8839 (KRASG13C)

RMC-8839 is an oral, selective, covalent inhibitor of KRASG13C(ON). The company believes RMC-8839 is the first compound to directly inhibit KRASG13C, an important therapeutic target primarily for NSCLC and select CRC patients unserved by a targeted RAS inhibitor.

The company expects to announce dosing of the first patient in a monotherapy dose-escalation study of RMC-8839 in late 2023 or early 2024.
RAS Innovation Engine

The company is leveraging its innovative tri-complex platform and advanced cancer discovery capabilities to identify additional orally bioavailable, tri-complex RAS(ON) Inhibitors to target RAS variants driving RAS-addicted cancers that are unserved by a targeted RAS inhibitor.

The company is pursuing multiple pipeline expansion programs focused on RAS mutation hotspots G12 (e.g., G12V and G12R), G13 (e.g., G13D) and Q61.
The company is on track to nominate a fifth RAS(ON) Inhibitor development candidate in the second half of 2022.
AACR Highlights

The company demonstrated sector leadership in RAS pathway targeting with seven oral presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. The presentations highlighted key themes in the company’s multi-part approach to outsmarting cancer.

RAS(ON) Inhibitors demonstrate compelling monotherapy activity in diverse preclinical models of genetically defined RAS cancers.
RMC-6236 achieved significant monotherapy responses in mouse clinical trials in KRASG12-mutant NSCLC, CRC, and pancreatic cancer models.
RMC-6291 demonstrated superiority over adagrasib (MRTX849) in a head-to-head mouse clinical trial in KRASG12C NSCLC models.
Selective inhibitor of KRASQ61H(ON) drove significant tumor regressions in a KRASQ61H pancreatic cancer model.
RAS(ON) Inhibitors can be combined with RAS Companion Inhibitors to improve anti-tumor activity in models that are less sensitive to RAS(ON) Inhibitor monotherapy.
RMC-6236 deployed as a RAS Companion Inhibitor in combination with RMC-6291 demonstrated enhanced anti-tumor activity in KRASG12C NSCLC and CRC models that were refractory to single agent treatments.
RAS(ON) Inhibitors as monotherapies reverse the immune-suppressive tumor microenvironment in RAS-driven cancers and can unlock profound anti-tumor immunity when combined with immune system modulators such as PD-1 checkpoint inhibitors.
RAS Companion Inhibitors

RMC-4630 (SHP2)

RMC-4630 is a potent, oral small molecule that is designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a central role in modulating cell survival and growth by facilitating RAS pathway signaling. RMC-4630 (also known as SAR442720) is progressing in a clinical program under the company’s partnership with Sanofi, the company’s global SHP2 development and commercialization partner.

RMC-4630 and KRASG12C Inhibitor Lumakras (sotorasib)

CodeBreaK 101c: Phase 1b trial sponsored by Amgen Inc. evaluating RMC-4630 in combination with Amgen’s KRASG12C(OFF) inhibitor, sotorasib, in patients with advanced solid tumors is progressing. Amgen recently announced that initial data from this trial were submitted to a medical congress taking place in the late summer.
RMC-4630-03: Global Phase 2 study of RMC-4630 in combination with sotorasib in patients with advanced NSCLC with a KRASG12C mutation who have failed prior standard therapy and who have not been previously treated with a RAS inhibitor is progressing. Revolution Medicines is sponsoring the trial as a complement to the CodeBreaK 101c trial under its global partnership with Sanofi, and in collaboration with Amgen, which is supplying sotorasib to trial sites globally. Revolution Medicines expects to complete enrollment of this study in the second half of 2022 and to provide preliminary evidence of clinical benefit of RMC-4630 as a RAS Companion Inhibitor in 2022. Additional evidence of clinical benefit of this compound is expected to be provided in 2023.
RMC-4630 and KRASG12C Inhibitor adagrasib

Sanofi is planning a Phase 1/2 dose escalation and expansion study under its global SHP2 partnership with Revolution Medicines, and in collaboration with Mirati. The study will evaluate RMC-4630 in combination with adagrasib (MRTX849), Mirati’s KRASG12C inhibitor, in patients with previously treated NSCLC who harbor KRASG12C mutations. This study expands the evaluation of the potential benefit of adding RMC-4630 in this class of KRASG12C(OFF) inhibitors.
RMC-4630 and PD-1 Inhibitor KEYTRUDA (pembrolizumab)

TCD16210: Phase 1 trial sponsored by Sanofi evaluating RMC-4630 in combination with KEYTRUDA (pembrolizumab), a PD-1 inhibitor is progressing. Sanofi is treating patients in an expansion cohort evaluating this combination in first-line treatment for patients with PDL-1 positive NSCLC.
RMC-5552 (mTORC1/4EPB1)

RMC-5552 is a potent, first-in-class, bi-steric mTORC1-selective inhibitor designed to suppress phosphorylation and inactivation of 4EBP1 for cancers with hyperactive mTORC1 signaling, including certain RAS-addicted cancers. The company intends to combine RMC-5552 with RAS(ON) Inhibitors in patients with cancers harboring RAS/mTOR pathway co-mutations.

An ongoing Phase 1/1b clinical trial evaluating RMC-5552 monotherapy is progressing. In January 2022, the company reported preliminary evidence of clinical activity, and dose optimization is underway to prepare for combination studies in RAS cancers. The company anticipates disclosing additional evidence of single agent activity in 2023.
The company aims to evaluate RMC-5552 in combination with RAS(ON) Inhibitors in patients carrying both RAS and mTOR pathway mutations, representing approximately 30,000 new patients per year in the United States.
First Quarter 2022 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities were $518.8 million as of March 31, 2022, compared to $577.1 million as of December 31, 2021. The decrease was primarily attributable to net loss for the quarter ended March 31, 2022.

Revenue: Total revenue, consisting of revenue from the company’s collaboration agreement with Sanofi, was $7.6 million for the quarter ended March 31, 2022, compared to $10.2 million for the quarter ended March 31, 2021. The decrease was related to lower reimbursed development costs under our collaboration agreement with Sanofi.

R&D Expenses: Research and development expenses were $56.5 million for the quarter ended March 31, 2022, compared to $40.9 million for the quarter ended March 31, 2021. The increase was primarily due to an increase in research expenses associated with the company’s pre-clinical research portfolio, an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation.

G&A Expenses: General and administrative expenses were $9.0 million for the quarter ended March 31, 2022, compared to $6.7 million for the quarter ended March 31, 2021. The increase was primarily due to an increase in stock-based compensation and an increase in personnel-related expenses related to additional headcount.

Net Loss: Net loss was $57.6 million for the quarter ended March 31, 2022, compared to net loss of $37.2 million for the quarter ended March 31, 2021.

2022 Financial Guidance

Revolution Medicines reiterates full year 2022 GAAP net loss to be between $260 million and $290 million, which includes estimated non-cash stock-based compensation expense of $35 million to $40 million.

Conference Call

Revolution Medicines will host a conference call and webcast this afternoon, May 9, 2022, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time).

To listen to the conference call, please dial (833) 423-0425 (U.S.) or + 1 (918) 922-3069 (international), provide conference ID: 6994747 and request the Revolution Medicines conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

On May 9, 2022 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the first quarter 2022 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 9, 2022, View Source [SID1234613912]).

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"We continue our progress in advancing pamrevlumab in three high value indications and are delighted to have completed enrollment of the ZEPHYRUS-1 Phase 3 study in idiopathic pulmonary fibrosis," said Enrique Conterno, Chief Executive Officer, FibroGen. "In addition, roxadustat is off to a strong start in 2022 in China with significant year over year volume growth."

Recent Developments:

Completed enrollment of the ZEPHYRUS-1 Phase 3 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
Completed enrollment of the LELANTOS-1 Phase 3 clinical trial of pamrevlumab in non-ambulatory patients with Duchenne muscular dystrophy (DMD).
Our partner Astellas received approval for roxadustat in Russia for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD), which triggered a $25 million milestone payable to FibroGen.
China Performance:

FibroGen’s net product revenue under U.S. GAAP from sale of roxadustat in China was $18.9 million compared to $15.4 million in the first quarter of 2021. Increase driven mainly due to release of deferred revenue.
First quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca was $43.5 million, flat as compared to the first quarter of 2021. This result was driven by an increase in volume of over 70% offset by the recent National Reimbursement Drug List (NRDL) price reduction.
Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China.
Upcoming Milestones:

Interim analysis of event free survival of the LAPIS Phase 3 study of pamrevlumab in locally advanced pancreatic cancer (LAPC) to be conducted in 2Q 2022.
Topline data from the LELANTOS-1 Phase 3 study of pamrevlumab in DMD expected 1H 2023.
Expect to complete enrollment in the LELANTOS-2 Phase 3 study of pamrevlumab in ambulatory patients with DMD in 2Q 2022.
Topline data from the ZEPHYRUS-1 Phase 3 study of pamrevlumab in IPF expected mid-2023.
Topline data from the MATTERHORN Phase 3 study of roxadustat in anemia of myelodysplastic syndromes (MDS) expected 1H 2023.
Financial:

Total revenue for the first quarter of 2022 was $60.8 million, as compared to $38.4 million for the first quarter of 2021.
Net loss for the first quarter of 2022 was $63.2 million, or $0.68 net loss per basic and diluted share, compared to a net loss of $71.8 million, or $0.78 net loss per basic and diluted share one year ago.
At March 31, 2022, FibroGen had $565.4 million in cash – defined as cash, cash equivalents, investments, and accounts receivable.
Based on our latest forecast, we estimate a 2022 ending cash balance of $310-340 million.
________________
1 Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.

Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, May 9, 2022, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the Company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen first quarter 2022 financial results conference call, and use confirmation number 2487763. A replay of the webcast will be available shortly after the call for a period of 7 days. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) and use passcode 2487763.

About Pamrevlumab
Pamrevlumab is a potential first-in-class antibody being developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD). Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for anemia of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA).

Roxadustat is approved in European Union (EU) member states, including the European Economic Area (EEA) countries, as well as in Japan, China, Chile, South Korea, Russia, and the UK for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities across the globe, and are currently under review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets not licensed to Astellas.

On May 9, 2022 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported financial results for the first quarter ended March 31, 2022 (Press release, CRISPR Therapeutics, MAY 9, 2022, View Source [SID1234613911]).

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"I am pleased with the ongoing momentum across our broad portfolio of innovative gene therapy candidates and anticipate important company milestones in 2022. Alongside our partner Vertex, we remain on track to submit global regulatory filings for CTX001 in late 2022 and have dosed more than 75 patients across both trials to date. We have also initiated two new Phase 3 trials of CTX001 in pediatric patients with TDT and SCD," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "We are also advancing our wholly-owned immuno-oncology pipeline, with new updates expected this year. In addition, enrollment and dosing continues in the Phase 1 clinical trial of VCTX210 for T1D with our partner, ViaCyte. We believe we are well positioned and well capitalized to advance our pipeline and platform to develop transformative medicines for patients suffering from serious diseases."

Recent Highlights and Outlook

Beta Thalassemia and Sickle Cell Disease

Following the completion of enrollment in the ongoing Phase 3 clinical trials for CTX001 in transfusion-dependent beta thalassemia (TDT) and severe sickle cell disease (SCD), announced last quarter, more than 75 patients across both trials have been dosed to date. CRISPR Therapeutics and Vertex anticipate presenting updated data from the clinical trials, with more patients and longer follow-up, at medical conferences in 2022.

CRISPR Therapeutics and Vertex have initiated two new Phase 3 studies of CTX001 in pediatric patients with TDT and SCD.

The companies anticipate submitting global regulatory filings for CTX001 in TDT and SCD in late 2022.

Immuno-Oncology Programs

CRISPR Therapeutics continues to enroll and dose patients in the pivotal trial of CTX110, its wholly-owned allogeneic chimeric antigen receptor T cell (CAR-T) investigational therapy targeting CD19+ B-cell malignancies. The Company expects to report additional data in 2022.

CRISPR Therapeutics’ Phase 1 clinical trials for CTX-120, its wholly-owned allogeneic CAR-T investigational therapy targeting B-cell maturation antigen for the treatment of relapsed or refractory multiple myeloma, and CTX130, its wholly-owned allogeneic CAR-T investigational therapy targeting CD70 for the treatment of both solid tumors and certain hematologic malignancies, are ongoing. Each trial is assessing safety and efficacy of several dose levels. The Company expects to provide updates from each trial in the first half of 2022.

Regenerative Medicine and In Vivo Programs

Enrollment and dosing are ongoing in the Phase 1 clinical trial of VCTX210 for the treatment of type 1 diabetes (T1D). VCTX210 is an investigational, allogeneic, gene-edited, stem cell-derived product developed in collaboration by applying CRISPR Therapeutics’ gene-editing technology to ViaCyte’s proprietary stem cell capabilities for the generation of pancreatic cells designed to evade recognition by the immune system. This immune-evasive cell replacement therapy is designed to enable patients to produce their own insulin.

Based upon ongoing progress with its in vivo approaches for liver gene editing utilizing both viral and non-viral delivery vehicles, CRISPR Therapeutics continues to expect to move multiple programs utilizing in vivo approaches into the clinic in the next 18 to 24 months.

Other Corporate Matters

In April, CRISPR Therapeutics proposed to elect Maria Fardis, Ph.D., MBA, to its Board of Directors at the Company’s upcoming annual general meeting of shareholders to be held later this year. The Company believes her extensive leadership in scaling companies and bringing novel therapies to patients will be an invaluable asset to CRISPR Therapeutics.

In April, CRISPR Therapeutics and Nkarta, Inc. presented preclinical data focused on its natural killer cell platform and pipeline at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. The data shows that CD70/CISH/CBLB triple KO CD70-CAR NK cells demonstrated enhanced anti-tumor activity against relevant solid tumor cell lines and provided greater resistance to tumor microenvironment inhibition. These data support the further exploration of CD70/CISH/CBLB triple gene knockout CD70 CAR NK cells for clinical application.

In April, CRISPR Therapeutics was awarded the 2022 Facility of the Year Category Award (FOYA) for Innovation by the International Society for Pharmaceutical Engineering (ISPE) for its state-of-the art manufacturing facility in Framingham, Massachusetts, USA. ISPE’s Facility of the Year Awards program is the premier global awards program recognizing innovation and creativity in the pharmaceutical and biotechnology manufacturing industries. Projects selected for recognition set the standard by demonstrating excellence in facility design, construction, and operations.
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $2,221.3 million as of March 31, 2022, compared to $2,379.1 million as of December 31, 2021. The decrease in cash of $157.8 million was primarily driven by cash used in operating activities to support ongoing research and development of the Company’s clinical and pre-clinical programs.

Revenue: Total collaboration revenue was $0.2 million for the first quarter of 2022 and 2021.

R&D Expenses: R&D expenses were $118.2 million for the first quarter of 2022, compared to $70.6 million for the first quarter of 2021. The increase in expense was driven by development activities supporting the advancement of our wholly-owned immuno-oncology programs, as well as expenses related to our new U.S. research and development headquarters.

G&A Expenses: General and administrative expenses were $28.0 million for the first quarter of 2022, compared to $24.5 million for the first quarter of 2021. The increase in general and administrative expenses was primarily driven by headcount-related expense.

Collaboration Expense: Collaboration expense, net, was $30.6 million for the first quarter of 2022, compared to $19.9 million for the first quarter of 2021. The increase in collaboration expense, net, was primarily driven by increased pre-commercial and manufacturing scale-up costs associated with our hemoglobinopathies programs under our collaboration with Vertex.

Net Loss: Net loss was $179.2 million for the first quarter of 2022, compared to a net loss of $113.2 million for the first quarter of 2021.
About CTX001
CTX001 is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy that is being evaluated for patients suffering from TDT or severe SCD, in which a patient’s hematopoietic stem cells are edited to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth, which then switches to the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate or eliminate transfusion requirements for patients with TDT and reduce or eliminate painful and debilitating sickle crises for patients with SCD. Earlier results from these ongoing trials were published as a Brief Report in The New England Journal of Medicine in January of 2021.

Based on progress in this program to date, CTX001 has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for both TDT and SCD. CTX001 has also been granted Orphan Drug Designation from the European Commission, as well as Priority Medicines (PRIME) designation from the European Medicines Agency (EMA), for both TDT and SCD.

Among gene-editing approaches being investigated/evaluated for TDT and SCD, CTX001 is the furthest advanced in clinical development.

About the CRISPR-Vertex Collaboration
Vertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. CTX001 represents the first potential treatment to emerge from the joint research program. Under a recently amended collaboration agreement, Vertex will lead global development, manufacturing and commercialization of CTX001 and split program costs and profits worldwide 60/40 with CRISPR Therapeutics.

About CLIMB-111
The ongoing Phase 1/2 open-label trial, CLIMB-Thal-111, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with TDT. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About CLIMB-121
The ongoing Phase 1/2 open-label trial, CLIMB-SCD-121, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 12 to 35 with severe SCD. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About CLIMB-131
This is a long-term, open-label trial to evaluate the safety and efficacy of CTX001 in patients who received CTX001 in CLIMB-111 or CLIMB-121. The trial is designed to follow participants for up to 15 years after CTX001 infusion.

About CTX110
CTX110, a wholly owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting cluster of differentiation 19, or CD19. CTX110 is being investigated in the ongoing CARBON trial. CTX110 has been granted Regenerative Medicine Advanced Therapy designation from the FDA.

About CARBON
The ongoing Phase 1 single-arm, multi-center, open label clinical trial, CARBON, is designed to assess the safety and efficacy of several dose levels of CTX110 for the treatment of relapsed or refractory B-cell malignancies.

About CTX120
CTX120, a wholly-owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting B-cell maturation antigen, or BCMA. CTX120 is being investigated in an ongoing Phase 1 single-arm, multi-center, open-label clinical trial designed to assess the safety and efficacy of several dose levels of CTX120 for the treatment of relapsed or refractory multiple myeloma. CTX120 has been granted Orphan Drug designation from the FDA.

About CTX130
CTX130, a wholly-owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting cluster of differentiation 70, or CD70, an antigen expressed on various solid tumors and hematologic malignancies. CTX130 is being developed for the treatment of both solid tumors, such as renal cell carcinoma, and T-cell and B-cell hematologic malignancies. CTX130 is being investigated in two ongoing independent Phase 1, single-arm, multi-center, open-label clinical trials that are designed to assess the safety and efficacy of several dose levels of CTX130 for the treatment of relapsed or refractory renal cell carcinoma and various subtypes of lymphoma, respectively. CTX120 has been granted Orphan Drug designation for the treatment of T-cell lymphoma from the FDA.

About VCTX210
VCTX210 is an investigational, allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D). VCTX210 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and ViaCyte, Inc.

On May 9, 2022 IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the "Company" or "IPA") (NASDAQ: IPA) (TSXV: IPA) is pleased to share that IPA’s subsidiary Biostrand, a Belgian end-to-end multi-omics analysis platform provider, reported that it has received a €460,000 round of grant funding from VLAIO (Flanders Innovation & Entrepreneurship), the research fund of the Flemish regional government in Belgium (Press release, ImmunoPrecise Antibodies, MAY 9, 2022, View Source [SID1234613910]). Conditionally awarded in January this year, BioStrand recently satisfied the remaining criteria for the award, which follows an original grant from VLAIO of €235,000 in 2020. Commenting on the latest grant, Dr. Ingrid Brands, General Manager and co-founder of BioStrand, stated, "Thus far, our patented HYFT-based methodology has been applied predominantly to streamline analysis at the syntactic level and combines sequence information with natural language processing. Using the presence, occurrence, and distribution of HYFT patterns, the focus has been on analysis and integration of sequence-based ‘syntactical’ information. We are now extending the methodology to combine syntactical and structural information and to expand our services portfolio with HYFT-based structural and functional modelling functionalities. By linking HYFTs with the 3D structure (and function) of proteins and expanding platform capabilities for AI discovery, we will be able to support an even wider array of applications, including assay development, biomarker discovery, and computer-aided drug design."

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The strategic objective driving this HYFT-based synthesis of syntactical and structural information is to extend BioStrand’s technology to encompass the structure of proteins. A key advantage of this blended approach is the detection of protein sequences with similar structures (and function) but without high sequence similarity (distant homologs). A primary application for this approach will be in protein structure prediction, with a particular first focus on antibodies as well as G protein coupled receptors (GPCRs). This will be extended to cover protein-protein interaction prediction (PPI) at a later stage.

BioStrand is also working on an AI Discovery platform that will leverage advanced AI techniques to facilitate integrated protein structure and function analysis. Combined with existing R&R and Variant Analyzer modules, natural language analysis capabilities and the HYFT-based unified syntactical plus structural methodology, BioStrand’s AI discovery platform will empower researchers to fully analyse their data and gain insights across the entire analysis pipeline, from raw sequencing data to biologically relevant aspects such as diagnostics and drug discovery.

The expansion of BioStrand’s omics platform with these advanced functionalities is crucial to become an ambitious market player and position BioStrand as a one-stop-shop for omics analysis," said Dr. Brands. "We believe that integrating sequence and 3D structure analysis in combination with natural language processing will revolutionize protein structure and function prediction and boost developments in biotechnology and precision medicine. Providing a powerful, integrated, and user-friendly data analysis platform for life sciences researchers is our contribution to ramping up the effectiveness of R&D cycles and enabling the real-time analysis of actionable patient data that will bring precision medicine to the next level. It also takes us one step further in our mission to create a truly effective omics data analysis solution."

The Company also announces the departure of Stefan Lang, Chief Business officer of IPA, effective immediately, and wishes him the best in his future endeavors.

On May 9, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in cell-free, enzymatic DNA production, reported that it will report fiscal 2022 second quarter financial results after market close on Thursday, May 12, 2022 (Press release, Applied DNA Sciences, MAY 9, 2022, View Source [SID1234613909]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. ET that same day. Presentation slides will also be posted to the ‘Company Events’ sub-page of the Company’s Investor Relations website and embedded into the live webcast.

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A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.