On August 5, 2020 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today provided a corporate and financial update for the second quarter ended June 30, 2020 (Press release, G1 Therapeutics, AUG 5, 2020, View Source [SID1234562917]).

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"We made substantial progress on a number of fronts in the first half of 2020, and sharpened our focus on bringing trilaciclib to patients in 2021. By forging four strategic collaborations and securing a flexible credit facility, we have achieved three important objectives: positioning G1 for a strong commercial launch of trilaciclib in the United States, providing global access to our therapies, and securing non-dilutive capital to support the continued development of trilaciclib in additional indications," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "We are now executing a comprehensive launch strategy for trilaciclib designed to raise awareness of the burden that chemotherapy-induced myelosuppression places on patients and the healthcare system, as well as implementing a robust development plan to evaluate the benefits of trilaciclib in additional tumor types and chemotherapy regimens."

Regulatory, Clinical and Corporate Highlights

NDA for trilaciclib in small cell lung cancer (SCLC) submitted in June 2020. Pending acceptance, the company expects to receive a PDUFA date assignment by the U.S. Food and Drug Administration (FDA) in August 2020. Trilaciclib has been assigned Breakthrough Therapy Designation by the FDA.

Entered into co-promotion agreement with Boehringer Ingelheim for trilaciclib in SCLC in the United States and Puerto Rico. Under the terms of the three-year agreement, G1 and Boehringer Ingelheim will collaborate on the commercialization of trilaciclib for its first potential indication in SCLC. G1 will lead marketing, market access and medical engagement initiatives, with Boehringer Ingelheim leading sales force engagement initiatives. G1 will book revenue and retain development and commercialization rights to trilaciclib (press release here).

Partnered with Simcere to develop and commercialize trilaciclib in Greater China. The company entered into an exclusive agreement with Simcere Pharmaceuticals Group for the development and commercialization of trilaciclib for all indications in Greater China (mainland China, Hong Kong, Macau, and Taiwan). Under the terms of the agreement, G1 received a $14 million upfront payment and is eligible to receive sales-based royalties and up to $156 million in potential milestone payments (press release here). As part of this agreement, the company will collaborate with Simcere on future clinical trials. G1 and Simcere will be responsible for all development and commercialization costs in their respective territories.

I-SPY 2 neoadjuvant breast cancer trial including trilaciclib initiated in 2Q20. Trilaciclib was selected for inclusion in the ongoing Phase 2 I-SPY 2 TRIAL, based on compelling overall survival findings in a Phase 2 triple-negative breast cancer (TNBC) trial (press release here). The I-SPY trial will generate data across a range of breast cancer subtypes that will allow the company to evaluate trilaciclib in combination with several broadly-used chemotherapy classes and an anti-PD-1 immunotherapy.

Rintodestrant and Ibrance combination trial initiated in 2Q20. The company previously announced preliminary safety, tolerability and efficacy data on rintodestrant, its oral selective estrogen receptor degrader (SERD) (press release here) as monotherapy treatment for ER+, HER2- breast cancer. Based on these findings, G1 initiated an additional arm of its ongoing Phase 1/2a trial to evaluate the combination regimen of rintodestrant and the CDK4/6 inhibitor Ibrance (palbociclib). Palbociclib is being provided by Pfizer Inc. under a non-exclusive clinical supply agreement.

Out-licensed global development and commercialization rights to lerociclib. The company entered into separate, exclusive agreements with EQRx (rights for U.S., Europe, Japan, and all markets outside Asia-Pacific) and Genor Biopharma (rights for Asia-Pacific, excluding Japan) for the development and commercialization of lerociclib in all indications. Combined, these agreements provided $26 million in upfront payments to G1, along with sales-based royalties and up to $330 million in potential milestone payments (see press releases on EQRx agreement and Genor agreement). EQRx and Genor are responsible for all costs related to the development and commercialization of lerociclib in their respective territories.

Out-licensed global development and commercialization rights to preclinical CDK2 inhibitor compounds. The company entered into an exclusive license agreement with ARC Therapeutics for global development and commercialization rights to its preclinical CDK2 inhibitor compounds. Under the terms of the agreement, G1 received an upfront payment and equity in ARC with an aggregate value of approximately $2.1 million. The company is also entitled to receive an additional milestone payment and sales-based royalties, and has right of first negotiation to re-acquire these assets.

Secured flexible credit financing for up to $100 million. The company announced it had entered into a debt financing agreement for up to $100 million with Hercules Capital, Inc. G1 has accessed $20 million to support the development and commercialization of trilaciclib (press release here).

Second Quarter 2020 Financial Highlights and 2020 Guidance

Cash Position: Cash and cash equivalents totaled $234.3 million as of June 30, 2020, compared to $269.2 million as of December 31, 2019.

License Revenue: License revenues were $2.1 million for the second quarter of 2020, related to the license of CDK2 inhibitor compounds to ARC Therapeutics.

Operating Expenses: Operating expenses were $33.0 million for the second quarter of 2020, compared to $32.6 million for the second quarter of 2019. GAAP operating expenses include stock-based compensation expense of $4.4 million for the second quarter of 2020, compared to $3.7 million for the second quarter of 2019.

Research and Development Expenses: Research and development (R&D) expenses for the second quarter of 2020 were $18.5 million, compared to $23.5 million for the second quarter of 2019. The decrease in R&D expenses was primarily due to a decrease in clinical program costs of $3.4 million and regulatory filing reimbursement received during the second quarter of 2020 for $3.0 million, offset by an increase in costs for manufacturing active pharmaceutical ingredients.

General and Administrative Expenses: General and administrative (G&A) expenses for the second quarter of 2020 were $14.4 million, compared to $9.1 million for the second quarter of 2019. The increase in G&A expenses was largely due to an increase in compensation due to additional headcount, increase in pre-commercialization activities, increase in medical affairs costs, and an increase in professional fees and other administrative costs necessary to support our operations.

Net Loss: G1 reported a net loss of $31.2 million for the second quarter of 2020, compared to $30.7 million for the second quarter of 2019.

2020 Guidance: The company is increasing its previous financial guidance and expects to end 2020 with $185-$200 million in cash and cash equivalents, up from previous guidance of $110-$130 million. This guidance includes receipt of upfront payments from recent agreements, but does not include consideration of potential additional proceeds from partnerships, collaboration activities, and/or other sources of capital.

Key Anticipated 2020 Milestones

NDA acceptance/PDUFA date assignment for trilaciclib in SCLC in August 2020.

Initiate Phase 3 clinical trial of trilaciclib in colorectal cancer in 4Q20.

Presentation of Phase 2 data of trilaciclib in triple-negative breast cancer in 4Q20.

Presentation of additional rintodestrant monotherapy data in 4Q20.

Webcast and Conference Call

The management team will host a webcast and conference call at 5:00 p.m. ET today to provide a corporate and financial update for the second quarter 2020 ended June 30, 2020. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 4648036. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

On August 5, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with severe diseases including solid tumors, hematologic cancers and autoimmune disease, reported financial results for the second quarter ended June 30, 2020 and recent business highlights (Press release, Atara Biotherapeutics, AUG 5, 2020, View Source [SID1234562916]).

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"I am proud of the continued tremendous progress made by Atara’s team in delivering on our strategic priorities and on our mission to bring transformative therapies to patients with severe diseases," said Pascal Touchon, President and Chief Executive Officer of Atara. "We remain on track to initiate a BLA submission for tab-cel for patients with EBV+ PTLD by the end of 2020, despite the COVID-19 outbreak. During the quarter we also reported positive ATA188 clinical data in progressive multiple sclerosis at EAN, successfully completed a follow-on financing, made key executive and board hires, and progressed our CAR T programs closer to the clinic."

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel (tabelecleucel)

Post-transplant lymphoproliferative disease (PTLD)

Atara remains on track to initiate a biologics license application (BLA) submission for patients with EBV+ PTLD by the end of 2020.

The Company continues to advance development of tab-cel in Phase 3 for patients with EBV+ PTLD, for which the Company has obtained Breakthrough Therapy Designation (BTD) in the United States (U.S.) and PRIority MEdicines (PRIME) designation in the European Union (EU).

The Company plans to conduct an interim analysis of the tab-cel Phase 3 study in the third quarter of 2020 and then discuss the totality of tab-cel data with the U.S. Food and Drug Administration (FDA) in a pre-BLA meeting prior to initiating the BLA submission.

Atara is in active discussions with the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) regarding a Pediatric Investigation Plan (PIP). Following discussion with the PRIME team and after EMA approval of the PIP, Atara plans to submit an EU marketing authorization application (MAA) for patients with EBV+ PTLD in 2021.

In the U.S., Europe and Australia, more than 40 clinical study sites are available for enrollment, with new sites in Spain, Austria and Belgium.

Given the severity of previously treated PTLD, time sensitivity for treatment and promising clinical results to date with tab-cel, Atara continues to provide tab-cel to patients in need under its expanded access protocol (EAP) and single patient use (SPU) programs.

Tab-cel Potential Additional Indications

Atara remains on track to initiate enrollment in the second half of 2020 in a tab-cel Phase 2 multi-cohort study, enriching the evidence base with the goal of expanding the potential label in PTLD and closely related diseases.

Atara will focus on extending further into IA-LPDs (immunodeficiency-associated lymphoproliferative diseases) as the next step in the tab-cel potential label expansion given the commonality of their EBV-driven mechanism of disease in immunocompromised patients, high unmet medical need and positive clinical data to date with tab-cel.

The multi-cohort study will evaluate both treatment-naïve and previously treated patients in six patient populations, including within IA-LPDs, two cohorts addressing front-line EBV+ PTLD patients with significant unmet need as well as two cohorts addressing EBV+ LPDs arising out of primary or acquired immune deficiencies including AID-LPD and PID-LPD (EBV+ acquired immunodeficiency-associated lymphoproliferative disease and EBV+ primary immunodeficiency-associated lymphoproliferative disease).

Altogether these populations represent an additional few thousand patients with addressable EBV-driven diseases in the U.S. alone.

Previously reported clinical data from ASH (Free ASH Whitepaper) (2018) and ESMO (Free ESMO Whitepaper) (2018) suggest that tab-cel may provide benefit for patients with other EBV-driven diseases. Atara will publish tab-cel efficacy and safety data in AID-LPD and PID-LPD in an e-poster accepted at ESMO (Free ESMO Whitepaper) 2020.

Based on a strategic prioritization to expand tab-cel business potential through the significant opportunity in IA-LPDs, the Company will now focus its tab-cel efforts on the initiation of the multi-cohort Phase 2 study and the planned BLA initiation in EBV+ PTLD.

The Company’s Phase 1b study of tab-cel in combination with anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC) achieved its safety endpoints and stable disease in a subset of patients. These data will be presented at an appropriate forum in the future.
At this time, Atara will not initiate the Phase 2 portion of the NPC study in combination with pembrolizumab but will generate additional translational data in NPC to further inform the Company’s strategy for this patient population.

ATA188 for Progressive Multiple Sclerosis (MS)

Atara’s Phase 1a clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive forms of MS is ongoing across clinical sites in the U.S. and Australia.

Safety and sustained disability improvement (SDI) 12-month data for cohorts 1-3, and six-month data for cohort 4, were presented at the 2020 European Academy of Neurology Virtual Congress (EAN) held in May 2020.

All patients in cohorts 1-3 showing SDI at six months maintained improvement at 12 months and there was a higher proportion of patients showing SDI with increasing dose. SDI is defined as clinically significant improvement in Expanded Disability Status Scale (EDSS) or timed 25-foot walk (T25FW) observed at two consecutive time points. While these data will need to be confirmed in a double-blind, placebo-controlled, randomized study, they indicate the potential for the first treatment option in progressive MS to halt or reverse the progression of disease. These results align with the body of evidence supporting the important role of EBV-infected B cells in the chronic autoimmune pathology of MS.

ATA188 was well-tolerated in patients with progressive forms of MS and no dose-limiting toxicities and no fatal adverse events (AEs) have been reported. ATA188 treatment showed no clinically meaningful effect on cytokine levels and no dose-related safety trends were identified. Rhinorrhea (runny nose) is the only treatment-related event that occurred in more than one subject.

Atara expects to present 12-month clinical results for cohort 4 at an appropriate forum in the second half of 2020.

Atara is re-treating patients in the open-label extension (OLE) of the Phase 1a study and expects to present preliminary OLE data, at an appropriate forum in the second half of 2020.

Based on the promising data presented at EAN, the cohort 3 dose from the Phase 1a study was selected for the double-blind, randomized placebo-controlled study evaluating the efficacy and safety of ATA188 in patients with progressive forms of MS. The study design allows for addition of the cohort 4 dose, if desired, based on the 12-month data for cohort 4 that will be available in the third quarter of 2020.

The study enrolled its first patient in June 2020. In addition to measuring change in disability measures compared to baseline, especially sustained disability improvement over time, the study will also include multiple measures of patients’ function as well as various biomarkers.

CAR T Programs

ATA2271/ATA3271 (Solid tumors)

Atara’s next generation CAR T immunotherapy programs include autologous ATA2271 targeting mesothelin–a tumor antigen expressed on a number of solid tumors including mesothelioma, ovarian cancer, pancreatic cancer, non-small cell lung cancer, and other tumors over-expressing mesothelin.

ATA2271 is designed to improve efficacy, persistence, and durability of response versus CD28/CD3z-based CARs in using a novel 1XX CAR co-stimulatory signaling domain and cell intrinsic checkpoint inhibition technology with a PD-1 dominant negative receptor (DNR).

Data from IND-enabling studies for ATA2271 were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II in June 2020. These data support the first application of the combination of 1XX CAR co-stimulatory domain and cell intrinsic checkpoint inhibition technology with a PD-1 DNR, that are associated with less cell exhaustion, improvements in functional persistence, serial cell killing, and in vivo efficacy which was maintained through multiple tumor re-challenges when compared with first-generation CD28/CD3z-based mesothelin CAR.

ATA2271 collaborators at Memorial Sloan Kettering Cancer Center (MSK) recently submitted an Investigational New Drug (IND) application to the FDA for patients with advanced mesothelioma.

Atara is also developing and has initiated IND-enabling studies for ATA3271, an off-the-shelf, allogeneic CAR T immunotherapy targeting mesothelin using its novel combination of 1XX CAR co-stimulatory signaling domain and cell intrinsic checkpoint inhibition technology with a PD-1 DNR through its EBV T-cell platform.

ATA3219 (B-cell)

Atara is developing ATA3219, an off-the-shelf, allogeneic CD19 CAR T immunotherapy targeting B-cell malignancies as a potential best-in-class therapy using the next-generation 1XX CAR co-stimulatory domain and EBV T-cell platform. Atara intends to leverage the differentiation of 1XX and allogeneic EBV T cell to address remaining unmet need despite currently approved autologous CD19 CAR T and other allogeneic CD19 cell therapies in development.

Findings from an academic, off-the-shelf, allogeneic CD19 CAR T clinical study using an allogeneic EBV T-cell construct and CD28/CD3z co-stimulatory domain for patients with relapsed/refractory B-cell malignancies provided initial clinical proof-of-principle that an EBV T-cell platform has the potential to generate off-the-shelf, allogeneic CAR T immunotherapies with high response rates, durable responses, and low risk of toxicity. These results were presented in February at the 2020 Transplantation and Cellular Therapy Meetings.

The Company has initiated IND-enabling studies for ATA3219 and anticipates filing an IND in 2021.

Operations

Atara continues to advance key elements of its off-the-shelf, allogeneic T-cell immunotherapy platform.

Atara is completing the manufacturing process validation activities for tab-cel while building inventory according to its commercial product supply strategy.

Atara continues to scale its EBV T-cell manufacturing platform to improve product yields from a single donor leukapheresis. The Company has generated data confirming the use of stirred-tank perfusion bioreactors to improve yield and cell growth productivity.

These data confirm that ATA188 can be manufactured in stirred-tank perfusion bioreactors, with the potential to produce up to 40,000 doses per donor leukapheresis.

Atara’s scale-up technology is a key enabler to deliver biologic-like cost of goods manufactured and will be leveraged across its portfolio, including the Company’s CAR T programs.

Despite the challenges of the COVID-19 environment, Atara continues to consistently deliver product from inventory to clinical sites on time.

Executive and Board Appointments

Two scientific leaders in the field of cell and gene therapy recently joined Atara in its mission to leverage its novel, allogeneic EBV T-cell platform to develop transformative therapies for patients with severe diseases:

Jakob Dupont, M.D. was named Executive Vice President, Global Head of R&D. He possesses deep and diverse expertise from cell therapy research to oncology clinical development and global regulatory approvals. Dr. Dupont joined Atara from Gossamer Bio where he served as Chief Medical Officer, and held previous roles at Genentech/Roche and OncoMed. At Memorial Sloan Kettering Cancer Center (MSK), Dr. Dupont served on faculty and worked in the laboratories of Richard O’Reilly, M.D., the scientific inventor of tab-cel, and Michel Sadelain, M.D., Ph.D, Atara’s collaborator on multiple next generation CAR T programs.

Maria Grazia Roncarolo, M.D. was appointed to the Board of Directors. Dr. Roncarolo holds several professorships and director roles at Stanford University, and in 2014 established the Stanford Center for Definitive and Curative Medicine. The center is dedicated to the development of innovative stem cell and gene therapies for patients with currently incurable diseases. Dr. Roncarolo is one of the world’s leading experts in immunology and T cells and has a record of translating scientific discoveries in cell and gene therapy into novel treatments.

Second Quarter 2020 Financial Results

Cash, cash equivalents and short-term investments as of June 30, 2020 totaled $347.7 million, as compared to $214.6 million as of March 31, 2020.

June 30, 2020 cash balance of $347.7 million included aggregate net proceeds of $189.3 million from the sale of 14,958,039 shares of common stock and pre-funded warrants to purchase 2,866,961 shares of common stock in May and June of 2020 in an underwritten public offering, including the full exercise of the option to purchase additional shares by the underwriters.

Atara believes that its cash, cash equivalents and short-term investments as of June 30, 2020 are sufficient to fund planned operations into 2022.

Net cash used in operating activities was $56.6 million for the second quarter of 2020, as compared to $54.6 million for the same period in 2019.

The number of outstanding shares of common stock and pre-funded common stock warrants as of June 30, 2020 was 74,307,894 shares and warrants to purchase 5,755,487 shares, respectively.

Atara reported net losses of $77.5 million, or $1.14 per share, for the second quarter of 2020, as compared to $74.3 million, or $1.60 per share, for the same period in 2019.

Total operating expenses include non-cash expenses of $15.9 million for the second quarter 2020, as compared to $16.9 million for the same period in 2019.

Research and development expenses were $61.6 million for the second quarter of 2020, as compared to $52.3 million for the same period in 2019. The increase in the 2020 period was due to costs associated with the Company’s continuing expansion of research and development activities, including:

Clinical study, manufacturing and process performance qualification activities related to tab-cel.

Higher employee-related costs from increased headcount.

Research and development expenses include $8.5 million of non-cash stock-based compensation expenses for the second quarter of 2020, as compared to $6.7 million for the same period in 2019.

General and administrative expenses were $16.4 million for the second quarter of 2020, as compared to $23.3 million for the same period in 2019. The decrease in the 2020 period was primarily due to a decrease in outside services costs and non-cash stock-based compensation expenses.

General and administrative expenses include $5.4 million of non-cash stock-based compensation expenses for the second quarter of 2020, as compared to $8.5 million for the same period in 2019.

On August 5, 2020 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported financial results for its fiscal third quarter ended June 30, 2020 (Press release, Arrowhead Research Corporation, AUG 5, 2020, View Source [SID1234562915]). The company is hosting a conference call at 4:30 p.m. EDT to discuss results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 6856804.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 6856804.

Selected Recent Events

Earned a $20 million milestone payment from Amgen following the administration of the first dose of AMG 890, formerly referred to as ARO-LPA, in a Phase 2 clinical study

Hosted a key opinion leader webinar on ARO-ENaC, the company’s investigational RNAi therapeutic being developed as a treatment for patients with cystic fibrosis

Completed dosing in healthy volunteer cohorts in AROHSD1001, a Phase 1/2 clinical study of ARO-HSD, the company’s investigational RNAi therapeutic being developed as

a treatment for patients with alcohol related and nonalcohol related liver diseases, such as nonalcoholic steatohepatitis

Completed dosing of the first sequential cohort and collected the first 6-month repeat biopsy in the AROAAT2002 study, a pilot open-label, multi-dose, Phase 2 study to assess changes in a novel histological activity scale in response to ARO-AAT over time in patients with alpha-1 antitrypsin deficiency associated liver disease

Completed planned enrollment and dosing of 93 subjects in AROANG1001, a Phase 1/2 clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic being developed for the treatment of mixed dyslipidemia

Completed planned enrollment and dosing of 80 subjects in AROAPOC31001, a Phase 1/2 clinical study of ARO-APOC3, the company’s investigational RNAi therapeutic being developed for the treatment of hypertriglyceridemia, and expanded the study to include up 112 subjects

On August 5, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported it has entered into an exclusive worldwide license agreement with Mirati Therapeutics, Inc. (Nasdaq: MRTX), a leading targeted oncology company dedicated to advancing novel therapeutics (Press release, ORIC Pharmaceuticals, AUG 5, 2020, View Source [SID1234562914]). ORIC will have exclusive worldwide rights for the development activities and commercialization of a small molecule allosteric inhibitor program directed towards the polycomb repressive complex 2 (PRC2), a validated oncogenic target across several cancers with promising therapeutic potential in prostate cancer, among other indications.

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"We are excited to add another program to our pipeline that is well aligned with our mission of overcoming cancer resistance and our expertise in hormone-dependent cancers, key tumor dependencies and precision oncology," said Jacob Chacko, M.D., president and chief executive officer of ORIC. "Our lead program, ORIC-101, and the rest of our innovative, wholly-owned pipeline of precision medicines have thus far been internally generated by our fully integrated drug discovery and development team. This PRC2 inhibitor is the first externally sourced program we’ve added to our pipeline and, based on work conducted at ORIC, we believe Mirati’s novel approach in targeting PRC2 may address an area of significant unmet medical need in treatment-resistant prostate cancer."

"We are pleased to enter into this agreement with ORIC, which enables the continued advancement of Mirati’s PRC2 inhibitors" said James G. Christensen, Ph.D., executive vice president and chief scientific officer of Mirati. "With ORIC’s focus on novel treatments for prostate cancer, ORIC is an ideal partner to further the research and development of this program."

Mirati has developed highly selective allosteric inhibitors of PRC2, including a lead candidate now designated as ORIC-944, that target its regulatory embryonic ectoderm development (EED) subunit and may represent a best-in-class approach for the treatment of advanced prostate cancer. Prior to entering into the license agreement with Mirati, ORIC generated compelling in vivo efficacy data in enzalutamide-resistant prostate cancer models with ORIC-944. ORIC expects to file an IND for ORIC-944 in the second half of 2021.

Under the terms of the agreement, in exchange for an exclusive worldwide license to develop and commercialize Mirati’s PRC2 inhibitor program, ORIC paid to Mirati a one-time non-cash payment of $20 million in shares of ORIC common stock. The number of shares issued to Mirati was based on a price of $34.00 per share, representing a premium of 10% to the 60-day trailing volume-weighted average trading price of ORIC’s common stock. ORIC is not subject to any future milestone or royalty payment obligations to Mirati.

Webcast and Conference Call

ORIC will host a webcast and conference call today, August 5th, at 4:30 p.m. ET. To participate in the conference call, please dial (866) 393-4306 (domestic) or (734) 385-2616 (international) and refer to conference ID: 5167646. Please join the conference call at least 15 minutes early to register. A live webcast will be available in the Investors section of the company’s website at www.oricpharma.com. The webcast will be archived for 60 days following the presentation.

About PRC2

The polycomb repressive complex 2 (PRC2) has methyltransferase activity required for long term epigenetic silencing of chromatin and plays a critical role in cancer. PRC2 core subunits EED, EZH2, and SUZ12 function as part of a complex to selectively repress gene expression by regulating the transfer of methyl groups to a distinct lysine residue on histone proteins associated with DNA. Overexpression and/or mutations in PRC2 can result in aberrant methylation activity, leading to tumorigenesis in multiple solid tumors and hematological malignancies. In particular, PRC2 dysfunction can lead to decreased expression of tumor suppressor genes and other target genes that have been associated with poor prognosis in patients with metastatic prostate cancer.

First-generation PRC2 inhibitors, which target the catalytic EZH2 subunit, have demonstrated clinical activity in several cancers, and one has been approved by the FDA for the treatment of epithelioid sarcoma and follicular lymphoma. More recent scientific advances have focused on developing allosteric inhibitors of PRC2, which may help to address several limitations of first-generation PRC2 inhibitors. Research conducted at ORIC demonstrated that allosteric inhibitors of PRC2 are more efficacious in treatment-resistant prostate cancer models than has been reported by traditional non-allosteric PRC2 inhibitors.

On August 5, 2020 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the company will present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 12, 2020, at 1:45 p.m. ET/10:45 a.m. PT (Press release, Alpine Immune Sciences, AUG 5, 2020, View Source [SID1234562913]).

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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

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A live webcast of the presentation will be available online in the investor relations section of the company’s website at View Source A replay of the presentation will be available on the company website for 90 days following the webcast.