1stOncology™: Cancer Intelligence Service – Page 9954 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

XTANDI® (enzalutamide soft capsules) Approved by China NMPA for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer

On November 6, 2020 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that the China National Medical Products Administration (NMPA) has approved XTANDI (enzalutamide soft capsules) for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) with high risk of metastasis (Press release, Astellas, NOV 6, 2020, View Source [SID1234570123]). This is the second approved indication in China for enzalutamide, which is already available for adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT), in whom chemotherapy is not yet indicated.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

The approval is based on results from the PROSPER trial, a double-blind, placebo-controlled, pivotal Phase 3 trial that evaluated enzalutamide plus ADT versus placebo plus ADT in 1,401 men with nmCRPC and rapidly rising prostate-specific antigen levels. PROSPER met its primary endpoint of metastasis-free survival (MFS), with a median MFS of 36.6 months for men who received enzalutamide plus ADT, compared to 14.7 months with placebo plus ADT. Results demonstrated a 71 percent reduction in the risk of radiographic progression or death in men who received enzalutamide plus ADT, compared to placebo plus ADT (hazard ratio=0.29 [95% confidence interval: 0.24-0.35]; p<0.001).

The most common adverse events of any grade for patients ≥10% and higher for enzalutamide plus ADT vs. placebo plus ADT were: fatigue (33% vs. 14%), hot flush (13% vs. 8%), hypertension (12% vs. 5%), nausea (11% vs. 9%), fall (11% vs. 4%), dizziness (10% vs. 4%) and decreased appetite (10% vs. 4%). These results were published in the New England Journal of Medicine in 2018. Results from the study’s overall survival secondary endpoint were published in the New England Journal of Medicine in 2020.

"In order to maintain quality of life for men with non-metastatic prostate cancer, new treatments are needed to delay the progression of prostate cancer and prevent it from spreading to other areas in the body. In clinical studies, enzalutamide significantly reduced the risk of the cancer spreading or death compared to placebo alone," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas.

"Enzalutamide in non-metastatic castration-resistant prostate cancer provides patients and their doctors with an important new option for the treatment of their advancing prostate cancer," said Hiroshi Hamaguchi, President, Greater China Commercial, Astellas. "We look forward to serving more patients and physicians as we expand our work in prostate cancer and continue to grow the Astellas oncology program in China."

Astellas reflected the impact from this approval in its financial forecast of the current fiscal year ending March 31, 2021.

Apollomics, Inc. Closes $124 Million Series C Financing

On November 6, 2020 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies, reported the completion of a $124.2 million Series C Financing led by Ping An Capital with participation from several new and existing investors (Press release, Apollomics, NOV 6, 2020, View Source [SID1234570122]). Dong Liu, PhD nominated by Ping An Capital will also join the Apollomics Board of Directors effective today.

Proceeds from the Series C financing will support the development of the Apollomics pipeline with a focus on the Company’s lead programs: APL-101 and APL-106. APL-101 is a novel, orally administered, selective c-MET inhibitor currently enrolling an international multicenter, Phase 2 portion of a combined Phase 1/2 clinical trial, titled SPARTA. APL-106 (uproleselan) is a first-in-class, targeted E-selectin antagonist that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) in relapsed and refractory acute myeloid leukemia. Apollomics is actively planning to initiate a Phase 1 PK study and, in parallel, a Phase 3 bridging clinical trial in China.

"Apollomics is focused on a precision medicine approach that targets specific mutations, amplifications and resistance mechanisms to bring transformative therapies to cancer patients, said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "We appreciate the profound level of support and interest we received during this financing and welcome several new investors to our shareholder base. With this infusion of capital, we will continue our ambitious plans to progress our current pipeline and expand our programs globally."

Sanjeev Redkar, PhD, Co-Founder and President, added, "Since our founding in 2016, we have established a broad portfolio of single agent and combination programs through our internal research efforts and strategic collaborations. In conjunction with our partners, we now have six assets in over ten clinical trials in the U.S. and China. We are pleased with the progress we have made thus far and expect to maintain this momentum going forward as our pipeline evolves."

Artiva Biotherapeutics and Affimed Announce Platform-to-Platform R&D Collaboration for Targeted Off-the-Shelf NK Cell Therapies

On November 5, 2020 Artiva Biotherapeutics, Inc., and Affimed N.V. (NASDAQ: AFMD), both immuno-oncology companies focused on developing and commercializing therapies utilizing the innate immune system, reported that that they have entered into an exclusive collaboration agreement to assess combining elements of their respective platforms in the generation of targeted, off-the-shelf allogeneic NK cell therapies (Press release, Affimed, NOV 5, 2020, View Source [SID1234615396]).

The R&D collaboration will assess the feasibility and preclinical activity of combinations of Artiva’s allogeneic NK cell product AB-101 and Affimed’s ICE molecules, building on earlier preclinical studies demonstrating synergistic cytotoxic activity. Under the agreement, Affimed’s ICE molecules targeting EGFR and other undisclosed targets will be combined with Artiva’s GMP-grade allogeneic NK cells during the cell manufacturing process. The pre-manufacturing process will include the loading of AB-101 with Affimed ICE molecules prior to cryopreservation, creating specifically targeted allogeneic cells without the requirement for viral transduction. The resulting cryopreserved, off-the-shelf, targeted allogeneic NK cell products will be assessed for anti-tumor activity and development potential. The costs of manufacturing and preclinical assessments will be shared by both companies. The agreement provides for potential further development of selected combination products.

"The combination of Artiva’s highly scaled, optimized NK-cell manufacturing platform with Affimed’s tumor-targeting ICE molecules has the potential for an efficient and flexible therapeutic combination product platform, and preclinical assessments have already demonstrated the potential of this approach," said Tom Farrell, President and CEO of Artiva. "Our NK cells are activated during the manufacturing process resulting in high and consistent expression of innate tumor engagement receptors, including CD16A, making them the ideal platform to combine with tumor-specific targeting ICE from Affimed’s platform."

"The collaboration with Artiva represents a visionary approach which can lead to a new class of drugs providing a potent and targeted innate immune system-cytotoxic response," said Dr. Adi Hoess, Affimed’s Chief Executive Officer. "Our ROCK platform has been proven to rapidly and predictably generate a set of diverse innate cell engagers, with consistent profiles in tumor lysis and safety making our ICE molecules optimally suited for combination therapy with NK cells."

Using its ROCK (Redirected Optimized Cell Killing) platform, Affimed has developed a novel pipeline of ICE products; tetravalent, bispecific therapeutics specific for tumor targets such as epidermal growth factor receptor (EGFR) and CD30 and maintaining high affinity CD16A-binding for enhanced activation of innate immunity, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

Artiva’s AB-101 is a universal NK cell therapy for use in combination with monoclonal antibodies or novel modalities such as NK cell engagers. In preclinical studies, AB-101 has demonstrated enhanced antibody-dependent cellular cytotoxicity with a variety of therapeutic antibodies. The company plans to enter the clinic this year with AB-101, assessing monotherapy safety and efficacy and subsequent therapeutic potential in combination with an anti-CD20 monoclonal antibody for the treatment of relapsed refractory B-cell lymphoma. The first batches of AB-101 drug product, manufactured at very large scale and cryopreserved in infusion-ready media, have already been produced for clinical use.

DXC Technology Reports Second Quarter Fiscal 2021 Results

On November 5, 2020 DXC Technology (NYSE: DXC) reported results for the second quarter of fiscal year 2021 (Press release, DynPort Vaccine Company, NOV 5, 2020, View Source [SID1234574201]). Revenue of $4.55 billion and non-GAAP diluted EPS of $0.64 exceeded the top end of our guidance.

"We delivered strong second quarter results as the ‘new DXC’, exceeding our revenue and non-GAAP diluted EPS targets. We also improved margins sequentially, and achieved a book-to-bill of 1.1x. We are making good progress on the three key areas of our transformation journey, which are: focus on customers, optimize costs, and seize the market," said Mike Salvino, DXC president and chief executive officer.

"We recently closed the sale of our U.S. State and Local Health and Human Services business for $5.0 billion and paid down $3.5 billion of debt, strengthening our balance sheet. We are also on track to close the sale of our Healthcare Provider Software business to Dedalus by the end of this fiscal year. I want to thank our people for driving the momentum and helping us deliver our strong financial results this quarter and their commitment to delivering for our customers."

Financial Highlights – Second Quarter Fiscal 2021

Revenue in the second quarter was $4,554 million.
Net loss was $246 million for the second quarter including pre-tax special items of $265 million in restructuring costs, $101 million in transaction, separation, and integration-related costs, and $152 million in amortization of acquired intangibles.
Non-GAAP net income was $161 million, excluding those special items, net of tax.
Diluted earnings per share was $(0.96) in the second quarter; non-GAAP diluted earnings per share was $0.64.
Net cash provided by operating activities was $472 million in the second quarter.
Adjusted free cash flow was $237 million in the second quarter.
Financial Information by Segment

Global Business Services (GBS)

GBS bookings for the quarter totaled $2.4 billion for a book-to-bill ratio of 1.1x.
GBS revenue was $2,242 million in the quarter. GBS revenue decreased 1.9% year-over-year.
In constant currency, GBS revenues decreased 3.4% year-over-year and increased 0.5% sequentially.
GBS profit margin in the quarter was 14.1%, an increase of 4.2% vs. the prior quarter. Year-over-year, margins were down 1.6%, reflecting prior terminations and price-downs along with customer settlements that were actioned in the quarter, offset by the timing of cost take out initiatives.
Global Infrastructure Services (GIS)

GIS bookings for the quarter was $2.5 billion for a book-to-bill ratio of 1.1x.
GIS revenue was $2,312 million in the quarter. GIS revenues decreased 9.9% year-over-year.
In constant currency, GIS revenues decreased 11.6% year-over-year and decreased 4.0% sequentially.
GIS profit margin in the quarter was 1.6%, an increase of 0.6% vs. the prior quarter. Year-over-year, margins were down 7.9% due to the impact of prior terminations and price-downs along with customer settlements that were actioned in the quarter.
Earnings

EBIT and adjusted EBIT in the quarter were $(235) million and $283 million, respectively. EBIT and adjusted EBIT margins were (5.2)% and 6.2%, respectively. Adjusted EBIT margin in the quarter was better than anticipated, benefiting from our cost optimization initiatives.
Diluted EPS and non-GAAP diluted EPS were $(0.96) and $0.64, respectively, in the quarter. Diluted EPS and non-GAAP diluted EPS were impacted by a lower than expected tax rate of 24.1%.
Cash Flow

Net cash provided by operating activities was $472 million in the second quarter and adjusted free cash flow was $237 million. Operating cash flow and adjusted free cash flow benefited from working capital management. Adjusted free cash flow also benefited from lower capital expenditures during the quarter.
Earnings Conference Call and Webcast

DXC Technology senior management will host a conference call and webcast to discuss these results today at 4:45 p.m. EST. The dial-in number for domestic callers is 800-367-2403. Callers who reside outside of the United States should dial +1-334-777-6978. The passcode for all participants is 8144357. The webcast audio and any presentation slides will be available on DXC Technology’s Investor Relations website.

A replay of the conference call will be available from approximately two hours after the conclusion of the call until November 12, 2020. The replay passcode is 8144357.

Gritstone Oncology Reports Third Quarter Financial Results and Recent Highlights

On November 5, 2020 Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, reported financial results for the third quarter ended September 30, 2020 and reviewed business highlights (Press release, Gritstone Oncology, NOV 5, 2020, View Source [SID1234573684]).

"This year we have made important clinical and scientific progress in advancing our two immunotherapies, GRANITE and SLATE," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. "Recently, we began enrolling cancer patients in Phase 2 expansion cohorts for both programs. These cohorts are designed to build upon the evidence of clinical benefit seen in our Phase 1 studies, and we are expanding at dose level four, the highest dose level studied in Phase 1, which continues to be well-tolerated by patients. Our clinical work has confirmed the differentiated ability of our vaccine vectors to consistently drive robust CD8 T cell responses specific to administered antigens. Our clinical work with SLATE has demonstrated that certain antigens are immunodominant and can drive focused immune responses. With our strategy to develop two versions of an off-the-shelf cassette, we can be more specific to a patient’s mutations and address this phenomenon prospectively, ensuring that dominant neoantigens are not permitted to impair immune responses to other neoantigens."

Select Accomplishments

Presented preliminary efficacy, immunogenicity, and safety data up to dose level 3 from the ongoing Phase 1 study evaluating GRANITE in combination with immune checkpoint blockade for the treatment of patients with advanced solid tumors, including microsatellite stable colorectal cancer (MSS-CRC), gastroesophageal (GEA) cancer, metastatic non-small cell lung cancer (NSCLC), and bladder cancer
• Demonstrated consistent, strong neoantigen-specific CD8+ T cells generated in all patients tested and evidence of clinical benefit, as well as a favorable safety profile
Presented the same data types from the Phase 1 study evaluating SLATE in combination with immune checkpoint blockade for the treatment of patients with metastatic NSCLC, pancreatic ductal adenocarcinoma and MSS-CRC, as well as in patients with other solid tumor types who have relevant mutation/human leukocyte antigen (HLA) combinations
• Induced CD8+ T cells against multiple KRAS driver mutations, with the most pronounced response against immunodominant neoantigens such as TP53mut, and demonstrated a favorable safety profile
Initiated single-arm Phase 2 expansion cohorts with GRANITE for patients with MSS CRC who have progressed on FOLFOX/FOLFIRI therapy and a second cohort for patients with GEA who have progressed on chemotherapy
Initiated single-arm Phase 2 expansion cohorts with SLATE v1 in NSCLC patients with relevant KRAS mutations who have progressed on prior immunotherapy, and patients with tumors where a relevant TP53 mutation exists
Anticipated Upcoming Milestones

Nominate a lead bispecific antibody development candidate directed towards a novel solid tumor-specific HLA-peptide complex by the end of 2020
Present additional efficacy and safety data from the Phase 1 GRANITE study, including at the higher GRANITE dose level, in the first half of 2021
Present data from Phase 2 SLATE cohorts (v1 cassette) in the first half of 2021
Launch a SLATE v2 cassette into clinical trials in NSCLC patients in the first half of 2021, optimized for KRAS neoantigens (leveraging insights into immunodominance derived from v1 cassette)
Present data from Phase 2 GRANITE cohorts in the second half of 2021
Report data from SLATE v2 cassette in the second half of 2021
Third Quarter 2020 Financial Results
For the three months ended September 30, 2020, Gritstone reported a net loss of $26.1 million, compared to a net loss of $27.5 million for the three months ended September 30, 2019.

Collaboration revenue was $0.8 million for the three months ended September 30, 2020, compared to $1.0 million for the three months ended September 30, 2019. Collaboration revenue was due to the Research Collaboration and License Agreement with bluebird bio Inc and another small collaboration agreement.

Total research and development expenses were $22.1 million for the three months ended September 30, 2020, compared to $24.9 million for the three months ended September 30, 2019. The decrease was primarily attributable to a decrease in milestone and license payments and outside services and consultants, offset by increases in manufacturing-related expenses, lab supplies and research and development personnel.

General and administrative expenses were $5.0 million for the three months ended September 30, 2020, compared to $4.6 million for the three months ended September 30, 2019. The increase was primarily attributable to an increase in personnel-related expenses.

Cash, cash equivalents, marketable securities and restricted cash were $72.1 million as of September 30, 2020, compared to $128.8 million as of December 31, 2019.