On August 9, 2021 AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) reported that Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1) (Press release, AstraZeneca, AUG 9, 2021, View Source [SID1234586068]).

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At a planned interim analysis, the Independent Data Monitoring Committee (IDMC) concluded that DESTINY-Breast03 met the primary endpoint of progression-free survival (PFS) showing a highly statistically significant and clinically meaningful improvement for patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

In DESTINY-Breast03, Enhertu also showed a strong trend toward improved overall survival (OS) compared to T-DM1 in a key secondary endpoint, although the OS data are still immature. The safety profile of Enhertu was consistent with previous clinical trials, with no new safety concerns identified and no Grade 4 or 5 treatment-related interstitial lung disease events.

Susan Galbraith, Executive Vice President, Oncology R&D, said: "There is a continued need for new options and better outcomes for patients with HER2-positive metastatic breast cancer who often experience disease progression after initial treatment with available standards of care. These transformative progression-free survival results demonstrate the superiority of Enhertu compared to T-DM1, and the encouraging safety data may open future opportunities to bring this benefit to patients in earlier treatment settings."

Ken Takeshita, Global Head, Research and Development, Daiichi Sankyo, said: "DESTINY-Breast03 is the first global Phase III head-to-head trial of Enhertu against an active control and supports the potential of this medicine to become the new standard of care for patients with HER2-positive metastatic breast cancer following initial treatment with trastuzumab and a taxane. We believe this highly sophisticated and specifically engineered ADC is fulfilling its promise to reshape the treatment of HER2-positive metastatic breast cancer, with the goal to move into earlier lines of treatment for HER2-positive breast cancer and many other HER2-expressing tumour types across our broad clinical trial programme."

The data will be presented at an upcoming medical meeting and shared with health authorities.

Enhertu is approved for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting in the US, Japan, the EU and several other countries based on the results from the DESTINY-Breast01 trial.

Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.

HER2-positive breast cancer
Breast cancer remains the most common cancer and is one of the leading causes of cancer-related deaths in women worldwide.1 More than two million patients with breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately one in five patients with breast cancer are considered HER2-positive.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast, gastric, lung and colorectal cancers.3 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and a poor prognosis in breast cancer.4

Despite initial treatment with trastuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression.5 More effective options are needed to further delay progression and extend survival.5-7

DESTINY-Breast03
DESTINY-Breast03 is a global head-to-head, randomised, open-label, registrational Phase III trial evaluating the safety and efficacy of Enhertu (5.4mg/kg) versus T-DM1 in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The primary efficacy endpoint of DESTINY-Breast03 is PFS based on blinded independent central review. Secondary efficacy endpoints include OS, objective response rate, duration of response, clinical benefit rate, PFS based on investigator assessment and safety.

DESTINY-Breast03 enrolled approximately 500 patients at multiple sites in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in Canada, the EU, Israel, Japan, the UK and the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the results from the DESTINY-Breast01 trial.

Enhertu (6.4mg/kg) is also approved in Israel, Japan and the US for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

Enhertu development programme
A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Enhertu was highlighted in the Clinical Cancer Advances 2021 report as one of two significant advancements in the "ASCO Clinical Advance of the Year: Molecular Profiling Driving Progress in GI Cancers," based on data from both the DESTINY-CRC01 and DESTINY-Gastric01 trials, as well as one of the targeted therapy advances of the year in non-small cell lung cancer (NSCLC), based on the interim results of the HER2-mutated cohort of the DESTINY-Lung01 trial.

In May 2020, Enhertu also received Breakthrough Therapy Designation for the treatment of patients with metastatic NSCLC whose tumours have a HER2-mutation and with disease progression on or after platinum-based therapy.

Daiichi Sankyo collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and the next-generation oral SERD and potential new medicine AZD9833.

PARP inhibitor, Lynparza (olaparib) is a targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease.

Building on the first approval of Enhertu, a HER2-directed ADC, in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings. To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi (durvalumab) in combination with other oncology medicines, including Lynparza and Enhertu, investigating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On August 9, 2021 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, reported financial results for the second quarter ended June 30, 2021 (Press release, Allakos, AUG 9, 2021, View Source [SID1234586108]).

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Recent Accomplishments

Presented new data at Digestive Disease Week (DDW) 2021 suggesting eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) is significantly underdiagnosed and may be a common cause of moderate-to-severe gastrointestinal symptoms. Forty-five percent (45%, 181/405) of patients with chronic functional gastrointestinal symptoms who underwent upper endoscopy with biopsy met the diagnostic criteria for EG/EoD.
Completed patient enrollment in Phase 3 EG/EoD and Phase 2/3 eosinophilic esophagitis (EoE) clinical trials of lirentelimab (AK002).
Upcoming 2021 Milestones

Topline data from a randomized, double-blind, placebo-controlled Phase 3 study of lirentelimab in patients with EG/EoD expected in the fourth quarter of 2021.
Topline data from a randomized, double-blind, placebo-controlled Phase 2/3 study of lirentelimab in patients with EoE expected in the fourth quarter of 2021.
Initiation of a randomized, double-blind, placebo-controlled Phase 2/3 study of subcutaneous lirentelimab in patients with EG and/or EoD expected in the second half of 2021.
Initiation of a Phase 2 study in a non-eosinophilic gastrointestinal disease in the second half of 2021.
Second Quarter 2021 Financial Results

Research and development expenses were $41.0 million in the second quarter of 2021 as compared to $28.3 million in the same period in 2020, an increase of $12.7 million.

General and administrative expenses were $16.2 million in the second quarter of 2021 as compared to $12.1 million in the same period in 2020, an increase of $4.1 million.

Allakos reported a net loss of $57.2 million in the second quarter of 2021 as compared to $39.3 million in the same period in 2020, an increase of $17.9 million. Net loss per basic and diluted share was $1.07 for the second quarter of 2021 compared to $0.80 in the same period in 2020.

Allakos ended the second quarter of 2021 with $559.7 million in cash, cash equivalents and marketable securities.

On August 9, 2021 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the second quarter ended June 30, 2021 and provided pipeline updates (Press release, AnaptysBio, AUG 9, 2021, View Source [SID1234586124]).

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"We continue to make progress in advancing our wholly-owned pipeline and look forward to multiple clinical data readouts over the upcoming 18 months," said Hamza Suria, president and chief executive officer of AnaptysBio. "The recent approval of JEMPERLI, which is the first AnaptysBio-generated antibody to be approved in the US and EU, validates AnaptysBio’s antibody discovery platform and provides additional revenues to support our capital-efficient business model."

Imsidolimab (Anti-IL-36 Receptor) Program

Following an end-of-Phase 2 meeting with the FDA in Q2, we publicly disclosed trial designs for our imsidolimab generalized pustular psoriasis (GPP) Phase 3 trials, called GEMINI-1 and GEMINI-2. We anticipate initiating GEMINI-1 in Q3 2021. The primary endpoint of our Phase 3 program is the proportion of patients achieving clear or almost clear skin as determined by a Generalized Pustular Psoriasis Physician’s Global Assessment (GPPPGA) score of zero or 1 at week 4 of GEMINI-1, while GEMINI-2 is designed for 6 months of safety follow-up assessment.
We continue to enroll GPP patients in our worldwide registry of GPP patients, called RADIANCE, which is designed to improve our understanding of GPP patient journeys and support enrollment of our GEMINI Phase 3 trials. Medical claims analyses recently conducted by IQVIA indicate approximately 37,000 unique patients were diagnosed with GPP at least once, and approximately 15,000 unique patients were diagnosed with GPP at least twice, in the United States by a physician between 2017 and 2019 using the International Classification of Diseases 10th Revision (ICD-10) billing code pertaining to GPP (L40.1).
Full data from our completed Phase 2 GALLOP trial of imsidolimab in GPP, including efficacy and safety of imsidolimab treatment through week 16, will be disclosed in an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress on October 2nd, 2021.
We are continuing to advance imsidolimab through Phase 2 clinical trials in multiple additional indications associated with IL-36 signaling dysfunction. Our 120-patient placebo-controlled ACORN Phase 2 trial of imsidolimab in moderate-to-severe acne is anticipated to read out top-line data in the first half of 2022. Imsidolimab is also being tested versus placebo in hidradenitis suppurativa, where our 120-patient HARP trial is anticipated to generate top-line data in the second half of 2022. We continue to enroll our 45-patient placebo-controlled EMERGE Phase 2 trial of imsidolimab in EGFR/MEK-mediated skin toxicities, where we anticipate an interim analysis by the end of 2021. We also continue to enroll patients in our INSPIRE Phase 2 trial in ichthyosis where top-line data is anticipated during 2022.
Rosnilimab (Anti-PD-1 Agonist) Program

We anticipate top-line data in Q4 2021 from our ongoing Phase 1 healthy volunteer clinical trial of rosnilimab, our wholly-owned PD-1 agonist antibody, designed to assess the safety, pharmacokinetics and pharmacodynamics of rosnilimab in single and multiple ascending dose cohorts.
We plan to initiate a placebo-controlled Phase 2 clinical trial of rosnilimab in alopecia areata in Q4 2021.
ANB032 (Anti-BTLA Modulator) Program

We are advancing ANB032, our wholly-owned BTLA modulator antibody, in a healthy volunteer Phase 1 single and multiple ascending dose clinical trial where top-line data is anticipated during the first half of 2022.
GSK Partnered Programs

JEMPERLI (dostarlimab), our proprietary anti-PD-1 antagonist antibody, was approved by the FDA and the European Medicines Agency (EMA) during April 2021 for treatment of advanced or recurrent mismatch repair deficient endometrial cancer. This is the first AnaptysBio-generated antibody, of eight currently under clinical development, to obtain regulatory approval. GSK has recently disclosed peak annual sales estimates of £1-£2 billion for JEMPERLI, and AnaptysBio will earn 8-25% royalties on global net sales of JEMPERLI. We received $20 million and $10 million milestone payments upon FDA and EMA approval of JEMPERLI, respectively. We anticipate earning an additional $20 million milestone payment upon a second FDA BLA approval for JEMPERLI in pan-deficient mismatch repair tumors during the second half of 2021. AnaptysBio is due an additional $15 million and $165 million upon certain JEMPERLI regulatory and commercial milestones, respectively.
Second Quarter Financial Results

Cash, cash equivalents and investments totaled $396.3 million as of June 30, 2021, compared to $411.2 million as of December 31, 2020, for a decrease of $14.9 million. The decrease relates primarily to cash used for operating activities.
Collaboration revenue was $30 million and $41.3 million for the three and six months ended June 30, 2021. The $30 million earned during the second quarter relates to milestone revenue for the US and EU approval of JEMPERLI (dostarlimab), compared to zero and $15 million of milestone revenue for the three and six months ended June 30, 2020.
Research and development expenses were $25.3 million and $49.5 million for the three and six months ended June 30, 2021, compared to $17.9 million and $38.9 million for the three and six months ended June 30, 2020. The increase was due primarily to continued advancement of the Company’s clinical programs.
General and administrative expenses were $5.2 million and $10.7 million for the three and six months ended June 30, 2021, compared to $4.7 million and $9 million for the three and six months ended June 30, 2020. The increase was due primarily to personnel-related expenses, including share-based compensation.
Net loss was $0.4 million and $18.6 million for the three and six months ended June 30, 2021, or a net loss per share of $0.02, and $0.68, compared to a net loss of $21.5 million and $29.8 million for the three and six months ended June 30, 2020, or a net loss per share of $0.79 and $1.09.
Financial Guidance

AnaptysBio expects its net cash burn in 2021 will be less than $100 million. We anticipate that our cash, cash equivalents and anticipated revenues will fund our current operating plan at least into 2024.

On August 9, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported financial results for the second quarter of 2021 (Press release, Agenus, AUG 9, 2021, View Source [SID1234586140]).

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"In the first half of this year, we announced a collaboration with BMS and advanced our flagship clinical candidate AGEN1181 to an important data inflection point," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "In the second half, we will disclose this data at a key cancer conference and be ready with our commercial platform in preparation for a balstilimab launch."

AGEN1181 (Fc-enhanced anti-CTLA-4): Clinical data support superior activity in difficult-to-treat cancers

Updated clinical data for AGEN1181 alone and in combination with balstilimab will be presented at an upcoming conference.

Clinical responses seen in patients refractory to approved immunotherapies, including patients with microsatellite stable (MSS) tumors and melanoma, endometrial, and ovarian cancer with the low-affinity FcyRIIIA allele. No immune mediated hypophysitis, pneumonitis, or hepatitis (typically seen with first generation anti-CTLA-4s) were reported.

Registrational trials targeted to commence by year-end 2021 with a focus on rapid path to Biologics License Application (BLA) submission.
MiNK Therapeutics: Allogeneic iNKT cell therapy company advances towards IPO

MiNK Therapeutics (currently an Agenus company) filed a confidential S-1 to support a planned Initial Public Offering (IPO).

Phase 1 trial of AGENT-797 in hematologic cancers dose cohorts completed with data readouts planned in the second half of 2021; Phase 1/2 expansion trials in viral acute respiratory distress syndrome (ARDS) are underway.
AGEN1777 (Fc-enhanced anti-TIGIT bispecific): Collaboration with BMS provides additional cash resources to advance Agenus’ high value drivers

Global exclusive license with Bristol Myers Squibb for AGEN1777 provides $200 million upfront cash. In addition, Agenus to receive up to $1.36 billion in development, regulatory, and commercial milestones, and tiered double-digit royalties upon product sales.

FDA cleared Investigational New Drug (IND) application; Phase 1 dosing with AGEN1777 alone and in combination with an anti-PD-1 in advanced solid tumors planned to begin this quarter.
Balstilimab (anti-PD-1): BLA accepted for Priority Review by U.S. FDA; data updates presented at ASCO (Free ASCO Whitepaper)

Balstilimab BLA accepted for Priority Review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2021.

Commercial preparation underway for a highly efficient, targeted launch to provide broad product access to physicians and patients while laying the foundation for future Agenus products.

Clinical data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting:

Phase 2 data for balstilimab showed a response rate of 20% in PD-L1 positive tumors, overall response rate of 15%, and median duration of response of 15.4 months.
Balstilimab showed superior tumor killing compared to approved anti-PD-1s such as pembrolizumab and nivolumab.

Results from a Phase 2 trial of balstilimab plus zalifrelimab combination in recurrent or metastatic cervical cancer to be presented in a Mini Oral Session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 on September 19 from 11:35 – 11:40am ET.
Additional programs

Phase 1 data for AGEN2373, a CD137 agonist antibody, in patients with advanced solid tumors were presented at ASCO (Free ASCO Whitepaper) 2021.

No dose limiting toxicities were seen at doses up to 3 mg/kg, including no liver toxicity. Combination trials are in planning.

Process for scale up of QS-21 manufacturing continues to advance.

VISION platform knowledge base expanding to support AGEN1181 response prediction and combination discovery.
Management appointments

Steven O’Day, MD appointed to Chief Medical Officer.

Andy Hurley appointed to Chief Commercial Officer.

Marc Wiles, PhD appointed to Vice President of Regulatory Affairs.

Julie DeSander promoted to Chief Business Officer.

Joseph Grossman, MD, appointed to Vice President of Exploratory Medicine.

Jason Paragas appointed to Vice President of Data Sciences.

Jennifer Buell, PhD, appointed to Chief Executive Officer of MiNK Therapeutics. Dr. Buell will continue as a member of the Agenus Executive Committee.
Second Quarter Financial Results

We ended the second quarter of 2021 with a cash balance of $74 million as compared to $100 million at December 31, 2020. Subsequent to the quarter end we received $200 million related to our BMS partnership.

For the second quarter ended June 30, 2021, our cash used in operations was $56 million and we reported a net loss of $84 million or $0.37 per share which included a number of non-cash items. This compares to cash used in operations for the same period in 2020 of $37 million and a net loss of $48 million or $0.28 per share. Non-cash operating expenses for the second quarter ended June 30, 2021 were $30 million compared to $18 million for the second quarter of 2020.

Our cash used in operations for the six months ended June 30, 2021 was $98 million with a net loss of $138 million or $0.65 per share compared to cash used in operations of $72 million and a net loss for the same period in 2020 of $94 million or $0.59 per share.

We recognized revenue of $22 million and $42 million for the six-months ended June 30, 2021 and 2020, respectively, which includes revenue related to non-cash royalties earned, revenue recognized under our collaboration agreements, and in 2020, $14 million from an upfront license fee received.

Webcast
A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

On August 9, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher") reported that it has priced an offering of $3.1 billion aggregate principal amount (the "Offering") of the following notes (Press release, Thermo Fisher Scientific, AUG 9, 2021, View Source [SID1234586157]):

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$700 million aggregate principal amount of its 1.750% senior notes due 2028, at the issue price of 99.952% of their principal amount,
$1.2 billion aggregate principal amount of its 2.000% senior notes due 2031, at the issue price of 98.827% of their principal amount, and
$1.2 billion aggregate principal amount of its 2.800% senior notes due 2041, at the issue price of 99.508% of their principal amount.
The Offering is expected to close on or about August 23, 2021, subject to customary closing conditions. The notes will pay interest on a semi-annual basis.

Thermo Fisher intends to use the net proceeds of the Offering to pay a portion of the cash consideration payable for the pending acquisition of PPD, Inc., a Delaware corporation.

The joint book-running managers for the Offering are Barclays Capital Inc., Morgan Stanley & Co. LLC, BofA Securities, Inc. and Citigroup Global Markets Inc.

The Offering is being made pursuant to an effective registration statement on Form S-3 filed with the U.S. Securities and Exchange Commission (the "SEC"). Prospective investors should read the prospectus forming a part of that registration statement and the prospectus supplement related to the Offering and the other documents that Thermo Fisher has filed with the SEC for more complete information about Thermo Fisher and this Offering. These documents are available at no charge by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Thermo Fisher, the underwriters or any dealer participating in this offering will arrange to send you the prospectus if you request it by calling Barclays Capital Inc. toll-free at 1-888-603-5847; Morgan Stanley & Co. LLC toll-free at 1-866-718-1649; BofA Securities, Inc. toll-free at 1-800-294-1322;or Citigroup Global Markets Inc. toll-free at 1-800-831-9146.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the notes, nor shall there be any offer, solicitation or sale of the notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.