On July 22, 2021 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will report its second quarter 2021 financial results on Thursday, August 5, 2021 (Press release, BioCryst Pharmaceuticals, JUL 22, 2021, View Source [SID1234585061]).

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BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 9886913. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 9886913.

On July 22, 2021 Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) reported a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC (PROteolysis TArgeting Chimera) estrogen receptor protein degrader (Press release, Arvinas, JUL 22, 2021, View Source [SID1234585060]). The estrogen receptor is a well-known disease driver in most breast cancers . ARV-471 is currently in a Phase 2 dose expansion clinical trial for the treatment of patients with estrogen receptor (ER) positive / human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer. Under the terms of the agreement, Pfizer will pay Arvinas $650 million upfront. Separately, Pfizer will make a $350 million equity investment in Arvinas. The companies will equally share worldwide development costs, commercialization expenses, and profits.

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"This collaboration has the potential to be transformational, as it combines our leadership in targeted protein degradation with Pfizer’s global capabilities and deep expertise in breast cancer. This should significantly enhance and accelerate the development and potential commercialization of ARV-471 while also advancing Arvinas’ strategy of building a global, integrated biopharmaceutical company," said John Houston, Ph.D., Chief Executive Officer at Arvinas. "We share Pfizer’s deep commitment to people with breast cancer and are thrilled to partner with them to develop this potentially best-in-class therapy. Despite advancements in oncology in recent years, considerable unmet need persists in the treatment of HR+ breast cancer. Together with Pfizer, we will deploy our PROTAC technology in an effort to help people with this devastating disease."

"Building on Pfizer’s established leadership position in breast cancer science and CDK 4/6 inhibition, we are excited to work with Arvinas to maximize ARV-471, the first PROTAC for breast cancer with encouraging early clinical data and a potential novel hormonal therapy backbone for HR+ breast cancer," said Jeff Settleman, Ph.D., Chief Scientific Officer for Oncology Research and Development at Pfizer. "This partnership complements Pfizer’s robust research activities in breast cancer, including our multiple next-generation CDK inhibitors currently in early clinical development."

ER is the primary driver of hormone receptor (HR) positive breast cancer, which is the most common breast cancer subtype. Endocrine therapy is a backbone of ER+ breast cancer treatment and is used as monotherapy or as combination therapy as a standard of care across treatment settings. Arvinas and Pfizer are seeking to develop ARV-471 as the potential endocrine therapy of choice for patients and their physicians.

Interim data presented in December 2020 from the ongoing Phase 1 dose escalation clinical trial of ARV-471 in patients with locally advanced or metastatic ER+/HER2- breast cancer indicated its potential as a novel oral ER targeted therapy. This study has enrolled heavily pretreated patients, with all patients having received prior treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors. Despite the advanced stage of disease and heavy pretreatment, these interim data, as of December 2020, demonstrated that ARV-471 can promote substantial ER degradation and exhibits an encouraging clinical efficacy and tolerability profile.

ARV-471 currently is being evaluated as a treatment for metastatic breast cancer in a Phase 1 dose escalation study, a Phase 1b combination study with Pfizer’s IBRANCE (palbociclib), and a Phase 2 monotherapy dose expansion study (VERITAC). Arvinas and Pfizer expect to initiate two additional trials of ARV-471 in 2021, including a second Phase 1b combination trial with everolimus and a trial in the neoadjuvant setting. In 2022, Arvinas and Pfizer expect to initiate Phase 3 studies across lines of therapy in metastatic breast cancer, including combinations with IBRANCE, followed by pivotal studies in the early breast cancer setting. The two companies had previously announced in 2018 a separate research collaboration and license agreement for the discovery and development of drug candidates using Arvinas’ PROTAC technology.

Terms of the Collaboration

The agreement is a worldwide co-development and co-commercialization collaboration. ARV-471 is wholly owned by Arvinas and under the financial terms of the agreement, Pfizer will pay Arvinas $650 million upfront. Separately, Pfizer will invest $350 million in Arvinas, receiving approximately 3.5 million newly issued shares of Arvinas common stock, priced at a 30% premium to the 30-day volume weighted average price on July 20, 2021. This represents an equity ownership stake by Pfizer of approximately 7%.

Arvinas is also eligible to receive up to $400 million in approval milestones and up to $1 billion in commercial milestones, in addition to sharing profits on ARV-471 worldwide.

Arvinas and Pfizer will jointly develop ARV-471 through a robust clinical program designed to position ARV-471 as an endocrine backbone therapy of choice across the breast cancer treatment paradigm, from the adjuvant setting through late-line metastatic disease.

Closing of the equity investment agreement is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions.

Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Arvinas.

Investor Conference Call Details

A conference call and webcast will be held at 8:30 AM ET today with Arvinas and Pfizer Oncology executives to discuss the collaboration. Participants are invited to listen by dialing (844) 467-7654 (domestic) or (602) 563-8497 (international) five minutes prior to the start of the call and providing the passcode 6569429.

Supporting materials for the conference call and webcast will be available here or on the Company’s website at www.arvinas.com under Events + Presentations. A replay of the webcast will be archived on the Arvinas website following the presentation.

On June 22, 2021 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2021 (Press release, Abbott, JUL 22, 2021, View Source [SID1234585059]).

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Second-quarter sales of $10.2 billion increased 39.5 percent on a reported basis and 35.0 percent on an organic basis, which excludes the impact of foreign exchange.
Second-quarter GAAP diluted EPS was $0.66 and adjusted diluted EPS, which excludes specified items, was $1.17, reflecting 105.3 percent growth versus the prior year.1
Abbott continues to project full-year 2021 diluted EPS from continuing operations on a GAAP basis of $2.75 to $2.95 and full-year adjusted diluted EPS from continuing operations of $4.30 to $4.50, reflecting strong, double-digit growth versus the prior year.
Diagnostics sales increased 62.8 percent on a reported basis and 57.2 percent on an organic basis in the second quarter. Global COVID-19 testing-related sales were $1.3 billion in the second quarter.
Nutrition sales increased 11.9 percent on a reported basis and 9.5 percent on an organic basis in the second quarter. Sales performance was led by double-digit growth in Adult Nutrition globally.
Established Pharmaceuticals sales increased 16.4 percent on a reported basis and 14.5 percent on an organic basis in the second quarter. Sales performance was led by double-digit growth in several countries, including India, China, Russia, and several countries across Latin America.
Medical Devices sales increased 51.3 percent on a reported basis and 45.1 percent on an organic basis in the second quarter. Compared to pre-pandemic sales in 2019, Medical Devices sales increased 19.2 percent on a reported basis and 15.6 percent on an organic basis in the second quarter, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.2
"We’re achieving very strong growth across our portfolio," said Robert B. Ford, president and chief executive officer, Abbott. "Perhaps most impressively, excluding COVID testing-related sales, our sales grew more than 11 percent on an organic basis compared to pre-pandemic levels in the second quarter of 2019, which demonstrates the fundamental strength of our performance."

SECOND-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business. Organic sales growth excludes the impact of foreign exchange.

Following are sales by business segment and commentary for the second quarter 2021:

* Total 1H 2021 Abbott sales from continuing operations include Other Sales of approximately $38 million.

n/a = Not Applicable.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second-quarter 2021 worldwide sales of $10.2 billion increased 39.5 percent on a reported basis and 35.0 percent on an organic basis.

Compared to pre-pandemic sales in 2019, worldwide sales increased 12.3 percent on a reported basis and 11.3 percent on an organic basis in the second quarter, excluding COVID-19 testing-related sales.3

Worldwide Nutrition sales increased 11.9 percent on a reported basis and 9.5 percent on an organic basis in the second quarter. Strong performance of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes nutrition brand, led to global Adult Nutrition sales growth of 18.2 percent on a reported basis and 15.6 percent on an organic basis.

Worldwide Pediatric Nutrition sales increased 6.7 percent on a reported basis and 4.4 percent on an organic basis. Strong performance of Abbott’s market-leading toddler brands, Pedialyte and PediaSure, and continued share growth in infant nutrition led to U.S. Pediatric Nutrition growth of 8.9 percent.

Worldwide Diagnostics sales increased 62.8 percent on a reported basis in the second quarter and increased 57.2 percent on an organic basis. Global COVID-19 testing-related sales were $1.3 billion in the second quarter, led by combined sales of $1.0 billion from Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms. Excluding COVID-19 testing-related sales, worldwide diagnostics sales increased 42.5 percent on a reported basis in the second quarter and 37.2 percent on an organic basis.4 Compared to 2019, sales in Core Laboratory and Molecular Diagnostics, excluding COVID-19 testing-related sales, grew 6.8 percent and 8.3 percent, respectively, on a reported basis in the second quarter and grew 4.2 percent and 6.5 percent, respectively, on an organic basis.5

Established Pharmaceuticals sales increased 16.4 percent on a reported basis in the second quarter and increased 14.5 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 19.7 percent on a reported basis in the quarter and increased 18.4 percent on an organic basis. Organic sales growth was led by strong growth across several geographies, including India, China, Russia, and several countries across Latin America.

Other sales increased 6.5 percent on a reported basis in the quarter and increased 2.6 percent on an organic basis.

Worldwide Medical Devices sales increased 51.3 percent on a reported basis in the second quarter and increased 45.1 percent on an organic basis. Strong growth in the quarter was driven by continued strong recovery from the COVID-19 pandemic.

Compared to pre-pandemic sales in 2019, Medical Devices sales increased 19.2 percent on a reported basis and 15.6 percent on an organic basis in the second quarter, led by double-digit growth in Electrophysiology, Heart Failure, Structural Heart and Diabetes Care.2

In Structural Heart, MitraClip sales increased 88.0 percent on a reported basis and 82.1 percent on an organic basis in the second quarter compared to the prior year, driven by the highest-ever number of MitraClip procedures in the second quarter.

In Diabetes Care, sales of FreeStyle Libre and Libre Sense were $904 million in the quarter, which represents 52.5 percent reported sales growth and 42.9 percent organic sales growth compared to the prior year.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects 2021 diluted earnings per share from continuing operations under GAAP of $2.75 to $2.95. Abbott forecasts specified items for the full-year 2021 of $1.55 per share primarily related to intangible amortization, restructuring and cost reduction initiatives, including expenses to align its COVID-19 testing-related business with current and projected demand, expenses associated with acquisitions and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be $4.30 to $4.50 for full-year 2021.

ABBOTT DECLARES 390TH CONSECUTIVE QUARTERLY DIVIDEND
On June 11, 2021, the board of directors of Abbott declared the company’s quarterly dividend of $0.45 per share. Abbott’s cash dividend is payable Aug. 16, 2021 to shareholders of record at the close of business on July 15, 2021.

Abbott has increased its dividend payout for 49 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On July 22, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the Bellberry Human Research Ethics Committee (HREC) in Australia has approved the clinical trial application of the phase 1 trial of ATG-101 in patients with metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL) (Press release, Antengene, JUL 22, 2021, View Source [SID1234585036]). This approval marks an important milestone for Antengene as ATG-101 is the in-house developed innovative molecule with global rights entering clinical stage. In addition, ATG-101 is the first PD-L1/4-1BB bispecific antibody entering clinical stage in Australia. This multi-center, open-label, Phase I trial is designed to evaluate the safety and tolerability of ATG-101 as a single agent in patients with advanced solid tumors and NHL.

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According to the World Health Organization’s (WHO) estimates, there were approximately 19.3 million diagnoses of cancer and 10 million cancer-related deaths worldwide in 2020 and most of the top 10 cancer types were solid tumors. As the most common blood cancer, non-Hodgkin lymphoma accounted for 544,000 new cases and 260,000 deaths in 2020 globally with some of the highest incidence rates reported in Australia and New Zealand. Since the majority of cancers become resistant or refractory to conventional therapies (including hormonal treatments, chemotherapy regimens and monoclonal antibodies), there remains enormous unmet needs in the treatment of patients with this disease. While immuno-oncology therapy has improved patient outcomes dramatically over the last 10 years, a growing body of evidence also has shown that bispecific antibodies have the potential to be effective treatments for multiple malignant cancers.

ATG-101, a novel PD-L1/4-1BB bi-specific antibody, can activate anti-tumor immune effectors by blocking the immunosuppressive binding of PD-L1 to PD-1 while at the same time activating 4-1BB immunostimulatory signals, thereby enhancing safety and efficacy. Preclinical studies showed that ATG-101 could activate 4-1BB in a very controlled manner in human peripheral blood mononuclear cells (PBMC). Testing in various animal models, including those resistant to or progressing on anti-PD(L)1 treatment, has confirmed the potent in vivo anti-tumor activity and safety of ATG-101. In addition, in vivo testing has shown that ATG-101 can increase the number of CD8+ T-cells and reduce regulatory T-cells (Treg), a unique mechanism of action that enhances anti-cancer immune profile and can potentially improve treatment outcomes.

Dr. Jay Mei, Founder, Chairman and CEO of Antengene, said "Having gained approval for this first-in-human trial of ATG-101 as planned marks a milestone achievement that validates Antengene’s capability in effectively advancing preclinical programs. Exploring a novel mechanism of action, multiple bispecific antibodies have begun entering clinical development in recent years. Compared to monoclonal antibodies, bispecific antibodies have the advantages of being able to target multiple epitopes, with a lower production cost and shorter production cycle than using a combination of conventional monoclonal antibodies, therefore representing a novel therapeutic approach with enormous clinical potential. We have observed that ATG-101 has anti-tumor activities in vivo and in vitro and so we are very enthusiastic to test this approach in the clinic. We will advance the clinical development program and prepare to submit Investigational New Drug (IND) applications for ATG-101 in the U.S. and China this year."

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of cancer. ATG-101 can activate anti-tumor immune effectors by simultaneously blocking PD-L1/PD-1 binding and inducing 4-1BB stimulation. In the presence of PD-L1 over-expressed cancer cells, ATG-101 has shown a significant and PD-L1 crosslinking-dependent 4-1BB agonist activity, thus enhancing therapeutic efficacy, and mitigating hepatoxicity simultaneously.

On July 21, 2021 EpiVax reported that new dates for this year’s Amsterdam Immunogenicity & Tolerance Seminar (Press release, EpiVax, JUL 21, 2021, View Source [SID1234590457])!

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The seminar is now a two-day, afternoon-only format. This arrangement leaves mornings free for attendees to network, collaborate in small groups, and enjoy the beautiful city of Amsterdam.

All events will take place at the Hilton Apollolaan. Apollolaan 138, 1077 BG, Amsterdam, Netherlands

Day 1, Thursday, November 4th
12:00 PM- 6 PM CET (Central European Time)

Lunch will be provided from 12-1 PM

A cocktail reception will be held at immediately following completion of Day 1 talks, from 6 – 8 PM

Day 2, Friday November 5th
1 PM – 5 PM CET (Central European Time)

Lunch will provided from 12-1 PM

The seminar will focus on translational research in the fields of immunogenicity and tolerance, with case studies touching on vaccines and biologics.

Interested in attending this free event? Register here!

We are so excited to return to Amsterdam and meet safely and responsibly with our colleagues for this in-person event. Please note that we will be monitoring the COVID-19 pandemic and travel restrictions, and we will communicate any changes in advance if the events cannot safely take place.

Special Guest Speakers will include:

Annie De Groot, MD
Research Professor, Center for Vaccines and Immunology, University of Georgia
CEO/CSO, EpiVax, Inc.

Amy Rosenberg, MD
Senior Director of Immunology and Protein Therapeutics, EpiVax, Inc.