On April 22, 2021 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales performance for the first quarter of 2021 (Press release, Ipsen, APR 22, 2021, View Source [SID1234578316]):

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Total Sales growth of 5.5% at CER, or 0.6% as reported, to €658.5m, despite impact of the pandemic
An increase in Specialty Care sales of 6.4%1 to €611.5m, driven by the growth of Cabometyx (cabozantinib), Decapeptyl (triptorelin), Somatuline (lanreotide) and Dysport (botulinum toxin type A)
A Consumer Healthcare sales decline of 5.4%1 to €47.0m, reflecting the ongoing effects of COVID-19, partly offset by recovery in China
European Commission approval of Cabometyx, in combination with nivolumab, as a first-line treatment for patients living with advanced renal cell carcinoma
Guidance for FY 2021 confirmed
David Loew, Chief Executive Officer, commented:
"We delivered a strong performance in the first quarter, despite the persistently difficult COVID-19 environment, driven by our unrelenting focus on patients. Our execution was in line with our plans and our financial guidance for the year. Ipsen’s Oncology medicines stood out in the period, while the regulatory approval in Europe of the Cabometyx combination with nivolumab in first-line renal cell carcinoma marked the start of an important launch. The anticipated registration of a lanreotide-generic medicine in Europe is fully aligned with our expectations.

In the near term, we look forward to trial results in first-line liver cancer for the Cabometyx combination with atezolizumab, as well as regulatory progress with palovarotene in FOP. We continue to support our ambitions of strengthening the pipeline and driving sustainable growth, based on our patient-focused strategy. I am very proud of the great execution by colleagues around the world, especially as many teams continue to experience challenging conditions during the pandemic."

FY 2021 guidance
The Company today confirms its financial guidance for FY 2021, which incorporates an assumed progressive global recovery from COVID-19 by H2 2021. A phased launch of generic lanreotide in Europe by mid-2021 is also assumed, as is a limited impact of the potential launch of octreotide or lanreotide generics in the U.S.

Total Sales

Growth of more than 4.0% at CER

Core Operating Margin

Greater than 30.0%, excluding any potential impact of incremental investments from external innovation

Currency impact
Ipsen anticipates an adverse impact of 2% from currencies on Total Sales in FY 2021, based on the level of exchange rates at the end of March 2021.

Somatuline-generic update
During the quarter, a positive outcome was received for a generic formulation of lanreotide in 60mg, 90mg and 120mg dose presentations by the Reference Member State, Denmark; the closure of the Decentralized Procedure was also achieved. National marketing authorizations have recently been granted for a lanreotide generic medicine in France, Denmark, Hungary and Latvia. These developments were consistent with Ipsen’s expectations.

Business development
In the quarter, Ipsen and Fusion Pharmaceuticals Inc. completed an asset purchase agreement to acquire Ipsen’s intellectual property and assets related to IPN-1087, a small molecule in Phase I development targeting neurotensin receptor 1, a protein expressed on multiple solid-tumor types.

Conference call
A conference call and webcast for investors and analysts will begin at 2:30pm Paris time today. Participants should dial in to the call early and can register here; a recording will be available on ipsen.com, while the webcast can be accessed here. The event ID is 2495337.

Calendar
The Company intends to publish its H1 2021 results on 29 July 2021 and its nine-months’ sales update on 21 October 2021. The Annual Shareholders’ Meeting will be held behind closed doors on 27 May 2021.

Notes
All financial figures are in € millions (€m). The performance shown in this announcement covers the three-month period to 31 March 2021 (the quarter, the first quarter or Q1 2021), compared to three-month period to 31 March 2020 (Q1 2020) respectively, unless stated otherwise. Growth rates are at CER, unless stated otherwise. Commentary on performance is based on CER, unless stated otherwise.

On April 21, 2021 Allogene Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-715 in relapsed/refractory multiple myeloma (Press release, Allogene, APR 21, 2021, View Source [SID1234631116]). The FDA granted RMAT designation based on the potential of ALLO-715 to address the growing unmet need for patients who have failed other multiple myeloma therapies.

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"RMAT designation was granted based on our encouraging initial clinical experience in heavily pretreated patients. ALLO-715 demonstrated for the first time that an allogeneic CAR T therapy directed at BCMA can achieve deep clinical responses while eliminating the need for bridging therapy and delays associated with autologous CAR T manufacturing," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "We look forward to completing the UNIVERSAL study and working closely with the FDA as we seek to rapidly advance this important therapeutic alternative to patients with advanced multiple myeloma."

Initial results from the UNIVERSAL study were presented at an oral session of the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2020. As part of the Company’s anti-BCMA strategy, the Phase 1 UNIVERSAL study continues to optimize the dosing regimen of ALLO-715 and ALLO-647. The UNIVERSAL study is also enrolling patients to receive ALLO-715 in combination with SpringWorks Therapeutics’ investigational gamma secretase inhibitor, nirogacestat.

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation. An investigational cell therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with FDA that may be used to discuss potential surrogate or intermediate endpoints and potential ways to satisfy post approval requirements.

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On April 21, 2021 Centessa Pharmaceuticals reported that it is aiming for the public markets (Press release, Centessa Pharmaceuticals, APR 21, 2021, View Source [SID1234578396]). The company filed on Wednesday to raise up to $100 million in its Nasdaq IPO, but, if recent deals are any indication, it will likely rake in considerably more.

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The news comes a month after chief scientific officer, Moncef Slaoui, M.D., departed the company amidst allegations of sexual assault at his former employer, GlaxoSmithKline.

The proceeds will fund several clinical trials that are already underway, including a phase 3 safety study for lixivaptan, a treatment for autosomal dominant polycystic kidney disease, and a phase 2a study for SerpinC, a treatment for the blood disorders hemophilia A and B, the company said in a securities filing.

RELATED: GSK cuts ties with Slaoui over sexual harassment allegations as CEO Walmsley vows to rename R&D site

The funds will also bankroll future clinical trials, including a pivotal phase 3 trial for lixivaptan; a phase 1 study for ZF887, a treatment for the genetic disorder alpha-1-antitrypsin deficiency, which can cause liver and lung disease; and a phase 2 study for imgatuzumab, an anti-EGFR antibody for the treatment of cutaneous squamous cell carcinoma, the second most common form of skin cancer.

Centessa will also invest in its discovery, manufacturing and R&D capabilities, as well as the design and execution of preclinical and clinical studies for its earlier-stage pipeline. And the capital could go toward acquiring and developing yet more programs, according to the securities filing.

The company came out of the shadows in February, having acquired 11 biotech companies and raised $250 million in series A funding. Its goal was to create an asset-centric drug developer without the R&D inefficiencies that strike "classical pharmaceutical companies," in the words of co-founder Francesco De Rubertis, Ph.D., a partner at Medicxi and chairman of Centessa’s board of directors.

The companies that merged to become Centessa continue to develop their assets under the leadership of the Centessa team and with access to centralized resources such as manufacturing, regulatory and operational support as well as capital.

RELATED: Slaoui’s Centessa adds ex-FDA commish Califf, biotech bigwigs to its board

"This approach encourages an environment where scientific teams are incentivized to maintain an unwavering focus on advancing medicines to key go/no-go inflection points based on data-driven decisions," said Centessa CEO Saurabh Saha, M.D., Ph.D., previously senior vice president of R&D and global head of translational medicine at BMS.

Centessa started out with Saha at the helm and Slaoui, the former co-leader of the U.S. government’s Operation Warp Speed effort and longtime GlaxoSmithKline executive, as chief scientific officer. But Slaoui’s tenure at the new biotech was short-lived. Barely a month after Centessa’s launch, his former employer cut ties with him following allegations from an employee of sexual harassment that occurred several years ago at GSK. A day later, he stepped down from his role at Centessa.

On April 21, 2021 Versant Ventures reported $950 million in additional capital allocated across a platform of three separate vehicles (Press release, Versant Ventures, APR 21, 2021, View Source [SID1234578394]). These included Versant Venture Capital VIII, a $560 million primary global biotech fund; Versant Voyageurs II, a $140 million booster fund; and Versant Vantage II, a $250 million later-stage opportunity fund.

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All three funds exceeded their initial targets and were heavily oversubscribed. The capital from existing investors and a select number of new top-tier limited partners will support Versant’s highly successful biotech investment strategy and portfolio construction model.

Versant Venture Capital VIII – primary global biotech fund

Fund VIII closed at $560 million and will be allocated to 20 or more biotechnology start-ups in the U.S., Canada and Europe. These newcos will be focused on translating breakthrough innovation into the next generation of therapeutics targeting the most important unmet medical needs. The emphasis will be placed on building sustainable companies that follow business models with dual paths to liquidity.

The fund will be deployed by the same team and will follow the same investment strategy that is consistently producing outlier returns. More specifically, Versant’s three predecessor funds are currently demonstrating top decile performance across the venture industry.

"The pace of scientific discovery and technology development in the healthcare sector continues to accelerate, including advances in engineering new cell and gene therapies, developing the next generation of antibodies and therapeutic proteins, and even conceiving novel small molecule constructs for previously intractable targets in the human proteome," said Brad Bolzon, Ph.D., chairman and managing director of Versant. "These innovations are at the heart of our investment model."

Versant expects the majority of Fund VIII portfolio companies to be created de novo by working directly with talented entrepreneurs or through the firm’s existing Discovery Engines that support about 60 scientists working in wet labs across North America and Europe.

Versant Voyageurs II – strategic booster fund

Versant Voyageurs II closed at $140 million and will co-invest with Fund VIII in a select number of Series A opportunities that show early potential to be breakout companies.

"During the course of constructing any given portfolio, we inevitably generate a select number of deals showing exceptional potential from the outset," said Dr. Bolzon. "In these circumstances, we now have the ability to access additional Versant capital beyond our typical Series A investment allocations to increase momentum."

Rather than extend Versant’s main fund and jeopardize reserves planned for other valuable portfolio companies, the Voyageurs II capital will be available to participate alongside those specific Series A rounds. Thus, Voyageurs II will serve as a booster fund for a handful of select deals.

Versant Vantage II – strategic opportunity fund

Versant Vantage II closed at $250 million and will primarily invest in Series B or later rounds of existing Versant portfolio companies that are nearing a liquidity event.

The remit of Vantage II is similar to its predecessor fund, Versant Vantage I, which was designed to provide later-stage investment opportunities in portfolio companies believed to be within 12 months of an exit.

"Vantage I launched in March 2019 and has exceeded expectations. Of the fund’s 15 later-stage commitments, there already are 11 liquid companies with an average time to IPO or M&A event of about six months," noted Dr. Bolzon. "We expect similar outcomes from Vantage II, which already has a deep lineup of potential Versant companies in which to invest."

Managing directors leading investments for the new funds include Dr. Bolzon, Jerel Davis, Ph.D., Alex Mayweg, Ph.D., Clare Ozawa, Ph.D., and Tom Woiwode, Ph.D.