On October 22, 2021 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the third quarter of fiscal year 2021 (Press release, Chugai, OCT 22, 2021, View Source [SID1234591824]).

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"We achieved robust double-digit growth in both revenues and profits in the nine months under review. This was due to significant increases in both domestic and overseas sales, driven by new products and mainstay products, as well as continued growth in royalty income. As a result, we raised our full year forecast for FY2021. In terms of R&D, I am very pleased that our first mid-size molecule project, LUNA18, has entered the clinical development phase. Mid-size molecule drugs are expected to become the third modality to drive our future growth. Concerning COVID-19, we have filed Ronapreve for subcutaneous administration and the additional indications of treatment for asymptomatic patients and prophylaxis. In order to satisfy unmet medical needs through innovation, we will continue pursuing world-leading science and technology to contribute to patients awaiting treatments." said Dr. Osamu Okuda, Chugai’s President and CEO.

[Third quarter results for 2021]

Revenues and Core operating profit increased by approximately 17% and 25%, respectively, for the third quarter (nine months, Core-basis), mainly due to increases in sales and royalty and profit-sharing income.

Revenues increased by approximately 20% in total since sales, which recorded flat year-on-year growth for the first half, turned to double-digit growth. Domestic sales increased by double digits as the strong oncology field grew further with a mainstay product Tecentriq maintaining high growth despite the NHI price revision in August this year, and the contribution of a new product Polivy. In the primary field, sales increased approximately 30% after reporting a decrease by roughly 10% in the first half. The growth was driven by new products, with the supply of Ronapreve to the government and the market penetration of Enspryng, and double-digit growth of mainstay products, Actemra and Hemlibra. Overseas sales recovered growth and increased by approximately 10% as the further growth of Hemlibra outweighed the decrease in the sales of Actemra. Royalties and other operating income increased by approximately 20% mainly due to increases in royalty and profit-sharing income related to Hemlibra, despite a continued decrease in other operating income resulting from one-time income.

Cost to sales ratio improved by 1.2% points year-on-year to 41.9%, mainly due to an increase in the proportion of in-house products including Hemlibra. Operating expenses increased approximately by 10% as research and development, marketing and distribution, and general and administration expenses all increased. Research and development expenses increased by double digits, continued from the first half, associated with the progress of projects. The increases in marketing and distribution expenses were affected by last year’s decrease in activities due to the spread of the COVID-19. General and administration expenses increased owing to the enterprise tax and various expenses. As a result, core operating profit increased by approximately 25%.
The Company also made good progress in research and development. Its first mid-size molecule project, LUNA18, has entered the clinical development phase. Chugai has been focusing on mid-size molecule drugs as a new modality to constitute the mainstay for driving its medium-to long-term growth. LUNA18 is an oral cyclic peptide RAS inhibitor, and a Phase I clinical trial has been initiated for solid tumors. As for other in-house projects, Chugai has started development of Enspryng in generalized Myasthenia Gravis (gMG), initiating a Phase III clinical trial.

In the efforts to develop treatments for COVID-19, Chugai filed an application for the antibody cocktail Ronapreve, which had received Special Approval in July. The filing is to obtain approval for additional indications for prophylaxis of COVID-19 and treatment of asymptomatic COVID-19, and additional subcutaneous administration. In addition, an application for approval was filed in Europe for Actemra for an additional indication of COVID-19 pneumonia.

[Revision of Full-Year Forecast for 2021]

Chugai raised forecasts (Core-basis) for FY2021 following the strong nine-month results. Regarding domestic sales, the sales forecast attributable to the supply of Ronapreve to the government, which was not expected at the beginning of the fiscal year, has been included, and the progress and revised assumptions have been reflected for each product including Avastin and Tecentriq, which are progressing ahead of the initial forecast. The forecast for overseas sales has been revised upward reflecting that sales of Actemra and Hemlibra should exceed the original forecast. Royalties and other operating income have been also revised upward. As a result, the revenues have been raised to ¥970 billion, an increase of ¥170 billion from the initial forecast. Operating profit forecast has been revised to ¥400 billion, up ¥80 billion from the initial forecast, taking into account a higher cost to sales ratio due to a change in the product mix, and increases in some expenses including the foreign exchange effects.

In accordance with the revision of the financial forecast, year-end dividends forecast was also revised to an undecided value. Reflecting the significant changes in the profit structures, year-end dividends will be decided based on the Company’s dividend policy* after the fiscal year ends.

*Regarding income distribution, taking into account the strategic funding needs and earning prospects, Chugai aims for a consolidated dividend payout ratio of 45% on average in comparison with Core EPS to provide a stable allocation of profit to all shareholders.

On October 22, 2021 RaySearch Laboratories AB (publ) and Mevion Medical Systems, two companies that are leading the field of proton therapy, reported a collaboration to develop advanced treatment planning techniques for FLASH delivery with the MEVION S250i Proton Therapy System (Press release, Mevion Medical Systems, OCT 22, 2021, View Source [SID1234591792]).

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The collaboration will explore FLASH intensity modulated proton therapy (IMPT) delivery using a technique that supports the delivery of large-volume clinical FLASH fields through the combination of smaller fields, each delivered at FLASH dose rates which complements Mevion’s advanced HYPERSCAN delivery system.

Townsend Zwart, Vice President of Advanced Development, Mevion Medical Systems, says: "Mevion is pleased to continue our long partnership with RaySearch to develop ultra-high dose rate (FLASH) intensity modulated proton therapy. Optimizing FLASH delivery requires explicit consideration of the time dependent dose delivery and sequencing of proton spots. Overlapping spots or spots with multiple pulses may have complex FLASH weighting factors. Differing tissue types or tissue properties may also need to be included in an effective dose weighting model. The RaySearch development team is uniquely qualified to incorporate these features into a FLASH dose calculation module."

Kjell Eriksson, Chief Science Officer, RaySearch, says: "RayStation already supports IMPT planning for Mevion’s HYPERSCAN system with Monte Carlo dose calculation for both optimization and final dose calculation. We are now excited to explore how RayStation can create optimal FLASH plans for the HYPERSCAN system and to further deepening our partnership."

Since 2014, RaySearch and Mevion have collaborated to provide advanced treatment planning capabilities for Mevion’s HYPERSCAN pencil-beam scanning and Adaptive Aperture pMLC. Both companies will be exhibiting at the upcoming American Society for Radiation Oncology (ASTRO) annual meeting in Chicago, October 24–26. Attendees are invited to the respective booths to learn more.

* FLASH therapy is currently under preclinical research and is not yet available for commercial sale or clinical use.

On October 22, 2021 Agenus (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 a strategic decision to withdraw its Biologics License Application (BLA) for balstilimab, its PD-1 inhibitor (Press release, Agenus, OCT 22, 2021, View Source [SID1234591771]). The decision to withdraw the BLA does not change the development plans for balstilimab combinations.

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Following the full approval of pembrolizumab, announced four months earlier than the FDA goal date, the U.S. Food and Drug Administration (FDA) no longer considered it appropriate to review the BLA for accelerated approval and recommended Agenus withdraw. The BLA submission for balstilimab received Fast Track and Priority Review designation from the FDA, with a target action date of December 16, 2021. As part of the BLA review process, Agenus successfully completed 3 FDA inspections with no cited issues, concerns, or Form-483s.

As previously reported, in the largest single-arm trial to date in this population (140 evaluable patients), balstilimab demonstrated objective responses in both PD-L1 positive and negative patients, with an objective response rate (ORR) of 20% and 8% respectively1. Pembrolizumab has demonstrated an ORR of 14% and 0% in PD-L1 positive and negative patients respectively, which led to its accelerated approval in 2018. Balstilimab has shown superior killing of PD-L1 negative tumors compared to other anti PD-1 therapies, including pembrolizumab, suggesting a broader mechanism consistent with balstilimab’s clinical activity in both PD-L1 positive and negative cervical cancer2.

Concurrent with the withdrawal, Agenus will discontinue its ongoing confirmatory trial (BRAVA) in this population, which is expected to reduce R&D expenses by over $100M. However, given the clinical benefit demonstrated by balstilimab, Agenus plans to launch expanded access programs to give patients and doctors access to balstilimab in several countries, including the US, pending regulatory processes.

"While the commercial market for balstilimab monotherapy in second line cervical cancer was always anticipated to be small, Agenus’ priority remains developing balstilimab as a necessary component of highly effective and affordable combination therapies, both with its own portfolio and with partners, including in combination with Agenus’ next-generation CTLA-4, AGEN1181," said Garo Armen, CEO and Chairman of Agenus.

"Balstilimab has demonstrated meaningful clinical activity and an excellent safety profile in second-line cervical cancer, including in PD-L1 negative patients, who are ineligible to receive standard of care anti-PD-1 therapy, which makes the decision to withdraw so difficult for us," said Steven O’Day, MD, Chief Medical Officer of Agenus. "Balstilimab remains a critical component of our combination regimens, including with our next-generation CTLA-4 agent, AGEN1181. Concomitant with presentation of new data at SITC (Free SITC Whitepaper) next month, we continue to accelerate development of AGEN1181 in combination with balstilimab in trials designed to rapidly support full or accelerated approval in multiple tumor types."

Agenus executives will host a conference call to discuss this update at 8:30AM ET today.

Conference Call

Dial-in numbers: (833) 614-1394 (US) or (914) 987-7115 (International); Conference ID: 5399638.

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

References

1. D.M. O’Malley, A. Oaknin, B.J. Monk, et al., Phase II study of the safety and efficacy of the anti-PD-1 antibody balstilimab inpatients with rec…, Gynecologic Oncology, View Source

2. C. Joyce, D. Chand et al., Differentiated activity profile for the PD-1 inhibitor balstilimab. Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021) 5529-5529.

About Balstilimab

Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market.

On October 22, 2021 CEL-SCI Corporation (NYSE American: CVM) reported it has completed the expansion of its existing dedicated Multikine* (Leukocyte Interleukin, Injection) cGMP manufacturing facility (Press release, Cel-Sci, OCT 22, 2021, View Source [SID1234591793]). The expansion was undertaken in anticipation of filing a Biologics License Application (BLA) which, if approved, will allow Multikine produced in the facility to be commercially distributed. The construction, which began in 2020, expanded the facility and added various upgrades to ensure it will be in compliance with all requirements of the FDA’s Current Good Manufacturing Practice (GMP) regulations. The facility’s production capacity has been doubled to meet anticipated market demand for Multikine once it is licensed. The renovations also anticipate that additional personnel will be required to staff a second manufacturing shift to meet the eventual market demand for Multikine. Following an $11 million investment to increase production, CEL-SCI staff recently moved back into the renovated facility.

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"We are now validating the facility and will begin preparing our facility license application for Multikine. We continue to hire and train additional personnel required to efficiently operate the manufacturing facility in compliance with all federal and state requirements," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported topline results in June 2021 from its landmark pivotal Phase 3 study of Multikine as a neoadjuvant treatment of advanced primary previously untreated head and neck cancer, which is believed to be the largest study in the world for this indication.

On October 22, 2021 Applied DNA Sciences, Inc. (Applied DNA or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, reported signing a mutual collaboration agreement (the "Agreement") with Ganesha Ecosphere Ltd. (Ganesha), the largest recycled polyester (rPET) fiber producer in India with over 300-plus customers, 250-plus suppliers, and 500-plus product variants (Press release, Applied DNA Sciences, OCT 22, 2021, View Source [SID1234591772]). Under the terms of the Agreement, Ganesha will deploy the CertainT platform, Applied DNA’s traceability system, to tag an initial pilot production of recycled polyester (rPET) at Ganesha’s facilities in India and conduct confirmatory samples testing at Applied DNA’s laboratories in India and the U.S. The collaboration between the two companies will provide brands and textile manufacturers with a trusted solution to support their sustainability goals for rPET and confirm raw material authenticity at all stages of the textile value chain.

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The Agreement enables Ganesha to introduce and apply CertainT-verified rPET to provide assurance for the raw material with textile and apparel customers. Ganesha will also employ Applied DNA’s recently introduced SigNature T-100 tracer system that enables rPET source material to be quantified in polyester blends by the CertainT platform. SigNature T-100 is a proprietary molecular-based tracer system used to identify, analyze, and verify rPET, polypropylene, acrylic, and potentially other man-made materials for claims of both identification and quantification of the raw material tagged and subsequently spun into yarn for various textile products.