On October 25, 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 the signing of an agreement with Sagard Healthcare Royalty Partners to monetize a portion of AnaptysBio’s future JEMPERLI royalties and milestones (Press release, AnaptysBio, OCT 25, 2021, View Source [SID1234591922]). AnaptysBio intends to utilize the proceeds of the transaction towards funding of its wholly-owned preclinical and clinical-stage antibody programs.

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"We believe this transaction with Sagard validates the future commercial potential of JEMPERLI and brings significant non-dilutive funding to AnaptysBio," said Hamza Suria, president and chief executive officer of AnaptysBio. "Using our capital-efficient business model, AnaptysBio will continue to focus on advancing wholly-owned therapeutic antibodies to clinical data catalysts and the discovery of novel preclinical antibodies to emerging inflammation and immuno-oncology targets."

"We are thrilled to partner with AnaptysBio on this royalty transaction which reflects our confidence in JEMPERLI as a treatment for patients with certain endometrial and solid tumor cancers. Sagard’s investment is aligned with our goal of accelerating biopharmaceutical innovation by providing our partners with flexible sources of financing," said Ali Alagheband, Partner at Sagard Holdings.

Upon closing of this transaction, which is anticipated by the end of 2021, Sagard will pay AnaptysBio $250 million upfront in exchange for royalties payable to AnaptysBio under its GSK collaboration on annual global net sales of JEMPERLI below $1 billion starting October 2021. The royalty rate applicable below the $1 billion annual net sales threshold is 8%. Sagard may also receive up to a total of $105 million in potential cash milestones, of which $15 million are subject to certain future JEMPERLI regulatory filing and approval milestones and up to $90 million are subject to certain commercial sales milestones due prior to JEMPERLI achieving the $1 billion in annual global net sales threshold.

Royalties payable above $1 billion JEMPERLI annual global net sales, which are paid by GSK at 12% to 25%, and certain milestones payable on annual sales at or above $1 billion are retained by AnaptysBio and are not subject to this Agreement. Royalties and milestones due upon development and commercialization of the AnaptysBio-generated anti-TIM-3 antagonist (cobolimab) or anti-LAG-3 antagonist (GSK4074386) antibodies under the GSK collaboration, including in combination with JEMPERLI, are also not subject to this Agreement. In addition, royalties due to AnaptysBio from GSK’s global net sales of ZEJULA (niraparib) are excluded from this Agreement.

The aggregate JEMPERLI royalties and milestones to be received by Sagard under this Agreement is capped at certain fixed multiples of the upfront payment based upon time. Once Sagard receives an aggregate of either $312.5 million (125% of the upfront) by the end of 2026, or $337.5 million (135% of the upfront) during 2027 or $412.5 million (165% of the upfront) at any time after 2027, the Agreement will expire resulting in AnaptysBio regaining all subsequent JEMPERLI royalties and milestones. The closing of the transaction is subject to the satisfaction of customary closing conditions.

About JEMPERLI
Dostarlimab, the anti-PD-1 antagonist antibody commercially known as JEMPERLI, was generated by AnaptysBio using its proprietary somatic hypermutation (SHM) antibody platform and subsequently developed by TESARO, Inc., now a part of GSK, under a collaboration agreement. In April 2021, JEMPERLI was granted accelerated approval by the FDA for the treatment of certain adult patients with mismatch repair deficient (dMMR) endometrial cancer and conditional approval by the EMA for certain adult patients with dMMR or microsatellite instability-high (MSI-H) endometrial cancer. In August 2021, JEMPERLI was granted accelerated approval by the FDA for certain adult patients with dMMR solid tumors. JEMPERLI is also being developed by GSK for the treatment of other tumor types, including a currently ongoing phase III trial in first-line endometrial cancer (RUBY), an ongoing phase III trial with JEMPERLI and niraparib versus standard of care platinum-based therapy as first-line treatment of ovarian cancer (FIRST), and Phase II trials in non-small cell lung cancer, colorectal cancer, cervical cancer, multiple myeloma and melanoma. In June 2021, GSK estimated potential peak annual global JEMPERLI sales on a non-risk adjusted basis of £1-2 billion pounds, which is currently equal to approximately $1.4-$2.8 billion, for currently approved indications and first-line use in endometrial and ovarian cancer only.

On October 25, 2021 GE Healthcare reported that it will showcase over 15 innovative multi-modality radiation therapy solutions, offering medical practitioners imaging tools and support they need to improve patient-centered care and advance the practice of precision medicine (Press release, GE Healthcare, OCT 25, 2021, View Source [SID1234591921]).

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"GE Healthcare aims to drive improved patient outcomes through cutting-edge multi-modality radiation therapy planning and guidance solutions. Our expertise in clinical workflows, deep learning image reconstruction and image segmentation, and precision analytics can help support the delivery of more efficient, precise and personalized care," said Jan Makela, President & CEO, Imaging at GE Healthcare.

GE Healthcare’s precision radiation oncology technologies, including those listed below, provide clinicians with images and information for precise tailoring of treatments.

Below are highlights that GE Healthcare will be showcasing at ASTRO 2021 from October 24th to 27th:

Vysioneer VBrain: GE Healthcare is proud to announce its collaboration with Vysioneer. Vysioneer’s VBrain solution applies auto-contouring to the three most common types of brain tumors: brain metastasis, meningioma and acoustic neuroma. VBrain demonstrates 12.2 percent higher sensitivity for lesion detection while decreasing treatment planning time at a median of 30.8 percent. VBrain is vendor-neutral, integrating with different treatment planning systems by supporting data routing to and from DICOM nodes within a hospital network.[1]
Spectronic Medical Synthetic CT, MR[2] auto-segmentation: GE Healthcare will integrate Spectronic Medical AB’s AI-based software for more precise cancer treatment planning. This AI solution, in combination with GE Healthcare’s advanced AIR Recon DL technology, offers a deep learning solution and radiation therapy treatment planning alternative to standard CT images. The combined solution begins with GE Healthcare’s AIR Recon DL, a deep learning image reconstruction technology that leverages raw data from the MR scanner to reduce image noise, maximize image quality and resolution, and shorten scan times. The high-quality MR images generated by the GE scanner are then converted into synthetic CT images by Spectronic Medical’s AI-based solution, providing clinicians with the CT images they have come to expect with MR soft tissue details to more accurately target lesions and help improve patient outcomes.[3]
Mirada RTx[4]: As a part of their strategic collaboration to improve outcomes for patients, GE Healthcare and Mirada Medical are focusing on advancing automation and Artificial Intelligence (AI) technologies to enable faster, more consistent and more precise cancer radiotherapy treatment. To do so, the Mirada Medical RTx product has been integrated into the GE Healthcare AW Workstation and AW Server to enable enhanced cancer visualization and diagnostic capabilities. These integrations result in increased automation to deliver improvements in care workflows and help drive efficiency and time savings.
Discovery MI Gen 2: GE Healthcare’s Discovery MI Gen 2 brings together the high sensitivity[5] of digital detection with the company’s industry-first CT image reconstruction technology: Deep Learning Image Reconstruction for TrueFidelity CT Images. Generated using a dedicated deep neural network, TrueFidelity CT Images have the potential to improve reading confidence in a wide range of clinical applications such as head, whole body and cardiovascular, for patients across age groups.. The system also offers Q.Clear for up to 2x improvement in image quality (SNR) as well as MotionFree for up to 67 percent improvement in lesion volume measurements[6].
Revolution Platform: GE Healthcare’s family of intelligent CT scanners helps clinicians plan treatments to deliver more precise and efficient RT imaging solutions. The powerful Revolution platform is built on the wide-coverage Gemstone Clarity detector, Deep Learning Image Reconstruction and Gemstone Spectral Imaging to deliver superb clarity for optimizing treatment planning and diagnostic images. It empowers clinicians to stay ahead of the curve in an increasingly competitive market with scalable solutions that broaden healthcare system capabilities today and tomorrow.
Discovery RT Gen 3: Discovery RT is a wide-bore scanner providing a thorough approach to radiation therapy planning. In addition to providing a streamlined workflow and sub-millimetric images that are effectively free of motion and metal artifacts, the system also allows for simulation across an 80 cm wide bore with 80 cm field of view reconstruction. Discovery RT expands capabilities to also meet specific needs in diagnostic, interventional and bariatric imaging.
Through these and a variety of additional solutions, GE Healthcare aims to further reinforce its role as a core partner in multidisciplinary cancer care and provide increasingly accessible, more precise, and high-value radiation therapy.

GE Healthcare will be exhibiting at booth 1337 from October 24th to 27th.

On October 25, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes, reported it has entered into a clinical trial collaboration agreement with Merck (Press release, Hummingbird Bioscience, OCT 25, 2021, View Source [SID1234591920]).

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Under this collaboration, Hummingbird will evaluate the safety, tolerability, and anti-tumor activity of its novel anti-VISTA antibody, HMBD-002, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC) and other cancers with high VISTA expression. HMBD-002 is anticipated to enter a Phase 1 clinical trial in 2021.

VISTA is a co-inhibitory immune checkpoint receptor that is involved in suppressing an anti-tumor immune response. Overexpression of VISTA in the immune cells in tumors has also been associated with acquired resistance to other checkpoint therapies, such as anti-PD1 therapies. TNBC and NSCLC were identified as priority indications for clinical investigation based on the unmet need for new treatment options and widespread expression of VISTA in these tumor types. HMBD-002 is the only IgG4 isotype anti-VISTA antibody currently in development. It is precisely engineered to bind to VISTA at a specific site that is predicted to be essential for ligand-binding and function, and thereby inhibits VISTA by neutralizing its immunosuppressive activity without depleting other VISTA expressing cells that play many important roles in the immune system. Preclinical studies have demonstrated potent anti-tumor activity both as single agent and in combination with PD-1 therapy.

"Our preclinical studies have shown that VISTA in combination with PD-1 therapy can enhance anti-tumor activity. We look forward to initiating clinical trials for HMBD-002 as we aim to develop new treatment options for patients who do not respond to existing therapies," said Piers Ingram, Chief Executive Officer and co-founder of Hummingbird.

About HMBD-002

HMBD-002 represents a unique first-in-class anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. It was engineered to bind to VISTA at a specific site that was predicted to be essential for ligand-binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA expressing cells that play many important roles in the immune system. Preclinical models have shown that HMBD-002 as a monotherapy inhibits tumor growth and significantly prolongs progression-free survival, with no observed toxicity. HMBD-002 has also shown enhanced anti-tumor activity when used in combination with anti-PD-1 therapy. HMBD-002 is being developed for multiple cancers that have strong evidence of VISTA mediated suppression both as a monotherapy and in combination with PD-1 inhibitor. The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded Hummingbird a US$13.1 million product development grant to advance HMBD-002 into clinical trials.

On October 25, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that Juventas Cell Therapy Ltd. ("Juventas") has completed a Series C financing round through which it raised more than RMB410 million (approximately $63 million (USD)) (Press release, CASI Pharmaceuticals, OCT 25, 2021, View Source [SID1234591919]). Juventas states that the funds will be used to pursue a new drug application in China and launch implementation of a commercialization and international research and development plan for CNCT19.

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CASI shares global co-commercial and profit-sharing rights with Juventas and indirectly owns a 12.0098% equity stake in Juventas on a fully diluted basis following completion of the Series C financing round. The Juventas’ financing was led by CICC Capital.

Dr. Wei-Wu He, CEO and Chairman of CASI comments: "CASI, through its commercialization of Evomela in China, has built a robust commercial team in the hematology-oncology market. Juventas is a leading cell therapy innovator in China. The collaboration between CASI and Juventas will speed up the adoption of CAR-T therapy in China, helping thousands of patients in need of this breakthrough therapy."

About CNCT19

CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas will co-commercialize CNCT19 under the direction of the program’s joint steering committee.

On October 25, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in four upcoming virtual investor conferences (Press release, BioMarin, OCT 25, 2021, View Source [SID1234591918]). An audio webcast of the presentations will be available live. You can access the webcasts at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

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