On January 25, 2024 Alphamab Oncology (stock code: 9966.HK) and 3DMedicines (stock code: 1244.HK) ("Licensors") reported that we entered into a license agreement with Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals Ltd. (BSE: 532296，NSE: GLENMARK) for the subcutaneous injection PD-L1 antibody drug (R&D code: KN035, generic name: Envafolimab), pursuant to which, Glenmark was granted exclusive licensing interests in clinical development and commercialization of oncology indications in India, Asia Pacific(except Singapore, Thailand, Malaysia), the Middle East and Africa, Russia, CIS and Latin America. Glenmark will develop and commercialize KN035 in the Field in the Territory at its own cost and expense.

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Under the License Agreement, Licensors will receive from GSSA (a) a total of up to US$700.8 million of a non-refundable upfront payment and milestones payments subject to the achievement of certain development, regulatory and commercialization milestones, and (b) a single to double digits percentage royalty fee according to the level of net sales of KN035. The Licensors’ respective entitlement to the payments (including the upfront payment, milestone payment and the royalty fees) under the License Agreement are subject to the agreements between Jiangsu Alphamab and 3D Medicines.Jiangsu Alphamab retains its sole right to manufacture KN035 for any purpose within or outside the Territory. 3D Medicines retains the right to develop and commercialize KN035 for any purpose in the field of tumor outside the Territory.

We believe that the cooperation will enable Jiangsu Alphamab to effectively utilize the existing team and resources of Glenmark and establish a favorable market position for KN035 in the Territory rapidly. The implementation of the License Agreement will have a positive impact on the commercialization of KN035 in the Territory.

Dr. Ting Xu, Chairman, and CEO of Alphamab Oncology, remarked, "This collaboration holds significant importance for the continued advancement of Envafolimab. Leveraging Glenmark’s robust development and commercialization capabilities, we are confident that Envafolimab will reach a substantial number of patients in the specified territory, especially in regions where cancer patients face underserved conditions. The notable advantages of Envafolimab in terms of safety, convenience, and compliance position it as a competitive product. We eagerly anticipate a successful collaboration."

Dr. Gong Zhaolong, Chairman and CEO of 3D Medicines, remarked, "We are very pleased that Envolizumab can help more cancer patients. This cooperation is good news for more cancer patients. In a wide range of emerging markets, patients need more convenient and innovative treatments. We will work together to serve more cancer patients and help them live longer and better."

"This marks an important milestone for us at Glenmark, through this transformational deal we get access to the first recombinant humanized single domain antibody against PD-L1 in a SubQ formulation for a wide territory globally. We are excited to take this innovative product across our territory and meaningfully contribute to the spread of immune Oncology treatments to potentially help cancer patients across emerging markets." remarked Glenn Saldanha, Chairman & Managing Director Glenmark Pharmaceuticals Ltd.

About Envafolimab（KN035）

Envafolimab is a single domain Fc fusion PD-L1 antibody independently invented by Alphamab Oncology，and co-developed with 3D (Beijing) Medicines since 2016. On March 30, 2020, Alphamab Oncology, 3DMed, and Simcere reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, and 3DMed is responsible for the clinical development in oncology field, and Simcere is responsible for the exclusive commercial promotion of products in mainland China.

Based on its unique design that allows rapid subcutaneous injection, it has advantages of improved safety, convenience in drug administration, and treatment compliance. Patients do not require an intravenous infusion which lowers medical costs. At present, Envafolimab is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phase III clinical trials in multiple indications. Envafolimab obtained orphan drug designation from the US FDA for the treatment of advanced biliary tract cancer and soft tissue sarcoma. In November 2021, Envafolimab obtained the market approval by the Chinese National Medical Products Administration for the treatment of MSI-H or dMMR advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens as well as patients with other advanced solid tumors who have experienced disease progression following prior treatment and have no satisfactory alternative treatment options.

(Press release, Alphamab, JAN 25, 2024, View Source [SID1234657017])

On January 25, 2024, HOOKIPA Pharma Inc. ("HOOKIPA") received written notice (the "Notice") from F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (collectively referred to as "Roche") of their decision to terminate the Research Collaboration and License Agreement (the "Collaboration Agreement") among Roche and Hookipa Biotech GmbH ("HOOKIPA GmbH," and together with HOOKIPA, the "Company"), a wholly-owned subsidiary of HOOKIPA, dated October 18, 2022 (Filing, Hoffmann-La Roche, JAN 25, 2024, View Source [SID1234642009]). Roche’s decision to terminate the Collaboration Agreement was made according to Roche’s right to terminate without cause, acknowledging that, to date, HOOKIPA met all go-forward criteria under the Collaboration Agreement.

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The Collaboration Agreement was entered into to (i) grant Roche an exclusive license to research, develop, manufacture and commercialize the Company’s pre-clinical HB-700 cancer program, an arenaviral immunotherapeutic for KRAS-mutated cancers, and (ii) grant Roche an option right to exclusively license for research, development manufacturing and commercialization, a second, novel arenaviral immunotherapeutic program targeting undisclosed cancer antigens.

Pursuant to the terms of the Collaboration Agreement and the Notice, the Collaboration Agreement will be terminated on April 25, 2024. The Company remains eligible for a final milestone payment associated with an IND submission. Effective April 25, 2024, the Company will regain full control of the associated intellectual property portfolio and will have full collaboration and licensing rights for the HB-700 program. After the termination of the Collaboration Agreement, and except as disclosed above, there is no other material relationship between the Company and Roche.

On January 25, 2024 Be Biopharma, Inc. ("Be Bio"), a company pioneering the development of engineered B Cell Medicines (BCMs), reported an oral presentation and poster presentation at the Keystone Symposia on Emerging Cellular Therapies meeting, held from January 22 to 25, 2024 in Santa Fe, New Mexico (Press release, Be Biopharma, JAN 25, 2024, View Source [SID1234639549]). The data being presented support the utility of engineered B cell medicines (BCMs) across a broad range of applications. Together, the data demonstrate in vitro production and activity of several therapeutic proteins, as well as in vivo engraftment without preconditioning and activity in multiple model systems.

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"Gene and cell therapies have transformative potential to treat previously intractable diseases, but have barriers to adoption such as lack of durability, inability to re-dose, and requirement of preconditioning for engraftment. Our BCM platform has the potential to address these barriers," said Richard A. Morgan, Ph.D., Chief Scientific Officer, Be Bio. "The in vivo preclinical data presented today validates key attributes of our BCM platform – efficient protein production, editing and insertional efficiency, and durable protein production without preconditioning – while demonstrating its potential therapeutic benefits in genetic disease and cancer."

Presentation Summary: Development of an Ex Vivo Precision Gene Engineered B Cell Medicine Platform that Produces Active and Sustained Levels of Therapeutic Proteins with Broad Utility

BCMs were produced via a precision genome engineering platform that achieves gene knockouts with greater than 90% efficiency and targeted HDR-mediated gene insertions at up to 60%. Modularity of the BCM platform was demonstrated across multiple models and proteins, including production of firefly luciferase, lysosomal storage disease enzyme acid sphingomyelinase, an anti-CD19/CD3 bispecific T cell engager, clotting factor IX, and fusion protein of tissue nonspecific alkaline phosphatase (ALP). These examples demonstrate that these BCMs can produce proteins with enzyme specific activity higher than recombinant proteins (ASM), show efficacy in tumor treatment (anti-CD19/CD3 scFv), and are stably expressed for at least 20 weeks in vivo (FIX). Engraftment in all models was achieved without preconditioning which broadens BCM clinical utility for patients for whom preconditioning toxicities are unacceptable or outweigh therapeutic benefit, and could facilitate additional rounds of treatment as needed. BCMs capable of expressing therapeutically relevant transgenes have the potential for broad and meaningful therapeutic utility in genetic diseases, cancer, and beyond.

Details for the oral presentation of this study are as follows:

Title: "Development of an Ex Vivo Precision Gene Engineered
B Cell Medicine Platform that Produces Active and Sustained Levels of Therapeutic Proteins with Broad Utility"

Lead Author: Hanlan Liu, Ph.D., MBA, Senior VP, Pipeline and Non-clinical Development, Be Biopharma

Presenter: Hanlan Liu, Ph.D., MBA, Senior VP, Pipeline and Non-clinical Development, Be Biopharma

Date/Time: Tuesday, January 23, 2024, 5:00-7:00pm (MST)

Session: Strategies for Engineered Cell Therapies

Poster Summary: Development of an Ex Vivo Precision Gene Engineered B Cell Medicine Platform that Produces Active and Sustained Levels of Therapeutic Proteins with Broad Utility in Rare Diseases and Cancer

This study demonstrates production of BCMs via editing, expansion and differentiation of primary human B cells. Cells engineered to express firefly luciferase were engrafted into NOG-hIL6 mice and demonstrated in vivo persistence for 125 days. Data are also presented on BCMs engineered to produce FIX, which demonstrates activity via the chromogenic and aPTT assay. These BCMs were engrafted into NOG-hIL6 mice and demonstrate durable FIX secretion to 168 days. In addition to FIX, BCMs were engineered to produce an anti-CD19/CD3 bispecific T cell engager, which demonstrated potent activity in an in vivo PdX model of ALL, ALP, which corrected HPP-related bone mineralization deficits in vitro, and ASM, which demonstrated in vitro phenotypic correction in SMPD1 knockout cells. In addition, ex vivo-rhesus macaque plasma cells were generated and labeled with a radioactive tracer. These cells were administered without preconditioning and demonstrated homing to and engraftment in plasma cell niches in an autologous rhesus macaque.

Details for the poster presentation of this study are as follows:

Title: "Development of an Ex Vivo Precision Gene Engineered B Cell Medicine Platform that Produces Active and Sustained Levels of Therapeutic Proteins with Broad Utility in Rare Diseases and Cancer"

Lead Author: Hanlan Liu, Ph.D., MBA, Senior VP, Pipeline and Non-clinical Development, Be Biopharma

Presenter: Hanlan Liu, Ph.D., MBA, Senior VP, Pipeline and Non-clinical Development, Be Biopharma

Poster #: 2

Poster Session: Wednesday, January 24, 2024, 7:30pm (MST)

About Engineered B Cell Medicines – A New Class of Cellular Medicines

The B cell is a powerful cell that produces thousands of proteins per cell per second at constant levels, over decades. Precision genome editing can now be used to engineer B Cells that produce therapeutic proteins of interest, driving a new class of cellular medicines – Engineered B Cell Medicines (BCMs) – with the potential to be durable, allogeneic, redosable and administered without pre-conditioning. The promise of BCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

On January 25, 2024 ArriVent BioPharma, Inc. ("ArriVent") (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported the pricing of its upsized initial public offering of 9,722,222 shares of its common stock at a public offering price of $18.00 per share (Press release, ArriVent Biopharma, JAN 25, 2024, https://arrivent.com/arrivent-announces-pricing-of-upsized-initial-public-offering/?utm_source=rss&utm_medium=rss&utm_campaign=arrivent-announces-pricing-of-upsized-initial-public-offering [SID1234639545]). All of the shares of common stock are being offered by ArriVent. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by ArriVent, are expected to be approximately $175.0 million. ArriVent’s common stock are expected to begin trading on the Nasdaq Global Market on January 26, 2024 under the ticker symbol "AVBP." The offering is expected to close on January 30, 2024, subject to the satisfaction of customary closing conditions. In addition, ArriVent has granted the underwriters a 30-day option to purchase up to an additional 1,458,333 shares of its common stock at the initial public offering price, less underwriting discounts and commissions.

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Goldman Sachs & Co. LLC, Jefferies and Citigroup are acting as joint book-running managers for the offering. LifeSci Capital is acting as the lead manager for the offering.

Registration statements relating to the shares being sold in this offering have been filed with the Securities and Exchange Commission (the "SEC") and became effective on January 25, 2024. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering is being made only by means of a written prospectus. A copy of the final prospectus related to the offering will be filed with the SEC, and may be obtained, when available, from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, via telephone: (866) 471-2526, or via email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, via telephone: (877) 821-7388, or via email: [email protected]; or Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or via telephone: (800) 831-9146.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state, province, territory or other jurisdiction.

On January 25, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported the publication of two new studies in Nature Medicine evaluating Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera (Press release, Natera, JAN 25, 2024, View Source [SID1234639490]).

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The first study shows results from the single-arm, phase I AMPLIFY-201 trial evaluating the ELI-002 cancer vaccine. The study enrolled a total of 25 patients (20 pancreatic, 5 colorectal), 21 of whom were Signatera-positive after locoregional treatment. Signatera dynamics were also used as a secondary endpoint to assess tumor biomarker response, together with serum tumor antigens. This study is the first of its kind to have utilized circulating tumor DNA (ctDNA)-positivity in conjunction with other tumor biomarkers for enrollment, highlighting the use of Signatera for detecting early evidence of anti-tumor activity of a drug candidate to help assess for a dose response.

The study reported that tumor biomarker responses were observed in 21/25 patients (84%), and ctDNA clearance was observed in 6/25 patients (24%). In contrast, serum tumor antigens declined but did not clear, highlighting the potential utility of ctDNA to be used as a reliable surrogate biomarker for treatment efficacy.

"We are excited about our partnership with Natera, which has resulted in a successful prospective, phase I clinical trial focused on trial enrichment by enrolling Signatera-positive patients and monitoring therapy response in patients receiving a cancer vaccine," said Christopher Haqq, MD, PhD, Elicio Therapeutic, Inc’s executive vice president, head of research and development, and chief medical officer. "We are optimistic about the potential for this study to improve outcomes for patients with pancreatic and colorectal cancer, who face clinical challenges and are often incurable when ctDNA is detected after treatment."

A second study published in Nature Medicine, called PANDA, is a single-arm, open-label, phase II study that investigated preoperative atezolizumab plus chemotherapy in patients with resectable, non-metastatic gastric and gastroesophageal junction adenocarcinoma. The study included 20 patients who underwent surgery and were evaluated for safety, pathologic response, and survival endpoints, and Signatera was used to detect and monitor ctDNA dynamics in all 20 patients.

The PANDA study found that ctDNA clearance after neoadjuvant therapy correlated with pathologic response in 11/11 patients, while 3/6 patients with poor pathologic response remained ctDNA-positive (P=0.029). None of the patients with complete pathologic response (pCR) were ctDNA-positive, and among the nonresponders who were ctDNA negative (n=3), the study reported superior long-term outcomes. Additionally, ctDNA-positivity at the MRD and follow-up time points was associated with a recurrence rate of 100%.

"We’re pleased to see these excellent results from the PANDA study which demonstrate the strong correlation between ctDNA and pathologic response pre-surgery and the therewith associated recurrence risk, highlighting the potential utility of Signatera in gastric and gastroesophageal cancers," said Myriam Chalabi MD, PhD, medical oncologist, Netherlands Cancer Institute, and principal investigator of the PANDA study.

"PANDA and AMPLIFY-201 add to the growing number of studies supporting the use of Signatera across various GI indications, showing the promise of tumor-informed ctDNA testing to help personalize treatment strategies," said Alexey Aleshin, general manager of oncology and early cancer detection at Natera. "These studies also point to the valuable insights longitudinal ctDNA monitoring can provide in the evaluation of novel therapies."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers.