On December 2, 2021 BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that clinical results and updates from its diverse immuno-oncology portfolio will be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2021 being held December 8-11, 2021 (Press release, BeiGene, DEC 2, 2021, View Source [SID1234596410]).

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"Despite recent advances in immuno-oncology, chemotherapy remains the standard of care for many patients living with cancer around the world. We look forward to presenting findings on the potential of our anti-PD-1 antibody tislelizumab to treat nasopharyngeal cancer, a rare cancer that is more common in underserved areas of the world, as well as in melanoma and ovarian cancer," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "Our R&D team, one of the largest oncology R&D teams in the world, is exploring novel combinations and mechanisms of action around the PD-1 axis to identify potential synergies and overcome PD-1 resistance, as we work to increase access to innovative medicines for patients with limited treatment options."

To learn more about BeiGene’s research and development and activities at ESMO (Free ESMO Whitepaper) IO, please visit View Source

Broad Clinical Program to Address Unmet Needs

To bring forth potential new treatment options and uncover further insights into checkpoint inhibition in solid tumors and hematological malignancies, BeiGene is evaluating tislelizumab, a potentially differentiated anti-PD-1 antibody, in a broad clinical program, including 13 Phase 3 trials and four pivotal Phase 2 trials, and in collaboration with Novartis.

At ESMO (Free ESMO Whitepaper) IO, results from an interim analysis of the randomized, double-blind, Phase 3 RATIONALE 309 trial (NCT03924986) evaluating tislelizumab in combination with chemotherapy in recurrent or metastatic nasopharyngeal cancer (RM-NPC) will be presented in a Proffered Paper. These results supported the regulatory submission in China for NPC.

Novel Combination Therapies to Expand Clinical Benefit of Anti-PD-1 Antibodies

Combination strategy is considered key to overcoming primary and acquired resistance to anti-PD-1 therapy and expanding clinical benefit of immunotherapy to more patients. BeiGene is investigating the potential of novel tislelizumab combinations to drive stronger and more sustained tumor responses and impede tumor immune escape. At ESMO (Free ESMO Whitepaper) IO, results from two cohorts of a Phase 1b trial (NCT03666143) evaluating tislelizumab in combination with the oral, spectrum-selective kinase inhibitor sitravatinib in metastatic melanoma and platinum-resistant ovarian cancer will be presented. BeiGene is developing sitravatinib in collaboration with Mirati Therapeutics, Inc.

Additionally, BeiGene will share details on the design of the Phase 3 AdvanTIG-301 trial (NCT04866017) evaluating its investigational Fc-competent anti-TIGIT-antibody ociperlimab in combination with tislelizumab and concurrent chemoradiotherapy (eCRT) as a first-line treatment for patients with locally advanced, unresectable non-small cell lung cancer.

BeiGene’s Presentations at ESMO (Free ESMO Whitepaper) IO Congress 2021

Presentation Information

Date and Time

Lead Author

121O—RATIONALE 309: A randomized, global, double-blind, Phase 3 trial of tislelizumab versus placebo, plus gemcitabine + cisplatin, as first-line treatment for recurrent/metastatic nasopharyngeal cancer

Proffered Paper Session 2

Fri, Dec 10 at 9 AM CET

Yunpeng Yang

156P—BGB-900-103 Cohort G: Safety/tolerability and antitumor activity of sitravatinib plus tislelizumab in patients with PD-(L)1-refractory/ resistant unresectable or metastatic melanoma from a Phase 1b study

ePoster Display: Therapeutic Development

Thu, Dec 9 at 11:30 AM CET

Chuanliang Cui

153P—BGB-900-103 Cohort E: Safety/tolerability and antitumor activity of sitravatinib plus tislelizumab in patients with advanced platinum-resistant ovarian cancer

ePoster Display: Therapeutic Development

Thu, Dec 9 at 10:30 AM CET

Jeffrey Goh
144P—Tislelizumab combined with chemotherapy as neoadjuvant therapy for surgically resectable esophageal cancer (TD-NICE): a single arm, phase II study

ePoster Display: Therapeutic Development

Thu, Dec 9 at 7:30 AM CET

Xiaolong Yan

148P—A Phase II Study of tislelizumab plus chemotherapy in EGFR mutated advanced non-squamous NSCLC patients failed to EGFR TKI therapies: first analysis

ePoster Display: Therapeutic Development

Thu, Dec 9 at 8:50 AM CET

Baohui Han

167TiP—AdvanTIG-301: Anti-TIGIT monoclonal antibody ociperlimab plus tislelizumab plus concurrent chemoradiotherapy followed by ociperlimab plus tislelizumab or tislelizumab plus concurrent chemoradiotherapy followed by tislelizumab versus concurrent chemoradiotherapy followed by durvalumab in previously untreated, locally advanced, unresectable non-small cell lung cancer

ePoster Display: Therapeutic Development

Thu, Dec 9 at 3:10 PM CET

Ligang Xing

BeiGene Oncology

BeiGene is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D team of approximately 2,750 colleagues dedicated to advancing more than 70 clinical trials involving more than 14,000 patients and healthy volunteers. Our expansive portfolio is directed by a predominantly internalized clinical development team supporting trials in more than 45 countries. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. We currently market three medicines discovered and developed in our labs: BTK inhibitor BRUKINSA in the United States, China, Canada, Australia and additional international markets; and non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen and Bristol Myers Squibb. We also plan to address greater areas of unmet need globally through our collaborations including with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen, and Zymeworks. BeiGene has also entered into a collaboration with Novartis granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

On December 2, 2021 Lupin Inc., a wholly-owned subsidiary of global pharma major, Lupin Limited (Lupin) reported that it has entered into an agreement with TTP plc (The Technology Partnership plc) to acquire the exclusive worldwide rights to develop, manufacture and commercialize inhalation products using TTP’s soft-mist inhalation technology platform (Press release, Lupin, DEC 2, 2021, View Source [SID1234596429]). By leveraging this technology, Lupin expects to provide healthcare professionals with alternative solutions for delivering affordable inhaled medicines to patients across the globe.

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Soft-mist inhalation (SMI) technology allows for delivery of inhalation drugs from a small, portable hand-held inhaler device without the use of propellants. The individual doses are delivered using a precisely engineered nozzle system to produce a slow-moving and long-sustaining aerosol cloud. Lupin anticipates applications across respiratory care.

Lupin and TTP will jointly develop the device. Lupin will commercially manufacture the device through its network of in-house and external manufacturing locations. Lupin will also develop and manufacture formulations to be delivered through the device, obtain the necessary regulatory approvals, and commercialize the products globally.

Commenting on the development Vinita Gupta, Global CEO, Lupin said, "Inhalation is a strategic pillar of Lupin’s growth story, as we strive to bring affordable medicines to patients across the globe. The partnership with TTP for SMI technology platform is a strategic addition to our broad Inhalation capabilities."

Alok Sonig, CEO – US Generics & Global R&D Head, Lupin added, "Lupin is excited to be partnering with TTP. The organizations will work together to develop products using TTP’s SMI technology that complement Lupin’s portfolio of complex inhalation products."

Commenting on the development, Sam Hyde, Managing Director, TTP said, "We are excited to be partnering with Lupin to commercialize our SMI technology so that it can benefit patients suffering with chronic respiratory conditions. TTP has deep expertise in aerosol science, and we have been working with our clients for over 30 years in complex drug delivery device development – this partnership represents an exciting next step for us in this innovative area of respiratory drug delivery."

On December 2, 2021 Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, reported recent pipeline and business progress and third quarter 2021 financial results (Press release, Xilio Therapeutics, DEC 2, 2021, View Source [SID1234596393]).

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"Xilio made significant progress in 2021 as we transitioned to a clinical stage organization with XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, and XTX202, a tumor-selective IL-2, in clinical development," said René Russo, Pharm. D., president and chief executive officer of Xilio. "With the recent completion of our IPO and a strong and experienced team in place, we are well-positioned to leverage our geographically precise solutions (GPS) platform to advance our pipeline of immuno-oncology therapies that have the potential to achieve meaningful anti-tumor activity while minimizing serious, systemic effects for the benefit of cancer patients."

Recent Pipeline and Business Progress

Cytokine Programs

In October 2021, the U.S. Food and Drug Administration (FDA) cleared Xilio’s investigational new drug application (IND) to evaluate XTX202, a tumor-selective interleukin-2 (IL-2), as a potential treatment for patients with solid tumors. XTX202 is designed to localize activity in the tumor microenvironment, with the goal of overcoming the known toxicity challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity.
In November 2021, at the Society for Immunotherapy in Cancer’s 36th Annual Meeting, Xilio reported data from preclinical studies for XTX301, a tumor-selective interleukin-12 (IL-12). Findings demonstrated selective anti-tumor activity and favorable tolerability with minimal systemic effects observed in mouse models evaluating a murine surrogate for XTX301 and non-human primate models evaluating XTX301.
Checkpoint Inhibitor Program

In September 2021, Xilio initiated patient dosing in its Phase 1/2 clinical trial evaluating XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, for the treatment of solid tumors as a monotherapy and in combination with pembrolizumab, an anti-PD-1. XTX101 is designed to improve upon the therapeutic index of existing anti-CTLA-4 therapies by overcoming their historical potency and tolerability limitations, as well as the inability to use existing anti-CTLA-4 therapies at their full dose in combination with other immuno-oncology therapies.
Recent Business Highlights

On October 26, 2021, Xilio closed its initial public offering (IPO). In connection with the IPO, Xilio issued and sold 7,353,000 shares of common stock at a public offering price of $16.00 per share, and on November 1, 2021, Xilio issued and sold an additional 766,106 shares of common stock at a public offering price of $16.00 per share pursuant to the partial exercise by the underwriters of their option to purchase additional shares. Xilio received aggregate gross proceeds of approximately $129.9 million or aggregate net proceeds of approximately $116.3 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by Xilio.
Appointed Tim Hunt as Xilio’s chief culture and corporate affairs officer in October 2021.
Appointed Sara Bonstein, chief financial officer of Insmed, Inc., to Xilio’s board of directors in August 2021.
Anticipated Milestones in 2022

Xilio currently anticipates the following milestones in 2022:

Initiation of a Phase 1/2 clinical trial to evaluate XTX202 in multiple solid tumor types in the first quarter of 2022
Presentation of preliminary data for the monotherapy cohort of the Phase 1/2 clinical trial evaluating XTX101 in patients with advanced solid tumors in the middle of 2022
Presentation of preliminary Phase 1 data for XTX202 in patients with multiple solid tumor types in the second half of 2022
Presentation of preliminary data from the combination cohort for the Phase 1/2 clinical trial evaluating XTX101 in patients with advanced solid tumors in the second half of 2022
Submission of an IND for XTX301 in the second half of 2022
Third Quarter 2021 Financial Results

Cash Position and Guidance: Cash and cash equivalents were $99.8 million as of September 30, 2021, compared to $19.2 million as of December 31, 2020. Cash and cash equivalents as of September 30, 2021 do not include $116.3 million in estimated net proceeds from Xilio’s October 2021 IPO. Xilio believes that its existing cash and cash equivalents, together with the net proceeds from its IPO, will enable it to fund its operating expenses and capital expenditure requirements into 2024.
Research & Development (R&D) Expenses: R&D expenses were $10.5 million for the third quarter of 2021, compared to $11.5 million for the third quarter of 2020. This decrease was primarily driven by lower comparable costs associated with manufacturing development activities for the XTX101 and XTX202 programs, partially offset by higher personnel-related costs due to increased headcount and preclinical research and clinical development expenses.
General & Administrative (G&A) Expenses: G&A expenses were $5.5 million for the third quarter of 2021, compared to $3.2 million for the third quarter of 2020. This increase was primarily driven by higher personnel-related costs due to increased headcount and higher professional fees related to ongoing business activities and preparations related to operating as a public company.
Net Loss: Net loss was $16.3 million for the third quarter of 2021, compared to $14.8 million for the third quarter of 2020.

On December 2, 2021 ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company and Navigo Proteins GmbH, a premier protein engineering company developing optimized scaffold protein-based affinity ligands called Affilin molecules from its Precision Targeting toolbox, reported a research collaboration for the development of a fibroblast activation protein (FAP)-targeted radiopharmaceutical program for the treatment of solid tumors (Press release, ITM Isotopen Technologien Munchen, DEC 2, 2021, View Source [SID1234596411]). The program is planned to be added to ITM’s growing proprietary pipeline of Targeted Radionuclide Therapies spanning multiple radioisotopes and targeting molecules for optimal therapeutic effect. FAP-Targeted Radionuclide Therapy is a promising new approach to treating cancer within the precision oncology field.

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Under the terms of the agreement, Navigo’s proprietary protein engineering platform will be used to develop and select a FAP-targeting Affilin molecule which will then be coupled with a therapeutic radioisotope provided by ITM. Following candidate selection, ITM will have the exclusive rights to further advance the radiolabeled FAP-specific Affilin through clinical testing in potentially multiple cancer indications. The agreement also includes a non-exclusive license for diagnostic use in radio-imaging. Further details of the agreement were not disclosed.

"FAP-targeting approaches have received heightened attention for good reason. We believe this approach holds the potential to treat a wide range of cancer indications. As such, we look forward to exploring this innovative targeted radiopharmaceutical approach for our growing precision oncology pipeline, further expanding its reach and breadth. We believe that developing a new candidate by combining our radioisotopes with an Affilin ligand targeting FAP has the opportunity to make a difference in the lives of patients," commented Steffen Schuster, CEO of ITM.

FAP is a highly attractive tumor target for Targeted Radionuclide Therapy that is preferentially expressed on cancer cells and in particular on cancer associated fibroblasts (CAFs). It is detectable in most epithelial cancers, including over 90% of breast, lung, colorectal and pancreatic carcinomas. High expression levels are associated with poor prognosis, and therefore warrant additional medical research and focus. ITM and Navigo are addressing this urgent need through their research collaboration and combined efforts to develop a promising FAP-targeted radiopharmaceutical.

"We welcome the opportunity to extend our productive partnership with ITM with yet another promising project. We strongly believe in the potential of our technology to generate high-quality Affilin ligands targeting FAP and capable of breaking the tumor microenvironment. By joining forces with ITM, we are fully equipped to build a strong FAP-targeting candidate, that ITM will then advance through clinical development," said Henning Afflerbach, CEO of Navigo Proteins.

The therapeutic candidate developed together by ITM and Navigo will enable a direct attack against tumor cells by irradiating them via crossfire effects in a highly precise manner. Through the direct depletion of CAFs it additionally provides a new access point to modify the tumor microenvironment in which CAFs play a central role in upholding the barrier for effective immune cell infiltration.

This agreement further strengthens the existing partnership between the two organizations, combining ITM’s deep expertise in developing promising Targeted Radionuclide Therapies for cancer patients with Navigo’s proprietary Affilin molecules and protein engineering proficiency.

On December 2, 2021 Omeros Corporation (Nasdaq: OMER) reported that it has entered into a definitive agreement for the sale of OMIDRIA to Rayner Surgical Group Limited (Press release, Omeros, DEC 2, 2021, View Source [SID1234596430]). Expected to close on or before December 31, 2021, the transaction includes an upfront payment of $125 million with an additional $200 million in a commercial milestone payment . Omeros will also retain its accounts receivable balance at the closing, which was $34 million at the end of last quarter. Together with substantial royalties to be paid by Rayner to Omeros on net sales of OMIDRIA, the transaction is valued in excess of $1 billion.

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Rayner will pay Omeros royalties on both U.S. and ex-U.S. net sales of OMIDRIA. In the U.S., the royalty rate will be 50 percent of U.S. net sales until the earlier of either January 1, 2025 or payment of the $200-million commercial milestone, after which Omeros will receive royalties of 30 percent of U.S. net sales for the life of OMIDRIA’s U.S. patent estate. The commercial milestone payment is triggered if separate payment for OMIDRIA is secured for a continuous period of at least four years. Outside of the U.S., Omeros will receive a 15-percent royalty rate on OMIDRIA net sales throughout the applicable patent life on a country-by-country basis.

OMIDRIA will become a key product in Rayner’s ophthalmology franchise, which includes intraocular lenses, ophthalmic viscoelastic devices and dry eye treatments. As part of the agreement, Rayner will acquire the OMIDRIA commercial organization, including the OMIDRIA sales force. In addition, Rayner plans to expand the sales force in both the U.S. and ex-U.S., further strengthening its commercial presence internationally and further accelerating U.S. market growth of OMIDRIA.

"OMIDRIA will be an important part of our ophthalmic product portfolio internationally and a key strategic focus for Rayner," said Tim Clover, chief executive officer of Rayner. "Our new OMIDRIA business and commercial team of seasoned industry professionals are an ideal fit for Rayner as we focus on broadly serving ophthalmic surgeons with our pipeline of innovative products, including the recently FDA-approved RayOne EMV intraocular lens. We look forward to continue growing U.S. sales of OMIDRIA and the rest of our portfolio and to launching EMA-approved OMIDRIA throughout Europe and other regions of the world, consistent with our mission of offering superior products and outcomes for surgeons and their patients."

The transaction is subject to customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

"We are immensely proud of our OMIDRIA team and its achievements over the last seven years," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "OMIDRIA has become an important part of cataract surgery, de-risking the procedure for surgeons and improving patient outcomes. This transaction recognizes both the current and future value that OMIDRIA brings to cataract surgery, affording Omeros a significant ongoing economic interest in the expected growth of OMIDRIA, while allowing us to focus our efforts primarily on our complement franchise of large- and small-molecule MASP-2 and MASP-3 inhibitors as well as on the rest of our innovative pipeline. We believe that Rayner, with its expertise and increasingly strong international presence in ophthalmology, represents a great home for OMIDRIA and the product’s commercial team, and Omeros is committed to assist Rayner, throughout the transition and beyond, to maximize OMIDRIA utilization and revenues."

Conference Call Details

Omeros’ management will host a conference call to discuss today’s announcement. The call will be held today at 8:30 a.m. Eastern Time; 5:30 a.m. Pacific Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 9080996. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 9080996.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at View Source

About OMIDRIA

Omeros’ OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is the first and only FDA-approved product of its kind and is marketed in the U.S. for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. OMIDRIA also is the only NSAID-containing product FDA-approved for intraocular use. In post-launch studies across conventional and femtosecond laser-assisted cataract surgery, OMIDRIA has been shown to (1) prevent intraoperative floppy iris syndrome (IFIS) and iris prolapse, (2) significantly reduce complication rates (including sight-threatening cystoid macular edema and breakthrough iritis), use of pupil-expansion devices, and surgical times, (3) significantly reduce intraoperative use of the opioid fentanyl and postoperative prescription opioids, (4) enable performance of surgery and postoperative care without the use of steroids, and (5) significantly improve uncorrected visual acuity on the first day following cataract surgery. While OMIDRIA is broadly indicated for use in cataract surgery, the post-launch outcomes cited above are not in its currently approved labeling.

Important Safety Information for OMIDRIA Systemic exposure of phenylephrine may cause elevations in blood pressure. In clinical trials, the most common reported ocular adverse reactions at two percent or greater are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation; incidence of adverse events was similar between placebo-treated and OMIDRIA-treated patients. OMIDRIA must be added to irrigation solution prior to intraocular use.