On April 28, 2022 BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, reported that the BTK inhibitor BRUKINSA (zanubrutinib) has been approved in Uruguay for the treatment of adult patients with previously treated mantle cell lymphoma (MCL), relapsed or refractory marginal zone lymphoma (MZL), and Waldenström’s macroglobulinemia (WM) (Press release, BeiGene, APR 28, 2022, View Source [SID1234613173]). BeiGene and Adium entered into an exclusive distribution agreement for Adium to commercialize BRUKINSA in Latin America.

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"Tolerability of treatments for B-cell malignancies is an important consideration with BTK inhibition, and BRUKINSA was designed with that in mind to maximize BTK occupancy and minimize off-target binding. Today, we have a new treatment option for patients with MCL, MZL and WM in Uruguay, providing hope for improved treatment outcomes," said Dr. Karina Cicinelli, Corporate Medical Director at Adium.

"We are proud of the progress BeiGene has made in Latin America over the past year, with this approval in three indications in Uruguay following recent launches in Brazil, Chile and Ecuador. With Adium’s established commercial presence in Latin America, we hope patients with MCL, MZL, and WM will soon have access to this important treatment option," commented Eduardo Molinari, Senior Director of New Market Development in Latin America at BeiGene.

About BRUKINSA

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

BRUKINSA has previously been approved for three indications in the United States: for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (Nov. 2019)*; for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) (Aug. 2021); and for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (Sept. 2021)*.

BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the United States, China, the EU and Great Britain, Canada, Australia and additional international markets. Currently, more than 40 additional regulatory submissions are in review around the world.

* This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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 and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. 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. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the 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, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.

On April 28, 2022 Chimera Bioengineering ("Chimera") a biotherapeutics company building next-generation CAR-T therapeutics focused primarily on solid tumors, reported the appointment of Vlad Hogenhuis, M.D., as Chief Executive Officer (CEO) (Press release, Chimera Bioengineering, APR 28, 2022, View Source [SID1234613172]). Previously, Dr. Hogenhuis was Chief Operating Officer at Ultragenyx Pharmaceuticals and Head of Specialty Pharma and Oncology at GSK. The Company also announced it won AFCR’s 2021 BRACE Award Venture Competition, in recognition of Chimera’s breakthrough science for the development of transformative cancer therapeutics. Chimera’s lead candidate, CBIO-007, is a conditionally armed CAR-T cell therapy in preclinical development as a potential treatment for major solid tumors, such as lung, breast, colorectal, pancreatic, prostate, and ovarian cancers. CBIO-007 was generated from Chimera’s proprietary GOLD Platform technology, which creates conditional, location-specific activation of tumor microenvironment (TME)-modifying payloads by CAR-T cell therapies.

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"When I was evaluating opportunities, I was immediately struck by the elegance and enormous potential impact of Chimera’s approach to enhance CAR-T efficacy while minimizing their toxicity," said Dr. Hogenhuis. "We are thrilled to have won AFCR’s BRACE Award, which has not only connected us to investors and advisors, it also has provided key funding and validation of our approach and current dataset. We’ve generated compelling preclinical data confirming delivery of potent immunomodulatory payloads to solid tumors without systemic exposure, and this data gives us confidence that Chimera’s GOLD Platform technology can unlock the potential of CAR-T to treat a broad range of cancers, including solid tumors."

AFCR’s BRACE Award is a first-of-its-kind program for early stage oncology technology companies focused on Asian-prevalent cancers. With this honor, AFCR, Bluedot Bio, and other new investors contributed $7.5 million of new capital, joining Chimera’s existing investors, including Viking Global Investors, Founders Fund, and Illumina Accelerator, to bring the company’s total amount raised to $26 million, since the company was founded in 2015. Since that time, Chimera has established a pipeline of therapies from its proprietary GOLD Platform technology, which creates conditional, location-specific activation of tumor microenvironment (TME)-modifying payloads by CAR-T therapies. The company’s preclinical dataset on its lead candidate, CBIO-007, in pancreatic, prostate, and triple negative breast cancer xenograft tumor models, demonstrates that CBIO-007 efficiently eliminates tumors, while unarmed CAR-T cells are unable to control them.

AFCR’s Chief Executive Officer and Founder Sujuan Ba, Ph.D., said, "AFCR’s BRACE Award Venture Competition is designed to accelerate the commercialization of innovative cancer research discoveries for cancer patients, in Asia and worldwide, and we believe Chimera’s novel approach to spatially controlling CAR-T cells, for safer, more potent therapies, has the potential to improve the treatment of a broad range of cancers from hematologic cancers to solid tumors."

"During the evaluation of Chimera for AFCR’s BRACE Award, I was impressed with Chimera’s insightful approach to counteract the suppressive tumor microenvironment by leveraging natural mechanisms in the engineering of T cells to selectively deliver a payload only when they are activated by tumor cells," said Raju Kucherlapati, Ph.D., Paul C. Cabot Professor of Genetics at Harvard Medical school, who led the committee for the AFCR’s BRACE Award Venture Competition and founded several biotechs, including Cell Genesys, Abgenix (acquired by Amgen) and Millennium (acquired by Takeda). "Furthermore, Chimera’s initial data in preclinical models provides support for the ability of their GOLD Platform technology to direct the curative potential of CAR-T therapies to treating solid tumors, which continues to be a leading cause of death around the world."

About Chimera’s GOLD Platform Technology

Chimera’s GOLD Platform harnesses programmable, RNA-based gene regulation circuits inherent to immune cells to control CAR-T therapies conditionally armed with therapeutic payloads that target the tumor microenvironment (TME). Chimera applies its proprietary GOLD Platform to engineer potent CAR-T cell therapies for solid tumors that target the immunosuppressive TME, which has historically limited conventional CAR-T therapeutic efficacy. In preclinical studies, the GOLD Platform spatially restricts to the site of solid tumors the delivery of high levels of powerful therapeutic payloads by armed CAR-T cells, weakening the TME and maximizing CAR-T potency. Specifically, Chimera demonstrated in head-to head preclinical experiments with unarmed as well as a constitutively armed IL-12 payload that GOLD-controlled CAR-Ts eliminated xenograft tumors from prostate, pancreas, and triple negative breast cancer cell lines. Chimera’s chimeric receptor engagement-dependent payload delivery approach is designed to prevent toxic, systemic payload exposures that can decrease the therapeutic index of armed CAR-T cells.

On April 28, 2022 Chimera Bioengineering reported that it has been selected as the winner of the Asian Fund for Cancer Research’s (AFCR) 2021 BRACE Award Venture Competition—a first-of-its-kind program for early stage oncology technology companies focused on Asian-prevalent cancers. Chimera is developing an innovative CAR-T cell therapy platform for conditional, location-specific activation to target solid tumors (Press release, Chimera Bioengineering, APR 28, 2022, View Source [SID1234613171]).

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As a result of its win, Chimera received US$500,000 in investment from AFCR and additional investments from AFCR-syndicated co-investors, bringing in a total of US$7.5 million of new funds for the company. This follows a rigorous review and evaluation process performed by the BRACE program’s three blue ribbon Committees: Selection, Judging and Investment.

BRACE Award Venture Competition winners not only receive AFCR’s investments, but also feedback and validation from key opinion leaders in the life sciences field. Additionally, the BRACE program provides participating companies with connections and access to cancer experts within AFCR’s worldwide network, as well as amplification for visibility and publicity.

"We are excited to be named the winner of the 2021 BRACE Award Venture Competition, and are thrilled by the support we have received from new investors and the connections we have made to high-caliber advisors," stated Chimera Bioengineering Chief Scientific Officer and Co-Founder Gus Zeiner, Ph.D. "We greatly value the enhanced credibility and exposure from winning the 2021 BRACE Award Venture Competition and look forward to having AFCR being a part of our journey to provide transformative therapies for cancer patients in Asia and beyond."

"During the evaluation for AFCR’s BRACE Award, I was impressed with Chimera’s insightful approach of leveraging natural mechanisms to engineer T cells," said BRACE Award Venture Competition Selection and Judging Committee Co-Chair Raju Kucherlapati, Ph.D. "The company is developing a way to engineer these critical immune system cells to selectively activate when they encounter tumor cells and deliver a payload to counteract the suppressive tumor microenvironment."

"Furthermore, Chimera’s initial data in preclinical models provide support for the ability of their platform technology to apply the curative potential of CAR-T therapies to treating solid tumors," added Dr. Kucherlapati, the Paul C. Cabot Professor of Genetics at Harvard Medical School and co-founder of multiple successful biotechnology companies, including Millennium Pharmaceuticals.

"I am proud that interest in the BRACE Award Venture Competition has spread around the world, and it is being recognized as a valuable source of investment for early stage oncology companies," expressed Asian Fund for Cancer Research Chief Executive Officer and Founder Sujuan Ba, Ph.D. "Like the potentially transformative CAR-T technology being pursued by Chimera, AFCR’s BRACE Award Venture Competition is designed to accelerate the commercialization of innovative cancer research discoveries for cancer patients, in Asia and worldwide."

"The BRACE Award Venture Competition is an annual event to support promising early stage oncology start-ups that work on cancers prevalent in Asia," exclaimed Asian Fund for Cancer Research Chairman Lance Kawaguchi. "In addition to the investment into winners such as Chimera Bioengineering, AFCR brings to the company other valuable resources, such as access to the National Foundation for Cancer Research and AIM-HI Accelerator Fund, which are founding partners of the BRACE Award Venture Competition."

Learn more about the BRACE Award Venture Competition, including the 2022 iteration of the program, now in its fourth year, at View Source

About the BRACE Award Venture Competition

The annual Bridging Research from Academia to Cancer Entrepreneurship (BRACE) program, launched in 2019, is designed to accelerate the commercialization of innovative laboratory discoveries on cancers that are prevalent in Asia. BRACE Award Venture Competitions provide start-up companies with investment capital, visibility and access to a network of world-class key opinion leaders, life sciences industry experts, investors and entrepreneurs.

On April 28, 2022 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended March 31, 2022 (Press release, NovoCure, APR 28, 2022, View Source [SID1234613170]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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"The first quarter was another period of solid execution for Novocure," said Asaf Danziger, Novocure’s Chief Executive Officer. "Our core glioblastoma business continues to provide the financial strength for significant investment in future growth drivers. We believe these investments, especially the expansion of our clinical pipeline and product enhancements, ultimately will enable many more cancer patients to benefit from TTFields therapy."

"2022 marks the beginning of what we expect to be a transformational period for our company and patients," said William Doyle, Novocure’s Executive Chairman. "In 2022, we expect to release clinical data from multiple studies, complete enrollment of our third pivotal study in less than 12 months, and initiate a limited release of next generation arrays in Europe. After many years building to this point, we are excited to kick off what should be a fruitful year for Novocure."

Financial updates for the first quarter ended March 31, 2022:

Total net revenues for the quarter were $137.5 million, an increase of 2% compared to the same period in 2021.
The United States, EMEA and Japan contributed $97.4 million, $27.0 million, and $8.8 million in quarterly net revenues, respectively.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.4 million.
Gross margin for the quarter was 80%.
Research, development and clinical studies expenses for the quarter were $42.2 million, a decrease of 8% from the same period in 2021. Direct clinical trial costs can fluctuate quarter-to-quarter depending on the clinical research organization services delivered and clinical trial materials procured, and we are investing aggressively in future growth and development initiatives.
Sales and marketing expenses for the quarter were $37.9 million, an increase of 21% compared to the same period in 2021. This reflects increased investments in market access capabilities as well as early commercial capabilities in anticipation of potential future approvals and launches in new indications.
General and administrative expenses for the quarter were $30.5 million, a decrease of 2% compared to the same period in 2021.
Net loss for the quarter was $4.6 million with loss per share of $0.04.
Adjusted EBITDA* for the quarter was $26.8 million.
Cash, cash equivalents and short-term investments were $932.3 million as of March 31, 2022.
Operational updates for the first quarter ended March 31, 2022:

As of March 31, 2022, there were 3,549 active patients on therapy. Active patients from North America, EMEA and Japan contributed 2,257, 965 and 327 active patients, respectively.
1,384 prescriptions were received in the quarter. Prescriptions from North America, EMEA and Japan contributed 935, 347 and 102 prescriptions, respectively.
Quarterly achievements:

In February, Novocure founder and TTFields inventor Yoram Palti won the 2022 Israel Prize in Entrepreneurship and Technological Innovation. This prize is regarded as the State of Israel’s highest cultural honor and recognizes Israeli citizens who have shown special excellence and a breakthrough in their field or who have made a special contribution to Israeli society.
In March, an independent data monitoring committee ("DMC") conducted a pre-specified interim analysis of the phase 3 pivotal INNOVATE-3 study for the treatment of ovarian cancer. Following completion of the interim analysis, the DMC recommended that the study should continue to final analysis as planned. Data will be reviewed in 2023, following an 18 month follow-up period.
2022 Outlook:

We expect to achieve active patient growth between 2% to 5% in 2022, in-line with the growth rate experienced in the first quarter of 2022. Longer term, the company continues to expect further adoption in its core GBM business.
Anticipated clinical milestones:

Data from phase 2 pilot EF-31 study in gastric cancer (2022)
Data from phase 2 pilot EF-33 study with high-intensity arrays in recurrent GBM (2022)
Last patient enrollment in phase 3 pivotal METIS study in brain metastases (2022)
Data from phase 3 pivotal LUNAR study in NSCLC (2022)
Last patient enrollment in phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer (2023)
Data from phase 3 pivotal INNOVATE-3 study in recurrent ovarian cancer (2023)
Data from phase 3 pivotal METIS study in brain metastases (2023)
Data from phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss first quarter 2022 financial results at 8 a.m. EDT today, Thursday, April 28, 2022. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 1476184.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On April 28, 2022 ChemoCentryx, Inc., (Nasdaq: CCXI), reported that the Company’s first quarter 2022 financial results will be released after market close on Thursday, May 5, 2022 (Press release, ChemoCentryx, APR 28, 2022, View Source [SID1234613169]). ChemoCentryx executive management will host a conference call and webcast beginning at 5:00 p.m. Eastern Time on May 5, 2022 to discuss these results and to answer questions.

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To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 6597218. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the call.