On March 21, 2022 Volastra Therapeutics, an oncology company focused on exploiting chromosomal instability (CIN) as a vulnerability for cancer cells, reported a collaboration with Bristol Myers Squibb to discover, develop and commercialize new medicines (Press release, Volastra Therapeutics, MAR 21, 2022, View Source [SID1234610456]).

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The multi-year collaboration will leverage Volastra’s proprietary CINtech platform, to identify CIN-related, synthetic lethal targets as drug candidates. Synthetic lethality is a well-established genetic approach of target discovery that involves exploiting vulnerabilities in tumor cells to induce tumor cell death while sparing normal cells. In pre-clinical models, Volastra has demonstrated that synthetical lethal approaches can be particularly effective in tumors with high levels of CIN.

"The combination of Bristol Myers Squibb’s expertise in oncology and Volastra’s deep understanding of chromosomal instability as cancer’s Achilles heel makes for an ideal partnership to advance novel therapies for patients," said Charles Hugh-Jones, M.D., FRCP, Chief Executive Officer at Volastra. "Through this collaboration, Volastra will apply our innovative platform towards the creation of effective CIN-targeted medicines. We look forward to working together with Bristol Myers Squibb to transform cancer treatment."

"We look forward to collaborating with Volastra and utilizing their chromosomal instability targeting platform to identify important drug discovery insights," said Rupert Vessey, M.A., B.M., B.Ch., FRCP, D.Phil., Executive Vice President, Research & Early Development, Bristol Myers Squibb. "New therapies targeting CIN have the potential to enhance treatment selectivity and improve patient outcomes."

Under the terms of the agreement, Volastra will be responsible for conducting various activities for undisclosed targets. For select targets, Volastra will conduct all research activities through development candidate selection and Bristol Myers Squibb may take on the responsibilities for all subsequent development, regulatory and commercialization activities of the development candidates under an exclusive worldwide license.

Volastra will receive $30 million in an upfront payment and will also be eligible to receive up to $1.1 billion in development, regulatory and commercial milestone payments. Additionally, Volastra is entitled to receive royalties on net global sales of any product commercialized by Bristol Myers Squibb resulting from the collaboration.

About Volastra’s CINtech Platform

Volastra’s CINtech platform harnesses a deep biological understanding of chromosomal instability (CIN) as cancer’s most targetable vulnerability to develop promising therapies for patients. CINtech integrates proprietary imaging technologies, model cell line systems and computational analytics to drive a broad and differentiated pipeline.

On March 20, 2022 GenScript Biotech, the world’s leading biotech company, reported its annual results as of December 31, 2021 (Press release, GenScript, MAR 20, 2022, View Source [SID1234610393]).

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"2021 is a pivotal year for GenScript. Our continuous investments in innovation and optimization of current business portfolio over the past few years lead to encouraging results.", said Dr. Patrick Liu, Rotating CEO of GenScript. "In the life science segment, we are pushing forward our business through automation and industrial-scale production. In the emerging gene and cell therapy CDMO segment, GenScript ProBio achieved explosive revenue growth thanks to strategic investment, advanced platforms and high quality standards. Bestzyme reached breakeven, which is made possible by business optimization and product innovation. With continued investment in synthetic biology, Bestzyme will further unfold its potential in the future. In early 2022, our subsidiary Legend Biotech, an innovative cell therapy company, together with our partner J&J, successfully commercialized CarvyktiTM, which is a monumental event for the cell therapy industry and demonstrates innovation capabilities of China’s biopharmaceutical industry. Looking ahead, GenScript Group will continue investment in innovation capabilities to address challenges in the fields of gene and cell therapy and synthetic biology. We will stay committed to our mission to "make people and nature healthier through biotechnology" by accelerating innovation in the biotech industry, and continuously create value for our shareholders."

Results Analysis of the Four Business Segments

Life-science services and products

During the Reporting Period, revenue from life-science services and products was approximately US$315.8 million, representing an increase of 26.4% as compared with approximately US$249.8 million for the year ended December 31, 2020. During the Reporting Period, the gross profit was approximately US$183.3 million, representing an increase of 10.8% as compared with approximately US$165.4 million for the year ended December 31, 2020. During the Reporting Period, the operating profit of life-science services and products was approximately US$91.6 million, representing an increase of 6.5% from approximately US$86.0 million for the same period in 2020.

The growth of revenue and gross profit was mainly attributable to the (i) expanded capacity and productivity, (ii) successful commercial operation that focused on the novel products such as oligo synthesis and cPass services and kit, (iii) successful development of key accounts, and (iv) the improvement of online commercial platform and tools to attract new customers. The decrease in gross profit margin was primarily attributable to the (i) significant decrease of exchange rate of USD against RMB as compared to 2020 which caused an increase of converted cost as the majority of production cost occurred in Mainland China, (ii) increased freight and duty costs, and (iii) change of product portfolio strategy. The increase in operating profit was primarily attributable to the improved capacity utilization and operational efficiency, and was partially offset by increased investment in research and development.

Biologics development services

During the Reporting Period, revenue from biologics development services was approximately US$81.4 million, representing an increase of 101.5% as compared with approximately US$40.4 million for the year ended December 31, 2020. During the Reporting Period, the gross profit was approximately US$25.6 million, representing an increase of 158.6% as compared with approximately US$9.9 million for the year ended December 31, 2020. Total backlog for biologics development services increased by 108.4% from US$94.7 million as at December 31, 2020 to US$197.4 million as at December 31, 2021. The gross profit margin increased from 24.5% for the same period in 2020 to 31.4% this year. During the Reporting Period, the operating loss of biologics development services was approximately US$4.5 million, whilst the operating loss was approximately US$7.6 million for the same period in 2020.

The increase in revenue was primarily attributable to the (i) accumulated biologics development track records and expanded global customer base, (ii) expanded capacity and productivity of pre-clinical and clinical development, (iii) shorter delivery time for antibody and protein drug development, and (iv) significant increase in plasmid revenue from the boosting GCT market, including mRNA related applications. The increase in gross profit was primarily attributable to the (i) increased revenue, (ii) production cost reduction and quality improvement, and (iii) improved capacity utilization. The operating loss was primarily attributable to the (i) investment in selling and distribution, and (ii) investment in research and development activities.

Industrial synthetic biology products

During the Reporting Period, revenue from industrial synthetic biology products was approximately US$38.6 million, representing an increase of 33.6% as compared with approximately US$28.9 million for the year ended December 31, 2020. During the Reporting Period, the gross profit was approximately US$11.3 million, representing an increase of 31.4% as compared with US$8.6 million for the year ended December 31, 2020. During the Reporting Period, the industrial synthetic biology products segment has achieved operating break-even this Year, whilst the operating loss was approximately US$3.0 million for the same period in 2020.

The increase in revenue and gross profit was primarily attributable to the (i) launch of innovative products, (ii) increased penetration into big industrial customers, and (iii) business development in overseas markets. The gross profit margin remained stable during the Reporting Period.

Cell therapy

During the Reporting Period, revenue from cell therapy was approximately US$89.8 million, representing an increase of 18.6% as compared with approximately US$75.7 million for the year ended December 31, 2020. During the Reporting Period, gross profit was approximately US$89.8 million, representing an increase of 18.6% as compared with approximately US$75.7 million for the year ended December 31, 2020. During the Reporting Period, the operating loss of cell therapy was approximately US$373.9 million, whilst the operating loss was approximately US$233.4 million for the same period in 2020.

The increase in both revenue and gross profit was primarily attributable to additional milestones achieved in 2020 and 2021, and thus further recognition of contract revenue from the collaboration with Janssen on developing cilta-cel. The operating loss was primarily attributable to the (i) investment in clinical trials, higher patients enrollment and more pipelines, (ii) cost for commercial preparation activities for the launch of cilta-cel, and (iii) expansion of administrative functions.

Revenue

In 2021, the Group recorded revenue of approximately US$511.1 million, representing an increase of 30.8% from approximately US$390.8 million in 2020. This was primarily attributable to (i) the continued increase of non-cell therapy products and services from major strategic customers and new competitive services and products, and (ii) the increase of contract revenue derived from Legend’s collaboration with Janssen with new milestones achieved.

Gross Profit

In 2021, the Group’s gross profit increased 18.6% to approximately US$303.5 million from approximately US$255.9 million in 2020. The increase in gross profit was primarily attributable to the (i) rapid growth of revenue, and (ii) operational efficiency improvement. The increase in gross profit was partially offset by unfavorable exchange rate fluctuation and increased shipping costs.

Selling and distribution expenses

The selling and distribution expenses increased by 56.6% to approximately US$168.0 million in 2021 from approximately US$107.3 million in 2020. This was mainly attributable to the (i) recruiting of more experienced personnel and improved incentive packages to enhance the business development capability, and (ii) increased marketing and advertising expenses, primarily attributable to the global expansion of our business, including Legend’s collaboration with Janssen.

Administrative expenses

The administrative expenses increased by 48.9% to approximately US$134.5 million in 2021 from approximately US$90.3 million in 2020. This was mainly caused by (i) reinforcing key administrative functions such as information technology, supply chain and legal to support the Group’s overall business expansion and ensure compliance with certain updated requirements, (ii) one-time consultation expenses and other costs related to the Investigation, and (iii) the CARVYKTI application and the Follow-on Public Offering of Legend.

Research and development expenses

The research and development expenses increased by 36.1% to approximately US$358.4 million in 2021 from approximately US$263.4 million in 2020. This was mainly due to the (i) increase in clinical trial expenses and preclinical study costs in the cell therapy segment, (ii) investment in new research and development projects to strengthen our competitiveness in the GCT market and related supply chain, (iii) investment in development projects that improved our production efficiency, and (iv) increase in compensation package including equity-settled share-based compensation expense for research and development personnel.

On March 19, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported full results from the pivotal SORAYA trial evaluating the efficacy and safety of mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab) (Press release, ImmunoGen, MAR 19, 2022, View Source [SID1234610379]). The results are being presented by Dr. Ursula Matulonis in the late-breaking abstract plenary session on Saturday, March 19 at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting in Phoenix, AZ.

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"Patients with platinum-resistant ovarian cancer have limited treatment options, and these are associated with low response rates and significant toxicity," said Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator. "With an objective response rate of 32.4%, far exceeding that seen with current therapies, and a median duration of response approaching seven months, mirvetuximab continues to demonstrate impressive efficacy in patients with platinum-resistant disease who have already received bevacizumab. The anti-tumor activity and consistent safety and tolerability data from the SORAYA trial further underscore the potential of mirvetuximab, if approved, to become a practice-changing, biomarker-driven standard of care for these patients."

SORAYA is a single-arm study of mirvetuximab in patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα and who have been treated with one to three prior regimens – at least one of which included bevacizumab. The primary endpoint for the study is confirmed objective response rate (ORR) as assessed by investigator and the key secondary endpoint is duration of response (DOR). ORR was also assessed by blinded independent central review (BICR). The study is designed to rule out a 12% ORR, based on expected outcomes of 4% to 13% with available single agent chemotherapy. Data previously generated in a post-hoc pooled analysis of seventy patients from prior studies of mirvetuximab in platinum-resistant disease formed the basis for the design of SORAYA, with an investigator-assessed ORR of 31.4%, median DOR of 7.8 months, and median progression-free survival (PFS) of 4.4 months.

Key Findings from SORAYA

SORAYA enrolled 106 patients with a median of three prior lines of therapy; 51% had three prior lines of therapy and 48% had one to two prior lines of therapy. All patients received prior bevacizumab; 48% of patients received a prior PARP inhibitor (PARPi).

Confirmed ORR by investigator was 32.4% (95% confidence interval [CI]: 23.6%, 42.2%), including five complete responses (CRs). ORR by BICR was 31.6% (95% CI: 22.4%, 41.9%), including five CRs. Response rates were consistent regardless of number of prior lines of therapies or prior PARPi.
1-2 prior lines of therapy: ORR by investigator was 35.3% (95% CI: 22.4%, 49.9%).
3 prior lines of therapy: ORR by investigator was 30.2% (95% CI: 18.3%, 44.3%).
Prior PARPi exposure: ORR by investigator was 38.0% (95% CI: 24.7%, 52.8%).
Without prior PARPi exposure: ORR by investigator was 27.5% (95% CI: 15.9%, 41.7%).
The median DOR was 6.9 months (95% CI: 5.6, 8.1) by investigator as of the March 3, 2022 data cut-off.
The median PFS was 4.3 months (95% CI: 3.7, 5.1) by investigator and 5.5 months (95% CI: 3.8, 6.9) by BICR.
Mirvetuximab was well-tolerated, consistent with the known safety profile seen in more than 700 patients treated in the broader mirvetuximab program. Treatment-related adverse events led to dose reductions in 19% of patients, dose delays in 32% of patients, and discontinuations in 7% of patients. The most common treatment-related adverse events were low-grade and generally reversible, including blurred vision (41% all grade; 6% grade 3), keratopathy (36% all grade; 8% grade 3+), and nausea (29% all grade; 0% grade 3).
"We are thrilled with the SORAYA results, which are remarkably consistent with data previously generated with mirvetuximab in a heavily-pretreated population of platinum-resistant ovarian cancer patients that included prior exposure to bevacizumab. Based on the impressive anti-tumor activity, durability of response, and safety profile observed in SORAYA, we believe mirvetuximab has the potential to displace single-agent chemotherapy as the standard of care for FRα-high platinum-resistant ovarian cancer," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "We are very grateful for all of the patients and physicians who committed their time and effort to this study, and with these positive results, we expect to submit the BLA for mirvetuximab this month to support potential accelerated approval in the US this year. The strength and consistency of the SORAYA data give us confidence in a positive outcome in the ongoing confirmatory MIRASOL trial, intended to support the potential full approval of mirvetuximab, with top-line data anticipated in the third quarter."

Oral Presentation Details

Title: Efficacy and Safety of Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer with High Folate Receptor Alpha Expression: Results from the SORAYA Study
Session: Scientific Plenary IV: Late-Breaking Abstracts
Session Date: Saturday, March 19, 2022
Session Time: 4:15 pm to 5:45 pm MST/7:15 pm to 8:45 pm EDT

Other Presentations

Trial in progress posters from ImmunoGen’s MIRASOL and PICCOLO trials of mirvetuximab in ovarian cancer and a Phase 2 investigator-sponsored combination trial of mirvetuximab with carboplatin as a neoadjuvant therapy for patients with newly diagnosed ovarian cancer will also be presented. Final data from the mirvetuximab plus bevacizumab platinum-agnostic combination, which were originally shared at ASCO (Free ASCO Whitepaper) 2021, will also be featured in a seminal presentation.

Additional information can be found at www.sgo.org.

INVESTOR EVENT INFORMATION

ImmunoGen will hold an investor event to discuss the SORAYA oral presentation, featuring a roundtable with key opinion leaders, on Sunday, March 20 at 7:30 am MST/10:30 am EDT in the Moly Meeting Room at the Westin Phoenix Downtown. To access the live event by phone, dial (877) 621-5803; the conference ID is 1986619. The event may also be accessed via webstream on the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.

On March 18, 2022 Galapagos NV (Euronext & NASDAQ: GLPG) reported a share capital increase arising from subscription right exercises (Press release, Galapagos, MAR 18, 2022, View Source [SID1234610880]).

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Galapagos issued 95,500 new ordinary shares on 18 March 2022, for a total capital increase (including issuance premium) of €2,159,600.00.

Pursuant to the subscription right exercise program of Galapagos’ management board, members of the management board automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, our CEO Onno van de Stolpe exercised 15,000 subscription rights and one management board member exercised 5,000 subscription rights. In total our CEO exercised 50,000 subscription rights and the aforementioned management board member 10,000 subscription rights, as these subscription rights are due to expire in July 2022.

In accordance with Belgian transparency legislation1, Galapagos notes that its total share capital currently amounts to €355,098,660.11, the total number of securities conferring voting rights amounts to 65,648,221, which is also the total number of voting rights (the "denominator"), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights (formerly known as warrants) to subscribe to not yet issued securities conferring voting rights is (i) 8,322,710 subscription rights under several outstanding employee subscription right plans, which equals 8,322,710 voting rights that may result from the exercise of those subscription rights, and (ii) one subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead and its affiliates to 29.9% of the actually issued and outstanding shares after the exercise of the subscription right. This excludes the 1,000,000 subscription rights of Subscription Right Plan 2022 (B), which were created subject to acceptance. Galapagos does not have any convertible bonds or shares without voting rights outstanding.

On March 18, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), reported the grant of patent no. 7030750 entitled "Antibody molecules to LAG-3 and uses thereof" by the Japanese Patent Office (Press release, Immutep, MAR 18, 2022, View Source [SID1234610441]).

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This new Japanese patent was filed as a divisional application and follows the grant of the parent Japanese patent announced in 2019. Corresponding patents in this family have been granted in other territories including Australia, China, Europe and the United States, as announced in 2018 through 2021.

The claims of the patent are directed to pharmaceutical compositions for use in the treatment of cancer, where the composition comprises LAG525 in a specific dose and for use in a defined treatment regimen. The compositions may also be administered in combination with a second agent such as an anti-PD-1 antibody, an anti-PD-L1 antibody or a chemotherapeutic agent.

The patent is co-owned by Novartis AG and Immutep S.A.S., and will expire on 13 March 2035.

LAG525 (INN: leramilimab) is a humanised form of Immutep’s IMP701 antibody, the rights to which are fully out-licensed to Novartis.