Emergent BioSolutions Announces Stock Repurchase Program

On November 11, 2021 Emergent BioSolutions Inc. (NYSE: EBS) reported that its Board of Directors has authorized management to repurchase up to $250 million of the company’s common stock from time to time on the open market or in privately negotiated transactions (Press release, Emergent BioSolutions, NOV 11, 2021, View Source [SID1234595335]). This repurchase authorization expires on November 11, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As part of a balanced capital management plan, we believe the company’s stock can represent an attractive investment opportunity," said Robert G. Kramer, president and chief executive officer at Emergent BioSolutions. "This announcement demonstrates our confidence in Emergent’s business and the strength of our balance sheet and cash position, providing the flexibility to implement this program while simultaneously pursuing opportunities to invest and grow the business both organically and through potential acquisitions."

The timing and amount of any shares repurchased will be determined by the company’s management based on its evaluation of market conditions and other factors, consistent with its insider trading policy. Repurchases may also be made under a pre-established trading plan under Rule 10b5-1 that might result in shares being repurchased when the company might otherwise be precluded from doing so. The repurchase program may be suspended or discontinued at any time. Any repurchased shares will be held in treasury shares and will be available for use in connection with the company’s stock plans and for other corporate purposes.

The repurchase program will be funded using the company’s cash on hand and cash from operations. As of September 30, 2021, the company had cash and cash equivalents of $403.8 million.

The company had approximately 53.7 million shares of common stock outstanding as of September 30, 2021.

Corporate Presentation

On November 11, 2021 Gamida Cell Presented The Corporate Presentation (Presentation, Gamida Cell, NOV 11, 2021, View Source [SID1234595333]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Acrivon Therapeutics Closes Oversubscribed $100 Million Series B Financing to Advance its Innovative Precision Proteomics Platform and Clinical Oncology Pipeline

On November 11, 2021 Acrivon Therapeutics, Inc., a clinical-stage oncology therapeutics company with proprietary technologies driving a new era of precision-based medicine, reported the successful completion of an oversubscribed $100 million Series B financing (Press release, Acrivon Therapeutics, NOV 11, 2021, View Source [SID1234595330]). The financing was co-led by Wellington Management Company and Surveyor Capital (a Citadel company), with key participation from RA Capital Management and Perceptive Advisors. Additional new investors in the financing included Sands Capital, HBM Healthcare Investments, Marshall Wace, HealthCor Management, BB Pureos Bioventures, Acorn Bioventures, and existing investors, including Alexandria Venture Investments and Chione Ltd. In connection with the financing, Derek DiRocco, Ph.D., partner at RA Capital Management, will join the company’s Board of Directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Acrivon’s Predictive Precision Proteomics (AP3) technology platform enables the development of drug-tailored OncoSignature companion diagnostics that link drug mechanisms to the active disease-driving processes of cancer in patients, uncovering drug sensitivity not achievable through traditional genomics analyses. Acrivon’s pipeline will be advanced in clinical trials selectively enrolling patients predicted to benefit from treatment based on its proprietary OncoSignature companion diagnostics. The company’s clinically advanced lead product candidate ACR-368 (also known as prexasertib, in-licensed from Eli Lilly and Company) is a potent, second generation CHK1/2 inhibitor which has shown durable, single-agent anticancer activity, including complete responses, in a proportion of patients across multiple cancers in Phase 2 studies.

"On the heels of the company’s recent public launch in late June, we are pleased to have attracted a top-tier syndicate of leading private/public investors that recognize the transformative potential of our platform and pipeline," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer and founder of Acrivon. "Appropriate patient selection is one of the biggest unmet needs for targeted oncology therapeutics and is currently not possible for the majority of common solid cancers. We are excited to now leverage the broader potential of our AP3 platform, which enables us to decipher a drug’s true mechanism-of-action at high resolution and accurately match that with the disease-driving processes in a patient’s tumor. This allows us to not only predict individual patient response, but also identify new indications and rational drug combinations, as well as hurdles that block patient responses, such as resistance mechanisms. The initial application of our technology is for the development of ACR-368 and two other undisclosed pipeline programs targeting solid tumors."

Derek DiRocco, Ph.D., partner at RA Capital and member of the board added, "Acrivon’s lead asset ACR-368 has demonstrated impressive monotherapy activity in several cancers, and the late-stage Phase 2 development strategy using their proprietary patient selection methodology can lead to multiple accelerated approval opportunities in these high unmet need cancers. We are impressed by the company’s foundational technologies and believe they are broadly applicable to therapeutics beyond ACR-368 and have the potential to usher in a new era of precision-based medicine beyond the industry’s current approaches, which are largely limited to the use of genomic biomarkers."

"We are thrilled by the support from these notable investors," said Kristina Masson, Ph.D., co-founder and site head of Acrivon AB, Acrivon’s phospho-proteomic and drug discovery hub located in Medicon Village, Lund, Sweden. "We have strategically built our phospho-proteomics capabilities here to leverage the proximity to our academic co-founder, professor Jesper Olsen at the University of Copenhagen, Denmark, who is a recognized leader in the field of phospho-proteomics. Likewise, our structure-guided drug discovery programs benefit from local expertise in structural biology and medicinal chemistry. The excellent infrastructure and world-leading proteomics expertise established at our hub in Scandinavia remains a major competitive advantage for Acrivon, and we are excited to also welcome several European investors to join our investor syndicate."

About Acrivon Precision Predictive Proteomics
Acrivon Predictive Precision Proteomics, AP3, is a proprietary, streamlined approach to develop patient selection tumor biopsy tests, called OncoSignature tests. The technology is engineered to be agnostic to underlying genetic alterations and enables identification and treatment of the patients whose tumors are regulated by and sensitive to the drug based on direct protein measurement of the critical tumor-driving mechanisms. The AP3 approach leverages unbiased differential global phosphoproteomic drug profiling using mass spectrometry, biased tumor model analyses, and quantitative multispectral in situ imaging of patient derived xenograft (PDX) in vivo models and intended-use tumor samples and clinical trial biopsies, to identify and evaluate biomarkers. The output of AP3 is clinically actionable, drug-tailored, proprietary OncoSignature tests. These are automated, quantitative protein multiplex imaging tests applied to pretreatment tumor biopsies as a companion diagnostic (CDx) to select and treat the patients predicted to benefit from the drug. The AP3 method is broadly applicable across drugs and is a transformative, efficient method to accurately match the right therapy to the right patient.

About ACR-368 (also known as prexasertib)
ACR-368 is a potent, selective inhibitor of CHK1 and CHK2 which has shown deep durable single agent activity, including complete responses, in a proportion of patients across several Phase 2 studies of platinum-resistant ovarian cancer and in squamous cell cancers, including anal cancer for which FDA has granted orphan drug designation. ACR-368 has been tested in >1,000 patients as monotherapy and in combination, showing excellent pharmacokinetic and pharmacological properties and a favorable safety profile at the recommended Phase 2 dose across monotherapy studies. Acrivon has obtained exclusive, world-wide rights to develop and commercialize ACR-368 under a license agreement with Eli Lilly and Company.

Compugen Announces Collaboration Expansion with Bristol Myers Squibb alongside $20 Million Equity Investment

On November 11, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that Bristol Myers Squibb (NYSE: BMY) completed its $20 million investment in Compugen in consideration for the issuance of 2,332,815 shares of Compugen purchased at $8.57333 per share, representing a 33% premium over the closing price on November 9, 2021 (Press release, Compugen, NOV 11, 2021, View Source [SID1234595311]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As part of the expansion of the collaboration, a joint steering committee has been formed to facilitate strategic oversight and guidance for the programs run under the collaboration. This will run alongside the existing joint development committee which acts at an operational level.

"Bristol Myers Squibb’s strategic investment in Compugen strengthens our relationship and the goal of both companies to take forward our clinical studies conducted under our collaboration in bringing innovative therapies to cancer patients," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We value Bristol Myers Squibb’s continued support of Compugen and in our evaluation of our DNAM axis hypothesis by testing COM701 in combination with nivolumab as a dual combination and in combination with nivolumab and BMS-986207 as a triple combination targeting PVRIG, PD-1 and TIGIT."

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. In pre-clinical studies, blockade of PVRIG by COM701 has demonstrated potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. Compugen has identified PVRIG and TIGIT as key parallel and complementary inhibitory pathways in the DNAM axis, which also intersect with the well-established PD-1 pathway. Research from Compugen suggests that these three pathways have different dominance in different tumor types and patients, implying that to induce effective antitumor responses, certain patient populations may require the blockade of different combinations of these three pathways. To test this hypothesis, Compugen has established a science-driven, biomarker informed clinical program, which evaluates different combinations of these axis members across tumor types. Compugen is the only company with clinical assets targeting both PVRIG and TIGIT in its portfolio allowing it to explore the potential of blocking these parallel and complementary members of the DNAM axis comprehensively to drive robust immune responses.

Lunit Presents Studies at SITC 2021, Highlighting the Effectiveness of AI in Predicting Response to Immunotherapy in a Clinical Trial Setting

On November 11, 2021 Lunit reported that it will present three abstracts at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held in Washington D.C. and virtually November 10-14, 2021 (Press release, Lunit, NOV 11, 2021, View Source [SID1234595310]). The abstracts feature the predictive power of the company’s AI biomarker platform ‘Lunit SCOPE IO’, which is also on demonstration during the event in its booth #423, Exhibition Hall E.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As a leading medical AI provider, Lunit focuses on developing the AI biomarker platform Lunit SCOPE IO, which analyzes cancer patients’ tissue slide images and predicts response to immunotherapy. According to the company, Lunit SCOPE IO analyzes a patient’s cancer tissue slide image by observing the distribution of tumor-infiltrating lymphocytes (TIL), one of the representative immune cells, and accurately classifying the result into three immune phenotypes (3-IP; inflamed, excluded, desert).

Lunit’s AI biomarker platform, Lunit SCOPE IO

In the main study presented at SITC (Free SITC Whitepaper) 2021, Lunit SCOPE IO was applied in a phase I/II clinical trial of a TGF-β inhibitor, MedPacto’s vactosertib, in combination with pembrolizumab to treat metastatic colorectal cancer patients. This clinical trial is significant because the novel treatment regimen targets a subpopulation of colorectal cancer patients known to have a very low overall response rate. The regular lack of response to immune checkpoint inhibitors such as pembrolizumab is expected to be overcome via combination with the TGF-β inhibitor vactosertib, changing the biology of the cancer to be responsive to the combination.

According to the study, among the group of patients categorized as high "immune-excluded" by Lunit SCOPE IO, 25% responded to treatment, compared to no response among the group of patients categorized as low "immune-excluded" by Lunit SCOPE IO.

"These results demonstrate that the AI-powered analysis of the immune cells surrounding the cancer is highly predictive of response to immunotherapy, and adds significant evidence to the usefulness of applying this technology in clinical practice to identify the right target patient population," explained Chan-Young Ock, Chief Medical Officer of Lunit.

"This study is also significant because the usefulness of Lunit SCOPE has been successfully demonstrated for combination immunotherapy, in addition to its usefulness for predicting response to monotherapy of immune checkpoint inhibitors, as previously demonstrated in ASCO (Free ASCO Whitepaper) 2019, 2020, 2021 and ESMO (Free ESMO Whitepaper) 2021," added Ock.

In the other two studies, the molecular mechanisms that are associated with Lunit SCOPE IO’s prediction of response to immunotherapy have been demonstrated. According to the studies, the "immune excluded" subpopulation categorized by Lunit SCOPE IO is linked to the APOBEC signature and subclonal tumor heterogeneity, as well as oncogenic PI3K/Akt/mTOR pathway, adding biological plausibility to why Lunit SCOPE IO is highly predictive of response to immunotherapy.

"Over the years we have been validating the predictive power of our AI biomarker through multiple studies and we are excited to present meaningful results at SITC (Free SITC Whitepaper) showing its further potential," said Brandon Suh, CEO of Lunit. "With the official launch of Lunit SCOPE IO for research use approaching within a few months, we hope our AI will contribute to offering optimized treatment to solid tumor cancer patients."

Lunit at SITC (Free SITC Whitepaper) 2021

Exhibition booth: #423, Exhibition Hall E (floor plan)

Poster Title: Spatial analysis of tumor-infiltrating lymphocytes correlates with the response of metastatic colorectal cancer patients treated with vactosertibin combination with pembrolizumab
Abstract number: 823
Session Date/Time: Nov. 12, 7:00 a.m. – 8:30 p.m. ET (on-site) and Nov. 12, 7:00 a.m. ET (ePoster)

Poster Title: Artificial intelligence powered spatial analysis of tumor infiltrating lymphocytes reveals Immune excluded phenotype related to APOBEC signature and clonal evolution of cancer
Abstract number: 830
Session Date/Time: Nov. 13, 7:00 a.m. – 8:30 p.m. ET (on-site) and Nov. 12, 7:00 a.m. ET (ePoster)

Poster Title: Comparison of PI3K/AKT/mTOR Pathway Profiles Amongst Three Immune Phenotypes Classified by Artificial Intelligence-Powered H&E Analyzer in Non-Small Cell Lung Cancer
Abstract number: 921
Session Date/Time: Nov. 12, 7:00 a.m. – 8:30 p.m. ET (on-site) and Nov. 12, 7:00 a.m. ET (ePoster)