On September 17, 2021 PerkinElmer, Inc. (NYSE: PKI) a global leader committed to innovating for a healthier world, reported it has completed its acquisition of BioLegend, a leading, worldwide provider of life science antibodies and reagents for a total consideration of approximately $5.25 billion (Press release, PerkinElmer, SEP 17, 2021, View Source [SID1234587892]).

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The acquisition, the largest in PerkinElmer’s history, further expands the Company’s life science franchise into high-growth areas such as cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation and bioprocessing.

Commenting on the collaboration ahead, Prahlad Singh, president and chief executive officer of PerkinElmer, said "BioLegend’s stellar leaders, teams and technologies will play a critical role in our combined companies’ ability to provide new, innovative solutions to scientists — helping drive novel therapeutic discovery and development. We also look forward to BioLegend significantly enhancing our leading reagents portfolio as we partner together to innovate and advance science for our customers."

Gene Lay, founder, president and chief executive officer of BioLegend, added "We are very excited to roll up our sleeves and work together with our new PerkinElmer colleagues to mutually leverage our portfolios, people and shared passion for innovation and science to accelerate the discovery and development of novel therapeutics. PerkinElmer’s broad life science platform and strong global infrastructure will help BioLegend continue to extend our mission of enabling our customers to do legendary discovery."

Additional Details

As previously communicated, it is expected that BioLegend will contribute an incremental $380 million of revenue and $0.30 of adjusted earnings per share accretion to PerkinElmer in fiscal year 2022. Additional commentary regarding its expected financial contribution to the remainder of the current fiscal year will be provided on the Company’s upcoming third quarter 2021 earnings call.

PerkinElmer’s expectations for incremental adjusted earnings per share accretion for fiscal year 2022 attributable to BioLegend is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measure without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items PerkinElmer excludes from this non-GAAP measure. The timing and amounts of such events and items could be material to PerkinElmer’s results prepared in accordance with GAAP.

Factors Affecting Future Performance

This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities, acquisitions and divestitures. Words such as "believes," "intends," "anticipates," "plans," "expects," "projects," "forecasts," "will" and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on management’s current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) markets into which we sell our products declining or not growing as anticipated; (2) the effect of the COVID-19 pandemic on our sales and operations; (3) fluctuations in the global economic and political environments; (4) our failure to introduce new products in a timely manner; (5) our ability to execute acquisitions and license technologies, or to successfully integrate acquired businesses, such as BioLegend, and licensed technologies into our existing business or to make them profitable, or successfully divest businesses; (6) our ability to compete effectively; (7) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (8) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services; (9) disruptions in the supply of raw materials and supplies; (10) our ability to retain key personnel; (11) significant disruption in our information technology systems, or cybercrime; (12) our ability to realize the full value of our intangible assets; (13) our failure to adequately protect our intellectual property; (14) the loss of any of our licenses or licensed rights; (15) the manufacture and sale of products exposing us to product liability claims; (16) our failure to maintain compliance with applicable government regulations; (17) regulatory changes; (18) our failure to comply with healthcare industry regulations; (19) economic, political and other risks associated with foreign operations; (20) the United Kingdom’s withdrawal from the European Union; (21) our ability to obtain future financing; (22) restrictions in our credit agreements; (23) discontinuation or replacement of LIBOR; (24) significant fluctuations in our stock price; (25) reduction or elimination of dividends on our common stock; and (26) other factors which we describe under the caption "Risk Factors" in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

On September 17, 2021 Lunit reported that its AI for tissue analysis has been applied in a clinical trial for drug development, accurately predicting the patients’ response to immunotherapy (Press release, Lunit, SEP 17, 2021, View Source;findings-presented-at-esmo-2021-301379353.html [SID1234587910]). Including this major finding, the company presented three studies at European Society for Medical Oncology(ESMO) Congress 2021.

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Lunit has been focusing on developing novel AI biomarkers that can be applied in cancer treatment. Since 2019, it has been validating the effectiveness of its AI-based tissue analysis platform ‘Lunit SCOPE’ that accurately predicts cancer patients’ response to immunotherapy.

The highlight of Lunit at ESMO (Free ESMO Whitepaper) 2021 is its announcement that Lunit SCOPE IO—one of Lunit SCOPE product lines—has been applied to a phase 1 clinical trial of a new drug for the first time. In a joint study with Y Biologics, a South Korean clinical-stage antibody biotech company, Lunit SCOPE IO accurately predicted immunotherapy response of all the patients who participated in the study.

"From 2019, Lunit has proven that response to immunotherapy varies depending on the spatial distribution of immune cells in cancer tissue, which has been the foundation for the AI platform ‘Lunit SCOPE IO’," said Chan-Young Ock, Chief Medical Officer of Lunit. "This study is the first case where Lunit SCOPE IO was applied to actual drug development clinical trials, and it is a meaningful study that demonstrated high potential for AI-powered biomarkers."

Lunit presented another study using Lunit SCOPE IO, validating the correlation between spatial information of tumor-infiltrating lymphocytes(TIL) and prognosis of colorectal cancer. The team analyzed 461 colorectal cancer data among TCGA data and showed that high TIL density in relation to tumor cells may improve prognostic power.

The company’s other major study was on Lunit SCOPE PD-L1, an AI-powered PD-L1 tumor proportion score(TPS) analyzer developed by Lunit. According to the study, assistance with Lunit SCOPE PD-L1 substantially improved pathologists’ consensus and found more patients who were eligible for immunotherapy.

"Although PD-L1 expression is the standard biomarker for advanced non-small cell lung cancer, manual evaluation of PD-L1 TPS by pathologists has practical limitations of interobserver bias and intensive labor," said Kyunghyun Paeng, Chief Product Officer of Lunit. "This study aimed to explore whether the AI-powered TPS analyzer could reduce the interobserver variation and increase the accuracy of analysis."

Three pathologists evaluated the PD-L1 TPS of 479 NSCLC data. Comparing the results of the analysis, the discordant rate in the subgroups of TPS <1% decreased from 32% to 10% when assisted with Lunit AI. Furthermore, 23 out of 81 were found to be eligible for immunotherapy even though they were evaluated to be TPS <1% by pathologists, meaning an additional 30% of patients could be treated with immunotherapy, who would otherwise have not been recommended for immunotherapy.

"We are now in the process of proving and creating the direction we want to achieve in the field of cancer treatment," said Brandon Suh, CEO of Lunit. "This year’s ESMO (Free ESMO Whitepaper) is particularly meaningful as one of our Lunit SCOPE products was used in a clinical trial for the first time and showed its predictable value. Our validation of AI-powered biomarkers for immunotherapy will be applied to many other drugs and larger clinical studies in the near future. In light of these positive results, Lunit SCOPE will be commercially made available by the end of this year."

Lunit Abstract Information at ESMO (Free ESMO Whitepaper) 2021

Virtual Meeting: E-Posters
September 16 – 21, 2021

Abstract 977P

Title: Interim results of phase I dose escalation study of YBL-006: A novel anti-PD-1 monoclonal antibody in advanced solid tumors

Abstract 398P

Title: AI-powered whole-slide image analysis of tumor-infiltrating lymphocytes for prediction of prognosis in colorectal cancer

Abstract 1805P

Title: Assistance with an artificial intelligence-powered PD-L1 analyzer reduces interobserver variation in pathologic reading of tumor proportion score in non-small cell lung cancer

On September 16, 2021 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a biopharmaceutical company focused on the discovery and development of irreversible small molecules to treat patients with genetically defined cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug application to begin a Phase I trial of BMF-219, a selective irreversible menin inhibitor, in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation (Press release, Biomea Fusion, SEP 16, 2021, View Source [SID1234587811]).

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"First of all, I would like to take this opportunity to thank the FDA, the Contract Research Organizations, our consultants, our investors, and of course TEAM FUSION for the commitment, guidance, support, and tireless effort in getting BMF-219, an investigational new drug, in the hands of patients in need. It was a true community effort, and we are so blessed here at Biomea to be in position to provide an impactful therapy against aggressive cancers," said Thomas Butler, Biomea’s CEO and Chairman of the Board. "This is just the beginning for BMF-219 as we are planning to pursue multiple indications with our novel molecule. This is also just the beginning for the company, as we continue to make significant progress with our pipeline programs. We are in a strong position to continue to bring novel small molecules into the clinic and help the many patients with life threatening and life altering diseases."

"Over the past 6 months, we have brought together a first-class team of biotech professionals to tackle our next phase of growth, which will include clinical development of BMF-219 in not only liquid but also solid tumors," said Ramses Erdtmann, Biomea’s COO and President. "BMF-219 is a very special compound, with a unique effect on menin which we believe will lead to improved outcomes for patients with specific gene arrangement and mutations."

An irreversible small molecule, such as BMF-219, is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional reversible drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.

The Phase 1, first-in-human, open-label, dose-escalation and dose-expansion clinical trial of BMF-219 will assess the safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile of BMF-219 in adult patients with relapsed or refractory acute leukemia including those with an MLL/KM2TA gene rearrangement or NPM1 mutation.

About Acute Myeloid Leukemia (AML)

AML is the most common form of acute leukemia in adults and represents the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the lymph nodes, spleen, and central nervous system. Approximately 30,000 people in the U.S. and Europe are diagnosed with AML each year, and the five-year overall survival rate in adults roughly 29%. Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin dependent genetic drivers (MML-r or NPM1).

About BMF-219

BMF-219 is an irreversibly binding inhibitor of menin, a protein that is known to play an essential role in oncogenic signaling in genetically defined leukemias. Preclinically, BMF-219 has demonstrated robust downregulation of key leukemogenic genes in addition to menin itself (via MEN1) in well-established MLLr AML cell lines. Additionally, BMF-219 has shown efficacy in multiple in vivo and in vitro models of acute leukemias. BMF-219 will be evaluated in a first-in-human trial in patients with relapsed or refractory acute leukemia with MLL/KM2TA gene rearrangement or NPM1 mutation.

On September 16, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported the pricing of an underwritten public offering of 9,375,000 shares of its common stock at a public offering price of $8.00 per share(Press release, aTyr Pharma, SEP 16, 2021, View Source [SID1234587832]). The gross proceeds to aTyr from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $75.0 million. In addition, aTyr has granted the underwriters a 30-day option to purchase up to an additional 1,406,250 shares of its common stock. All of the shares to be sold in the offering are to be sold by aTyr. The offering is expected to close on or about September 20, 2021, subject to customary closing conditions.

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Piper Sandler and RBC Capital Markets are acting as joint book-running managers for the offering. Laidlaw & Company (UK) Ltd. is acting as the lead manager for the offering. Roth Capital Partners LLC is acting as financial advisor.

The offering is being made pursuant effective registration statements, filed by aTyr with the Securities and Exchange Commission ("SEC"). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement on Form S-3. An electronic copy of the final prospectus supplement, when available, and accompanying prospectus relating to the offering will be available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at [email protected]; or RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, New York 10281, by telephone at (877) 822-4089 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 or other jurisdiction.

On September 16, 2021 Endeavor BioMedicines, a clinical-stage precision medicine company targeting the core drivers of multiple terminal diseases including oncology and fibrosis, reported the in-licensing of a ULK1/2 inhibitor program from the Salk Institute for Biological Studies and Sanford Burnham Prebys (Press release, Endeavor BioMedicines, SEP 16, 2021, View Source [SID1234587860]). The license agreement provides Endeavor with exclusive worldwide rights to ENV-201, an orally available small molecule inhibitor of ULK1/2, a critical enzyme in a cellular recycling process called autophagy that is often linked to drug resistance in RAS- and LKB1-mutated cancers. Endeavor plans to complete IND-enabling studies and advance the program into the clinic initially in colorectal and lung cancers in the next 18 months.

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"The Salk Institute and Sanford Burnham Prebys have pioneered early research on the ULK1/2 pathway in RAS-mutated cancers, including those that have become resistant to current standard of care," said John Hood, Ph.D., Co-Founder, CEO and Chairman of Endeavor. "This powerful ULK1/2 program that we have acquired is synergistic with our growing portfolio of precision medicine treatments and has the potential to be an important new treatment option for patients with life-threatening colorectal and lung cancers."

Mutations in the tumor suppressor LKB1 are found in approximately 15% of all people with non-small cell lung cancer and a significant number of individuals with other cancers, including colorectal carcinoma. LKB1 mutations remove a "brake" preventing oncogenesis and are frequently co-mutated with KRAS oncogenes which stimulates oncogenesis. These patients are generally resistant to the standard of care (chemotherapy or immuno-oncology treatment) and face a very poor prognosis. In preclinical models, the ULK1/2 inhibitor ENV-201 demonstrated single-agent activity against these tumors providing a potential therapeutic option where there is none today. Endeavor intends to advance the orally available, small molecule compound as a single-agent treatment, and the company also plans to explore combination treatment with cancer immunotherapy in refractory patients.

"Since we initially discovered how cancer cells starved of nutrients activate ULK1/2, we focused on finding a drug that could block its activity," said Nicholas Cosford, Ph.D., professor and deputy director of the NCI-designated Cancer Center at Sanford Burnham Prebys. "Using medicinal chemistry, chemical biology and rational drug design, we created compounds that inhibit ULK1/2 and we are hopeful this approach will have an impact as an anti-cancer treatment. This agreement with Endeavor BioMedicines moves our efforts closer to our goal of helping people living with cancer."

"We are excited that Endeavor BioMedicines will be advancing the ULK1/2 program into clinical development – a program that has the potential to be an extraordinary therapeutic option for patients who have certain genetically defined, life-threatening cancers," said Reuben Shaw, Ph.D., professor, Molecular and Cell Biology Laboratory, William R. Brody Chair, Salk Institute for Biological Studies. "It is the right time to pass the baton to Endeavor for late preclinical and clinical development, and it underscores the strength of San Diego’s biotech ecosystem for the benefit of patients who have significant unmet medical need."

Targeting a Cellular Recycling Progress in Cancer Biology

The laboratories of Shaw and Cosford collaborated to develop a portfolio of small molecule inhibitors of ULK1/2, a critical enzyme in a cellular recycling process called autophagy. Tumor cells use this cellular recycling process to supply much-needed nutrients and metabolites when there are not enough nutrients in the available blood supply. Tumors with high levels of autophagy are resistant to standard therapies and those patients generally have a very poor prognosis. Researchers have also found that specific genetic mutations frequently found in lung, colorectal and pancreatic cancer make those tumors highly dependent on this recycling pathway. The combined research suggests that drugs targeting ULK1/2 to inhibit autophagy should work well in genetically defined cancers alone or in combination with existing chemo-, targeted- and immuno-therapeutics.