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Sirnaomics Secures $105 Million Series E Financing

On July 1, 2021 Sirnaomics Ltd., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that it has sealed $105 million in a Series E financing (Press release, Sirnaomics, JUL 1, 2021, View Sourcesirnaomics-secures-105-million-series-e-financing/" target="_blank" title="View Sourcesirnaomics-secures-105-million-series-e-financing/" rel="nofollow">View Source [SID1234584548]). This round of funding was led by Rotating Boulder Fund, an investor that has been supporting the company since its Series B round, with participation from existing investors and a well-recognized syndicate of new investors.

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Proceeds from the financing will be used to fund the continued development of Sirnaomics’ novel RNAi therapeutics for treating diverse human disorders, which include cancers, viral infections, fibrosis, and metabolic diseases. Sirnaomics will also further advance its delivery technology platforms and strengthen its large-scale manufacturing capacity to support the company’s fast-growing product pipeline at different clinical stages (See: View Source).

Sirnaomics’ product candidates, STP705 and STP707, are dual targeting siRNA therapeutics against TGF-β1 and COX-2 for either local or systemic administration to treat various types of cancers and fibrotic diseases. Based on successful clinical and preclinical studies, a future clinical focus will be targeted towards immune oncological evaluation, with combination design of the novel RNAi drug candidate and immune checkpoint inhibitors, such as PD-1/PD-L1 monoclonal antibodies. With further expansion of the company’s systemic RNAi drug delivery platforms, encompassing siRNA-chemodrug conjugates and proprietary GalNAc-siRNA conjugates, Sirnaomics is poised to address multiple therapeutic areas.

"We are pleased to close the Series E round of financing with oversubscription from a very diversified and strong investor base," commented Patrick Lu, Ph.D., Founder, President and Chief Executive Officer. "This is another powerful validation that the RNAi therapeutics, fuelled by innovative delivery platforms, ground-breaking CMC technologies, and fast expansion of multiple clinical programs with positive results, are attracting significant interests from the investment community. We appreciate strong trust and persistent support from our existing investors, and we are very excited with this addition of a well-regarded syndicate of investors for the Series E financing. This combination of existing and new investors will not only strengthen our financial foundation, but also bring tremendous experience and expertise to Sirnaomics as it enters the next phase of growth."

Pulse Biosciences Announces $50 Million Private Placement

On July 1, 2021 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported that it has entered into a stock purchase agreement with Robert W. Duggan, an experienced life sciences executive and the Company’s Board Chairman, for the purchase of 3,048,780 shares of the Company’s common stock at a price of $16.40 per share, the last reported sale price of the Company’s common stock on June 30, 2021, the immediately preceding trading day (Press release, Pulse Biosciences, JUL 1, 2021, View Source [SID1234584547]). All indebtedness owed by the Company to Mr. Duggan pursuant to the loan agreement between Mr. Duggan and the Company dated as of March 11, 2021, including the principal balance of $41.0 million and accrued and unpaid interest of $0.6 million, will be paid through the cancellation and extinguishment of such indebtedness and the issuance of the common stock shares in the private placement. As part of the private placement, Mr. Duggan will invest an additional $8.4 million as new capital.

"This capital strengthens our balance sheet and enables greater flexibility to drive our top business priorities, the CellFX System Controlled Launch Program and the ongoing product development and initiatives to expand the clinical applications for NPS technology," said Darrin Uecker, President and CEO of Pulse Biosciences. "We appreciate the continued support and leadership from the Chairman of our Board of Directors. The entire team at Pulse Biosciences is excited and committed to deliver the clinically differentiated benefits of Nano-Pulse Stimulation technology to as many patients as possible, starting in aesthetic dermatology."

Mr. Duggan, who currently owns approximately 46% of the Company’s outstanding common stock, will become the beneficial owner of approximately 51% of the Company’s outstanding common stock after giving effect to the private placement. Accordingly, after the closing of the private placement, the Company will be considered a "controlled" company under applicable Nasdaq Stock Market rules.

No warrants will be provided, or other discounts given, to Mr. Duggan in the private placement, and the private placement is being facilitated directly by the Company. As such, no investment banking or placement fees are being incurred by the Company. The private placement is expected to close on or about July 7, 2021, subject to the satisfaction of customary preclosing conditions.

This announcement is neither an offer to sell nor a solicitation to buy any securities, nor shall there be any offer, solicitation or sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

The shares of common stock being issued in the private placement have not been registered under the Securities Act of 1933, as amended (the "Act"), or any state securities laws, and unless so registered, may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Act and applicable state laws.

Aileron Therapeutics Announces Initiation of Randomized, Double-Blind, Placebo-Controlled Trial of ALRN-6924 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

On July 1, 2021 Aileron Therapeutics, Inc. (Nasdaq: ALRN) reported that it has initiated a randomized, double-blind, placebo-controlled clinical trial in the US and in Europe of ALRN-6924 as a chemoprotective agent to treat patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy (Press release, Aileron Therapeutics, JUL 1, 2021, View Source [SID1234584538]). Aileron plans to enroll 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors in this Phase 1b trial. Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects while preserving chemotherapy’s attack on cancer cells, a concept known as chemoprotection.

"We are pleased to initiate this trial, which builds on promising data we previously reported from our proof-of-concept trial of ALRN-6924 in patients with small cell lung cancer (SCLC)," said Manuel Aivado, M.D., Ph.D., President and CEO of Aileron. "This NSCLC trial represents important progress in our clinical development strategy, as it involves a p53-mutated cancer indication that affects one of the largest cancer patient populations, and it is our first randomized, double-blind, placebo-controlled trial. In addition, the trial is designed to help us further advance our ultimate goal of pursuing a tumor-agnostic indication for ALRN-6924 as a chemoprotective agent for patients with p53-mutated cancers regardless of type of cancer or chemotherapy, with the potential to help millions of patients."

1 American Cancer Society

Nashat Gabrail, M.D., founder of the Gabrail Cancer Center in Canton, Ohio, President of Innovative Community Oncology Practices (ICOP) and an investigator in the ALRN-6924 NSCLC trial, commented, "Proactively protecting patients against chemotherapy-induced toxicities that impact bone marrow cells and other cells throughout the body closely aligns with our mission to improve the health and quality of life for patients. This is a significantly unaddressed need impacting nearly every patient who undergoes chemotherapy. When devising treatment strategies for today’s cancer patients, the use of targeted therapies is certainly preferred when possible. We are proud to participate in this trial to help explore the potential of ALRN-6924 as a novel chemoprotective agent that utilizes a biomarker-driven approach, thereby potentially bringing the promise of precision medicine to the field of supportive care drugs."

Patients enrolled in Aileron’s NSCLC trial will be randomized 1:1 to receive carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or placebo for at least four 21-day treatment cycles. Primary endpoints are the proportion of treatment cycles free of severe hematological and other toxicities, including Grade ≥ 3 neutropenia, Grade ≥ 3 thrombocytopenia, Grade ≥ 3 anemia, Grade 4 neutropenia and febrile neutropenia, as well as duration of Grade 4 neutropenia. An additional primary endpoint is the proportion of completed treatment cycles without chemotherapy dose reduction or without the use of growth factors or transfusions. Other endpoints include the proportion of patients with National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE) Grade 3/4 treatment-emergent adverse events (TEAEs), quality of life, overall response rate, and progression-free survival.

Aileron anticipates reporting first interim safety data from the trial late in the fourth quarter of 2021 and full results in mid-2022.

The NSCLC trial follows Aileron’s presentation in October 2020 of clinical data from its completed Phase 1b clinical trial of ALRN-6924 in SCLC demonstrating clinical proof-of-concept that treatment with ALRN-6924 resulted in a protective effect against severe anemia, thrombocytopenia and neutropenia in patients with p53-mutated SCLC treated with topotecan. A link to the SCLC presentation can be found here.

About ALRN-6924
Aileron is developing ALRN-6924, a novel chemoprotective medicine, to selectively protect healthy cells in patients with cancers that harbor p53 mutations to reduce or eliminate chemotherapy-induced side effects.

Chemotherapy preferentially acts on cells that are cycling, i.e. undergoing the process of cell division. In cancer cells, the cell cycle is unchecked, which leads to uncontrolled cell proliferation, a hallmark of cancer. Certain types of healthy cells also naturally need to cycle, such as bone marrow cells, hair follicle cells, skin cells, and cells lining the oral cavity and the gastrointestinal tract. As a result, chemotherapy preferentially targets and kills both cycling healthy cells and cycling cancer cells. This, in turn, can lead to a spectrum of chemotherapy-induced side effects, from unpleasant to life-threatening and fatal.

ALRN-6924, an investigational first-in-class MDM2/MDMX dual inhibitor, is administered prior to chemotherapy to patients with p53-mutant cancers. ALRN-6924 is designed to activate normal p53 protein in patients’ healthy cells, temporarily and reversibly pausing cell cycling to selectively shield the patients’ healthy cells from chemotherapy. The protection is limited to healthy cells, as ALRN-6924 cannot work in p53-mutated cancer cells given that mutated p53 has lost its function in those cells. Therefore, p53-mutated cancer cells continue to cycle uninterrupted and remain fully susceptible to being killed by chemotherapy.

Enterome to Present at Upcoming Investor Conferences

On July 1, 2021 ENTEROME SA, a clinical stage biopharmaceutical company developing novel drugs based on its unique ability to de-code molecular interactions in the gut microbiome impacting human health, reported that Pierre Belichard, CEO, will present an overview of the Company and take part in 1-on-1 meetings with institutional investors at the following conferences (Press release, Enterome, JUL 1, 2021, View Source;utm_medium=rss&utm_campaign=enterome-to-present-at-upcoming-investor-conferences [SID1234584546]):

BTIG Virtual Biotechnology Conference: August 9-10
C. Wainwright 23rd Annual Global Investment Conference: September 13-14

Labcorp Launches Companion Diagnostic for Amgen’s Newly-approved Lung Cancer Therapy

On July 1, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported the availability of therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for treatment with LUMAKRAS (sotorasib), a new treatment option developed by Amgen (Press release, LabCorp, JUL 1, 2021, View Source [SID1234584545]).

Labcorp’s oncology platform brings together the company’s leadership in diagnostic testing with its comprehensive drug development services, helping to pioneer scientific breakthroughs like the KRAS companion diagnostic to identify patients eligible for cutting-edge targeted therapies.

"Every day, cancer patients across the country anxiously await test results that directly impact treatment decisions. Through our collaboration with QIAGEN and participation in their Day-One Lab Readiness Program, Labcorp is committed to ensuring critical biomarker testing for KRAS is immediately accessible to physicians to ensure every patient who may benefit from sotorasib is appropriately identified and treated," said Prasanth Reddy, M.D., MPH, senior vice president and oncology head at Labcorp, and a triple-board certified hematology and oncology physician. "Labcorp is proud to be one of the first labs to make the therascreen KRAS test available, in addition to the many other diagnostic tests in our testing portfolio, including companion diagnostics that have been made available soon after FDA approval for breast, lung, colorectal, bladder and other cancers."

The therapy and this indicated use of the test as a companion diagnostic received approval from the U.S. Food and Drug Administration (FDA) in late May 2021. The therascreen KRAS PCR Mutation Analysis is now available for ordering from Labcorp to determine if patients carry a specific mutation in the KRAS gene.

QIAGEN (NYSE: QGEN, Frankfurt Stock Exchange: QIA) developed the assay, and Labcorp applied its scientific validation process to be able to offer the assay through its CAP accredited, CLIA-certified specialty labs. Using the lung biopsy specimen, the assay identifies whether a patient with NSCLC has a specific mutation in the KRAS gene and is eligible for treatment with LUMAKRAS (sotorasib) which was developed by Amgen (NASDAQ: AMGN). This is the first FDA-approved biomarker-driven, targeted therapy for the treatment of adults with NSCLC whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. KRAS mutations have been found to enable cells in certain cancers to grow and spread more easily.

According to the American Cancer Society, in 2020, 10-12% of the 228,000 people diagnosed with lung cancer carry the G12C KRAS mutation. Lung cancer is still one of the most common cancers worldwide. Approximately 84% of lung cancers are NSCLC.

"We have a longstanding relationship with Labcorp and are delighted to collaborate with them again to bring this new companion diagnostic indication to NSCLC patients," said Jonathan Arnold, vice president, Oncology and Partnering for Precision Diagnostics at QIAGEN. "The expanded indication on our QIAGEN therascreen KRAS test will provide clinically relevant information to aid physicians in identifying patients eligible for a new class of treatment in NSCLC."

During the last 25 years, Labcorp has played a significant role in launching hallmark testing options for the treatment of cancer. The company remains committed to further developing companion diagnostics and precision medicines. This new offering adds to its growing portfolio of tests that specialize in more personalized care, leading to more specific treatment choices. In addition to single marker tests, Labcorp offers full panels of testing powered by advanced next generation-sequencing (NGS) technology for complete profiling of a patient’s unique tumor, including mutations in KRAS.

For more information about Labcorp’s full menu of companion and complementary diagnostic tests, visit oncology.labcorp.com.

LUMAKRAS is a trademark of Amgen, Inc.

therascreen is a registered trademark of QIAGEN.