On January 28, 2021 ARCH Venture Partners reported the closing of ARCH Venture Fund XI, with over $1.85 billion to invest in the creation and funding of early stage biotechnology companies (Press release, ARCH Venture Partners, JAN 28, 2021, View Source [SID1234574438]).

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"From its start, ARCH sought out great science with the potential to significantly improve human health. While Fund XI is our largest to date, we have always invested at levels that each company or technology needed to advance, whether it’s $50,000 or $250 million. We are continually proud to help bring together and advise scientists and entrepreneurs to create successful enterprises," said co-founder and Managing Director Robert Nelsen.

ARCH will invest Fund XI in early stage biotechnology companies working on infectious disease, mental health, immunology, oncology, neurology, manufacturing, clinical trials, anti-aging medicines, genomic and biological tools, data sciences, and ways of reimagining diagnostics and therapies. ARCH continues to take a special interest in how healthcare is delivered to patients – from data collection to therapeutics manufacturing to direct patient care. ARCH will also examine areas exposed by the pandemic where innovation can solve challenges such as vaccine distribution, medical professionals being overworked and understaffed, and the scarcity of quality mental health services.

"Particularly in the midst of the ongoing pandemic, companies that can bring cutting-edge medicines and tools forward are both clearly important and good investments. Now more than ever, we have a sense of urgency and purpose to back companies that could meaningfully change medicine for the better," said Managing Director Kristina Burow.

"With this new fund, we are excited to continue finding new areas of science where a bright idea, paired with resources and know how, could spark the next significant improvement in human health," said co-founder and Managing Director Keith Crandell.

In addition to ARCH Fund XI, the firm announced updates on its team. Paul Berns, previously a Venture Partner, has been named a Managing Director. Berns brings over 30 years of pharma and biopharma experience. He is a board member for Unity Biotechnology, EQRX, and is Chairman of Epirum Bio. He previously served as Chairman, President and Chief Executive Officer at Anacor Pharmaceuticals, Inc., President and Chief Executive Officer of Allos Therapeutics, Inc., and was President and Chief Executive Officer of Bone Care International, Inc. Earlier in his career, he held various senior leadership positions at Abbott Laboratories, BASF Pharmaceuticals/Knoll, and Bristol-Myers Squibb Company.

Jay Markowitz also joined ARCH as a Senior Partner, bringing more than 19 years analyzing, investing, and working in the biopharmaceutical industry. His experience includes nine years at T. Rowe Price, seven years at Capital Group, and three years as a Senior Vice President at Regeneron Pharmaceuticals. Prior to his investment career, Markowitz was a transplant surgeon at Johns Hopkins University.

Carol Suh and Sean Kendall have been named Principals and Corey Ritter and Nilay Thakar were both promoted to Senior Associate.

On January 28, 2021 Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a clinical stage biotechnology company developing a new modality of orally delivered medicines, reported the pricing of an underwritten public offering of 4,500,000 shares of its common stock, at a public offering price of $15.00 per share, before underwriting discounts and commissions. Evelo also granted the underwriters a 30-day option, solely to cover over-allotments, if any, to purchase up to an additional 675,000 shares of its common stock (Press release, Evelo Biosciences, JAN 28, 2021, View Source [SID1234574400]). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $67,500,000 million, excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares in the offering are to be sold by Evelo.

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Morgan Stanley, Cowen and BMO Capital Markets are acting as joint book-running managers for the offering. The offering is expected to close on or about February 2, 2021, subject to customary closing conditions.

Evelo intends to use the net proceeds from the offering, in addition to its existing cash resources, for the following purposes: (i) continue the development of EDP1815 in a Phase 2 trial in psoriasis and initiate a Phase 2 trial of EDP1815 in atopic dermatitis; (ii) prepare to advance EDP1815 in multiple Phase 3 trials in psoriasis and atopic dermatitis, upon receipt of positive Phase 2 data; (iii) continue the Phase 2 and Phase 2/3 clinical trials of EDP1815 for the treatment of hyperinflammation caused by SARs-CoV-2; (iv) advance EDP1867 in a Phase 1b trial in atopic dermatitis; (v) progress its first bacterial extracellular vesicle product candidates into the clinic, including EDP2939 for inflammation and EDP1908 for oncology; (vi) other research and development activities for additional product candidates, including advancing additional oral product candidates through preclinical development across therapeutic areas; and (vii) the remainder, if any, for working capital and other general corporate purposes.

The securities described are being offered by Evelo pursuant to a shelf registration statement on Form S-3 (Reg. No. 333-231911), including a base prospectus, which was declared effective by the Securities and Exchange Commission ("SEC") on June 6, 2019. The securities are being offered only by means of a prospectus supplement and accompanying prospectus forming a part of the effective registration statement. A preliminary prospectus supplement related to and describing the terms of the offering was filed with the SEC on January 28, 2021. The final prospectus related to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 28, 2021 Charles River Laboratories International, Inc. (NYSE: CRL) reported that it has entered into a strategic partnership with Cypre, Inc., a biotechnology company that is using 3D hydrogel technology to advance the understanding of the tumor microenvironment and predict therapeutic efficacy (Press release, Charles River Laboratories, JAN 28, 2021, View Source [SID1234574398]). The partnership will provide Charles River clients with access to Cypre’s proprietary 3D tumor model platform, Falcon-X, which will expand Charles River’s 3D in vitro testing services to further optimize immuno-oncological approaches for its clients.

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The Falcon-X 3D In Vitro Tumor Assay Platform is a high content analysis screening option for cancer immunotherapy and targeted therapy. Utilizing Cypre’s patented 3D hydrogel patterning technology, Symphony and VersaGel, and proprietary methods that synergize with the breadth and depth of Charles River’s tumor model collection, the platform recreates the tumor microenvironment and enables predictive screening of innovative immuno-oncology compounds. As a part of Charles River’s integrated tumor model service platform, including patient-derived xenografts (PDX), Falcon-X will provide human data that translates to the clinic and identifies the efficacy of specific immunotherapy and targeted therapeutic treatments for patients.

Charles River offers a range of cancer cell-based assays, including PDX assays and assays representing the entire tumor microenvironment (TME), so therapies are not only tested for their effect on real patient materials, but also their interaction with the human immune systems. Through this collaboration, Charles River will now have a critical new addition to our human oncology assay repertoire, allowing identification of therapeutics that overcome cancer immunotherapy resistance.

The partnership will also allow Cypre to screen multiple therapeutic modalities alone or in combination utilizing Charles River’s genomically annotated and in vivo characterized cancer model database. The database is comprised of more than 700 tumor models, including PDX, cell lines and cell line derived xenografts. These models have been extensively profiled for histological features, molecular data, and sensitivity to standard-of-care compounds, allowing a precise selection of suitable tumor models for preclinical anti-cancer agent testing. The biological advantages of PDX include the retention of histological and genetic characteristics of the donor tumor and the preservation of cell-autonomous heterogeneity, which increase the translational relevance of the Cypre platform significantly. The breadth and depth of Charles River’s cancer model database enable the offering of a clinically relevant tumor panel in Cypre’s innovative 3D platform, and the platform’s compelling predictivity for in vivo PDX models allows streamlined programs and translation to the clinic.

Approved Quotes

"Immunotherapy is a complex, yet promising area of development in cancer treatment. Cypre’s platform enables the ideal tumor culturing conditions for assaying various immunotherapies and targeted therapies and provides robust, reproducible data sets without compromising throughput that strongly correlates to our PDX in vivo results. By broadening our 3D in vitro services with this collaboration, we can provide our clients with a complete, integrated tumor model service platform." – Birgit Girshick, Corporate Executive Vice President, Discovery and Safety Assessment, Biologics Testing Solutions, and Avian Vaccine Services, Charles River
"Charles River is the premier CRO in discovery and early development services, and we are thrilled to partner with their team to drive a combined offering. Our Falcon-X platform provides Charles River customers with expanded access to patient-derived 3D in vitro screening services and a new way to assay the immune cell compartment within the tumor microenvironment. We look forward to building this relationship and providing more customers with our unique solution that will improve targeted and immuno-therapeutic options for cancer patients." – Kolin Hribar, PhD, Founder and CEO, Cypre

On January 28, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases in both humans and animals, reported that has an abstract presented at the world’s largest lung cancer meeting, the WCLC, which is being held virtually this year (Press release, VolitionRX, JAN 28, 2021, View Source [SID1234574397]).

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The poster presentation given by Dr. Tung-Ming Tsai of the National Taiwan University Hospital will be featured in the WCLC’s Screening and Early Detection session and is entitled "Circulating Nucleosomes in Lung Cancer Diagnosis following Low-Dose Computed Tomography". The key message from the presentation is that, based on an interim analysis of a subset of subjects in an ongoing study, Nu.Q assays could help identify non-cancerous nodules following a scan thereby reducing unnecessary biopsies by as much as 32%.

Watch a short interview where Chief Scientific Officer, Dr. Jake Micallef discusses the results – View Source

Professor Chen Jin-Shing, Principal Investigator of the study said "The results of this interim analysis of a subset of our 1,200-subject study are very promising. Low-Dose Computed tomography (LDCT) is the widely accepted standard for screening of individuals at high risk of lung cancer. However, LDCT has several limitations including poor specificity (high false positives). Results from this study suggest that Nucleosomes and Histone PTMs may discriminate well between non-cancerous benign nodules versus early-stage lung cancer (stages 0, I and II) in non-familial lung cancer history patients. The ability to distinguish between cancerous and non-cancerous nodules could reduce both unnecessary biopsies and the frequency of radiation exposure from repeated LDCT scanning. To accomplish this result through a non-invasive blood test would be an important step forward in lung cancer screening. We look forward to completing the study and publishing our findings in the coming months."

Dr. Jasmine Kway, Chief Executive Officer of Singapore Volition said "Lung cancer remains the deadliest of all the cancers and there is a high unmet clinical need for improved diagnosis. We are hopeful that our Nu.Q assays can help identify non-cancerous nodules following a scan. We are delighted that our world-renowned collaborators are presenting this data at such a prestigious conference and share our collaborator’s excitement to complete this study and share the findings at scientific conferences later this year."

The abstract can be found here.

To view the poster presentation video please register for the WCLC here

About the Study

A large-scale lung cancer study is being conducted under the supervision of Professor Chen Jin-Shing in the Department of Surgery of the prestigious National Taiwan University Hospital ("NTUH"). The study will include 1,200 subjects receiving LDCT scans, including 1,000 with lung cancer. Collection commenced in the summer of 2019 and will be completed in May 2021. This interim analysis is based on a subset of 220 subjects.

On January 28, 2021 Amgen (NASDAQ: AMGN) reported results from the Phase 2 cohort of the CodeBreaK 100 clinical study evaluating investigational sotorasib (AMG 510) in 126 patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) (Press release, Amgen, JAN 28, 2021, View Source [SID1234574396]). The results will be presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) and are the first from a completed pivotal Phase 2 study in NSCLC with a median follow-up of more than one year.

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Sotorasib demonstrated a confirmed objective response rate (ORR) and disease control rate (DCR) of 37.1% and 80.6%, respectively, and a median duration of response of 10 months (data cutoff of Dec.1, 2020; median follow-up time was 12.2 months). The results also highlighted that sotorasib is the first KRASG12C inhibitor to show progression-free survival (median of 6.8 months) in a Phase 2 study, which is consistent with earlier Phase 1 results in previously treated patients with KRAS G12C-mutated advanced NSCLC.

Patients were treated with sotorasib 960 mg once daily orally. Prior to the trial, 81% of patients had progressed on both platinum-based chemotherapy and PD1/L1 inhibitors, with the remainder progressing after having received one of these therapies.

"Patients with advanced non-small cell lung cancer who have failed first-line treatment face extremely poor outcomes with limited treatment options available to them, and Amgen has been committed to changing that," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Targeting KRAS has been a 40-year quest by scientists and researchers around the world, and we are extremely pleased that sotorasib has successfully demonstrated rapid, deep and durable responses in this registrational Phase 2 study that was conducted in record time. We are proud that sotorasib may potentially become the first approved targeted therapy for these patients."

Over 80% of patients achieved disease control, including three complete responses and 43 partial responses, and the median best tumor shrinkage among all responders (n=46) was 60%. The median time to objective response was 1.4 months. Sotorasib had a favorable benefit-risk profile with most treatment-related adverse events (TRAEs) mild-to-moderate (grade 1 or 2) and no treatment-related deaths. Grade 3 TRAEs were reported in 25 (19.8%) patients and only one patient (0.8%) reported a Grade 4 TRAE. The most frequently reported TRAEs (any grade) were diarrhea (31.0%), nausea (19.0%), increased alanine aminotransferase (15.1%) and increased aspartate aminotransferase (15.1%). TRAEs led to treatment discontinuation in only 7.1% of patients.

"These results are encouraging and clinically meaningful for patients with advanced NSCLC harboring the KRAS G12C mutation," said Bob T. Li, MD, PhD, MPH, medical oncologist and principal investigator at Memorial Sloan Kettering Cancer Center. "These are patients who have progressive disease after standard treatment, so they need additional treatments, and the fact that we are seeing rapid tumor shrinkages and durable responses in these patients, is for me a step forward and a win for patients."

In exploratory analyses, encouraging tumor response to sotorasib was observed across a range of biomarker subgroups, including patients with negative or low PD-L1 expression level and those with STK11 mutation. This co-mutation has been associated with poor outcomes in NSCLC patients treated with checkpoint inhibitors and chemotherapy.

"Despite recent treatment advances, survival outcomes remain poor for patients with advanced stage non-small cell lung cancer on second and third-line therapies with the KRAS G12C mutation. Currently there are no targeted treatment options for them, and I am excited about the advances that Amgen is pioneering in this field to potentially help improve patient outcomes," said Dr. Upal Basu Roy, vice president of Research, LUNGevity.

Following recent regulatory submissions in the U.S., European Union, Australia, Brazil, Canada and UK, Amgen is working with regulatory agencies across the globe to bring sotorasib to NSCLC patients as quickly as possible. Sotorasib has achieved Breakthrough Therapy Designation in the U.S.

NSCLC accounts for 80%-85% of all lung cancers, and most patients (66%) have advanced or metastatic disease at initial diagnosis.1,2 KRAS G12C is one of the most common driver mutations in NSCLC and there is a high unmet need and poor outcomes associated in the second-line treatment of KRAS G12C driven NSCLC.3 In the U.S., about 13% of patients with NSCLC harbor the KRAS G12C mutation,4,5 and each year approximately 25,000 new patients in the U.S. are diagnosed with KRAS G12C-mutated NSCLC.6

Amgen Webcast Investor Call
Amgen will host a webcast call for the investment community in conjunction with WCLC 2020. On Friday, Jan. 29, 2021, at 5 p.m. PST, David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss registrational Phase 2 NSCLC data being presented on the Company’s investigational KRASG12C inhibitor sotorasib.

Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit www.AmgenOncology.com.

About Sotorasib
Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor.7 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning five continents. In just over two years, the sotorasib clinical program has established the largest clinical data set with more than 700 patients studied across 13 tumor types to date.

Sotorasib has demonstrated a positive benefit-risk profile with fast, deep and durable anticancer activity in patients with NSCLC harboring the KRAS G12C mutation with a once daily oral formulation. Promising responses have also been observed in multiple other solid tumors.8

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has more than 10 Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.