On February 17, 2021 Micronoma, the first cancer detection biotech company that utilizes signals from the tumor-related microbiome to diagnose cancer at an early stage with liquid biopsy technology, reported the closing of $3.5 million in convertible debt financing (Press release, Micronoma, FEB 17, 2021, View Source [SID1234575167]). The contributions came from existing investor, US-based SymBiosis, LLC, and new European investor, The Seerave Foundation. The investments bring Micronoma’s total amount of funding to $6.5 million since the company’s first seed round six months ago.

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!

Micronoma decrypts signals from some of the most ancient matter in the world, the microbiome, to detect cancer early, from all genomes. The additional financing will enable Micronoma to complete its validation study on lung cancer prediction, set up CLIA (Clinical Laboratory Improvement Amendments) operations, establish its go-to-market strategy utilizing its Oncobiota platform, and initiate work on a second cancer target.

"The Seerave Foundation is a strong supporter of efforts enabling personalized cancer treatments. We are confident that the nutrition-microbiome-immune system axis is a significant factor in each patient’s journey," said David Rees, founder of The Seerave Foundation. "Thus, we recognize early diagnosis of cancer-associated microbial DNA as a key element to transforming cancer diagnostics and treatment going forward. We are convinced that the Micronoma platform will complement our other research activities and help in translating scientific innovations for practical applications. We are interested in being able to enhance the standard of care with a more holistic and patient-centric approach. Our ultimate goal is to move from a therapeutic into a preventive setting of personalized medicine which is where Micronoma’s innovation and expertise come into play, to empower physicians with actionable biomarkers."

Micronoma’s promising research was published in Nature last year, showing unique predictive microbial signatures in tissue and blood for most major types of cancer. Accurate, early cancer detection via liquid biopsy remains a challenge that Micronoma may be able to solve through its proprietary Oncobiota platform. Though having the potential to be a pan-cancer diagnostic tool, Micronoma will start with lung cancer, and with this recent funding, move toward pancreatic cancer diagnostics.

"We are grateful for the continued and new support from like-minded organizations that are as dedicated as we are to finding innovative and precise ways to significantly improve early cancer diagnosis," said Sandrine Miller-Montgomery, CEO of Micronoma. "SymBiosis has been an amazing partner and we are so happy to now have Seerave, expanding our support globally. Together, we can expand the limits of care and revolutionize what practitioners and patients have come to understand as status quo. We are all very passionate about bringing this technology to market as quickly and thoroughly as possible."

Each year, there are approximately 18 million new cancer cases worldwide and nine million cancer deaths. It is estimated that with early detection, up to 4 million of those deaths could be prevented every year. The diagnostic implications of microbiome markers in liquid and tissue biopsies are extensive, and Micronoma is prepared to lead the way on helping prevent unnecessary suffering caused by later-stage cancer diagnosis.

On February 16, 2021 Nanocan Therapeutics Corporation, an early-stage biotechnology company, reported an exclusive global licensing agreement with Brigham and Women’s Hospital (Boston, MA), a teaching hospital of Harvard University’s Medical School, to develop and commercialize Immunogenic Smart Radiotherapy Biomaterials (iSRBs) for the treatment of pancreatic, lung, and cervical cancer (Press release, Nanocan Therapeutics, FEB 16, 2021, View Source [SID1234625677]). This technology has the potential to enhance radiotherapy mechanisms via delivery of immunoadjuvants that improve both local and metastatic tumor kill. iSRBs could also potentially reduce treatment time and cost for cancer patients, improve convenience, and significantly improve global patient access to cancer treatment.

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!

iSRBs can provide both CT and MRI imaging contrast crucial for image-guided radiotherapy and can also provide sustained delivery of immunoadjuvant payloads. In conjunction with an immunoadjuvant, a boost in abscopal effect causing regression in both treated and untreated tumors has been observed in animal models, with minimal normal tissue toxicity.

"Pancreatic cancer, our lead indication, remains a challenging diagnosis with high mortality," said Eric Broyles, Founder and CEO of Nanocan Therapeutic Corporation. "With our expertise in nanotechnology delivery, and grant investments from the NIH, NCI, and DoD, Nanocan is well positioned to further develop iSRBs in pursuit of providing a new standard of care for pancreatic, lung, and cervical cancers. We also see potential application in breast, liver, and prostate cancers, as well as glioblastoma."

We’re encouraged by the research undertaken by scientists at Brigham and Women’s Hospital and excited about this global licensing agreement," said Jack Markell, two-term Governor of Delaware and Nanocan Advisory Board member. "We are deeply committed to improving the lives of cancer patients around the world and will place a special emphasis on bringing these life-saving technologies to underserved and developing countries."

On February 16, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended December 31st, 2020 and provided a business update (Press release, Sonnet BioTherapeutics, FEB 16, 2021, View Source [SID1234579514]).

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!

"During the past few months, we have continued to accrue pre-clinical data for our lead platform asset, SON-1010. IL-12 has historically been a difficult target given the toxicities associated with its use," commented Pankaj Mohan, Ph.D., Founder and CEO. "To this end, we are increasingly more encouraged that our FHAB technology has the capacity to improve the therapeutic window of IL-12 and will help Sonnet position the SON-1010 asset as a potentially viable therapeutic candidate of significant value to patients and physicians."

First Quarter FY 2021 and Recent Corporate Updates
Sonnet provided the following updates on its lead pipeline assets:

The Company successfully completed a single- and multiple-dose non-human primate (NHP) study with SON-1010, the Company’s proprietary fully human Interleukin 12 (IL-12) therapeutic candidate configured using the Fully Human Albumin Binding (FHAB) platform. These two studies help to inform and de-risk the design of follow-on NHP studies needed to file an IND with the FDA. Importantly, the data demonstrated a well-tolerated agent with interferon-γ levels suggesting potent on-target activity. The Company will present additional data from the NHP studies at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting in April. The Company plans to file an IND and initiate Phase 1 clinical development in SON-1010 in the second half of 2021.

In SON-080 (low-dose recombinant fully human Interleukin 6, or IL-6), the Company is planning to file an IND and initiate Phase 1b/2a pilot efficacy clinical trials during the second half of 2021 for Chemotherapy Induced Peripheral Neuropathy (CIPN), followed by a Phase 1b/2a pilot efficacy trial for Diabetic Peripheral Neuropathy (SON-081) in 2022.

The previously announced letter of intent to negotiate a licensing agreement with New Life Therapeutics with respect to SON-080 and SON-081 continues on-track. The Company expects to finalize this agreement during the first quarter of 2021.

Sonnet is also developing SON-1210 (IL15-FHAB-IL12), the Company’s lead bispecific construct combining FHAB with fully human IL-12 and fully human Interleukin 15 (IL-15), for solid tumor indications, including colorectal cancer. An IND submission for SON-1210 is expected during the second half of 2021.

Fiscal 2021 First Quarter Ended December 31, 2020 Financial Results

Jay Cross, CFO, commented, "Our cash management strategies have been successful over the past quarter, but more importantly we have recently begun to draw from our ATM offering program, strengthening our balance sheet. With the ATM open, we also decided to close the share subscription facility."

As of December 31, 2020, Sonnet had $2.3 million cash on hand.
As previously announced, on February 5, 2021, Sonnet entered into an at-the-market sales agreement with BTIG, LLC, for an aggregate offering of up to $15.9 million. As of today, the Company has sold 380,199 shares for net proceeds of $1.1 million to Sonnet.
All of the Company’s previously outstanding Series A and Series B warrants (except for approximately 42 thousand Series B warrants) have been exercised. The Company has 11.3 million Series C Warrants outstanding with an exercise price of $3.19 that will expire on October 16, 2025. In the event all the Series C Warrants were exercised for cash, the Company would receive up to an additional $36.1 million.
Research and development expenses were $3.9 million for the three months ended December 31, 2020, compared to $1.4 million for the three months ended December 31, 2019. The increase of $2.5 million was primarily due to the development of the cell line for IL12-FHAB and IL12-FHAB-IL15 manufacturing and increased costs for research and development activities due to the acquisition of Relief Therapeutics SA, including an increase in payroll and share-based compensation expense as the Company expanded its operations.
General and administrative expenses were $2.0 million for the three months ended December 31, 2020, compared to $1.1 million for the three months ended December 31, 2019. The increase of $0.9 million was primarily due to an increase in insurance expenses related to directors and officer’s insurance, and an increase in payroll and share-based compensation expense as the Company expanded its operations to support its overall business objectives.
The $20 million share subscription facility that was previously in place has been terminated.

On February 16, 2021 Artios Pharma ("Artios"), a leading DNA Damage Response (DDR) company developing a broad pipeline of precision medicines for the treatment of cancer, reported it is scheduled to participate in the following upcoming virtual conferences (Press release, Artios Pharma, FEB 16, 2021, View Source [SID1234578233]):

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!

LifeSci Partners Precision Oncology Day

17 February 2021

Niall Martin, Chief Executive Officer at Artios Pharma will present an overview of the company at 10.00am ET.

A replay of the presentation will be available to view after the conference on the Artios website.

10th Annual SVB Leerink Virtual Global Healthcare Conference

22 -26 February 2021

Niall Martin, Chief Executive Officer, Tania Dimitrova, Chief Business Officer, and Abid Ansari, Chief Financial Officer will participate in 1 x 1 meetings.

Barclays Healthcare Conference 2021

9 -11 March 2021

Tania Dimitrova, Chief Business Officer at Artios Pharma will present an overview of the company at 9.45am ET on Tuesday 9 March.

Niall Martin, Chief Executive Officer, Tania Dimitrova, Chief Business Officer, and Abid Ansari, Chief Financial Officer will participate in 1:1 meetings.

A replay of the presentation will be available to view after the conference on the Artios website.

On February 16, 2021 Cend Therapeutics, Inc., a clinical-stage biotech company, and Qilu Pharmaceutical, a major Chinese pharmaceutical company, reported that the companies have entered a Collaboration and License Agreement to develop and commercialize Cend’s investigational drug, CEND-1, in Greater China (Press release, CEND Therapeutics, FEB 16, 2021, View Source [SID1234575230]).

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!

Cend presented favorable clinical results at the European Society for Molecular Oncology (ESMO) (Free ESMO Whitepaper) meeting September 2020 and is advancing into Phase 2 clinical trials in pancreatic cancer with CEND-1 in combination with gemcitabine and nab-paclitaxel. The Company is planning registration clinical trials in pancreatic cancer and will explore combinations with additional therapies, including immunotherapies, as well as expansion of its programs into additional solid tumor cancers.

"This partnership with Qilu will help us bring our treatment to patients with pancreatic and other solid tumor cancers in China. This collaboration will also speed global development to bring the treatment to market expeditiously. Qilu’s excellent development team and market position will position CEND-1 for success in China," commented David Slack, CEO of Cend.

"CEND-1 has generated encouraging clinical results in combination with standard of care chemotherapy for the treatment of pancreatic cancer, which remains a significant health issue in China. We are pleased to work with Cend to advance this program and explore broader potential applications for CEND-1," commented Oliver Kong, MD, Chief Medical Officer and Corporate Vice President of Qilu.

About the Qilu-Cend Partnership

In the Collaboration and License Agreement, Qilu will gain exclusive rights to CEND-1 in Greater China, including Taiwan, Hong Kong and Macau. Qilu will take on development as well as commercialization responsibilities within Greater China. Cend will continue to retain all rights outside of Greater China. Qilu will pay Cend an up-front license fee of US$10 million. Cend will be eligible to receive up to $225 million in milestones as well as tiered double digit royalties on product sales in the region.

About CEND-1

CEND-1 is an investigational drug that modifies the tumor microenvironment. It is targeted to tumors by its affinity for alpha-v integrins, which are selectively expressed in tumors but not normally expressed in healthy tissues. CEND-1 is a cyclic peptide that, once bound to these integrins, is cleaved by protease expressed in tumors to release a peptide fragment, called a CendR fragment, which binds to a second receptor, called neuropilin, to activate a novel uptake pathway that causes anticancer drugs to more selectively penetrate solid tumors. CEND-1 has also been shown to further modify the tumor microenvironment by selectively depleting tumor-infiltrating immunosuppressive cells, including T regulatory cells, and to increase the number of cancer-fighting immune cells within the tumor, potentially enabling patients’ immune systems or immunotherapies to more effectively fight cancer.