On September 19, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage drug development company, reported a company name change to Imunon, Inc., reflecting the evolution of the Company’s business focus and its commitment to developing cutting-edge immunotherapies and next-generation vaccines to treat cancer and infectious diseases (Press release, Celsion, SEP 19, 2022, View Source [SID1234619652]).

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!

The Company’s common stock will trade on the Nasdaq Stock Market under the new ticker symbol "IMNN" effective as of the opening of trading on September 21, 2022. The Company has filed an amendment to its Articles of Incorporation to effect the new corporate name and is introducing a new logo and a new corporate website, www.imunon.com.

Imunon is establishing a leadership position in immunology by developing DNA-mediated therapies with a lead asset targeting advanced ovarian cancer. The new name better reflects the Company’s progress in immunology and emphasizes its commitment to harnessing the building blocks of life to work in harmony with the body’s immune system.

"Our new name, Imunon, ideally captures the essence of our scientific endeavors and our mission," said Dr. Corinne Le Goff, president and CEO of Imunon. "With this name change, we are underscoring our commitment to create a new category of medicines leveraging our proprietary plasmid DNA technology platform in the fields of immuno-oncology and vaccines. With a strong balance sheet supporting current operations into 2025, we are well positioned to build a differentiated company to deliver on the promise of our gene-based therapies."

On September 19, 2022 BlueSphere Bio, a T-cell receptor (TCR) T-cell therapy company developing a powerful TCR discovery platform and novel therapeutic candidates for patients with hematologic malignancies and solid tumors, reported the company will present a poster, at the 7th Annual CAR-TCR Summit, being held in Boston, MA from September 19 – 22, 2022 (Press release, BlueSphere Bio, SEP 19, 2022, View Source [SID1234619651]). The summit brings together over 200 industry leaders to discuss discovery through to the commercialization of viable cell therapies.

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!

Title: TCXpress and iTCXpress: A Direct, High-throughput Platform Utilizing Parallel Processes for Efficient and Cost-Effective Discovery and Characterization of Novel TCRs.

About TCXpress

TCXpress is a proprietary high-throughput and efficient T-cell receptor (TCR) capture, expression and functional screening platform capable of processing thousands of single T cells directly into functionally expressed TCRs within a matter of days, thereby creating extensive libraries without the need for lengthy predictive sequencing.

On September 19, 2022 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported that it has entered into definitive agreements with several institutional investors for the issuance and sale in a registered direct offering of 13,636,365 of the Company’s American Depositary Shares (ADSs) and warrants to purchase up to an aggregate of 13,636,365 ADSs, at a combined purchase price of $1.10 per ADS and associated warrant (Press release, BioLineRx, SEP 19, 2022, View Source [SID1234619650]). Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The offering is expected to close on or about September 21, 2022, subject to satisfaction of customary closing conditions.

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!

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $1.15 per ADS and will be exercisable at any time upon issuance and will expire five years from the date of issuance.

The gross proceeds from the offering (without taking into account any proceeds from any future exercises of warrants issued in the private placement), before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be $15 million. BioLineRx intends to use the net proceeds to facilitate the commercial launch of Motixafortide in autologous stem cell mobilization for multiple myeloma patients and general corporate purposes, which may include working capital and funding clinical trials.

The securities described above are being offered by BioLineRx pursuant to a "shelf" registration statement on Form F-3 (File No. 333-251857) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on December 31, 2020 and declared effective by the SEC on January 11, 2021. The offering of such securities will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, any of the securities described herein, 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 September 19, 2022 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that an article highlighting preclinical data from BT8009, a Nectin-4 targeting Bicycle Toxin Conjugate, was published in Molecular Cancer Therapeutics (Press release, Bicycle Therapeutics, SEP 19, 2022, View Source [SID1234619649]). The article, titled "BT8009: a Nectin-4 targeting Bicycle Toxin Conjugate for treatment of solid tumors" is available online via this link.

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!

"Having already announced interim, positive results from our ongoing Phase I trial of BT8009, we are pleased to describe the work leading to its identification and the preclinical studies that support its potential to rapidly diffuse into, and to kill, solid tumor cells." said Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics. "The data published in Molecular Cancer Therapeutics describe BT8009’s pre-clinical efficacy in a wide range of cell-derived xenograft and patient-derived xenograft tumor models, with full tumor regression frequently seen in large and small tumors. We look forward to providing additional clinical data on BT8009 later this year."

On September 19, 2022 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech" or "AXIM"), an international healthcare solutions company targeting ocular surface diseases, reported that it has signed an exclusive global commercial partnership agreement with Verséa Ophthalmics, LLC, a business division of Verséa Holdings, Inc. ("Verséa"), one of the fastest growing U.S. healthcare companies, specialized in the sale and distribution of ocular diagnostic and therapeutic solutions (Press release, AXIM Biotechnologies, SEP 19, 2022, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-signs-exclusive-global-commercialization-agreement-with-versea-ophthalmics-for-distribution-and-sales-of-novel-ophthalmic-diagnostics-solutions [SID1234619648]).

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!

The agreement will provide Verséa with the exclusive commercial right to AXIM’s proprietary portfolio of point-of-care (POC) lab testing readers and three key biomarker diagnostic tests designed specifically to assist eye-care physicians in detecting and quantifying biomarkers associated with aqueous deficient Dry Eye Disease and non-specific allergic conjunctivitis. The three AXIM’s key biomarker tests – the Ocular Immunoglobulin E (IgE) test, the Lactoferrin test, and the future MMP-9 test – require the collection of 0.5 microliters in tears and provide quantitative results in under 10 minutes, an industry-leading return time.

Verséa plans to launch IgE and Lactoferrin tests at the upcoming 2022 American Academy of Ophthalmology (AAO) and American Academy of Optometry (AAOPT) conferences. The MMP-9 test is anticipated to follow in the next 18-24 months.

In recent months, AXIM has been preparing for the scaling of production of its tests in anticipation of an agreement such as the one reached with Verséa and is now prepared to support new orders associated with the agreement and subsequent launch.

"This is an exciting day for AXIM, one that has been years in the making – this is the moment where we move from a development-stage biotech company to a revenue generating healthcare organization," said John W. Huemoeller II, Chief Executive Officer of AXIM Biotech. "Since the development of our novel ocular diagnostic tests and subsequent success in proving their effectiveness, rather than building an internal team to commercialize the tests, we have been searching for a partner with a solid commercial infrastructure and a firm commitment to eye care, capable of bringing our tests to clinical offices on a global scale. I am more than confident that we have found that partner in Verséa. With existing sales channels to support their human amniotic membrane therapeutics, Verséa has expressed strong support for our business and a true excitement for adding our technology to their expanding portfolio of healthcare solutions. I personally believe that together, we will be able to change the landscape of dry eye disease diagnosis."

The agreement is an illustration of Verséa’s recent commitment to the eye care space following its appointment of Dr. Rob Sambursky, MD, as their President of Corporate and of Verséa Ophthalmics, a new business division set to provide innovative solutions for the diagnosis, treatment and management of ocular surface diseases.

"We are delighted to be selected by AXIM as their exclusive partner for the commercialization of their innovative suite of diagnostic solutions," said Sean Fetcho, CEO and co-founder of Verséa. "With exclusive global licensing rights to AXIM’s Eye Diagnostics portfolio, Verséa will be introducing a new innovative, rapid, tear-based, POC lab-testing platform designed specifically to assist eye-care clinicians in detecting and quantifying a variety of biomarkers associated with external ocular disorders."

The President of Verséa Ophthalmics, Dr. Sambursky, MD, explained the significance of the new diagnostic technology: "Mild allergic conjunctivitis is frequently confused with dry eye, while more severe allergic disease is frequently misdiagnosed as viral conjunctivitis; yet the appropriate clinical management and treatments are different. The AXIM diagnostic technology will allow eye doctors to not only identify and differentiate clinically overlapping conditions but also drive more targeted therapeutic interventions. Having access to real-time quantitative results (a specific number) at the office visit will significantly help to confirm therapeutic impact, leading to overall improved personalized patient care."

Lactoferrin is a protein contained in tears that protects the ocular surface with its antimicrobial and anti-inflammatory properties. Lower concentrations of lactoferrin have been demonstrated in patients with dry eye, which is associated with decreased aqueous tear production. Ocular Immunoglobulin E (IgE) is a biomarker for allergies and a key biomarker primarily associated with allergic conjunctivitis. Both tests are FDA-cleared and have dedicated Medicare CPT codes.

The third test, a quantitative tear Matrix Metalloproteinase 9 (MMP-9) test, is a significant advancement in the measurement of the intensity of inflammation affecting dry eye patients. Being a quantitative test for MMP-9, this test allows for a more objective classification and management of dry eye disease as well as subsequent pre-surgical and post-surgical therapeutic guidance. Post-surgical complications, such as worsening symptoms of dry eye and refractive error, may be mitigated by identifying and treating dry eye prior to cataract and refractive surgery corneal measurements.