On February 12, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") reported that it has executed the definitive Asset Purchase Agreement dated February 11th, 2024 to acquire the entire portfolio of discovery, preclinical and clinical development stage assets in oncology, infectious disease, antigen desensitization, and other immunological fields based on the DPX immune educating platform technology, developed by Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., and IMV USA ("IMV") (Press release, BioVaxys Technology, FEB 12, 2024, View Source [SID1234639986]). BioVaxys acquired the extensive technology portfolio from HIMV, LLC, an acquisition vehicle formed by Horizon Technology Finance Corporation (NASDAQ: HRZN) and IMV’s other secured creditors for the purpose of acquiring IMV’s intellectual property through a secured party credit bid in the proceedings commenced in Canada by IMV under the Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended (the "CCAA").

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Horizon Technology Finance Corporation, an affiliate of Monroe Capital, is a leading specialty finance company that provides capital in the form of secured loans to companies in the technology, life science, healthcare information and services, and sustainability industries. Horizon is headquartered in Farmington, Connecticut, with a regional office in Pleasanton, California, and investment professionals located throughout the U.S.

Key transaction elements include a USD$750,000 upfront cash payment, various clinical development and regulatory milestone payments, a 15% share in license revenues, and a 6% gross sales royalty on product sales (such future gross sales royalties cancellable and extinguishable upon a one-time payment of USD$25,000,000 in cash) and shares of BioVaxys common stock with a deemed value of US$250,000, calculated at a price per share equal to the volume-weighted average price of the common shares during the 20 trading day period immediately prior to closing and will be subject to a hold period of four months and one day. HIMV will also be entitled to appoint an observer to BioVaxys’s Board of Directors.

The DPX antigen delivery platform acquired by BioVaxys is designed to stimulate a specific, coordinated and persistent anti-tumor immune response, improving the lives of patients with solid or hematological cancers. DPX can package a wide range of bioactive molecules in a single formulation, such as multiple nucleic acids/mRNA, proteins, peptides, virus-like particles, innate immune activators, and small molecules, to "feed" them to Dendritic Cells and Antigen Presenting Cells (or "APC’s") to stimulate a specific immune response.

The transaction supplements BioVaxys’ existing cancer vaccine portfolio with the addition of maveropepimut-S (MVP-S), a DPX-formulated cancer vaccine that delivers antigenic peptides from survivin, a cancer antigen commonly overexpressed in advanced cancers. MVP-S also delivers an innate immune activator and a universal CD4 T cell helper peptide. These elements foster maturation of antigen presenting cells as well as robust activation of CD8 T cell effector and memory function. Maveropepimut-S was recently in Phase IIB clinical trials for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and is being clinically evaluated in bladder and breast cancer. In prior clinical studies, MVP-S treatment has been well tolerated and has demonstrated favorable clinical outcomes in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. Most recently, data were presented by IMV at the 2023 SGO Annual Meeting on Women’s Cancer on a phase 1b/2 multicenter trial designed to evaluate MVP-S combined with intermittent low dose of cyclophosphamide in patients with recurrent, epithelial ovarian, fallopian tube, or peritoneal cancer. Findings showed clinical benefit to patients with recurrent ovarian cancer, regardless of platinum sensitivity or BRCA mutational status.

DPX formulations are not limited to cancer immunotherapies. With its unique cargo carrying capacity and non-circulating lipid delivery, there is potential with DPX to develop improved mRNA vaccines, multivalent viral vaccines, vaccines for desensitizing immune response for allergies, and immune system diseases. Prior clinical studies by IMV have supported proof of concept and a superior immune response with a DPX-RSV formulation, DPX-rHA/DPX-FLU influenza vaccine, DPX-packaged survivin/MAGE-Ag for advanced metastatic bladder cancer, and certain other infectious diseases.

Through the transaction, BioVaxys has acquired 25 distinct families of patents and/or patent applications, with over one hundred related international filings related to maveropepimut-S, DPX and its use across a range of immune system-related diseases, associated trademarks, and other intellectual property. The deal also assigns to Biovaxys a royalty-bearing License and Supply Agreement with Wisconsin-based SpayVac for Wildlife Inc., on sales of animal vaccine products using technology acquired by BioVaxys, a milestone payments and royalty bearing license agreement with Pfizer animal health spin-out Zoetis Inc, the world’s largest producer of medicine and vaccinations for pets and livestock, for their development and sale of various animal health products using the technology acquired by BioVaxys, and German pharmaceuticals company Merck KGaA for survivin proteins. Survivins are highly expressed in most cancers and are associated with a poor clinical outcome, with the differential expression of survivin in cancer cells compared to normal tissues and its role as a nodal protein in a number of cellular pathways make it a significant target for cancer therapeutics.

Kenneth Kovan, BioVaxys President & Chief Operating Officer stated: "This is an absolutely transformational transaction for Biovaxys that is synergistic with our pre-existing personalized immunotherapeutic vaccines based on our HapTenix© ‘neoantigen’ tumor cell construct platform, and BVX-0918, our ovarian cancer vaccine candidate. The DPX platform and addition of maveropepimut-S to our pre-existing clinical pipeline immediately positions BioVaxys as a major player in ovarian cancer, and expands our pipeline to include advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL), bladder and breast cancer." Kovan added, "We see tremendous commercial potential with the DPX platform, which was a major driver of the transaction. The range of antigens that can be packaged and the cargo capacity of DPX present the opportunity for BioVaxys to monetize multiple development partnerships such as in the multi-valent and mRNA vaccine fields, expand our own immunotherapeutric pipeline, and establish what we believe will be an almost perpetual string of new BioVaxys IP derived from novel DPX formulations. We envision DPX enabling new immunotherapeutics not just from BioVaxys, but from a number of other companies via business development partnerships"

James Passin, Biovaxys CEO, stated: "We are honored to continue to advance the outstanding scientific work completed by the former IMV Inc. The overwhelming support that we have received from our investors for this transaction reinforces our conviction that the antigen-packaging and presenting technology that we have acquired will position BioVaxys as a potential world leader in cancer immunotherapy with further growth potential in other significant verticals including allergy desensitization and mRNA."

It is anticipated that the transaction will fully close within ten days.

On February 12, 2024 Sana Biotechnology, Inc. (Nasdaq: SANA), a company focused on changing the possible for patients through engineered cells, reported that it has closed its underwritten upsized public offering of 21,772,728 shares of its common stock, which includes the full exercise of the underwriters’ option to purchase 4,500,000 additional shares of its common stock, at a price to the public of $5.50 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 12,727,272 shares of its common stock at a price to the public of $5.4999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.0001 per share exercise price for each pre-funded warrant (Press release, Sana Biotechnology, FEB 12, 2024, View Source [SID1234639985]). All of the shares and pre-funded warrants were sold by Sana. The gross proceeds from the offering were approximately $189.75 million before deducting underwriting discounts and commissions and other offering expenses.

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Morgan Stanley, J.P. Morgan, Goldman Sachs & Co. LLC, and BofA Securities acted as joint book-running managers for the offering.

The offering was made pursuant to a Registration Statement on Form S-3, including a base prospectus, previously filed with and declared effective by the SEC. Sana has filed with the SEC the final prospectus supplement and accompanying prospectus relating to the offering. These documents can be accessed for free through the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 or by email at [email protected]; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; Goldman Sachs & Co. LLC, Attn: Prospectus Department, at 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; or BofA Securities, Attn: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of any such state or jurisdiction.

On February 12, 2024 Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, reported an upfront cash payment and equity investment from TG Therapeutics, Inc. (Nasdaq: TGTX) for an exclusive license to develop Azercabtagene Zapreleucel (azer-cel) for autoimmune diseases, and other indications outside of cancer (Press release, Precision Biosciences, FEB 12, 2024, View Source [SID1234639984]). This is the first in a series of payments, with Precision to receive a total of $17.5 million in upfront and potential near-term payments as part of the consideration for this license.

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In exchange for global rights to azer-cel for autoimmune diseases and indications outside of cancer, Precision has received an upfront payment totaling $7.5 million, consisting of cash and the purchase of 2,920,816 shares of Precision common stock by TG Therapeutics at a price of $0.77 per share, a 100% premium to the 30-day volume-weighted average price (VWAP) prior to purchase.

Precision will also receive an additional $2.5 million within 11 months, as an equity investment in Precision’s common stock at 100% premium to the then 30-day VWAP prior to purchase. Upon the achievement of certain near-term clinical milestones, Precision will also receive an additional $7.5 million payment. Precision is eligible to receive up to $288 million in milestone payments in addition to high-single-digit to low-double-digit royalties on net sales.

Precision expects that these recent payments from its azer-cel transactions, along with existing cash and cash equivalents, expected operational receipts, continued fiscal and operating discipline, and availability of Precision’s at-the-market (ATM) facility will extend Precision’s cash runway into the first half of 2026, through phase 1 clinical readouts for its wholly owned programs.

On February 12, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported the initiation of a REM-001 15-patient clinical trial (NCT05374915) in cutaneous metastatic breast cancer (CMBC) patients (Press release, Kintara Therapeutics, FEB 12, 2024, View Source [SID1234639983]).

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This open label 15-patient study in CMBC patients is evaluating REM-001, a second-generation photodynamic therapy (PDT) photosensitizer agent, and is designed to test the 0.8 mg dose as well as optimize the study design in advance of a Phase 3 trial initiation. The primary endpoint in the study is Best Overall Objective Response Rate (bORR) (complete response or partial response) of the target treatment fields at any time from treatment up to, and including, week 24.

In June 2023, Kintara was awarded a $2.0 million Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical development of REM-001 in CMBC. This grant will cover the majority of the costs to run this clinical study.

"We are encouraged by the extensive data from prior REM-001 therapy trials supporting its strong efficacy in CMBC patients, providing us with an opportunity to address a significant unmet medical need," said Robert E. Hoffman, President and CEO of Kintara. "With an 80% complete response rate for evaluable lesions in CMBC patients observed in previous late-stage clinical trials and the support of the NIH, along with the FDA’s Fast Track Designation, we are confident in the potential of REM-001 to help CMBC patients."

"CMBC is a devastating disease with limited treatment options for patients," said Alina Markova, M.D., Section Head, General Dermatology and Oncodermatology at Memorial Sloan Kettering Cancer Center and Principal Investigator of the REM-001 15-patient study. "I am looking forward to testing the therapeutic potential of REM-001 in this trial and bringing novel therapies to CMBC patients to improve their quality of life."

Cutaneous metastases can develop with any metastatic cancer but are believed to occur most frequently in metastatic breast cancer. A 2003 meta-analysis of over 20,000 metastatic cancer patients found that 24% of the breast cancer patients included in the analysis had developed cutaneous metastases, which was the highest rate of any cancer type. Based on a 2017 analysis, the current prevalence of metastatic breast cancer in the United States is estimated to be over 168,000. Accordingly, the prevalence of CMBC may be in excess of 40,000 cases annually in the United States.

On February 12, 2024 AbbVie (NYSE: ABBV) reported that it has completed its acquisition of ImmunoGen (NASDAQ: IMGN) (Press release, ImmunoGen, FEB 12, 2024, View Source [SID1234639982]). With the completion of the acquisition, ImmunoGen is now part of AbbVie.

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"Together with ImmunoGen, we have the potential to continue redefining the standard of care for those living with cancer," said Robert A. Michael, president and chief operating officer, AbbVie. "The addition of ImmunoGen’s treatment for ovarian cancer will accelerate our ability to help patients today, expand our oncology pipeline and drive long-term revenue growth well into the next decade. I want to thank ImmunoGen for their efforts to advance science for patients and we look forward to welcoming our new colleagues to AbbVie."

ELAHERE (mirvetuximab soravtansine-gynx) is the first and only antibody-drug conjugate (ADC) approved by the U.S. Food and Drug Administration (FDA) in ovarian cancer. The FDA granted accelerated approval for ELAHERE in folate receptor-alpha (FRα) positive platinum-resistant ovarian cancer (PROC) patients based on response data. Results from a confirmatory trial currently under review by the FDA show that ELAHERE is the first targeted agent to offer a survival benefit in PROC, with label expansion opportunities across larger segments of the ovarian cancer market.

ImmunoGen’s follow-on pipeline of ADCs further builds on AbbVie’s existing solid tumor pipeline of novel targeted therapies and next-generation immuno-oncology assets, which have the potential to create new treatment possibilities across multiple solid tumors and hematologic malignancies. Through focused R&D efforts, AbbVie has developed novel ADC technology and has unique strengths in antibody engineering, drug linker chemistry and toxin research. AbbVie and ImmunoGen’s combined capabilities represent an opportunity to deliver potentially transformative ADC therapies to patients.

ImmunoGen’s investigational Phase 1 asset, IMGN-151, is a next-generation FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications.

Pivekimab sunirine, currently in Phase 2, is an investigational anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for the treatment of relapsed/refractory BPDCN.

For additional background on the acquisition, please read the announcement press release here and view AbbVie’s investor presentation here.

Financial Terms

AbbVie has acquired all outstanding ImmunoGen common stock for $31.26 per share. It is expected that ImmunoGen’s common stock will cease to trade on the NASDAQ stock exchange prior to market open on February 12, 2024. AbbVie expects its acquisition of ImmunoGen to be accretive to AbbVie’s diluted EPS beginning in 2027 and significantly accretive over the long-term.

Full-Year 2024 Outlook

AbbVie is reaffirming its previously issued 2024 full-year adjusted diluted EPS guidance range of $11.05-$11.25. This guidance now includes a $0.42 per share dilutive impact related to the completed ImmunoGen acquisition, as well as the pending Cerevel Therapeutics acquisition, which is anticipated to close in mid-2024. AbbVie’s 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred during 2024, as both cannot be reliably forecasted.

AbbVie is updating its previously issued 2024 first-quarter adjusted diluted EPS guidance range from $2.30-$2.34 to $2.26-$2.30. This guidance now includes a $0.04 per share dilutive impact related to the ImmunoGen acquisition. AbbVie’s 2024 first-quarter adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred in the quarter, as both cannot be reliably forecasted.

About ELAHERE (mirvetuximab soravtansine-gynx)

ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The prescribing information includes a boxed warning. ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis. Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated. Administer prophylactic artificial tears and ophthalmic topical steroids. Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose. Discontinue ELAHERE for Grade 4 ocular toxicities.

Serious adverse reactions occurred in 31% of patients. The most common (≥2%) serious adverse reactions were intestinal obstruction (8%), ascites (4%), infection (3%), and pleural effusion (3%). Fatal adverse reactions occurred in 2% of patients, including small intestinal obstruction (1%) and pneumonitis (1%).The most common (≥20%) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

Please see full Prescribing Information, including Boxed Warning for ELAHERE.