On December 16, 2021 Evofem Biosciences, Inc. (NASDAQ: EVFM) and Orion Biotechnology Canada Ltd. reported that they have entered into a collaboration agreement to evaluate the compatibility and stability of Orion’s novel CCR5 antagonist, OB-002, in Evofem’s Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel with the goal of developing a Multipurpose Prevention Technology (MPT) product candidate for indications including the prevention of HIV in women (Press release, Orion Biotechnology, DEC 16, 2021, View Source [SID1234597407]).

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The World Health Organization reported in 2020 that approximately 37.6 million people globally were living with HIV and an estimated 1.5 million individuals were newly diagnosed as HIV-positive. There are limited methods available to prevent transmission of HIV, and no products are approved to simultaneously prevent pregnancy, STIs and HIV.

This collaboration will focus on determining compatibility and stability of OB-002 in Phexxi and is expected to yield results in the third quarter of 2022. Assuming positive results, the companies will seek government and philanthropic funding for subsequent clinical trials of the MPT vaginal gel product candidate.

"For too long, women have had to assemble a grab-bag of products to protect against pregnancy, various STIs, and HIV," said Saundra Pelletier, Chief Executive Officer of Evofem Biosciences. "This partnership with Orion aims to develop a first-of-its-kind product with potential to revolutionize the way women protect their sexual and reproductive health: no unintended pregnancies, no STIs, and no HIV — all in one applicator."

Ian McGowan, Chief Medical Officer of Orion Biotechnology, added, "It is unacceptable that we are still seeing high rates of new HIV infections among women each year and there is clearly a compelling need to expand the HIV prevention portfolio. Orion is very excited to be collaborating with Evofem to address this important issue and develop an MPT product for women across the world."

In trials to date of Orion’s novel CCR5 antagonist, OB-002 has demonstrated best-in-class in vitro potency. OB-002 was 100% effective in blocking transmission of HIV infection in a non-human primate model.1 A 15-subject Phase 1 study of vaginally administered OB-002 gel demonstrated that the OB-002 gel was safe and well tolerated, with no evidence of systemic absorption.2

Phexxi is a hormone-free, on-demand prescription contraceptive vaginal gel that was launched in the U.S. in September 2020. Top-line data is expected from Evofem’s pivotal Phase 3 trial for the prevention of chlamydia and gonorrhea in women in the second half of 2022.

1 Veazey et al. Topical OB-002 is highly effective in preventing vaginal transmission of SHIV1623P in a non-human primate (NHP) model of HIV infection. JID, 2009.

2 McGowan et al. Evaluation of the Safety, Acceptability, and Pharmacokinetic Profile of a Gel Formulation of OB-002 in Healthy Volunteers. AIDS Res Hum Retroviruses, 2021.

On December 16, 2021 Denovo Biopharma LLC ("Denovo"), a pioneer in applying precision medicine to the development of innovative therapies, reported it discovered a novel genetic biomarker, Denovo Genomic Marker 7 (DGM7 TM), using its proprietary biomarker discovery platform (Press release, Denovo Biopharma, DEC 16, 2021, View Source [SID1234597358]). DGM7 has been shown to be associated with response to treatment of recurrent high grade glioma (HGG) with an investigational gene therapy combination treatment, DB107, via retrospective analysis. DB107 is an investigational combination product consisting Toca 511 (vocimagene amiretrorepvec) in combination with Toca FC (extended-release flucytosine, [5-FC]), which is part of the retroviral replicating vector (RRV) platform that was acquired from Tocagen in 2020.

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In addition to potentially being useful for selecting patients who may respond to DB107 therapy, the utility of this genetic biomarker may extend to the broader RRV platform. This RRV platform has the capability of carrying a wide variety of genes, in addition to the gene carried by DB107. Furthermore, this finding demonstrates that Denovo’s biomarker discovery platform has broad utility for such disparate drug modalities as small molecules and viral vectors.

Denovo’s biomarker platform has utility for disparate drug modalities such as small molecules and viral vectors.

"Biomarker-guided DB107 treatment brings a much needed treatment option to patients with recurrent high-grade glioma, a major unmet medical need with median survival less than a year," said Wen Luo, PhD, Denovo’s Chief Executive Officer and Chief Scientific Officer. "Denovo now has three biomarker-guided programs in active development using biomarkers discovered using its biomarker platform, which once again shows that it can deliver repeatable success."

About Denovo’s RRV Platform and DB107
DB107 is an innovative approach utilizing a proprietary gene therapy platform, RRV, combined with a prodrug, to selectively infect and kill cancer cells while stimulating a robust and durable anti-cancer immune response against a tumor with minimal toxicity. DB107 has been tested clinically in solid tumors including recurrent high-grade GBM and colorectal cancer, most recently in a randomized 403-patient Phase 3 trial. DB107 received Orphan Drug Designation in GBM from the FDA and EMA, and Fast Track Designation from the FDA.

About HGG and Glioblastoma
Most common type of HGG is Glioblastoma multiforme (GBM), which is also the most common type of adult primary malignant brain cancer, with 18,000 newly-diagnosed patients in the US and 13,000 deaths annually. Standard treatment for patients with newly diagnosed GBM can include surgery followed by radiation and chemotherapy, but treatment options are limited. The five-year survival rate of patients with GBM is less than five percent.

On December 16, 2021 Histogen Inc. (NASDAQ: HSTO), a clinical-stage company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported that it has entered into securities purchase agreements with certain institutional and accredited investors to issue, in a private placement, 8,235,297 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to an aggregate of 8,235,297 shares of common stock, at a purchase price of $0.425 per share of common stock (or pre-funded warrant) and associated warrant, for expected gross proceeds to Histogen of approximately $3.5 million, before deducting placement agent fees and other offering expenses payable by the Company (Press release, Conatus Pharmaceuticals, DEC 16, 2021, View Source [SID1234597353]). The warrants have an exercise price of $0.425 per share of common stock, will be exercisable commencing six months and one day following the date of issuance for a period of five and one-half years from the date of issuance.

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

The closing of the private placement is expected to occur on or about December 20, 2021, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the private placement for working capital and general corporate purposes.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Under an agreement with the investors, the Company agreed to file an initial registration statement with the Securities and Exchange Commission (the "SEC") covering the resale of the shares of common stock to be issued to the investors (including the shares of common stock issuable upon the exercise of the warrants) no later than 15 days and to use commercially reasonable efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 75 days in the event of a "full review" by the SEC.

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

On December 16 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, reported the licensing of certain intellectual property from the UT Southwestern Medical Center (Press release, BerGenBio, DEC 16, 2021, View Source [SID1234597352]). The exclusive license to intellectual property generated by researchers at UT Southwestern Medical Center supports the Company’s existing IP position underlying use of AXL inhibitors, including its lead product candidate bemcentinib, for the treatment of patients harboring STK11 mutations in NSCLC. No financial terms have been disclosed.

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The STK11 mutation is observed in up to 20% of NSCLC patients. STK11 is an important tumor suppressor gene associated with a poor prognosis in NSCLC patients and which has been reported in some studies to confer resistance to immune checkpoint inhibitors.

Researchers at the UT Southwestern Medical Center and BerGenBio recently presented data at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting exploring why patients harboring a mutation to the STK11 gene may not respond to anti-PD1 therapy, a commonly used treatment in first line NSCLC patients. Preclinical research further indicated that the addition of the selective AXL inhibitor bemcentinib restored the activity of anti-PD1 treatment in relevant lung cancer models

Martin Olin, Chief Executive Officer at BerGenBio, commented: "The license agreement with UT Southwestern Medical Center complements our existing intellectual property filings in this important patient population which appears to poorly respond to anti-PD1 therapy. We will continue to explore how this target group might be addressed by the combination of bemcentinib and an immune checkpoint inhibitor."

On December 16, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) and Skyline Therapeutics (formerly Geneception), a gene and cell therapy company focused on developing novel treatments for unmet medical needs, reported a multi-year global strategic collaboration for the discovery, development and commercialization of Adeno-Associated Virus (AAV) gene therapies to treat genetic cardiovascular diseases (Press release, BioMarin, DEC 16, 2021, View Source [SID1234597351]).

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The partnership will leverage Skyline Therapeutics’ integrated AAV gene therapy platform based on its proprietary vector engineering and design technology and manufacturing capability to develop innovative gene therapies with a focus on genetic dilated cardiomyopathies (DCM), a group of progressively advancing, devastating diseases with no targeted treatment options.

Under the agreement, BioMarin and Skyline Therapeutics will collaborate on discovery and research through to an Investigational New Drug Application (IND). BioMarin brings experience in gene therapy development, cardiovascular biology and insights into genetic basis of diseases, and Skyline contributes its expertise in developing gene therapy products including vector engineering and design technology and manufacturing capabilities to this collaboration. Each company will advance the programs through clinical development in their pre-defined territories.

In support of its R&D efforts for the collaborative projects, Skyline Therapeutics will receive an undisclosed payment associated with signing, comprising an upfront payment and an equity investment from BioMarin, and is eligible to receive pre-specified payments for R&D, regulatory and commercial milestones.

BioMarin will have the rights to commercialize therapeutic products resulting from the collaboration in its territories, including the United States, Europe, and Latin America, and Skyline Therapeutics will be responsible for commercialization in the Asia-Pacific region. In addition, Skyline Therapeutics will be eligible to receive royalty payments on future sales from BioMarin in its territories.

"We are thrilled to announce what we anticipate will be a fruitful collaboration at the interface between Skyline’s innovative approach to AAV vector engineering and design and our team’s proven expertise in creating and developing gene therapies," said Kevin Eggan, Group Vice President, Head of Research and Early Development, from BioMarin.

"We are excited to partner with Skyline Therapeutics to tackle these genetic forms of dilated cardiomyopathy. This collaboration strengthens our leadership in cardiac gene therapy and extends our R&D collaboration to Asia, where a large number of patients suffer from these devastating diseases," said Brinda Balakrishnan, Group Vice President, Corporate and Business Development at BioMarin. "We look forward to fostering this collaboration and bringing transformative medicines to patients worldwide."

"Dilated cardiomyopathy is a serious cardiac disorder in which structural or functional abnormalities of the heart muscle can lead to complications such as arrhythmia and heart failure, resulting in substantial morbidity and mortality. Mutations in many genes are associated with the development of DCM, among other etiologies for the disease," said Jay Hou, Chief Scientific Officer at Skyline Therapeutics. "Together with BioMarin’s team we have identified a number of critical genes associated with DCM. We are delighted to work closely with BioMarin and apply our AAV vector technology to interrogate these new targets and develop novel treatments for DCM patients."

"The collaboration with BioMarin leverages both companies’ capabilities in the development of gene therapies. With the BioMarin team, we share the goal of working in concert to develop therapies for genetic cardiovascular disease that address high unmet medical needs," said Amber Cai, CEO of Skyline Therapeutics. "Together, we will utilize gene therapy to tackle cardiovascular diseases with a disease modifying trailblazing approach that could change the treatment paradigm in these conditions."

About Dilated Cardiomyopathy (DCM)

DCM is a common cause of heart failure and end-stage DCM, which often leads to heart transplantation. Despite improvements in pharmacotherapy and care, the five-year survival rate of DCM is only about 50%. Hundreds of thousands of patients suffer from the genetic forms of DCM in U.S., EU, China, and Japan. More than 50 genes associated with DCM have been identified, accounting for 40-50% of familial DCM cases. Many of these genes encode proteins with important known functions in cardiomyocytes related to cytoskeletal, sarcomere and nuclear envelope biology. Our aim is to correct the pathways altered by these genetic contributors to DCM through AAV based gene therapy, in each case addressing the root cause of the disease.