On August 2, 2022 BioLife Solutions, Inc. (NASDAQ: BLFS), a leading supplier of class-defining bioproduction tools and services for the cell and gene therapies ("CGT") and broader biopharma markets, reported the Company’s second quarter 2022 financial results will be released after market close on Tuesday, August 9th (Press release, BioLife Science, AUG 2, 2022, View Source [SID1234617310]). The Company will host a conference call and live webcast at 4:30pm ET (1:30pm PT) that day. Management will provide an overview of the Company’s financial results and a general business update.

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To access the webcast, log onto the Investor Relations page of the BioLife Solutions website at View Sourceearnings." target="_blank" title="View Sourceearnings." rel="nofollow">View Source In addition, the conference call will be accessible by dialing toll-free (800) 715-9871 for domestic callers and (646) 307-1963 for international callers. The conference ID number is 2389359. A webcast replay will be available approximately two hours after the call and will be archived on View Source for 90 days.

On August 2, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported the closing of its previously announced underwritten public offering of 3,450,000 shares of its common stock, including the exercise in full of the underwriter’s overallotment option, at a public offering price of $2.00 per share (Press release, VolitionRX, AUG 2, 2022, View Source [SID1234617309]). The gross proceeds to Volition from the offering were $6.9 million, before deducting the underwriting commissions and other estimated offering expenses payable by Volition. All of the shares of common stock sold in the offering were offered by Volition.

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Volition intends to use the net proceeds from the offering for research and continued product development, clinical studies, product commercialization, working capital and other general corporate purposes, including potential strategic acquisitions.

Newbridge Securities Corporation acted as the sole book-running manager of the offering.

The securities were issued by Volition pursuant to a "shelf" registration statement on Form S-3 (File No. 333-259783) previously filed with the Securities and Exchange Commission (the "SEC") on September 24, 2021 and declared effective by the SEC on November 8, 2021. A final prospectus supplement and an accompanying base prospectus relating to the offering were filed with the SEC on August 1, 2022 and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying base prospectus relating to the offering can also be obtained from Newbridge Securities Corporation, Attn: Equity Syndicate Department, 1200 North Federal Highway, Suite 400, Boca Raton, FL 33432, by email at [email protected], or by telephone at (877) 447-9625.

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 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 August 2, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the first patient has been dosed in the Phase I PROBE-CN trial to evaluate ATG-101 as a monotherapy in patients with advanced/metastatic solid tumors or B-cell non-Hodgkin lymphoma (B-NHL) in China (Press release, Antengene, AUG 2, 2022, View Source [SID1234617308]).

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Shanghai East Hospital of Tongji University is the lead site for the study, which will be conducted at four centers across China. This open-label, multicenter Phase I study is designed to assess the safety and tolerability of intravenously administered ATG-101 monotherapy in patients with advanced/metastatic solid tumors and B-NHL. The study will be conducted in two parts (dose-escalation and a dose-expansion).

ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also shown an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies.

"Since many patients with advanced cancer are resistant to existing chemotherapy, targeted drugs, and monoclonal antibodies or relapse in a short time after receiving treatment, there is an urgent need for innovative therapies that can improve treatment options. Increasing evidence suggests that bispecific antibodies will become a critical component of cancer therapy. We are excited to have the opportunity to collaborate with a number of prominent investigators in China to conduct the first clinical study of ATG-101, a novel PD-L1/4-1BB bispecific antibody," said Professor Ye Guo, Deputy Director of Medical Oncology at Shanghai East Hospital of Tongji University, Director of the hospital’s center for Phase I trials, and principal investigator of the study. "ATG-101 has a high affinity for PD-L1 and can achieve conditional activation of 4-1BB agonist, which is expected to bring a lower risk of systemic toxicity, particularly the hepatotoxicity that has been seen with previous agonists of 4-1BB. We hope that ATG-101 will demonstrate efficacy and safety, and bring a new treatment option to patients with resistant or relapsed cancers."

"The development of novel therapies to improve and advance the care of patients with resistant, relapsed, or advanced cancers is central to Antengene’s mission. Compounds that combine the well-established efficacy of inhibition of the PD-1/PD-L1 axis with activation of 4-1BB represent a fascinating opportunity in oncology. In our view, ATG-101’s ability to activate exhausted T-cells and render ‘cold tumors’ hot has the potential to open the door to wide applicability in resistant/relapsed diseases. These qualities,together with a robust preclinical data package, position ATG-101 to be a potentially best-in-class molecule." said Dr. Kevin Lynch, Antengene’s Chief Medical Officer.

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL). ATG-101 was designed to activate anti-tumor immune effectors by forming a cell-antibody-cell trimer to simultaneously block the binding of PD-L1/PD-1 and induce 4-1BB stimulation. In PD-L1 over-expressing cancer cells, ATG-101 has shown potent PD-L1 crosslinking-dependent 4-1BB agonist activity, with the potential for delivery of enhanced therapeutic efficacy whilst mitigating the risk of hepatoxicity.

Data presented at the Annual Meeting of Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) in 2021 showed that ATG-101 was active in anti-PD-L1 resistant and relapsed tumor models. ATG-101’s unique safety and efficacy properties make it a promising potential therapy for solid tumors and hematological cancers. To date, ATG-101 has received regulatory clearances in Australia, U.S., and China to enter a Phase I clinical study for the treatment of advanced/metastatic solid tumors and NHL. The study has already been initiated in Australia and China and is in the process of initiation in the U.S.

On August 2, 2022 PharmaJet, a biotech company that, with their innovative needle-free technology, has developed a more effective way of administering drugs and biologics to accelerate research, commercialization and public health outcomes, reported that its partner, Scancell, will include needle-free delivery of their Phase 2 clinical study for treatment of patients with advanced melanoma (Press release, Scancell, AUG 2, 2022, View Source [SID1234617307]).

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Skin cancer is by far the most common of all cancers. Melanoma accounts for only about 1% of skin cancers but causes a large majority of skin cancer deaths. The American Cancer Society’s estimates about 100,000 new melanomas will be diagnosed in the United States in 2022 and nearly 8% of those diagnosed are expected to die from it.1

Scancell’s immunotherapy platform uses the body’s immune system to identify, attack and destroy tumors. In the Phase 1/2 clinical trial, 89% of the resected patients survived for more than 5 years following vaccination with their SCIB1 vaccine. The Phase 2 study is designed to assess whether the addition of SCIB1 treatment to pembrolizumab or ipilimumab/nivolumab results in an improvement in patient outcomes for patients with metastatic disease. The updated protocol adds needle-free injection with the PharmaJet Stratis System as Scancell believes needle-free delivery could improve patient acceptance. Scancell is also using one of PharmaJet’s WHO-prequalified Needle-free Injection Systems for delivery of two SARS-CoV-2 DNA vaccine candidates, currently being evaluated in South Africa.

Chris Cappello, President and CEO, PharmaJet, commented, "We are pleased to be partnering with Scancell as they start their Phase 2 trial with a needle-free delivery option for patients with advanced melanoma. In addition to increasing patient acceptance, our partners have published data showing superior results to electroporation, and improved immunogenicity with DNA vaccines."

On August 2, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that it filed a lawsuit against Foresight Diagnostics Inc. for infringement of Personalis’ U.S. Patent Nos. 10,450,611, 11,299,783, and 11,384,394 (Press release, Personalis, AUG 2, 2022, View Source [SID1234617306]). These patents are part of Personalis’ intellectual property portfolio in the field of whole genome-enabled, tumor-informed molecular residual disease (MRD) testing.

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Personalis’ patent portfolio protects its pioneering work in whole genome sequencing to identify mutations that indicate the continued presence or recurrence of cancer with part-per-million sensitivity. Personalis is seeking both injunctive relief and monetary damages based upon Foresight’s infringement of these patents.

"Personalis has been active in whole human genome sequencing from very early on. By 2013, when we first began filing the applications that led to the patents we are asserting against Foresight, Personalis had already received customer orders to sequence and analyze over 1,000 human genomes and had realized the power of utilizing whole genome sequencing alongside our advanced targeted sequencing methods," said Personalis CEO, John West.

Personalis launched its ultra-sensitive MRD solution, NeXT Personal, in late 2021. NeXT Personal leverages many elements of the asserted patents, including the use of whole genome sequencing to identify up to 1,800 variants that are specific to a patient’s cancer, thereby achieving superior signal-to-noise in the detection of ctDNA in plasma samples. NeXT Personal is purpose-built to accurately detect MRD in patient samples with low overall ctDNA, which is particularly important for cancers that have low shedding or low mutational burden, such as breast and prostate cancers, or soon after resection.

"Personalis has invested hundreds of millions of dollars in research and development across a broad array of disciplines for over a decade, and we stand firm in our resolve to protect that investment and our leadership position in the field. NeXT Personal is our most recent product leveraging our pioneering work. We believe that it represents the most sensitive MRD approach for solid tumors and can be transformational in cancer, detecting residual disease and recurrence, and in actively fighting cancer after recurrence has been detected," Mr. West added.

About NeXT Personal

NeXT Personal is a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify MRD and recurrence in patients previously diagnosed with cancer. The assay is designed to deliver industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. It leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. This may enable earlier detection across a broader variety of cancers and stages, including typically challenging early-stage, low mutational burden, and low-shedding cancers. NeXT Personal is also designed to simultaneously detect and quantify clinically relevant mutations in ctDNA that may be used in the future to help guide therapy when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants that can emerge and change over time, especially under therapeutic pressure.