On January 20, 2022 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported that Frances L. Johnson, MD, Chief Executive Officer will participate in the Virtual Investor 2022 Top Picks Conference on Tuesday, January 25, 2022 at 11:00 AM ET (Press release, Viewpoint Molecular Targeting, JAN 20, 2022, https://viewpointmt.com/viewpoint-molecular-targeting-to-present-at-the-virtual-investor-2022-top-picks-conference/ [SID1234605650]).

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As part of the virtual event, the Company will provide a corporate presentation followed by a moderated interactive Q&A session. In addition to the moderated portion of the event, all investors and interested parties will have the opportunity to submit live questions. Interested parties may also submit questions in advance of the live event, which can be sent via the conference website at virtualinvestorco.com. The Company will answer as many questions as possible during the event.

A live video webcast of the Roundtable Event will be available on the Events page of the Company’s website (viewpointmt.com). A webcast replay will be available two hours following the live presentation and will be accessible for one year.

On January 20, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported it will host a conference call and webcast to provide a clinical update on Wednesday, January 26, 2022 at 4:30 p.m. EST (Press release, Cue Biopharma, JAN 20, 2022, View Source [SID1234608265]). Live and archived versions of the event can be accessed via the Company’s website.

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Members of the Cue Biopharma executive management team will provide an update from the Company’s ongoing clinical trials with CUE-101, its lead and representative IL-2 based drug product candidate from the CUE-100 series. CUE-101 is currently in a Phase 1b clinical trial for the treatment of HPV+ recurrent/metastatic head and neck squamous cell carcinoma. The discussion will focus on recent data updates from the Phase 1b monotherapy dose expansion trial and the dose escalation combination trial evaluating CUE-101 front line with Merck’s KEYTRUDA (pembrolizumab). Management will also provide an update on the Company’s pipeline development progress from the IL-2 based CUE-100 series including CUE-102, with an Investigational New Drug (IND) filing planned for the first quarter of 2022, as well as updates on its strategic objectives and anticipated milestones.

Webcast Details

Wednesday, January 26, 2022 at 4:30 p.m. EST
Investors: 877-407-9208
International: 201-493-6784
Conference ID: 13726509
Webcast: View Source;tp_key=7a7d92f501

On January 20, 2022, Apellis Pharmaceuticals, Inc., a Delaware corporation (the "Company"), entered into an Open Market Sale AgreementSM (the "Agreement") with Jefferies LLC, as agent ("Jefferies"), pursuant to which the Company may offer and sell shares of its common stock, $0.0001 par value per share (the "Shares"), from time to time through Jefferies (the "Offering") (Filing, 8-K, Apellis Pharmaceuticals, JAN 20, 2022, View Source [SID1234605614]). The Company has also filed a prospectus supplement with the Securities and Exchange Commission (the "SEC") in connection with the Offering (the "Prospectus Supplement") under the Company’s existing automatic shelf Registration Statement on Form S-3 (File No. 333-235830), which became effective on January 7, 2020 (the "Registration Statement"). Pursuant to the Prospectus Supplement, the Company may offer and sell Shares having an aggregate offering price of up to $300.0 million.

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Upon delivery of a placement notice and subject to the terms and conditions of the Agreement, Jefferies may sell the Shares at market prices by any method deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on or through The Nasdaq Global Select Market ("Nasdaq"), the existing trading market for the Company’s common stock.

The Company or Jefferies may suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions. Jefferies will act as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq.

The Company has agreed to pay Jefferies commissions for its services of acting as agent of up to 3.0% of the gross proceeds from the sale of the Shares pursuant to the Agreement. The Company has also agreed to provide Jefferies with customary indemnification and contribution rights.

A copy of the Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to such exhibit.

Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

The Shares will be sold pursuant to the Registration Statement, and offerings of the Shares will be made only by means of the Prospectus Supplement. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy the Shares, nor shall there be any sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

Item 1.02
Termination of a Material Definitive Agreement.

In connection with the entry into the Agreement on January 19, 2022, the Company terminated its prior amended and restated equity distribution agreement, dated as of October 4, 2019, by and among the Company, Citigroup Global Markets Inc. ("Citigroup") and Jefferies (the "Prior Agreement"), in accordance with its terms. The Prior Agreement provided for Citigroup and Jefferies to sell shares of common stock having an aggregate offering price of up to $150.0 million by any method deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act. The Company cannot make any further sales of its common stock pursuant to the Prior Agreement.

On January 20, 2022 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Silmitasertib, a highly selective inhibitor of casein kinase 2 (CK2) to treat patients with Biliary Tract Cancer (Press release, Senhwa Biosciences, JAN 20, 2022, View Source [SID1234605633]).

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"We are pleased to receive ODD for Silmitasertib for the treatment of Biliary Tract Cancer, a rare, malignant disease for which there are no effective therapies. ODD represents an important regulatory milestone that has the potential to expedite the clinical development of Silmitasertib, which is a potent and selective CK2 inhibitor," said Mei-Hui Kuo, Acting Chief Executive Officer of Senhwa Biosciences.

The US FDA grants ODD status to drugs and biologics that are intended to treat, prevent or diagnose a life-threatening or chronically debilitating rare disease with a prevalence of fewer than 200,000 people in the US. ODD affords certain financial incentives to support clinical development, including the potential for up to seven years of market exclusivity, in the US upon regulatory approval.

Biliary tract cancer (BTC) refers to a group of rare, diverse and aggressive cancers that arise from the bile duct system. BTCs are classified into four distinct subtypes based on the tissue where the cancer originates including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), gallbladder cancer (GBC) and ampullary cancer.

In its early-stages, patients with BTC often present with nonspecific symptoms which can complicate and delay diagnosis. Patients with BTC are usually diagnosed when the disease has already advanced and/or spread. First-line standard of care is a chemotherapy regimen of gemcitabine + cisplatin. There are no globally accepted standards of care for locally advanced or metastatic BTC after first line chemotherapy has failed. Pre-clinical studies demonstrate that inhibition of CK2 by Silmitasertib prevents DNA repair, induces apoptosis, and improves the antitumor activity of gemcitabine and cisplatin. There is a significant need for new BTC treatment options.

About Silmitasertib

Silmitasertib is a first-in-class small molecule drug that targets the CK2 pathway and acts as a CK2-inhibitor. Clinical studies thus far have shown Silmitasertib to be safe and well-tolerated in humans and is easily administered due to its oral formulation. Silmitasertib is currently under development in several oncology programs in adults and children with recurrent/advanced or metastatic cancer. To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed; currently, there are two ongoing Phase II studies of Silmitasertib.

The US FDA has granted Silmitasertib key drug designations: Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation and Orphan Drug Designation for the treatment of Medulloblastoma in July 2020 and December 2021, respectively. Fast Track Designation was granted in August 2021 for the treatment of recurrent Sonic Hedgehog driven Medulloblastoma.

On January 20, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported the results of two large scale clinical studies, which show that the company’s Nu.Q assays, when used in conjunction with the Fecal Immunochemical Test (FIT), can detect colorectal cancer and all high-risk advanced adenomas in symptomatic patients, and thereby reduce unnecessary colonoscopies (Press release, VolitionRX, JAN 20, 2022, View Source [SID1234605651]). The studies also demonstrated that the company’s Nu.Q assays can improve the detection of high-risk adenomas in asymptomatic patients.

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Principal Investigator, Professor Han-Mo Chiu, National Taiwan University, said "We are enormously encouraged by the findings of these two studies. Not only do they show that using Nu.Q assays in combination with FIT can potentially reduce unnecessary colonoscopies by up to 28% in patients with gastrointestinal symptoms, the studies also show that this dual approach could be used more widely to improve the effectiveness of FIT-based screening programs targeting asymptomatic patients. We look forward to presenting our findings to colleagues at ASCO (Free ASCO Whitepaper) GI 2022."

Dr. Marielle Herzog, Research and Development Director at Volition, said "Early diagnosis is key to improving outcomes for patients with colorectal cancer, and cancer screening programs are critical to every public health system. The results of our studies, using Volition’s Nu.Q assays in conjunction with FIT, are incredibly encouraging, not only in reducing unnecessary colonoscopies but also in detecting high-risk adenomas, both proximal and distal, which FIT, when used alone can miss. We are excited about the next stage, facilitating an independent, prospective validation study later this year."

The studies were undertaken by Volition and the Department of Internal Medicine at the National Taiwan University Hospital and findings will be presented at the 2022 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, later this week.

Volition is developing simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of life-altering diseases including cancer.

Colorectal cancer is the fourth most common cancer worldwide, with 1.9 million new cases in 2020, and accounts for over 9% of all cancer-related deaths each year¹. Population-based colorectal cancer screening programs are in place in many healthcare systems globally, and the most commonly recommended screening method² is the FIT, followed up with colonoscopy, an invasive visual examination. However, approximately 60% of FITs provide false-positive results³, leading to unnecessary and costly colonoscopies.

Posters to be presented at ASCO (Free ASCO Whitepaper) GI 2022 can be downloaded here:

1) Circulating nucleosomes levels improve FIT performance for detecting high-risk colorectal neoplasms in a symptomatic population.
2) Circulating nucleosomes for detection of colorectal cancer and high-risk advanced adenomas.

For more information about Volition’s Nu.Q technology go to: www.volition.com

Notes to editors:

References:

¹ World Health Organization International Agency for Research on Cancer (IARC). GLOBOCAN 2020: estimated cancer incidence, mortality and prevalence worldwide in 2020.

² Schliemann, D., Ramanathan, K., Matovu, N. et al. The implementation of colorectal cancer screening interventions in low-and middle-income countries: a scoping review. BMC Cancer 21, 1125 (2021).

³ Chiu HM, Chen SL, Yen AM, et al. Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program. Cancer. 2015;121(18):3221-3229.

About the studies

476 patients referred for surveillance colonoscopy or secondary to bowel symptom were enrolled: (i) CRC (n= 67), (ii) advanced adenoma (AA) (n=60), non-AA (n=123); (iv) non-neoplastic polyps (n=29); (vi) colonoscopy negative (controls) (n=197).
520 average-risk asymptomatic patients: (i) CRC (n= 33), (ii) advanced adenoma (AA) (n=123, including 18 with AA>2cm); (iii) non-AA (n=168); (iv) non-neoplastic polyps (n=30); (vi) colonoscopy negative control (n=166).
Plasma and stool samples were obtained prior to colonoscopy.
Circulating Nucleosome levels measured using Volition’s Nu.Q quantitative immuno-assays.
FIT: OC-SENSOR (Eiken Chemical Co., Ltd., Tokyo, Japan) using a positive cut-off of 20ug/g feces.