On December 06, 2021 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer, reported it will host an analyst and investor event on Thursday, December 16, 2021, at 12:00 pm ET (Press release, Sierra Oncology, DEC 6, 2021, View Source [SID1234596507]). The event will feature a presentation by Prithviraj Bose, MD, Department of Leukemia, MD Anderson Cancer Center, on the importance of treating anemia in myelofibrosis patients. Dr. Bose will also review momelotinib data from the Phase 3 SIMPLIFY studies. Sierra management will discuss the MOMENTUM trial design as well as highlight registration and commercialization preparations currently underway. An open question & answer session with all presenters will conclude the event.

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Analyst & Investor Event Webcast Information

Date and Time: Thursday, December 16, 2021, 12:00 pm ET

To register, please click here.

The presentation will be webcast live, and an archive of the presentation will be accessible for approximately 30 days after the event through the Sierra Oncology website: www.SierraOncology.com.

About Momelotinib

Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1/ALK2 inhibitor currently under investigation for the treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Sierra Oncology is currently awaiting topline results of the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study evaluating momelotinib for the treatment of symptomatic and anemic myelofibrosis patients. Top-line data are anticipated by February 2022. Assuming positive data, the company plans to file a New Drug Application with the US Food & Drug Administration (FDA) in the second quarter of 2022. The FDA has granted Fast Track designation for momelotinib.

On December 6, 2021 PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active off-the-shelf cancer vaccine, reported the completion of its Series B2 round of financing (Press release, PDC Line Pharma, DEC 6, 2021, View Source [SID1234596506]). The company has raised a total of €17.5 million ($20.3M) with Belgian and South-Korean investors.

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Less than two years after its €20M ($23.2M) B1 round of fundraising, announced in January 2020, PDC*line Pharma has attracted new investors and secured a further capital increase of €11.8M ($13.7M). In addition, the company has received a €5.7M ($6.6M) grant in repayable aid from the Walloon Region of Belgium, which has backed the company since its arrival in 2016. The company will therefore have raised a total of €37.5M euros in this series B round.

This financing round, led by Korea Investment Partners, a leading multi-billion dollar South-Korean fund, also involved a syndicate of new South-Korean investors in life sciences: Alpha Holdings, Brain Asset Management and Hansongneotech Co. Ltd. Existing investors also participated: Noshaq Group (ex-Meusinvest), Sambrinvest (the Charleroi investment fund), SFPI-FPIM (the Belgian Federal Holding and Investment Company), SRIW (The Regional Investment Company of Wallonia) and Smart Korea UTC Bio-Healthcare Venture Fund.

"I am delighted to welcome Alpha Holdings, Hansongneotech Co. Ltd. and Brain Asset Management to the syndicate. I would also like to thank our existing investors for their continued support of the PDC*line Pharma team," said Eric Halioua, CEO of PDC*line Pharma. "This new round represents an important validation of our platform and development strategy with the on-going phase I/II trial of PDC*lung01, our vaccine candidate for lung cancer."

The objectives of the phase I/II study (PDC-LUNG-101) are to assess the safety, tolerability, immunogenicity and preliminary clinical activity of the drug candidate, PDC*lung01, associated or not with anti-PD-1 treatment in NSCLC. A total of 64 evaluable HLA-A*02:01 positive NSCLC patients are expected in clinical centers in Belgium, France, Germany, the Netherlands and Poland. PDC*lung01 consists of PDC*line professional antigen-presenting cells loaded with HLA-A2 restricted peptides, derived from seven shared tumor antigens.

"We are delighted to lead this B2 series financing. PDC*line Pharma’s cancer vaccine platform is both highly innovative and meets an important medical need. The company leadership team has demonstrated its ability to deliver on an ambitious plan," said Sangwoo Lee, managing director at Korea Investment Partners.

"We welcome the continued strong support of the Walloon region and the new funding by a mix of Belgian and South-Korean investors. PDC*line Pharma is an emblematic example of a Belgian biotech company succeeding in its international development in Asia, thanks to its licensing deal with LG-Chem and the support of leading Asian investors," said François Fontaine, general advisor to PDC*line Pharma at SFPI-FPIM.

Legal advisors to PDC*line: Bird & Bird

On December 6, 2021 Bavarian Nordic A/S ("Bavarian Nordic" or the "Company") reported its intention to raise new capital through an accelerated bookbuilding process. The offering (the "Offering") of new shares (the "New Shares") in Bavarian Nordic has now been successfully completed. Reference is made to company announcement no. 40 of 6 December 2021 (Press release, Bavarian Nordic, DEC 6, 2021, View Source [SID1234596505]).

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Bavarian Nordic has successfully completed a directed issue and private placement of 6,373,680 new shares at an offer price of DKK 268 per share, raising gross proceeds to Bavarian Nordic of DKK 1,708 million.

The Offering has not been registered under the U.S. Securities Act and was made pursuant to applicable exemptions from the obligation to publish a prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions in a directed issue and private placement and subscribed for by eligible qualified institutional and professional investors in Denmark and in certain other jurisdictions at market price and without pre-emption rights for Bavarian Nordic’s existing shareholders.

The net proceeds from the Offering will be used in accordance with company announcement no. 40 of 6 December 2021.

As the Offering was oversubscribed, an individual allocation of the New Shares was made.

Bavarian Nordic has in connection with the Offering, agreed to undertake a lock-up commitment for 180 calendar days following settlement of the Offering (subject to certain exceptions). In addition, members elected at the general meeting of Bavarian Nordic’s board of directors as well as members of the executive management have in connection with the Offering, agreed to undertake a lock-up commitment for 90 calendar days following settlement of the Offering (subject to certain exceptions).

CAPITAL INCREASE
Subject to settlement, a share capital increase will be registered with the Danish Business Authority and the share capital of Bavarian Nordic will hereafter consist of 70,468,393 shares of DKK 10 each, equivalent to a registered share capital of DKK 704,683,930.

The New Shares represent approximately 9.94 % of Bavarian Nordic’s registered share capital before the capital increase and will account for approximately 9.04 % of Bavarian Nordic’s registered share capital upon completion of the capital increase.

ADMISSION TO TRADING AND OFFICIAL LISTING
The New Shares will be issued under the temporary ISIN code DK0061682721. No application for admission to trading and official listing has been, or will be, filed for the New Shares issued under the temporary ISIN code, and the temporary ISIN code will only be registered with VP Securities A/S for subscription of the New Shares. The temporary ISIN code in VP Securities A/S will be merged with the permanent ISIN code for the existing shares, DK0015998017, as soon as possible following registration of the share capital increase with the Danish Business Authority. The New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen A/S, in the permanent ISIN code for the existing shares, DK0015998017, on or around 10 December 2021.

The admission to trading and official listing of the New Shares is subject to the Offering not being withdrawn prior to the settlement of the Offering and the Company making an announcement to that effect.

EXPECTED TIMETABLE FOR THE OFFERING

Date Event
Thursday 9 December 2021 Settlement and payment for the New Shares
Thursday 9 December 2021 Registration of the capital increase with the Danish Business Authority
Friday 10 December 2021 Admission to trading and official listing of the New Shares on Nasdaq Copenhagen A/S
Monday 13 December 2021 Merger of the temporary ISIN code with the permanent ISIN code in the system of VP Securities A/S
NEW SHARES
The decision to launch an offering of new shares in a directed issue was made pursuant to Article 5a(2) in Bavarian Nordic’s articles of association pursuant to which its board of directors is authorised to make share capital increases without pre-emption rights for the existing shareholders at market price.

The New Shares will rank pari passu in all respects with existing shares in Bavarian Nordic. The New Shares will be negotiable instruments, and no restrictions will apply to their transferability. No shares, including the New Shares, carry or will carry any special rights. Rights conferred by the New Shares, including voting rights and dividend rights, will apply from the time when the capital increase is registered with the Danish Business Authority. The New Shares must be registered in the name of the holder in the Company’s register of shareholders.

JOINT GLOBAL COORDINATORS AND JOINT BOOKRUNNERS
Citigroup Global Markets Limited and Nordea Danmark, filial af Nordea Bank Abp, Finland are acting as Joint Global Coordinators and Joint Bookrunners in connection with the Offering (jointly the "Joint Global Coordinators and Joint Bookrunners").

Kromann Reumert and Latham & Watkins LLP act as Danish and U.S. legal advisors respectively to the Company. Plesner acts as Danish legal advisors to the Joint Global Coordinators and Joint Bookrunners.

On December 6, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead program investigating ST101 for the treatment of recurrent glioblastoma (GBM) (Press release, Sapience Therapeutics, DEC 6, 2021, View Source [SID1234596504]). ST101 is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors, which includes a GBM expansion cohort.

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In the ongoing Phase 1-2 study, ST101 demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients with refractory solid tumors.

"Glioblastoma is the most aggressive, fatal form of brain cancer with limited-to-no therapeutic options. With the efficacy data from solid tumors and its ability to cross the blood-brain barrier, ST101 could meaningfully improve outcomes for patients battling this debilitating disease and we look forward to advancing it into Phase 2," said Dr. Barry Kappel, Sapience’s CEO and President.

Dr. Gina Capiaux, PhD, Sapience’s Head of Regulatory Affairs added, "This is an exciting regulatory milestone for our program. Fast Track designation for ST101 highlights this unmet need and allows us to work closely with the FDA to deliver this novel therapy to people with GBM as soon as possible."

Fast Track designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Sapience previously received Orphan Drug Designation from the FDA and European Commission for ST101 for the treatment of glioma.

About Glioblastoma
Glioblastomas are a class of malignant glioma and represent the most common and serious type of primary brain tumors. GBMs account for approximately 14% of all primary brain and Central Nervous System (CNS) tumors and 50% of all malignant brain tumors. Despite standard treatments including surgery, chemotherapy, and radiation, GBM has a rapid progression and high mortality with a median survival less than 8 months and a five-year survival rate of 6.6%.

About ST101
ST101, a peptide antagonist of C/EBPβ, is currently being evaluated in an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). In the ongoing study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. Following conclusion of the final dose-escalation cohort, Sapience plans to initiate four Phase 2 expansion cohorts in refractory, locally advanced and metastatic cutaneous melanoma, hormone-receptor-positive breast cancer, castrate-resistant prostate cancer, and glioblastoma starting in the second half of 2021. ST101 has been granted orphan drug product designation from the U.S. Food and Drug Administration and orphan medicinal product designation by the European Commission for the treatment of glioma.

On December 6, 2021 Purple Biotech (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported the initiation of Part 2 of its ongoing Phase 1/2 clinical trial of NT219, a novel small molecule inhibiting simultaneously IRS1/2 and STAT3, for the treatment of multiple cancers (Press release, Purple Biotech, DEC 6, 2021, View Source [SID1234596503]). Part 2 is a dose escalation study of NT219, beginning with 6mg/kg, in combination with the standard dose of cetuximab (ERBITUX), in patients with recurrent or metastatic squamous cell carcinoma of head and neck cancer (SCCHN) or colorectal adenocarcinoma.

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The monotherapy portion of the study, Part 1, is progressing as planned, and is now dosing patients with advanced solid tumors in the 24mg/kg cohort. To date, no drug limiting toxicities have been observed in the trial, and NT219 has been found to be well-tolerated with minimal serious adverse events.

Initial efficacy data previously reported from the first dose level in Part 1, and additional efficacy signals in the following two cohorts, support the immediate extension of the study to Part 2 of the study, dosing NT219 at its recommended Phase 2 dose in combination with cetuximab in patients with recurrent or metastatic SCCHN, as well as the potential expansion of the clinical program to new indications, which is anticipated to commence during the second half of 2022.

Additional preliminary efficacy data from Part 1 of the trial is expected to be presented at a medical meeting in the first half of 2022.

"The advancement of our ongoing Phase 1/2 clinical trial to Part 2 represents an important achievement for our NT-219 clinical development program," said Michael Schickler, Ph.D., Head of Clinical and Regulatory Affairs of Purple Biotech. "We are encouraged by the initial signals of efficacy, as well as safety trends, observed in Part 1 of the study to date. We look forward to the availability of additional preliminary efficacy data from Part 1 of the study in the first half of 2022, as well as to the further advancement of our development program to Part 2 of the study, and to the potential expansion of the clinical program into other unmet cancer indications, in the second half of 2022."