South-Korean biotech Y-Biologics and French mid-pharma Pierre Fabre enter into a worldwide exclusive license agreement in the highly innovative field of immuno-oncology

On July 6, 2021 The South Korean biotech company Y-Biologics and the French pharmaceutical group Pierre Fabre reported that they have entered into a license agreement granting worldwide exclusive rights to Pierre Fabre to develop and commercialize a family of human antibodies generated through the phage display human antibody Ymax-ABL library owned by Y-Biologics (Press release, Pierre Fabre, JUL 6, 2021, View Source [SID1234584653]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

These antibodies have been functionally validated by the Pierre Fabre R&D teams for their specific properties on a pivotal immuno-oncology target acting on the tumoral microenvironment. Pierre Fabre intends to select a new therapeutic candidate in immuno-oncology for further developments.

This licensing agreement results from the strong and now proven complementarity between the two companies who have been collaborating since 2018. The final objective pursued by Y-Biologics and Pierre Fabre is to provide patients with innovative drugs to target refractory or relapsing cancer, taking advantage of the immune infiltrate to inhibit the growth of tumor cells.

This new milestone reached by the two companies reveals the effectiveness of the scientific means put in place by Y-Biologics, associated with the high expertise of Pierre Fabre in oncology.

Young Woo Park, CEO of Y-Biologics, stated: "We are very pleased to sign our first license agreement with Pierre Fabre. The collaboration between Y-Biologics and Pierre Fabre which is being conducted based on mutual trust, is expected to further advance the development of innovative immuno-oncology therapeutics targeting the tumor microenvironment."

"Since the beginning of our partnership, the collaboration with Y-Biologics has been very efficient and fruitful. Their library has allowed us to identify a family of human antibodies against a promising target defined by our researchers at our dedicated Center of Immunology. This new exciting license agreement will allow us to further support the development of this therapy for the benefit of patients," added Nathalie Corvaïa, Head of Immuno-Oncology Research, Center of Immunology Pierre Fabre (CIPF).

IDEAYA Announces Pricing of Public Offering of Common Stock

On July 7, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported the pricing of an underwritten public offering of 4,637,681 shares of its common stock at a public offering price of $17.25 per share, before underwriting discounts and commission (Press release, Ideaya Biosciences, JUL 7, 2021, View Source [SID1234584669])s. In addition, IDEAYA has granted the underwriters a 30-day option to purchase up to an additional 695,652 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by IDEAYA, are expected to be approximately $80.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about July 12, 2021, subject to the satisfaction of customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) clinical development of IDE397, its MAT2A inhibitor development candidate, (ii) preclinical and clinical development of other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, a MTAP synthetic lethality target (other than MAT2A), and DNA damage targets, as well as its share of costs for targeting WRN under IDEAYA’s Collaboration, Option and License Agreement with GSK, (iii) ongoing early clinical development of darovasertib (IDE196), its PKC inhibitor, in metastatic uveal melanoma, or MUM, and other solid tumors having GNAQ/11 hotspot mutations, including as monotherapy and as combination therapies with binimetinib, a MEK inhibitor, and independently with crizotinib, in each case pursuant to a clinical trial and drug supply agreement with Pfizer, (iv) synthetic lethality target and biomarker research and development activities and (v) working capital and other general corporate purposes.

J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities are acting as joint book-running managers for the offering.

The securities described above are being offered by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission, or the SEC. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained, when available, by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or Guggenheim Securities, by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-5548 or by email at [email protected].

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.

AbbVie to Host Second-Quarter 2021 Earnings Conference Call

On July 7, 2021 AbbVie (NYSE: ABBV) reported that it will announce its second-quarter 2021 financial results on Friday, July 30, 2021, before the market opens (Press release, AbbVie, JUL 7, 2021, View Source [SID1234584636]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time. It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TriAct Therapeutics Announces Iniparib Granted Orphan Drug Designation by the FDA for Treatment of Malignant Glioma

On July 7, 2021 TriAct Therapeutics, a private, late clinical stage oncology therapeutics company, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead drug, iniparib, for the treatment of patients with malignant gliomas (Press release, TriAct Therapeutics, JUL 7, 2021, View Source [SID1234584670]). The FDA noted that the designation granted is broader than the glioblastoma indication proposed in the Company’s request and that treatment of glioblastoma is within the scope of this orphan drug designation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The mission of the FDA Office of Orphan Products Development (OOPD) is to advance the development of products that demonstrate promise for the treatment of rare diseases which affect fewer than 200,000 people in the United States. Orphan drug designation entitles iniparib, once approved by the FDA, to seven years of market exclusivity in treating patients with malignant glioma. Additional incentives for orphan drug development include tax credits related to development expenses, a reduction in FDA user fees and FDA assistance in clinical trial design.

"Receiving orphan drug designation is an important milestone in our effort to bring this promising new therapy to both adult and pediatric patients suffering from malignant gliomas, including newly diagnosed glioblastoma," said Tom White, co-founder and Chief Executive Officer of TriAct. "With a three-year survival rate of 16% for newly diagnosed glioblastoma patients, this designation is also an acknowledgement of the urgent need to intelligently but expeditiously develop promising new therapies for these patients. Consequently, following FDA guidance from our end-of-phase 2 meeting earlier this year, we are also filing for Fast Track designation."

About Iniparib

Iniparib is a well characterized, clinical stage drug candidate that kills cancer cells by targeting their redox metabolism, spiking oxidative stress levels and triggering programmed cell death. Iniparib’s Phase 2 Study in newly diagnosed glioblastoma patients met its primary survival and safety end points. Based in part on these promising results TriAct is designing a pivotal trial intended to support submission of an NDA in the U.S. and MAA in Europe.

About Newly Diagnosed Glioblastoma

Glioblastoma (GBM) tumors are the most common and aggressive form of brain cancer, affecting approximately 15,000 patients annually in the United States (US). Annual incidence of GBM in the US is approximately 3 per 100,000 population. The standard of care since 2005 in the US comprises surgical resection of the tumor followed by adjuvant radiotherapy combined with temozolomide (TMZ), and subsequent maintenance TMZ. Currently, survival for GBM patients is poor, with approximately 75% of patients dying within 2 years of diagnosis and 95% dying within 5 years

Panbela to Present at Access to Giving Virtual Conference July 15 at 10:30 a.m. ET

On July 7, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that the company will present at Access to Giving Virtual Conference (Press release, Panbela Therapeutics, JUL 7, 2021, View Source [SID1234584688]). The presentation will be given by Panbela’s President & Chief Executive Officer, Jennifer K. Simpson, PhD, MSN, CRNP.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Registration Details
Date: Thusday, July 15, 2021
Time: 10:30 a.m. ET

Link: https://access-to-giving.events.issuerdirect.com/signup

To learn more about the event or to schedule a one-on-one meeting with Panbela management, please visit View Source or email [email protected].

About Access to Giving Virtual Conference
Access to Giving is a first-of-its-kind virtual investor conference where companies from microcap all the way up to megacap will have the opportunity to present their story and conduct 1×1 meetings with qualified investors, for charity. Investors will make donations to purchase a block of meetings to meet with companies.

About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse events are being evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source