On December 9, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 8,888,889 shares of common stock of the Company, at a price to the public of $4.50 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, DEC 9, 2020, View Source [SID1234572613]). The closing of the offering is expected to occur on or about December 14, 2020, subject to 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!

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 1,333,333 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $40.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail 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.

On December 9, 2020 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported the presentation of updated Phase 3 PFS and OS data demonstrating clinical benefits in efficacy and tolerability of oral paclitaxel versus IVP in patients with metastatic breast cancer (MBC) (Press release, Athenex, DEC 9, 2020, View Source [SID1234573868]). The findings further support the superiority of increased ORR observed with oral paclitaxel. These data were presented today during a spotlight poster presentation at the 2020 San Antonio Breast Cancer Symposium (SABCS).

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!

"Having previously presented superior efficacy on overall response rate and favorable tolerability versus IV paclitaxel at SABCS 2019, it is gratifying to report that our pivotal Phase 3 trial continues to show sustained efficacy and manageable adverse events with oral paclitaxel and encequidar," said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "The updated Phase 3 PFS and OS data further support the clinical rationale for oral paclitaxel as an efficacious and tolerable treatment option for people living with metastatic breast cancer."

The spotlight poster presentation at SABCS featured an update on PFS and OS data from the Phase 3 trial. In the prespecified modified intent-to-treat (mITT) population (n = 360), the median PFS data showed a benefit for oral paclitaxel versus IVP (8.4 vs. 7.4 months, respectively; hazard ratio [HR] = 0.739; 95% confidence interval [CI]: 0.561, 0.974; p = 0.023). Median OS data also showed a benefit for oral paclitaxel versus IVP (23.3 months vs. 16.3 months, respectively; HR = 0.735; 95% CI: 0.556, 0.972; p = 0.026).

In the intent-to-treat (ITT) population, which included all 402 randomized patients, the median PFS showed a benefit for oral paclitaxel versus IVP (8.4 months vs. 7.4 months, respectively; HR = 0.768; 95% CI: 0.584, 1.01; p = 0.046). The median OS data demonstrated a trend favoring oral paclitaxel versus IVP (22.7 months vs. 16.5 months, respectively; HR = 0.794; 95% CI: 0.607, 1.037; p = 0.082).

Updated safety analyses of up to 112 weeks continue to demonstrate the reduction in incidence and severity of neuropathy favoring oral paclitaxel versus IVP: all grades of neuropathy were 22% vs. 64%, and grade 3 neuropathy was 2% vs. 15%.

Also presented were data on the effect of prophylactic treatments on the incidence and severity of gastrointestinal-related adverse events. After approximately 30% of patients were enrolled, the Phase 3 trial protocol was amended to allow patients randomized to the oral paclitaxel arm to receive prophylactic pre-medications for gastrointestinal side effects. Overall gastrointestinal (GI)-related adverse events (AEs) were less frequent in the IV paclitaxel arm. GI-related AEs improved in the oral paclitaxel arm following the amendment, as measured by lower incidences of grade 2 vomiting before and after amendment (24% vs. 7%) and grade 2 diarrhea before and after amendment (27% vs. 16%).

"The oral paclitaxel regimen appears to overcome some of the limitations of IV therapy, particularly in terms of reducing the risk of neuropathy," commented lead investigator Gerardo Antonio Umanzor Fúnez, M.D., a medical oncologist at Centro Oncologico Integral, working with DEMEDICA of San Pedro Sula, Honduras. "The lessened burden of neuropathy, the ability to manage GI side effects with prophylactic treatments, and the convenience of home-based administration, could be transformational in the treatment of metastatic breast cancer, especially in the current environment."

Oral paclitaxel has been granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic breast cancer with a PDUFA date of February 28, 2021.

About the Phase 3 Oral Paclitaxel and Encequidar Clinical Trial
The Phase 3 trial randomized 402 patients with any metastatic breast cancer subtypes in a 2:1 ratio to receive either the oral paclitaxel regimen (205 mg/m2 of oral paclitaxel plus 15 mg of encequidar) for three days a week or the approved IV paclitaxel regimen (175 mg/m2) as a three-hour infusion every three weeks. The primary efficacy endpoint was overall response rate (ORR) confirmed at two consecutive timepoints by a blinded, independent radiology review that used RECIST v1.1 criteria to evaluate patients’ tumors for response. The trial was designed to demonstrate superiority of oral paclitaxel over IVP on the primary end point of ORR. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). The trial was not powered to demonstrate superiority of oral paclitaxel versus IVP on the secondary survival endpoints of PFS and OS. These secondary endpoints were not controlled for multiplicity. P-values presented are nominal.

About Oral Paclitaxel
Athenex’s oral paclitaxel and encequidar ("oral paclitaxel") is the first oral formulation of paclitaxel in late-stage development for the treatment of metastatic breast cancer (MBC), and is also in earlier stages of development for other malignancies. Encequidar, the cornerstone of Athenex’s Orascovery technology platform, is a highly specific and potent inhibitor of the transport protein called P-glycoprotein (P-gp) in the gastrointestinal (GI) tract. By localizing P-gp inhibitory activity in the GI tract, encequidar improves the absorption of chemotherapeutic agents while limiting the potential for unnecessary P-gp inhibition at other sites in the body. The potency, selectivity, and low absorption of encequidar enables the oral administration of IV chemotherapies, several of which are under development by Athenex.

On December 9, 2020 Boehringer Ingelheim reported the execution of the agreement on the acquisition of Labor Dr. Merk & Kollegen (Press release, Boehringer Ingelheim, DEC 9, 2020, View Source [SID1234572470]). The acquisition will enable Boehringer Ingelheim to further expand and accelerate its comprehensive program for the development of ATMP-based immuno-oncology therapies including the Vesicular Stomatitis Virus (VSV) with modified glycoprotein (GP) platform and cancer vaccines platforms. Labor Dr. Merk & Kollegen has outstanding experience in process development, manufacturing and analytical characterization in virology besides expertise in microbiology and cell culture. Labor Dr. Merk & Kollegen has already worked in close collaboration with Boehringer Ingelheim on viral-based therapy development since 2015.

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 acquisition of Labor Dr. Merk & Kollegen is strengthening our promising pipeline with diverse potential first-in-class cancer immunology and cancer cell directed therapies for patients with hard-to-treat cancer," said Dr. Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. "The trusting and highly effective collaboration between our scientists and the Labor Dr. Merk & Kollegen team has already contributed significantly to our progress in viral-based cancer therapies. We will welcome the Labor Dr. Merk & Kollegen team and look forward to jointly advancing our program in this area."

Boehringer Ingelheim is taking cancer on by strengthening its position in cancer immunology, with a focus on cancer vaccines, oncolytic viruses, T-cell engagers, stromal modulators and myeloid cell modulators by combining its world-class, in-house research and development with that of highly innovative external companies. The addition of Labor Dr. Merk & Kollegen’s site will enable Boehringer Ingelheim to further strengthen its oncolytic virus and cancer vaccine development capabilities and capacities by establishing an end-to-end fully integrated center of excellence for virus development and clinical manufacturing. It will add to a series of strategic acquisitions and collaborations over the past years, including the acquisition of ViraTherapeutics and AMAL Therapeutics, which are contributing assets that will be further developed at Labor Dr. Merk & Kollegen’s site.

Labor Dr. Merk & Kollegen is a privately-held company founded in 1971. It is headquartered in Ochsenhausen, Germany, close to Boehringer Ingelheim’s Biberach R&D site. As a center of excellence in virology, Labor Dr. Merk & Kollegen has a long track record in GLP and GMP certified biosafety testing. In recent years Labor Dr. Merk & Kollegen established its GMP-virus manufacturing facility. With around 130 highly qualified and specialized employees, the company has built considerable expertise in process development, manufacturing and analytical characterization of viral therapeutics and oncolytic viral therapeutics. Labor Dr. Merk & Kollegen will be integrated with all employees as a new unit into Boehringer Ingelheim’s Development organization and continue to operate at its Ochsenhausen site. A future expansion is planned.

"Following our successful strategic partnership, we are really excited to join forces with Boehringer Ingelheim," said Dr. Ingrid Rapp, CEO at Labor Dr. Merk & Kollegen. "Boehringer Ingelheim is a truly global pharmaceutical company with excellent R&D capacities. We look forward to taking our next development step in oncology as part of this outstanding team."

The companies did not disclose the financial terms of the deal. The transaction is subject to the approval of the competition authorities in Germany. Closing will follow thereafter.

On December 9, 2020 Incyte (Nasdaq:INCY) reported that it will present at the 39th Annual J. P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021 at 7:30 a.m. EST (Press release, Incyte, DEC 9, 2020, View Source [SID1234572509]).

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 presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

On December 9, 2020 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, and WuXi Biologics (2269.HK), a global company with leading open-access biologics technology platforms, reported an expansion of their existing strategic relationship under which the parties will discover anti-CD39 antibodies using WuXi Bio’s proprietary technology (Press release, Arcus Biosciences, DEC 9, 2020, View Source [SID1234572544]). This CD39 collaboration represents the fourth antibody development program on which the two companies have joined forces. Arcus was granted exclusive worldwide rights to anti-CD39 antibodies discovered under the collaboration and will be responsible for all further development and commercialization activities of such anti-CD39 antibodies.

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 ATP-adenosine axis is believed to play a critical role in maintaining an immunosuppressed tumor microenvironment. Inhibition of one or more of the key nodes (CD39, CD73, or adenosine A2a and A2b receptors) along this axis aims to reduce the formation or activity of the highly immunosuppressive adenosine. A potential additional benefit of CD39 inhibition, aside from blocking an important source of adenosine, is the increase in intra-tumoral ATP, an important molecule for the recruitment and activation of dendritic cells. Preclinical experiments indicate that the combination of CD39 inhibition with either CD73 or adenosine receptor inhibition provides robust inhibition of this axis and increased anti-tumor immunity.

"WuXi Biologics is a global leader in the development and manufacture of therapeutic antibodies. Our relationship with WuXi Biologics started in 2017 with a clinic-ready anti-PD1 antibody, zimberelimab, which possesses molecular properties similar to those of marketed anti-PD1 therapies and has shown impressive clinical anti-tumor activity," said Juan Jaen, Ph.D., president and head of research at Arcus Biosciences. "Furthermore, WuXi Biologics has been an excellent manufacturing partner for our anti-TIGIT antibodies, domvanalimab (AB154) and AB308. We are excited to now extend our existing relationship with WuXi Biologics by combining core competencies to discover anti-CD39 antibodies that have the potential to synergize with adenosine-targeted molecules in our existing portfolio of clinical agents. This will allow us to continue to maintain our position as one of the industry’s leading companies in the targeting of the ATP-adenosine axis for the treatment of cancer."

"We’re thrilled to expand our strategic partnership with Arcus Biosciences to further enable this innovative company to bring new biologics solutions using WuXi Biologics’ proprietary integrated platforms. This partnership is a strong testament to our industry-leading capabilities and expertise," said Dr. Chris Chen, CEO of WuXi Biologics. "We’re committed to offering global open-access technology platforms with premier quality standards to support our global partners as they build their innovative ideas into transformative new treatments for patients worldwide."

Financial terms of the agreement were not disclosed, and the development of any anti-CD39 antibodies from the collaboration is not expected to materially impact Arcus’s financial position over the current cash runway.