On March 12, 2021 EVERSANA reported The U.S. Food and Drug Administration (FDA) an official Oncology Drugs Advisory Committee (ODAC) meeting to review six indications across a group of PD-1 and PD-L1 inhibitors that have recently had their indications withdrawn in the U.S. due to an accelerated approvals crackdown (Press release, EVERSANA, MAR 12, 2021, View Source [SID1234576584]).

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 panel will assess a group of inhibitors that were granted under the agency’s accelerated approval pathway with confirmatory trials that have not verified clinical benefit, such as Bristol Myers Squibb’s Opdivo (nivolumab), Merck’s Keytruda (pembrolizumab) and Roche’s Tecentriq (atezolizumab) across six different indications in breast, urothelial, gastric and hepatocellular cancers.

Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence, noted that the committee is "committed to ensuring the integrity of the accelerated approval program, which is designed to bring safe and effective drugs to patients with unmet medical needs as quickly as possible.

"The program allows the FDA to approve a drug or biologic product intended to treat a serious or life-threatening condition based on an outcome that can be measured earlier than survival that demonstrates a meaningful advantage over available therapies. However, when confirmatory trials do not confirm clinical benefit, a reevaluation must be performed to determine if the approval should be withdrawn."

Oncology drugs and indications up for review:

Genentech recently announced that it was voluntarily withdrawing the U.S. indication for Tecentriq in prior-platinum treated metastatic urothelial carcinoma, in a joint decision made in consultation with the FDA.

Merck also voluntarily withdrew its U.S. indication for Keytruda for patients with metastatic small-cell lung cancer (SCLC) who experience disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy earlier in March, and in December 2020, Bristol Myers Squibb also announced its withdrawal from the FDA of an application regarding Opdivo (nivolumab) in SCLC.

BMS issued a note of support for the FDA’s decision, stating that "In HCC, despite evolution of the treatment landscape over the past few years, we believe Opdivo continues to address an unmet medical need for patients in the post-sorafenib setting, and we appreciate the opportunity to discuss this in more depth with the Committee."

The special three-day public hearing on April 27 to 29 will "give oncology experts outside of the FDA and patients with cancer an opportunity to describe their experiences with the drugs," explained Pazdur.

According to the FDA, only 6% of accelerated approvals for oncology drugs have been withdrawn over the whole duration of the pathway’s use, including the four recent withdrawals.

On March 12, 2021 Jounce Therapeutics, Inc. (Nasdaq: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported the closing of its previously announced underwritten public offering of 5,750,000 shares of its common stock at a public offering price of $11.25 per share, including 750,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares (Press release, Jounce Therapeutics, MAR 12, 2021, View Source [SID1234576585]). Gross proceeds from the sale of the shares, before deducting underwriting discounts and commissions and offering expenses, were approximately $64.7 million.

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!

Cowen and Piper Sandler acted as joint book-running managers for the offering.

The shares were offered by Jounce pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on March 8, 2018 and declared effective by the SEC on May 1, 2018. The offering was made solely by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A final prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering can be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at 833-297-2926; or from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 12, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that it has completed enrolment into Cohort C1 of its Phase II study (BGBC008) of bemcentinib in combination with anti-PD-1 therapy Keytruda (pembrolizumab) in refractory non-small cell lung cancer (NSCLC) patients (Press release, BerGenBio, MAR 12, 2021, https://www.bergenbio.com/bergenbio-completes-enrolment-into-latest-cohort-of-phase-ii-bemcentinib-combination-study-in-refractory-nsclc/ [SID1234578614]).

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 BGBC008 trial ClinicalTrials.gov Identifier: NCT03184571 is being conducted in three cohorts evaluating the safety and benefit of bemcentinib and pembrolizumab combination in refractory NSCLC patients. Cohort C is assessing second line patients refractory to first line treatment with checkpoint inhibitors in combination with chemotherapy. A total of 13 patients have been enrolled in Cohort C1 and the first efficacy data is expected within 24 weeks. If successful the trial will expand to Cohort C2, assessing a further 29 patients.

The study is being sponsored by BerGenBio in collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, New Jersey, USA, who continue to supply Keytruda (pembrolizumab) for use in the study, under a collaboration agreement signed in March 2017.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are pleased to have completed enrolment into the first stage of the third cohort planned for this study. We are excited by the potential patient benefit of
selective AXL inhibition with bemcentinib, to reverse acquired resistance to immune checkpoint inhibitors in cAXL-positive patients who have relapsed on immunotherapy and chemotherapy. There are currently limited treatment options for patients for whom first line therapies in NSCLC have been ineffective. If successful, this combination treatment could provide an important alternative to second line chemotherapy standard-of-care. I look forward to providing an update on the data from this cohort in due course."

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor to ACE2, to which the spike protein of the Sars-Cov-2 virus attaches and enters the host cell, and AXL expression is upregulated that leads to suppression of the Type 1 Interferon immune response by host cells and in their environment. Research data confirms bemcentinib inhibits SARS-CoV-2 host cell entry and promotes the anti-viral Type I interferon response.

In cancer, increase in AXL expression has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers. AXL suppresses the body’s immune response to tumours and drives treatment failure across many cancers. High AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib, therefore, have potential high value as monotherapy and as the cornerstone of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases including fibrosis.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent and highly selective AXL inhibitor, currently in a broad phase II clinical development programme. It is administered as an oral capsule and taken once per day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity.

On March 12, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that the Company’s fourth quarter 2020 financial results will be released on Tuesday, March 16, 2021 (Press release, Calithera Biosciences, MAR 12, 2021, View Source [SID1234576586]). Company management will host a conference call on Tuesday, March 16, 2021 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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 press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 6250035. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.

On March 12, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company, reported it will publish fourth quarter and fiscal year 2020 financial results and provide a business update on Thursday, March 18, 2021 (Press release, Precision Biosciences, MAR 12, 2021, View Source [SID1234576692]).

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!