On August 23, 2022 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immuno-oncology company focused on the discovery and development of next generation therapeutics for cancer, reported that Company management will participate in the following investor conferences in September 2022 (Press release, Sensei Biotherapeutics, AUG 23, 2022, View Source [SID1234618571]):

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Citi’s 17th Annual Biopharma Conference
September 7th-8th
Boston, MA

Wells Fargo’s 2022 Healthcare Conference
September 7th-9th
Boston, MA

Portfolio managers and analysts who would like to request a meeting with management should contact their representative at the respective hosting firms.

On August 23, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported positive results from a pivotal study of Abivertinib on 209 response evaluable, heavily pretreated NSCLC patients by an IRC assessment with matured long-term follow up data (Press release, Sorrento Therapeutics, AUG 23, 2022, View Source [SID1234618572]).

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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

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Abivertinib is a pyrrolopyrimidine-based, third-generation EGFR inhibitor, which is structurally distinct from osimertinib. Abivertinib selectively inhibits EGFR-activating and resistant mutation with nearly 300-fold greater potency as compared with wild-type EGFR. Previously, a positive interim result assessed by investigators was published in the peer-reviewed Clinical Cancer Research journal with interim data (View Source). In these IRC-assessed preliminary topline results with more matured long-term follow up data (previously 16.8 months, now 38.8 months), Abivertinib showed significant treatment benefits in 209 response evaluable, heavily treated NSCLC patients with ORR of 56.5%, and notably a significant CR rate was seen with Abivertinib (5.3%) in comparison with that of osimertinib (Tagrisso) (0.5%)*, while the ORR rate is comparable between the two drugs. This combined data, the ORR of 56.5%, the CR rate of 5.3%, and median OS of 28.2 months (versus Tagrisso’s median OS of 26.8 months)**, is potentially superior to that of the approved third generation EGFR inhibitor (osimertinib). Abivertinib demonstrated significantly efficacious effects in overcoming the resistant mutation in NSCLC. Based on these results, Sorrento is closing the study and preparing the pre-NDA materials and NDA package. Sorrento will request a pre-NDA meeting with the FDA and other regulatory agencies around the world with potential NDA filings pending agreements with the regulatory agencies in different countries.

"We are very encouraged by the significant positive results of Abivertinib assessed by the IRC with long-term follow up data and look forward to meeting with the FDA and other regulatory authorities for the possibility of bringing Abivertinib to the U.S. and global markets," said Dr. Henry Ji, Chairman and CEO of Sorrento. Abivertinib is one of the multiple clinical and pre-clinical stage assets obtained by Sorrento in the previously completed acquisition of ACEA Therapeutics, Inc. in June of 2021.

On August 23, 2022 I-Mab ("I-Mab" or the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that it plans to implement share repurchases pursuant to the share repurchase program previously authorized by its Board of Directors (Press release, I-Mab Biopharma, AUG 23, 2022, View Source [SID1234618591]). On the same day, the Company was also informed by Dr. Jingwu Zang, Chairman and Acting Chief Executive Officer of the Company, and other members of senior management of their intention to use personal funds to purchase the Company’s American Depositary Shares (the "ADSs") on the open market. Under the share purchase plans, the Company and the senior management may purchase up to US$40 million of ADSs in aggregate.

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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

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The timing and dollar amount of share repurchase and share purchase transactions will be subject to the applicable U.S. Securities and Exchange Commission rule requirements. The Company’s Board of Directors will review the implementation of share repurchases periodically, and may authorize adjustment of its terms and size.

On August 23, 2022 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported financial results for the second quarter and half year ended June 30, 2022 and provided a business update (Press release, BerGenBio, AUG 23, 2022, View Source [SID1234618557]).

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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

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"The prioritization of bemcentinib development in two key areas in the second quarter has created momentum entering the second half of the year," said Martin Olin, Chief Executive Officer of BerGenBio. "By following strong scientific rationale, clinical and preclinical data, and areas of significant unmet medical need, we are confidently enthusiastic about bemcentinib’s potential in aiding patients in two indications of focus: STK11 mutated Non-Small Cell Lung Cancer and patients hospitalized by COVID-19. The initiation of the next phase of clinical development for both indications in 2H22 moves us a meaningful step closer to addressing two large patient populations that are in need of better treatments."

Clinical Development

Bemcentinib

BerGenBio’s lead compound, bemcentinib, is a potent, first-in-class, oral, small molecule, highly selective inhibitor of the receptor tyrosine kinase AXL, which is overexpressed in response to cellular stress, inflammation, hypoxia and chemotherapy. Bemcentinib inhibits the host cells’ ability to propagate the progression of serious disease through the modulation of resistance mechanisms and the adaptive immune system.

The Company is advancing bemcentinib development in two lung indications, STK11 mutated (STK11m) Non-Small Cell Lung Cancer (NSCLC) and Hospitalized COVID-19 patients, where bemcentinib’s novel mechanisms of action and primary accumulation in the lungs make it uniquely positioned to address severe lung diseases.

First-Line STK11m NSCLC

BerGenBio is preparing a Phase 1b/2a trial of bemcentinib in 1L STK11m NSCLC, a group that represents approximately 20% of NSCLC patients. Mutations in the STK11 gene are highly correlated with poor treatment response and survival with today’s standard of care treatments, including immune checkpoint inhibitors in NSCLC. Through inhibition of AXL, bemcentinib seeks to prevent AXL activation, consequently removing the innate immunosuppression that it causes and driving the proliferation of immune cells to restore sensitivity to immune checkpoint therapy. UT Southwestern Medical Center in Texas has shown that bemcentinib in models of NSCLC has the ability to restore the sensitivity of checkpoint inhibitors. Further bemcentinib is also believed to delay the development of chemoresistance.

The detrimental effect of mutations in the STK11 gene on clinical outcomes was further highlighted by several academic groups at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in June 2022. In a retrospective study funded by Roche, Spain (Abstract #9047), of real-world outcomes in 1L NSCLC patients, STK11m was identified as having the poorest prognosis in all effectiveness outcomes, including lower response, progression free survival and overall survival, of 185 detected mutations.
The Company is preparing and has post period filed an IND with the purpose to initiate a Phase 1b/2a trial evaluating bemcentinib in combination with a checkpoint inhibitor and doublet chemotherapy in 1L STK11m NSCLC patients in the second half of 2022.
In parallel with the preparation of the Phase 1b/2a trial, the Company is evaluating the role of STK11 mutations in combination with other relevant co-mutations such as TP53, KRAS and KEAP1 to further characterize the potential of bemcentinib is this area of high unmet medical need.
Hospitalized COVID-19 Patients

Bemcentinib is currently being studied in a Phase 2b clinical trial in hospitalized COVID-19 patients. AXL, when induced by an infection, such as COVID-19, is known to play a variety of key roles in transporting the virus into cells, aiding replication, and dampening immune responses. Bemcentinib selectively inhibits AXL to block viral entry, stimulate the innate immune system and facilitate tissue repair regardless of known variants or mutations.

In the ACCORD2 UK platform study of hospitalized COVID-19 patients, bemcentinib treatment resulted in a clear reduction in clinical deterioration, causing: a significant reduction in deaths, patients requiring less supplementary oxygen, a significant reduction in the need for intubation or ventilation and a shortening of hospital stays compared to the control group.
Bemcentinib has been selected by an expert group to be studied in a Phase 2b trial under the EU-SolidAct platform through a sub-protocol enrolling 500 hospitalized COVID-19 patients across Europe.
Mipasetamab Uzoptirine

Post period, ADC Therapeutics announced that the first patient was dosed in a Phase 1 clinical trial evaluating mipasetamab uzoptirine as a single agent and in combination with gemcitabine in patients with selected advanced solid tumors. Mipasetamab uzoptirine contains an AXL-targeting humanized monoclonal antibody licensed from BerGenBio.

Corporate Activities

BerGenBio strengthened its leadership team in April 2022 with the addition of Cristina Oliva, M.D., as Chief Medical Officer. Dr. Oliva is a Board-certified oncologist with over 20 years of senior clinical development experience across large pharmaceutical, biotechnology and CROs, including her most recent position as Vice President, Oncology and Head of Oncology Centre of Excellence at IQVIA, Ltd.

Second Quarter 2022 Financial Highlights

(Figures in brackets = same period 2021 unless otherwise stated)

Revenue amounted to NOK 0.0 million (NOK 0.0 million) for the second quarter 2022
Total operating expenses for the second quarter were NOK 88.2 million (NOK 92.3 million)
The operating loss for the second quarter came to NOK 88.2 million (NOK 92.3 million)
Cash and cash equivalents amounted to NOK 292.1 million (NOK 367.8 million at the end of the first quarter 2022).
Presentation and Webcast Details

The live webcast link is available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

Webcast link: https://channel.royalcast.com/landingpage/hegnarmedia/20220823_9/

The first quarter report and presentation are available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.

On August 23, 2022 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported its liver drug candidate Namodenoson has been approved for compassionate use for the treatment of patients with advanced liver cancer in Romania (Press release, Can-Fite BioPharma, AUG 23, 2022, View Source [SID1234618573]). Namodenoson was previously approved for compassionate use in Israel, where advanced liver cancer patients have been treated for several years.

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In parallel, Can-Fite’s pivotal Phase III study in patients with advanced liver cancer (hepatocellular carcinoma), is open for patient enrolment and will recruit patients in Israel, the U.S., and five countries in Europe. This pivotal study received a ‘green light’ to proceed from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and if successfully concluded, the Company will be in a position to submit the drug for approval with each of the regulatory authorities. Namodenoson has Orphan Drug Status with both the FDA and EMA and Fast Track Status with the FDA. A registration plan has been submitted to and accepted by the FDA.

"We are committed to providing Namodenoson, with an excellent safety profile and strong efficacy in this patient population in clinical trials to date, to fulfill an urgent unmet medical need. The anti-cancer effect of Namodenoson together with its liver protective properties make it unique among anti-cancer drugs for this devastating disease," stated Can-Fite CEO Dr. Pnina Fishman.

The hepatocellular carcinoma (HCC) drug market is expected to reach $3.8 billion in 2027 in the G8 countries according to DelveInsight. The American Cancer Society estimates that in the U.S., liver cancer incidence has tripled since 1980, with an estimated 41,000 cases diagnosed and 31,000 deaths annually. Incidence of liver cancer is much higher in other countries, with more than 800,000 diagnoses and 700,000 deaths estimated globally each year.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for advanced hepatocellular carcinoma in a pivotal Phase III trial. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.