On August 24, 2022 Nordic Nanovector ASA (OSE: NANOV) reported that it will report its results for the second quarter and first half 2022 on Wednesday, 31 August 2022 (Press release, Nordic Nanovector, AUG 24, 2022, View Source [SID1234618622]).

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A presentation by Nordic Nanovector’s senior management team will be held in-person and webcast live beginning at 8:30am CEST.

Venue: Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: Bjørvika

The webcast can be accessed from www.nordicnanovector.com in the section: Investors & Media and a recording will also be available on this page after the event.

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2022 from 7:00am CEST the same day.

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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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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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 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, and The University of Texas MD Anderson Cancer Center (MD Anderson), reported a strategic research and development collaboration to evaluate multiple agents from Erasca’s pipeline targeting the RAS/MAPK pathway as either single-agent or combination therapies (Press release, Erasca, AUG 23, 2022, View Source [SID1234639376]).

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The initial focus of the alliance will be Erasca’s potentially best-in-class ERK1/2 inhibitor ERAS-007 and its potentially best-in-class SHP2 inhibitor ERAS-601, which together comprise Erasca’s first MAPKlamp combination. ERAS-007 is being investigated in multiple ongoing trials, including in non-small cell lung cancer (NSCLC) as part of the HERKULES-2 master protocol and in gastrointestinal (GI) malignancies as part of the HERKULES-3 master protocol. ERAS-601 is being investigated in multiple ongoing trials, including the FLAGSHP-1 trial in triple wildtype (KRAS/NRAS/BRAF wildtype) colorectal cancer (CRC) and human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC) and the HERKULES-2 NSCLC master protocol.

"Our strategic collaboration with MD Anderson broadens the evaluation of ERAS-007 and ERAS-601 and explores additional therapeutic opportunities across our pipeline," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "The RAS/MAPK pathway is one of cancer’s most frequently altered pathways, affecting more than 5 million new patients with cancer annually worldwide. We have designed our pipeline to comprehensively shut down this highly oncogenic pathway at multiple critical nodes, and we’re excited to work with MD Anderson to potentially address major unmet needs in the treatment of cancer."

The alliance will build on Erasca’s existing collaborations with MD Anderson investigators Scott Kopetz, M.D., Ph.D., professor of Gastrointestinal Medical Oncology, and David S. Hong, M.D., professor of Investigational Cancer Therapeutics. Kopetz is an investigator in HERKULES-3, which is evaluating ERAS-007 plus encorafenib and cetuximab in BRAF V600E-mutant metastatic CRC and ERAS-007 plus palbociclib in KRAS-mutant/NRAS-mutant CRC and KRAS-mutant pancreatic cancer. Hong is an investigator in FLAGSHP-1, which is evaluating ERAS-601 as monotherapy and in combination with cetuximab in triple wildtype CRC and HPV-negative advanced HNSCC.

"Durability and treatment resistance continue to present challenges in the treatment of lung cancers and GI malignancies, particularly stemming from reactivation of the RAS/MAPK pathway. Erasca’s pipeline of agents that target key nodes, including previously undruggable genetic drivers, has the potential to improve durability and minimize resistance," Kopetz said. "We look forward to collaborating with Erasca to further maximize the potential of promising treatment combinations across its pipeline."

The new strategic collaboration will enhance Erasca’s and MD Anderson’s evaluation of ERAS-007 and ERAS-601 in combination with investigational and standard-of-care agents, including with Erasca’s proprietary pipeline programs, such as the KRAS G12D inhibitor ERAS-4. Under the terms of the five-year agreement, collaborative preclinical and clinical studies will be conducted in NSCLC, GI malignancies and additional mutually agreed-upon indications.

About ERAS-007
ERAS-007 is a potential best-in-class oral ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. The broad therapeutic potential of ERAS-007 is being investigated initially across a series of HERKULES clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp combination) in advanced solid tumors. HERKULES-2 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with NSCLC. HERKULES-3 is a Phase 1b/2 clinical trial for ERAS-007 in combination with various agents in patients with GI cancers.

About ERAS-601
ERAS-601 is a potential best-in-class oral, selective SHP2 inhibitor being investigated alone or in combination. SHP2 acts as a convergent node for receptor tyrosine kinase (RTK) signaling, relaying growth and survival signals from RTKs to intracellular signaling pathways. ERAS-601 is being investigated across a series of clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents. FLAGSHP-1 is a Phase 1/1b dose escalation trial evaluating ERAS-601 as a monotherapy in advanced solid tumors and in combination in triple wildtype CRC and HPV-negative advanced HNSCC. HERKULES-2 is a Phase 1b/2 master protocol clinical trial that includes evaluation of ERAS-601 in combination with various agents in patients with NSCLC.

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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"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.