On September 13, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), reported that Dr. Henry Ji, Chairman and CEO, will participate in the H.C. Wainwright 23rd Global Investment Conference (www.hcwevents.com/annualconference) (Press release, Sorrento Therapeutics, SEP 13, 2021, View Source [SID1234587594]). The conference is being held virtually on September 13-15, 2021.

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Dr. Henry Ji, Chairman and CEO of Sorrento, will provide corporate updates and highlights associated with Sorrento’s product pipeline in the strategic focus areas of the company: COVID-19, Cancer and Autoimmune Therapeutics, and Non-Opioid Pain Management.

COVID-19 Product Portfolio Highlights:

COVISTIX: COVID-19 Rapid Antigen Detection Test in commercialization in Mexico with an EUA from COFEPRIS. Regulatory approval processes in progress in the US, Canada, Brazil, and WHO EUL (Emergency Use Listing), with active partnering discussions for global commercialization.
COVIDROPS (STI-2099): Intranasal neutralizing antibody (nAb) formulation in Phase 2 trials in UK, US and soon in Mexico for newly diagnosed COVID patients in an outpatient setting.
COVI-AMG (STI-2020): Potentially highly potent/low dose antibody in a 2 minute IV-push in Phase 2 trials for systemic treatment in an outpatient setting.
COVISHIELD antibody (STI-9167): Demonstrating potent in vitro virus neutralization across all currently known variants of concern (VoCs) and reducing replicating virus in the lungs of infected transgenic K18 mice (with human ACE2 receptor) to undetectable levels (following infection by SARS-CoV-2 WA-1 strain or VoCs including Alpha, Beta, Gamma, Delta, and Lambda).
MPI-8 and its SAR-Improved Analog (1121): Small molecule antiviral targeting SARS-CoV-2 main protease, demonstrating broad-spectrum, potent antiviral activities against SARS-CoV-2 and all currently known VoCs.
Multivalent mRNA COVID-19 Vaccine: Elicited a stronger humoral immune response against Delta VoC as compared to SARS-CoV-2 intramuscular mRNA vaccine in preclinical studies.
Recombinant RBD Subunit Vaccine: Demonstrated strong humoral immune response against WA-1 and Delta VoC in preclinical studies.
Abivertinib: Phase 2 studies for treatment of acute respiratory distress syndrome (ARDS) in hospitalized COVID patients in US (96 Pts) and Brazil (400 Pts) are completed.
COVI-MSC: Phase 2 for ARDS in ICU COVID patients are ongoing in US and Brazil.
Cancer and Autoimmune Product Portfolio Highlights:

Abivertinib: Phase 3 topline data in NSCLC available Q4 2021.
Abivertinib: IND for Phase 2 in Prostate Cancer to be filed Q4 2021.
PD-L1 antibody: In Phase 3 for SCLC and NDA submission in China for recurrent or metastatic cervical cancer.
CD38 ADC: In Phase 1 for Amyloidosis and Multiple Myeloma.
CD38 DAR-T: In Phase 1 for Relapsed and Refractory Multiple Myeloma.
CD47 antibody: In Phase 1 in solid tumors.
SOFUSA: Lymphatic delivery of Enbrel in Phase 1b in refractory rheumatoid arthritis patients.
Non-Opioid Pain Management Product Portfolio Highlights:

ZTlido: Commercial with strong sales growth and expanded coverage for up to 65% of lives nationally.
SP-102: Phase 3/pivotal trial (US) completed full enrollment.
Resiniferatoxin (RTX): In Phase 2 for Osteoarthritis pain management.
RTX: In Phase 2 trial for intractable cancer pain (pending FDA clearance).
An updated corporate presentation will also be available at www.sorrentotherapeutics.com

On September 13, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that it has successfully completed the placement of the subordinated non-interest-bearing mandatory convertible bond, which the Company’s Executive Board had resolved to issue with the approval of the Supervisory Board (Press release, Epigenomics, SEP 13, 2021, View Source [SID1234587593]). The maximum volume of the mandatory convertible bond was placed in the aggregate principal amount of EUR 16,500,000.00. The mandatory convertible bond consists of 165,000 notes, which – subject to adjustments of the conversion price due to anti-dilution clauses – are convertible into 15,000,000 registered no-par value shares of the Company. Further details of the transaction were announced in the corporate news dated August 24, 2021. The gross proceeds from the issuance of the mandatory convertible bond amount to EUR 16,500,000.00.

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As announced in the ad-hoc announcements of June 11, 2021, and August 20, 2021, the issuance of the mandatory convertible bond was secured by a back-stop agreement with Deutsche Balaton Aktiengesellschaft. In connection with this back-stop agreement, Deutsche Balaton has subscribed for notes in the aggregate principal amount of EUR 2,717,800.00.

Epigenomics AG plans to use the proceeds from the issuance of the mandatory convertible bond to finance its operations, in particular the further development of the blood-based colorectal cancer screening test Epi proColon Next-Gen. For this purpose, the Company plans to conduct a clinical study in the U.S.A., which is required to obtain approval for the test by the U.S. Food and Drug Administration (FDA).

The full terms and conditions of the mandatory convertible bond are available on Epigenomics AG’s website at View Source

On September 13, 2021, Bellicum Pharmaceuticals, Inc. presented the corporate presentation (Presentation, Bellicum Pharmaceuticals, SEP 13, 2021, View Source [SID1234587592]).

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On September 13, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported a late-breaking presentation of early poziotinib efficacy and safety data in first-line patients with non-small cell lung cancer (NSCLC) with HER2 exon 20 mutations from cohort 4 of the ZENITH20 clinical trial at the upcoming European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper) 2021 that will take place virtually September 16-20, 2021 (Press release, Spectrum Pharmaceuticals, SEP 13, 2021, View Source [SID1234587589]).

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Details of the ESMO (Free ESMO Whitepaper) presentation are as follows:

Title: Efficacy and safety of poziotinib in treatment-naïve NSCLC harboring HER2 exon 20 mutations: A multinational Phase 2 study (ZENITH20-4)
Speaker: Robin Cornelissen, MD, PhD, Erasmus MC Cancer Institute, Department of Pulmonology, Rotterdam, The Netherlands
Session: Proffered Paper session – NSCLC, metastatic 1
Location: Channel 1
Date and Time: September 18, 2021 from 2:20-2:30 p.m. CEST
Presentation Number: LBA46
Abstract Number: 2581

The presentation will be available for viewing by registered participants during the conference via the ESMO (Free ESMO Whitepaper) website on September 18, 2021.

About the ZENITH20 Clinical Trial

The ZENITH20 study consists of seven cohorts of NSCLC patients. Cohorts 1 (EGFR) and 2 (HER2) in previously treated NSCLS patients with exon 20 mutations and Cohort 3 (EGFR) in first-line patients have completed enrollment. Cohort 4 (HER2) in first-line NSCLC patients with exon 20 mutations is still enrolling patients. Cohorts 1- 4 are each independently powered for a pre-specified statistical hypothesis and the primary endpoint is objective response rate (ORR). Cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Cohort 6 includes NSCLC patients with classical EGFR mutations who progressed while on treatment with first-line osimertinib and developed an additional EGFR mutation. Cohort 7 includes NSCLC patients with a variety of less common mutations in EGFR or HER2 exons 18-21 or the extracellular or transmembrane domains.

On September 13, 2021 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported the Company will be presenting initial data from the first-line cohort of the DisTinGuish study, a Phase 2a clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.’s anti-PD-1 antibody, and chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ), at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held virtually on September 16-21, 2021 (Press release, Leap Therapeutics, SEP 13, 2021, View Source [SID1234587588]). The Company will host a conference call on Friday, September 17, 2021 to discuss preliminary results from the study.

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"Initial data from the DisTinGuish study is extremely promising as it shows DKN-01 in combination with tislelizumab and chemotherapy to have high response rates in first-line patients suffering from gastric and gastroesophageal junction cancer," said Cynthia Sirard, MD, Chief Medical Officer of Leap. "Patients whose tumors have high levels of DKK1 expression, which is known to correlate with aggressive disease and poor prognosis, showed the highest response rates, suggesting how important the biomarker may be in predicting response to therapy. Additional data will be presented at ESMO (Free ESMO Whitepaper) and in our conference call to demonstrate the potential DKN-01 has as part of first-line therapy in this difficult-to-treat indication."

About the DisTinGuish Study

The DisTinGuish study (NCT04363801) is a Phase 2a study of DKN-01 in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy as first-line or second-line therapy in patients with inoperable, locally advanced, G/GEJ adenocarcinoma. The study is being conducted in two parts, in the United States and the Republic of Korea. Enrollment of Part A has been completed with 25 first-line HER2- G/GEJ cancer patients whose tumors express either high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low). Part B of the study will enroll up to 48 patients with second-line, DKK1-high G/GEJ cancer. Leap is conducting this combination study as part of an exclusive option and license agreement with BeiGene for the development of DKN-01 in Asia (excluding Japan), Australia, and New Zealand.

Key Findings

DKN-01 in combination with tislelizumab and chemotherapy demonstrated compelling overall response rates (ORR) as a first-line treatment for advanced G/GEJ cancer
In the primary efficacy analysis, including all patients who received a full cycle of DKN-01 therapy, the ORR was 68.2%, with 90% ORR in DKK1-high patients as compared to a 56% ORR in DKK1-low patients
In the overall intent to treat population, including those patients who did not receive a full cycle of therapy, the ORR was 60%, with 75% ORR in DKK1-high patients as compared to a 56% ORR in DKK1-low patients
As of the date of the abstract, 13 patients had experienced a partial response (PR), six patients had a best response of stable disease (SD), one patient was non-evaluable for response (NE), three patients were unable to complete a full cycle of therapy (non-modified ITT (mITT)), and two patients were pending their first tumor assessment. Of the 18 patients that had RNAscope DKK1 expression available for the abstract, 9 were DKK1-high [6 PR, 1 NE, and 2 non-mITT] and 9 were DKK1-low [5 PR, 4 SD]. Subsequent to the date of the abstract, the two patients who were pending their first scan for response to therapy were determined to have had PRs, and three additional patients were determined to have had DKK1-high tumors, each of whom experienced a PR.

Further results will be presented at the ESMO (Free ESMO Whitepaper) 2021 Congress from September 16 to 21, 2021.

Leap Presentation Details:

Title: DKN-01 in combination with tislelizumab and chemotherapy as a first-line therapy in unselected patients with advanced gastroesophageal adenocarcinoma (GEA): DisTinGuish Trial
Abstract Number: 2218
Session type: E-Poster Presentation
Presenter: Samuel J. Klempner, Harvard Medical School
Date and time: Thursday, September 16, 2021; 2:30 a.m. ET

Conference Call

Leap will host a conference call on Friday, September 17, 2021 at 8:00 a.m. Eastern Time to further discuss the data. In addition to Leap’s executive management team, Dr Jaffer Ajani of M.D. Anderson Cancer Center and Dr. Samuel Klempner of Massachusetts General Hospital will be on the call. The call can be accessed by dialing (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international). The passcode for the conference call is 1729397. The presentation will be webcast live and may be accessed on the Investors page of the Company’s website at View Source, where a replay of the event will also be available for a limited time.