On August 4, 2022 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision oncology products for patients with genomically defined cancers, reported financial results for the quarter ended June 30, 2022, and highlighted recent progress (Press release, Elevation Oncology, AUG 4, 2022, https://elevationoncology.com/elevation-oncology-reports-second-quarter-2022-financial-results-and-highlights-recent-company-progress/?utm_source=rss&utm_medium=rss&utm_campaign=elevation-oncology-reports-second-quarter-2022-financial-results-and-highlights-recent-company-progress [SID1234617522]).

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!

"Presenting the first-ever Phase 2 CRESTONE data for seribantumab at ASCO (Free ASCO Whitepaper) 2022, including two complete responses and two partial responses in patients whose tumors harbor NRG1 fusions, was a significant milestone for Elevation. We also completed the enrollment of the first 20 patients into Cohort 1 of CRESTONE, another milestone, and now look forward to reporting additional interim data from the ongoing study in the first half of next year," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "Additionally, we are excited to announce the licensing of EO-3021, a differentiated antibody-drug conjugate targeting Claudin18.2 which is highly expressed especially in several types of cancers including gastrointestinal tumors. Our expanded pipeline now includes two clinical candidates for patients with solid tumors and speaks to the successful execution of our business development strategy to build an industry leading precision oncology company."

Recent Progress and Highlights

Seribatumab

Initial Phase 2 CRESTONE data presented in oral presentation at ASCO (Free ASCO Whitepaper) 2022. As of the April 18, 2022 cut-off date, findings presented at ASCO (Free ASCO Whitepaper) 2022 represent positive clinical proof-of-concept data supporting the potential of seribantumab to induce deep and durable benefit for patients with tumors harboring NRG1 fusions.
From 12 evaluable patients (per RECIST v1.1) in Cohort 1 with a median of one line of prior systemic therapy, the investigator-assessed objective response rate (INV-ORR) was 33% across all tumor types, including two complete responses (CRs; 17%) and two partial responses (PRs; 17%) In patients with non-small cell lung cancer (n=11), the INV-ORR was 36%.
Durations of response range from 1.4 – 11.5 months.
Seribantumab demonstrated a favorable and tolerable safety profile across the 35 patients with eight different tumor types evaluable for safety from Cohorts 1, 2, and 3 along with those from the safety run-in portion of the study. The majority (80%) of adverse events (AEs) were mild or moderate (Grade 1 or 2) in severity, with two Grade 3 treatment-related adverse events (TRAEs) and no Grade 4 or 5 TRAEs. No patients discontinued seribantumab due to AEs.
Seribantumab received Fast Track designation. In May 2022, Elevation Oncology announced the U.S. Food and Drug Administration’s (FDA) decision to grant Fast Track designation to seribantumab for the tumor-agnostic treatment of advanced solid tumors harboring NRG1 gene fusions. A drug candidate that receives Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval, and allows for eligibility for Accelerated Approval and Priority Review if relevant criteria are met.
First 20 patients enrolled into Cohort 1 of the Phase 2 CRESTONE study. Elevation Oncology achieved its enrollment milestone for the CRESTONE study in mid-2022. Patients in Cohort 1 have advanced solid tumors harboring NRG1 fusions as determined by local testing, have had no prior pan-ERBB, HER2 or HER3 targeted therapy, and are treated with seribantumab 3g QW. The Company is on track to report additional interim data from Cohort 1 including results in the first half of 2023.
EO-3021

Expanded pipeline through licensing of EO-3021. In July 2022, Elevation Oncology announced an exclusive licensing agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited, to develop and commercialize EO-3021 (SYSA1801), a differentiated, clinical-stage anti-Claudin18.2 antibody-drug conjugate (ADC), in all global territories outside of Greater China. The agreement includes an upfront payment of $27 million to CSPC. CSPC will also be eligible to receive up to $148 million in potential development and regulatory milestones and up to $1.0 billion in potential commercial milestones, plus royalties on net sales. Elevation Oncology expects to initiate a Phase 1 clinical trial in the US to evaluate EO-3021 in solid tumors in 2023.
Claudin18.2 is a clinically validated oncology target expressed in several solid tumor types.
EO-3021 (SYSA1801) is an ADC that binds to Claudin18.2 and delivers a cytotoxic payload to eliminate tumor cells. ADCs are a proven therapeutic modality in the clinical setting, and the FDA has approved multiple ADCs in recent years to treat various cancers.
Corporate

Secured $50 million loan facility. In July 2022, Elevation Oncology secured a $50 million loan facility from K2 HealthVentures, a leading healthcare-focused investment firm. An initial tranche of $30 million was made available immediately, with a second tranche consisting of up to $20 million to be available in the future, subject to both parties’ mutual agreement. The initial proceeds from the facility were used primarily to fund an upfront payment of $27 million for the licensing of EO-3021 (SYSA1801) from CSPC Pharmaceutical Group.
Expected Upcoming Milestones and Operational Objectives

Additional interim seribantumab data from the Phase 2 CRESTONE study are expected in the first half of 2023
Phase 1 clinical trial in the US to evaluate EO-3021 expected to initiate in 2023
Topline data for seribantumab from the Phase 2 CRESTONE study results are expected in 2024
Ongoing target evaluation and continued execution of the Company’s strategy for future pipeline expansion
Second Quarter 2022 Financial Results

As of June 30, 2022, the Company had cash, cash equivalents and marketable securities totaling $122.5 million, compared to $132.1 million as of March 31, 2022.

Research and development expenses for the second quarter 2022 were $16.3 million, compared to $3.9 million for the second quarter 2021. The increase in R&D expense was primarily related to an increase in manufacturing, personnel costs and other expenses associated with the Phase 2 CRESTONE study.

General and administrative expenses for the second quarter 2022 were $3.8 million, compared to $1.1 million for the second quarter 2021. The increase in G&A expense was primarily related to personnel costs, professional services and other administrative costs.

Net loss for the second quarter 2022 was $19.9 million, compared to $5.1 million for the second quarter 2021.

Financial Outlook

Elevation Oncology expects its cash, cash equivalents and marketable securities as of June 30, 2022, and following the licensing of EO-3021 and the initial tranche of the loan facility, to fund current operations, including the continued development of seribantumab and EO-3021, into 2024.

On August 4, 2022 Sanofi and Innovent Biologics (HKEX: 1801.HK, "Innovent") reported a collaboration to bring innovative medicines to patients in China with difficult-to-treat cancers. Innovent is a leading biopharmaceutical company with strong clinical development capabilities and a broad commercial footprint in China (Press release, Sanofi, AUG 4, 2022, View Source [SID1234617521]). Both companies are committed to accelerating the development and commercialization of two Sanofi key clinical stage oncology assets: Phase III SAR408701 (tusamitamab ravtansine; anti-CEACAM5 antibody-drug conjugate) and Phase II SAR444245 (non-alpha IL-2), combining with sintilimab, the leading checkpoint inhibitor in China.

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!

In addition to the collaboration and license agreement, Sanofi will invest €300 million in Innovent through subscription of new common shares.

John Reed, M.D., Ph.D.
Global Head of Research and Development at Sanofi

"This strategic collaboration with Innovent will not only accelerate the development, market access and future commercialization of two of our key oncology medicines in selected combinations with sintilimab, but also bolster our overall presence in oncology in China. We look forward to a successful partnership with Innovent, one of the most innovative companies in China, and to leveraging their development capabilities and market leadership in the country."

Michael Yu, Ph.D.
Founder, Chairman and CEO of Innovent

"This strategic collaboration with Sanofi, a leading global pharmaceutical company, opens the pathway to great synergy for accelerating the pace of innovation. This pioneering partnership will leverage the synergy between Sanofi and Innovent’s pipeline and R&D resources with the mutual aim to address major unmet medical needs for cancer patients. We hope this agreement will be a great start of the two parties’ long-term partnership, and we look forward to bringing more innovative therapies to patients."

Clinical development and commercialization of tusamitamab ravtansine

SAR408701 (tusamitamab ravtansine) is a potential first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. SAR408701 is currently in a Phase 3 study for 2L NSCLC globally including China, and global Phase 2 studies in additional indications including 1L NSCLC, gastric cancers and other solid tumors.

According to the agreement, Innovent will be responsible for developing and exclusively commercializing tusamitamab in multiple oncology-based indications in China. Sanofi will be entitled to receive up to €80 million development milestone payment and royalties on the net sales of the product in China upon approval.

Clinical development and commercialization of SAR444245

SAR444245 is a potential first-in-class reprogrammed, site-directed, single PEGylated, recombinant human IL-2 (rIL-2) variant with extended half-life that specifically binds to the low-affinity IL-2 receptor but lacks binding affinity for the αlpha chain of the high-affinity IL-2 receptor. SAR444245(IL-2) is currently under global Phase 2 studies for skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma.

Innovent and Sanofi will jointly explore the development of SAR444245 in China in various cancer types, where Innovent will lead the clinical development. Sanofi remains the sole Marketing Authorization holder for both assets and will be fully responsible for SAR245 commercialization. Innovent will be entitled to receive up to €60 million development milestone payments and royalties on the net sales of the product in China upon approval.

Sanofi’s initial strategic equity investment in Innovent for €300 million

In addition to the strategic multi-product collaboration and license agreement, Sanofi, subject to conditions precedent including regulatory approval and customary closing conditions, will invest in new common shares issued by Innovent for €300 million, at a price of HK $42.42 per share, representing a 20% premium to the Innovent 30-trading-day average share price as of August 3, 2022, one day prior to the signing of the agreements.

Subject to mutual agreement of both parties in the future, Sanofi will have the right to acquire additional Innovent new common shares for €300 million, at a subscription price that represents 20% premium to Innovent 30-trading-day average share price as the date of the separate agreement that may be entered into by both parties.

About SAR408701

SAR408701 (tusamitamab ravtansine) is a potential first-in-class antibody-drug conjugate (ADC) targeting CEACAM5 (carcinoembryonic antigen-related cell adhesion molecule 5), a cell-surface glycoprotein that is highly expressed in non-small cell lung cancer (NSCLC), gastric cancer and other cancers. Tusamitamab ravtansine is currently in a Phase 3 study for second-line NSCLC globally including China, and global Phase 2 studies in additional indications including first-line NSCLC, gastric cancers and other solid tumors.

About SAR444245
SAR444245 is a potential first-in-class recombinant human IL-2 (rIL-2) variant that includes a site-directed single PEG moiety/chain that prevents it from binding to the α chain of the IL-2 receptor while retaining near-native affinity for the beta/gamma subunits.

SAR444245 is currently being investigated in global Phase 2 studies for the treatment of skin cancers, gastrointestinal cancer, NSCLC / mesothelioma, head and neck tumors, and lymphoma.

About Sintilimab (TYVYT)
Sintilimab, marketed as TYVYT (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. In China, sintilimab has been approved for six indications including relapsed or refractory classic Hodgkin’s lymphoma, first-line treatment of non-squamous NSCLC, first-line treatment of squamous NSCLC, first-line treatment of hepatocellular carcinoma, first-line treatment of esophageal squamous cell carcinoma, and first-line treatment of gastric or gastroesophageal junction adenocarcinoma, of which the first four indications have been included in the National Reimbursement Drug List (NRDL).

Note:
SAR408701 and SAR444245 are not approved products in China

On August 4, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) and MiroBio, a privately-held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, reported that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in cash, subject to customary adjustments (Press release, Gilead Sciences, AUG 4, 2022, View Source [SID1234617520]).

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 will provide Gilead with MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator (BTLA) and has entered Phase 1 clinical trials, with the first patient dosed earlier this week. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.

MiroBio’s I-ReSToRE platform (REceptor Selection and Targeting to Reinstate immune Equilibrium) has the potential to be used to develop best-in-class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases. The I-ReSToRE platform supports identification and development of therapeutics that utilize inhibitory signaling networks with the goal of restoring immune homeostasis for patients. Gilead anticipates advancing additional agonists derived from MiroBio’s I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programs, over the next several years.

"The team at MiroBio has spearheaded foundational research for agonist antibodies following a rigorous scientific approach," said Flavius Martin, Executive Vice President, Research, Gilead Sciences. "We believe that MiroBio’s unique platform technology has the potential to produce best-in-class agonist antibodies targeting immune inhibitory receptors."

"We are excited to be joining Gilead," said Eliot Charles, Chairman of MiroBio. "MiroBio has a deep understanding of checkpoint receptor signaling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead’s drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease."

Under the terms of the agreement, Gilead will acquire all of the outstanding share capital of MiroBio for a total of $405 million in cash consideration, subject to customary adjustments, which is payable at closing. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with MiroBio to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.30-$0.35. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

Cowen is acting as financial advisor to Gilead. Centerview Partners is acting as financial advisor to MiroBio. Davis Polk & Wardwell LLP, Mayer Brown LLP, and Mishcon de Reya LLP are serving as legal counsel to Gilead, and Goodwin Procter LLP and Wilson Sonsini Goodrich & Rosati are serving as legal counsel to MiroBio.

On August 4, 2022 Applied DNA Sciences, Inc., (NASDAQ: APDN) (the "Company" or "Applied DNA"), a leader in polymerase chain reaction ("PCR")-based technologies, reported the pricing of a public offering of 3,000,000 shares of its common stock (or common stock equivalents in lieu thereof), together with Series A warrants to purchase up to 3,000,000 shares of its common stock and Series B warrants to purchase up to 3,000,000 shares of its common stock at a combined offering price to the public of $4.00 per share (or common stock equivalent) and associated warrants, priced at a premium to market under Nasdaq rules (Press release, Applied DNA Sciences, AUG 4, 2022, View Source [SID1234617519]). The Series A warrants will have an exercise price of $4.00 per share, are exercisable immediately upon issuance, and will expire five years following the date of issuance. The Series B warrants will have an exercise price of $4.00 per share, are exercisable immediately upon issuance, and will expire thirteen months following the date of issuance. The closing of the offering is expected to occur on or about August 8, 2022, subject to the 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 exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be $12 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering for further development of the Company’s Therapeutic DNA Production and MDx Testing Services, as well as general corporate purposes, which may include research and development expenses, capital expenditures, working capital and general and administrative expenses, and potential acquisitions of or investments in businesses, products and technologies that complement our business, although the Company has no present commitments or agreements to make any such acquisitions or investments

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-266223) previously filed with the Securities and Exchange Commission (SEC) which became effective on August 4, 2022 and an additional registration statement filed pursuant to Rule 462(b) which became automatically effective on August 4, 2022. The offering is being made only by means of a prospectus, which is part of the effective registration statements. When available, electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

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

On August 4, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported it has received approval from the Australian Human Research Ethics Committee (HREC) to expand the company’s global clinical trial to Australia, to study SBP-101 in combination with Gemcitabine and Nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma, which is referred to as the ASPIRE trial (Press release, Panbela Therapeutics, AUG 4, 2022, View Source [SID1234617518]). The ASPIRE trial is designed as a randomized double-blind placebo-controlled trial, with a primary endpoint of overall survival.

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!

Australia marks the second country activated, with approximately 90 additional sites expected to be activated across 10 countries by early 2023. Panbela has commenced screening for eligible patients, with enrollment to the interim analysis expected to complete in early 2024.

About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.

SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months which is final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increase polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment is well tolerated and has potential activity.