On March 27, 2023 On Target Laboratories, Inc., a privately held biotechnology company developing intraoperative molecular imaging (IMI) agents to target and illuminate cancer during surgery, reported publication of results from the ELUCIDATE Phase 3 Trial of CYTALUX (pafolacianine) injection for use of IMI for cancer in the lung (Press release, On Target Laboratories, MAR 27, 2023, View Source [SID1234629394]). The results were published in the peer-reviewed Journal of Thoracic and Cardiovascular Surgery. In December 2022, the U.S. Food and Drug Administration expanded the indication of CYTALUX after previously granting approval for ovarian cancer in 2021, making it the first and only targeted molecular imaging agent that intraoperatively illuminates lung and ovarian cancers in real-time during surgery.

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In the ELUCIDATE trial (n=112), patients with suspected or biopsy-confirmed cancer in the lung scheduled for lung resection were administered CYTALUX intravenously within 24 hours before surgery. The research article reports that, in patients randomized to receive IMI with CYTALUX, a clinically significant event (CSE) occurred in 53% of patients (N=53 out of 100, p < 0.0001).* CSEs included locating the primary lesion that the surgeon could not otherwise locate with conventional techniques in 19% of patients, discovery of one or more additional cancerous lesions which was previously unknown in 8% of patients, and identification of a close resection margin (10mm) in 38% of patients. Among additional cancerous lesions discovered with CYTALUX, 73% were outside the planned resection field. Overall, surgeons reported changing the scope of their surgical plan in 29% patients (22 increase, 7 decrease). No drug-related serious adverse events occurred.

"Identification of lesions during surgery can be challenging, especially if the lesions are small or deep below the surface of the lung," said Inderpal Sarkaria, MD, Thoracic Surgeon at the University of Pittsburgh Medical Center and lead author on the publication. "Our research confirmed that CYTALUX helps surgeons more easily visualize lesions and detect additional cancer at one of the most critical moments – during their operation."

"We’re thrilled that this trial contributed to CYTALUX being available as a first-in-class agent to aid thoracic surgeons in visualizing otherwise undetectable cancerous lesions in the lung," said Chris Barys, President, Chief Executive Officer and Board Member of On Target Laboratories. "We believe that the adjunctive use of CYTALUX during lung cancer surgery will add significant value to surgeons, helping them make decisions in real-time that potentially lead to removing more cancer from their patient and improving outcomes."

* N=53 out of 100 patients with cancer in the lung. CYTALUX USPI describes a clinically significant event rate of 24% (N=24 out of 100) based on localization of the primary lesion (N=19 out of 100, 19%) and identification of a synchronous cancerous lesions (N=8 out of 100, 8%).

About the ELUCIDATE Trial

The ELUCIDATE (Enabling LUng Cancer IDentification Using FolATE Receptor Targeting) trial was a Phase 3, multi-center, single dose, open label trial and included 12 sites across the United States. The clinical trial (NCT04241315) investigated the use of CYTALUX (pafolacianine) injection in patients scheduled to undergo thoracic surgery for confirmed or suspected lung cancer.

About Intraoperative Molecular Imaging

To date, there have been limited ways for surgeons to confidently assess the location and full extent of cancerous tissue while operating. Intraoperative Molecular Imaging (IMI) is an emerging category of technology for surgical oncology in which targeted imaging agents are injected into patients to highlight cancer cells making them visible during surgery.

On March 27, 2023 Merck reported that it has strengthened its Oncology franchise by regaining exclusive worldwide rights to develop, manufacture, and commercialize anti-programmed death ligand-1 (PD-L1) antibody BAVENCIO (avelumab) following the termination of their Alliance agreement with Pfizer (Press release, Merck & Co, MAR 27, 2023, View Source [SID1234629392]).

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"On behalf of Merck, I’d like to thank Pfizer for their partnership and collaboration over the last nine years, and for the role they have played in the success of BAVENCIO," said Belén Garijo, Chair of the Executive Board and CEO of Merck. "Our joint efforts have delivered meaningful therapeutic value to patients around the world who are living with cancer. This has been an incredible journey for us, and thanks to Pfizer’s partnership we are now very well positioned to continue to deliver this therapy to patients in need."

"Our alliance with Merck allowed us to combine our complementary strengths to develop and launch BAVENCIO to help meet the needs of people with cancer globally," said Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer. "We are proud of our achievements together, including introducing BAVENCIO as an important treatment option for patients with metastatic Merkel cell carcinoma, locally advanced or metastatic urothelial carcinoma, and in combination with INLYTA for advanced renal cell carcinoma. We thank our colleagues at Merck for a tremendous partnership and wish them well in their future plans for BAVENCIO."

Reflecting a long-held interest of Merck, effective June 30, 2023, Merck, through its affiliate Ares Trading S.A., will take full control of the global commercialization of BAVENCIO. The current profit share will be replaced by a 15% royalty to Pfizer on net sales of BAVENCIO. Merck and Pfizer will continue to operationalize their respective ongoing clinical trials for BAVENCIO, and Merck will control all future research and development activities. As it is currently, product manufacturing and supply chain will remain solely with Merck, ensuring continuous and reliable access to BAVENCIO for patients.

"This is an excellent example of our focused leadership strategy in action, as we are now fully accountable to reinforce BAVENCIO’s position as a standard of care in advanced urothelial carcinoma for the benefit of patients in need, and as an important therapeutic option for appropriate patients with renal cell carcinoma and Merkel cell carcinoma," says Peter Guenter, Chief Executive Officer Healthcare at Merck. "With our late-stage pipeline, our broader Oncology portfolio, and now with full ownership of BAVENCIO, we look forward to demonstrating the strength of our Oncology Franchise as we amplify our efforts to deliver important innovation to patients."

BAVENCIO was discovered in-house at Merck. The Alliance between Merck and Pfizer was executed in 2014 to co-develop and co-commercialize BAVENCIO with the goal to accelerate development of the human anti PD-L1 antibody. With this announcement, Bavencio will further contribute to Merck’s Big 3 strategy focusing on new Healthcare products, Process Solutions and Life Science Services, as well as Semiconductor Solutions.

BAVENCIO is an anti PD-L1 monoclonal antibody that is widely recognized in international guidelines as the standard-of-care for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. BAVENCIO in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). BAVENCIO is also authorized for use as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

About BAVENCIO (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.1-3 In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications

The European Commission (EC) has authorized the use of BAVENCIO as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. BAVENCIO in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). BAVENCIO is also authorized by the EC for use as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

In the US, BAVENCIO is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced RCC. Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic MCC. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients in 68 countries for at least one use.

BAVENCIO Safety Profile from the EU Summary of Product Characteristics (SmPC)

The special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions. The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity.

The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.

On March 27, 2023 Harpoon Therapeutics, Inc. (NASDAQ: HARP) (the "Company"), a clinical-stage immuno-oncology company developing novel T cell engagers, reported that it has closed a private placement of redeemable preferred stock and warrants to purchase common stock to certain institutional and other accredited investors for aggregate gross proceeds to the Company of $25 million, before deducting offering expenses, which does not include any proceeds that may be received upon exercise of the warrants (Press release, Harpoon Therapeutics, MAR 27, 2023, View Source [SID1234629391]).

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The private placement included participation from new and existing investors, including New Leaf, Arix Bioscience, Invus, OrbiMed and K2 HealthVentures.

SVB Securities provided exclusive financial advisory services to the Company.

The Company intends to use the net proceeds to complete its ongoing Phase 1 clinical studies for two TriTAC T cell engagers, including HPN217 (BCMA) being studied in a Phase 1 trial for patients with relapsed and refractory multiple myeloma, and HPN328 (DLL3), a Phase 1 / 2 study for patients with multiple neuroendocrine tumors, including small cell lung cancer and neuroendocrine prostate cancer. The proceeds will also be used for working capital and other general corporate purposes.

"In these challenging markets we are appreciative of the ongoing support from our investors, including those who have been with us for many years and have supported the discovery and development of our novel T cell engagers. This support will provide us sufficient capital, beyond our anticipated 2023 milestones, into the second half of 2024," said Julie Eastland, President and CEO of Harpoon.

Investors purchased an aggregate of (i) 25,000 shares of preferred stock at a price per share of $1,000 and (ii) warrants to purchase 7,485,762 shares of common stock with an exercise price of $0.978885 per share, which represents a 35% premium to the closing price of common stock at the time of the signing of the definitive agreements with respect to the private placement. The preferred stock issued in the private placement is not convertible into common stock and is redeemable at any time at the option of the Company and mandatorily redeemable by the Company upon the occurrence of certain events, including the receipt of proceeds in connection with certain strategic transactions, and on the third anniversary of the closing date, in each case subject to a return multiple.

Additional information regarding the private placement will be included in a Form 8-K to be filed by the Company with the Securities and Exchange Commission, and this press release is subject to the further detail provided in the Form 8-K.

The offer and sale of the foregoing securities were made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

On March 27, 2023 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, non-alcoholic steatohepatitis (NASH) and obesity today reported financial results for the fourth quarter and full year ended December 31, 2022 and corporate updates (Press release, Terns Pharmaceuticals, MAR 27, 2023, View Source [SID1234629390]).

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"As announced in our release earlier this month, 2023 promises to be another transformative year for Terns as we make meaningful strides to advance our pipeline of medicines to address serious unmet needs. In addition to data from our Phase 2a DUET trial in NASH, expected in the third quarter of 2023, we also anticipate key clinical readouts in 2024 from our clinical trials in chronic myeloid leukemia and obesity. We are fortunate to have a strong balance sheet to support development activities and the growth of our company into 2026," said Mark Vignola, chief financial officer of Terns.

"We look forward to having Emil join us as chief medical officer of Terns oncology, as his deep relationships and clinical development experience in hematologic and solid malignancies will be vital as we advance TERN-701 for CML and expand our oncology development team," said Sen Sundaram, chief executive officer at Terns. "Jay brings over a decade of experience across finance and biotech industries, and we are excited to have him lead our strategic business development efforts across both metabolic disease and oncology. Together, these new appointments further strengthen our senior leadership team, and we are well positioned to advance our pipeline towards three significant readouts in the next 18 months or so."

Key Leadership Appointments

Emil Kuriakose, MD will join Terns in May 2023 as chief medical officer of Terns oncology, bringing over a decade of clinical development expertise including early through late-stage development in several oncology indications. Prior to Terns, Dr. Kuriakose served as chief medical officer at Calithera Biosciences overseeing clinical development strategy and execution
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Jason Lettiere joined Terns in November 2022 as vice president of business development, bringing more than 13 years of experience in the finance and biotechnology industries

Fourth Quarter and Full Year Financial Results

Cash Position: As of December 31, 2022, cash, cash equivalents and marketable securities were $283.1 million as compared with $166.0 million as of December 31, 2021. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.
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Research and Development (R&D) Expenses: R&D expenses were $10.7 million and $39.6 million for the quarter and year ended December 31, 2022, respectively, as compared with $9.5 million and $31.3 million for the quarter and year ended December 31, 2021, respectively.
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General and Administrative (G&A) Expenses: G&A expenses were $6.2 million and $22.4 million for the quarter and year ended December 31, 2022, respectively, as compared with $5.4 million and $19.5 million for the quarter and year ended December 31, 2021, respectively.
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Net Loss: Net loss was $15.8 million and $60.3 million for the quarter and year ended December 31, 2022, respectively, as compared with $14.2 million and $50.2 million for the quarter and year ended December 31, 2021, respectively.
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Common Stock and Pre-Funded Warrants: As of December 31, 2022, there were 53.7 million shares of common stock and 14.6 million pre-funded warrants issued and outstanding.

On March 27, 2023 ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics, reported that David Lockhart, Ph.D., President and Chief Scientific Officer of ReCode Therapeutics, will participate in a fireside chat at 9:35 a.m. ET on Monday, April 3, 2023 at the virtual Guggenheim Healthcare Talks: Genomic Medicines and Rare Disease Days (Press release, ReCode Therapeutics, MAR 27, 2023, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-to-present-at-guggenheim-healthcare-talks-genomic-medicines-and-rare-disease-days [SID1234629389]).

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