On February 22, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported the promotion of John Goldberg, M.D. to Chief Medical Officer (Press release, Oncorus, FEB 22, 2022, View Source [SID1234608807]). Dr. Goldberg joined Oncorus in October 2018 as Senior Vice President of Clinical Development with responsibilities including oversight of all clinical studies, drug development and regulatory strategies.

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"We are delighted to announce John’s promotion to Chief Medical Officer as he has been an integral part of our company’s progress thus far. His first-hand experience as a practicing oncologist with over 15 years of experience enrolling patients into clinical trials, coupled with expertise across a range of immunotherapies, have been crucial to our pipeline progress and we are incredibly pleased to have his continued guidance in this new role," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We look forward to John’s leadership as we continue to advance our viral immunotherapy candidate, ONCR-177, through the clinic with additional data from multiple cohorts expected later this year, in addition to progressing our ONCR-GBM program and selectively self-amplifying viral RNA (vRNA) product candidates ONCR-021 and ONCR-788."

"It’s an honor to take on the role of Chief Medical Officer at Oncorus, and I’m incredibly excited and motivated by the unique opportunity that Oncorus has to make a meaningful difference in cancer patients’ lives via its dual platform approach to unleashing the full potential of viral immunotherapies," said Dr. Goldberg. "Both the HSV and selectively self-amplifying vRNA platforms create a uniquely diverse pipeline rooted in compelling science and promising future growth. I believe that Oncorus has the potential to meaningfully impact the current standard of care in oncology, and, in partnership with the rest of the executive team, I look forward to advancing this innovative technology."

Dr. Goldberg has served as Senior Vice President of Clinical Development since he joined Oncorus in 2018. Prior to joining Oncorus, Dr. Goldberg served as Senior Medical Director of H3 Biomedicine, a developer of genomics-based cancer therapies. While at H3 Biomedicine, he supervised the clinical development of H3B-8800, the first-in-human spliceosome modulator. Previously, Dr. Goldberg held clinical roles in cancer drug development, leading the pediatric oncology Phase 1 program at the University of Miami and working as Medical Director for Agenus. His immunotherapy experience includes first-in-human neo-antigen vaccines, dendritic cell vaccine and GVAX trials, as well as check point inhibitors and costimulatory agonists. Dr. Goldberg is also a pediatric oncologist with 15 years of experience treating children with cancer and enrolling patients in clinical trials. He received his pediatric hematology oncology training from the Dana-Farber Cancer Institute and Children’s Hospital Boston and his general pediatrics training from the University of Rochester. Dr. Goldberg holds an M.D. from the University of Massachusetts Medical School and a A.B. in Biological Sciences from the University of Chicago. In addition to his current role at Oncorus, Dr. Goldberg is a Medical Advisory Board Member for the Sarcoma Foundation of America and a member of the Advisory Group at MassBio.

On February 22, 2022 Cumulus Oncology, Europe’s first oncology biotech creation company, reported that it has secured a £4.1 million ($5.6 million) investment led by St Andrews-based investment firm Eos Advisory (Press release, Cumulus Oncology, FEB 22, 2022, View Source [SID1234608825]). Scottish Enterprise invested alongside Eos as Cumulus plans further scale, while an additional £1.5 million ($2 million) will follow in the coming months.

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Cumulus was founded in 2017 to identify novel oncology assets to de-risk and add value to, before creating spin-out companies to commercialise novel cancer therapies. After founding Nodus Oncology in April 2020 to conduct research into DNA damage response (DDR), Cumulus formed Modulus Oncology in September 2020 alongside the University of Sheffield.

CEO and co-founder Clare Wareing said: "With the support of our cornerstone investors, we will accelerate our business model to identify and develop new oncology treatments that target the unmet medical needs of specific cancer patient populations."

Andrew McNeill, Managing Partner, Eos Advisory, said: "Clare and her team have made tremendous progress over the last few years, are at the forefront of their field in the European context, and we are pleased to continue our support of the business as Cumulus enters its next phase of growth."

Kerry Sharp, Director of Growth Investments at Scottish Enterprise, said: "It’s fantastic to see the progress Cumulus Oncology is making in the field of cancer therapies. With Scottish Enterprise investment, which focuses on early stage high growth potential companies, this company can continue to develop its ambitious plans."

Cumulus is also announcing that Dr Russell Greig will be joining the board as Chairman. Greig, a GlobalScot, spent much of his career working on both the drug development and investment sides of the business at GlaxoSmithKline, where he held a number of positions including President, International Pharmaceuticals, and Senior Vice President, Worldwide Business Development. More recently, he has held board roles for a series of biotechs and has advised life science VCs and biotechnology companies in the USA, Europe, and Asia via his Philadelphia-based Greig Biotechnology Global Consulting business.

Dr Russell Greig, Chairman, Cumulus Oncology, said: "Cumulus has established a unique position in Europe, and is set to make an impact further afield in other regions including North America. I look forward to helping to guide Clare and her expert team around strategic focus over the months and years ahead."

On February 22, 2022 GT Medical Technologies Inc., reported that creators of GammaTile Therapy, a Surgically Targeted Radiation Treatment for operable brain tumors, reported its 2021 roster of ELITE Distinguished Brain Tumor Specialists that have completed 10 or more GammaTile Therapy procedures in 2021 (Press release, GT Medical Technologies, FEB 22, 2022, View Source [SID1234608841]). This year’s introduction into the ELITE program includes Piedmont Atlanta Hospital, Vidant Medical Center, Emory Healthcare, and The University of Kansas Health System. These hospitals join the existing ELITE Distinguished Brain Tumor specialists awarded in 2020, including Memorial Sloan Kettering Cancer Center, M Health Fairview, HonorHealth Scottsdale Osborn Medical Center, NorthShore University HealthSystem, and Mayfield Brain & Spine.

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GammaTile ELITE institutions share GT Medical Technologies’ purpose of improving the lives of patients with brain tumors. These medical centers are each committed to excellence by putting quality of life for their patients first and embracing evidence-based innovation.

"GammaTile represents a major upgrade compared to standard radiotherapy options," said Roukoz Chamoun, MD, Neurosurgeon and Associate Professor, Department of Neurosurgery, The University of Kansas Health System in Kansas City, KS. "With GammaTile, radiation is delivered precisely where it is needed resulting in increased efficacy and minimal potential for side effects. In addition, because it is placed during surgery immediately after tumor resection, it eliminates unnecessary and potentially dangerous delay in radiation therapy."

"GammaTile allows us to treat previously untreatable patients and has allowed selected patients to achieve astonishing survival durations. At Piedmont we love having this tool in our toolbox," said Adam Nowlan, MD, MPH, Medical Director, Radiation Oncology, Piedmont Atlanta Hospital in Georgia.

GammaTile Therapy features a bioresorbable, conformable, 3D-collagen tile that is implanted in the last five minutes of brain tumor removal surgery. The sustained, controlled, and therapeutic dose of radiation immediately begins targeting tumor cells, sparing healthy tissue. Patients receive their radiation treatment while going about their daily life, without the necessity of daily trips to a medical center for external radiation. Over time, the tile naturally resorbs into the adjacent tissue with no need for additional surgery to remove it. GammaTile Therapy is shown to improve local tumor control, which can extend a patient’s life. GammaTile was FDA-cleared in 2018 for recurrent brain tumors, including recurrent high-grade gliomas, glioblastomas, meningiomas, and brain metastases. In 2020, the FDA expanded that indication to include newly diagnosed malignant brain tumors.

"We are pleased to see this technology become available to patients with brain tumors across the United States, with over 60 leading institutions now offering GammaTile," said Matthew Likens, President & CEO of GT Medical Technologies. "We take great pleasure in welcoming these prestigious institutions into the GammaTile ELITE program and commend them on their commitment to innovation and quality patient care."

GT Medical Technologies was founded by five Arizona brain tumor specialists in 2017 to overcome the limitations of the current standard of care for patients with brain tumors. The treatment has since helped hundreds of patients receive life-altering cancer treatment in top brain tumor centers across the U.S. Healthcare providers can learn more by visiting View Source

On February 22, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported that it has entered into a securities purchase agreement with an institutional investor, providing for the purchase and sale of 1,496,400 shares of common stock (or common stock equivalents) at a price of $2.80 per share, in a registered direct offering, resulting in total gross proceeds of approximately $4.2 million, before deducting the placement agent’s fees and other estimated offering expenses (Press release, Applied DNA Sciences, FEB 22, 2022, View Source [SID1234608792]). The Company has also agreed to issue to the investor unregistered warrants to purchase up to an aggregate of 1,496,400 shares of common stock in a concurrent private placement. The warrants will have an exercise price of $2.84 per share, be exercisable six months from the date of issuance and will expire five years from the initial exercise date.

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The offering is expected to close on or about February 24, 2022, subject to the satisfaction of customary closing conditions.

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital, and to advance the adoption of its LinearDNA manufacturing platform.

Roth Capital Partners served as sole placement agent for the transaction.

The shares of common stock (or common stock equivalents) described above (but not the warrants or the shares of common stock underlying the warrants) are being made pursuant to a shelf registration statement on Form S-3 (File No. 333-238557) (including a prospectus) previously filed with the Securities and Exchange Commission (the "SEC") on May 21, 2020, and declared effective by the SEC on June 1, 2020. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

On February 22, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with cancer, reported it has entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals, Inc. ("CPP"), a private clinical stage company developing therapeutics to reduce the risk and recurrence of cancer and rare diseases, for a combination of stock and future milestone payments (Press release, Panbela Therapeutics, FEB 22, 2022, View Source;utm_medium=rss&utm_campaign=panbela-therapeutics-inc-to-acquire-cancer-prevention-pharmaceuticals-inc [SID1234608808]).

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Strategic Rationale and Benefits of the Transaction

The combined entity will have an expanded pipeline addressing an estimated aggregate $5 billion market opportunity for the areas of initial focus: familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs boast a steady cadence of catalysts with programs ranging from pre-clinical to registration studies, including CPP’s lead asset with a fully funded registration trial scheduled to begin this year. In addition, the transaction facilitates operational and commercial synergies, under the leadership of a highly experienced management team with a proven history of drug discovery, development, and commercialization expertise. "This transaction is an important step towards our goal of creating a diversified pipeline with an ability to hit multiple targets and thereby expanding the potential of the combined company," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "The combined platforms will be better positioned to treat more patients. This transaction is a tremendous strategic fit and we feel creates robust stockholder value."

CPP co-founder and CEO, Jeff Jacob, stated, "I strongly believe Panbela is the right choice to carry our efforts forward and continue the outstanding work our team has done to build our clinical stage orphan and oncology pipeline into what it is today and to continue the development of Flynpovi, our lead asset. Flynpovi, a combination of CPP-1X (eflornithine) and sulindac has a dual mechanism both inhibiting polyamine synthesis and increased polyamine export and catabolism. By leveraging the established infrastructure of Panbela, we expect to continue to expand our pipeline. After a full assessment of strategic alternatives, our Board of Directors believes the transactions signifies the best value opportunity for CPP stakeholders."

CPP is developing therapeutics designed to reduce the risk of cancer and other diseases. In addition to the fully funded FAP registration trial scheduled to begin by year-end, a phase 3 trial in colon cancer survivors is currently underway and is sponsored by the Southwest Oncology Group (SWOG). Additionally, clinical trials in neuroblastoma, gastric cancer, and early-onset type-1 diabetes are underway in collaboration with various nonprofit groups.

Transaction Details

Under the terms of the agreement and plan of merger, the holders of CPP’s outstanding capital stock immediately prior to the merger will receive shares of common stock of Panbela upon closing of the mergers. On a pro forma and fully diluted basis, holders of Panbela common stock are expected to own approximately 59% of the post-merger holding company and holders of CPP securities, including converted indebtedness, are expected to beneficially own approximately 41% of post-merger holding company. CPP stockholders will be eligible to receive contingent payments totaling a maximum of $60 million from milestone and royalty payments associated with the potential approval and commercialization of the lead asset.

The proposed mergers have been unanimously approved by the boards of directors of each company and the stockholders of CPP. A closing is expected to occur by the second quarter of 2022, subject to approval of the issuance of securities in the transactions by Panbela’s stockholders, and satisfaction of other customary closing conditions.

Additional Information

The combined company will be led by Jennifer Simpson, Chief Executive Officer of Panbela and will remain headquartered in Waconia, Minnesota. The board of the combined company is expected to optimize the value of this transaction and beyond and will include at least two members initially designated by CPP, CPP Chief Executive Officer, Jeff Jacob, and CPP Director, Dan Donovan.

Canaccord Genuity LLC is acting as the exclusive financial advisor to Panbela, and Faegre Drinker Biddle & Reath LLP is acting as its legal counsel. The Sage Group is acting as the exclusive financial advisor to CPP, and Blank Rome LLP is acting as its legal counsel.

About: 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 12.0 months which is not yet 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 .