On November 18, 2022 Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, reported the appointment of Herbert B. Slade, MD, FAAAAI as Chief Medical Officer of Palisade Bio (Press release, Seneca Biopharma, NOV 18, 2022, View Source [SID1234624398]).

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!

Dr. Slade is a proven medical and regulatory professional with over 25 years of leadership experience in the pharmaceutical and medical device industries. Over the course of his career, he has demonstrated execution of regulatory negotiations with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the design, conduct and reporting of clinical programs.

"Over the past six months Dr. Slade has provided important input and guidance in advancing the development of LB1148 as a clinical advisor to the Company. We firmly believe his appointment as Chief Medical Officer will be a natural transition, and we are very pleased to welcome him to the executive leadership team. Throughout his career, he has amassed valuable expertise across the healthcare industry and academia and has developed a deep-rooted, respected skillset in research and development that we believe will be critical as we move our development programs forward. We will continue to leverage Dr. Slade’s perspective and leadership as we work to unlock the full potential of the Company and LB1148 for all stakeholders," commented JD Finley, interim CEO of Palisade Bio.

"There remains a significant unmet need when it comes to addressing acute and chronic gastrointestinal post-surgical complications and the serious risks that come with them. I believe that the demonstrated mechanism to protect intestinal barrier health and the data seen to date well position LB1148 to become a potential standard of care, and I am dedicated to further advancing its development. With the prioritization on the prevention of adhesions program, I believe we have the potential to offer millions of patients an important therapeutic option and provide a much-needed benefit. Having closely worked with the Palisade Bio team as a clinical advisor for LB1148 over the past several months, I am excited to continue building on the progress made and look forward to bringing its development successfully across the finish line," added Dr. Slade.

Dr. Slade currently serves as the Adjunct Clinical Associate Professor, Dept. of Pediatrics, Texas College of Osteopathic Medicine, UNTHSC and as Treasurer and member of the Board of Directors of The Wound Healing Society. He joins Palisade Bio having most recently served as the President and Managing Director of Chisholm Clinical Research Services, LLC (CCRS) where he provided assistance with clinical testing and development of promising new products for 11 client companies in seven countries. Prior to CCRS, Dr. Slade served as Chief Scientific and Medical Officer, Advanced Wound Management of Smith and Nephew plc before transitioning to Sr. Vice President, Research & Development where he was responsible for restructuring three strategic business unit R&D departments and two clinical groups into a single worldwide R&D organization, adding post-marketing surveillance. Prior to that he served as Chief Medical Officer and Senior Vice President at DFB Pharmaceuticals until it was acquired by Smith & Nephew in 2012. Additional career appointments include Chief Medical Officer of 3M Pharmaceuticals where he was responsible for all Medical, Clinical Research, Biometrics, Data Management and Pharmacovigilance personnel worldwide for 12 years. Dr. Slade also was afforded the unique opportunity to work at Rhône-Poulenc Rorer (RPR) with the prestigious Dr. Jonas Salk, as the principal physician and clinical immunologist on the Salk HIV Immunogen project. During that time, he assisted Dr. Salk on a wide range of program issues including the scientific validity of a therapeutic vaccine (now termed Theracines or Pharmacines), and the importance of the Th1/Th2 concept.

Dr. Slade has authored or co-authored over 100 publications. He has held academic positions at a number of universities including University of Michigan Medical School, Cornell University Medical College, University of North Texas Health Science Center, and University of Pennsylvania Medical School. Dr. Slade received his undergraduate degree in biology from Hamilton College and his M.D. from State University of New York Upstate Medical University in Syracuse, New York. He completed post doctorate work at S.U.N.Y. Upstate Medical Center and C.S. Mott Children’s Hospital and completed his fellowship at the University of Michigan.

On November 18, 2022 Shanghai Fosun Pharma reported it has licensed US rights to a PD-1 candidate from its longstanding partner, Henlius Biotech, in an $840 million agreement (Press release, Fosun Pharma, NOV 18, 2022, View Source [SID1234624259]). Although Fosun is Henlius’s controlling shareholder, Henlius declared it was looking for a US partner as recently as three months ago. Despite their relationship, Henlius negotiated an enviable contract with Fosun, consisting of a $140 million upfront payment, a one-time $50 million regulatory milestone payment and up to $650 million in sales milestones, plus royalties. The PD-1, serplulimab, was the thirteenth PD-1/L1 inhibitor approved 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!

On November 18, 2022, 2seventy bio, Inc. (the "Company") reported that entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen") to sell shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock"), having an aggregate offering price of up to $150,000,000 (the "Placement Shares"), from time to time during the term of the Sales Agreement, through an "at the market" equity offering program under which Cowen will act as the Company’s sales agent (Filing, 8-K, 2seventy bio, NOV 18, 2022, View Source [SID1234624258]).

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!

Under the Sales Agreement, the Company will set the parameters for the sale of the Placement Shares, including the number of Placement Shares to be issued, the time period during which sales are requested to be made, any limitation on the number of Placement Shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, Cowen may sell the Placement Shares by methods deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Global Select Market ("Nasdaq"), on any other existing trading market for the Common Stock. In addition, if expressly authorized by the Company, Cowen may also sell shares in privately negotiated transactions. In conducting such sales activities, Cowen will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of Nasdaq. The Company has no obligation to make any sales of Common Stock under the Sales Agreement, and the Sales Agreement may be suspended or terminated by the Company upon prior notice to Cowen or by Cowen upon prior notice to the Company, or at any time under certain circumstances, including, but not limited to, the occurrence of a material adverse change in the Company.
The Company will pay Cowen a commission equal to up to three percent (3.0%) of the gross sales proceeds of any Placement Shares sold through Cowen under the Sales Agreement, and also has provided Cowen with customary indemnification rights.

Any sales of Placement Shares under the Sales Agreement will be made pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-268222) filed with the Securities and Exchange Commission (the "Commission") on November 7, 2022 and declared effective on November 18, 2022. The Company filed a prospectus supplement with the Commission on November 18, 2022 in connection with the offer and sale of the Placement Shares pursuant to the Sales Agreement.
The foregoing description of the material terms of the Sales Agreement is qualified in its entirety by reference to the full agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On November 18, 2022, Genprex, Inc. (the "Company") reported that entered into an Equity Distribution Agreement (the "Agreement") with JMP Securities LLC, serving as agent (the "Agent") with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.001 per share (the "Common Stock"), having an aggregate offering price of up to $50.0 million (the "Shares") through the Placement Agent (the "Offering") (Filing, 8-K, Genprex, NOV 18, 2022, View Source [SID1234624257]). Any Shares offered and sold in the Offering will be issued pursuant to the Company’s Registration Statement on Form S-3 filed with the Securities and Exchange Commission (the "SEC") on June 12, 2020, as amended on July 1, 2020, which was declared effective on July 17, 2020, the prospectus supplement relating to the Offering filed with the SEC on November 18, 2022 and any applicable additional prospectus supplements related to the Offering that form a part of the Registration Statement. A copy of the opinion of Lowenstein Sandler LLP relating to the legality of the issuance and sale of the Shares is attached as Exhibit 5.1 hereto.

The Agent may sell the Shares by any method permitted by law deemed to be an "at the market offering" as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Capital Market ("Nasdaq") or on any other existing trading market for the Common Stock. The Agent will use commercially reasonable efforts to sell the Shares from time to time consistent with its normal sales practices and applicable federal rules, regulations and Nasdaq rules, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay the Agent a commission equal to three percent (3%) of the gross sales proceeds of any Shares sold through the Agent under the Agreement, and also has provided the Agent with customary indemnification and contribution rights.

The Agent is not required to sell any specific number or dollar amount of securities, but will use commercially reasonable efforts to sell, on behalf of the Company, all of the shares of common stock requested to be sold by the Company, consistent with its normal trading and sales practices, on mutually agreed terms between the Agent and the Company. There is no arrangement for funds to be received in any escrow, trust or similar arrangement.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. A copy of the opinion of Lowenstein Sandler LLP relating to the legality of the issuance and sale of the shares in the Offering is attached as Exhibit 5.1 hereto.

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!

On November 18, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported the U.S. Food and Drug Administration (FDA) approval of a supplemental Biologics License Application (sBLA) to add a Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) (Press release, Jazz Pharmaceuticals, NOV 18, 2022, View Source [SID1234624252]). Rylaze is approved for use in the U.S. as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase.

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!

Rylaze was first approved in the U.S. in June 2021 under the FDA Real-Time Oncology Review (RTOR) program. The approval with a dosing schedule of 25 mg/m2 administered IM every 48 hours met the immediate patient need for a non-E.coli-derived asparaginase treatment option while the clinical trial was still ongoing to evaluate additional dosing and administration options.

"With the addition of a Monday/Wednesday/Friday dosing schedule for Rylaze, patients will have another dosing option, which provides sustained asparaginase activity throughout the entire course of Rylaze treatment," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "Jazz has been consistently committed to ensuring access to the reliable, high-quality supply of this important therapy so patients and healthcare providers have the opportunity to complete the full course of asparaginase therapy. As part of our efforts to improve patient and healthcare provider experience with Rylaze, we have evaluated additional dosing and administration options, and are also seeking approval for Rylaze globally."

"The expansion of the Rylaze label to include a Monday/Wednesday/Friday dosing schedule provides another option to support patients in completing their planned asparaginase treatment regimen. The benefit of completing the full course of asparaginase has been shown in various publications, and discontinuation of asparaginase has been associated with inferior disease-free survival," said Dr. Luke Maese, associate professor at the University of Utah, Primary Children’s Hospital and Huntsman Cancer Institute. "Rylaze is an effective and reliable treatment option for patients with ALL and LBL that have developed hypersensitivity to an E. coli-derived asparaginase."

The MWF dosing option was approved by the FDA under the RTOR program based on data from the intramuscular administration part of the Phase 2/3 trial (JZP458-201 or AALL1931), which was developed and conducted in close collaboration with the Children’s Oncology Group (COG) and was the basis for the initial approval of Rylaze in June 2021.

Results show that a dosing regimen of 25 mg/m2 administered intramuscularly on Monday morning and Wednesday morning, and 50 mg/m2 administered on Friday afternoon demonstrated a positive benefit-to-risk profile, with ≥90% of the patients achieving nadir serum asparaginase activity (NSAA) ≥0.1 U/mL by simulation.1

Overall, the safety profile of Rylaze was consistent with the reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy. There were no new safety signals observed in the trial.1

Rylaze was granted orphan drug designation for the treatment of ALL/LBL in June 2021 and was added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) in July 2021. Jazz also completed the submission of an sBLA to the FDA seeking approval for an intravenous route of administration for Rylaze as well as the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency for JZP458.

About Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Rylaze, also known as JZP458, is approved in the U.S. for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze has orphan drug designation for the treatment of ALL/LBL in the United States. Rylaze is a distinct recombinant Erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform for production. JZP458 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in October 2019 for the treatment of this patient population. Rylaze was approved as part of the Real-Time Oncology Review program, an initiative of the FDA’s Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.

The full U.S. Prescribing Information for Rylaze is available at: <View Source>

Important Safety Information

Rylaze should not be given to people who have had:

Serious allergic reactions to Rylaze
Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
Rylaze may cause serious side effects, including:

Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing), some of which may be life-threatening
Swelling of the pancreas (stomach pain)
Blood clots (may have a headache or pain in leg, arm, or chest)
Bleeding
Liver problems
Contact your doctor immediately if any of these side effects occur.

Some of the most common side effects with Rylaze include: liver problems, nausea, bone and muscle pain, infection, tiredness, headache, fever with low white blood cell count, fever, bleeding, mouth swelling (sometimes with sores), pain in the abdomen, decreased appetite, serious allergic reactions, a high blood sugar level, diarrhea, swelling of the pancreas and low levels of potassium in your blood.

Rylaze can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving Rylaze and for 1 week after the final dose.

Tell your healthcare provider if there are any side effects that are bothersome or that do not go away.

These are not all the possible side effects of Rylaze. For more information, ask your healthcare provider.

Call your doctor for medical advice about any side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

About Acute Lymphoblastic Leukemia
Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that can be fast growing.2 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.3 Although it is one of the most common cancers in children, ALL is among the most curable of the pediatric malignancies due to recent advancements in treatment.4 Adults can also develop ALL, and about four of every 10 cases of ALL diagnosed are in adults.5 The American Cancer Society estimates that about 6,600 new cases of ALL will be diagnosed in the United States in 2022.5

About Lymphoblastic Lymphoma
Lymphoblastic lymphoma (LBL) is a rare, fast-growing, aggressive subtype of non-Hodgkin’s lymphoma (NHL), most often seen in children and teenagers.6 In LBL, the abnormal lymphocytes are present in the lymph nodes or thymus gland, whereas in ALL, the abnormal lymphocytes are mainly in the blood and bone marrow.6