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]).

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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.

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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.

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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

On November 18, 2022 DELBERT Laboratories reported the acquisition from Noventia Pharma Srl of the European MA of CEPLENE 0.5mg/0.5ml, solution for injection (histamine dihydrochloride) on September 12, 2022, and strengthens its commitment in hematology-oncology in Europe (Press release, Laboratoires DELBERT, NOV 18, 2022, View Source [SID1234624251]).

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Ceplene demonstrated a clinical interest in maintenance treatment of acute myeloid leukemia (AML) in patients below 60 years of age in first "complete remission" (symptom-free period of disease after initial treatment) in a clinical study published in Blood in 2006 and received orphan drug designation in 2005 1,2,3.

Acute myeloid leukemias are rare genetic diseases. In Europe, the incidence is estimated at 3.7/100,000 new cases per year. The prognosis for AML is unfavourable with a 5-year relative survival rate of 19%4.

DELBERT Laboratories (View Source) is a French pharmaceutical company specialized in the "renewal of essential medicines" frequently affected by marketing termination, stock shortages, particularly in times of crisis.

"We are focused on keeping essential medicines available to patients in 3 therapeutic areas (Antiinfectives, CNS and Oncology), with the mission of maintaining the therapeutic arsenal of doctors and preventing well-balanced patients from changing treatments.The acquisition of Ceplene’s MA in Europe is part of this strategy to maintain essential medicines and make available medicines with clinical benefit in rare diseases," said Eric Fidelin (Head of Strategy & Global Development).

With this acquisition, DELBERT Laboratories strengthens its presence in hematological oncology.

On November 18, 2022 Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) reported that it has reached an agreement in principal with FutureChem based in Seoul, South Korea, a radiopharmaceutical company, for the clinical supply of radioisotope, Lu-177 n.c.a. (Lutetium-177 non-carrier-added), to support FutureChem’s Investigational New Drug IND-enabling Phase 2 clinical trial with Ludotadipep, 177Lu-FC705 to assess the efficacy and safety for repeated administration of the recommended Ludotadipep dose in patients with metastatic castration resistant prostate cancer (mCRPC) (Press release, Eczacıbaşı-Monrol Nuclear Products, NOV 18, 2022, View Source [SID1234624250]). Clinical supply contract signed by two parties on 18th of Oct 2022 in Barcelona. A new supply contract between Monrol and FutureChem will be signed following the commercialization of the product in South Korea and US.

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Monrol General Manager Aydın Küçük, added: "We are delighted to be working with FutureChem to have a clinical supply agreement to support clinical development program of an innovative radiopharmaceutical product Ludotadipep, 177Lu-FC705 to assess the efficacy and safety in patients with metastatic castration resistant prostate cancer (mCRPC). Collaboration with FutureChem is another example of we continue our mission to improve quality of life for cancer patients and transform patient care for the future."

Dae Yoon Chi, Chief Executive Officer, FutureChem said: "FutureChem is thrilled to be partnering with Monrol, a company with a broad set of offerings to support our development programs and pipeline. We look forward to rolling out the supply of high-quality radioisotopes to our Phase 2a clinical trial patients in US soon. We have a future prospect to expand this partnership, supply of radioisotope, Lu-177 n.c.a. by Monrol for the commercialization of the Ludotadipep, 177Lu-FC705".