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ORIC Pharmaceuticals to Participate in the Guggenheim 2022 Oncology Conference

On February 2, 2022 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will participate in a virtual fireside chat at the Guggenheim 2022 Oncology Conference on Thursday, February 10, 2022, at 2:00 p.m. ET (Press release, ORIC Pharmaceuticals, FEB 2, 2022, View Source [SID1234607663]).

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A live webcast of the fireside chat will be available through the investor section of the company’s website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.

Calidi Biotherapeutics and Edoc Acquisition Corp. Agree to Merge and Create a Publicly Listed, Clinical-Stage Biotechnology Company Utilizing Stem Cell-Based Platforms to Revolutionize Oncolytic Virotherapies

On February 2, 2022 Calidi Biotherapeutics, Inc. ("Calidi" or the "Company"), a clinical-stage biotechnology company that is pioneering the development of cell-based delivery of oncolytic viruses, and Edoc Acquisition Corp. ("Edoc") (NASDAQ: ADOC), a blank check company organized to acquire or merge with one or more businesses, reported that they have entered into a definitive merger agreement (Press release, Calidi Biotherapeutics, FEB 2, 2022, View Source [SID1234607657]). Upon closing the transaction, anticipated to occur in the second quarter of 2022, the combined company will be named Calidi Biotherapeutics, Inc. and led by Allan Camaisa, CEO and Chairman of the Board. In addition, the combined company’s common stock intends to list on the Nasdaq Capital Market.

"We are excited about combining with Edoc to advance our mission of delivering life-saving oncolytic virus therapies with the potential to revolutionize patient care," said Mr. Camaisa. "This business combination positions us well as we enter the next phase of our growth, delivering on the promise of our NeuroNova (NNV) and SuperNova (SNV) platforms, to surpass the deficiencies of the first generation oncolytic viruses existing in the marketplace. Furthermore, it will allow us to leverage Edoc’s extensive 400+ physician network across many disciplines."

"Calidi’s innovative stem cell-based delivery platforms are being developed to overcome the immune system’s ability to eliminate oncolytic viruses, potentially allowing oncolytic viral therapy to be successful," said Dr. Kevin Chen, Chairman and CEO of Edoc. "We aim to invest in people and companies that can change the healthcare landscape, and we believe that Calidi’s technology is differentiated and has the potential to transform cancer therapy."

The transaction includes gross proceeds of up to $92 million in trust at Edoc (less any redemptions by existing Edoc shareholders) and a concurrent $25 million PIPE from institutional investors.

Additionally, Edoc entered into backstop arrangements with certain institutional investors for the purchase of up to 2.2 million shares of Edoc Class A ordinary shares in connection with Edoc’s shareholder meeting to approve the business combination as well as Edoc’s February 9, 2022 shareholder meeting to approve an extension of time to complete its business combination, with the actual amount dependent upon the amount of cash available after each such shareholder meeting after any redemptions.

Net proceeds from the transaction are expected to provide Calidi with capital to advance its pipeline through multiple clinical milestones, such as:

NNV1 Phase 2 initiation: allogeneic neural stem cells loaded with an oncolytic adenovirus for the treatment of newly diagnosed glioblastoma.
NNV2 Phase 1 initiation: allogeneic neural stem cells loaded with an oncolytic adenovirus for the treatment of recurrent glioblastoma.
SNV1 Phase 1 initiation: allogeneic adipose-derived mesenchymal stem cells (AD-MSC) loaded with an oncolytic vaccinia virus for the treatment of advanced metastatic solid tumors.
Support expansion of Calidi’s stem cell-based delivery platforms into additional indications
Key Transaction Terms

Upon closing of the business combination (the "Business Combination"), and assuming no redemptions of shares of Edoc by its public shareholders, Calidi would be expected to have cash and cash equivalents, prior to transaction expenses, of approximately $117 million (less any redemptions and transaction expenses) and a pro forma enterprise valuation of $449 million.

The boards of directors of Calidi and Edoc unanimously approved the proposed transaction, which is anticipated to close in the second quarter of 2022. The closing of the transaction is subject to the approval of Edoc shareholders, regulatory approval and the satisfaction or waiver of certain other customary closing conditions.

A Current Report on Form 8-K, filed by Edoc with the Securities and Exchange Commission (SEC), will provide additional information about the proposed business combination, related financings and backstop arrangements, and will be available on the SEC’s website at www.sec.gov. In addition, Edoc intends to file a registration statement on Form S-4 with the SEC, including a proxy statement/prospectus, and will file other documents regarding the proposed transaction with the SEC.

Advisors

H.C. Wainwright & Co. served as financial advisor to Calidi. Lewis Brisbois Bisgaard & Smith LLP acted as legal counsel to Calidi. Ellenoff Grossman & Schole LLP acted as legal counsel to Edoc, and I-Bankers Securities, Inc. as financial advisor to Edoc.

Titan Pharmaceuticals Announces Pricing of $5.5 Million Registered Direct and PIPE Offering Priced At-The-Market

On February 2, 2022 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company") reported that it has entered into a securities purchase agreement with a single institutional investor to purchase 3,374,242 shares of its common stock (or pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Titan Pharmaceuticals, FEB 2, 2022, View Source [SID1234607648]). In a concurrent private placement, Titan has also agreed to issue and sell to the investor 1,289,796 pre-funded warrants, at the same purchase price as in the registered direct offering. In addition, the Company has agreed to issue to the investor in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,664,038 shares of common stock. The combined offering price of each share or pre-funded warrant and each warrant will be $1.18. The warrants will be immediately exercisable, will expire on the five year and six month anniversary of the issuance date and will have an exercise price of $1.14 per share.

The aggregate gross proceeds to the Company of both offerings is expected to be approximately $5.5 million. The offerings are expected to close on or about February 4, 2022, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the exclusive placement agent in connection with the offerings.

The shares of common stock (or pre-funded warrants in lieu thereof) in the registered direct offering are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-230742), which was declared effective by the United States Securities and Exchange Commission ("SEC") on April 24, 2019. The pre-funded warrants and warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants 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 have not been registered under the Act or applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock (or pre-funded warrants in lieu thereof) issued in the registered direct offering will be filed by Titan with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

Pimera Therapeutics Awarded Grant by US Department of Defense to Evaluate PMR-116, a Novel Inhibitor of RNA Polymerase I (Pol I) Transcription, in Patients with Prostate Cancer

On February 2, 2022 Pimera Therapeutics, Inc., a clinical-stage biotechnology company focused on developing breakthrough medicines for cancer and other diseases with high unmet medical need, reported that the Company and its collaborators Dr. Luc Furic, Head, Translational Prostate Cancer Research at Peter MacCallum Cancer Centre and Professor Ross Hannan, Centenary Chair in Cancer Research and Head of the ACRF Department of Cancer Biology and Therapeutics, Associate Dean Research (Biomedical and Translational) at Australian National University, have been awarded a Prostate Cancer Research Program (PCRP) grant from the Department of Defense to advance its lead program PMR-116 to the clinic for prostate cancer (Press release, Pimera Therapeutics, FEB 2, 2022, View Source [SID1234607653]).

Pimera is developing PMR-116, a novel inhibitor of RNA polymerase I (Pol I), a transcription factor for MYC driven cancers, for the treatment of multiple solid tumor oncology indications. The grant award, which totals more than $1 million, will support efficacy studies of PMR-116 in patient-derived models, identification of novel combination therapies, and identification of biomarkers of response from the ongoing Phase 1 study of PMR-116.

"PMR-116 is a very exciting program with a novel mechanism of action and an encouraging efficacy and safety profile to date. In preclinical studies, we observed robust efficacy in several MYC-driven models, including those that are resistant to standard-of-care therapy. In the ongoing Phase 1 study, PMR-116 demonstrated favorable target engagement and early clinical efficacy signals in multiple solid tumor patients," said Mustapha Haddach, Ph.D., President and CEO of Pimera. "This recognition from the DOD on the potential of PMR-116 further validates our approach with PMR-116 to improve care for cancer patients, and in particular, prostate cancer, which is one of the leading causes of cancer death in men in the US. We look forward to advancing PMR-116 through dose escalation, expanding into additional indications, and into Phase 2 to address several large cancer markets and improve patient outcomes."

"PMR-116 suppresses the ability of cancer cells to synthesize the machinery required to express the high level of proteins required for cancer growth. What we’ve demonstrated in pre-clinical models of CRPC and NEPC with PMR-116 is a powerful new way to inhibit proliferation in the most advanced stages of prostate cancer," added Dr. Luc Furic, Head, Translational Prostate Cancer Research at Peter MacCallum Cancer Centre. "The significant support from this DOD Award will allow us to further characterize biomarkers of response to PMR-116 and perform the ground word required to bring PMR-116 to the clinic for prostate cancer patients."

This grant was supported by the Department of Defense of the U.S. Army Medical Research Acquisition under Award Number FY21-PCRP-TSA. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Defense.

About PMR-116
PMR-116 is our lead therapeutic in clinical development for multiple cancer indications including solid tumors. PMR-116 acts through a novel mechanism of action, targeting the RNA polymerase I, or POL I, a transcription factor for MYC driven cancers and other diseases with high unmet medical need. In preclinical studies, PMR-116 has demonstrated robust preclinical efficacy in multiple MYC-driven models, including those that are resistant to standard-of-care treatments. PMR-116 is currently in the dose escalation stage of a Phase 1a/b clinical trial being conducted in Australia. Pimera intends to expand the development of PMR-116 in patients with MYC overexpressing solid tumors in a tumor type-agnostic approach. For more information about the ongoing clinical trial, please visit ANZCTR.

Jazz Pharmaceuticals Completes U.S. FDA Supplemental Biologics License Application for Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) Monday/Wednesday/Friday Dosing Schedule

On February 2, 2022 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Company has completed the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for a Monday/Wednesday/Friday (M/W/F) intramuscular (IM) dosing schedule for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), 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 and older who have developed hypersensitivity to E. coli-derived asparaginase (Press release, Jazz Pharmaceuticals, FEB 2, 2022, View Source [SID1234607651]). The submission will be reviewed under the Real-Time Oncology Review (RTOR) program, an initiative of FDA’s Oncology Center of Excellence designed for efficient review of safe and effective cancer treatments, and follows Rylaze’s initial approval under the RTOR program in June 2021.

"We were pleased Rylaze, a much-needed therapeutic option, was approved under the RTOR program while the clinical trial was ongoing. Our science-led and patient-focused development program has enabled us to deliver a clinically significant advancement for patients," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "With a dosing schedule of Rylaze administered 25/25/50 mg/m2 on Monday/Wednesday/Friday, patients maintain a clinically meaningful level of nadir serum asparaginase activity through the entire duration of treatment. We look forward to submitting two additional regulatory applications this year to ensure as many patients as possible can have access to a reliable and high-quality supply of this important therapy, including another regulatory application to FDA to support the intravenous route of administration and an additional application in Europe later this year."

The sBLA submitted by Jazz is supported by data from the three-cohort intramuscular administration part of the Phase 2/3 trial of Rylaze in adult and pediatric patients with ALL and LBL who have developed hypersensitivity to an E. coli-derived asparaginase. The trial studied three dosing regimens of Rylaze, with cohort 1a receiving 25 mg/m2 administered M/W/F, cohort 1b receiving 37.5 mg/m2 administered M/W/F and cohort 1c receiving 25 mg/m2 administered Monday and Wednesday and 50 mg/m2 administered on Friday. Initial results showed that in cohort 1c, a dosing regimen of Rylaze administered 25 mg/m2 on Monday and Wednesday and 50 mg/m2 on Friday demonstrated a positive benefit-to-risk profile, showing that Rylaze maintains a clinically meaningful level of nadir serum asparaginase activity (NSAA) ≥0.1 IU/mL at both 48 and 72 hours (from Friday to Monday). In addition, the safety profile of Rylaze was consistent with the reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy. Initial results from the trial were presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021.1

The sBLA follows FDA approval of Rylaze in June 2021 under the RTOR program.2 Rylaze was also 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 2021.3

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 recombinant erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. 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, tiredness, infection, headache, fever, allergic reactions, fever with low white blood cell count, decreased appetite, mouth swelling (sometimes with sores), bleeding, and too much sugar in the 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.

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 (ALL)
ALL is a cancer of the blood and bone marrow that can progress quickly if not treated.4 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.5 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.6,7 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 almost 6,000 new cases of ALL will be diagnosed in the United States in 2021.5 Asparaginase is a core component of multi-agent chemotherapeutic regimens in ALL.8 However, asparaginase treatments derived from E. coli are associated with the potential for development of hypersensitivity reactions.9

About Lymphoblastic Lymphoma (LBL)
LBL is a rare, fast-growing, aggressive subtype of Non-Hodgkin’s lymphoma, most often seen in teenagers and young adults.10 LBL is a very aggressive lymphoma – also called high-grade lymphoma – which means the lymphoma grows quickly with early spread to different parts of the body.11,12