On October 21, 2021 IVERIC bio, Inc. (Nasdaq: ISEE) (the "Company"), reported the pricing of an upsized underwritten public offering of 9,000,000 shares of its common stock at a price to the public of $16.75 per share, less underwriting discounts and commissions (Press release, Ophthotech, OCT 21, 2021, View Source [SID1234591896]). In addition, in connection with the offering, the Company has granted the underwriters an option for a period of 30 days to purchase up to an additional 1,350,000 shares of common stock at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by the Company.

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The gross proceeds from the offering are expected to be approximately $150.8 million, before underwriting discounts and commissions and offering expenses payable by the Company, and without giving effect to any exercise by the underwriters of their option to purchase additional shares.

Morgan Stanley, Cowen, Stifel and Credit Suisse are acting as the book-running managers for the offering. The offering is expected to close on or about October 26, 2021, subject to customary closing conditions.

The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of an automatically effective registration statement. A final prospectus supplement related to the offering will be filed with the Securities and Exchange Commission (the "SEC") and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, by contacting: Morgan Stanley, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, or by telephone: 1-866-718-1649; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by emailing [email protected], or by telephone: (833) 297-2926; Stifel, Nicolaus & Company, Incorporated, One Montgomery Street, Suite 3700, San Francisco, CA 94104, Attention: Prospectus Department, or by emailing [email protected], or by telephone: (415) 364-2720; or Credit Suisse Securities (USA) LLC, 6933 Louis Stephens Drive, Morrisville, North Carolina 27560, Attn: Prospectus Department, or by emailing [email protected], or by telephone: (800) 221-1037.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or jurisdiction.

On October 21, 2021 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported the first patient has been dosed in the Phase 1/2 ASPEN-05 study evaluating the combination of evorpacept, a next-generation CD47 blocker, with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia ("AML") (Press release, ALX Oncology, OCT 21, 2021, View Source [SID1234591867]).

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The Phase 1 portion of the ASPEN-05 study will characterize the safety and confirm the dose of evorpacept in combination with venetoclax and azacitidine in patients with relapsed/refractory AML and previously untreated AML who are not candidates for intensive induction therapy. The Phase 2 portion of the study will evaluate the efficacy of the combination in patients with previously untreated AML who are not candidates for intensive induction therapy.

ASPEN-05 is based on promising preclinical data with evorpacept in combination with venetoclax and azacitidine in non-clinical models of leukemia, as well as clinical data from an ongoing phase 1 study (NCT03013218) evaluating evorpacept in combination with multiple anti-cancer agents in both solid and hematologic malignancies.

"Patients with either relapsed/refractory AML or previously untreated AML who are not considered eligible for intensive induction regimens remain in urgent need of tolerable and effective new therapies," said Harry Erba, M.D., Ph.D., Director of the Leukemia Program at the Duke Cancer Institute. "We are looking forward to evaluating the addition of evorpacept to venetoclax and azacitidine. ALX148 was specifically designed for use in combination to maximize phagocytosis of tumor cells while minimizing the toxicities commonly associated with other CD47-targeted approaches."

"ASPEN-05 builds upon compelling evorpacept combination activity observed in non-clinical models of leukemia. With demonstrated tolerability of evorpacept in multi-agent chemotherapy regimens, we are excited to characterize evorpacept with this standard backbone of AML therapy," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer of ALX Oncology. "Through blockade of the CD47 myeloid checkpoint, evorpacept in combination with venetoclax and azacitidine may potentially transform treatment options for patients with AML."

The ASPEN-05 trial is registered under NCT04755244. ALX Oncology owns worldwide commercial rights to evorpacept.

About Acute Myeloid Leukemia

AML is an aggressive blood cell cancer that can rapidly progress and lead to death if not treated promptly. AML is the most common form of acute leukemia in adults, with an estimated 19,940 new cases and 11,180 deaths from AML in the United States. Due to advanced age and comorbidities at the time of diagnosis, a significant number of patients are not considered eligible for intensive and potentially curative therapies. Despite advances in available care, the estimated 5-year survival for patients in the United States with AML remains only 29%.

On October 21, 2021 Johnson & Johnson and partner Legend Biotech reported that they are expecting an FDA decision for their first CAR-T product, cilta-cel, in November (Press release, Johnson & Johnson, OCT 21, 2021, View Source [SID1234591823]). To prepare for the upcoming launch of the personalized cell therapy, the Big Pharma company is planning a specialized patient support program, a dedicated sales team and more.

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J&J intends to roll out a customized program to help cilta-cel-prescribed multiple myeloma patients navigate the treatment journey, Serge Messerlian, Janssen’s U.S. oncology president, said in a recent interview.

CAR-T therapies modify a patient’s own T cells to make them better weapons against cancer bearing a specific biomarker. For such a personalized medicine, "one needs to be very thoughtful not just [about] the product, but there’s a very important service component to that," Messerlian said.

RELATED: J&J, Legend Biotech’s multiple myeloma CAR-T scores FDA priority review, setting up a clash with BMS’ Abecma

Because of the complexity in production, CAR-T products can be pricey. Before cilta-cel, Bristol Myers Squibb recently introduced a rival BCMA-targeted cell therapy, Abecma, at a list price of $419,500. Patients need to travel to designated treatment centers to have their T cells drawn and later to receive the final product. They must also monitor for a potentially life-threatening side effect known as cytokine release syndrome after treatment.

For J&J’s program, each patient will get one-on-one assistance navigating access challenges and help with the logistics associated with treatment, Messerlian said. For the upcoming launch, J&J is working on CAR-T site initiations and making sure the market is ready to receive the medicine. Although the company already has a popular multiple myeloma therapy, Darzalex, cilta-cel will have a separate sales team, he said.

Building personalized cancer drug support programs
J&J has a separate personalized patient assistance program for Darzalex, called Janssen Compass, which also covers prostate cancer med Erleada. The company is now rolling out Janssen Compass on a national scope after a limited run, Messerlian said.

"Compass is a very patient-centric, patient-oriented platform; it almost serves like a shepherd," Messerlian explained. In Janssen Compass, a single point of contact—a nurse—is assigned to help bring the right resources to a patient to manage obstacles along the way, including access challenges and side effects.

RELATED: J&J cell therapy partner Legend carves out production foothold in Belgium as myeloma drug nears finish line

About half of the patients that get on any drug drop off within six months, Messerlian noted, and not all of them are related to costs.

Sometimes, patients don’t understand what to expect on the treatment journey or fully acknowledge the benefits of the medicine, so they may not be committed to the therapy, Messerlian said. In Janssen Compass, a "care navigator" will help set expectations, educate each patient on how to manage potential obstacles and support them in developing a care plan to communicate with doctors.

Gaining treatment insights to develop better care
In return, J&J is getting valuable insights. Janssen Compass allows the company to "understand and analyze which patients will be most likely to drop off, and what are some interventions we can [use to] predict and prevent … these types of patient drop-offs," Messerlian said.

Beyond patient support, J&J is also teaming up with healthcare facilities and specialty networks to help train doctors, especially in the community setting. The goal of such education is, as Messerlian put it, about "bending the quality-of-life curve."

RELATED: Pharmas’ return on $5B spent yearly on patient support programs? Only 3% are using them: survey

Working with its care partners, J&J is collecting and analyzing data to map out how various patients move through the treatment process, aiming to improve outcomes along the way.

"It comes down to understanding, what are the inputs of this care process, what are the decisions along the process, and can you standardize to that," Messerlian said. "[With] a standard set, you can then roll that out in partnership with other practices to ultimately elevate the standard of care."

On October 21, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported the signing of a collaboration agreement granting China Resources Double-Crane Pharmaceutical Co., Ltd. (CRDC) exclusive Asia territorial rights to develop a novel investigational oral COVID-19 antiviral therapeutic compound using Ligand’s BEPro technology (Press release, Ligand, OCT 21, 2021, View Source [SID1234591822]). Ligand will receive an upfront payment in respect of the collaboration, and if the program advances, clinical and regulatory milestone payments, and tiered royalties on net sales. CRDC will be responsible for all costs related to the program.

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BEPro is a proprietary prodrug technology that is specifically applicable to nucleotides and nucleotide analogs for the development of compounds with improved product profiles. Ligand has generated preclinical pharmacokinetics data showing its oral BEPro-enabled COVID-19 antivirals to have a favorable blood concentration profile and generate lower levels of active nucleotide in the kidney, a potential site for toxicity, than other oral and intravenous comparators. Ligand has filed multiple patents globally on the BEPro technology and potential antiviral compounds.

"This transaction with CRDC is another deal in a long history of success converting our inventions, data and intellectual property into licenses to advance important medicines and deliver value to our shareholders," said John Higgins, CEO of Ligand Pharmaceuticals. "We are proud of the important work our team has contributed toward addressing the pandemic and are pleased with this new collaboration. China Resources Group is one of the largest Chinese pharmaceutical companies and is looking forward to robust development of this program through their subsidiary CRDC."

On October 21, 2021 Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage leader in immune stimulatory vaccines for cancer, reported its universal cancer vaccine, UV1, in combination with checkpoint inhibitors has received Fast Track designation from the U.S. FDA in the treatment of unresectable or metastatic melanoma – either as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab (Press release, Ultimovacs, OCT 21, 2021, View Source [SID1234591774]). Ultimovacs is currently evaluating UV1 as add-on therapy to ipilimumab and nivolumab as first-line treatment for unresectable or metastatic melanoma in a Phase II study named INITIUM.

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Ultimovacs senior management will host a webcast on the Fast Track designation and the supporting clinical data at 13.00 CET on Thursday October 21.

The FDA Fast Track process is designed to facilitate the development and expedite the review of drugs that meet urgent needs in serious medical conditions. Fast Track designation enables early and frequent communication with the FDA to support the drug’s development, as well as entitlement to a Rolling Review of the Biologic License Application. Drugs with Fast Track designation may also be considered for Accelerated Approval and Priority Review provided certain criteria are met.

"We are delighted UV1 has received the Fast Track designation and look forward to working more closely with the FDA to bring UV1 to melanoma patients as soon as possible," said Carlos de Sousa, Chief Executive Officer of Ultimovacs. "The FDA’s decision recognizes the potential synergy of UV1 and checkpoint inhibitors and will greatly encourage physicians and patients involved in our Phase II clinical trial INITIUM. We remain committed to progressing UV1 in our four ongoing Phase II clinical studies and assessing development of UV1 with pembrolizumab in advanced melanoma."

The Fast Track designation is based on data from two separate Phase I trials of UV1 in combination with checkpoint inhibitors, either with pembrolizumab (anti-PD-1) or with ipilimumab (anti-CTLA-4). According to data disclosed recently, UV1 in combination with pembrolizumab as a first-line treatment in advanced melanoma was shown to be safe with promising early efficacy data; an objective response rate (ORR) of 57% was reached with 30% of patients achieving a complete response (CR), or complete disappearance of their tumors. At 24 months follow up, 80% of patients were alive. In a second cohort, similar levels of tumor destruction were seen with 90% of patients remained alive after one year. Peer-reviewed data published in May 2021 in Frontiers in Immunology demonstrated that UV1 with ipilimumab was safe and showed signals of prolonged efficacy in advanced melanoma, the combination achieving ORR of 33% and 5-year overall survival (OS) rate of 50%.

UV1 is currently being investigated in combination with checkpoint inhibitors in four Phase II trials: in unresectable or metastatic melanoma, ovarian cancer, head and neck squamous cell carcinoma and malignant pleural mesothelioma.

Ultimovacs’ webcast on the Fast Track designation and clinical data at 13.00 CET (7.00 am EST) on Thursday 21 October 2021 will be accessible here and from the company website.