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Imvax to Present Preclinical Data on IGV-001 Mechanism of Action at SITC Annual Meeting

On October 21, 2021 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported a poster presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in Washington, D.C., from November 10-14, 2021 (Press release, Imvax, OCT 21, 2021, View Source;utm_medium=rss&utm_campaign=imvax-to-present-preclinical-data-on-igv-001-mechanism-of-action-at-sitc-annual-meeting [SID1234596598]).

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The poster highlights recent preclinical data for the company’s most advanced product candidate, IGV-001. The data elucidate potential mechanisms for the observed immune-stimulating and tumor-suppressing activity of IGV-001 seen in the Phase 1 clinical study for glioblastoma.

"We’re pleased to share new insights into the mechanism of action of IGV-001, which are supportive of the clinical efficacy data we’ve previously reported," said John Furey, Chief Executive Officer. "These insights are valuable both as we prepare for a Phase 2b trial in glioblastoma and as we expand our platform to address other solid tumor types."

Details of the poster presentation are as follows:

Title: Autologous glioblastoma tumor cells and an antisense oligonucleotide against insulin-like growth factor type 1 receptor protect against tumor challenge and generate T cell anti-tumor responses

Number: P218

Timing: November 13, 2021, 7:00 a.m-8:30 p.m. EST

Presenter: Mark Exley, Ph.D., Chief Scientific Officer

Ipsen delivers strong sales growth for the first nine months and improves its full-year guidance

EDISON Publishes Healthcare QuickView on Cannabics Pharmaceuticals: CNBX

On October 21, 2021 Cannabics reported that develops cannabinoid-based, tumour reducing therapies (Press release, Cannabics Pharmaceuticals, OCT 21, 2021, View Source [SID1234593956]). Its bioinformatics platform evaluates the efficacy of thousands of cannabinoid compounds on various cancers. In addition, it has recently launched a psychedelic inspired research programme focused on neuropsychiatric disorders. Its most advanced therapies target the $18bn colorectal cancer market, with human clinical trials planned to commence in 2022. Earlierstage therapies target breast cancer, prostate cancer and melanomas. Cannabics has five granted patents and 20 patents pending.

Preparing pre-IND packages
Cannabics is currently preparing a pre-IND meeting package for its colorectal cancer treatment RCC-33. In June 2021, Cannabics announced RCC-33 in-vivo interim results that showed a 30% reduction in tumour volume versus a control group. The company expects Phase I/IIa to commence in the second half of 2022 and be complete by the end of 2024 at an estimated cost of $5m. Also targeting colorectal pre-cancerous polyps, PLP-33 is in preparation for a pre-IND meeting package and synopsis for a Phase I.

Beefing up the board
In combination with Cannabics’s recent initiation of research into a new melanoma treatment, Professor Caroline Robert (MD PhD), a melanoma expert, has recently (August 2021) joined the company’s clinical advisory board. Also joining in August was Dr Sigal Tavor (MD), a haemato-oncology expert. In September 2021, Neuropsychiatrist Dr Ilya Reznik (MD) joined the company management as head of psychedelic inspired medicine as part of the strategy to develop new psychedelic inspired medicines and therapies to address severe mental health related conditions.

Addressing major markets
Cannabics therapies addressing melanoma (MLN-33), breast cancer (BRST-33) and prostate cancer (PRST-33) are in preclinical in-vitro trials. All three are expected to move to in-vivo studies in 2022. Neuropsychiatry therapies targeting mental health conditions are in the discovery phase.

Financials
For the most recent quarter ending May 2021, Cannabics had cash and cash equivalents of $2m. During the quarter, the company reported a net loss of $1.3m including a non-recurring expense of $0.6m

Iveric Bio Announces Pricing of Upsized Public Offering of Common Stock

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.

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.

ALX Oncology Announces First Patient Dosed in ASPEN-05, a Phase 1/2 Study of Evorpacept in Combination with Venetoclax and Azacitidine in Patients with Acute Myeloid Leukemia

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]).

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%.