ALX Oncology Strengthens Immuno-Oncology Pipeline with Acquisition of ScalmiBio

On October 7, 2021 ALX Oncology Holdings Inc. ("ALX Oncology") (Nasdaq: ALXO), a clinical-stage immuno-oncology company, and ScalmiBio, Inc. ("ScalmiBio") reported that ALX Oncology has acquired ScalmiBio (Press release, ALX Oncology, OCT 7, 2021, View Source [SID1234591870]).

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ALX Oncology further expands its pipeline with plans to develop new anti-cancer drug candidates based on ScalmiBio’s platform; these new molecules will be designed to address unmet cancer patient needs as stand-alone therapeutics and in combination with ALX Oncology’s lead product candidate, evorpacept, a next-generation CD47 blocker designed to leverage the immune activation of broadly used anti-cancer agents through combination strategies.

"ALX Oncology was founded to address limitations of CD47 blockade through protein engineering," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "ScalmiBio’s universal SHIELD technology allows us to expand our pipeline and bring more treatment options to patients. We are building on our foundational strength of utilizing protein engineering to more broadly address limitations of other clinically and commercially validated anti-cancer targets through the design of conditionally activated antibodies and novel antibody-drug conjugates or ADCs."

ScalmiBio’s SHIELD technology is designed to minimize interaction of an antibody therapeutic with normal tissue and maximize its target binding capability within tumor microenvironment. Many cancer targets are relatively abundant in cancer cells but also expressed in normal cells leading to on-target, off-tumor toxicities that limit patient access to potentially life changing treatments. ScalmiBio’s conditional activation technology aims to increase therapeutic index by minimizing dose limiting toxicities of existing checkpoint inhibitors and other targeted anti-cancer biologics as well as enable the design of ADCs with higher drug-to-antibody ratios for improved anti-cancer activity. ALX Oncology has also acquired ScalmiBio’s proprietary cytotoxic payloads for the development of ADCs.

Under the terms of the share purchase agreement, ALX Oncology made an initial payment to the stockholders of ScalmiBio at closing on October 4, 2021 of approximately $4.5 million in cash, net of certain expenses and adjustments, and will make an additional payment of $2.0 million in cash at the one-year anniversary of the transaction subject to certain conditions. In addition, ALX Oncology has agreed to pay certain milestones based on the clinical development of the acquired ScalmiBio technology and has also agreed to pay a low single digit royalty on net sales of any products developed from the ScalmiBio acquired technology for a defined term.

US Patent Granted for SDC-1802 TYK2/JAK1 Inhibitor

On October 7, 2021 Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases, reported that, further to its announcement of 30 July 2021, the United States Patent and Trademark Office has now formally approved its patent in respect of an invention associated with Sareum’s proprietary SDC-1802 TYK2/JAK1 Kinase Inhibitor Programme (the "SDC-1802 Programme").

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The patent (US 11,154,539) will grant on 26 October 2021 and will protect the SDC-1802 molecule and pharmaceutical preparations thereof as a therapeutic to treat cancer selected from pancreatic, colorectal and kidney cancers, melanoma, and B-cell lymphoma by inhibiting TYK2 kinase. This programme is in preclinical development.

Sareum’s CSO, Dr John Reader, commented:

"We are pleased to confirm the grant of this US patent for SDC-1802, adding another layer of protection around this promising candidate in key territories. Our SDC-1802 programme is in preclinical development currently and we are designing the translational studies needed to define the optimal cancer application prior to completing toxicology and manufacturing studies. We look forward to providing further updates on progress as we achieve key milestones."

2021 Q3 Report: Global Trends in Biopharma Transactions

On October 7, 2021 Locust Walk reported that deal team members compile key statistics and trends on strategic transactions and financings (Press release, Locust Walk Partners, OCT 7, 2021, View Source;utm_medium=rss&utm_campaign=2021-q3-report-global-trends-in-biopharma-transactions [SID1234591035]). Our 2021 Q3 Report: Global Trends in Biopharma Transactions applies the latest data to analyze current activities in the life sciences deal landscape. ​

In this report you can find an overview and analysis of the following across the biopharma market in the US, Europe, and Asia (Japan and China):​

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Key performance indicators for the life science market​​
IPO and private financing activity and performance​​
Deal activity for strategic partnership and M&A​
A look ahead and our predictions of the future

United States

Biotech indices declined in Q3 2021 (-1.2% NBI, -4.0% BTK), compared to the 0.2% gains of the benchmark S&P 500 this quarter​
The US biopharma IPO momentum slowed in Q3 in terms of total aggregate deal value but with slightly higher deal volume compared to Q2​
The healthcare SPAC IPO market which began to cool down in Q2 2021 continued its cooling in Q3, with the volume and aggregate deal value of biotech dedicated SPACs falling to near pre-pandemic levels​
Despite the apparent slowdown from the previous quarter, public and private financing activity remains strong relative to historical standards​
Biopharma companies from the IPO Classes of 2019, 2020, and 2021, on average, all underperformed the major biotech indices this quarter​
Strong deal flow among licensing deals demonstrated sustained interest in strategic licensing transactions. Additionally, a dramatic increase in M&A average deal size revealed that the market values clinical-stage biotechnology companies

Europe

The steadily impressive increases in private investment into EU biotech since Q1 2020 has taken a break, raising just over $1B in Q3 2021, a fall of ~35% after the record-setting of ~$1.6B raised in Q2 2021 but still higher than Q3 in 2020 or 2019
Public financings slowed down significantly in Q3 compared to the last two quarters. There were only five small IPOs, all in home exchanges; no biopharmas have crossed the pond this quarter to go public on the US markets
European M&A activity stays consistent in terms of deal volume but total deal value back towards levels seen in Q1 2020
Notably, Q3 EU biopharma licensing agreements surpassed $8.1B in aggregate value, beating the impressive $7.8B of Q2. The deal activity in this quarter was again driven by a strong focus on immuno-oncology, but also by the revival of CNS through three significant deals

Japan

The biotech sector in Q3 2021 fell -13.8% with noticeable drops end of July while the pharma sector stayed flat, and overall growth of the two sectors since the beginning of 2020 is underperforming market​
All 5 in-licensing deals in Q3 2021 involved over $200M in deal size, and are split between either phase 3 assets or discovery stage transactions​
Following a strong quarter in venture financing in Q2 2021, the trend continues in Q3 which featured 9 deals with aggregate value of $50M; volume and value in 9 months of 2021 already beat the full year record in 2020​

China

Average share price of top Chinese pharma dropped by 14.1% due to speculations that the tightening of regulation for IT companies may also happen in the health care sector, while the SSE Composite Index was stable​
In-licensing deal volume and value in Q3 2021 outperform Q2 the previous year: 21 in-licensing deals closed including 16 deals with over $50M in total deal size and 15 with over $5M upfront payment​
Out-licensing activity was slow in Q3, but with large deal size: RemeGen’s $2.6B deal for ADC program to Seagen​
Venture financing for biotech companies continue to exceed previous levels, as 35 companies raised capital for an aggregate total of $2.4B in Q3 alone

Pyxis Announces Pricing of Upsized Initial Public Offering

On October 7, 2021 Pyxis Oncology, Inc. (Nasdaq: PYXS), a preclinical oncology company focused on developing an arsenal of next-generation therapeutics to target difficult-to-treat cancers and improve quality of life for patients, reported the pricing of its upsized initial public offering of 10,500,000 shares of common stock at an initial public offering price of $16.00 per share (Press release, Pyxis Oncology, OCT 7, 2021, View Source [SID1234591034]). All of the shares are being offered by Pyxis. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Pyxis, are expected to be $168.0 million. The shares are expected to begin trading on the Nasdaq Global Select Market on October 8, 2021 under the ticker symbol "PYXS." The offering is expected to close on October 13, 2021, subject to the satisfaction of customary closing conditions. In addition, Pyxis has granted the underwriters a 30-day option to purchase up to an additional 1,575,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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BofA Securities, Jefferies, Credit Suisse and William Blair are acting as joint book-running managers for the offering. LifeSci Capital is also acting as an underwriter for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission and became effective on October 7, 2021. The offering will be made only by means of a prospectus. When available, copies of the final prospectus may be obtained from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at [email protected]; from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected] or by telephone at 877-821-7388; from Credit Suisse Securities (USA) LLC, Attn: Prospectus Department, 6933 Louis 31 Stephens Drive, Morrisville, North Carolina 27560, Telephone:1-800-221-1037, or by email at [email protected]; or from William Blair, Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, or by telephone at(800) 621-0687 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Zai Lab Says HER2 Drug Meets Endpoints in Bridging Trial

On October 7, 2021 Shanghai’s Zai Lab reported its in-licensed HER2 drug met its endpoints in patients with previously treated HER2+ breast cancer. Zai acquired China rights to margetuximab as part of a $165 million, three-drug deal from MacroGenics in 2018 (Press release, Zai Laboratory, OCT 7, 2021, View Source [SID1234591033]). MacroGenics was approved to launch margetuximab in the US last year in combination with chemotherapy as a third-line treatment for HER2 positive breast cancer. Zai plans to file a BFA in China before the end of the year.

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