Last week biotech news was largely overshadowed by US election news. Time will tell whether the outcome will prove positive for the sector. Some expect an increase in M&A and deal making, however uncertainty with respect to policymaking, regulations, and impact on the FDA remains a concern for many.
On the private side, new launches and VC led private rounds were particularly muted. Whilst the IPO window is closed for now, many public companies filed prospectuses to the SEC to raise significant follow on rounds.
The shift to immunology continues.
Celldex Therapeutics
and
Nkarta, Inc.
joined the rapidly growing list of biotechs who have dropped oncology programs to focus on inflammatory and autoimmune diseases.?
?? New Biotech Launches …
- Oblenio Bio was launched by venture firm
Aditum Bio
with an autoimmune tri-specific T-cell engager licensed from China based Lead Biolabs. Link
- Peptide development specialist
Endevica Bio
has span out Abisati to further develop a preclinical stage oral peptide for weight loss, with both companies currently being led by CEO
Russell Potterfield
. Link?
?? Private Raises…
?? New VC funds…
J.P. 摩根
Life Sciences Private Capital, led by chief investment officer
Stephen Squinto
, is reported to be raising a new fund, focusing on late stage companies. Link?
??Research collaborations…
-
Daiichi Sankyo
and
阿斯利康
are collaborating with Korea based
ALTEOGEN Inc.
to develop subcutaneous Enhertu products in a deal worth $20M upfront and up to $300M in milestone payments. Link
-
诺和诺德
and
Ascendis Pharma
signed a collaboration to develop and commercialize once-monthly GLP-1 drugs, in a deal worth up to $285M. Link
-
Nxera Pharma
, formally Sosei Heptares, entered a collaboration with UK based
Antiverse
to design generative AI discovered antibodies for GPCR targets. Link
-
858 Therapeutics
entered a collaboration with
OpenBench
to discover small molecule drugs against RNA targets using OpenBench's structure-based ML platform. Link
-
Synaffix BV
, a
龙沙
company, Collaborates with
BigHat Biosciences
on the Development of a Machine Learning-Designed ADC. Link?
??Asset licensing deals…
- In the deal referenced above in New Biotech Launches, Lead Biolabs will receive $35M upfront and up to $579M in milestone payments for ex-China rights to the tri-specific T-cell engager. Link
- New York based
Y-mAbs Therapeutics, Inc.
Announce Exclusive License and Distribution Agreement with
Nobelpharma America, LLC
for DANYELZA? (naxitamab-gqgk) in Japan. Link
?? M&A…
- Boston based
AlloVir
has entered into a merger agreement with publicly traded California based
Kalaris Therapeutics
, with the combined company expecting to have $100M cash to continue advancing Kalaris's pipeline of clinical stage ophthalmology programs. Link
-
Renexxion Ireland Ltd
is to go public via a reverse merger with Swiss biotech
RELIEF THERAPEUTICS Holding SA
, with plans to strengthen their balance sheets and advance Renexxion's phase 2n GI asset. Link
??? Other Public Raises…
- Boston based
Disc Medicine
secured a $200M non-dilutive financing from Hercules Capital to advance its clinical pipeline of hematoloty programs. Link
-
Travere Therapeutics
announced the pricing of a $125M public offering to fund advancement of its late stage pipeline of rare kidney and metabolic diseases. Link
- Commercial stage
Geron Corporation
announced up to $375M funding from
Royalty Pharma
and Pharmakon Advisors to support commercial launch of RYYELO in the US and potential EU for lower-risk MDS patients. Link
-
Syndax Pharmaceuticals
also raised money from Royalty pharma, raising $350M to launch its graft-versus-host and leukemia drugs. Link
- New York based
Neurogene Inc.
announced a $200M oversubscribed private placement to continue advancing its clinical pipeline of next generation gene therapy drugs for CNS diseases. Link
- San Diego based
Acadia Pharmaceuticals Inc.
sold its priority review voucher for $150M, with plans to invest the proceeds to support its commercial business operations and R&D programs in rare and CNS diseases. Link
- Dover, Delaware based
Lomond Therapeutics
completed a reverse merger with Venetian-1 Acquisiton Corp and closed a $44M private placement, with plans to continue advancing its phase 1b AML small molecule program. Link
- San Diego based
Belite Bio
announced a $28.75M exercise of warrants to enable further development of its clinical pipeline of retinal disease drugs. Link
- Boston based
Kronos Bio
filed a prospectus to raise $250M in a public offering of shares to further advance its clinical pipeline of cancer and autoimmune drugs. Link
-
Tourmaline Bio
, a US-based biotechnology company that develops drugs for immune diseases, has announced plans to raise $350 million in public offering of shares. Link
-
SCYNEXIS, Inc.
, a US-based pharmaceutical company that? develops novel anti-infectives for serious fungal infections, has filed prospectus to raise up to $50 million in public offering of shares. Link?
?? Other investments and expansions…
-
辉瑞
is commuting $1B to invest in a new R&D facility in Beijing over the next 5 years with the aim of improving innovation in China's biotech ecosystem. Link
?? Positive clinical development updates…
-
阿斯利康
and
安进
's Tezspire met both co-primary endpoints in the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps. Link
-
Shanghai Minghui Pharmaceutical
presented positive results from its phase 1 bispecific antibody program for solid tumors. Link
-
OSE Immunotherapeutics
Announced Statistically Significant and Clinically Meaningful Results from the Phase 2 Study of Anti-IL7R mAb Lusvertikimab for the Treatment of Ulcerative Colitis. Link
-
RELIEF THERAPEUTICS Holding SA
Announced Positive Final Results of RLF-TD011 Clinical Trial in Epidermolysis Bullosa, a genetic condition characterized by fragile skin and chronic wounds. Link
-
Viking Therapeutics, Inc.
presented positive data from its phase 1 obesity program, with encouraging tolerability and mild adverse events. Link
-
阿斯利康
highlighted positive data from its phase 1 pipeline of GLP-1 obesity drugs combos, insitting that it is 'playing to win' in the crowded field. Link
-
Palleon Pharmaceuticals
Presented Results from the Phase 1/2 GLIMMER-01 Trial of E-602 in Combination with Cemiplimab in Patients with Solid Tumors at SITC. Link
-
Kanvas Biosciences
Unveiled Clinical Data on the Gut Microbiome’s Impact on Anti-Tumoral Immunity at SITC. Link
-
Indapta Therapeutics
Presents Clinical and Preclinical Data of Allogenic Natural Killer Cell Therapy at Society for Immunotherapy of Cancer Meeting. Link?
?? Designations & Recommendations…
-
AskBio Inc.
Receives FDA Rare Pediatric Disease and Orphan-Drug Designations for AB-1003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2I/R9. Link?
? Regulatory Approvals…
-
Autolus Therapeutics
Announced FDA Approval of AUCATZYL for adults with relapsed/refractory B-cell acute lymphoblastic leukemia, the first CAR T therapy approved by the FDA with no requirement for a Risk Evaluation Mitigation Strategy program. Link
-
Sanofi
's Dupixent was approved in the EU as the first and only medicine for young children with eosinophilic esophagitis. Link
That's all for this week, thanks for tuning in. Subscribe for alerts to the latest positive news in the biotech industry delivered to your inbox every Monday ????
About the author: Max Robinson is an ex-scientist turned talent leader in the biotechnology industry, and currently Global Head of Discovery, Preclinical & Translational Research at Proclinical.
