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Pharvaris’ $300 million public offering; Genentech’s breast cancer trial success; new neuromuscular disease target discovered

Here is Labiotech’s weekly roundup of the latest biotech news. Stay in the loop by subscribing to our newsletter for direct updates to your inbox.

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      The latest biotech news in fundraising

      Pharvaris bags $300 million in public offering

      Swiss company Pharvaris received $300 million in a public offering, the company announced in a press release. Earlier this month, it put out another release documenting its phase 2 trial for its treatment of hereditary angioedema. It was found that patients experienced an 84.5% reduction in monthly attacks. This comes a year after the candidate was placed on hold by the U.S. Food and Drug Administration (FDA).

      SpringWorks Therapeutics closes public offering

      American precision medicine company SpringWorks Therapeutics has closed a public offering worth $316.25 million. This comes a few weeks after its treatment for adult patients with desmoid tumors obtained the green light from the FDA to enter the U.S. market. The drug nirogacestat is an oral, selective, small molecule gamma secretase inhibitor that is being evaluated in other patient cohorts as well.

      EyePoint Pharmaceuticals secures $230 million

      EyePoint Pharmaceuticals has secured around $230 million via a public offering. The eye disease therapeutics company, which is headquartered in Massachusetts in the U.S., will use the funds to advance its wet age-related macular degeneration (AMD) candidate to phase 3 trials. The candidate EYP-1901 consists of Durasert and Vorolanib is an IVT injection to treat VEGF-mediated retinal diseases. The funds will also be used to support the biotech’s other clinical trials with EYP-1901 in nonproliferative diabetic retinopathy (NPDR) as well as its other candidate EYP-2301.

      Genomic medicines startup launches with $213 million

      Tome Biosciences, a company based in Massachusetts in the U.S., launched two days ago. To help set it in motion, the company obtained $213 million in series A and B funding. With the funds, it aims to develop its programmable genomic integration (PGI) technology. Combining the site-specificity of CRISPR/Cas9 with enzymes that are capable of writing DNA sequences, PGI can insert a DNA sequence of any size into a programmed genomic location. 

      Investors who were part of the fundraise included Andreessen Horowitz (a16z) Bio + Health, ARCH Venture Partners, GV, Longwood Fund, Polaris Partners, Bruker Corporation, FUJIFILM Corporation, and Alexandria Venture Investments, among others.

      Spyre Therapeutics lands a $180 million investment

      American company Spyre Therapeutics received $180 million in a private investment in public equity (PIPE), according to a press release last week. The company is currently advancing its antibody therapeutics against inflammatory bowel disease (IBD). The financing saw participation from investors like Access Biotechnology, Venrock Healthcare Capital Partners, Perceptive Advisors, RTW Investments, LP, Braidwell LP, Fairmount, Cormorant Asset Management, Polar Capital, Boxer Capital, Deep Track Capital, Great Point Partners LLC, Affinity Asset Advisors, Commodore Capital, and Woodline Partners LP.

      Bicara Therapeutics awarded $165 million to develop cancer treatments

      Bicara Therapeutics has received $165 million in a series C round. The proceeds from the fundraise will go towards accelerating Bicara Therapeutics’ lead candidate BCA101, which is a bifunctional EGFR/TGF-β inhibitor being evaluated in the clinic for cancers like head and neck squamous cell carcinoma (HNSCC), advanced squamous non-small cell lung cancer (SqNSCLC) and cutaneous squamous cell carcinoma, among others. The candidate showed encouraging interim results in a phase 1/1b trial in combination with pembrolizumab in patients with HPV-negative R/M HNSCC. Further data will be released next year.

      The financing was co-led by Braidwell LP and TPG, and investors like Deerfield Management, Fairmount, and Aisling Capital joined along with investors from the series B round.

      89bio receives $150 million in public offering

      Clinical-stage company 89bio based in the U.S., closed its public offering worth $150 million. The biotech is focused on advancing pegozafermin, its lead candidate for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG), to the clinic. The candidate is a specifically engineered, fibroblast growth factor 21 (FGF21) analog with glycoPEGylated technology. It has received Breakthrough Therapy designation from the FDA for NASH. 

      Wave Life Sciences secures around $100 million 

      Massachusetts-based Wave Life Sciences has secured around $100 million in a public offering. The RNA medicines company is selling all of the ordinary shares in the offering. Moreover, the company has granted the underwriters a 30-day option to buy up to an additional 3,000,000 of its ordinary shares on the same terms and conditions. The offering closed earlier this week.

      ARTBIO raises oversubscribed $90 million to develop radioligand therapies

      ARTBIO received more than it had bargained for in a $90 million series A financing round. The funds will help stabilize the company’s Pb212 isolation technology AlphaDirect as well as take its lead program AB001 to the clinic for prostate cancer. The round was co-led by Third Rock Ventures and an undisclosed healthcare fund. The company is also looking to develop a distributed manufacturing network with its AlphaDirect technology.

      New iPSCs therapy company launches out of stealth

      Shinobi Therapeutics has closed a 51 million series A financing to boost its launch. The company’s approach is to edit iPS-T Cell (iPSCs) to become immune evasive, after which they are differentiated with the help of its Katana platform,

      “Shinobi’s Katana platform has the potential to make CAR-T cell therapies accessible to patients on a global scale,” said Carl June, who has been appointed to Shinobi’s Scientific Advisory Board.

      The funding round was led by EQT Life Sciences, F-Prime Capital and Eight Roads Ventures Japan. Astellas Venture Management, Fast Track Initiative (FTI), JIC Venture Growth Investments, and D3 LLC participated as well.

      Major series A funding raised to advance women’s reproductive immunotherapies

      Danish company Freya Biosciences has gained $38 million in a series A funding, one of the largest to advance women’s reproductive immunotherapies. With the money, it will progress its lead candidate for treating infertility in women with dysbiotic vaginal microbiota who are undergoing assisted reproductive technology (ART). Vaginal dysbiosis has been linked to an increased susceptibility to sexually transmitted infections (STIs), owing to an imbalance in the vaginal microbiome, particularly with regards to lactobacilli.

      The funding round was led by Sofinnova Partners and OMX Ventures, and saw participation from The Export and Investment Fund of Denmark, Angelini Ventures, Mike Jafar Family Office, CE-Ventures, Corundum Systems Biology, and Indaco Venture Partners.

      Hoba Therapeutics’ series A to advance chronic neuropathic pain candidate

      More than 400 million people are affected by neuropathic pain. Danish biotech Hoba Therapeutics has bagged €23 million ($25 million) to advance its non-opioid compound HB-086 to reverse neuropathic pain. Preclinical data showed that the candidate is capable of relieving pain. The series A funding will help push HB-086 towards completing a phase 1 clinical study in patients for painful chemotherapy-induced peripheral neuropathy (CIPN).

      The funding was co-led by Indaco Venture Partners and Medical Incubator Japan. Other investors that took part include Novo Holdings, Eir Ventures, and the Export and Investment Fund of Denmark (EIFO and Horizon Europe.

      The latest biotech news in mergers, acquisitions, and strategic partnerships

      AbbVie to spend nearly $9 billion on Cerevel Therapeutics buyout

      Multinational pharmaceutical AbbVie is set to buy American neuroscience company Cerevel Therapeutics for $8.7 billion, it said in a press release last week. This acquisition will enable the pharma giant to gain access to the latter’s clinical and preclinical candidates that treat a range of neurological conditions like schizophrenia, Parkinson’s disease, and mood disorders, hence widening AbbVie’s existing neuroscience portfolio. This means that AbbVie will own the rights to Cerevel’s emraclidine, a positive allosteric modulator (PAM) of the muscarinic M4 receptor, to treat people with schizophrenia. The candidate has shown encouraging results in previous clinical trials, and is also being evaluated in a phase 1 Alzheimer’s disease program.

      AstraZeneca to purchase vaccine developer Icosavax

      AstraZeneca announced its prospective acquisition of Icosavax, earlier this week. American vaccine maker Icosavax, has created a VLP vaccine which targets respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), which is ready for phase 3 studies. The vaccine candidate IVX-A12 presented robust immune responses against both viruses in a phase 2 study. VLP vaccines tend to stimulate stronger immune responses than non-VLP vaccines because of their ability to mimic how a virus would typically enter the immune system. As part of the agreement, Icosavax is eligible to receive up to $1.1 billion.

      Laboratoires Théa to snap up RNA therapies from eye disease therapeutics company

      French multinational Laboratoires Théa is set to grab Netherlands-based ProQR Therapeutics’ RNA-based assets. This includes sepofarsen and ultevursen, both drugs used to restore vision in people with eye diseases. Sepofarsen is an RNA therapy to treat Leber congenital amaurosis, a rare genetic condition caused by gene defects leading to early-onset vision loss. Ultevursen is an ​​RNA-based oligonucleotide which aims to curb loss of sight in people who have retinitis pigmentosa, a hereditary eye disease that affects the retina.

      ProQR Therapeutics has received an upfront payment of €8 million ($8.79 million) and is eligible to obtain up to  €165 million ($181.28 million) in milestone payments as well as royalties based on commercial sales in the U.S. and European Union. 

      SystImmune and Bristol Myers Squibb to collaborate to develop cancer treatment

      Antibody therapy company SystImmune is collaborating with Bristol Myers Squibb (BMS) to develop and commercialize BL-B01D1, a bispecific antibody-drug conjugate (ADC). The candidate is in phase 1 trials to assess its safety and efficacy in people with metastatic or unresectable non-small cell lung cancer (NSCLC). However, SystImmune will be responsible for development, commercialization, and manufacturing in Mainland China. 

      “Recent BL-B01D1 trials have shown broad potential across different solid tumors as well as a manageable safety profile,” said Dr. Yi Zhu, chief executive officer at SystImmune. “We have long admired Bristol Myers Squibb’s global clinical development and commercialization capabilities in oncology, and this strategic collaboration is an exciting step forward in delivering potential antitumor medicines to patients worldwide. We look forward to a productive partnership.”

      BMS will pay SystImmune $800 million upfront followed by $500 million in contingent near-term payments. The company is also eligible to receive up to $7.1 billion in milestone payments.

      C4 Therapeutics partners with Merck to develop degrader-antibody conjugates 

      Clinical-stage biotech C4 Therapeutics is joining forces with big pharma Merck to discover and develop degrader-antibody conjugates (DACs). These are an emerging class of medicines that selectively target and neutralize disease-causing proteins in cancer cells. C4 Therapeutics will use its TORPEDO platform to develop degrader payloads in the discovery phase while Merck will look into the antibody conjugation process to create DACs. The partnership will see C4 Therapeutics receive $10 million upfront along with up to $600 million in milestone payments as well as tiered royalties on future sales.

      NAYA Biosciences and ONK Therapeutics collaborate to develop combination therapy

      American biotech NAYA Biosciences has teamed up with Irish oncology therapeutics company ONK Therapeutics to develop a combination therapy consisting of NAYA’s FLEX-NK bispecific antibodies and the latter’s engineered natural killer (NK) cells to treat cancer. The two companies will assess the combination therapies’ performances in preclinical studies next year. The FLEX-NK antibodies are based on a  tetravalent, multifunctional format with flexible linkers, which can trigger natural killer cells to kill tumor cells.

      AstraZeneca partners with AbelZeta Pharma to codevelop CAR-T therapy in China

      British multinational company AstraZeneca has decided to co-develop a glypican 3 (gpc3) armored CAR-T therapy in China. C-CAR031 IS an autologous, armored GPC3-targeting chimeric antigen receptor T Cells CAR-T therapy that aims to treat hepatocellular carcinoma (HCC). At present, the growth factor-beta receptor II (TGFβRII) dominant negative armoring discovery platform, which helped design C-CAR031 is manufactured by AbelZeta in China. The terms of the agreement are undisclosed at the moment.

      The latest biotech news in clinical trials

      Genentech’s breast cancer trial reaps positive results

      American company Genentech owned by multinational pharmaceutical Roche, obtained positive results from a phase 3 trial investigating navolisib, in combination with palbociclib and fulvestrant for treating PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The trial, which had 325 patients, met its primary endpoint of progression-free survival (PFS). The therapy was also found to be well-tolerated.

      Merck fails multiple sclerosis clinical trial

      Merck’s phase 3 trial for Evobrutinib, a Bruton’s tyrosine kinase inhibitor, did not meet its primary endpoint with regards to efficacy and safety in patients with relapsing multiple sclerosis. The candidate was unable to reduce annualized relapse rates (ARR) compared to oral teriflunomide, an immunomodulatory drug for multiple sclerosis.

      Connect Biopharma sees promise in asthma trial

      A global phase 2b trial run by global clinical-stage Connect Biopharma in adult patients with moderate-to-severe persistent asthma met its primary endpoint as both doses of rademikibart treatment significantly improved lung function at week 12. Lung function significantly improved with two doses of the drug compared with the placebo. With  322 participants in the trial, it was held in several countries – the U.S., Poland, Hungary, China and South Korea. 

      Pharvaris trial proves efficacy

      A phase 2 study held by Pharvaris to test Deucrictibant in patients with hereditary angioedema (HAE) attacks proved to be successful. The oral bradykinin B2 receptor antagonist met its primary endpoint in the trial as more than a 90% reduction in the occurrence of moderate and severe attacks was observed. Not only that, nearly 93% fewer attacks were treated with on-demand medication. Plus, the drug candidate was well-tolerated, according to the results of the study.

      Multiple myeloma drug candidate brings success

      C4 Therapeutics’ relapsed/refractory multiple myeloma candidate CFT7455 brought encouraging news for the company. The candidate, which was evaluated in a phase 1 trial, showed signs of anti-myeloma activity and was regarded to be well-tolerated. As a monotherapy, the candidate exhibited immunomodulatory effects, whereas in combination with the steroid Dexamethasone, it demonstrated IMWG – a response criteria for myeloma – responses at the first two dose levels. Phase 1 dose escalation is expected to be completed next year.

      The latest biotech news in science

      New target for neuromuscular disease opens doors for novel treatments

      Spinal muscular atrophy (SMA) is a genetic disorder that affects around 1 in 10,000 people. Researchers at Ann & Robert H. Lurie Children’s Hospital Of Chicago in the U.S. have discovered a mechanism that leads to motor neuron degeneration in SMA. The team found that an enzyme called cyclin-dependent kinase 5 (Cdk5) can impair the proper functioning of the mitochondria, contributing to motor neuron degeneration. In preclinical studies, it was found that a Cdk5 inhibitor could halt neurodegeneration.

      “In our previous research, we established that all patients with SMA have the mitochondrial defect. This means that inhibiting Cdk5 could treat all patients, including children whose SMA subtype makes them ineligible for gene therapy. This new approach also could potentially be used in combination with gene therapy,” said senior author Dr. Ma, Associate Professor of Pediatrics, Neurology, and Neuroscience at Northwestern University Feinberg School of Medicine. “The currently available Cdk5 inhibitor is too toxic, so we want to develop a better inhibitor that is safer and more effective”

      New gene therapy could treat heart disease

      Researchers at the Hubrecht Institute in the Netherlands are developing a gene therapy that they believe could treat the genetic heart disease arrhythmogenic cardiomyopathy (ACM). ACM is typically treated by administering  antiarrhythmic drugs and implantable cardioverter-defibrillators (ICDs), which address the symptoms but not the root cause of the disease, which is actually a mutant gene. This new approach aims to replace the PKP2 gene, which showed promise in laboratory models. Clinical trials are poised to begin next year.

      New cancer treatment to target RAS mutations

      Currently, there are no effective ways to treat patients who have relapsed with multiple myeloma. A new cancer treatment could change this. Researchers at NYU Grossman School of Medicine and Tezcat Biosciences in the U.S., have found that a monobody protein linked to the drug MMAE can halt cancer cell growth. The scientists created a monobody engulfed by cancer cells that contain RAS mutations. This stopped the cells from multiplying. Although preclinical studies have been conducted, the treatment is yet to enter the clinic.

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